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Institutional review board capabilities to oversee new technology: social media as a case study

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INSTITUTIONAL REVIEW BOARD CAPABILITIES TO OVERSEE NEW TECHNOLOGY:
SOCIAL MEDIA AS A CASE STUDY
by

Susan N. Pusek

Qualifying Materials Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE

May 2020

Copyright 2020 Susan N. Pusek

ii
Dedication……....
I dedicate this thesis to my parents for modeling a tireless work ethic and to the research subjects I have
had the honor of working with.

iii
Acknowledgements
I would like to express my deepest appreciation to Dr. Eunjoo Pacifici for her enthusiasm,
encouragement, patience, and insights throughout the multiple years of this project. Her guidance was
invaluable at the earliest stages of clarifying my question, to choosing the right way to phrase a survey
question from the myriad of seemingly similar options, to the final push to interpret and present the data.
I also want to thank Dr. Pacifici and her husband Robert for their gracious hospitality every time I came
to Los Angeles. I am looking forward to hearing more stories about Rosie!
None of this would be possible without the vision and leadership of Dr. Frances Richmond. I
have a special appreciation of what it takes to shepherd an idea through to an actual program in academia.
I am so grateful to Dr. Richmond for navigating the hurdles and creating this opportunity. She has made
a lasting imprint on regulatory science and I thank her for recognizing that individuals from a variety of
backgrounds can contribute to the field.
I would also like to thank the other members of my thesis committee, Drs. Pire-Smerkanich,
Church and Berenger, for their contributions to shaping the final product. And to my classmates, thank
you for the memories from our trips, your diligent work in our group projects, and your stories along the
way.
Many thanks also go to the faculty and staff of the USC Department of Regulatory & Quality
Sciences. I recognize that working with non-traditional students can be frustrating, unpredictable and I
am sure at times, funny. Thank you for being expert at your jobs and so welcoming each time I was on
campus. A special nod to Randa- it was so touching to see how happy and proud you were at graduation-
the students are truly lucky to have you!
Finally, thank you to my dear friends who knew when to listen, to challenge, and to distract me
throughout this process. I promise to support you in whatever new adventures you decide to take on!

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TABLE OF CONTENTS
Dedication…….... ........................................................................................................................... ii
Acknowledgements ........................................................................................................................ iii
List of Tables….. .......................................................................................................................... vii
List of Figures .. ............................................................................................................................ ix
Abstract ……….. .............................................................................................................................x
CHAPTER 1. OVERVIEW .........................................................................................................1
1.1 Introduction ................................................................................................................. 1
1.2 Statement of the Problem ............................................................................................ 4
1.3 Purpose of the Study ................................................................................................... 5
1.4 Importance of the Study .............................................................................................. 5
1.5 Limitation, Delimitations, Assumptions ..................................................................... 6
1.5.1 Delimitations ................................................................................................. 6
1.5.2 Limitations ..................................................................................................... 7
1.6 Organization of Thesis ................................................................................................ 8
CHAPTER 2. LITERATURE REVIEW .....................................................................................9
2.1 Overview of Institutional Review Boards in the United States .................................. 9
2.1.1 Regulatory Framework for IRBs ................................................................. 10
2.1.2 How IRBs Review Clinical Trial Protocols ................................................. 11
2.1.2.1 The IRB Deliberation Process ........................................................ 14
2.2 Overview of Social Media ........................................................................................ 16
2.2.1 Digital Engagement ..................................................................................... 18
2.2.2 Social Media in Healthcare .......................................................................... 20
2.2.3 Social Media Activity Among Other Stakeholders ..................................... 20
2.2.3.1 Use of Social Media by the FDA .................................................... 20
2.2.3.2 Use of Social Media by the Pharmaceutical Industry
Clinical Trial Sponsors ................................................................... 22
2.2.3.3 Use of Social Media by Healthcare Organizations and
Providers ......................................................................................... 24
2.3 Social Media in Clinical Trials ................................................................................. 25
2.3.1 Social Media Use by Clinical Trial Sponsors .............................................. 26
2.3.2 Social Media Use for Subject Recruitment, Tracking, and
Follow-Up ................................................................................................... 27

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2.3.3 Disseminating Research Results .................................................................. 29
2.3.4 Social Media Facilitates “Virtual Clinical Trials” ....................................... 30
2.4 IRB Evaluation of Social Media in Clinical Trials ................................................... 31
2.4.1 Applying Existing Guidances to Social Media ............................................ 32
2.4.2 Consensus Recommendations ..................................................................... 33
2.4.3 Other IRB and Academic Resources ........................................................... 33
2.4.4 Concerns Regarding Social Media in Research ........................................... 34
2.4.4.1 Privacy ............................................................................................ 34
2.4.4.2 Third Party Vendors ....................................................................... 35
2.4.4.3 Concerns Regarding Data Integrity ................................................ 36
2.4.5 IRB’s Access to Technical Expertise on Social Media ............................... 37
2.5 Research Framework ................................................................................................. 37
2.5.1 Technology Readiness Index ....................................................................... 39
2.5.2 Unified Theory of Acceptance and Use of Technology .............................. 40
2.5.3 Applying the Combined Research Framework ............................................ 42
CHAPTER 3. METHODOLOGY .............................................................................................44
3.1 Introduction ............................................................................................................... 44
3.2 Development of the Survey ....................................................................................... 44
3.3 Focus Group Testing and Development of Final Survey .......................................... 45
3.4 Survey Distribution ................................................................................................... 47
3.5 Data Analysis ............................................................................................................ 47
CHAPTER 4. RESULTS ...........................................................................................................48
4.1 Respondent and IRB Characteristics ......................................................................... 48
4.2 IRB Capacity for the Review of Social Media .......................................................... 55
4.2.1 Social Media Expertise on IRB Committee ................................................. 55
4.2.2 Training on Social Media ............................................................................ 58
4.2.3 Policies on Social Media ............................................................................. 61
4.2.4 Level of Preparedness to Review Social Media .......................................... 64
4.3 Experience with the review of social media ............................................................. 67
4.3.1 Use of Social Media in Deliberated Protocols ............................................. 69
4.3.2 Resources for Protocol Review ................................................................... 70
4.3.3 Challenges Related to Review of Social Media........................................... 72
4.3.4 Comparison of Social Media to Other Technologies ................................... 73
4.4 Social Media Use in Clinical Trials .......................................................................... 76
4.4.1 Social Media and Clinical Trial Integrity .................................................... 78

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4.5 Respondents’ Personal Use and Experience with Social Media ............................... 80
4.6 Analysis of Technology Readiness Index Domains .................................................. 83
4.7 Understanding Issues Facing IRB Members in Review of Social Media ................. 86
CHAPTER 5. DISCUSSION .....................................................................................................91
5.1 Overview ................................................................................................................... 91
5.2 Methodological Considerations ................................................................................ 92
5.2.1 Delimitations ............................................................................................... 92
5.2.2 Limitations ................................................................................................... 93
5.3 Consideration of Results ........................................................................................... 94
5.3.1 Facilitating Conditions that Influence IRB Review of Social
Media ........................................................................................................... 94
5.3.2 Performance Expectancy ............................................................................. 98
5.3.3 Effort Expectancy ...................................................................................... 100
5.3.4 Social Influence ......................................................................................... 103
5.4 Conclusions and Future Directions ......................................................................... 106
References………. .......................................................................................................................108
Appendix A.……….. ...................................................................................................................130
Appendix B. ……….. ..................................................................................................................134
Appendix C. ……….. ..................................................................................................................148

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List of Tables.
Table 2.1: Definitions and Examples of Social Media Platforms ................................................17
Table 2.2: FDA Postmarket Guidances for Social Media ............................................................23
Table 3.1: Focus Group Participants ............................................................................................45
Table 4.1: Other IRB Affiliations ................................................................................................52
Table 4.2 Type of Research ........................................................................................................53
Table 4.3: Other Types of Research Reviewed ...........................................................................53
Table 4.4: Other Expertise on IRB Committee ............................................................................57
Table 4.5: Type of Social Media Expertise on IRB Committee by Affiliation ...........................57
Table 4.6 Training by Affiliation ................................................................................................59
Table 4.7 Type of Social Media Training ...................................................................................59
Table 4.8: Topics for Further Training ........................................................................................60
Table 4.9 Policies by IRB Affiliation .........................................................................................62
Table 4.10: Topics that Should be Addressed in IRB policies ......................................................64
Table 4.11 Level of Preparedness Based on Training Status .......................................................66
Table 4.12: Level of Preparedness and Years of IRB Service .......................................................66
Table 4.13 Level of Preparedness by Number of Primary Reviews per Year ..............................67
Table 4.14 Deliberation by Affiliation .........................................................................................68
Table 4.15: Other Uses of Social Media in Deliberated Protocols ................................................70
Table 4.16: Supplementary Resources for Protocol Review .........................................................71
Table 4.17: Resources Helpful for IRB Review of Social Media ..................................................72
Table 4.18: Most Challenging/Concerning Issues in Review of Social Media .............................73
Table 4.19 Difficulty of Social Media Review Compared to Other Technologies by
Years of IRB Experience .......................................................................................75
Table 4.20 Difficulty of Social Media Review Compared to Other Technologies by
Number of Protocols as Primary Reviewer Per Year ............................................76
Table 4.21 Usefulness of Social Media in Research ....................................................................77
Table 4.22 Awareness of Social Media Influence on Clinical Trials ...........................................78
Table 4.23 Clinical Trial Integrity Concerns by Early Technology Adopter Status ....................82
Table 4.24: Other Personal Uses of Social Media by Respondents ...............................................83
Table 4.25 Attitudes on Social Media ..........................................................................................84
Table 4.26 Level of Review Difficulty by TRI Domain of Optimism .........................................85

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Table 4.27 Concern About Trial Integrity by TRI Domain of Insecurity.....................................85
Table 4.28 Themes of Narrative Comments .................................................................................86

ix
List of Figures
Figure 2.1: Abbreviated OHRP Chart 1: Is an Activity Research Involving Human
Subjects? ................................................................................................................11
Figure 2.2: Criteria for IRB Approval of Research .......................................................................14
Figure 2.3: Percentage of American Adults Who Use Social Networking Sites, By Age ............18
Figure 2.4: Stages of Digital Engagement ....................................................................................19
Figure 2.5 Example of IRB Approved Process for Study Tracking and Follow-Up
Using Social Media ................................................................................................29
Figure 2.6: Unified Theory of Acceptance and Use of Technology .............................................41
Figure 2.7: Research Framework ..................................................................................................43
Figure 4.1 Study Distribution .......................................................................................................49
Figure 4.2: Years of IRB Experience ............................................................................................50
Figure 4.3: IRB Affiliation ............................................................................................................51
Figure 4.4 Number of Reviews ....................................................................................................54
Figure 4.5: Number of Full Board Reviews in Past Year .............................................................55
Figure 4.6: Social Media Expertise on IRB Committee ................................................................56
Figure 4.7 Training on Social Media ...........................................................................................58
Figure 4.8 Policies on Social Media ............................................................................................61
Figure 4.9 Information in IRB Policies ........................................................................................63
Figure 4.10 Level of Preparedness to Review Social Media .........................................................65
Figure 4.11 Number of Respondents Who Have Deliberated on Social Media ............................68
Figure 4.12 Uses of Social Media in Deliberated Protocols ..........................................................69
Figure 4.13: Difficulty of IRB Review of Social Media Compared to Other
Technologies ..........................................................................................................74
Figure 4.14: Degree of Concern about Social Media Affecting Clinical Trial Integrity ...........79
Figure 4.15: IRB Actions Regarding Social Media ....................................................................80
Figure 4.16: Early Technology Adopter Status of Respondents ................................................81
Figure 4.17: Personal Use of Social Media by Respondents......................................................83

x
Abstract ………..
Institutional Review Boards (IRBs) conduct an independent evaluation of clinical research and
have the authority to decide whether clinical trials should be allowed to proceed, be modified, or be
halted. To make their decisions, IRB reviewers use a regulatory and ethical framework that has remained
largely unchanged for many decades. But the rapid pace of scientific discoveries and emergence of
technological innovations in recent years have raised concerns that these existing paradigms may not be
adequate. Social media is an example of a technology that has received much attention for its potential
use in clinical trials. While touted to offer solutions to persistent clinical trial problems such as poor
subject recruitment and retention, social media also introduces unprecedented risks to individual privacy,
data security, and, potentially, overall clinical trial integrity. The goal of this project was to survey IRB
Chairs in the United States to understand the extent of social media training and expertise available for
IRBs, established social media policies, and the perspectives and experiences of IRB reviewers regarding
social media in clinical trials. According to the study findings, most respondents recognized the potential
usefulness of social media in clinical trials. However, IRBs in general did not have adequate access to
social media training or experts. Additionally, most respondents had limited exposure to social media
within clinical trials and reported that their institutions did not have established policies on social media.
Yet respondents still felt prepared to review social media in clinical trials and did not believe new
regulations specific to social media were necessary. Instead, respondents preferred greater access to
training and expertise that would enable them to apply existing frameworks to specific situations. The
findings of this study revealed that the majority of respondents were not concerned or unsure about the
effect of social media on clinical trial integrity and do not view social media to be more difficult to review
than other new technologies.

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CHAPTER 1. OVERVIEW
1.1 Introduction
Regulatory oversight for research involving human subjects arose in the 20
th
century in response
to a series of tragic events and unethical practices. To prevent the recurrence of practices like those
described in the Nazi war crime trials and the Tuskegee Syphilis Study, the United States created a system
of oversight using Institutional Review Boards (IRBs) (Breault, 2006). The IRBs provide an independent
evaluation of clinical research and have the authority to decide whether scientific and technologic
innovations progress into clinical trials. IRBs also have the authority to suspend or terminate ongoing
research if new information during study conduct changes the ratio of risks to benefits for the subjects.
To make these decisions, IRB members interpret broad federal regulations and local policies and apply
them to the specific context of individual research protocols. In the last few decades, the rapid pace of
scientific discovery and the emergence of tools such as social media have challenged existing review
paradigms and ethical norms. With no defined regulatory mechanism to adapt to the changing landscape,
it is not clear whether IRB members believe that they have sufficient regulatory guidance to evaluate
clinical research that incorporates new technologies.
The IRB system in the United States has been the target of criticism from the research community
for being outdated and unable to keep up with scientific advances and innovations. This is in part
attributed to the fact that the regulations that IRBs use to make decisions have undergone few major
changes since their initial passage. Further, anecdotes and actual data identify discordance between IRB
decisions and federal regulations, administrative processes contributing to perceived inefficiencies, and
claims that IRB members may have become distanced from the views of the subjects they are supposed to
protect. Perhaps the most challenging critique is that even with all the review and oversight measures in
place, the system sometimes fails to protect human subjects. Adding to these concerns is that in addition
to tasks required by federal regulations, some IRBs are responsible for other local activities including

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investigator training and monitoring conflicts of interest (Grady, 2015b). With 3,499 registered IRBs in
the United States undertaking 675,390 reviews each year, the IRB enterprise has been called a “dense
network” that many say is overwhelmed (DHHS, 2017, Clapp et al., 2017). Against this background, the
rapid emergence of digital technologies has illuminated new gaps in federal regulations, surfaced unique
ethical dilemmas, and challenged existing review practices. These new technologies include mobile apps,
electronic health records, and wearable diagnostics that have numerous potential applications to
biomedical research. Concurrent with the emergence of these technologies is the growth of social media.
Social media has already substantially changed communication and information gathering over the
internet by allowing users to create and share content. When proposed for use in clinical trials, social
media presents opportunities to invigorate the design and conduct of clinical trials, but also raises unique
ethical and practical challenges for the current IRB process.
One reason for the interest in social media is that it has the potential to infuse the patient voice
throughout the clinical trial process. Sponsors, researchers and regulators are making efforts to engage
with patients and the public to increase the real-world relevance of clinical trials, to improve trial
efficiency, and to increase transparency about the research process. In addition, patients have already
used social media to influence product development. Yet it is unclear if IRBs find the existing regulatory
framework adequate to inform decisions about the use of social media within clinical trials. Examining
the opinions of IRB members on social media use may provide useful insights into IRB views on the
changing role of patients and the public in research. It may also reveal information about IRB capabilities
to review and oversee other new technologies.
A number of applications of social media to clinical trials evolved from the popularity of using
social media for health maintenance and treatment of disease. In fact, the use of social media is so
widespread in this area that an entirely new vocabulary describes the “digital engagement” of “e-patients”
using “mHealth” tools. The true paradigm shift brought by social media is the ability for users to
generate their own content, to spread this content themselves, and to interact with other users. Social

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media is an effective tool to educate the public, provide social support, and promote positive (and
negative) changes in health behaviors. However, it remains an unregulated technology with little to no
oversight of the quality of shared content. Hence, it is possible to spread false or incorrect information
that may influence poor decisions by other users. Nevertheless, patients have readily adopted social
media to increase their knowledge and engagement in health care, including using social media to
facilitate partnerships with other clinical research stakeholders that include the FDA, sponsors, and
researchers.
A highly cited example that demonstrates how patients use social media to influence clinical trials
is a study developed and conducted entirely by patients through a social network site. Following a
published report suggesting positive outcomes from the use of lithium for amyotrophic lateral sclerosis
(ALS) symptoms, the ALS community communicated through the site PatientsLikeMe (PLM) to design
and conduct a patient-led study evaluating the effects of lithium. Without review or oversight by an IRB,
patients used information from the published article to self-administer lithium and then directly report
their safety and efficacy outcomes on the PLM website. Regrettably, this patient-led study did not
support the findings from the published article and, in fact, indicated that lithium may worsen ALS
symptoms. However, this study did motivate the research community to conduct a randomized
controlled phase IIb study that later confirmed the results. The patient-led ALS study, in the eyes of
many, pointed to the legitimacy of using social media as a clinical trial platform to collect real-world data
and answer pressing questions quickly but without regulatory, ethical, or professional oversight.
Despite the potential promise of social media to disrupt the clinical trial landscape, several unique
aspects of social media present challenges to more widespread use in clinical trials. There are no federal
regulations specific to social media and a limited number of guidance documents issued by the U.S. Food
and Drug Administration (FDA). To date, these guidances mainly reference the postmarket setting. The
lack of direction from the FDA leaves IRBs to interpret and apply the same set of federal regulations to a
wide variety of research designs, populations, settings, and technologies. This may discourage

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researchers and sponsors from proposing innovative uses of social media due to fear of delays in the IRB
review process and the potential that the IRB may ultimately not approve the proposal. Another
challenge is that even though social media is already widely available and used by the public, there is
little data available to IRBs to evaluate risks and benefits. Hence, it is likely that IRB members rely on
anecdotal information, experiences they hear about outside of clinical trials, or their own personal
experiences when considering benefits and risks associated with social media. Furthermore, it is unclear
what resources such as technical expertise and training are available to IRBs to inform their deliberations.
Without more insight into the opinions of IRB members on social media, sponsors and research teams are
likely to be reluctant to integrate this technology into future clinical trials and the research community
will miss the opportunity to evaluate social media’s actual benefits and risks.
1.2 Statement of the Problem
Changes in science, technology, and public engagement are transforming clinical research but the
development of a regulatory framework for IRBs to address this new landscape is lagging. IRBs rely on
regulations instituted many decades ago and the research community continues to identify instances
where the regulations may not provide sufficient guidance. In these cases, IRB reviewers must interpret
the regulations for each specific study while researchers and sponsors have little guidance on what
information to include in IRB submissions. Against this background, the emergence of social media has
further illuminated deficiencies in the current regulatory system. Social media is distinct from other
technologies in several ways. First, social media permits individuals to create and share information with
little to no regulation of the quality of the content or control over who views the information. Second,
social media is rapidly evolving under the control of social media site operators who define procedures
for collection and protection of data and thus, social media applications used in research may not be
controlled by the researchers. This may limit the information available to researchers and IRB reviewers
and require different models of oversight during a study. Third, because social media is readily available
to the public unlike other new technologies evaluated in clinical trials, IRBs must also consider that

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potential research subjects have likely developed opinions on the risks and benefits of using social media.
In addition, these opinions might be very different from those of IRB reviewers depending on the
characteristics of the potential subject population. This raises questions about how IRBs discover these
opinions and weigh them during IRB review. Finally, the use of social media by subjects or the public
may have positive and negative effects on clinical trial integrity. We do not know if IRB members
believe that the current regulatory framework adequately addresses these issues nor if IRBs have access to
other resources to help with their reviews. It is also not clear if IRB members are aware of how social
media is already influencing clinical trials and whether they believe there may be potential benefits to
using social media. Without this knowledge, researchers and sponsors will be reluctant to propose social
media in future clinical trials and the research community will not have the opportunity to learn if social
media can address clinical trial inefficiencies and if social media can more fully engage patients and the
public in the clinical trial process.
1.3 Purpose of the Study
The purpose of this study is to understand the current views of IRB Chairs on the use of social
media in clinical research, the adequacy of the existing regulatory framework in providing direction for
IRB reviewers when evaluating this technology, and the capacity of the IRB committee to review social
media. IRB Chairs were surveyed about their knowledge and direct experience with social media and
about aspects of the review process. Questions were based on validated frameworks of technology
adoption and technology use that were adapted to the clinical trial setting.
1.4 Importance of the Study
Social media is one example of a new technology that presents a number of potential
opportunities to improve the efficiency of the clinical research process and to engage patients and the
public. However, social media also raises unprecedented challenges to existing ethical norms and the
regulations that currently guide IRB review. Social media is unlike other scientific discoveries in that it is

6
widely available outside of clinical trials. The public and patients have already demonstrated their
interest in using social media to influence clinical trials in both positive and negative ways. Social media
vendors, contract research organizations and patients themselves are charging ahead with social media
applications promised to expand access to research, expedite data collection, and improve communication
between patients, researchers, sponsors, and regulators. Without the integration of social media into
formal research proposals with ongoing oversight, the effects of social media will remain anecdotal and
objective data will not be collected to help determine the actual risks and benefits of social media in
clinical trials. The findings from this study will provide insight into the primary concerns of IRB
reviewers about social media that researchers and sponsors can use to inform future protocol submissions
and begin to build an evidence base on social media for the research community. The findings of this
study could also be useful to the IRB community to further elucidate how different IRBs approach the
review of social media, resources that are helpful, and their actual experience with social media in
approved studies. Finally, study results may also help to inform future regulations and policies as they
relate to IRB capabilities to oversee new technology.
1.5 Limitation, Delimitations, Assumptions
1.5.1 Delimitations
This study focuses on IRB Chairs in the United States and the survey asked respondents to
consider only studies conducted in the United States. While the clinical trial industry is global, the
structure of IRBs differs, and surveying ethics committee members from other countries would require
additional approvals affecting the feasibility of this work. In addition, the regulatory climate regarding
digital technologies in other countries, particularly Europe, is different from the United States. For
example, the recent General Data Protection Regulation (GDPR) implemented in Europe in spring 2018 is
one example of legislation that may generate additional questions but also potential solutions for data

7
handling, privacy, and confidentiality. However, these may not be relevant to all studies in the United
States.
A second delimitation is that the survey population is IRB Chairs. Because an IRB committee
must have diversity in its membership, IRB Chairs represent only some of the views of an IRB
committee. The rationale for directing the survey to IRB Chairs is that Chairs are aware of all protocols
reviewed by a committee versus only those for which they are reviewers. In addition, they may be more
aware of resources, policies, and expertise available within the local environment and broader IRB
community.
A third delimitation is that the survey focuses on FDA-regulated clinical trials. Clinical trials also
include social and behavioral interventions and methods; however, the scope of this research is broad and
introduces too much variation in the responses.
1.5.2 Limitations
A limitation of this research is that some survey respondents may have little experience reviewing
or deliberating on social media. Differences may also exist across IRBs regarding the frequency and the
types of social media that are included in study protocols. To address this limitation, this research
combines two frameworks. One framework was validated for use in individuals who do not have direct
experience with a technology and elicits the individual’s receptiveness to technology versus their actual
experience. The second framework is appropriate to use in individuals who have direct experience with a
technology.
A second limitation is that respondents may have different levels of familiarity with social media
and have formulated opinions based on social media activity outside of the clinical research setting. As a
result, their responses may not be representative of concerns or events relevant to clinical trials.

8
A third limitation is that survey respondents may not represent the full range of IRBs in terms of
size and affiliation and that because the survey is anonymous, there is no information on the
characteristics of the nonrespondents or why they chose not to respond.
Finally, the survey results are limited in that they are interpreted within the context of current
regulations and guidances. Given the rapid evolution of social media to date and the interest among
stakeholders in using social media for clinical trials, it is possible that new policies or even best practices
will emerge that would influence responses to questions in the survey.
1.6 Organization of Thesis
This research is organized into 5 chapters. Chapter 1 provides an overview of the topic, the
significance of the research, delimitations, and limitations. Chapter 2 is a review of the current literature
on the use of social media in the health care setting and clinical trials, the existing regulatory framework
guiding review of social media by IRBs, and the experience with social media in clinical trials to date.
Chapter 3 delineates the methods used in this study, including the theoretical framework that will guide
the development of the survey instrument. Chapter 4 presents the survey results and Chapter 5 is a
discussion of the results within the current context of clinical trials.

9
CHAPTER 2. LITERATURE REVIEW
2.1 Overview of Institutional Review Boards in the United States
In order to understand how IRBs might approach the review of social media, it is helpful to
consider the reasons IRBs were established and the practices they currently use to meet their regulatory
mandate to protect human subjects. The first guiding principles for research with human subjects
emerged in 1948 after the Nuremberg trials revealed egregious ethical violations in human research
studies. The subsequent Nuremberg Code established three ethical principles that must be present for
research to proceed: favorable risk/benefit ratio, voluntary informed consent, and the right to withdraw
from research without penalty. Unfortunately, the following decades witnessed further instances where
the scientific community came under scrutiny for questionable ethical practices in human subjects
research. For example, the US government conducted experiments on the effects of radiation on
vulnerable individuals (e.g. cancer patients, military personnel) without letting participants know they
were being studied (Resnick, 2019). The Declaration of Helsinki, passed in 1964, expanded upon the
Nuremberg Code by introducing the idea that a committee independent of the investigator and the sponsor
should give “comment, guidance and approval” on the research protocol (WMA, 1964). Despite this
recommendation, the United States did not take any action to formalize such a committee.
The Tuskegee Syphilis Study was the inciting event that catalyzed the creation of the system of
research oversight in the United States today. Conducted between 1932 and 1972, the goal of the study
was to describe the natural history of syphilis infection. As designed, the researchers knew that the study
risks outweighed the benefits for the study population of low-income African American males. The
researchers deceived the participants by not providing complete information to the subjects during the
process of informed consent (Breault, 2006). Further, even though penicillin, the cure for syphilis, was
discovered during the study, the researchers did not to stop the study and chose to withhold penicillin
from the participants. When details of the study became available in 1972, the public outcry about the

10
unethical practices drove Congress to pass the National Research Act in 1974. This Act established IRBs
as the main oversight body for human subjects research. This Act also created the commission that wrote
the Belmont Report, a document outlining ethical principles intended to be a “preliminary, protective
ethical framework” to guide IRBs in their deliberations on specific research projects (Friesen et al., 2017).
Despite its intended preliminary nature, after over 40 years the Belmont Report remains the primary
document guiding the assessment of risks and benefits in human subjects’ research today.
2.1.1 Regulatory Framework for IRBs
IRBs operate within a regulatory framework comprised of federal, state, and local regulations.
Federal regulations governing biomedical research are contained in the Code of Federal Regulations, 45
CFR 46 parts A-D. To signify that 15 federal agencies adhere to these same regulations for research, the
regulation is known as the Common Rule. On July 19, 2018 changes to the Common Rule went into
effect after seven years of input and administrative delays. These changes focus on the consent process
and review procedures for minimal risk studies. They do not specifically address the review of new
technologies like social media. For research that involves FDA-regulated products, further direction is
contained in 21 CFR 50 for the informed consent process and 21 CFR 56 for IRB operations. IRBs must
also consider federal Health Insurance Portability and Accountability Act (HIPAA) regulations that
primarily influence the subject recruitment plan, the informed consent process, and data collection
procedures. In addition to federal regulations, IRB members must consider local regulations and
practices. Many states have laws applicable to clinical research, such as the California Health and Safety
Code that specifies processes for obtaining consent and other details of study implementation (State of
California, 2005). Academic institutions or healthcare facilities also have policies governing research
(e.g. access to electronic health records or required training for study teams). Local policies may require
IRBs to perform other tasks such as monitoring conflict of interest or training researchers. This has led to
commentary that IRBs are showing “mission creep” (Clapp et al., 2017) and a federal evaluation of the

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IRB system in 1996 concluded that IRBs were “overburdened” (Inspector General, 1998), limiting IRB
ability to provide adequate review.
2.1.2 How IRBs Review Clinical Trial Protocols
The IRB determines the review pathway for a protocol based on characteristics of the research
and the IRB’s judgment of the level of risk. To assist the research community in interpreting federal
regulations, the federal Office of Human Research Protections (OHRP) offers eight decision charts that
map characteristics of the research to specific federal regulations and types of review. An example of the
first of these charts is in Figure 2.1. This chart illustrates the steps to determine if a proposed activity fits
the definition of research involving human subjects and requires further IRB review.
Figure 2.1: Abbreviated OHRP Chart 1: Is an Activity Research Involving Human Subjects?

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If a project fits the definition of research involving human subjects, the next step is to determine
if the project qualifies for exemption from further IRB review. The regulation 45 CFR 46.101(b) defines
a project as being exempt from further IRB review if it involves: research in an educational setting;
educational tests/surveys/interviews or observations of public behavior; collection of information that is
not identifiable or if disclosed would not place the subject at risk; collects only existing
data/documents/records/pathological or diagnostic specimens; studies public benefit or service programs;
or is a taste and food quality evaluation, or a consumer acceptance study. The Revised Common Rule
now defines eight categories described in 45 CFR 46.104(d) with the additional two categories reflecting
procedures for obtaining broad consent from subjects for future use of research data and/or specimens.
Studies not meeting the exemption criteria undergo an assessment of the level of risk. In this case, IRB
members judge whether the research involves greater than minimal risk based on the vulnerability of the
population, the sensitivity of the research question, and potential for physical risks. Projects judged to
have no more than minimal risk may undergo expedited review while all other research must undergo full
board review.
The process of full board review can be quite different across IRBs. An institution can have one
review committee that sees all types of research or may divide the IRB into subcommittees with unique
expertise that review only specific types of research. Institutions can defer review to IRBs of other
institutions or to commercial or independent IRBs that do not have an affiliation with a specific
institution. The number and expertise of IRB members within a committee can also vary. Federal
regulations stipulate that IRBs must have at least 5 members with “varying backgrounds to include an
expert in scientific concerns, a nonscientific member, a member who represents the views of the potential
subjects, and a member who is not affiliated with the institution or a family member of another IRB
member ” (CFR, 1974). Beyond these requirements, IRBs have the flexibility to include additional
voting members who represent specific populations (e.g. prisoners), to direct proposals to outside review
committees (e.g. radiation safety), and/or to obtain protocol reviews from nonvoting ad hoc members who

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have specialized knowledge. During full board review, the primary reviewers of a study present their
reviews and recommendations to the overall committee, followed by discussion and voting by committee
members to reach a final decision. If the decision is that the project requires modification or IRB
members need more information, the IRB describes their questions in the form of stipulations issued to
the study team. At this point, there may be multiple exchanges of information between the study team
and the IRB before a decision is made that the project is approvable, requires further modification, or in
some cases, there were such substantial issues that the project cannot move forward.
Variations to the above process occur based on the type of research or the study sponsor. For
example, for multi-center industry-sponsored projects, each site independently reviews the protocol.
Since this type of review can lead to inconsistencies in recruitment practices, consent documents and
study procedures across sites, sponsors may elect to have independent IRBs serve as a single IRB for the
entire study, or individual IRBs may choose to defer review to another IRB. In both cases, the local IRB
must agree to abide by the other IRB’s decisions. This practice has been adopted by The National
Institutes of Health (NIH) that now mandates that domestic multi-site clinical trials funded by the NIH
arrange for single IRB review (NIH, 2019). Another type of variation in the IRB review process occurs
at the site level when local policies dictate whether additional committees must review protocols. A
Scientific Review Committees (SRC) is one example where the separate committee attempts to enhance
scientific rigor by focusing on study design and statistical aspects of protocols. SRC review typically
takes place before IRB review so that the IRB can consider the opinions of the SRC in their deliberations.
Finally, for Investigational New Drug applications or Investigational Device Exemption studies, FDA
review is required in addition to IRB review. It is the responsibility of investigators and sponsors to keep
abreast of evolving federal requirements and local policies.

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2.1.2.1 The IRB Deliberation Process
While federal regulations in 45 CFR 46.111 contain the criteria by which IRBs evaluate research
(Figure 2.2), there is little documentation about how IRBs actually weigh these criteria and make
decisions for specific protocols.
Figure 2.2: Criteria for IRB Approval of Research

IRBs supplement the criteria in Figure 2.2 with the three ethical principles described in the Belmont
Report. The first principle, respect for persons, requires that the study team recognize an individual’s
autonomy to make decisions. The second principle, beneficence, states that researchers and IRBs should
seek to maximize benefits of research and minimize risks. The third principle, justice, requires that
research risks are distributed among the populations that may benefit from the research. IRB members
apply these general ethical principles as a framework for weighing the specific benefits and risks of a
study and deciding whether the balance of benefits and risks warrants study approval.
The IRB deliberation process faces ongoing criticism that it lacks transparency, consistency and
adequate representation of the views of subjects. Several authors find difficulty with the fact that
researchers receive only the final IRB decision but no accounting of IRB deliberations or the specific
criteria used to make decisions (Coleman, 2004; Meslin et al., 1994; Emanuel and Menikoff, 2011).
Others note that IRBs differentially interpret and apply regulations (Anderson and DuBois, 2012b), do not
even discuss some elements of the Common Rule (Lidz and Garverich, 2013), and sometimes make

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decisions incongruent with regulations (Abbott and Grady, 2011). These criticisms led one author to
conclude that IRBs are “chronically arbitrary and capricious” (Schneider, 2015). The lack of information
on deliberations increases the frustration of research teams and delays approval timelines because
research teams and sponsors are not able to learn what information may improve their subsequent
submissions. In addition, research on the experiences of nonscientific and nonaffiliated members of
IRBs shows that they often do not receive sufficient training on their expected role and do not understand
how they can adequately represent the opinions of all potential patient populations (Sengupta and Lo,
2003; Klitzman, 2012). Work has been ongoing for several decades to identify ways to improve these
concerns.
Ethicists, researchers, and even law scholars have proposed new frameworks to make IRB
deliberations more systematic, data-driven, and transparent. Much of this literature focuses on how IRBs
determine the level of risk. In 2010 Rid, Emanuel, and Wendler published a 4-step framework called the
“Systematic Evaluation of Research Risks” (Rid and Wendler, 2011) and in 2012, Anderson and DuBois
followed with a proposal for “evidence-based research ethics review” (Anderson and DuBois, 2012a).
These frameworks require that IRBs find and consider data on the actual experience with research
interventions and procedures as a basis for their decisions. Yet for some interventions (e.g. those using
new technologies), these data may not be available. A second problem is that these alternative
approaches do not address the additional problem that IRBs often misinterpret how subjects perceive risk
(Decker et al., 2011; Bell and Salmon, 2011). IRBs are criticized for being paternalistic when they
prioritize their own opinions of benefits and risks over those of potential study participants (Williams,
1984). A related critique is that the IRB system overall has “not kept pace” with changes in the views of
human subjects (Grady, 2015a). Further fueling the concern that the IRB process is out of date is the
arrival of technological advances that have been readily adopted by the public but were “unimaginable at
the time that foundational ethical frameworks for research were formalized” (Kahn et al., 2014). The

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phenomenon known as social media is one such technological advance that is further challenging the
status quo of the IRB review process.
2.2 Overview of Social Media
Defined as “forms of electronic communication through which users create online communities to
share information, ideas, personal messages, and other content” (Merriam-Webster, n.d.), social media’s
origin was insidious when advances in technology during the mid-1990s made it possible for the public to
shift from being passive consumers of the internet to active generators of online content. The rapid
adoption of social media is believed to reflect society’s shift toward a more participatory culture. Central
to this culture is the public’s demand for immediate access to information and consideration of the
expertise and opinions of the crowd when making decisions. Participatory culture has also migrated into
the health care setting with patients seeking greater participation in their health care and partnership with
providers in making decisions (Eysenbach, 2008). In fact, social media appears to be an ideal tool in this
environment where “participatory medicine may be the most important driving force for new models and
experiments in patient-centric practice, cost reform, and medical research” (Friedman, 2011).
The earliest forms of social media date back to the late 1990s. Weblogs, or “blogs”, and social
networks facilitated communication among users with common characteristics and/or interests. Blogs
depict “the experiences, observations, opinions…of the writer or a group of writers” (Blogpress, 2016)
whereas social networking sites organize and structure the ways users connect with other individuals.
New platforms for social media continue to emerge. Websites report anywhere from six categories
(SEOPressor, 2016) to ten (Foreman, 2017) or even 13 (DecidedlySocial, 2012). A summary of the six
most common types of social media is in Table 2.1.

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Table 2.1: Definitions and Examples of Social Media Platforms

The primary characteristics distinguishing different types of social media are how communication
occurs and through what type of medium it is communicated. For example, blogs or forums contain
communication initiated or moderated by one individual on a specific theme (e.g. recipes) while other
platforms house communication by different users on random topics (e.g. Facebook). Some platforms
focus primarily on pictures or video while others incorporate multiple forms of media within one site.
Most authors agree that when trying to understand the significance of social media in society, it is more
important to appreciate that regardless of platform, the opportunities and challenges of social media arise
from the largely unstructured and unregulated communication initiated by users.
Social media use is steadily growing across the globe. In the United States (US), social media
use by adults grew from 5% of the population in 2005 to 72% in 2018 (Pew, 2019). Figure 2.3 depicts
the percentage of the population using social media by age categories. Importantly, social media use
continues to increase across all categories of race, gender, income, education or community setting.
According to most sources, Facebook and YouTube are the most popular social media sites, but younger
age groups tend to prefer video or chat platforms while older populations prefer Facebook.

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Figure 2.3: Percentage of American Adults Who Use Social Networking Sites, By Age

Globally, rates of social media show a similar pattern of increasing growth each year with the availability
of mobile devices believed to be a primary driver of this growth. In 2019, it was estimated that 42% of
the world’s population were mobile social media users, a number that increased by 3% from estimates in
2018 (Chaffey, 2019). According to this same source, when comparing countries across the world by
social media penetration, Saudi Arabia has the largest penetration at 99% of the population while the US
is estimated to be at 70%, and the African countries of Ghana, Kenya, and Nigeria with the lowest levels
of penetration at less than 20%.
2.2.1 Digital Engagement
Digital engagement describes the extent to which individuals and organizations use social media
to create content and interact with users. Importantly, the goal of digital engagement is to mobilize a
community around an issue (Lloyd, 2016) and/or to stimulate an action or response (e.g. getting users to
purchase a product or to comment on a political topic). Figure 2.4 depicts the different stages of digital
engagement.

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Figure 2.4: Stages of Digital Engagement

On one end of the spectrum of digital engagement is using social media in a one-way fashion, for
example, to distribute internal company information or to listen to the social media activity of others.
This type of use does not involve interaction with users and is particularly attractive to healthcare
organizations and pharmaceutical sponsors concerned about potential privacy and other regulatory issues
if they communicate with outside users. For example, social media listening is used to learn the public’s
opinion on specific topics or an organization and its products or competitors (Summers, 2015). On the
other end of the spectrum, high digital engagement describes using multiple social media sites with 2 (or
more)-way communication leading to co-creation of products or services, “viral” propagation of
information, and/or community action to solve problems (Papworth, 2011). There is a growing body of
research in diverse fields attempting to characterize how the level and type of digital engagement by an
organization or individual ultimately influences decision-making by the user audience.

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2.2.2 Social Media in Healthcare
The public shows high levels of digital engagement in health information and disease
management topics. As a result, social media is recognized as playing a major role in ushering in the era
of “Medicine 2.0” or “consumer-directed medicine.” (Eysenbach, 2008). The internet is the first source
of health information for almost 70% of adults (Volkman et al., 2014) with 86% of individuals reported to
consult “Dr. Google” before scheduling a doctor’s visit (Fathom, 2014). Through the internet, users
access social media to glean the opinions of other users. This is seen in reports showing that 42% of
individuals consult consumer reviews on health providers and facilities (HealthResearchInstitute, 2012)
and two-thirds of individuals with chronic diseases refer to information found online before making
treatment decisions (Fox and Purcell, 2010). Social media communities focused on specific diseases are
sources of information and emotional support for caregivers and patients by sharing ways to manage
conditions and providing a portal for communication with people who have similar challenges
(Smailhodzic et al., 2016). As a result of the ability of patients to derive health-related information from
social media, patients are equipped with “the knowledge, skills, ability, and willingness to partner with
providers and manage their own care” (James, 2013). The patient-provider relationship is now shifting
from one of hierarchy to partnership with patients demanding more ownership of their health information
and voice in decision-making.
2.2.3 Social Media Activity Among Other Stakeholders
Compared to patients, other stakeholders involved in regulating health care products, developing
biopharmaceutical products, or delivering health care exhibit different levels of digital engagement based
on their regulatory constraints and specific goals.
2.2.3.1 Use of Social Media by the FDA
The FDA appears to recognize the power of social media to reach the public and to accomplish
many of its business functions. The FDA uses multiple social media channels and generates original

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content such as FDA podcasts on health topics. Social media is also a potential tool for data collection
during public health emergencies. During the H1N1 flu (Gesser-Edelsburg et al., 2015) and the SARS
outbreaks, social media activity revealed patterns of disease transmission and was used to disseminate
real-time information to the public about the status of the outbreaks (Yang et al., 2013; Corley et al.,
2010). The FDA has even issued its own employee social media policy, encouraging employees to use
social media in ways that “benefit public health” (FDA, 2015).
The FDA is also exploring the value of social media in pharmacovigilance activities. For
example, newly available informatics techniques can monitor and aggregate information posted on social
media as supplementary data for voluntary adverse event reporting systems (e.g. MedWatch, the FDA
Adverse Event Reporting System). Some researchers propose that social media data could identify early
adverse event signals or validate/reject previously reported information. In one published example,
patient experiences with the drug Lexapro discussed on the PatientsLikeMe social media community were
supported by results from formal postmarketing studies (Brownstein et al., 2009). In a more recent study,
a team including an author from the FDA developed an automated way to harvest “proto-AEs”, or “posts
with a resemblance to an adverse event” from social media for 10 recognized postmarket safety signals.
The authors concluded that it is feasible to use automated systems to surveil social media and this practice
may yield earlier notice of potential safety signals than voluntary reports (Pierce et al., 2017). More
recently, researchers have added natural language processing techniques to social media surveillance
efforts for adverse events and reported detecting events 7 months earlier than they were reported in the
literature (Nikfarjam et al., 2019). Evidence of FDA’s recognition that social media is potentially useful
in pharmacovigilance activities is that the FDA has entered into a collaborative agreement with PLM to
access patient-reported data on the PLM site (PatientsLikeMe, 2015).

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2.2.3.2 Use of Social Media by the Pharmaceutical Industry Clinical Trial Sponsors
Existing regulatory constraints have shaped how clinical trial sponsors from the pharmaceutical
industry, hereinafter referred to as sponsors, use social media. According to a white paper by the Tufts
Center for the Study of Drug Development, seven of 13 sponsors surveyed state they “regularly engage”
in social media listening to understand attitudes and behaviors of consumers as well as their views on the
company, its products, and its competitors (Tufts, 2014). Sponsors recognize that a social media presence
may “humanize the company” (Belbey, 2016), increase transparency about the sponsor’s mission and
activities, and demonstrate a more patient-focused approach to product development (MacDaniel, 2016).
However, sponsors report two major impediments to using social media: potential regulatory risks and a
lack of technical expertise. In response, some sponsors contract with outside technical experts to develop
and manage their social media presence. This practice solves the problem of access to technical expertise
while also mitigating regulatory concerns because the sponsor maintains distance from direct contact with
patients.
Another potential use of social media for the pharmaceutical industry is for product promotion.
Sponsors carefully create direct-to-consumer messages to adhere closely to FDA regulations. With social
media, however, sponsors are not able to maintain control of product messaging. Users and even
competitors can post information of varying quality or could alter sponsor messages that then spread to a
wider audience. Of concern from a regulatory perspective are messages that violate the fair balance
principle when links to risk information are removed from social media messages by users and/or when
users endorse off-label or incorrect use of marketed products. The FDA has responded to stakeholder
concerns about regulatory ambiguity on these issues by issuing four guidance documents specific to social
media (Table 2.2). These guidance documents focus primarily on postmarketing issues related to product
promotion.

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Table 2.2: FDA Postmarket Guidances for Social Media

To date, the FDA has taken few regulatory actions in response to inappropriate social media
activity but the number of actions appears to be growing. One analysis showed that over the last 10 years,
only two of 73 citations related to online direct-to-consumer product promotion (versus traditional media
and health professional directed promotion) referenced social media messages (Kim, 2015). However,
researchers and industry analysts suspect that this small number reflected the early stage of social media
adoption during the study timeframe, a lack of FDA surveillance capacity, and an inability to identify the
sponsor as the actual source of the messaging (Carpentier, 2016). More recently, the FDA has issued
warning letters to sponsors that “like” descriptions of off-label uses of their products and for testimonials,
particularly video testimonials, that are shared through social media (Sullivan, 2018). The FDA works
with another federal agency, the Federal Trade Commission (FTC), to surveil social media because of the
common mission of both agencies to monitor for deceptive advertising. In June of 2019, the two
agencies sent four warning letters to companies regarding product postings made by individuals described
as social media “influencers” (e.g. people believed to have access to a large social media audience who
influence the behavior of the audience). The influencers did not mention risk information for the products
they endorsed (FTC, 2019). Despite regulatory surveillance and actions increasing, the progress toward

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specific FDA guidances for the use of social media is described as incremental (Thoren and Zegarelli,
2014) and “a perfect storm of rapid evolution and stagnant regulation” (Mackey, 2016).
2.2.3.3 Use of Social Media by Healthcare Organizations and Providers
Like sponsors, healthcare organizations and providers are risk-averse and must consider
regulatory implications when determining how to use social media. The major motivation for these
groups to explore social media is the Health Information Technology for Economic and Clinical Health
(HITECH) Act of 1996. This Act requires healthcare facilities and providers to increase the use of digital
technologies for patient interactions and carries financial incentives for adoption and penalties for not
meeting adoption milestones (Anderson, 2010). One common strategy used to meet the HITECH
mandate is the use of patient portals, or web-based interfaces facilitating communication between
patients, organizations, and providers. Among the reported benefits of these portals are improved patient
outcomes and disease management, enhanced patient-provider communication, and increased patient
satisfaction (Osborn et al., 2010; Kruse et al., 2015). While there is tremendous variety in the types of
portals, many include social media platforms to encourage reviews of the practice or provider or to
communicate about health topics. Healthcare organizations also use social media to learn about the
patient as a consumer. In a survey of staff in 36 hospital systems, 70% of respondents stated that the
primary objective of social media efforts was to engage patients as customers of healthcare facilities
(CSC, 2012). Additional ways hospitals try to appeal to consumers are by using social media for health
education, to solicit testimonials, and as a mechanism by which patients can gain greater access to
providers through moderated chats.
An emerging use of social media by health care organizations is for research on patient
experiences and outcomes. In the last decade, the concept of the “learning health system” was coined to
describe health systems that combine internal data on quality with external data on patient outcomes and
opinions (AHRQ, 2019). The goal is that the system will “learn” by using evidence from the real-world

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to inform future healthcare practices. Social media data are one source of external data that researchers
are exploring to learn patient outcomes and the effects of educational, behavioral or therapeutic
interventions. This practice introduces questions about whether it is appropriate and valid to draw
conclusions from social media data and whether there are ethical issues in accessing public social media
posts for research. As a result, ethicists are calling for consideration of new ethical and oversight models
for these activities (Faden et al., 2013).
2.3 Social Media in Clinical Trials
While health systems, researchers and ethicists are concerned about blurring lines between patient
care and research, patients have already moved ahead in including research topics in their ongoing social
media conversations about health and disease. The participatory culture of social media empowers
patients and the public to take an active role in identifying gaps in available treatments, setting research
agendas, developing new research models, and even implementing clinical research studies. At the same
time, there are concerns that social media may have negative effects on the clinical trial process through
the propagation of false information and threats to patient privacy and clinical trial data integrity. Adding
to these concerns is that the social media activities of patients and the public are unregulated and may
occur outside of participation in an actual clinical trial. For example, Lipsett pointed out that even social
media discussions about the potential use of a new drug and the public’s interpretation of social media
comments may influence the development of a drug before it gets to market (Marcus, 2014). Clinical
investigators and sponsors have no direction from the FDA on their responsibilities when they learn of
social media activity that they believe could negatively influence a clinical trial, and while IRBs review
communications between sponsors, researchers, and patients, information on whether IRB members are
aware of these concerns and how they view these issues is nonexistent. In this ambiguous regulatory
landscape, sponsors are taking a conservative approach toward use of social media while patients and
social media vendors move ahead with using social media in multiple ways that influence the clinical trial
process.

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2.3.1 Social Media Use by Clinical Trial Sponsors
Sponsors choosing to use social media for clinical trials employ several strategies to mitigate
regulatory risks. Roche directly manages its web-based patient engagement site through a digital
community manager who refers potentially concerning communications to the company’s legal and/or
compliance groups. Novartis and Genentech focus mainly on study recruitment, using social media
listening to target recruitment messages to highly active social media groups. It is believed that
individuals in these groups proactively seek information to manage their diseases and may be “more
predisposed” to participate in clinical research (Gebhart, 2014; Allison, 2009) than individuals who find
recruitment messages “by chance” (Shere et al., 2014). Other sponsors limit their use of social media to
activities designed to inform study planning. Genentech reports making several changes to its clinical
trials because of patient input from social media communities. These include changes in the location of
study centers, the randomization ratio of drug to placebo, and adding patient-friendly ways of collecting
study data (Comstock, 2014). Sanofi uses social media to identify subject matter experts who have been
helpful in “reducing the number of subject visits, increasing overall patient satisfaction levels, and
generally improving” clinical trial research programs (ACRP, 2016). Because the FDA now considers
patient experiences and risk tolerances in regulatory decision-making as mandated by the Patient-Focused
Drug Development program, industry analysts believe sponsors will continue these types of social media
activities as a way to access valuable input from “the world’s largest focus group” (Ramble and Balatero,
2016).
Because of the increased interest in using social media as a source of data to inform patient-
focused drug development, the FDA recently issued the guidance “Patient-Focused Drug Development:
Collecting Comprehensive and Representative Input”. While not focused directly on social media, the
FDA does suggest that stakeholders explore the use of social media to provide information on patient
experiences (FDA, 2018). Importantly, this guidance documents the FDA’s current thinking on the

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strengths and limitations of social media data and documents the view that social media may be useful in
early stages of research and as a supplement to more traditional research methods.
Some sponsors have elected to mitigate potential regulatory risks of social media by accessing
patients or data indirectly through commercial vendors. Many for-profit vendors use social media to
cultivate patient interest in services (e.g. genotyping from 23andMe or medication safety monitoring from
MediGuard™). These services collect biological samples and/or information that then serves as a
resource for later research. According to one vendor, the reason for this approach is that “you can’t create
a community just about clinical trials” (Borfitz, 2009). Other vendors offer education, disease
management tools, and portals for patient/caregiver discussions. These more “holistic” techniques aim to
cultivate relationships with patients that are believed to expedite patient enrollment in clinical trials and
make patients more amenable to use of their data or biological samples for later research (Quintiles,
2016). These methods also place a firewall between sponsors and direct communication with patients,
thus minimizing the regulatory risks.
2.3.2 Social Media Use for Subject Recruitment, Tracking, and Follow-Up
The most common use of social media in clinical trials described in the literature is for study
recruitment. Social media applications have been shown to be potentially useful for automating and
directing information about clinical trials to specific audiences (Reuter et al., 2016; Reuter et al., 2018).
Social media has also been reported to be particularly effective for recruitment of populations that are
more challenging to reach including adolescents (Amon et al., 2014), substance abusers (Thornton et al.,
2016), and patients with rare diseases (Schumacher et al., 2014). To alleviate IRB concerns regarding
privacy and spontaneous, unapproved communications between researchers and potential subjects,
researchers limit the information distributed through social media and direct interested potential subjects
to more secure, HIPAA-compliant portals to further discuss study enrollment (Grajales Iii et al., 2014).
Peer-to-peer recruitment facilitated by social media networking is a newer technique evolving from

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discussions about study enrollment posted by study subjects. While shown to be effective, this technique
may present risks such as inadvertent breaches of confidentiality if study messages referencing a disease
or condition are visible to the public, or risks resulting from the spread of inaccurate information about a
study (Bull et al., 2011; NIH, 2016).
Overall, the literature reveals mixed enthusiasm and data on the effectiveness of social media for
recruitment. Researchers report that social media was only somewhat, or not, effective in accelerating
recruitment because messages did not reach the appropriate individuals or messages targeted to patient
communities were perceived as intrusive, possibly even decreasing trust between researchers and
potential subjects (Denecke et al., 2015). Another concern is that social media recruitment results in
biased study samples. Others in the research community believe the value of social media is that it can
expand access to research, expedite enrollment and may even be a preferred method for some populations
to engage in clinical research. More formal study is needed to inform IRB deliberations about how
specific populations use social media and to provide some indication of the actual effect on study
recruitment metrics.
In addition to reports on how social media works for study recruitment, the literature contains
some information about social media for patient follow-up and tracking. In this case, the studies reporting
experience using social media for subject tracking are those involving populations that may be more
likely to lose contact with a study site and miss study visits or data collection. The experience of one
team notes that obtaining IRB approval for this use of social media was “prohibitively lengthy” with
confidentiality concerns being “a major obstacle” (Mitchell et al., 2015). Figure 2.5 identifies the
requirements imposed by the IRB for this study team to use social media.

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Figure 2.5 Example of IRB Approved Process for Study Tracking and Follow-Up Using Social
Media

Despite the regulatory hurdles, the research team concluded that social media sites are useful for follow-
up and tracking but recommended that social media be considered by the study team during protocol
development rather than added on later in a study. By doing so, there can be discussion of the potential
social media contact plan in the protocol and consent form and study teams can obtain a subject’s
agreement during the initial informed consent process for this future method of contact. Bhatia-Lin also
endorses this approach and offers recommendations for researchers and IRBs based on experience using
Facebook for subject follow-up (Bhatia-Lin et al., 2019). This recent literature provides some data for
IRB reviewers to consider when weighing the risks of social media subject follow-up compared to the
benefit of subject retention.
2.3.3 Disseminating Research Results
One of the benefits of research for individuals and society is learning the answer to a research
question. Indeed, the importance of obtaining the research answer is one of the factors IRBs consider in
determining whether risks to subjects are justified. Yet the literature documents numerous instances

30
where study results remain unpublished and not available to the public or other researchers (Bassler et al.,
2016; Long et al., 2017). IRB guidance on dissemination of research results is lacking but critical
because of the IRB’s role in reviewing interactions between researchers/sponsors and patients and the
concern about potential harm to research subjects and the public from incorrect interpretations of research
results (Kozanczyn et al., 2007). Given that social media is a medium to facilitate conversations, several
investigators propose that social media could be an effective tool for disseminating and explaining
research findings (Adams et al., 2016; Pemmaraju et al., 2015; Buckarma et al., Regenberg, 2010). Here
again, the potential benefits of social media to improve public access to research results and to facilitate
conversations among stakeholders about research implications must be balanced against the potential
risks that include verifying the identity of individuals reporting and receiving information and spread of
information that is incorrect.
2.3.4 Social Media Facilitates “Virtual Clinical Trials”
The lithium study conducted by ALS patients was the first example of how patients could use
social media to mobilize themselves to conduct a clinical trial without maintaining a traditional
relationship with a research site. Subsequent to this study, the ALS community engaged in two additional
efforts to advance research in ALS that also used social media. These efforts were markedly different
from the lithium study in that they occurred while industry-sponsored randomized controlled trials were
ongoing for the same compounds. The examples involved the compounds NP001 that was in a phase II
trial, and dexpramipexole that was being studied in a phase III trial. Enrolled subjects of these trials
posted information about their progress on the PLM site. They documented their symptoms and potential
response to the study intervention using the same validated scale in the industry studies. Subjects
communicated on PLM about their attempts to unblind themselves to the study assignment based on their
side effects. PLM site directors pointed out that these data represented a new dataset on response and side
effects for both drugs because “around a third of the total NP001 group and 10% of US dexpramipexole
patients recorded data online” (Wicks et al., 2014). There is no regulatory precedent to guide the FDA,

31
sponsors or social media site operators on potential responses to these activities, including how the
additional data on PLM may or may not contribute to regulatory decisions. These studies highlight the
interest of patients in using social media to take an active role in clinical trials but at the same time
illustrate the potential risks to the integrity of ongoing clinical trials and the gaps that exist in current
regulations.
Sponsors also recognize the capabilities of social media to facilitate remote clinical trials. In a
recent report in 2018, pharmaceutical sponsors are reported to be migrating to this type of trial with the
hope of improving speed of recruitment, diversity in trial subjects, and better patient retention (Smalley,
2018). Pfizer was the first sponsor to obtain approval for a formal virtual trial from the FDA and
contracted with the company Mytrus (now Medidata) to provide the technology for a clinical trial that did
not require visits to a research site. The goal of the study was to validate the use of a virtual approach by
comparing the results to a completed phase IV study. Interestingly, the trial ended early due to
insufficient enrollment. According to Pfizer, the trial demonstrated that it was possible to obtain
regulatory approval from the FDA for this type of trial and the technology was successful in obtaining
consent and collecting data. However, Pfizer also conjectured that subjects had less commitment to a
study without an in-person connection to an actual study team and as such, using technology in this way
may not be ideal for all patient groups (Koberstein, 2012). This trial also demonstrated the potential of
social media to expand dissemination of study recruitment messages but revealed that while many
interested individuals responded to study advertisements, a small proportion met the actual inclusion
criteria. Despite these results, the literature and industry press project growth in this type of clinical trial
activity.
2.4 IRB Evaluation of Social Media in Clinical Trials
As described earlier, IRBs deliberate on research based upon federal regulations and the Belmont
Principles. This framework is broad and leaves IRBs with significant latitude to interpret the regulations

32
and ethical principles according to the context of a specific study. Identifying the benefits and risks of
social media may be particularly challenging for several reasons. First, the low level of social media use
in clinical trials means that there is little data upon which to base decisions. Second, social media is
rapidly evolving and site operators have control of procedures for data collection, security and subject
privacy. This information may be proprietary and/or can change without knowledge of researchers or
sponsors. Finally, because social media is readily available to the public, IRBs need to develop ways to
understand the opinions of a subject population on the risks and benefits of using social media as well as
whether use of social media is appropriate for individual subjects. For example, certain groups may be
familiar with or prefer social media while others do not. These attitudes may also change over the course
of a study. With the exception of the one FDA guidance issued in 2018 delineating the strengths and
limitations of using social media, there is little new regulatory information to guide IRBs in their
deliberations on these topics nor to suggest oversight practices during a study.
2.4.1 Applying Existing Guidances to Social Media
There are several existing guidances issued by federal agencies and professional organizations
that are potentially useful for review of social media. With respect to digital or internet-based
technologies, the FDA offers guidance on electronic informed consent, using the internet for subject
recruitment, and electronic data management (FDA, 2016; FDA, 1998-2016). As mentioned earlier, the
FDA recently provided its current thinking on the strengths and limitations of social media for obtaining
information on patient experiences with a product. In this guidance, the FDA acknowledges that social
media may provide access to hard to reach populations and mimic “dynamic, immediate, conversational”
exchanges similar to everyday interactions but also that the users may represent a biased sample (FDA,
2018). The OHRP website houses current thinking on issues such as collaboration with internet survey
firms and types of internet-mediated research that are exempt from IRB review. However, the OHRP
itself states that “current human subjects regulations, originally written over thirty years ago, do not
address many issues raised by the unique characteristics of Internet research.” (OHRP, 2017).

33
Recognizing that regulations are slow to change, the OHRP maintains several “Frequently Asked
Questions” webpages intended for more rapid communication of changing perspectives. Most of these
resources do not directly address emerging challenges of social media and digital technologies.
2.4.2 Consensus Recommendations
Other resources for IRBs are consensus recommendations of expert committees on internet
research. The three most referenced recommendations are from the Association of Internet Researchers
(AoIR), the Secretary’s Advisory Committee on Human Research Protections (SACHRP), and a
collaborative report from the American Association for the Advancement of Science (AAAS) and the
NIH, now known as OHRP. One consistent recommendation by all groups that is relevant to social media
is that IRB members should have access to experts in technology. These experts can more readily
identify the potential risks, benefits, and protections afforded by specific social media platforms. There is
little information available on whether IRB members have adequate access to social media training and/or
have available technology experts to weigh in on social media protocols.
2.4.3 Other IRB and Academic Resources
Academicians and IRBs themselves have taken steps to create resources for the IRB community
on social media and digital technologies. A paper by Gelinas offers an approach for IRB review of social
media in subject recruitment called “non-exceptionalism”. This view suggests that social media be
evaluated using the same ethical principles IRBs already use as noted in the Belmont report. For
example, an IRB would evaluate subject recruitment via social media by applying the same standards as
more traditional methods of recruitment such as protection of confidentiality, potential for coercion and
others (Gelinas et al., 2017). A resource developed with input of some members of the IRB community is
the Connected and Open Research Ethics (CORE) program that could be examined to learn how other
IRBs have addressed social media topics (Carbary and Parrish, 2018). IRB members could also access
information through the Public Responsibility in Medicine and Research (PRIM&R) Forum and the

34
PRIM&R blog called Ampersand, which are tools for the IRB community to post questions and obtain
answers from other IRB professionals. The independent IRB Quorum, now called Advarra, has issued
several statements on their interpretations of existing regulations applied to social media, mainly related
to subject recruitment. It is unclear if IRBs are aware of these resources and if so, if they are useful
within the decision-making process.
2.4.4 Concerns Regarding Social Media in Research
Findings from social and behavioral research using online social computing or big data can
illuminate some operational and ethical concerns related to the use of social media in research in general
and by extension, in clinical trials. These include issues of privacy, consent, data disposition, and
technical expertise.
2.4.4.1 Privacy
Social media environments appear to emphasize open communication and transparency; however,
research shows that some social media users expect a level of privacy. The distinction between private
and public environments is central for IRBs because these settings have different ethical and regulatory
implications. Based on the popularity of large social networks that are completely open and link an often
global community of “friends”, researchers might infer that users on these platforms have no expectations
of privacy and further, that the information posted by users can be included in research (Moreno et al.,
2013). Similarly, users who intentionally maximize the distribution of their content may be viewed to
imply consent for that information to be used by researchers (Mikal et al., 2016). On the other hand,
some researchers report that users may not fully appreciate the public nature of social media (Burkell et
al., 2014) and assume some ownership of their social media interactions (Bond, Ahmed, Hind, Thomas, &
Hewitt-Taylor, 2013; Reuter et al., 2019). These conflicting opinions make it difficult for researchers and
IRBs to determine the most appropriate procedures for informed consent.

35
An example that illustrates the privacy concerns on social media and the challenges faced by
IRBs is the Tastes, Ties, and Time (TTT) project. Conducted in 2006, this project received IRB approval
to collect longitudinal data from Facebook profiles of college students at a single university. When
researchers released the dataset and codebook, it took only days for people to identify the specific school
attended by the subjects (Zimmer, 2010). Researchers soon took the dataset offline, realizing that the
identity of individual students might be revealed while the research community asked questions whether
the students and members of their networks expected privacy. These events introduced concerns that
IRBs may not have the capabilities to recognize potential risks of social media, to understand the views of
the public, and ultimately to evaluate this type of social media use in research.
2.4.4.2 Third Party Vendors
Commercial vendors like 23andMe are entering the clinical research space by using social media
to facilitate collection of data or samples that are later repurposed for health-related research. Vendors
cite that this approach is more efficient for data collection than traditional clinical trials, allows greater
access to research for dispersed populations, and removes possible coercion to participate in research
because individuals self-identify they are interested in participation. Opposing these views are
researchers and ethicists who voice concerns about the validity of self-reported social media data and
challenge the adequacy of informed consent procedures used by vendors. In the first genome-wide
association study using 23andMe data, the journal editors delayed publication for six months to obtain
outside expert review of the study’s consent process. The experts concluded that the consent form used to
obtain samples had “technical jargon” and “ambiguity,” and noted that the consent form likely would not
have received IRB approval (Gibson and Copenhaver, 2010). Yet, the editors concluded that the methods
used to generate this research and the importance of the results were significant enough to publish the
work despite the inadequate informed consent. An analysis of consent forms used for other social media
sites identified “substantial variability in policies related to autonomy” that determine ownership of data
and whether participants will be re-consented for additional use of their data or samples for research

36
(Tobin et al., 2012). These concerns have stimulated additional conversations on the process of informed
consent for services through social media that generate data and/or samples later used for research.
2.4.4.3 Concerns Regarding Data Integrity
Both the Tastes, Ties and Time study and other studies conducted directly by social media site
operators demonstrate that social media is a tool to collect data with potential relevance to human health
and disease. The enthusiasm for this approach, however, is limited by issues including the lack of a
defined process to prevent multiple data entries by one participant, no external checks to confirm
eligibility for inclusion into research samples, and inaccuracies in user-provided data making study
conclusions suspect (Allison, 2009; FDA, 2018). In addition, data ownership and sharing policies may be
unclear and consent forms have complicated explanations of relationships between researchers and social
media site operators. To one ethicist, social media site operators “commoditize data and maximize its
monetary value” and consider the Belmont principles “secondary or even irrelevant” (Swirsky et al.,
2014). The terms of service are also concerning and described as “contracts of adhesion” because the
service provider can change the terms without any approval, making the researchers unable to guarantee
participants’ privacy (Swirsky et al., 2014). All of these concerns contribute to feelings within the
research community that the value of social media data should be carefully considered in the current
environment where “new configurations of technologies, service providers and users challenge existing
regulatory categories, present novel opportunities, and risks, and raise important ethical questions”
(Morrison et al., 2016).
Sponsors have also raised concerns about the effect of social media on data integrity for FDA-
regulated clinical trials. A 2014 opinion piece in Nature Medicine about the “eParticipant” describes how
patients might coach other patients to meet eligibility requirements, to report adverse events, or discuss
information or symptoms that could unblind their treatment assignment (Lipset, 2014). Subsequent
literature reiterates these concerns, providing examples of studies in which enrolled subjects used

37
Facebook to determine which subjects were in the control group, raising concern for study dropout
(Ledford, 2018). It is unclear whether sponsors and researchers should monitor on-line discussions that
could reveal safety events and whether this information should be reported to IRBs (McNair, 2016). To
address these potential problems, researchers have modified consent forms to educate patients about the
potential impact of social media postings about research (Marcus, 2014) while others question whether
sponsors should monitor study-specific social forums (Glickman et al., 2012). It is not clear if IRB
members share similar concerns as other stakeholders on this potential impact of social media on study
integrity and subject safety.
2.4.5 IRB’s Access to Technical Expertise on Social Media
As described above, the recommendation from consensus groups is that IRBs seek access to
outside expertise to assist in review of social media. In addition, according to the AoIR, IRBs should also
obtain input from members of the virtual communities being studied who may have experience with a
platform and be able to weigh in on benefits and risks (Ess and AoIR Committee, 2002). Other strategies
for IRBs to access expertise include the use of social media facilitators who are expert in social media and
research to serve as a bridge between patients, IRBs, and researchers (Regenberg, 2010), or the inclusion
of social media site operators in IRB discussions (Moreno et al., 2013). Without technical expertise to
understand the nuances and implications of social media, IRBs are said to be “scrambling” to keep abreast
of changes and to enhance safeguards for individual studies (Swirsky et al., 2014). The literature offers
little information about the extent to which IRBs identify and consult technology experts, representatives
of study populations, or social media site operators in their deliberations on specific protocols.
2.5 Research Framework
Federal regulations on human subjects’ research have undergone only one substantial revision in
several decades. This is amidst a background of rapid advances in science and technology and the
emergence of new stakeholders in the clinical research environment. IRBs face mounting critiques that

38
the review process is outdated, inefficient, and unhelpful in guiding determinations on the vast array of
new technologies available to researchers. Social media is one example of a tool that is widely used in
health care but is still at a relatively early stage of implementation in clinical trials. With little data
available on the actual benefits and risks of social media in the clinical trial setting, IRB members likely
rely on their personal knowledge, experiences, and attitudes toward technology to make decisions about
whether social media is appropriate within a clinical trial. This research will probe how IRB members
view social media by using tools from the field of technology assessment. Specifically, this research uses
a framework that combines two independently validated technology assessment frameworks: the
Technology Readiness Index (TRI) to capture individual factors related to receptiveness toward
technology adoption, and the Unified Theory of Acceptance and Use of Technology (UTAUT) to capture
characteristics of the technology itself that determine its implementation (Parasuraman and Charles, 2014;
Venkatesh et al., 2003).
There are two reasons to combine these frameworks. First, technology use models such as the
UTAUT probe for what factors influenced the decision of individuals to use a technology. They are
viewed to be useful, but less valid when populations have little or no direct experience with a technology.
Second, the original application of technology use models was not in health-related settings and
researchers believe the models omit specific variables and constructs important in technology decisions
for health-related topics. Prior researchers who use these existing models typically add variables or
change the original definitions of model constructs, leading to concerns of compromised model validity.
An alternative approach suggested in the literature is to combine the UTAUT with a tool that measures
the beliefs individuals have about technology overall (Holden and Karsh, 2010). Doing so allows
individuals who do not have experience with a technology to articulate what factors might influence their
decisions. Therefore, this study will supplement UTAUT with elements of the TRI to explore the beliefs
of IRB members about social media.

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The following section will describe the main constructs of each framework followed by a description of
adaptations made in combining the two into the final framework.
2.5.1 Technology Readiness Index
The Technology Readiness Index (TRI) is a 36-item scale initially published in 2000 that describes an
individual’s “propensity to embrace and use new technologies” (Parasuraman, 2000). The TRI was
updated in 2015 in direct response to the emergence of technologies such as “high-speed Internet access,
mobile commerce, social media and cloud computing” which the authors believed were significant
enough to require an update to the wording of earlier questions and the removal of references to obsolete
technologies (Parasuraman and Charles, 2014). The revised scale has 16 items and validation studies
suggest it is appropriate for measuring technology readiness levels within groups such as those defined by
profession, market segment, or other demographics. The TRI classifies an individual’s readiness to
accept technology based on four dimensions:
• Optimism: a belief that technology offers increased control, flexibility and efficiency
• Innovativeness: a tendency for an individual to be an early adopter of technology
• Discomfort: a feeling of being overwhelmed by technology or to not have control over
technology
• Insecurity: a distrust of technology and skepticism about whether it works properly
According to this model, individuals who have high scores for optimism and innovativeness are more
receptive to adopting a technology while those who have high scores for discomfort and insecurity are
potentially more resistant to adopting a technology.
Originally, the TRI sought to describe the readiness of customers to accept new services through
which companies and customers interact virtually (e.g. self-service technologies replacing customer
service personnel). Examples in the literature demonstrate that the TRI can identify factors that might
improve the uptake of new technology. For example, a study in 2006 used the TRI to assess the

40
technology readiness of medical and nursing students and concluded that specific changes to curricula
would improve the adoption of education technologies (Caison et al., 2008). Other applications of the
TRI include assessments of the readiness of nurses to adopt electronic patient monitoring systems and
physicians to adopt health information systems (Kuo et al., 2013; Melas et al., 2014). In a lay population,
the TRI has been used to assess readiness to use electronic “self-diagnosis” tools found on the internet
(Lanseng and Andreassen, 2007). In each of these cases, the TRI was able to characterize segments of the
population that were most likely to be early adopters of technology and to identify potential ways to
alleviate the concerns of those who were more reticent.
2.5.2 Unified Theory of Acceptance and Use of Technology
The Unified Theory of Acceptance and Use of Technology (UTAUT) integrates components of
the eight most used models to predict the actual use of technology, or “use behavior.” In the UTAUT, an
individual’s use of a technology is thought to be influenced by two main factors – the environment,
referred to as facilitating conditions, and attributes of a technology and how it is used by others that might
affect a user’s decision to use a technology, referred to as behavioral intention (Figure 2.56).
Facilitating conditions are aspects of the user’s environment that make it easier or more difficult
to use a technology. Examples of facilitating conditions include training programs or resources such as
help desks. In the context of this research, facilitating conditions are federal regulations, guidances and
local policies, access to expertise on social media during IRB review, and the availability of training on
social media for IRB members.

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Figure 2.6: Unified Theory of Acceptance and Use of Technology

Behavioral intention is determined by three domains: performance expectancy, effort expectancy,
and social influence. Performance expectancy is the user’s expectation of how well a technology will
perform for a specific purpose. Applying this concept to social media in clinical trials, performance
expectancy could include anecdotes and marketing materials that point to the expected benefits of social
media for research education, subject recruitment, study implementation, and results dissemination.
Whether an IRB reviewer believes social media would perform well for a certain use (e.g. be an
appropriate recruitment tool for a specific audience) may influence the reviewer’s view of relative benefit
versus risk. Conversely, if an IRB reviewer believes social media is not useful for a clinical trial use, he
or she may believe the risks outweigh the benefits. Effort expectancy refers to the perceived ease of use
associated with a technology. Similar to performance expectancy, the belief that social media is easy to
use for the proposed purpose is likely to influence the assessment of benefits and risks. Effort expectancy
for social media in clinical trials is present in the IRB reviewer’s perception of how well the study team
describes the specific social media platform within the protocol and informed consent, how easy it
appears for the subjects to use, and the IRB reviewer’s impression of whether difficulties in using social

42
media increase the study risks. Social influence is the degree to which the opinions of others influence
the decision to use a technology. In the context of social media in clinical trials, we will consider this
construct in three areas. First, social influence may occur within IRB decision-making because IRB
members consider each other’s opinions during study deliberations. Second, social influence potentially
arises from an IRB reviewer’s knowledge of how a study population views social media. IRB reviewers
may be aware that specific populations are actively engaged in social media (e.g. adolescents) and prefer
its use or may determine that social media use increases risk for specific populations. Finally, IRB
reviewers may also consider the opinions of IRB colleagues outside of their IRB. Probing for opinions in
all three constructs that comprise behavioral intention will allow us to generate a clearer picture of how
IRB reviewers prioritize certain information when reviewing social media.
Finally, the UTAUT also includes several moderating factors of gender, age, experience, and
voluntariness that could influence the relationship between the primary factors of facilitating conditions
and behavioral intent, and the outcome of use behavior. For example, gender has been shown to explain
differences in whether individuals use information kiosks (Wang and Shih, 2009). Voluntariness, or
whether use of a technology is mandatory or voluntary, is another aspect of social influence because if use
of a technology is mandatory, it clearly influences adoption by individual users. Experience is included in
the model because as an individual gains experience with a technology, it is easier to use (improved effort
expectancy), the opinions of others may be less important (social influence), and resources to support
ongoing use of the technology become more important (facilitating conditions). We will not probe for
these additional aspects of the UTAUT in this research because they are beyond the scope of the primary
study question.
2.5.3 Applying the Combined Research Framework
The final research framework combines the TRI and UTAUT to assess the perspectives of IRB
members on social media overall as well as on social media proposed within clinical trials. Three

43
adaptations were made to fit the goals of this research. First, the primary outcome of the combined
framework is behavioral intent instead of use behavior. The rationale for this adaptation is that the goal
of this research is to assess the views of IRB members on their willingness to accept the use of social
media for a particular protocol rather than whether they use, or will use, social media themselves.
Correspondingly, the second adaptation is that we will consider facilitating conditions to contribute
directly to behavioral intent. Finally, the moderating factors of gender, age, experience, and voluntariness
included in the UTAUT are not included in this framework because they are not areas of focus for this
research. Figure 2.7 depicts the final framework for this research.
Figure 2.7: Research Framework

Findings from this research will provide a deeper understanding of the views of IRB members on
social media within the context of clinical research and inform study teams and sponsors as they consider
incorporating social media components within their study protocols. In addition, results from this work
may identify resources and infrastructure needed to support IRB members during their review of
protocols using new technologies like social media.

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CHAPTER 3. METHODOLOGY
3.1 Introduction
The purpose of this study is to elucidate the opinions of IRB members on social media use within
clinical trials and to understand the resources available to IRBs when reviewing social media. Questions
were developed to account for the fact that some respondents may have no direct experience reviewing
social media in their IRB role. A subset of questions was also included for those respondents with direct
experience reviewing social media.
3.2 Development of the Survey
The combined framework customized for this study guided the development of survey questions.
The specific questions are based on information found in the literature, consultations with IRB members
and other research professionals, and discussions with social media experts. Qualtrics was used to
develop the survey tool (www.Qualtrics.com). The initial survey consisted of 28 questions. The
estimated length of time for survey completion was 15-20 minutes.
Section 1 of the survey contained demographic information about the respondent to provide
context for their responses (e.g. level and type of experience with social media in personal and IRB
setting). Section 1 also asked respondents to identify the setting and scope of the respondent’s IRB and
the extent of the respondent’s experience with the review of social media in clinical trial protocols.
Section 2 questions focused on characterizing the IRB review process for studies that incorporate social
media and environmental factors such availability of policies and technical expertise. Section 3 contained
questions probing for the views of IRB members on the adequacy of current regulations and the
respondents’ awareness of potential applications of social media to clinical trials. Question types
consisted of multiple-choice, single answer, dropdown, and open text fields. Skip patterns were used to
allow IRB members without direct experience in the review of social media to skip certain questions.

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3.3 Focus Group Testing and Development of Final Survey
We convened a focus group to provide feedback on survey readability, relevance to the IRB
audience, and to verify the estimated amount of time needed to complete the survey. Nine focus group
participants were recruited and asked to review the survey in advance of the meeting. Four participants
attended the in-person meeting, three participated via conference call and two provided written comments
(Table 3.1).
Table 3.1: Focus Group Participants
Participant Title Role Mode of input
Lindsay MacNair, MD,
MPH, MSB
Chief Medical Officer at
WIRB- Copernicus Group
IRB Chair Conference call
Kim Boggess, MD Professor, Maternal and Fetal
Medicine; UNC
IRB Chair Conference call
Katherine Hawthorne,
RN
Program Manager, USC Office
for the Protection of Research
Subjects
IRB
Representative
In-person
David Collins Department Business Manager,
UNC (retired)
IRB member Conference call
Eunjoo Pacifici,
PharmD PhD
Director, International Center
for Regulatory Science,
Assistant Professor of
Regulatory and Quality
Sciences, USC
Faculty
Advisor
In-person
Nancy Pire-Smerkanich,
DRSc, MS
Assistant Professor, Clinical
Pharmacy, USC
Committee
member
In-person
Frances Richmond, PhD Chair, Department of
Regulatory and Quality
Sciences, USC
Committee
member
In-person
Kathryn Morbitzer,
PharmD
Assistant Professor, UNC
Eshelman School of Pharmacy
IRB member Written
comments
David Weber, MD MPH Professor, Medicine, Infectious
Disease, Pediatrics, UNC
IRB Chair Written
comments

46
The 90-minute focus group session began with a short presentation on the goals of the research, the
research framework, and the proposed survey recruitment plan. Focus group members first informed the
research team how long it took them to complete the survey. This estimate did not include time to
provide narrative comments. The rest of the focus group session focused on evaluation of the clarity,
format, and order of each question and the relevance of the information to the IRB audience. Focus group
members provided suggestions to improve readability and suggested alternate wording of questions
and/or response choices to improve clarity.
Several changes were made to the survey as a result of input from the focus group. First, the
order of questions changed to place more of the demographic questions at the end of the survey. The one
demographic question that remained at the beginning was the question about total years of service on an
IRB. Focus group participants agreed that participants would be more engaged in completing the survey
if the questions first addressed social media versus beginning with demographic questions. Second, we
made wording changes to several of the original survey questions. For example, the term central IRB was
changed to independent IRB to more accurately reflect current terminology. Another suggestion offered
by focus group participants was to include more discrete response options instead of open text fields. The
rationale for this change was that some respondents “don’t know what they don’t know” and would not be
able to provide detailed narrative comments.
The final survey consisted of 30 questions (Appendix C). An additional question at the end of
the survey directed respondents outside of the survey if they wished to provide contact information to
participate in a raffle for an incentive and/or to receive a summary of the aggregate results of the survey.
This was done to ensure that the main survey responses remained anonymous. The identifying
information collected resides in a separate dataset from the main survey and there is no linkage between
the two datasets. The Institutional Review Board of the University of Southern California judged the
research exempt from further review. The final survey was then tested by 3 individuals who had not seen
the survey before to ensure it could be completed on a mobile device or desktop/laptop, to confirm that

47
skip patterns were functional, and to verify that the survey function directing participants to a separate
survey to provide contact information was operational.
3.4 Survey Distribution
A list of IRB Chairs and contact information was obtained through a Freedom of Information
request. The request was submitted on October 9, 2018 and included: names of active IRB boards in the
United States, the address, phone number and email of the board, the chairperson’s name and email, and
any other listed contact person and their contact information. We received a response on October 30,
2018 in the form of an Excel spreadsheet containing the requested information for 3388 IRBs. Prior to
survey distribution, the list was curated to remove duplicate emails that reflected the fact that one
individual was chair of multiple IRBs. We also removed IRBs with the titles social and/or behavioral
because our goal was to focus on FDA-regulated biomedical clinical trials. We uploaded a final list of
2991 unique emails into the Qualtrics Contact portal and launched the survey on December 13, 2018.
There were two subsequent reminders and the survey closed in January 29, 2019.
3.5 Data Analysis
Descriptive data is provided for all survey questions noting the frequency of each of the response
categories. Cross tabulation was done for specific variables to further delineate whether there may be an
association between certain variables.

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CHAPTER 4. RESULTS
Results are presented in six sections: 1) respondent and IRB characteristics, 2) resources for IRB review
of social media, 3) experiences with IRB review of social media, 4) social media use in clinical trials, 5)
personal experience and use of social media, and 6) analysis of text comments.
4.1 Respondent and IRB Characteristics
Figure 4.1 depicts the survey distribution process. From the initial 3388 email addresses, we
eliminated 397 because either their sole focus was on social and/or behavioral research so they would not
receive FDA-regulated research or because there were duplicate entries, (i.e. an individual was Chair of
more than one committee). After the initial distribution of 2991 invitations, 178 emails returned
undeliverable and 42 individuals responded that they were not completing the survey because they do not
review FDA-regulated clinical trials, they were no longer an IRB chair, or their IRB required a separate
IRB approval in order for them to complete the survey. We removed the emails for these respondents
from subsequent distribution lists so they would not receive additional survey reminders. Some
individuals who were no longer IRB chairs forwarded the survey link to the current chairs while others
provided the email address of the current chairs. In the latter case, we updated the distribution list to
reflect the email of the current chair. A final set of 2771 reminders was sent on December 21, 2018 and
on January 25, 2019. The survey closed January 29, 2019 with 529 surveys initiated, 122 incomplete
surveys, and 407 complete surveys, resulting in a 17% response rate and a 77% completion rate.
Because not all respondents completed every question in the survey, we included the actual number of
respondents completing each question with the results. A total of 178 individuals provided contact
information in the final survey question, of which 139 wanted both to be entered in the raffle and to
receive aggregate study results, 20 requested entry into the raffle only, and 9 requested a summary of
study results.

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Figure 4.1 Study Distribution

Respondents reflected a range of years of experience serving on IRBs. This question asked for
total service comprised of time as an IRB Chair in addition to time as a non-Chair member of the
committee. Figure 4.2 shows that close to half of the respondents reported more than 10 years of
experience (45%, 195/436) while the remaining respondents were divided among 5-10 years (32%,
139/436) and less than 5 years (23%, 102/436).

50
Figure 4.2: Years of IRB Experience
How many total years have you served on an IRB?

More than half of the respondents reported that their IRBs were affiliated with an academic
institution/academic medical center (68%, 277/406) followed by non-academic hospital, research institute
or healthcare organization (22%, 89/406). A few identified their IRBs as “independent” IRB (5%,
18/406) or “Other” (5%, 22/406) (Figure 4.3).

23% (102)
32% (139)
45% (195)
(N=406)
< 5 5-10 > 10

51
Figure 4.3: IRB Affiliation
What is the affiliation of your IRB?

The affiliations of the 22 individuals who responded as Other are presented in Table 4.1. This
question did not allow respondents to select more than one choice. Hence, two respondents entered
comments in the Other field to designate that they served on more than one IRB, and one stated that their
single IRB included two types of organizations.

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Table 4.1: Other IRB Affiliations

* State health department and academic
Community hospital and academic
** International non-government organization
Healthcare organization

Most IRB committees represented by the respondents review both biomedical and
social/behavioral research. For this question, respondents had the option to select more than one option
and, hence, the total number of responses was greater than the number of respondents. Overall, there is a
slightly greater representation of social/behavioral research (55%, 333/606) compared to biomedical
research (40%, 244/606) (Table 4.2). Four percent (27/606) of the responses were for Other with text
details grouped and listed in Table 4.3.

53
Table 4.2 Type of Research
What type of research does your specific IRB committee review? (select all that apply)

The 27 responses provided in the Other category are in Table 4.3.
Table 4.3: Other Types of Research Reviewed

To understand the experience levels of respondents as primary reviewers, a question was included
to explore their review responsibilities over the past year. The results show that the number of
respondents who served as primary reviewers for 0-12 initial reviews (46%, 185/405) was similar to those
who served for 13-120 initial reviews (47%, 190/405) while 6% (24/405) of respondents noted they
conducted more than 120 initial reviews (Figure 4.4).

54
Figure 4.4 Number of Reviews
About how many times have you performed an initial review as a primary reviewer in the past year?

To understand the level of IRB activity, an additional question asked about the overall number of
initial full board reviews conducted by their IRB committee. Approximately half of the respondents
estimated that their committee conducted 0-12 full board reviews (52%, 211/405) while almost 40%
conducted 13-120 (39%, 157/405) and 8% (32/405) conducted more than 120 (Figure 4.5).

46% (185)
47% (190)
6% (24)
1% (6)
(N=405)
0-12 13-120 >120 Do not know

55
Figure 4.5: Number of Full Board Reviews in Past Year
About how many initial full board reviews has your IRB has deliberated on in the past year?

4.2 IRB Capacity for the Review of Social Media
This section of the survey probed what resources were available to IRB reviewers for the review of
proposals using social media.
4.2.1 Social Media Expertise on IRB Committee
According to a majority of respondents, their IRB committees did not include individuals with
specific types of expertise that might be useful for the review of social media. As seen in Figure 4.6, a
third of respondents (33%, 142/435) reported having a researcher using social media on the committee
while approximately half (48%, 208/435) did not have this expertise and one out of five respondents
(20%, 85/435) did not know if this expertise was on their IRB committee. Institutional experts were
separated into two response categories: experts knowledgeable about some aspect of social media (e.g.
information technologist who addresses data security) and experts who use social media in their job (e.g.
communications expert). Both categories were similarly represented on IRB committees, with 30%
(134/441) having an expert knowledgeable about an aspect of social media on the committee and 22%
52% (211)
1% (5) 39% (157)
8% (32)
(N=405)
0-12 Do not know 13-120 >120

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(95/434) noting they had an expert who used social media in their job. The least represented type of
expertise (12%, 51/435) was that of individuals who were self-identified social media experts and were
non-researchers (i.e. nonscientific/lay IRB committee members). Between 10-20% of respondents
reported not knowing whether the specific type of expertise was present on their IRB committees.
Figure 4.6: Social Media Expertise on IRB Committee
Does your IRB committee include members with any of the following types of social media expertise?
(select all that apply)

Table 4.4 lists the other forms of expertise elaborated by the respondents. The two most
commonly described types of expertise were committee members who used social media in their own
research or were familiar with social media but were not experts, and groups outside of the IRB that
reviewed protocols for specific issues (e.g. data security), outside consultants, or committees that
provided input on an as-needed basis.

57
Table 4.4: Other Expertise on IRB Committee

A cross tabulation was conducted for the question on type of expertise and the affiliation of the
IRB to explore if there were differences in the types of expertise present across different IRB affiliations.
The IRBs affiliated with academic institutions/medical centers have the most of each category of
expertise (65-82%), followed by nonacademic hospitals/ research institutes/healthcare organizations (15-
28%) and independent IRBs (1-4%) (Table 4.5). Note that the numbers do not match those shown in
Figure 4.6 because there were missing values for the question on IRB affiliation.
Table 4.5: Type of Social Media Expertise on IRB Committee by Affiliation

*total due to rounding

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4.2.2 Training on Social Media
A second aspect of an IRB’s capacity to review social media is whether there is training available
to IRB members. Figure 4.7 illustrates that the majority of respondents have not received, nor been
offered, any training on the use of social media (87%, 382/437).
Figure 4.7 Training on Social Media
In your role as an IRB member, have you had, or been offered, any training on social media?

A cross tabulation was performed for the question on type of training and IRB affiliation to
explore whether there were differences in training by IRB affiliation. While 12% (32/277) of IRB
members at academic institutions/medical centers and 13% (12/89) at non-academic hospitals, research
institutes or healthcare organizations received training, none was reported by those at independent IRBs
or other affiliations (Table 4.6). (Note the total does not equal 55 because there were incomplete
responses to the affiliation question.)
13%
(55)
87%
(382)
(N=437)
Yes No

59
Table 4.6 Training by Affiliation
Training Affiliation of IRB
Academic institution/
medical center
Non-academic hospital, research
institute, healthcare organization
Yes 12%
(32/277)
13%
(12/89)
No 88%
(245/277)
87%
(77/89)

Respondents who had received or been offered training were asked what types of trainings were
received/offered. The most frequently selected item was training at a meeting for IRB professionals and
webinar/on-line training (both 30%, 28/93) followed by internal training (24%, 22/93), and external
training (12%, 11/93) (Table 4.7).
Table 4.7 Type of Social Media Training
What type of training was offered? (select all that apply)
Training type Percentage/
Number of
Responses
At IRB professionals meeting 30%
28/93
Webinar or online 30%
28/93
Internal to organization 24%
22/93
External to organization 12%
11/93
Other* 4%
4/93
*Other:
• We have discussed best practices and developed a policy statement on the use of social media in
research.
• Direct consultation with a contributor to the review and revision of the Common Rule.

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• How to prepare blogs.
• Attended some conference presentations and workshops on use of social media.

When respondents were provided the opportunity to identify specific topics for which they would
like more training, 128 responses were received. Many of the responses included multiple topics and
some responses addressed broader aspects of social media not specifically related to training. The
responses were grouped into topics and are listed in Table 4.8 along with the text comments in the Other
category.
Table 4.8: Topics for Further Training
If there are specific aspects of social media that you would like more training on, please describe them
below.

*Other:
• “I think a very direct correlation between social media and research review would be helpful - I
am able to use my high level of technological expertise and experience with social media as both
an individual and a researcher to make informed decisions, but it would be good to have specific
examples of where a decision might be different when social media is in play.”
• “Training on social media is ongoing due to constant changes to privacy, and new outlets for
social media.”
• “Any and all of it.”
• “Hard to say. The general policies about use of social media are clear but each protocol brings
unique circumstances that need to be interpreted in context of time and place.”
• “Monitoring.”

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• “Marketing. I serve on a public library board and would like to learn more about promoting our
programs.”
• “Most social media use is related to advertising and recruiting participants for clinical trials.
Other communications are not allowed to occur via social media per our institutional policies due
to HIPAA and information security regulations.”
• “Understanding on how sites that use avatars to identify people can or can't be used to identify
real individuals.”
• “Use of social media for projects where prior consent is not possible. A way to "inform the
community" and allow pts to "Opt out".”
• “Whether or not people who respond to a recruitment ad through social media are more or less
informed about the study at the time they respond than people who respond to a flyer or other
type of recruitment ad. Do those responding through social media differ in any way from those
who respond through more traditional means?”

4.2.3 Policies on Social Media
A final measure of IRB capacity to review social media is the existence of local and federal
regulations, policies, and guidances. A majority of respondents (72%, 311/434) indicated that their IRBs
do not have specific policies on social media (Figure 4.8).
Figure 4.8 Policies on Social Media
Does your IRB have specific policies that address the use of social media in research?

To explore differences across IRB affiliations, a cross tabulation was performed for the question
on IRB affiliation with the existence of policies. As seen in Table 4.9, the percentage of IRBs affiliated
72% (311)
19% (84)
9% (39)
(N=434)
No Yes Do not know

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with academic institutions/academic medical centers that reported having policies specific to the use of
social media in research (23%, 64/277) was twice that of nonacademic entities (11%, 10/89) and
independent IRBs (11%, 2/18).
Table 4.9 Policies by IRB Affiliation

Respondents who reported having social media policies were further probed to understand the
types of policies that were in place. The most common policies addressed the use of social media for
subject recruitment (90%, 74/82) and the protection of privacy of enrolled subjects (88%, 72/82),
followed by storage of social media data (62%, 51/82) and data management (55%, 45/82). Less
common were policies that required use of templated language on social media in consent forms (49%,
40/82) and far less common were policies requiring social media expertise on a research team (10%, 8/81)
(Figure 4.9).

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Figure 4.9 Information in IRB Policies
What information is covered in the policy or policies? (select all that apply)

The individuals who responded that their IRBs did not have policies on social media were
presented with the same topics listed in Figure 4.89 above and asked to indicate which ones should be
addressed in IRB policies. As can be seen in Table 4.10, results were similar to those above (Figure 4.9)
in that most responses were for procedures to protect privacy of enrolled subjects (22%, 261/1213)
followed by using social media for study recruitment (19%, 226/1213), procedures/standards for storage
of social media data (18%, 221/1213), procedures/standards for data management of social media data
(18%, 214/1213), templated language on social media for consent forms (16%, 194/1213), and
requirements for a social media consultant on the study team (5%, 63/1213).

64
Table 4.10: Topics that Should be Addressed in IRB policies
What topics do you think should be addressed in IRB policies? (select all that apply)

*Other:
• Existing policies cover social media (11)
• Privacy (4)
• Data storage/security (4)
• Limitations to use of social media in research, risks, data interpretation (3)
• Issues related to consent (2)
• No policies/unsure (2)
• No use of social media in research (1)
• Accountability (1)
• Policy for IT expert to be available to review proposals (1)

4.2.4 Level of Preparedness to Review Social Media
When asked if they felt prepared to review research protocols that use social media, two-thirds of
the respondents felt somewhat prepared (66%, 286/433) while 15% (66/433) felt very prepared and 19%
(81/433) felt not prepared (Figure 4.10).

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Figure 4.10 Level of Preparedness to Review Social Media
Please mark the option that best describes how prepared you feel to review research protocols that use
social media.

A series of cross tabulations was performed to identify factors that may be associated with
feelings of preparedness to review research protocols that use social media. Table 4.11 shows cross
tabulation of receiving training and greater level of preparedness. A higher percentage of respondents
who received training felt very prepared (32%, 17/66) when compared with respondents who did not
receive training (13%, 49/380). A majority of respondents in both groups reported feeling somewhat
prepared (received training: 62%, 33/53; received no training: 67%, 253/380).
66% (286)
15% (66)
19% (81)
(N=433)
Somewhat Very Not

66
Table 4.11 Level of Preparedness Based on Training Status

*total due to rounding
To explore if longer duration of IRB service was associated with a greater level of preparedness, a
cross tabulation was performed between years of IRB service and levels of preparedness. Table 4.12 shows
that while a greater percentage of respondents with more than 10 years of experience reported feeling very
prepared to review social media (16%, 31/192), the value was only a few percentage points different from
the other groups (5-10 years: 15%, 21/139; <5 years: 13%, 13/101). Most respondents, regardless of the
length of IRB service, reported that they were somewhat prepared to review social media protocols (>10
years: 63%, 121/192; 5-10 years: 68%, 95/139; <5 years: 69%, 70/101).
Table 4.12: Level of Preparedness and Years of IRB Service

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Finally, to explore if a higher level of review experience was associated with greater levels of
preparedness, a cross tabulation was performed between the number of reviews per year and the level of
preparedness. Table 4.13 shows that respondents who reviewed more than 120 primary reviews per year
reported higher levels of preparedness (very: 29%, 7/24; somewhat: 71%, 17/24) compared to those who
reviewed between 13 and 120 (very: 18%, 34/189; somewhat: 68%, 129/189) and those who reviewed
between 0 and 12 (very: 10%, 18/185; somewhat: 62%, 114/185).
Table 4.13 Level of Preparedness by Number of Primary Reviews per Year

*total due to rounding
4.3 Experience with the review of social media
Although most respondents (73%, 311/426) reported that they did not have direct experience
reviewing a clinical trial using social media, 27% (115/426) reported that they did have experience
(Figure 4.11).

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Figure 4.11 Number of Respondents Who Have Deliberated on Social Media
Have you deliberated on one or more clinical trial protocols using social media?

Cross tabulation was performed to explore if the deliberation experience of respondents was
associated with their IRB affiliations. Of the respondents who had deliberated on a social media protocol,
71% (77/108) were affiliated with academic centers while 23% (25/108) were affiliated with non-
academic entities (2/108) (Table 4.14).
Table 4.14 Deliberation by Affiliation

73% (311)
27% (115)
(N=426)
No Yes

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Respondents who have deliberated on clinical trial protocols that used social media were directed to
questions in sections 4.3.1 to 4.3.4 to further probe the nature of social media use, resources used, areas of
challenge, and difficulty of review compared to other technologies.
4.3.1 Use of Social Media in Deliberated Protocols
As shown in Figure 4.12, social media was most frequently used in study protocols for subject
recruitment (58%, 64/111) followed by study data collection (36%, 41/113), study subject tracking (23%,
24/106), and results dissemination (9%, 9/104).
Figure 4.12 Uses of Social Media in Deliberated Protocols
In the protocol(s) you deliberated on, how often was social media used in the ways below? (select all that
apply)

Other uses of social media identified by respondents were as an intervention, to find funding, to
keep participants engaged in a study, and as the source of primary data (Table 4.15).

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Table 4.15: Other Uses of Social Media in Deliberated Protocols

4.3.2 Resources for Protocol Review
The respondents were asked what supplementary materials were used to assist in the review of
social media. Respondents could select more than one response for this question. As shown in Table
4.16, federal and/or local policies were used most (23%, 63/269), followed in decreasing order by peer
reviewed literature (18% 49/29), terms of service of a social media provider (14%, 37/269), another IRB’s
policies (13%, 36/29), guidance/statements from professional organizations (12%, 32/269), and
consultation with a social media expert (11%, 29/269). Thirteen respondents (5%) provided text
descriptions of other resources, including IT professionals, legal experts, other IRBs, and professional
organizations.

71
Table 4.16: Supplementary Resources for Protocol Review
Check any of the resources below that you have used, in addition to the materials provided by the
research team, to help you review a research proposal using social media (check all that apply).

*Other:
• IT professionals (4): research IT, institution IT, IT, IT professional not social media expert
• Legal expertise (3): legal member of IRB, legal consultant to IRB, consultation with legal
team
• Other IRB staff or IRBs (3)
• Professional organization: PRIM&R and SBER network
• Principal Investigator experienced using social media in research
• Funder’s social media policy and procedures

When the respondents were asked to provide recommendations on what resources would assist
IRB members with the review of social media, the highest response was received for more training (23%,
63/274) followed by more access to experts (21%, 57/274) and a repository of IRB decisions (20%,
55/274). Fewer responses were received for additional federal guidances (18%, 49/274) and even fewer
for additional federal regulations (15%, 41/274). Four respondents (1%) thought that no additional
resources were needed (Table 4.17).

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Table 4.17: Resources Helpful for IRB Review of Social Media
In your opinion, which of the following would assist IRB members with the review of social media (check
all that apply)?

*Other:
• Additional federal guidelines/guidances (2)
• Peer-reviewed publications on the use of social media in clinical research (1)
• As more experience is gained (more protocols) then the IRB tends to have more
experience (1)
• A transparent society such that we protect subjects by penalizing improper use of
personal information, rather than attempting to block access to personal information.
Until we get that, social media and similar technologies will just keep fraying our
doomed attempts to protect subjects via privacy. (1)
4.3.3 Challenges Related to Review of Social Media
Data security/privacy protection when using social media was selected as the most challenging or
concerning issue for IRB review (33%, 94/289) followed by data collection procedures (21%, 61/289),
the informed consent language (19%, 55/289), subject recruitment procedures (15%, 42/289), and lack of
social media expertise on the research team (11%, 33/289) (Table 4.18).

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Table 4.18: Most Challenging/Concerning Issues in Review of Social Media
In your opinion, what issues are the most challenging or concerning for IRB members when reviewing
proposals that incorporate social media (check all that apply)?

*Other:
• Psychological risks (1)
• Ethical use of copyrighted images/text in social media posts (1)
• Limited (not lack of) social media expertise on the team (1)
• Consenting or participation on social media (1)
• Collection of data using social media (1)
4.3.4 Comparison of Social Media to Other Technologies
When asked to compare review of social media to other types of technology, 68% (76/112) of
respondents thought that reviewing protocols using social media was about the same in difficulty as
reviewing protocols using other types of technology, while 27% (30/112) thought that social media was
more difficult to review. Only one respondent thought it was less difficult and five did not know (Figure
4.13).

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Figure 4.13: Difficulty of IRB Review of Social Media Compared to Other Technologies
Please select the statement that best describes how IRB review of protocols using social media compares
to IRB review of other types of technology.

Cross tabulation was performed to explore the relationship between years of IRB experience and
the perceived level of difficulty of social media review. As seen in Table 4.19, a majority of respondents
across all levels of IRB experience perceived social media to be about the same difficulty to review as
other technologies. However, respondents with less than 5 years of IRB experience had a larger
proportion of do not know responses than the other levels of experience.
68% (76)
27% (30)
1% (1)
4% (5)
(N=112)
About the same More difficult
Less difficult Do not know

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Table 4.19 Difficulty of Social Media Review Compared to Other Technologies by Years of IRB
Experience

Additional cross tabulation was performed to see if the number of protocols reviewed by
respondents as primary reviewer was associated with the perceived difficulty of review of social media.
The results revealed that a majority of respondents, regardless of the number of reviews conducted per
year, viewed social media to be same in difficulty to review when compared to other technologies (Table
4.20). Similar to Table 4.19, respondents who reviewed fewer protocols per year had the highest
proportion of do not know responses.

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Table 4.20 Difficulty of Social Media Review Compared to Other Technologies by Number of
Protocols as Primary Reviewer Per Year

4.4 Social Media Use in Clinical Trials
When asked about their views on the usefulness of social media in research activities, almost all
respondents thought social media would be useful for disseminating education about research to the
public (very: 58%, 239/412; somewhat: 37%, 152/412), for increasing the public’s knowledge about FDA
or research sponsor activities (very: 48%, 196/412; somewhat: 41%, 169/412), and for recruiting study
subjects (very: 57%, 235/411; somewhat: 35%, 144/412). On the other hand, almost half of respondents
believed social media would not be useful for getting the public’s input on protocol design 44%
(181/412). The use of social media with the greatest number of cannot say responses was for using social
media to increase efficiency and innovation of clinical trial processes (24%, 100/410) (Table 4.21).

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Table 4.21 Usefulness of Social Media in Research
In your opinion, how useful do you think social media may be for the following research activities?
Please answer regardless of any direct experience with the activities through your IRB.

*total due to rounding

When respondents were asked to provide their level of awareness or direct experience with social
media activities reported by other research stakeholders to potentially influence clinical trials, most (42-
89%) reported that they never heard of or had direct experience with the items listed (Table 4.22).
Specifically, 89% (361/405) never heard of nor experienced cases where enrolled subjects were able to
learn how to unblind study material using social media while only 9% (36/406) heard about and 2%
(3/405) had direct experience with this type of activity. Similar results were observed for almost all other
items listed including cases where subjects posted informed consents on social media (never heard nor
experienced: 89%, 363/406; heard about: 10%, 41/405; had direct experience: 2%, 7/406); discussed
adverse events (never heard nor experienced: 79%, 319/405; heard about: 19%, 77/405; had direct
experience: 2%, 9/405); potential subjects were coached on eligibility (never heard nor experienced; 79%,
323/407; heard about: 18%, 74/407; had direct experience: 2%, 10/407); subject privacy was breached
(never heard nor experienced: 76%, 310/407; heard about: 21%, 86/407; had direct experience: 3%,
11/407); and enrolled subjects posted opinions on site, staff, and sponsor (never heard nor experienced:

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73%, 298/407; heard about: 23%, 94/407; had direct experience: 4%, 15/407). The one area where
respondents had noticeably more direct experience was in the use of social media to expedite subject
recruitment (22%, 90/407) compared to 36% (147/407) who had heard about this type of social media
use, and 42% (170/407) who never heard about nor experienced this use of social media.
Table 4.22 Awareness of Social Media Influence on Clinical Trials
Have you heard of, or had direct experience with, any of the events below related to social media and
clinical trials?

*total due to rounding

4.4.1 Social Media and Clinical Trial Integrity
Respondents were divided in their levels of concern about whether social media use ultimately
affects clinical trial integrity (Figure 4.14). Two separate questions were asked to understand whether
the level of concern about trial integrity was different if enrolled clinical trial subjects were using social
media (e.g. subjects posting potential adverse events on social media) compared to the general public (e.g.
discussing opinions about a sponsor, site, or specific trial). The level of concern reported by the
respondents was slightly higher for social media use by clinical trial subjects (26%, 106/411) than for
social media use by the public (22%, 92/411) with approximately one-third of respondents in both groups
reporting that they did not know.

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Figure 4.14: Degree of Concern about Social Media Affecting Clinical Trial Integrity
How concerned are you that social media use by enrolled clinical trial subjects (left) or the public (right)
affects clinical trial integrity?

According to the respondents, their IRBs had little experience in reviewing language in consent
forms that would limit the use of social media by enrolled subjects. Specifically, 8% (34/407) of
respondents had seen cases where subjects were asked to refrain from discussing the clinical trial on
social media and only 2% (9/407) where subjects were refrained from social media activity altogether
(Figure 4.15).

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Figure 4.15: IRB Actions Regarding Social Media
To your knowledge, has your IRB ever reviewed language in a consent form for a clinical trial using
social media that asked subjects to do the following?

4.5 Respondents’ Personal Use and Experience with Social Media
This section was included to characterize the attitudes of respondents toward technology and their
use of social media outside of IRB activities. When asked whether they consider themselves to be early
adopters of new technology, responses were similarly split between agreed (strongly: 9%, 37/402; agree:
28%, 112/402) and disagreed (strongly: 6%, 22/402; disagree: 29%, 118/402) with almost an equal
number (28%, 113/402) choosing neutral (Figure 4.16).

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Figure 4.16: Early Technology Adopter Status of Respondents
Please provide your level of agreement or disagreement with the statement: “I am usually an early
adopter of new technology.”

Cross tabulation was conducted to explore if respondents who considered themselves to be early
adopters of technology had different levels of concern about the effects of social media on clinical trial
integrity. As seen in Table 4.23, respondents who considered themselves to be early adopters of
technology (strongly agree/agree) had higher levels of concern about the effects of social media use by
both trial subjects (53%, 55/104) and the public (60%, 54/90) on clinical trial integrity when compared to
respondents who considered themselves not to be early adopters (strongly disagree/ disagree) (subjects:
30%, 31/104; public: 26%, 23/90).

9% (37)
28% (112)
28% (113)
29% (118) 6% (22)
(N=402)
strongly agree agree neutral disagree strongly disagree

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Table 4.23 Clinical Trial Integrity Concerns by Early Technology Adopter Status

*total due to rounding

When asked about personal use of social media, the respondents reported using social media in
varying frequencies across different activities (Figure 4.17). Respondents used social media most
frequently to communicate with people they know (one or more times/day: 28%, 113/403; few times a
week: 23%, 93/403; few times a month or less: 21%, 84/403) and to read and react to postings (one or
more times/day: 21%, 86/403; few times a week: 18%, 74/403; few times a month or less: 20%, 82/403).
In comparison, the respondents used social media less frequently to participate in on-line communities
(one or more times/day: 11%, 43/401; few times a week: 17%, 67/401; few times a month or less: 26%,
104/401) and even less to interact with the public (one or more times/day: 4%,16/402; few times a week:
7%, 27/402; few times a month or less: 20%, 82/402).

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Figure 4.17: Personal Use of Social Media by Respondents
How often do you use social media for the activities below?

There were 18 text responses noted in the Other category that described additional uses of social
media (Table 4.24).
Table 4.24: Other Personal Uses of Social Media by Respondents

4.6 Analysis of Technology Readiness Index Domains
Analysis of questions mapping to the TRI domains of insecurity, discomfort, and optimism about
technology revealed that 90% of the respondents agreed that social media can have negative
consequences (insecurity) (strongly agreed: 48%, 191/402; agreed: 42%, 169/402) while 60% agreed that
social media platforms do not have clear instructions (discomfort) (strongly agreed: 13%, 54/401; agreed:

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47%, 187/401). In contrast, only 34% agreed that social media was a more convenient way to accomplish
daily activities (optimism) (strongly agreed: 6%, 24/403, agreed: 28%, 112/403) (Table 4.25).
Table 4.25 Attitudes on Social Media

Cross tabulation was performed to explore relationships between the TRI measures of insecurity,
discomfort and optimism and opinions on how difficult social media is to review, whether social media
use affects clinical trial integrity, and how prepared respondents felt to review social media. As shown in
Table 4.26, among respondents who reported higher levels of optimism about social media (strongly
agree/agree), a slightly greater percentage thought social media was at the same level of difficulty to
review as other technologies (same: 54%, 19/35; more: 40%, 14/35). Among respondents who reported
neutral or less optimistic attitudes (strongly disagree/disagree) about technology, much higher percentages
thought social media was at the same level of difficulty to review (neutral same: 70%, 31/44; strongly
disagree/ disagree same: 81%, 22/27). It should be noted that the number of respondents is low because
the question about difficulty of review was limited to those respondents who had social media review
experience.

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Table 4.26 Level of Review Difficulty by TRI Domain of Optimism

Table 4.27 shows that respondents with higher levels of insecurity with technology (strongly
agree/agree) were twice as concerned as those with lower levels of insecurity (strongly disagree/disagree)
that social media use by subjects may affect clinical trial integrity (30%, 71/240 vs 15%, 5/34). A similar
association was seen regarding social media use by the public (25%, 59/240 vs 15%, 5/34).
Table 4.27 Concern About Trial Integrity by TRI Domain of Insecurity

*total due to rounding
Complete cross tab analyses for the TRI domains are included in Appendix A.

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4.7 Understanding Issues Facing IRB Members in Review of Social Media
The last question invited survey respondents to provide narrative comments. A total of 58
respondents provided comments, many of which included multiple topics with some expanding upon
answers they provided earlier in the survey or describing specific experiences with social media and
review of research proposals. Eleven comments were about the survey or the respondent themselves. For
example, several respondents noted that their IRB only reviews specific types of research, does not see
much social media, or the respondent has not reviewed social media. Two comments identified specific
survey questions or response categories that were confusing. The remaining comments were analyzed to
identify themes. A summary of the themes with excerpts from actual responses is in Table 4.28.
Complete text responses are in Appendix B.
Table 4.28 Themes of Narrative Comments
Provide any additional comments or information you feel will contribute to understanding the issues
facing IRB members in the review of social media.
Theme: Concerns about privacy
“Recent privacy breaches have made me very skeptical regarding the use of social media.”
“The most nebulous issue is how social media sites protect privacy and confidentiality.”
“What is the expectation of privacy on social media sites?”
“I’d like more training on the privacy policies and practices on different social media platforms.”
“As an investigator, I will not participate in research using social media as I will not be able to assure
protection for subjects.”

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Theme: Potential effect of social media on data integrity
“As convenient as social media can be, its use may destroy the integrity of research. Who knows who
is REALLY responding to a social media post, and under what conditions (including sobriety,
pathology, age).”
“the voices heard on social media represent those of the minority of users who interact or create content
and do not represent the voice of the general public.”
“Viral distribution of incorrect information- from all aspects of study matters.”
“I think that any exposure via social media will bias the outcome. It could be positive or negative, but
likely will have some impact on the outcome.”
“If the researcher is recruiting participants through social media, a self-selected sample is used- rather
than a random one.”
“The original hope for social media was that we would have shared knowledge. We now have greater
shared manipulation through false narratives and half-truths. This, in concert with crowd-think effects,
in my opinion, will either bias or pollute the data you get through social media.”
“What about researchers using apps for subject input? Probably easy to hack”
Theme: Role of social media in research
“The use of social media for recruitment tactic can be useful as long as traditional protection policy is
in place.”
“There is some utility (especially among younger potential participants) in using social media to inform
the public about the availability of research studies, basically replacing the role of newspaper/TV/radio
advertising.”
“I am interested in learning more about the role of social media in research. I think it could really help
us in keeping in touch with enrolled participants.”
“Overall I think social media is here to stay, and needs to be a part of research.”
“I am sure it is coming.”

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Theme: Recommendations and needs
“We do not have any guidelines for research and social media but I feel we should.”
“Given that this is a new area of research, more information/training is needed for IRB members to
review studies using social media.”
“ we may begin to add expertise in technology now becoming more common in research with human
subjects.”
“It would be of great help to have a consultant with discretion available to consult on any dimensions of
a protocol that involved social media, someone who is not charged with the full responsibility of IRB
membership.”
“Would need to see potential risks of adverse events due to use of social media as part of study protocols
to be mitigated somehow in the protocol.”
“A way to determine digital literacy for subjects capacity to consent given that the populace has
differential knowledge and experience with social media.”
Theme: Importance of topic
“Important issue. Doing survey raised interesting points to consider.”
“This is a huge challenge for the future. IRB guides will need to adapt to this rapid change of
communication.”
“To reiterate- IRB board members need to understand the nuances of how social media affects research
studies. Something I have not personally considered until this survey.”
“The survey poses questions our IRB will eventually have to consider.”

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Theme: Social media fit with existing regulations and policies
“social media is unregulated…and therefore does not meet the privacy protection guidelines of NIH”
“The need to evaluate if the communication modality of social media contributes a unique set of
challenges that current IRB policy isn’t flexible enough to accommodate.”
“issues concerning social media and HIPAA would be worth exploring.”
“A big problem is that the regulations have not caught up with the technology that is being used in
research. Even non-binding guidance is lacking. That said, I think IRB members have taken it upon
themselves to learn about the issues related to social media and in that sense are far ahead of regulators.”
“differences between social media and FERPA”
“implications for EU privacy policies”
“institutional information security regulations”
Theme: Need for additional regulations/policies/guidances
“I believe policies or procedures are needed on the underlying topics, but that they do not need to be
specific to social media (i.e. there needs to be a policy on “standards for storage of data”, not on
“standards for social media data.”
“I feel that our policies …are broad enough so that they are inclusive of social media.”
“I think all of these things are covered in general ways and I prefer this- it makes our policies more
adaptable.”
“studies involving social media should follow general IRB policies.”
Theme: Difficult to identify risks and benefits of social media in research
“it is hard for IRB members to fully appreciate the differences between protocols in terms of risk when
these protocols are using different social media platforms that present underlying variance in
security/privacy risk.”
“IRB members need to understand what are the risks- is someone going to be harmed, killed, break a
leg, commit suicide, kill someone, embarrassed- what are the risks?”
“The need to evaluate if the communication modality of social media contributes a unique set of
challenges that current IRB policy isn’t flexible enough to accommodate.”

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Theme: Challenges to the informed consent process introduced by social media
“Consent procedures: If data consists of publicly shared posts, does this automatically waive the
consent requirement?”
“A way to determine ‘digital literacy’ for subjects ala ‘capacity to consent’ given that the populace has
differential knowledge and experience with social media.”
“I would be very very circumspect about allowing consenting or participation to occur via social media
without a very clear explanation and protocol by the PI
“We need more information on…proper ways of consenting subjects”
“The changing best practice of obtaining consent with studies on public platforms.”
“Whether or not people who respond to a recruitment ad through social media are more or less informed
about the study at the time they respond than people who respond to a flyer or other type of recruitment
ad. Do those responding through social media differ in any way from those who respond through more
traditional means?”

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CHAPTER 5. DISCUSSION
5.1 Overview
Despite the adoption of social media by patients, providers, regulators, and sponsors for uses
related to health and disease, there is relatively limited use of social media in clinical trials. One of the
potential barriers to social media’s greater use in clinical trials may be IRBs, a key stakeholder tasked
with determining the benefits and risks of clinical investigations. Because IRBs make decisions on
whether a clinical trial and its proposed methods of recruitment, intervention and subject follow-up
should be allowed to move forward, IRB opinions determine if and how new technologies like social
media are incorporated into the clinical trial process. Hence, this study explored the views of IRBs
through their chairs on the readiness of IRBs to evaluate social media within the context of clinical
research. There were three major findings. First, views of the respondents indicate that IRBs need
greater access to social media training and specialized experts to contribute to IRB review of social
media. Second, unlike other clinical trial stakeholders, including industry and investigators, who
advocate for specific regulations and guidances on how to navigate social media, respondents in this
survey did not. Instead, they indicated that IRBs should be able to interpret and apply existing regulations
to individual studies that may introduce a new technology or scientific innovation. Finally, IRBs seem to
have low awareness of the ways in which social media is already influencing clinical trials and mixed
opinions about the potential effect of social media on clinical trial integrity. Discussion of the results is
organized according to the research framework by addressing facilitating conditions, performance/effort
expectancy, social influence, and technology readiness.

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5.2 Methodological Considerations
5.2.1 Delimitations
The survey sample was delimited to IRB committees in the United States because of differences
in clinical trial regulations and ethics committee review procedures that exist in different countries. Also,
ethical and cultural norms can differ across populations, particularly with respect to privacy, informed
consent, and subject recruitment. The sampling frame included all IRBs registered with the Office of
Human Research Protections (OHRP) in the United States. We considered two alternate methods of
obtaining a sampling frame but eliminated these methods due to concerns that they would introduce bias.
The first method considered was a manual search for specific IRBs. It was felt this would be tedious,
time-consuming and likely to be incomplete. The second method was distributing the survey through an
IRB professional organization such as PRIM&R. However, this organization did not allow distribution
through their membership listserve and suggested that we post the survey link within one of their on-line
forums. Doing so would not allow us to have a reliable denominator of potential participants and thus
would prevent calculation of an accurate response rate. Because the only records excluded from the
survey invitation were IRBs that exclusively reviewed social and/or behavioral research and chair names
that were duplicates, the sample should comprehensively represent the biomedically-oriented IRBs
located across the United States.
The number of survey questions was another delimitation. Prior research on whether the number
of survey questions correlates with response rate shows mixed results (Dillman et al., 1993). We focused
on selecting questions and question formats to allow respondents to complete the survey within
approximately 10-15 minutes. Comments from focus group testing were helpful in adjusting question
wording and to verify how long it took to complete the survey. Some respondents, however, likely spent
more time on the survey because they added extensive narrative comments. A total of 529 surveys were

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initiated, of which 407 were completed. Incomplete questions were distributed across the survey
questions.
A final delimitation was that the survey went only to IRB Chairs and not to other IRB members.
We based this decision on feasibility because it was possible to obtain a complete list of IRB Chairs and
their contact information through a Freedom of Information request while a comprehensive list of IRB
membership rosters for all US IRBs was not easily accessible. Several years ago, Dressler distributed a
survey about genetic research to IRB members using the PRIM&R website. Because the researchers did
not know exactly how many members were reached, the response rate was reported as “approximately
7.5%” based on the estimate of PRIM&R membership (Dressler et al., 2012). We chose to use the IRB
Chair list in order to have a greater control over survey dissemination and thereby calculate a more
accurate response rate.
5.2.2 Limitations
Response rates can vary greatly across different types of research using survey methodologies.
This survey used an online survey tool and had a response rate of 15%. Qualitative research methods like
focus groups and phone interviews typically achieve higher response rates, like those observed in prior
research administered to IRB Chairs that yielded response rates ranging between 23-67% (Williams et al.,
2012; Klitzman, 2013; Simon et al., 2011). A 72% response rate was seen when an anonymous survey
was administered by mail to IRB Chairs regarding conflict of interest policies. This high response rate
was achieved by identifying and targeting a narrow group of potential respondents consisting of the top
100 medical schools and 15 independent hospitals that are in the top tier of NIH funding (Vogeli et al.,
2009). A study by Kane on the informed consent process identified 350 IRB Chairs through an “extensive
internet search”. This study saw a response rate of 33% but the authors acknowledged a potential bias
resulting from their selection process (Kane and Gallo, 2017). It should also be noted that the surveys
generating higher response rates addressed a mandated function of IRBs (review of the informed consent

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process) and an issue that addressed compliance (conflict of interest). It is possible that respondents were
not interested in participating in this study that examines their views on social media because they had not
encountered it in their IRB role. Another limitation of this study is that the survey was anonymous and as
such, we do not know the characteristics of those who did not respond and their reasons for not
responding.
Although the original intent was to delimit the scope of the study to the IRBs that primarily
review biomedical FDA-regulated clinical trials, there was considerable representation by IRBs that also
review social/behavioral as well as other types of research. The response profile of this survey shows that
most respondents review different types of research. Hence, results of all respondents are included in the
analysis. In hindsight, individuals who review social/behavioral research may have had more experience
with social media than their colleagues on biomedical IRBs, but their comments may not be directly
relevant to FDA-regulated clinical trials.
An additional limitation was that most respondents had limited experience reviewing clinical
trials that included social media. This limitation was anticipated and documenting the level of experience
was one of the objectives of the study. Questions adapted from the Technology Readiness Index (TRI)
were included in the research framework because this instrument does not depend on whether an
individual has had direct experience with a technology. To maximize the number of completed surveys,
we placed questions that all respondents could answer (e.g. about their access to training) earlier in the
survey and placed more specific questions that correspond to their levels of experience later in the survey.
5.3 Consideration of Results
5.3.1 Facilitating Conditions that Influence IRB Review of Social Media
One of the goals of this research was to assess the capacity of IRBs to review social media. The
survey questions focused on three facilitating conditions: existence of IRB policies, expertise on the IRB

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committee, and types of training. The quantitative and qualitative results indicate that IRB Chairs in
general believe they are lacking adequate levels of facilitating conditions in all three areas. However,
although one might assume that such deficiencies may present IRB members with trepidations about
reviewing social media, an overwhelming majority of respondents (81%) felt prepared to review social
media (Figure 4.10). Further, those individuals who had experience reviewing social media reported that
it was no more difficult to review than other technologies (Figure 4.13).
These findings describing how IRB reviewers characterize their ability to review social media
were surprising, but in alignment with other published findings. Prior literature shows that despite having
limited expertise in a specific technology, IRB members believe they are capable of judging the
technology’s risks (Vitak et al., 2017). Vitak and coauthors posited that the confidence of reviewers in
approaching review of a new technology may be linked to how much overall experience they have
reviewing a broad spectrum of study protocols. The findings from the present study, however, did not
reveal a relationship between years of IRB service and feelings of being prepared to review social media
(Table 4.12) or assessment of difficulty reviewing social media compared to other technologies (Table
4.19). On the other hand, direct experience reviewing protocols as seen in the number of primary
reviews done by the respondent did seem to affect the level of preparedness, suggesting this direct
experience reviewing protocols contributes to greater confidence approaching new technologies (Table
4.13). This relationship was not present for difficulty of review (Table 4.19). Interestingly, individuals
with fewer years of IRB experience had a higher proportion of do not know responses for the question
asking for their assessment of the difficulty of social media review compared to other experience levels.
This may be due to less experience with the IRB process overall and confidence in applying existing
regulations to new technologies.
The survey results contained several implications regarding training. First, while training was the
most needed resource identified by respondents to help with social media review, it represented less than
one-quarter of the responses. Thus, almost three-quarters of this sample did not prioritize receiving

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training on social media. This could be because of the lack of exposure to social media in the current
sample and the idea that the optimal time for training is when IRB members have a social media protocol
to review. The survey did not probe for barriers to receiving training although based on prior literature,
one barrier is likely lack of time given that IRB members often have other professional roles and
responsibilities (GAO, 1996). A second implication for training was the need to combine basic training
on social media with specific examples of how to apply existing regulations to social media use in clinical
trials. These results are similar to those of Tamariz and colleagues who studied the preparedness of IRBs
to review community based participatory research (CBPR). This research also concluded that IRB
education must link principles of CBPR as a methodology with guidance on how to apply the regulations
to the unique context of CBPR in a research study (Tamariz et al., 2015). These results should help to
inform and prioritize training available at IRB professional meetings and training modules available on-
line.
As reported in Chapter 2, the need for regulations or guidance from the FDA on social media
remains a strong theme in the academic literature and industry press (Lipset, 2014; Reid, 2011;
Lipschultz, 2014; Shapiro and Ossorio, 2013; Bloss et al., 2016). According to recent polls, the public
also supports greater regulation of social media and digital technologies (Rainie, 2018; Segura Anaya et
al., 2018). The findings from this study, however, indicate that the IRBs would like to receive more
training and have access to expertise and a repository of IRB decisions rather than be burdened with
additional FDA guidances or new federal regulations. The text comments further support the view that
regulations should be broad and provide the IRBs the flexibility to interpret and apply them to specific
protocols:
“I believe policies or procedures are needed on the underlying topics, but that they do
not need to be specific to social media…”
“The general policies about use of social media are clear but each protocol brings
unique circumstances that need interpretation in context of time and place.”
“I think all of these things are covered in general ways and I prefer this- it makes our
policies more adaptable.”

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There are several possible reasons why the respondents did not favor additional regulations.
First, federal regulations are only one type of regulation or policy that IRB reviewers need to consider
when reviewing social media. Among the examples of other regulations/policies cited by respondents
were HIPAA, regulations governing educational records, state laws, local policies and “new European
regulations.” It appears that IRB reviewers are already grappling with a complex regulatory
environment, particularly in their experiences with social media to date, and further regulations may only
add to this complexity. As described earlier, Vitak suggests that IRB members believe that the optimal
way to become more proficient in reviewing a new technology is to become more proficient with IRB
review process overall (Vitak et al., 2017). If this theory is true, there may be initial delays in review
times that would improve over time as reviewers gain a greater level of experience. However, there is no
current literature that has reported on this idea and it may not apply to social media given how diverse
social media technologies are and how rapidly they are changing.
Instead of additional regulations, respondents prioritized getting more training and/or access to
expertise on social media, particularly in the areas of privacy protection and data security. The extent of
this need was evident from the large number of text comments provided by the respondents. A need for
greater access to technical expertise was also voiced by Regenberg, a social media expert for a bioethics
institute, who noted that IRB members were simply not hired to be social media experts and that it may
be helpful to engage social media facilitators or content experts in the review process (Regenberg, 2010).
Another suggestion offered in the literature is to convene a separate technology ethics board (Nebeker et
al., 2017), similar to ones currently being used for other types of specialized research like regenerative
medicine or radiation safety (Friesen et al., 2017; Bloss et al., 2016). While this approach seems like an
ideal way to improve access to expertise, the advantages of having multiple committees must be weighed
against the possible delays in review timelines and additional paperwork for researchers and sponsors. In
addition, experts in social media may have more stringent standards for privacy and data protection than
IRB reviewers that are difficult to meet or cost prohibitive.

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The findings related to facilitating conditions can be summarized in two themes. First,
researchers should appreciate that to date, IRB members have had limited exposure to social media in
clinical trials but believe they are prepared to apply the existing regulatory framework to review of social
media. This finding may motivate some researchers and sponsors to increase their use of social media
within clinical trials. A second related theme is that IRB reviewers acknowledge that they need more
training and access to technical expertise, particularly in the areas of privacy and data protection related to
social media use. The findings from this study should inform researchers and sponsors of specific IRB
concerns that can be addressed in their future submissions. For example, a useful approach may be to
present information on social media in a similar format as one would for a new drug or device, (e.g. prior
experience, anticipated and unanticipated risks, and procedures to protect against risks). This approach is
similar to the non-exceptionalism approach suggested by Gelinas that advises IRBs to employ the same
review procedures as they would for studies without social media (Gelinas et al., 2017). The findings
from questions on facilitating conditions provide guidance for researchers and sponsors on more relevant
information to include in protocol submissions, as well as guide the research community to offer
additional training on social media.
5.3.2 Performance Expectancy
A second goal of this research was to determine the views of IRB members on the role of social
media in clinical trials. Overall, the results indicate that IRB members thought that social media could be
used to recruit subjects, disseminate education, and inform the public about the FDA or research sponsors.
The respondents, on the other hand, did not view social media as being useful for obtaining public input
on protocol design or increasing the efficiency and innovation of clinical trial processes. Hence, the
results indicate that IRBs see social media primarily as a mechanism for distributing information rather
than an interactive platform. The finding that respondents in this sample also restricted their own social
media use primarily to communicating with known people rather than interacting with the public or
participating in on-line communities further supports this idea. Although FDA, sponsors, and researchers

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already use social media to obtain patient input on study designs, IRB members in this sample did not
appear to be aware of this type of social media use for patient engagement. As described in Chapter 2,
sponsors and researchers use social media to define unmet needs and potential study endpoints
(Stergiopoulos and Getz, 2015) and to target recruitment messages (Reuter et al., 2018). In addition, the
FDA acknowledges that social media is helpful to understand patient opinions and experiences (FDA,
2018). It is not clear if the results of this study are indicative of a lack of awareness of protocol design
activities that typically occur before IRB review, or if respondents actually believe social media is not an
appropriate tool for soliciting input on trial design. The text comments indicate that IRBs may have
broader concerns about the reliability of social media postings. Examples illustrating these concerns
include:
“…how to confirm the identity of respondent and validity of responses.”
“Who knows who is REALLY responding to a social media post, and under what
conditions (including sobriety, pathology, age).”
“We now have greater shared manipulation through false narratives and half-truths.
This, in concert with crowd-think effects, in my opinion, will either bias or pollute the
data you get from social media.”

The concerns of respondents about the validity of information on social media are similar to those
noted by the FDA (FDA, 2018). While the FDA and industry clearly acknowledge the risks and
limitations of social media, both groups continue to explore how social media can be used. Although
IRBs do not typically review pre-study activities, it may be particularly useful for IRBs to examine how
FDA and industry are using social media to engage patients and the public for this purpose. Similar
strategies could be used by IRBs to obtain input from nonscientific and nonaffiliated individuals on the
risks and benefits of social media and specific research projects. Not only is this input mandated by
Section 46.107(a) of the Code of Federal Regulations, understanding the perspectives of these other
stakeholders who are also potential research participants aligns with the Belmont principles of autonomy
and justice.

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5.3.3 Effort Expectancy
A third category of information collected was the views of respondents on how easy social media
is to use in research. These findings could inform IRB reviewers as they assess risks associated with a
study that includes social media. For example, if a technology is difficult for researchers or subjects to
use, it may lead to an increase in the overall level of risk in the study. According to the research findings,
characteristics of social media that were thought to complicate its use in research included inadequate
measures to protect the privacy of individuals and study data; to verify the authenticity of interactions
between the team and research subjects; and to confirm the accuracy of data collected. These issues are
similar to those raised by the broader research community and the survey results alert researchers and
sponsors that protocols and study procedures need to address these topics.
A major concern of respondents mentioned throughout the survey is that social media introduces
new potential risks to an individual’s privacy and data security and these risks are difficult to mitigate and
evaluate during protocol review. Accordingly, some respondents thought there was a need for more
training and additional IRB policies in the area of privacy and data protection. While only 1 out of 5
IRBs in this sample reported having policies specific to social media, most (88%) of those policies
focused on privacy protection (Figure 4.9). Text comments like those below provide more insights into
the difficulties encountered by IRB reviewers:
“When research is on a sensitive topic…how to protect the identity of survey
respondents (such as instructing them on how to alter their browser history to hide
their responding to the survey…)”
“How are cookies used and can they be traced back to a participant?”

Closely related to privacy protection is the protection of data. The timing of survey distribution
coincided with several well-publicized events regarding data privacy. There were several breaches of on-
line data exposing individual data to unauthorized individuals (Isaac and Frenkel, 2018). These breaches

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raised serious concerns among the public about the vulnerabilities of social media data and the
complicated terms of service and data sharing practices that may be difficult for individuals to understand.
Also occurring in a similar timeframe was the discovery that “loopholes” exist in Facebook allowing
outside vendors to access a user’s profile and their linked contacts without any consent or knowledge of
the user (Valdez, 2018; Isaac and Frenkel, 2018). While these events were not specific to clinical trial or
health research data, they clearly influenced the attitudes of the respondents toward using social media:
“Recent privacy breaches have made me very skeptical regarding the use of social
media.”
“SM platforms, most notably Facebook, have been found to play fast and loose with
account holder information.”

Other members of the research community raise similar concerns that have resulted in the development of
new frameworks that can be used to evaluate the adequacy of privacy and data security. (Cavoukian,
2011; Gelinas et al., 2017; Segura Anaya et al., 2018). Although these resources may be helpful to IRB
reviewers, efforts should be made to educate the IRB community about their availability and research
should be conducted to assess their effectiveness.
A second theme noted by the respondents is the need to verify the authenticity of interactions
with research subjects and the accuracy of information provided during the informed consent process.
These concerns were primarily expressed through the text comments (Table 4.28):
“it is too easy for people to do and say things that are inaccurate on social media
without any way for the researcher to know about it…”
“Who knows who is REALLY responding to a social media post, and under what
conditions (including sobriety, pathology, age).”

Sponsors have recognized these challenges and are developing ways to authenticate users who are
participating in social media study groups. For example, one multiple sclerosis trial required subjects to

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take pictures of medication bottles to verify actual enrollment before being allowed to enter the group
(Bookbinder, 2014). Survey respondents also mentioned that it was difficult to judge whether
information provided to subjects in the informed consent was accurate. Here again, the text comments
identified similar themes as those previously reported by researchers and ethicists:
“We need more information on…proper ways of consenting subjects…appropriate
information to subjects about what can happen to subjects after their information is
collected.”

As described in Chapter 2, social media platforms and their terms of service are difficult to understand
(Wilbanks, 2018; Gibson and Copenhaver, 2010) and may change without control of the researcher
(Swirsky et al., 2014). This suggests that subjects need to renew their consent if terms change during the
course of a study. Developing consents that are clear can be challenging for both research teams and
IRBs. In fact, IRBs have been criticized for “promulgating unreadable consent forms” (Paasche-Orlow et
al., 2003; Philipson et al., 1995) and for approving consent forms at reading levels that are too difficult for
comprehension by typical lay participants (Foe and Larson, 2016). In this area, digital technology could
provide a possible solution. For example, social media could facilitate a staged consent process
conducted over multiple interactions, allowing subjects more time to ask questions without the pressure to
make quick decisions. Social media may also be an effective tool to discuss changes to the consent form
that may be required during a study. Thus, some stakeholders believe that ongoing work to address the
challenges of social media (e.g. confirming user identities) should not impede efforts to explore whether
social media can be used to meet regulatory requirements for informed consent.
Social media is unique compared to other technologies because it is widely available and
extensively used. As a result, social media platform operators have information on who uses social
media, the incidence of data breaches, and measures to mitigate risks. Hence, a stronger partnership
among researchers, IRBs and social media platform operators would be useful during the review of
specific protocols and would support efforts to make IRB decision-making more data-driven. Martinez

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even suggests that social media vendors have a “social responsibility” to become part of research teams
because of the benefit they are deriving from the public’s use of social media (Martinez et al., 2014).
Others suggest that social media operators receive training in human subjects research. Each of these
suggestions illustrates the broader theme that the research environment is more complex, with new
stakeholders that potentially require new models of ethical decision-making. These suggestions also offer
solutions to concerns articulated by the research community that digital technologies as a whole do not fit
into commonly accepted ethical and regulatory paradigms (Bond et al., 2013; Vayena et al., 2012).
5.3.4 Social Influence
Social influence in the context of this study refers to how opinions of other groups or individuals
influence IRB reviewers. Because IRB decisions arise from consensus, a member who has a more
positive attitude toward technology may influence other IRB members to adopt a similar attitude.
Attitudes on technology were measured in this survey using questions adapted from the TRI framework to
determine level of comfort regarding technology. The survey sample had a similar proportion of
individuals who considered themselves early adopters (37%) as non-early adopters (34%) (Figure 4.146).
Adopter status appeared to have some effect on views of whether social media affects clinical trial
integrity. About half of the respondents who agreed with statements they were early adopters reported
they were very concerned about effects on clinical trial integrity compared to about 30% of those who did
not consider themselves early adopters (Table 4.23). This may be related to greater knowledge about the
capabilities of social media rather than decreased sensitivity to its potential liabilities. Another potential
explanation could be that while respondents use social media their use is not frequent enough to increase
their confidence in managing aspects such as privacy protection. Almost three quarters of this sample
reported using social media for communicating with known people. While this proportion is similar to
other surveys estimating between 72-86% of the population use social media (Pew, 2019; Herhold, 2018),
only 28% of this sample reported using social media more than once a day compared to estimates of 72%-
75% using social media multiple times a day.

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In addition to fellow IRB members, social influence could come from the opinions of patients and
the public on the benefits and risks of social media in a research study. In this sample, only 12% of
respondents reported that their IRB committees included nonscientific members with social media
expertise (Figure 4.6). In retrospect, additional questions may have provided more insight into how IRB
chairs define expertise and assess the expertise of both scientific and nonscientific committee members.
In addition, a more appropriate question may have been to ask about whether IRB chairs were aware of
the level of social media exposure of their nonscientific members. Similar to the theme described earlier
about training, social media expertise combines knowledge of social media with an understanding of
regulations and policies applicable to a specific protocol and subject population. Prior literature reports
that nonscientific members believe they do not have insights into all the populations they are representing
and do not receive training specific for their role in the IRB (Anderson, 2006; Sengupta and Lo, 2003).
Thus, it is important to pair social media training with more extensive training on the rationale for
including nonscientific members on IRB committees and an assessment of whether existing nonscientific
members can accurately represent the views of the specific population being reviewed. Results of this
study also indicate that IRBs do not typically go outside of the IRB committee to seek ad hoc input from
patients to supplement their deliberations on social media. This is concerning because prior studies noted
differences between how IRB reviewers and the public view risks and interpret informed consent
regulations (Buckle et al., 2010; Meyer, 2013; Kraft et al., 2016). More recent studies specific to social
media show the public has a complex perception of issues such as privacy related to social media that can
vary based on experience level and demographics (Reuter, 2019). This makes it even more important for
IRBs to have ways to obtain opinions from patient and participant stakeholders. With its wide availability
to the public, social media can serve as a tool to identify and incorporate the views of potential subjects
into the information available during IRB deliberations. Doing so may assist IRB reviewers during the
review process and allow IRBs to join in the overall movement toward greater patient participation in the
research process.

105
Another way the public and patients can have social influence on IRB decisions is through their
activities on social media that produce a negative impact on clinical trial integrity. When these activities
happen within a study, for example, a subject breaching the privacy of another subject on social media,
this could cause an IRB to modify or curtail social media use. This type of event could even cause an
IRB to develop future policies restricting the use of social media for a larger group of studies. Survey
respondents shared similar concerns about the potential negative impact of social media on trial integrity
as the FDA, researchers and sponsors (Table 4.28). These include the spread of false information,
recruitment of biased samples, and inability to confirm user identity. However, the respondents had
limited awareness of the specific types of social media activities by the public and trial subjects that
sponsors believe jeopardize trial integrity (Table 4.22). This may be because some of these activities
occur outside the trial setting and/or there is no defined mechanism to inform IRBs of their occurrence or
regulatory precedent for actions to take. Overall, the finding that only a quarter of respondents were very
concerned about the effect of social media on clinical trial integrity may be because there was no
definition of clinical trial integrity provided and the respondents were not aware of the reports of sponsors
and researchers in this area. Responses may have been different if examples of concerning social media
activity were presented before the question about the effect of social media on clinical trial integrity.
A last example of social influence is the influence of other IRBs and peer-reviewed literature on
IRB decision making. According to the study results, IRB members are most likely seeking training and
advice from their IRB colleagues and researchers rather than looking to the FDA for additional regulation
or guidance. Therefore, IRB members in this sample consider professional meetings and sharing of past
deliberations and decisions as the most valuable resources for IRB members. The idea of a formal
repository of IRB decisions has been suggested in the literature as a way to increase consistency and
transparency of IRB decision-making, but may not be feasible because IRB records are not properly
“curated, indexed, or easily-searchable by topic or type of issue raised.” (Lynch, 2018) In addition, to be
optimally useful, such a repository should be available to the broader research community but it is unclear

106
how receptive the IRB community would be to such transparency of IRB decisions. Results also indicate
that IRBs seek peer-reviewed literature during their reviews of social media. Hence, during the IRB
application stage, researchers should be diligent in examining and referencing relevant literature to
support how they intend to use social media in their research. Once the research is completed, researchers
and sponsors should make sure they publish how social media was used, including specific methods to
protect data and privacy. Reporting should also include data on any positive and negative experiences
associated with social media in order to add to the literature base for future studies.
Social influence acknowledges that the opinions and practices of others regarding use of a
technology influence an individual’s own opinions. Results of this survey indicate that IRBs would
prefer to consult peer reviewed literature and other IRBs for their experiences with social media rather
than specific guidance from regulators. Results of this survey also indicate that IRBs may not be
adequately incorporating patient perspectives during their deliberations. Given that the FDA, sponsors,
and researchers are using social media as a tool to integrate patient input into clinical trial practices, IRBs
could learn from these efforts and find ways to use social media to engage patients and obtain their
perspectives. In doing so, IRBs would accomplish the dual goals of learning more about social media
while also taking steps toward making IRB review more representative of patient views.
5.4 Conclusions and Future Directions
The findings in this study should inform researchers and sponsors who are considering including
social media in future clinical trials. It is clear, for example, that IRBs view social media to be useful in
various aspects of clinical trial activities. Hence, researchers should be encouraged to incorporate social
media within their studies in ways that address the primary concerns about social media raised by survey
respondents (e.g. measures to protect privacy and data.) Furthermore, based on the study findings, IRBs,
researchers, and even sponsors should have access to training focused on the more common uses of social
media proposed in clinical trials, experts to assist with deliberations on more complex issues, and

107
information on how IRBs have interpreted and applied the regulations to social media to date. One
priority is to raise awareness among IRBs members about existing repositories of IRB-approved
protocols, best practices, and IRB decisions on social media. The information obtained from this survey
provides a foundation for future work to understand the complex ethical, regulatory and resource issues
associated with IRB review of social media in clinical trials and the types of social media use that might
be more acceptable to IRB reviewers. A second priority is to consider the use of social media for specific
activities of importance to IRBs, such as improving the informed consent process or increasing access to
patient opinions on risks and benefits, which would allow IRB members to gain experience with this
technology while also defining its optimal uses in clinical trials. With continued research in this area, the
clinical trial community could develop a roadmap to realize the potential of social media and other
technologies to make clinical trials more efficient and relevant while maintaining standards of protection
for human subjects.

108
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Appendix A.………..
Cross tabs on TRI Domains
Additional cross tabs analysis was performed on three TRI domains to assess whether there was any
relationship between how a respondent viewed technology and their views on: level of preparedness to
review social media, perception of whether social media was more difficult to review than other
technologies, and opinions on whether social media use affects clinical trial integrity.
A. 1 TRI Measure: Optimism “Social media is a more convenient way to accomplish daily activities.”
A.1.1 Level of Preparedness to Review Social Media

*total due to rounding

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A.1.2 Perception of Whether Social Media is More Difficult to Review than Other Technologies

A.1.3 Social Media Affects Clinical Trial Integrity

132
A. 2 TRI Measure: Discomfort “Using social media can have negative consequences.”
A.2.1 Level of Preparedness to Review Social Media

*total due to rounding
A.2.2 Perception of Whether Social Media is More Difficult to Review than Other Technologies

A.2.3 Social Media Affects Clinical Trial Integrity

*total due to rounding

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A.3 TRI Domain: Insecurity “Social media platforms do not have clear instructions.”
A.3.1 Level of Preparedness to Review Social Media

A.3.2 Perception of Whether Social Media is More Difficult to Review than Other Technologies

A.3.3 Social Media Affects Clinical Trial Integrity

*total due to rounding

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Appendix B. ………..
B.1 Narrative Comments for Question 8
If there are specific aspects of social media that you would like more training on please describe them
below:
Social media and the protection of privacy/confidentiality
Confidentiality, bias related to social media, standards for capture rates in studies using social media.
We have not had much experience with research protocols using social media. It would be good to
discover lessons learned from others with more experience in this area.
The ability to be confidential with questionnaires and surveys with the various survey platforms. The
types of surveys that researchers can currently conduct on line. (I know there are business type
surveys) out there that are confused with research surveys.
I could be more informed about all forms because I don't think I know everything about anything.
privacy confidentiality
Interaction of HIPPA and social media -- how to ensure that one person does not answer surveys more
than once
What is considered public and what is not.
qualitative use of media for sensitive issues and among vulnerable populations
policies regarding public access; security
What ethical situations could arise from social media and studies. A specific framework or guideline to
follow.
Privacy protections associated with recruiting via social media
I think a very direct correlation between social media and research review would be helpful - I am able
to use my high level of technological expertise and experience with social media as both an individual
and a researcher to make informed decisions, but it would be good to have specific examples of where
a decision might be different when social media is in play.
privacy settings and options
What information would be considered public versus private.
Privacy standards.
Ensuring that the research is allowed under the privacy policies and terms of service of the social media
platforms being used.
Recruitment and storing of data obtained.
The number of ways data confidentiality can be breached.
HIPAA rules application to social media; what is allowed and to what extent; subject confidentiality
and safety of communications and data shared
Issues of confidentiality and privacy are my first concern, but I am functionally illiterate on most
aspects of social media, except for communicating with my grandchildren.

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I think the issues are different when research is done as part of a HIPAA covered entity. I don't really
need more training what I really need is for there to be some pathways for this to happen more easily.
How are cookies used and can they be traced back to a participant?
How to protect vulnerable populations who may participate in social media studies
We need training on all aspects of social media as they relate to IRB; we have reviewed 2 protocols
using social media in the past couple of years, relying on the investigator to explain safety measures
adequately to IRB members.
any implications for EU privacy policies
Security aspects of social media.
How to address privacy (or lack thereof)
Data security, privacy of study subjects
training on social media is ongoing due to constant changes to privacy, and new outlets for social
media.
privacy protections
Perhaps, on ways to assure confidentiality on subjects responses to surveys, if answered through these
venues.
Security issues
More in depth knowledge of how the platforms operate to share data —with or without permission;
Where are the vulnerable areas in research? What about researchers using Apps for subject input?
Probably easy to hack like video games are...
We need more information on security of interactions with subjects, proper ways of consenting
subjects, appropriate ways of advertising the study, appropriate information to subjects about what can
happen to subjects after their information is collected.
Policies/procedures for social media use.
Honestly I would need to start with the basics
None.
It is always unclear to me the extent to which different social media platforms store and retain data and
exactly what data is stored and how it is linked to individuals and their information.
data security
A module that provided an over view of types of social media as well as a review of the specific risks
and benefits encountered using social media in research. Another module that would discuss specific
things to think about when reviewing or considering the use of social media in research.
More info about the application of informed consent and confidentiality.
Issues around privacy. Accuracy and reproducibility of social media versus in-person encounter.
Consent procedures: if data consists of publically shared posts, does this automatically waive the
consent requirement? Ensuring privacy in social media, where it is very difficult to de-identify human
subjects.
Privacy and confidentiality

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privacy, generalizability
None.
Navigating the algorithms that choose news stories, information, research studies based off of the
researches past search histories.
How to evaluate security of information and confirm identity of respondent and validity of responses
I am not sure how to answer this question because social media has never come up in an IRB
applications or reviews that I have been involved in.
twitter do not have facebook very little experience with Instagram
Not knowledgeable enough to identify gaps
Security aspects with various media types
Safety safeguards
The potential that public sites are being evaluated for data without the owner's knowledge.
Privacy/confidentiality, how social media used for recruitment (like Facebook games) could expose
sensitive or confidential information about a person to the company or others through the sharing of
data.
Security, confidentiality, and confidence that it is actually your subject
More training on the benefits and risks of social media in biomedical research
Protecting data using social media.
Confidentiality when using social media as a data gathering device
Any and all of it
Don't know enough to ask good questions
privacy confidentiality
Hard to say. The general policies about use of social media are clear but each protocol brings unique
circumstances that need interpreted in context of time and place.
Confidentiality. How to recruit ethically---and effectiveness of recruitment. What is considered private
on social media versus public.
regulatory aspects of use of social media in research
Not specifically. I think all of this is a moving target and it is our responsibility to keep up with the
changes.
How it impacts consent, confidentiality, HIPAA, and securing/storage of data
What types of settings are available on social media platforms that can either increase or decrease data
security.
data security
Very concerned about use of social media by foreign powers hostile to the US who may wish to disrupt
our research enterprise. If this sounds a bit paranoid, our campus had some racial unrest a few years
ago, and Russian bots were subsequently found to have been involved in trying to further inflame what
was going on.
Anonymity, confidentiality, European guidelines,

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Maintaining confidentiality
privacy protections
Specifically, what specific aspects/issues of social media that I need to be aware of as related to serving
on an IRB.
Monitoring
Risks to patients participating (confidentiality and psychological risks) as well as how and to what
degree they can be minimized.
Privacy issues when using social media for research or recruiting.
When research is on a sensitive topic, such as a survey asking if they have been victims of domestic
violence, how to protect the identity of survey respondents (such as instructing them on how to alter
their browser history to hide their responding to the survey from their partner).
none
Maintaining confidentiality when a study involves participant engagement on social media.
Ethical and legal implications (i.e., information security concerns).
Recruiting subjects, following subjects, obtaining informed consent
Data security of such responses in multiple apps/domains
Marketing. I serve on a public library board and would like to learn more about promoting our
programs.
My concerns would be the ability of hackers getting and seeing either the solicitation for research or
the actual participation.
not really
Confidentiality issues
Provision for information security; greatest concern is HIPAA compliance.
Use of social media for research recruitment; techniques, methods, risks, benefits
Not really...since I tend to operate on a need to know, and since we have a separate committee that
deals with the technical aspects of social media and security, I feel prepared
Perhaps more training on issues related to privacy and social media.
Data privacy
The effect of having information disperse beyond the original targeted group. How big a problem is it.

Security issues, specifically regarding online data collection Security issues involving "sweat shop"
survey companies, such as MTurk (Amazon.com)

I would like to understand how social media reach and influence different populations. I would also
like to understand how expectations of privacy and the concept of public availability work in social
media.

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potential risks to social media users from security breech
Data security
Most social media use is related to advertising and recruiting participants for clinical trials. Other
communications are not allowed to occur via social media per our institutional policies due to HIPAA
and information security regulations.

data security, privacy protocols, etc, vary greatly across different social media platforms, and it is hard
for IRB members to fully appreciate the differences between protocols in terms of risk, when these
protocols are using different social media platforms that present underlying variance in security/privacy
risk

Confidentiality. Expected privacy. Public data.
IRB members need to understand what are the risks--is someone going to be harmed, killed, break a
leg, commit suicide, kill someone, embarrassed ..........What are the risks?
Concerns of PHI/PII as it relates to social media data collection.
Understanding on how sites that use avatars to identify people can or can't be used to identify real
individuals.
Hipaa compliance and protection of PHI
Use of social media for projects where prior consent is not possible. A way to "inform the community"
and allow pts to "Opt out".

Whether or not people who respond to a recruitment ad through social media are more or less informed
about the study at the time they respond than people who respond to a flyer or other type of recruitment
ad. Do those responding through social media differ in any way from those who respond through more
traditional means?

The changing best practice of obtaining consent with studies on public platforms.
I believe people do not realize how likely it is that the social media service is tracking which links they
click, or which pages they spend the most time on. This, inadvertently, can provide significant amounts
of identifying information.
Protection of PII within social media research applications. Social media and bias in research.
We recently reviewed a protocol in which the PI wanted to recruit participants to install software that
would allow the PI the ability to monitor (in real time) the participant's social media sites. The
participant would be fully informed of this and agree to install the software. Those who respond to the
participant's social media posts would not necessarily know that the sites were being monitored for
research purposes. We had a lengthy discussion about whether this was permissible, ethically and
legally. We had to contact the university's legal counsel to weigh in. We had to learn more about the
difference between a "one party consent state" and a "two party consent state," which pertain to the
laws about recording telephone conversations with or without a person's knowledge. We had to figure
out how the laws about recording television conversations without a person's permission were
applicable (and if they were applicable) to social media posts...be them public posts or direct messages.
Given that many people use their smart phones to engage in social media, we struggled with whether
the one-party or two-party laws apply based on the state in which the individual sends the message, or
the state in which the phone is "registered" (e.g., the area code). So, for example, if a person's cell

139
phone has an area code for a two party state but the individual makes a post while visiting a one party
state, what set of laws apply? These were new issues for our IRB, and I didn't feel like the people to
whom we were turning for guidance felt confident in their answers. Thus, given the likelihood that the
PI on our campus will likely submit similar protocols in the future, I'd be interested in learning more
about what social media information (posts, photos, etc) can be used for research purposes. I realize
that if information is posted on public sites, these issues may not be as difficult. But what about posts
that are made to an individual's social media account that is "private" except to the individual's
"friends?"

Specific risks associated with "crowd effect" and/or "fake news" on people's opinions regarding
matters, events, etc.

confidentiality
Risk /Benefit Informed consent
Considerations for subject recruiting and IC, particularly if subjects are intentionally or unintentionally
minors or otherwise presumed incapable of making legally binding or rational decisions. Using social
media for research purposes without subject prior knowledge, i.e. Facebook does this all the time, now
political scientists are analyzing data on political attitudes using postings etc. Considerations for using
social media algorithms to isolate subjects for recruitment.
I’d like more training on the privacy policies and practices on different social media platforms.
Social media basics as they relate to confidentiality and security.
security methods
Security of information, especially personal information of subjects.
Risks to data privacy.
How to insure confidentiality Who has ability to post What applications would be helpful
protection of privacy
Use of publicly available posts. Does that type of research need to be approved by IRB (e.g., public
twitter accounts)
don't really know enough to answer this
concerns with human subjects protections
I would like a training explaining in detail how social media can be used in research. Since i am IRB
chair at a state health department, I am curious as to how this would relate to HIPAA regulations.
we rely on traditional data gathering methods and rely on NIH guidelines.
How does informed consent work with social media? How does participant selection work?

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B.2 Narrative Comments for Question 7

Other: - Text
A way to determine ‘digital literacy’ for subjects ala ‘capacity to consent’ given that the
populace has differential knowledge and experience with social media.
I chair a hospital IRB for the last 12 years. Our consent processes and confidentiality issues
are governed by HIPAA. I believe that supersedes any issue of what medium, electronic or
otherwise, is used for transmitting information.
-- Limitations to the ability to ensure privacy when the study involves social media
participation -- Interaction between IRB policy and the corporate policies users agree to by
using social media platforms
I am unsure since none of these issues have arisen in our IRB
Our IRB has all of the above, policies were written to include social media as well as other
forms of media
availability of IT expert to review protocols and make recommendations to IRB
All of these topics should be addressed in relevant reviews, and those reviews can serve as
precedent for future reviews--no other policies are needed.
I do not believe one policy, unless very generalized, would be effective given the rapid
changes in social media technology and given the differences in data management and
security within those entities.
I don't believe this should be by policy - but guidance on the use of social media would be
helpful in all areas mentioned above
I think all of these things are covered in general ways and I prefer this - it makes our policies
more adaptable. Training is important in applying (how data works in social media, and how
to apply your procedures/standards in that environment).
specific risks of data integrity and subject protection with unauthorized access to accounts
(hackers). How likely or common is it?

141
Widespread breaches of privacy associated with social media make the use of these
technologies problematic for assuring confidentiality, required by the CFR. Until legislation
regulating the deceptive practices of these corporations is produced, a conscientious IRB
should simply deny the use of social media in recruiting subjects and in collecting
information.
Data storage.
all of the options seem useful to me except for the consent form one which I could never
imagine being appropriate for social media.
I checked the one listed policy that didn't mention social media. For all the others, except the
consultant, I believe policies or procedures are needed on the underlying topics, but that they
do not need to be specific to social media (i.e. there needs to be a policy on "standards for
storage of data", not on "standards for storage of social media data"
I would strongly disfavor the use of social media in research, as it is impossible to assure its
safeguarding and the privacy of users.
Social media as a barrier to participating in research. For example, no sentient being believes
that electronic data can be made private. How does that impede recruitment. Also, SM is age
specific eg. no one under 40 uses FB.
I think it would worthwhile for researchers to fully understand the extent to which social
media firms track, retain, and make use of data and how that data might be both identifying in
research studies and increase the risk to research participants.
I don't think specific policies need to be included for social media. Studies involving social
media should follow general IRB policies.
I am not sure these need to be policies. Each of these subjects should be explored and
understood first before any policy.
Limitations to the use of social media in research
none - there are already to too many policies and regulations. just leave to to the irb to do
what they think is best to protect human subjects
Don't think that policies specific to social media are necessary. All topics above are relevant
regardless of data source.

142
At this time, I feel that our policies that govern recruitment, data management, data storage,
etc., are broad enough that they are inclusive of social media research. I don't believe
separate policies are needed...but as our IRB sees more social media research I may come to
realize that separate policies are necessary.
Identity of subjects in social media (who is really filling out this info), differences between
social media and other electronic tools, social media and FERPA, social media and HIPAA,
social media and coercion, social media in deception research
Accountability
Risks associated with or increased by participation via research using social media.
Use of data (meta data), images, postings and reposts and comments or "likes" without
subject express consent. Age, competency verification of subjects engaged via social media.
Interpretation of SM data. Without knowing me, an analyst might easily misinterpret what I
say in satire.
Note: The primary use for social media that we have seen for FDA trials has been limited to
recruitment.
NONE
Information security in general. All researchers should have an information security plan for
their research program, including issues related to social media.

B.3 Narrative Comments for Question 32

In the space below, provide any additional comments or information you feel will contribute to
understanding the issues facing IRB members in the review of social media.

I think that any exposure via social media will bias the outcome. It could be positive or negative, but
likely will have some impact on the outcome.
It may be tangential to your central research question but issues concerning social media and HIPAA
would be worth exploring. One note of clarification: our IRB reviews approximately 3000 protocols
annually (full board, expedited, exempt). I am a co-chair of the social and behavioral panel which is
reviews the fewest full board applications though I review many expedited protocols annually.
This survey seems to present the idea that in some clinical trials the subjects are very active in
'comparing notes'. If true, this is an issue that needs to be addressed. But overall i think social media
is here to stay, and needs to be a part of research.

143
Social media is of concern in research, in part, because 1) if the researcher is recruiting participants
through social media, a self-selected sample is used - rather than a random one. 2) it is too easy for
people to do and say things that are inaccurate on social media without any way for the researcher to
know about it. 3) there are enough people who do not use social media that generalization of results
may be questionable. 4) it is difficult to control what information is disseminated once it is on social
media.
Would need to see potential risks of adverse events due to use of social media as part of study
protocols to be mitigated somehow in the protocol. It is concern how researchers can do that
effectively within their protocols, given that it's very difficult to limit social media use and have
control over certain potential impacts. Our IRB would have a lot of questions if we were to receive a
protocol that is using social media to recruit and/or manage/track subjects (lots of potential problems
with informed consent and potential risks that could otherwise be avoided) for human-subjects
research. Our institution conducts research in extremely resource-limited settings, among
vulnerable populations who generally do not have internet access to social media platforms. So that
is a consideration in the applicability of using social media platforms for research conducted by our
institution. I can see benefits in using social media to communicate study findings and engage the
public to discuss study results and ask questions, etc., but should be done so with caution. People say
terrible untrue things online and it's possible that readers will think of public’s commentary as fact
even that which is in direct opposition to the actual study's findings. Subjects could see adverse or
untrue comments long after the study period is over.
Recent privacy breaches have made me very skeptical regarding the use of social media. I think that
there are significant differences in how different age demographics view the use of social media and
privacy protections.
We are a small university IRB with no dedicated staff and a small volume of applicants (`60 per
year) of mostly behavioral research applications. However, we are fortunate enough to have a social
scientist on the IRB who uses social media as one form of intervention in his own studies, so we
have some expertise. I personally see social media primarily as a recruitment tool at present,
although increasingly emerging human researchers are clearly developing many ways to use this tool
as a methodology to generate data in a variety of research models.

The set of IRB members generally does not overlap the set of those skilled in social media, almost by
definition, since the experience required to serve on an IRB generally means a person is of a certain
age, not a digital native. It would be of great help to have a consultant with discretion available to
consult on any dimensions of a protocol that involved social media, someone who is not charged
with the full responsibility of IRB membership.
The majority of studies our IRB reviews are those pertaining to education. We've not encountered
much social media use in study protocols, but I believe this will change very soon.
Important issue. Doing survey raised interesting points to consider.
Need to be cognizant of security issues when using social media for research
'’Looks like a can of worms to me! ' '

144
Important to research this topic and educate IRB members. There are huge areas in the media— all
of it—whatever is digitized — where privacy is already breached and data is being monetized...
This is a huge challenge for the future. IRB guides will need to adapt to this rapid change of
communication.
I am still concerned about the risk for breach in subject confidentiality
Extremely important topic!!
The survey poses questions our IRB will eventually have to consider.
Viral distribution of incorrect information -- from all aspects of study matters.
I think that this is an important topic to understand.
Sorry, not much content from my responses. Our IRB is for our litigation consulting firm. We
acquire publicly available medical survey and accident and incident data bases for analysis and
sometimes the owner/provider of the data requires an IRB approval. We don't actually conduct any
trials or interviews. It's all trivial, because the data bases are anonymized, so our analysis can have
no physical effect on the underlying subjects and only a remote chance of privacy effect. Our IRB
chairman always approves the research by expedited review and it is exempt from written consent of
underlying subjects.
We are a non-profit University with two doctoral programs. Research is primarily social/behavioral.
No grant or clinical research.
I don’t personally use social media and have never reviewed a clinical trial IRB - our IRB is for a
very small college (less than 2,000 students)
The IRB doesn't have any say in what someone not under the PI's purview has to say about a study,
or about a test article (study drug) and its side effects. Long before social media was developed,
patients and professional research participants had ways to share information informally in print and
in conversation. The use of social medial just enlarges the pool of people who can communicate with
one another and the speed with which the message can move.
Recent hacks have validated my strongly held opinion that SM is pernicious and a detriment to civil
society. As an investigator, I will not participate in research using SM as I will not be able to assure
protection for subjects,
Limited or non-existing guidelines. Given that this is a new area of research, more
information/training is needed for IRB members to review studies using social media.
The need to evaluate if the communication modality of social media contributes a unique set of
challenges that current IRB policy isn't flexible enough to accommodate.

145
I anticipate the IRB members themselves are not of the generation that embraces social media so
would be unlikely to be familiar with risks and benefits.
Very interesting survey - just as we have traditionally sought IRB representation across a variety of
occupations (medical specialties, a range of different kinds of providers, law, clergy, educators.... we
may begin to add expertise in technology now becoming more common in research with human
subjects.
Sorry I could not be of much help with your study. I do not use social media and the IRB that I chair
reviews very few applications each year and, to my recollection, we have never had one using social
media.
I am interested in learning more about the role of social media in research. I think it could really
help us in keeping in touch with enrolled participants.
Social media (SM) has potential, but I would wonder about the representativeness of the subjects
who use SM. Our Board would have big concerns about the subject's privacy and the data that
would be trolled and shared with outside parties.
Social media can be helpful as related to IRB requests but it also raises privacy concerns for IRB
members and for subjects involved in research studies. Like anything, social media can be an
effective tool or it can be used to deceive or manipulate.
I’m sure it’s coming.
Can apply most regulatory issues to social media. Greatest concern is for protection of privacy and
confidentiality of subjects.
A big problem is that the regulations have not caught up with the technology that is being used in
research. Even non-binding guidance is lacking. That said, I think IRB members have taken it upon
themselves to learn about the issues related to social media and in that sense are far ahead of
regulators. I have seen great debates among IRB members about the use of social media in research,
for example, should consent be obtained before using data from social media. But that is how IRBs
operate. If they are not debating these issues, they are not doing their job.
I didn't really understand a lot of the questions posed here (especially early on before any examples
were given), so they were difficult to answer.
To clarify my doubts about social media use being a great way to disseminate information to the
general public or to interact with the general public, my concerns come from the huge discrepancy
between the number of people who consume social media and the number of people who create
social media content/interact. Far more people read social media content without interacting.
Therefore, the voices heard on social media represent those of the minority of users who interact or
create content and do not represent the voice of the general public.
Some questions listed response as very concerned or not concerned - As I was somewhat concerned
(not an option) I state no knowledge
This survey is fairly direct in its connection to FDA research; our board is much more oriented
toward non-FDA, non-clinical research

146
I do not know what a "primary reviewer" refers to. We review protocols and the informed consent
documents so they are in NIH compliance.
There is some utility (especially among younger potential participants) in using social media to
inform the public about the availability of research studies, basically replacing the role of
newspaper/TV/radio advertising. Because of insufficient privacy, social media are not appropriate
for most individual communication between investigators and subjects, including obtaining informed
consent, collecting information, and tracking.
I am the Chair of our IRB so I do not do any primary reviews, but I do a secondary review on all 200
or so of our yearly full board protocols.
Our IRB is primarily social/behavioral and does very few clinical trials. We currently have a
protocol that is specifically focused on Facebook use and recruits using Facebook. This protocol was
hotly debated and training on the subject would be nice.
questions in earlier part of the survey gave options that may miss nuances since they only asked very
concerned or not concerned, rather than degrees. I was unsure how to answer, since my response
would have been somewhere between the two, in most cases
I personally feel that the use of social media will provide a platform for significant dis-information
regarding research and a platform to potentially generate new "urban legends" relating the
participation in research. I do not possibly see how personal data and information can be positively
protected. The only possible use is for subject recruitment.
As convenient as social media can be, its use may destroy the integrity of research. Who knows who
is REALLY responding to a social media post, and under what conditions (including sobriety,
pathology, age).
We struggle with this issue on occasion, and I expect it will grow. What is the expectation of
privacy on social media sites? Who needs to give permission to scrape data? Tough questions.
To reiterate--IRB board members need to understand the nuances of how social media affects
research studies. Something I have not personally considered until this survey. A book and/or
podcast on the subject is needed.
Your question about training was misleading for me. For us, the actual review process is a form a
training in which we educate each other. I thought you were referring to more standardized
curriculum. Social media use has been discussed on IRB Forum, so I recommend searching that
online discussion board as a part of your research. At the very least, it provides a list of issues that
IRB members have considered sufficiently concerning to raise to others (i.e. it is a behavioral
measure to supplement the attitudinal measure represented by this survey).
The most nebulous issue is how the social media sites protect privacy and confidentiality.
Government agencies are likely to be far more conservative in how they view innovations such as
the use of social media in research. They have a higher level of responsibility in the eyes of the
public. We received one study that wanted to monitor Facebook usage of participants in a study of
marriage. It was not allowed.

147
I am extremely concerned about the use of social media in research and encourage reviewers to be
cautious. Social media, while it seems easy, often causes massive injustice in population researched
via self-selection issues and the results cannot be assumed to be useful. Beyond that, privacy and
security of online forums is not guaranteed. We hear new cases every day of parties, both honest and
dishonest, obtaining private information through some website or other. It is a short step from
stealing credit card info to stealing blackmail info about someone who has participated in a survey
and answered honestly.
I believe the anonymous nature of social media has promoted less civility in this country (maybe
world wide). The original hope for social media was that we would have shared knowledge. We now
have greater shared manipulation through false narratives and half-truths. This, in concert with
crowd-think effects, in my opinion, will either bias or pollute the data you get through social media.

Social media were not designed as platforms for recruiting research subjects. Moreover, there are not
uniform social conventions about what is appropriate or inappropriate for posting on LinkedIn or
Facebook or Imagur. SM platforms, most notably Facebook, have been found to play fast and loose
with account holder information. IRBs will have to think about those social expectations in assessing
the ethical issues regarding SM and clinical trials. IRBs will need to recognize that organizations like
Facebook don't share the ethical constraints a properly trained research organization would have
about securing information about someone who may have given IC to a researcher but was tracked
by FB and now the information is misplaced.

we have not reviewed clinical trials, but I do see the role of social media. There is a lot of mis-
information, so it would be good for real research to post and show connections to research
institutions.
We do not have any guidelines for research and social media but I feel we should.
The primary concern would be breaches of HIPAA requirements, as well as distribution of
misinformation to participants.
social media is unregulated and not managed therefor does not meet the privacy protection
guidelines established by NIH. The use of social media for recruitment tactic can be useful as long
as traditional protection policy is in place.

148
Appendix C. ………..
C.1 Survey Invitation Email
Dear IRB Chairperson,
My name is Susan Pusek and I am a doctoral student in the Regulatory Science program at the University
of Southern California. I am conducting a research study, in partial fulfillment of my degree
requirements, to learn about how IRB members view the use of social media within clinical trials and
human subjects research regulated by the Food and Drug Administration (FDA).

As you know, social media has readily been adopted by patients, healthcare organizations, the FDA, and
other clinical trial stakeholders for a variety of health-related uses. However, to date, there is relatively
limited use of social media in clinical trials. The literature contains opinions and anecdotes that social
media may improve clinical trial processes and transparency, but also that social media introduces new
potential risks.

Because IRB members have experience in evaluating the benefits and risks of new technologies, I would
like to invite you to complete a survey that asks about your experience with social media in the IRB
setting, and your opinions on current regulations and policies and how useful social media may be for
FDA-regulated clinical trial activities. You do not have to be a social media user to participate, nor do
you have to have direct experience reviewing a research proposal using social media in order to answer
the questions. Survey responses will be anonymized and there will be no way to link respondents to a
specific IRB.

If you have any questions about the survey you may contact me through email
at: suspusek@med.unc.edu.

Please click the link below to access the survey and complete the informed consent.

Thank you for considering participation,
Susan Pusek

Follow this link to the Survey:
Take the Survey
Or copy and paste the URL below into your internet browser:
https://unc.az1.qualtrics.com/jfe/form/SV_8Caf98AvyVngSc5?Q_DL=4ZvDcXVmyupnPCJ_8Caf98Avy
VngSc5_MLRP_cRWKGTJZ3REtsWh&Q_CHL=email

149
C.2 Survey Instrument: IRB Attitudes Social Media
Q1 This survey should take about 15 minutes. Completion of the survey is voluntary. You may choose
not to participate or stop taking the survey at any time, and you may skip any question for any
reason. You will not receive any direct benefit for being in this research study. However, we hope the
survey results will provide useful information to IRB members and the research community on current
practices and views of social media, and help to prioritize areas for further research and
discussion. You will not incur any costs by participating in this research. The only possible risk to
you of participating in this research study is embarrassment if your answers become public. However,
once you submit your answers they will be stored anonymously, without any identifying
information. Your computer or device IP address will not be stored. At the end of the survey you will
be given an opportunity to provide your email address if you want to receive a summary of the study
results and/or if you want to be entered into a raffle to receive one of two Amazon Fire 7 tablets with
Alexa. If you choose to provide your email address, you will be directed to a separate portal where your
contact information will be stored separately from your survey responses. I will report only summaries
of the aggregated data. Your responses will be combined with other responses and you will not be
identified. Deductive disclosure, which is the discerning of an individual respondent’s identity and
responses through the use of known characteristics of the individual is possible but unlikely since your
responses will not be stored with any identifying data. All research with human volunteers is reviewed
by a committee that evaluates research in order to protect your rights and welfare. If you have any
questions regarding your rights as a research subject you may contact the Institutional Review Board at
the University of Southern California at 323-442-0114. This study was reviewed and judged to be
exempt. If you agree to complete the survey, please proceed.
End of Block: Informed Consent

Start of Block: Demographics 1

Start of Block: Experience with social media

150
Q2 How many total years have you served on an IRB?
o Less than 5 years
o 5-10 years
o More than 10 years

Q3 The next questions ask about social media and its use in human subjects research regulated by the
Food and Drug Administration. We are not asking about large scale, "social computing" research in
which there is little or no interaction between the research team and research subjects, and we are not
asking about research that is limited to the observation of social media activity.
For purposes of this survey, please think of social media as:
Electronic forms of communication that enable users to post and distribute their own content and to
communicate with each other in a "two-way" fashion. Facebook, Instagram, Twitter, or blogs are
examples of social media because users can not only obtain information but can disseminate information
themselves and post their own reactions.

151
Q4 Does your IRB committee include members with any of the following types of social media
expertise?
Yes No Do not know
Self-identified social
media expert who is not
a biomedical researcher
▢ ▢ ▢
Researcher using social
media in their research
▢ ▢ ▢
Institutional expert
knowledgeable about
some aspect of social
media (e.g. information
technologist who
addresses data security)
▢ ▢ ▢
Institutional expert who
uses social media in
their job (e.g.
communications expert)
▢ ▢ ▢
Other (please specify:
▢ ▢ ▢

Q5 In your role as an IRB member, have you had, or been offered, any training on social media?
o Yes
o No

152
Display This Question:
If In your role as an IRB member, have you had, or been offered, any training on social media? = Yes
Q6 What type of training was offered? (select all that apply)
▢ Training by someone internal to your institution/organization (e.g. an information
technology, social media, or other expert)
▢ Training by someone external to your organization (e.g. information technology, social
media expert, or from another IRB)
▢ Session at a meeting for IRB professionals (e.g. PRIMR)
▢ Webinars or other on-line training
▢ Other (please specify): ________________________________________________

Q7 Please mark the option that best describes how prepared you feel to review research protocols that use
social media?
o Very prepared
o Somewhat prepared
o Not prepared

153
Q8 If there are specific aspects of social media that you would like more training on please describe them
below:
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________

Q9 Does your IRB have specific policies that address the use of social media in research?
o Yes
o No
o Do not know

Display This Question:
If Does your IRB have specific policies that address the use of social media in research? = Yes

154
Q10 What information is covered in the policy or policies?
Yes No Do not know
Using social media for
study recruitment
▢ ▢ ▢
Templated language on
social media for consent
forms
▢ ▢ ▢
Procedures to protect
privacy of enrolled
subjects
▢ ▢ ▢
Requirements for social
media consultant on the
study team
▢ ▢ ▢
Procedures/standards
for data management of
social media data
▢ ▢ ▢
Procedures/standards
for storage of social
media data
▢ ▢ ▢

Display This Question:
If Does your IRB have specific policies that address the use of social media in research? = No

155
Q11 What topics do you think should be addressed in IRB policies? (check all that apply)
▢ Using social media for study recruitment
▢ Templated language on social media for consent forms
▢ Procedures to protect privacy of enrolled subjects
▢ Requirements for social media consultant on the study team
▢ Procedures/standards for data management of social media data
▢ Procedures/standards for storage of social media data
▢ Other: ________________________________________________
End of Block: Experience with social media

Start of Block: Review of social media
Q12 Have you deliberated on one or more clinical trial protocols using social media? This includes any
research study "in which one or more human subjects are prospectively assigned to one or more
interventions to evaluate the effects of those interventions on health-related biomedical or behavioral
outcomes" (NIH, https://grants.nih.gov/policy/clinical-trials/definition.htm, 2017)
o Yes
o No
Skip To: End of Block If Have you deliberated on one or more clinical trial protocols using social media? This includes
an... = No

156
Q13 In the protocol(s) you deliberated on, how often was social media used in the ways below?
Frequently Occasionally Never
To recruit study
subjects
o o o
To collect study data
o o o
To track study subjects
for follow-up
o o o
To disseminate study
results
o o o

Q14 If you have seen other ways that social media was proposed, please describe them below:
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________

157
Q15 Check any of the resources below that you have used, in addition to the materials provided by the
research team, to help you review a research proposal using social media (select all that apply)
▢ Peer reviewed literature
▢ Consultation with a social media expert
▢ Another IRB's policies
▢ Federal and/or local policies
▢ Terms of service of the social media provider
▢ Guidances/statements from professional organizations
▢ Other (please specify): ________________________________________________
▢ I have never used any additional resources

158
Q16 In your opinion, what issues are the most challenging or concerning for IRB members when
reviewing proposals that incorporate social media? (select all that apply)
▢ Subject recruitment procedures or materials
▢ Process of informed consent including language in the consent form (e.g. description of
risks of social media)
▢ Data collection procedures using social media
▢ Procedures for data security/privacy protection of subjects
▢ Lack of social media expertise on the research team
▢ Other (please specify): ________________________________________________

Q17 Please select the statement that best describes how IRB review of protocols using social media
compares to IRB review of other types of technology:
o Review of social media is more difficult than other types of technology (may take more time
and/or require more exchanges of additional information between the research team and IRB)
o Review of social media is about the same in difficulty as other technologies
o Review of social media is less difficult than other types of technology
o Do not know

159
Q18 In your opinion, which of the following would assist IRB members with the review of social media?
(select all that apply)
▢ More access to social media expertise during protocol review or deliberation
▢ More training either locally or at national meetings for IRB professionals
▢ A repository of IRB decisions on different uses of social media
▢ Additional FDA guidances on social media
▢ New federal regulations on how to use social media in human subjects research
▢ Other (please specify): ________________________________________________
▢ Nothing additional is needed
End of Block: Review of social media

Start of Block: Social media and clinical trials
Q19 The next questions ask your personal opinions about social media and the impact of social media on
clinical trials.

160
Q20 How concerned are you that social use by enrolled clinical trial subjects affects clinical trial
integrity of the trial they are enrolled in?
o Very concerned
o Not concerned
o Do not know

Q21 How concerned are you that social media use by the public affects clinical trial integrity?
o Very concerned
o Not concerned
o Do not know

161
Q22 In your opinion, how useful do you think social media may be for the following research activities?
Please answer regardless of any direct experience with the activities through your IRB.
Very useful Somewhat useful Not useful Cannot say
Disseminating
education about
research to the
public
o o o o
Increasing public
knowledge about
FDA or research
sponsor activities
o o o o
Getting the public's
input on protocol
design (e.g. number
of visits, outcomes
studied)
o o o o
Recruiting study
subjects
o o o o
Tracking and
contacting subjects
o o o o
Disseminating study
results
o o o o
Enabling
researchers and the
public to "discuss"
study results
o o o o
Increasing
efficiency and
innovation of
clinical trial
processes
o o o o

162
Q23 Have you heard of, or had direct experience with, any of the events below related to social media and
clinical trials? Please consider all sources of information (e.g. anecdotes, information presented at
professional meetings, etc.) Direct experience means you know of a specific study in which the event
occurred.
Direct experience
Heard about, but no
direct experience
Never heard or
experienced
Social media expedited
subject recruitment
o o o
Potential subjects were
“coached” on study
eligibility requirements
by other subjects through
social media
o o o
Enrolled subjects posted
opinions about the study
site, staff and/or sponsor
on social media
o o o
The privacy of subjects
was breached on social
media
o o o
Enrolled subjects
discussed potential
adverse events on
social media forums
o o o
Enrolled subjects learned
how to unblind the study
material from reading
social media posts of
other subjects
o o o
Subjects posting the
informed consent
document on a social
media site
o o o

163
Q24 To your knowledge, has your IRB ever reviewed language in a consent form for a clinical trial using
social media that asked subjects to do the following?
Yes No Do not know
Refrain from discussing
the specific clinical
trial on social media
o o o
Refrain from any social
media activity before,
during, and after trial
participation
o o o
End of Block: Social media and clinical trials

Start of Block: Personal opinions on social media

164
Q25 Please provide your level of agreement or disagreement with the statements below regardless of
whether you yourself use social media.
Strongly agree Agree Neutral Disagree
Strongly
disagree
Social media is
a more
convenient
way to
accomplish
daily activities
o o o o o
I am usually an
early adopter
of new
technology
o o o o o
Social media
platforms do
not have clear
instructions
o o o o o
Using social
media can
have negative
consequences
o o o o o

165
Q26 How often do you use social media for the activities below?

One or more
times a day
Not daily but a
few times a week
A few times a
month or less
Do not use social
media for this
purpose
Communicate
with people you
know (e.g. family,
friends, or work
colleagues)
o o o o
Read and react to
postings of people
you do not know
(e.g. news topics,
restaurant
reviews)
o o o o
Interact with the
public for an
activity required
for your work
o o o o
Participate in an
on-line
community
o o o o
Other use (please
specify):
o o o o

166

Q27 The final questions are some additional demographic questions.

Q28 What is the affiliation of your IRB?
o Academic institution/academic medical center
o Non-academic hospital, research institute or healthcare organization
o Independent IRB
o Other (please specify): ________________________________________________

Q29 What type of research does your specific IRB committee review? (select all that apply)
▢ Biomedical: includes research regulated by the Food and Drug Administration and/or
the National Institutes of Health
▢ Social/behavioral
▢ Other (please specify): ________________________________________________

167
Q30 About how many initial full board reviews has your IRB committee deliberated on in the past
year?
o 0-12
o 13-120
o More than 120
o Do not know

Q31 About how many times have you performed an initial review as a primary reviewer in the past
year?
o 0-12
o 13-120
o More than 120
o Do not know

Q32 In the space below, provide any additional comments or information you feel will contribute to
understanding the issues facing IRB members in the review of social media.
________________________________________________________________
________________________________________________________________
________________________________________________________________

168
Q33 Thank you for completing this survey!
Would you like to provide your contact information to receive a summary of the study results and/or to be
entered in a drawing for one of two Amazon Fire 7 tablets with Alexa? If you answer yes, you will be
directed outside of this survey where your contact information will be stored separately from your survey
responses.
o Yes
o No
End of Block: Personal opinions on social media

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Asset Metadata

Creator Pusek, Susan N. (author)

Core Title Institutional review board capabilities to oversee new technology: social media as a case study

School School of Pharmacy

Degree Doctor of Regulatory Science

Degree Program Regulatory Science

Publication Date 05/04/2020

Defense Date 12/13/2019

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag clinical research,clinical trials,IRB,IRB chairs,OAI-PMH Harvest,recruitment,social media,survey,technology acceptance,technology readiness

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Pacifici, Eunjoo (committee chair), Beringer, Paul (committee member), Church, Terry (committee member), Pire-Smerkanich, Nancy (committee member), Richmond, Frances (committee member)

Creator Email spusek@gmail.com

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c89-297071

Unique identifier UC11664313

Identifier etd-PusekSusan-8415.pdf (filename),usctheses-c89-297071 (legacy record id)

Legacy Identifier etd-PusekSusan-8415.pdf

Dmrecord 297071

Document Type Dissertation

Rights Pusek, Susan N.

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Access Conditions The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...

Repository Name University of Southern California Digital Library

Repository Location USC Digital Library, University of Southern California, University Park Campus MC 2810, 3434 South Grand Avenue, 2nd Floor, Los Angeles, California 90089-2810, USA