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IRB insiders: perspectives from within the institutional review board

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IRB insiders: perspectives from within the institutional review board

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IRB Insiders: Perspectives from Within the Institutional Review Board
by
Brianne Mongeon

Rossier School of Education
University of Southern California
A dissertation submitted to the faculty
in partial fulfillment of the requirements for the degree of
Doctor of Education

May 2022

© Copyright by Brianne Mongeon 2022
All Rights Reserved

The Committee for Brianne Mongeon certifies the approval of this Dissertation

Patricia Tobey
Cathy Krop
Alexandra Wilcox, Committee Chair

Rossier School of Education
University of Southern California
2022
iv

Abstract
IRB insiders (author’s term) refers to the individuals within IRBs who make regulatory
determinations on research. The term also includes individuals who have the authority to make
decisions around how the IRB operates (e.g., associate director or director). This study sought to
understand the lived experiences of IRB insiders who review primarily social, behavioral, and
education research. More specifically, it combined Bronfenbrenner’s (1979) ecological systems
theory with the concept of interpersonal trust to develop a new framework for understanding how
IRB insiders experience their roles. IRB insiders from a variety of institutions were interviewed
about their experiences within the IRB. Data were analyzed and synthesized with current
literature to develop a set of recommendations for IRB insiders and institutions.
Keywords: Institutional Review Board, IRB, IRB insiders, ecological system theory,
interpersonal trust
v

Dedication
To my children, Sloane and Hudson:
You can do hard things.

vi

Acknowledgements
Over the course of the last three years, there have been many professors who supported
my research and encouraged me to go forward with my topic. However, there are five USC
professors in particular that were invested in getting me through this process and who deserve
special mention. First, I would like acknowledge Dr. Alexandra Wilcox, my dissertation chair,
for her incredible dedication and unwavering support. I am truly grateful for the feedback on
revisions, the Zoom calls, the persistent championing, cheerleading, advocating, and even the
occasional “mom” advice. I would like to thank Drs. Derisa Grant and Julie Slayton, who served
as committee members in the early stages of my research and provided valuable feedback.
Appreciation is also owed to Drs. Kathy Crop and Patricia Tobey, who stepped in at the eleventh
hour to help me across the finish line. Thank you all for your time, energy, and expertise through
this journey.
A debt of gratitude is owed to Dr. Richard Weaver for his unconditional support. Dr.
Weaver held me accountable with weekly update meetings, thought-provoking discussions, new
perspectives, varying theories, personal expertise and experience, and an endless supply of
encouragement. This project would not have been possible without you, and for that I am forever
grateful to have you as a friend, mentor, and colleague.
A special acknowledgement to Dr. Heather Miller, an IRB insider herself, for talking
sense into me when I needed it most, the many reviews, and conversations about getting this
thing done! I never would have made it without you. I treasure the friendship we have because of
our crazy IRB insider lives.
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I would not have wanted to spend the last three years with any other classmates than my
OCL Lucky 13 friends: Patrick Cates, Todd Philips, Tyler Peterson, Jennie Lender, Adam
Jackson-Boothby, and Nathan Mack. Thank you for all the laughter, support, and memories.
Completing this dissertation in the middle of a global pandemic was a memorable
challenge, one that required the support of my whole family. To my husband, Marc, who kept the
kids busy when I had class, rubbed my shoulders on the long nights when I was up writing (and
crying), and relentlessly told me I was going to get through this, you are the reason I was able to
persist, and I am incredibly lucky to have you by my side. To my babies, Sloane and Hudson,
who cheered me on to become a “teaching doctor” and to finish my “big book report,” I would
look at your sweet faces and know that failure was not an option. I did this to show you that
doing hard things and believing in yourself is a worthwhile pursuit. And finally, for my parents,
you have always believed that I could… so I did. Thank you for the unconditional love and
support throughout my academic journey. I promise to let you know when I am done!

viii

Table of Contents

Abstract .......................................................................................................................................... iv
Dedication ....................................................................................................................................... v
Acknowledgements ........................................................................................................................ vi
List of Tables .................................................................................................................................. x
List of Figures ................................................................................................................................ xi
Chapter One: Overview of the Study .............................................................................................. 1
Background of the Problem .................................................................................... 2
Importance of Addressing the Problem .................................................................. 3
Purpose of the Study ............................................................................................... 4
Field Context ........................................................................................................... 5
Conceptual Framework ........................................................................................... 5
Methodological Framework .................................................................................... 8
Definition of Terms................................................................................................. 9
Positionality ............................................................................................................ 9
Organization of the Project ................................................................................... 10
Chapter Two: Literature Review .................................................................................................. 11
The Evolution of the Regulatory Environment in Human Subjects Research...... 11
Establishment of Ethical Framework for Research With Human Subjects .......... 16
Regulations for Protection of HSR in the United States ....................................... 20
The Institutional Review Board Regulations ........................................................ 21
Ecological System ................................................................................................. 29
IRB Insiders .......................................................................................................... 30
Research on IRBs .................................................................................................. 31
Summary ............................................................................................................... 33
Chapter Three: Methodology ........................................................................................................ 34
Research Questions ............................................................................................... 34
Research Method and Design ............................................................................... 34
Participating Stakeholders .................................................................................... 35
Data Collection, Instrumentation, and Analysis Plan ........................................... 36
Credibility and Trustworthiness ............................................................................ 40
ix

Ethics and Role of the Researcher ........................................................................ 42
Summary ............................................................................................................... 43
Participating Stakeholders .................................................................................... 45
Findings................................................................................................................. 48
Research Question 1: What Are the Experiences of IRB Insiders Shepherding
Researchers Through the IRB Process? ................................................................ 50
Research Question 2: What Are the Experiences of IRB Insiders Related to the
Protection of Human Subjects? ............................................................................. 56
Research Question 3: What Are the Experiences of IRB Insiders Related to
Interactions With Their Institution? ...................................................................... 64
Research Question 4: What Are IRB Insiders’ Experiences With Balancing Forces
from Researchers, Their Institution, and Their Duty to Protect Human Subjects in
Research? .............................................................................................................. 71
Emergent Finding Unrelated to Research Questions ............................................ 78
Summary of Findings ............................................................................................ 80
Chapter Five: Discussion and Recommendations......................................................................... 82
Overview of the Study .......................................................................................... 82
Summary of the Findings ...................................................................................... 84
Recommendations for Practice ............................................................................. 93
Limitations and Delimitations ............................................................................. 101
Recommendations for Future Research .............................................................. 101
Conclusion .......................................................................................................... 103
Appendix A: Recruitment Messages and Email Communications ............................................. 120
Online Recruitment Message for IRB Forum and Facebook Group: ................. 120
Email to Confirm Participation ........................................................................... 120
Appendix B: Information Sheet .................................................................................................. 122
Appendix C: Interview Protocol ................................................................................................. 124
Appendix D: Data Collection Crosswalk .................................................................................... 130

x

List of Tables
Table 1 Participating Stakeholder Descriptions ............................................................................ 46
Table 2 Participants’ Institutional Descriptions and Reporting Structures ................................... 47
Table 3 Codes and Themes ........................................................................................................... 49
Table 4 Research Themes Across the Ecosystem ......................................................................... 86
Table 5 Recommendations for Stakeholders .............................................................................. 100

xi

List of Figures
Figure 1 Ecological Systems Theory ............................................................................................. 6
Figure 2 Conceptual Framework.................................................................................................... 8
Figure 3 IRB Ecosystem .............................................................................................................. 84

1

Chapter One: Overview of the Study
This dissertation examines Institutional Review Boards (IRBs) from an inside-out
perspective. Its purpose is to critically explore how people within IRBs, or IRB insiders (author’s
term) experience their everyday working lives and how that experience shapes their
understanding of the field of human subjects research. This research places IRB insiders at the
epicenter of a dynamic and complex ecosystem that helps explain insiders’ relationships to their
institution’s researchers and their duty to protect human subjects. In the changing landscape of
human subjects protection, IRB insiders grapple with factors such as how to ensure the
protection of data in large data repositories, research being conducted in “real-world” settings,
the amount and kind of information available to researchers for analysis, research conducted with
vulnerable populations, and the methods used to collect and disseminate research data, among a
myriad of other issues (Bankert et al., 2022). With an estimated 2.8 million people participating
in biomedical or clinical trials research in the United States each year (Goldstein, 2018), and an
unknown number of participants in social, behavioral, education research (SBER), the obligation
to provide ethical oversight in the protection of human subjects involved in all research falls
largely on IRBs (Cohen et al., 2014). Given the significant role and responsibility IRB insiders
play protecting human subjects in research, it is essential to understand their lived experiences.
Although researchers’ experiences with IRBs have been analyzed in the literature
(Gunsalus et al., 2007; White, 2007), little research exists regarding the experience of IRB
insiders—the people who work in IRBs and make regulatory determinations (e.g., IRB analysts,
IRB administrators, IRB chairs) and/or are in positions to impact how the IRB operates (e.g.,
IRB assistant directors and IRB directors). Most of the extant literature that does mention IRB
insiders focuses on IRB policies, the committee's composition, processes, workload, and
2

turnaround times (Anderson & DuBois, 2012; Burris & Moss, 2006; Whitney et al., 2008), or the
more operational factors of IRBs. However, with the charge of protecting millions of research
subjects every year, little is known about how those within the IRB balance their roles and
responsibilities to the various stakeholder groups in their ecosystem: their institution, the
researchers, and the duty to protect human subjects in research. This demonstrates a notable gap
in the literature.
Background of the Problem
Over the past two decades, research on IRBs has increased significantly. The largest body
of work around IRB examines the application of current IRB regulations to nonmedical or SBER
studies (Bell, 2014; Bledsoe et al., 2007; Dingwall, 2012; Heimer & Petty, 2010; Schrag, 2010).
This is largely because the set of regulations governing human subjects research is written
chiefly with a biomedical focus. To this point, legal scholar Feeley (2007) notes that the
biomedical standards in research seem reasonable given the risk in medical experimentation.
However, he argues that it is not reasonable to apply the same standards to social behavioral
research, stating that “after 30 years, social science research would still be assessed according to
a biomedical model, its disciplinary distinctiveness largely ignored” (p. 765). Other scholars
agree with Feeley’s legalistic assessment of IRBs as “increasingly risk adverse environments” (p.
765), noting that IRBs have become significant gatekeepers to research (Bledsoe et al., 2007;
Dingwall, 2012; Katz, 2007).
Although research scrutinizing the IRB persists today, when federal regulators changed
the Common Rule in 2018, a new set of research topics arose. Research around IRBs began to
evaluate the operationalization of the new changes (Crystal et al., 2020; Young, 2018), to
investigate the impact of single IRB review (Burr et al., 2019; Henrikson et al., 2019), and study
3

flexibility in the regulations (Walch-Patterson, 2020). Within the past five years, a significant
amount of data around various aspects of IRB has come into focus.
This dissertation aims to contextualize the extant research on IRBs from the IRB insiders’
perspective. More specifically, this research sought to understand how IRB insiders balance their
roles relative to the stakeholder groups they serve: institutions, researchers, and human subjects
in research. Research on IRBs within institutions revealed how IRBs operationalize the
regulations (Abbott & Grady, 2011; Burris & Moss, 2006; Klitzman, 2012) and the increasing
“hypercompliance” (Babb, 2020, p. 32) that have taken place in the field of IRBs. A larger body
of research examines the researchers’ experience navigating IRBs, concluding that IRB
processes, regulations, and determinations impact their research in various ways (Abbott &
Grady, 2011; Stryjewski et al., 2015; Whitney & Schneider, 2011). Little data exists on whether
IRBs fulfill their role in protecting human subjects (Lynch, et al., 2022; Lynch et al., 2019) or the
degree to which human subjects experience being protected by IRB oversight.
Importance of Addressing the Problem
Documenting and understanding the lived experiences of IRB insiders is critical for
several reasons. First, it will provide a perspective that is mainly absent from the body of
research around this topic. IRB insiders exist within a complex ecosystem of regulations,
institutions, researchers, and a duty to protect human subjects in research, among other facets,
and yet their voices are largely absent from our understanding of IRBs. Bridging this gap can
create a more holistic picture of the world of IRBs. Second, given the recent labeling of IRBs as
“hypercompliance” (Babb, 2020) entities, it is important to understand those responsible for
executing the regulations and document their experience. It is possible that the labeling and
stigmatization of hypercompliance is unfairly balanced toward the perspective of one stakeholder
4

group, which provides a space for generating a broader understanding of the field of IRBs that is
inclusive of those on the inside. The findings from this study will contribute to professional
knowledge around the lived experiences of IRB insiders. These experiences are embedded within
an ecosystem that includes three significant stakeholders: researchers, the institution of the IRB
insider, and the insiders’ duty to protect human subjects in research. The findings will inform
discussions about the IRB ecosystem from an insiders’ perspective.
Purpose of the Study
The purpose of this study was to examine how IRB insiders experience the varying forces
of their responsibilities to (a) shepherd researchers through the IRB process, (b) mitigate risk to
the university through compliance efforts, and (c) protect human subjects in research. Whereas a
comprehensive evaluation of IRB insiders' experiences would focus on all stakeholder groups,
for practical reasons, this study focused only on IRB insiders of SBER institutions. To determine
how IRB insiders understand and make sense of their working environment, four primary
research questions (RQs) were investigated:
RQ1. What are the experiences of IRB insiders shepherding researchers through the IRB
process?
RQ2. What are the experiences of IRB insiders related to protecting human subjects?
RQ3. What are the experiences of IRB insiders related to interactions with their
institution?
RQ4. What are IRB insiders’ experiences with balancing forces from researchers, their
institution, and their duty to protect human subjects in research?
5

Field Context
This dissertation focused on IRB insiders who worked for institutions engaged in SBER
studies in the United States. Institutions engaged in this type of research range from universities
to independent IRBs. A search conducted on the Office for Human Research Protection (2022)
website in January 2022 for domestic IRBs revealed 6,822, of which approximately 3,600 are
active (OHRP, n.d.). A further focus of search parameters allowed selecting IRBs that adhere
only to OHRP regulations and not to U.S. Food and Drug Administration (FDA) regulations,
revealing that approximately 1,900 domestic IRBs follow only OHRP regulations, meaning they
do not do clinical or medical research (OHRP, n.d.).
Conceptual Framework
This study leveraged Bronfenbrenner’s (1979) ecological systems theory alongside the
concept of interpersonal trust to create a new framework for understanding the lived
experiences of IRB insiders. Bronfenbrenner’s (1979) model consists of layers of
interconnected systems that move outward from the person at the center of the model. The
system is depicted with concentric circles, each having their own influence on the person in the
middle (Bronfenbrenner, 1979). The four systems, microsystem, mesosystem, exosystem, and
macrosystem, house varying aspects and settings that the person at the center must navigate
(Bronfenbrenner, 1979).
The microsystem houses the IRB insiders. The mesosystem is closest to the IRB insider
and houses the researchers that IRB insiders interact with and support. The exosystem contains
broader factors that influence the IRB insiders at the center. The human subject participants that
IRB insiders are charged with protecting can be found in this system. Finally, the macrosystem
includes the institution for which the IRB insider works. This system is responsible for setting
6

the tone for interactions between all systems (Bronfenbrenner, 1979). Figure 1 depicts the
ecological model, showing how communication and information can move between systems.
Figure 1
Ecological Systems Theory

Note: Adapted from Bronfenbrenner (1979).

7

Interpersonal Trust
In addition to Bronfenbrenner’s (1979) ecological systems theory, this study will
leverage the idea of interpersonal trust to understand the lived experiences of IRB insiders.
McAllister (1995) defines trust as “the extent to which a person is confident in, and willing to
act on the basis of, the words, actions, and decisions of another” (p. 25). Interpersonal trust
describes a trusting relationship between at trustor and a trustee, wherein the trustor trusts
others and the trustee is the person or entity being trusted (Ma et al., 2019). In the IRB insiders’
world, it is important that trust not only exists between the researchers who submit to the IRB
and IRB insiders but also occurs between the IRB insiders and the institution and, more
broadly, with people who participate in research studies. As a result, trust must move
bidirectionally between all levels of the IRB ecosystem. Figure 2 depicts the conceptual
framework used in this research. Trust is layered onto the IRB ecosystem, and it is depicted as a
bidirectional arrow crossing each level of the system.

8

Figure 2
Conceptual Framework

Note: Adapted from Bronfenbrenner (1979).

Methodological Framework
This study was designed to understand the lived experiences of IRB insiders who review
SBER at various institutions across the United States. To gain insight into the lived experiences
of IRB insiders, a phenomenological approach was used (Creswell & Creswell, 2018). This
required the IRB insiders’ experiences to be described in as much detail as possible. Purposive
sampling was used to select participants from a range of institutions that review SBER studies.
Participants were selected based on having two or more years in IRB at institutions that review
mostly SBER studies. Semi-structured interviews were conducted to understand better how IRB
insiders shepherd researchers through the IRB process, mitigate risk to their institution through
compliance, and protect human subjects in research. Interviews were conducted via Zoom,
9

recorded for accuracy, and later transcribed. A qualitative analysis using thematic coding was
conducted to inform the results of this study (Creswell & Creswell, 2018).
Definition of Terms
● Code of Federal Regulations (CFR)/Common Rule: This final rule is intended to better
protect human subjects involved in research, facilitate valuable research, and reduce
burden, delay, and ambiguity for investigators (OHRP, 2016).
● Human subjects research (HSR): Research involving a living person about whom data is
collected and used for research purposes (Office for Human Research Protection, 2021).
● IRB insider: Staff members of the IRB or IRB chairs who are able to make decisions on
IRB submissions by researchers.
● Researcher: any individual who is primarily responsible for the responsible conduct of
research involved in conducting HSR studies (OHRP, 2021).
Positionality
The impetus for this research study is a direct result of the nearly 14 years I spent as an
IRB insider. Throughout my career, I have held many positions within the IRB, from being an
analyst, to a senior analyst, to an assistant director, to the director of various IRBs. My
experiences and responsibilities are wide ranging within the IRB world. These experiences
provided a lens with which to view the body of research around IRBs and led me to understand
that a pivotal voice was missing. When I narrowed down the topic of study within the IRB
world, it became apparent how much of what I experienced as an IRB insider was missing. Study
after study on IRBs would document researchers’ experiences and interaction with the IRB or the
bureaucracy of IRBs, but very little was reported on how IRB insiders experienced their roles
within the ecosystem of IRBs.
10

I worked in IRBs within higher education, reviewing primarily SBER studies. I
acknowledge my bias in understanding and interpretating experiences with IRBs and how that
bias may inevitably impact my view of this study’s data. For example, my own experience of
being an IRB insider at public and nonprofit organizations sometimes differed from the
experiences of those in commercial IRBs or for-profit institutions. For this reason, special
attention had to be paid to my own assumptions based on personal experiences so as not to affect
how participants were questioned or how their responses were interpreted. Consequently,
reflective memos were a central aspect of managing this bias of thought and experience. Given
my position as the key data collection instrument, such acknowledgement of this positionality in
this research is critical to ensure the credibility and transferability of the study (Creswell &
Creswell, 2018).
Organization of the Project
This study is organized into five chapters. This chapter provided an introduction and
overview to IRBs. It also introduced the concept of IRB insiders existing within a complex and
dynamic ecosystem. Chapter 2 reviews the literature surrounding IRBs and highlights the various
documented phenomena in the IRB ecosystem. More specifically, the topics explored in Chapter
2 are the evolution of IRBs, current IRB regulations, how IRBs perform their duties, biomedical
IRBs versus social behavioral IRBs, and IRB insiders. Chapter 3 frames and details the
methodological approach for this study. Chapter 4 presents the findings of this study, and
Chapter 5 focuses on recommendations based on the data found in both the literature and this
study.

11

Chapter Two: Literature Review
Chapter 1 explored the concept of the IRB insider as part of a dynamic ecosystem. It
positioned the IRB insider as essential to both the operations and processes of the IRB. Chapter 1
also highlighted the importance of the IRB insiders’ role protecting human subjects. These
insiders carry a significant amount of decision-making authority at higher education institutions,
and little research has been done on this stakeholder group. Studies on IRB members and IRB
review outcomes have been done, but little information exists on IRB insiders as a working part
of a greater ecosystem and their experiences.
Chapter 2 will detail a historical overview of notable human subjects studies and frame
how the regulatory environment evolved. It will also highlight aspects of complexity within
IRBs, including distinctions between biomedical and social, behavioral, education research
(SBER), noting how the regulatory environment has become a source for confusion given the
singular set of regulations governing both types of research. This study will examine IRB
insiders’ experience as the stakeholder group of focus. Insiders’ roles, responsibilities, and
experiences enforcing compliance and navigating various competing goals within the IRB
ecosystem will also be explored.
The Evolution of the Regulatory Environment in Human Subjects Research
Levine (1988) notes that most guidance regarding research was “born in scandal” (p.
167). What follows is an account of the evolution of the regulatory environment for IRBs. Each
step toward greater ethics in research is tied to the transgressions of one or more studies
(Emanuel et al., 2008). However, as demonstrated in each case, if professional self-regulation
were generally adequate to the task of overseeing research on human subjects, the negative list of
historical events surrounding human experimentation would not have occurred (Heimer & Petty,
12

2010). Respected researchers carried out many studies in thoroughly reputable institutions well
integrated into the medical and scientific establishment (Heimer & Petty, 2010). The cases
outlined below has shaped cultural attitudes, ideologies, and values around research (Stark,
2012). Each historical event led to creating federal regulations and guiding documents for IRBs
today (Rice, 2008).
History of Research With Human Subjects
Medical experimentation with human subjects began as far back as 377 BCE, in the time
of Hippocrates (Resnik, 2018). Hippocrates was interested in studying disease and began
meticulously documenting data regarding the course in human subjects (Porter, 1998).
Recognizing the risk that could come from experimentation with human subjects, he developed
the Hippocratic oath, which at its core states to “do no harm.” What followed after the time of
Hippocrates were several cases where the boundaries for acceptable experimentation were
surpassed and resulted in research that was deemed unethical. The following examples from
Resnik’s (2018) book, The Ethics of Research with Human Subjects: Protecting People,
Advancing Science, Promoting Trust highlight snapshots of research that has been deemed
unethical but yet inform the current state of research ethics oversight. These examples represent
both biomedical and SBER genres that have been at the center of unethical research over time.
As noted by Resnik (2018), cultivating a deeper understanding of the research ethics
environment requires familiarity with important events and trends which have come into the
public’s awareness.
Smallpox
In 1796, Edward Jenner, an English physician, noted that dairymaids had resistance to
cowpox and hypothesized that exposure to cowpox would protect against smallpox (Resnik,
13

2018). To test this hypothesis, he inoculated his gardener’s son, 8-year-old James Phipps with
fluid from a cowpox pustule and charted the boy’s health after the injection (Centers for Disease
Control and Prevention, 2021). Six weeks post-injection, the boy was exposed to smallpox and
did not contract the disease. Seeing the success in Phipps, Jenner then tested the procedure on his
children, who did not contract smallpox. By today’s standards, tests or experimentation with
minors in this type of clinical study would receive the highest level of scrutiny through IRB
review.
The Rafferty Experiment
Thirty-year-old Mary Rafferty, who was described as feeble-minded, had a two-inch hole
in her head caused by a terminal cancerous ulcer (Lederer, 1995). In 1874, Robert Bartholomew,
an Army physician who later became a professor of medicine at the medical college in
Cincinnati, Ohio, inserted electrodes into the hole to stimulate her brain with electricity and
record the responses (Resnik, 2018). Having experienced distress, convulsions, and seizures
during the procedures, Rafferty fell into a coma and died (Lederer, 1995). Today, research
subjects, especially vulnerable subject populations, have a considerable amount of protections
Yellow Fever Experiment
Making a medical breakthrough to prevent the spread of yellow fever, Walter Reed, a
U.S. Army physician, helped pioneer the use of informed consent documents in research
(Resnik, 2018). After discovering that mosquitos were carriers of the disease, Reed asked
participants who had not been exposed to the disease to be bitten by mosquitos who had fed on
patients with the disease or to be injected with blood of an infected patient (Lederer, 1995). This
study is noteworthy because Reed asked participants to sign a document to demonstrate they
understood the possible risks of participating in the study, including death. Some studies on Reed
14

and his colleagues report that Reed was well aware of the grave sense of responsibility of
volunteer studies (Baxby, 2005; Lederer, 1995). As Resnik (2018) observed, Reed’s use of
consent documents for participants was long before it was common practice in research by the
1970s.
Tuskegee Syphilis Experiment
From 1932 to 1972, a clinical study led by the Public Health Service (PHS) was
conducted on the progression of untreated syphilis. The participants were poor Black men from
rural Alabama who thought their participation in the study meant they were receiving treatment
for their disease (Paul & Brookes, 2015). When penicillin, the cure for syphilis, was discovered
in the 1950s, the researchers did not administer the medication to participants so they could
continue to document the disease. As a result of this study, many participants either died or
infected others with syphilis because the U.S. doctors overseeing the study lied to them about
their health. The Tuskegee study has been touted as the impetus for the Belmont Report, which
provides the ethical foundation for the current regulatory environment for IRBs.
Medical Experiments on Prisoners in Nazi-Era Germany
During World War II, German military physicians, scientists, and even some civilians
conducted medical experiments on Jewish concentration camp prisoners (Resnik, 2018). Some of
the experiments prisoners were subjected to included testing hypoxia, hypothermia, or survival
after exposure to various poisonous agents (Craig & Desai, 2015). These unethical studies led to
the Nuremburg Trials, whereby a code of ethics was established to legally try the medical
doctors involved in these crimes against humanity. Yet, born out of these atrocities was the
foundation for what now guarantees protections for people participating in research studies,
medical or otherwise. Additionally, the Nazi-era experiments on human subjects in Germany led
15

to a deeper understanding of the need for fully informed consent and for studies to be free of
coercion (Shuster, 1997).
Research Abuses Experienced by American Indians
Before Tuskegee, American Indians/Alaskan Natives were subjected to research that
resulted in significant health risks and disfigurement and ran contrary to their cultural practices
(Hodge, 2012). In the 1950s, Alaska Natives were enrolled in a study by U.S. Air Force’s former
Arctic Aeromedical Laboratory, which sought to understand the role of the thyroid gland in
adjusting to cold weather (Hodge, 2012; National Research Council, 1996). Radioactive iodine
was administered to participants, including men, women, and children. The iodine level
administered to each participant exceeded recommended dosages for uses such as cancer
screening (Advisory Committee on Human Radiation Experiments, 1996). Because the dosages
were so high, according to Hodge (2012), current standards “would preclude use of minors,
lactating women, and potentially pregnant women; however, subjects in these categories were
not excluded” (p. 434). Further, researchers did not keep adequate records, making follow-up for
iodine exposure health-risk assessments impossible (Hodge, 2012).
In the 1990s, American Indians from the Havasupai tribe participated in research
conducted by Arizona State University (ASU) on type 2 diabetes (Couzin-Frankel, 2010). IRBs
had already been established, and the study, which took blood samples of over 200 Havasupai
members, had an IRB approval (Hodge, 2012). As part of the consent process, participants were
assured that their blood samples would be returned to them to satisfy their belief that “all
biological human material must be intact in order for an individual’s spirit to travel to the
afterlife” (Hodge, 2012, p. 435). Instead, the research team removed the samples from the study
site at Havasupai, stored them at ASU, and used them for other studies that participants had not
16

agreed upon (Couzin-Frankel, 2010; Hodge, 2012). As a result of these abuses, research with
tribal or indigenous populations may require tribal review and special permissions to access the
population as an added layer of protection.
Establishment of Ethical Framework for Research With Human Subjects
Today, IRBs have been established to provide a core protection for human subjects
through independent review of the ethical acceptability of the proposed research (Grady, 2015).
However, the evolution of the ethical framework for HSR was paved with several atrocities in
the name of research. Documenting the journey of research ethics and compliance oversight is an
essential endeavor to understanding how the complex and dynamic environment in which IRB
insiders exist evolved.
Nuremberg Code
In response to the horrific experiments conducted by Nazi physicians in the 1940s,
survivors demanded justice for the abuses they suffered (Weindling, 2004). As a result,
intelligence officials requested thorough documentation and a moral investigation of Nazi
research with human subjects (Weindling, 2004). At the time, there were no official ethical
guidelines outlining acceptable practices for medical research with human subjects for which the
physicians could be tried in a court of law (Rice, 2008). One officer, John W. Thompson, was
convinced that failure to act against the war crimes and crimes against humanity committed by
Nazi physicians would lead people to believe their behavior and experimentation were
acceptable and that type of experimentation would begin to spread to other countries (Weindling,
2004). Thompson was crucial in convening an international committee of medical experts and
legal investigators to analyze the experiments of the Nazi physicians (Weindling, 2004).
17

The Nuremberg Military Tribunal in 1947 issued the Nuremberg Code of 10 basic ethical
guidelines that human experimentation would follow to prevent future abuses (Fischer IV, 2006).
The most notable were voluntary informed consent, a favorable risk/benefit analysis, and the
right to withdraw from research without consequence (Rice, 2008). Though the Nuremberg Code
has not been “officially adopted in its entirety as law by any nation or as ethics by any major
medical association” (Shuster, 1997, p. 1439), the document has had a profound influence on
global human-rights law and medical ethics (Grodin & Annas, 1996).
Despite its impact on research with human subjects at the time, however, the response
from American physicians to the Nuremberg Code was of interest. Oral histories and scholarship
on U.S. physicians from that time recollect that the Nuremberg Code was only for barbarians
(Katz, 1996). An advisory committee on human radiation experiments conducted an oral history
project on the trials in Nuremberg. This committee discovered that even medical researchers who
might have been aware of the events at Nuremberg did not perceive the Nuremberg Code as
particularly applicable to them, as it was reserved for the truly heinous and egregious research
(Advisory Committee on Human Radiation Experiments, 1996). One participant describes in the
Oral History Project by the Advisory Committee on Human Radiation Experiments (1996) that
“in a sense, American physicians did not pay attention to the lessons of the Nuremberg Trials
because it was not convenient to do so” (p. 86). The accounts from this time indicate a cognitive
dissonance with how their field was being shaped by these atrocities and their relationship and
responsibility to the field (Advisory Committee on Human Radiation Experiments, 1996).
Declaration of Helsinki
In 1948, following one of the darkest moments in the history of medical research
(Carlson et al., 2004), the World Medical Association (WMA) issued a code of medical ethics
18

that stressed the standards for which physicians should hold themselves accountable, called the
Declaration of Geneva (DoG), named after the location in which it was drafted (Fischer IV,
2006). Some scholars and physicians of the time argued that the language was so vague that the
DoG did not adequately interpret the emerging field of medical ethics (Fischer IV, 2006). From
1953 to 1964, debates over the intent and language used in the DoG continued, until the WMA
met in Helsinki, Finland to draft a new, more comprehensive code of ethics known as the
Declaration of Helsinki (DoH) (Resnik, 2008).
The original DoH, adopted in 1964, was inspired by the Nuremberg Code and included
22 principles for the ethical conduct of medical research (Resnik, 2008). Though it has been
revised numerous times since its inception (WMA, 2018), DoH is regarded as the first document
to set standards for research with human subjects (Resnik, 2008). Representing the ethical norms
of physicians engaged in research at the time, DoH was much more formal than its predecessor
the DoG, in that it contained a preamble and specifically endeavored to balance useful medical
knowledge with the need to protect the health and interests of patients involved in research
(Ashcroft, 2008).
Whereas the Nuremberg Code was written by U.S. judges sitting in judgement of the
Nazi physicians, DoH was written by physicians. The Advisory Committee on Human Radiation
Experiments (1996) reports that
compared with the lofty, idealized language of the Nuremberg Code, the Declaration of
Helsinki may have seemed more sensible to many researchers in the early 1960s because
it offered rules that more closely resembled research practice in the clinical setting. (p.
92)
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Although physicians at the time were developing their sense of ethical standards for
experimentation within the backdrop of some of the most egregious research experiments on
human subjects, the standards outlined in DoH were more favored over the Nuremberg Code.
However, some critics of DoH say it has a more politicized nature, in that it is framed to serve
the physicians’ interests over that of the research subjects (Ashcroft, 2008). Those criticisms are
the underpinnings of researchers pushing back against the rules and regulations. This pushback
has been pervasive with each passing of a new code or new regulations overseeing research with
human subjects. Hence, as mentioned earlier, if researcher self-regulation were enough to protect
human participants in research, neither the numerous codes of ethics nor the regulatory
framework for HSR protection oversight would exist (Heimer & Petty, 2010).
The Belmont Report
Still, the lines were blurred between medical therapy and research. When the Tuskegee
study was exposed, the public was outraged (Resnik, 2008). This led to the Congressional
hearings on ethical considerations for participants in research and the passage of the National
Research Act, which was signed into law in 1974. It contained the charge to develop guidelines
for research with human subjects. As Beauchamp (2008) notes, the hope was to develop an
ethical framework and guidelines that would form the foundation for a U.S. research oversight
system. However, in line with the tensions around creating new regulations and guidelines, the
National Research Act established the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research with a caveat (Advisory Committee on Human
Radiation Experiments, 2008). The government did not want to support a national regulatory
body, and in return for agreeing to this, it would accept regulations governing federally funded
research studies (Advisory Committee on Human Radiation Experiments, 2008). According to
20

the Advisory Committee on Human Radiation Experiments final report (2008), “this meant that
the goal of oversight of all federally funded research would not be achieved and that whatever
oversight did exist was left to the funding agencies rather than an independent body” (p. 103). In
1979, the National Commission issued the Belmont Report that became the ethical framework
for research involving human subjects (National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, 1978).
Regulations for Protection of HSR in the United States
The Belmont Report served as the ethical foundation for the formal adoption of federal
regulations to protect human subjects by what is now known as the Department of Health and
Human Services (DHHS) (Porter & Koski, 2008). Prior to this formalized set of regulations,
there were policies by various PHS agencies for funded studies (Porter & Koski, 2008). In 1974,
DHHS (formerly the Department of Health, Education, and Welfare) published the regulations in
the Federal Register (39 Fed. Reg. 105, 1974) and codified what is now known as the Common
Rule, as it has been adopted by 17 different federal agencies, including the Food and Drug
Administration (FDA) (Department of Health and Human Services, 2009). These regulations
stipulated that each institution that would be awarded federal research grants would be required
to form a committee (what is now known as the Institutional Review Board, or IRB) to review
and approve research before it was sent to DHHS for funding (Advisory Committee on Human
Radiation Experiments, 2008).
According to Porter and Koski (2008), the regulations are process oriented, concerned
with defining terms of research, the terms of review, and the makeup of the IRB committee. The
authors also note that the regulations call out the assurance process, whereby institutions wishing
21

to receive federal funding must make a legally binding commitment to DHHS to uphold the code
of federal regulations governing research with human subjects.
However, even after the public’s awareness of research malfeasance was galvanized by
the conduct of numerous highly publicized unethical studies, researchers still criticized the new
regulatory environment. According to Porter and Koski (2008),
Policies requiring informed consent and peer review of proposed research, intended to
protect the interests of subjects and promote ethical conduct, were not enthusiastically
embraced by much of the research community, even after adoption of federal regulations.
Today, the research community readily, even if sometimes begrudgingly, acknowledges
the need for an appropriate mechanism for ethical review of research and for protection
of human research subjects. (p. 156)
Despite this acknowledgement of the need for IRB regulations, variation in the IRB process,
according to Klitzman (2011), is in part a result of the increasing scale of IRB regulations,
confusion over how to interpret and apply the regulations, and a lack of concrete guidance from
OHRP, which results in localized discretion of IRB regulations.
As researchers began to confront the new rules and regulations, an environment was
created where the necessity for oversight in HSR was both welcomed and rejected (Porter &
Koski, 2008).
The Institutional Review Board Regulations
The federal regulations define an IRB as a committee tasked with the ethical review and
compliance oversight of proposed research that includes human subjects (45 CFR 46, 2019,
section §46.107). The review conducted by IRBs must consider the three principles of the
Belmont Report: respect for persons, beneficence, and justice (National Commission for the
22

Protection of Human Subjects of Biomedical and Behavioral Research, 1978). Additionally, each
review considers the potential risk or harm to research participants and categorizes or makes
regulatory determinations on a case-by-case basis to determine the level of review required. The
Office for Human Research Protections (OHRP) under DHHS states that the IRB
Provides leadership in the protection of the rights, welfare, and wellbeing of subjects
involved in research conducted or supported by the U.S. Department of Health and
Human Services. ORHP helps ensure this by providing clarification and guidance,
developing educational programs and materials, maintaining regulatory oversight, and
providing advice on ethical and regulatory issues in biomedical and social-behavioral
research. (OHRP, n.d.)
For a research proposal to be reviewed by the IRB, two conditions must be met. First, the
proposal must meet the federal definition of “research,” and second, it must involve “human
subjects,” which is also federally defined (45 CFR 46, 2019, section §46.102). In the absence of
either component, the proposed research does not fall under the IRB’s purview. However, there
is far greater complexity in the actual operationalization of IRBs than merely making sure
proposals meet both definitions. In many instances, IRBs consider OHRP’s regulations as the
floor, or the lowest requirement for review, and end up reviewing different kinds of human
studies in various ways (Amdur & Bankert, 2007; Klitzman, 2015). When the IRB insider is
interpreting these definitions, they are defining their relationship to the regulations, or how they
view the application of the regulations through their reviews.
Complexity in the Application of IRB Terms
The term research is defined in the Code of Federal Regulations (CFRs) as
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A systematic investigation, including research development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge. Activities that meet this
definition constitute research for purposes of this policy, whether or not they are
conducted or supported under a program that is considered research for other purposes.
(45 CFR 46, 2019, section §46.102(l), p. 7261)
However, this very definition is at the forefront of many researchers’ complaints about IRBs and
has been debated by policymakers, ethicists, researchers, IRB insiders, and other stakeholders in
the HSR process (Hicks, 2014). In particular, the first phrase of the definition can be found in
both research and non-research projects (Amdur et al., 2006). This means that IRBs must grapple
with the application of the term, taking into account several different factors (e.g., is the
researcher trying to publish the work? Is the project for quality improvement (QI)?) (Amdur et
al., 2006), before deciding whether a project falls under the IRB’s purview.
Under scrutiny, the first part of the definition, “a systematic investigation,” adds
complexity to the interpretation and application of the regulation. Amdur et al. (2006) assert that
the intent must be at the center of this discussion, stating, “to determine whether a project should
be classified as research, it is important to understand that non-research activities may use
scientific methods [a systematic investigation] and produce results that are suitable for
publication…” (p. 104). This means that activities that appear to be a systematic investigation
may not always fall under the purview of the IRB. One example used by the authors is QI
practices. Oftentimes, QI initiatives are set up as a systematic investigation, whereby the intent is
to improve the performance of institutional practice, but the findings are not intended to be
generalizable to a greater audience (Amdur et al., 2006). The lines become slightly blurred when
a QI initiative intends to improve an institutional practice and the researchers want to use the
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findings for further publication or presentation. It is up to both the integrity of the researcher and
the IRB to determine at what point IRB review is necessary. This brief example is just one of the
many complexities in the decision-making process that IRB insiders must grapple with daily.
Two additional phrases that add to the complexity in the application of IRB definitions
are generalizable knowledge and designed to develop or contribute to…. The lack of substantial
guidance from the federal regulations on these definitions is a pain point for researchers and IRB
insiders. White (2007) asserts
If we construe generalizable in the broadest sense, any research that makes
generalizations apparently falls into this category. Consequently, the malleability of
concept generalizable has made it difficult to decide whether all, some, or none of the
research in journalism, communication, ethnology, and history come under the
jurisdiction of the Common Rule. (p. 552)
To White’s point, Baily (2008) highlights that IRBs have been federally investigated for not
clearly distinguishing which research activities are considered “generalizable.” One notable
example from an established research institution, Johns Hopkins, was investigated by OHRP for
a study that the IRB determined to not meet the definition of “research.” When a complaint was
filed to OHRP, OHRP investigated and wholly disagreed with Johns Hopkins IRB’s decision.
Noting the complexity of the regulations, Baily (2008) states
The fact that a sophisticated IRB interpreted the regulations differently from the OHRP is
a bad sign in itself. You know you are in the presence of dysfunctional regulations when
people can't easily tell what they are supposed to do. Currently, uncertainty about how
the OHRP will interpret the term “human-subjects research” and apply the regulations in
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specific situations causes great concern among people engaged in data-guided activities
in health care, since guessing wrong may result in bad publicity and severe sanctions.
The Johns Hopkins case is one that received national attention. However, the context behind
what happened helps to shed light on the complexity IRB insiders deal with when making
regulatory-based decisions.
Moreover, what would seem to be a straightforward definition of what constitutes a
“human subject” has some subjectivity built into the way it is defined in the federal regulations.
According to DHHS, a human subject is a “living individual about whom an investigator
(whether professional or student) conduct[s] research” (U.S. Department of Health and Human
Services 45 CFR 46, 2019 section §46.102(e)(1), p. 7261). The phrase “about whom” in this
definition creates some complexity for IRB insiders, as they must determine if the data being
collected is about the research participants themselves or the participants are simply the vehicle
for providing data about a facility or a process. For example, if a researcher plans to interview 50
employees of a national fast-food chain about how the food is prepared, although the researcher
is gathering data from a “living individual,” the data collected are not about that person, and
therefore, no IRB review would be necessary. However, in that same example, should the
researcher decide to collect data about how the food is prepared and ask participants how they
feel about their jobs, only then do they become a “human subject” engaged in research. It is this
very nuance with which researchers and IRB insiders struggle.
The sentiment in the extant research surrounding IRBs posit that these broad phrases in
CFRs—systematic investigation, generalizable knowledge, about whom—are the very reason for
the resistance toward IRB (Silberman & Kahn, 2011; White, 2007). In his study on mission creep
in IRBs, White (2007) asserts that “any research that does not meet this standard is excluded
26

from IRB scrutiny. The basic problem is how broadly any particular IRB might construe the
concept of generalizable knowledge” (p. 552). These terms are so broadly defined that the local
IRBs must interpret and apply the regulations to the best of their ability. Though OHRP provides
some guidance by way of documents or training, it is the IRB insiders, not OHRP at the local
level, making the daily determinations in IRBs. Each determination an insider makes further
shapes their relationship to the body of regulations governing HSR. Whether they decide to take
a broader interpretation or perhaps a use a more restricted view in their application, the IRB
insiders are interacting and defining their relationship to the body of regulations and to their role
in the protection of human subjects in research.
Complexity in the IRB Performing Its Duties
The variety of circumstances IRBs encounter in research proposals, as noted by Mazur
(2007), is “a never-ceasing challenge” (p. 19). Mazur’s (2007) book, written as a guide for IRB
members, illustrates the complexity and lack of uniformity in the IRB’s interpretation and
application of the regulations, the variance across academic disciplines submitting to the IRB,
the plausibility of generating significant new knowledge compared to risk, research design, and
more. Although the book is framed to analyze IRBs from the biomedical side, many have written
on the challenges faced by IRBs reviewing primarily social behavioral research.
In referencing the complexities of the operationalization of IRBs, Schrag (2010) notes
that IRB members may not want to spend too much time learning or understanding the
complexities of the IRB system. Supporting this statement, Amdur and Bankert (2007) wrote in
their IRB member handbook that “research ethics and research regulations are complex fields
with constantly changing standards and levels of complexity” (p. 3). The complexity referenced
in these books that IRB insiders experience when reviewing research protocols ties closely to the
27

body of research stating researchers experience a significant amount of difficulty when
navigating the IRB system from the submission side (Silberman & Kahn, 2011; White, 2007).
The variation in protocol reviews or complexity in the IRB process is due, in large part, to the
“fundamental flaw” in the two most critical federal documents—CFRs and the Belmont Report
(Vanderpool, 2006). According to Vanderpool (2006), although CFRs contain some degree of
specificity regarding how IRBs are to review protocols, ensure proper membership, and enforce
the regulations, they are silent on ethical considerations surrounding research. Conversely,
Vanderpool (2006) draws attention to the notion that the Belmont Report’s three ethical
principles—respect for persons, beneficence, and justice—and their corresponding application to
research are not discussed in CFRs. He argues that due to this challenge, IRBs narrowly focus on
the rules and regulations, which marginalizes the ethical concerns protecting human subjects in
research (Vanderpool, 2006).
Regulating Biomedical Research and Social, Behavioral, and Education Research
Research with human subjects was originally regulated because of the concerns related to
biomedical experimentation (Mertenes & Ginsberg, 2009). As the public’s awareness of such
experiments grew, so did the social pressure to create an ethical framework that would guide
these studies (Schrag, 2010). At the onset of the Belmont Report and the Common Rule, the
focus was mainly on biomedical research, with only a few mentions of SBER (Schrag, 2010). It
was not until December 1966 that PHS announced that both biomedical research and SBER
would be required to adhere to ethical and regulatory standards (Cowan, 1975).
Behavioral studies conducted in the 1960s and 1970s solidified the need for social and
behavioral research to be regulated, as it can carry just as much risk or harm as a biomedical
studies (Bailey, 2014). More specifically, SBER studies can impact “psychological well-being,
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violate autonomy and privacy, and [cause] reputational damage[s]” (Bailey, 2014, p. 2).
Throughout history, there are famous examples of such studies that only need to be recognized
by the last name of the researcher or the title of the experiment, such as Stanley Milgram’s
(1963) behavioral study on obedience, Zimbardo’s (1971) Stanford Prison Experiment, or the
Tearoom Trade study where Humphreys (1975) used deception to collect data on men having sex
with men in public restrooms.
Complexity in Social, Behavioral, Education Research Reviews
Scholars have documented their frustration with the system of regulations developed primarily
for biomedical research but now applicable to SBER research (Bledsoe et al., 2007; Oakes, 2002;
Schrag, 2010; White, 2007). According to Oakes (2002), “there are two reasons, which when
taken together explain why such sentiments appear to be increasing: 1) regulations were
developed for biomedical research [and] 2) interpretations of regulations have become more
strict” (p. 447). Both biomedical research and SBER studies are necessary, but it is more difficult
for SBER to be reviewed in IRBs. This is due to, as mentioned, the regulations being grounded
in biomedical studies but also the lack of federal guidance available for IRB insiders to draw
upon when making their decisions. As Heimer and Petty (2010) note, “in a radically
decentralized regulatory system such as the IRB system, particularly one operating with
relatively few firm rules, we can expect a good deal of local variation” (p. 610). This means that
the absence of concrete regulation and guidance leaves a considerable amount of discretion at the
local IRB level. This amount of discretion has been documented as one of the main sources of
researchers’ frustrations in the IRB process, causing long review times, multiple iterations of
review prior to approval, and other issues (Burris & Welsh, 2007; Gunsalus et al., 2007;
Klitzman, 2015; Schrag, 2010).
29

Ecological System
Bronfenbrenner’s (1979) ecological systems theory posits that the individual is
surrounded by layers of relationships, much like a set of Russian nesting dolls (see Figure 1). A
fundamental principle of the theory suggests that progress is a function of forces stemming
from multiple settings and the relations among these settings (Bronfenbrenner & Morris, 2007).
More specifically, the model proposes that the individual and the environment are constantly
interacting with one another, creating new meanings through this interaction. The ecological
systems theory framework is ideal for examining the lived experiences of IRB insiders because
these are nested within varying systems that may sometimes have competing goals.
Figure 1 depicts Bronfenbrenner’s (1979) ecosystem. The macrosystem, or the outermost
layer, contains the attitudes, ideologies, and values of a culture (Bronfenbrenner, 1979). The
exosystem contains settings or events on the periphery of the microsystem but still has a great
impact on the microsystem (Bronfenbrenner, 1979). The next level, the mesosystem, moves
inward and is where relationships between two or more systems can be explained. This system
describes relationships and also houses the social networks of the microsystem (B. M. Newman
& Newman, 2020). The mesosystem helps to identify the relationships between systems rather
than housing individuals, entities, or settings (B. M. Newman & Newman, 2020). The final
system, which is influenced by all the systems, is the microsystem. The subject at the center of
the circle (Bronfenbrenner, 1979) exists in the microsystem, alongside other individuals, entities,
and settings. Information can flow both inward and outward in this system and across the various
systems.
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IRB Insiders
Klitzman (2015) wrote that IRB staff, or IRB insiders, are the “face of the IRB” (p. 57)
and “serve as the local face representing the regulations and the regulatory agencies” (p. 59). As
the regulations and their application become increasingly complex (Heimer & Petty, 2010), so
does the need for highly trained IRB insiders. They have a considerable amount of authority
when interpreting and applying the regulations to proposed research. Some scholars argue that
IRBs, and by extension IRB insiders, hold too much power (Gunsalus et al., 2007; White, 2007),
but in practice, IRB insiders are constrained entirely by the existing body of regulations and
guidance (Klitzman, 2012).
IRB insiders manage the operationalization of the IRB regulations: they are responsible
for responding to researchers’ inquiries, triaging protocols, reviewing protocols if the level of
review can be done outside of a full-board review, organizing and managing IRB full-board
meetings, and communicating the IRB’s stipulations to researchers to secure approval (Sieber,
1994). Additionally, McGough (2006) describes in greater detail the functions of IRB insiders as
screening protocols prior to IRB review (to ensure all the documents and supplementary
documentation is present), preparing agendas for IRB full-board meetings, taking detailed
minutes, drafting correspondence, triaging adverse event and safety reports, supervising staff,
responding to subject concerns, triaging protocol violations, executing interinstitutional
agreements, managing external relationships, meeting logistics, and handling office procedures,
IRB policy and procedures, outreach, and education.
Beyond managing the myriad of responsibilities listed above, Heimer and Petty (2010)
described the importance of the IRB insider role and the service they provide in protecting
against an emerging risk in HSR. The authors are referencing IRB insiders acting as agents to
31

protect their institution against the threat of sanctions from OHRP, stating that “OHRP will
suspend a university’s research program for failure to comply with regulations or failure to
document that it has complied” (Heimer & Petty, 2010, p. 617). Much like the example of Johns
Hopkins failing to properly review a study (Bailey, 2008), IRB insiders exist in this high-stakes
environment (Roberts et al., 2005). Failure to account for every detail could potentially be
catastrophic to the institution, meaning they could lose federal funding for research (Heimer &
Petty, 2010). This multifaceted view of IRB insiders provides insight into how they experience
the operations of an IRB.
Research on IRBs
IRBs have been studied more systematically in recent history. Empirical data gathered
from a variety of perspectives have documented delays in IRB reviews (Abbott & Grady, 2011;
Gunsalus et al., 2007; Klitzman, 2012; Whitney et al., 2008), inconsistencies between IRBs in
their reviews (Larson et al., 2004; Lidz et al., 2012; Silberman & Kahn, 2011), emphasis on
protecting the reputation of the institution (Dingwall, 2012; Hedgecoe, 2016), and an overly
conservative analysis of risk and benefits (Abbott & Grady, 2011; Grinnell et al., 2017; Shah et
al., 2004).
Addressing the list of complaints about IRBs being dysfunctional (Fost & Levine, 2007),
overreaching (Gunsalus et al., 2007), and inefficient (Whitney et al., 2008), Abbott and Grady
(2011) responded with one of the first systematic reviews of IRBs. Their study compiled 1,576
publications on IRBs (Abbott & Grady, 2011). After narrowing the search parameters to include
research on domestic IRBs that was written in English, reporting empirical findings, using either
qualitative or quantitative methodologies, and excluding anecdotal experiences or QI
32

assessments, 52 studies were left for analysis (Abbott & Grady, 2011). The study found that
complaints around IRBs were justified, given that
overwhelmingly, these data show that IRB practices and decisions, including
determinations of which studies require full or expedited review, whether the level of risk
was minimal or greater than minimal, and practices related to recruitment, vary from IRB
to IRB, often without a clear justification for the variation. (Abbott & Grady, 2011, p. 13)
The study also found that variation in the IRB process “seems irrational and could feasibly
impact both safety and scientific rigor” (Abbott & Grady, 2011, p. 15).
According to Babb’s (2020) book Regulating Human Research: IRBs from Peer Review
to Compliance Bureaucracy, IRBs have transformed in the last decade. Babb (2020) documented
how IRBs changed from faculty-led boards concerned with interpreting and applying the
regulations appropriately to becoming an industry whereby the “professionalization” of IRB
careers has taken over. Babb (2020) interviewed 50 IRB staff members to understand the
migration of American IRB from primarily faculty-led committees that conducted the majority of
IRB business and reviews to a model of paid administrators primarily responsible for IRB
oversight. In Babb’s (2020) assessment, one of the values of the transformation toward
professionalization was making IRBs more compliant and efficient. However, an unintended
consequence was that IRB professionals stress compliance or form over function (Babb, 2020).
In her review of Babb’s (2020) book, Godwyn (2021) notes, “by stressing elements such as the
constitution of committees, adherence to local policies, and consideration of mandated criteria,
the treatment of human subjects fades into the background. Audits, then, create an environment
of compliance in form not substance” (p. 971). These sentiments on the IRB have been long-
standing in the literature.
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Summary
The extant research in this chapter presented Bronfenbrenner’s (1979) ecological systems
theory to understand and evaluate IRB insiders’ experiences. In Chapter 2, a review of the
related literature revealed the historical context behind IRBs as making them necessary and
highlighted the complexity of their regulations and processes. The complexity in the regulations
and the process help create a fundamental understanding of challenges faced by IRB insiders.
Research on IRBs is generated mostly from the researcher’s perspective or serves to report
metrics on the operationalization of IRBs. These are important factors, but they do not
encompass a fully formed picture of IRBs, given that the insiders’ voices are absent. Chapter 3
will introduce the research design and methodology used to collect and analyze data from the
framework developed in this chapter.

34

Chapter Three: Methodology
This study sought to understand the lived experiences of IRB insiders. The two previous
chapters situated the IRB insiders as part of a complex and dynamic ecosystem where trust
permeates the various layers. This chapter will present the design of the research study by
providing an overview of the research questions, a description of the methodology and design,
and a discussion on how data is analyzed to answer the research questions. The chapter will
continue with a discussion of the credibility and trustworthiness of the study and conclude with
the ethical underpinnings on which the study was designed.
Research Questions
The four research questions that guided this study were as follows:
RQ1. What are the experiences of IRB insiders shepherding researchers through the IRB
process?
RQ2. What are the experiences of IRB insiders related to protecting human subjects?
RQ3. What are the experiences of IRB insiders related to interactions with their
institution?
RQ4. What are IRB insiders’ experiences with balancing forces from researchers, their
institution, and their duty to protect human subjects in research?
Research Method and Design
This study was based on a qualitative design. A qualitative approach was selected
because it allowed for an in-depth understanding of how individuals make meaning out of their
lived experiences (Merriam & Tisdell, 2016). Providing an opportunity for IRB insiders to
articulate their experiences allowed for exploring how they experience their complex and
dynamic world and what meaning they make out of it.
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Phenomenological research seeks to understand a particular phenomenon by exploring
participants’ experiences (Merriam & Tisdell, 2016). Central to this approach is the idea that the
underlying phenomenon of interest can be best understood by documenting, analyzing, and
comparing individuals’ experiences of it (Merriam & Tisdell, 2016). As such, this
phenomenological study sought to depict the essence or basic structure of IRB insiders’
experiences (Merriam & Tisdell, 2016). Additionally, phenomenological research was deemed
most appropriate given the questions that this research answers. Phenomenology allows for the
identification and exploration of various aspects of people’s lives, and as a result, generates a
more in-depth understanding of the population under study and the phenomena they experience
in their everyday lives (Hopkins et al., 2017).
Participating Stakeholders
The sample population was selected from one source, a Facebook group of IRB insiders
who are either studying for or have already passed the Certified IRB Professional (CIP) exam in
the field. To be eligible to take this exam, one must have a minimum of two years of experience
in IRB. This online group has approximately 1,700 members.
Participants from this group were recruited through an initial recruitment post, provided
in Appendix A. The recruitment message offered basic study information, including a statement
about the research intent of the study, what participation entails, and the researcher’s contact
information. Because this study was looking for rich data on the lived experiences of IRB
insiders, participants were asked to self-assess whether they meet the following eligibility
requirements: 18 years of age or older, a minimum of two years’ experience in a decision-
making role within SBER IRBs, ability to speak and read English, and agreement to be audio and
video recorded for the interview. Once a potential participant contacted the researcher via email,
36

the researcher emailed back to verify that participants met eligibility requirements for interviews
and set up a date and time with the participant for the one-hour interview. The initial response
email can be found in Appendix A. With an agreed-upon date and time, the researcher emailed
out the information sheet, found in Appendix B, which served to satisfy the basic elements of
informed consent. Because this study was reviewed at the Exempt level through the IRB, there is
no formal requirement for obtaining signatures or verbal consent from participants (45 CFR 46,
2019, section §46.104(d)). However, the researcher provided ample space at the onset of the
interview to discuss in greater detail participant confidentiality, privacy, and the voluntariness of
the study and offered to answer any questions the participant had about the study. This helped to
ensure truly informed consent, a process whereby the participant comes to fully know and
understand what their participation entails.
Twelve people agreed to participate, and all 12 were interviewed. After participants self-
assessed whether they met the inclusion criteria, interviews were scheduled. All candidates who
responded were female, which is representative of the field of IRB insiders. The organization
Public Responsibility in Medicine & Research (PRIM&R) conducts an annual workload and
salary survey of IRB insiders around the globe, which can be accessed through paid membership
in the organization. In 2017, it received 656 responses from roughly 200 IRBs, mainly in the
United States (PRIM&R, 2017). Of those respondents, 79% were female, 19% were male, 2%
declined to answer, and 1% were transgender.
Data Collection, Instrumentation, and Analysis Plan
The method of data collection used in this study was semi-structured interviewing.
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Interview Protocol
Semi-structured interviewing was best suited for this study because it allowed the
researcher the flexibility to explore nuance in any given topic (Merriam & Tisdell, 2016). The
interview protocol, found in Appendix C, lists the questions and potential follow-up questions
used in the interviews; however, depending on topic or direction of the discussion, there was
latitude to deviate from the protocol if the interviewee provided new directions to explore. This
allowed the researcher to keep the interview more conversational and explore topics related to
the research questions in greater detail.
The questions in this study were designed after Patton’s (2002) question typology. Patton
(2002) suggests six types of questions: background and demographic, experience and behavior,
opinions and values, feeling, knowledge, and sensory. Background and demographic questions
help provide context and a framework for the interviewees by eliciting information such as age,
education, and work history (Patton, 2002). Experience and behavior questions relate how a
person responds to things, both past and present (Patton, 2002). Opinions and value questions
center on understanding how people interpret and understand various situations. Feeling
questions help tap into the human experience, and knowledge questions inquire about what the
interviewee knows through factual information (Patton, 2002). Finally, sensory questions ask
about what is seen, heard, tasted, touched, and smelled (Patton, 2002).
The questions in the study leveraged three of Patton’s (2002) six types: background and
demographic, experience and behavior, and opinion and value. Background questions were used
to establish the participant’s role and to understand the years of experience working in IRBs, the
number of protocols they process, and the size and type of their institution. The background and
demographic questions aided in defining the scope of the study. Experience and behavior
38

questions were used to assess people’s experience with the complexity of IRB work, complexity
and nuance within their roles relative to the major stakeholder groups, and how that impacted
them. The behavior questions invited participants to think about their role in the research
ecosystem and to reflect on their behaviors and interactions with various stakeholder groups.
Finally, the questions on opinions and values explored the roles participants played relative to
the protection of human subjects, the researchers, and the larger organization.
Interview Procedures
Interviews were conducted in October–November 2021. Participants were recruited
through the two online spaces: PRIM&Rs IRBForum and the Facebook CIP Study Group. The
general recruitment post (see Online Recruitment Message in Appendix A) provided my contact
information, allowing participants to reach out if they were interested in participation. If a person
met eligibility requirements through self-screening, they were sent a confirmation email (see
Email to Confirm Participation in Appendix A). This message included the information sheet for
exempt research (see Appendix B).
Interviews were 35 minutes to over 1 hour and conducted via the Zoom video
conferencing platform (www.zoom.us). During the COVID-19 pandemic, most professionals
were working remotely. Because of this, Zoom was a familiar way to conduct digital face-to-face
interviews; an additional benefit was the geographical reach. Participants from all over the
country were recruited and participated without having to meet in person. All participants agreed
to meet over Zoom for the interviews and be recorded.
At the offset of each interview participants were reminded of the confidentiality and
privacy measures of the study. They were allowed the time and space to ask any questions about
their rights as participants or any other questions they may have had. Participants noted how odd
39

it felt to be a participant in a study and to have someone else tell them about privacy and
confidentiality, given their line of work in the IRB. Once all questions were answered, the
recording was turned on in Zoom.
In addition to the recording, the researcher took handwritten notes on a printed set of the
interview questions. According to Merriam and Tisdell (2016), taking notes during an interview
that is being recorded helps researchers to be present to capture their reactions to what is being
said in the interview. It also helped the researcher jot down follow-up questions or observations
about what was being discussed in the moment and served as a useful tool for both reflection and
reducing researcher bias after each interview.
Upon completing each interview, participants were again allowed to ask questions.
Several participants asked if the results of the study could be shared with them. Their contact
information was stored separate from their data so that the researcher could email the final study
to them.
Data Analysis
Once each interview was complete, it was transcribed using a platform called Otter.ai
(www.otter.ai). Otter.ai allows researchers to upload Zoom recordings to their secure servers,
and it transcribes the interviews into a downloadable file format. Once the file was ready for
export, it was exported into Word. The researcher reviewed the transcript for any discrepancies
or missing information and used the video recording to clarify any oddities in the transcription.
Once the transcripts were cleaned, the video recordings were deleted.
Creswell and Creswell (2018) provide a general overview of how qualitative data is
analyzed, including the following five operational or procedural steps: preparing the data for
analysis, reading all the data, coding the data, identifying themes, and interpreting the findings
40

(Creswell & Creswell, 2018). Preparing the data included the process described above whereby
the Zoom file of the recording was processed through a transcription service and checked for
clarity. Once an initial readthrough of the data was conducted, the researcher paired the
handwritten notes with the interview transcripts to get a broad understanding of the material. The
data were read through three times before uploading into a qualitative analysis software called
Dedoose.
The phenomenological nature of this study lent itself to an inductive approach whereby
the themes of the research emerged after the thorough review of each transcript. While coding
the data in Dedoose, the researcher was careful to call attention to personal biases that might
impact the coding process (Creswell & Creswell, 2018) Then, using open coding, codes were
developed as a result of the themes which emerged from the interviews and then collapsed into
larger, broader themes. The coded data then formed the foundation for the study’s findings.
Chapter 4 will discuss such findings. Chapter 5 will use the findings coupled with literature to
generate a robust discussion on the lived experiences of IRB insiders and offer recommendations
for the IRB field.
Credibility and Trustworthiness
According to Merriam and Tisdell (2016), the trustworthiness of a qualitative study can
be determined by evaluating its credibility and its consistency. The credibility of a study
indicates how believable the findings are, and consistency denotes to what extent those findings
make sense in the context of the data collected (Merriam & Tisdell, 2016). To maximize the
trustworthiness of the study, several strategies were employed.
The study’s credibility involves establishing that the results of the research are believable
and have meaning to those who would interpret the findings (Creswell & Creswell, 2018;
41

Merriam & Tisdell, 2016). In this sense, the richness of the data gathered is of greater
importance than the amount of data gathered (Merriam & Tisdell, 2016). At the completion of
the study, credibility will be established through two main mechanisms: rich data and reflexivity.
The use of “rich, thick description” whereby robust descriptions are used to report
findings so that results are transported to the study experience, which in turn enhances the
realism of the study (Creswell & Creswell, 2018, p. 315), was employed. Quantitative research
aims for precision, but this type of qualitative research is marked by its complexity and richness
(Tracy, 2010). To achieve this, detailed notes from each interview were used to capture more
than just what the transcript of the interview can. When rich data is combined with detailed field
notes, a fuller, more comprehensive picture comes into focus, which helps to enhance credibility
(Maxwell, 2013).
Merriam and Tisdell (2016) refer to the second mechanism used to establish both
credibility and consistency as reflexivity. It was used to draw into focus research bias and detail
the background of the researcher and how that might impact the implementation of this study
(Creswell & Creswell, 2018). According to Merriam and Tisdell (2016), reflexivity is an ongoing
process of reflection that helps us shape our understanding of social realities as we interact with
one another. In this sense, the researcher continually checked in with individual interpretations,
working toward understanding the relationship of that interpretation and how that affects the
study.
Finally, an “audit trail” (Merriam & Tisdell, 2016, p. 252) was used as an additional step
to establish consistency. An audit trail is a detailed log of the steps taken during the data analysis
phase. It allows readers to trace the logic and rationale of the researcher to determine whether the
42

study’s findings may be relied upon as a platform for further inquiry (Merriam and Tisdell,
2016). The audit trail was created when the data for this study was analyzed.
Ethics and Role of the Researcher
Upholding the system of protection put in place for humans involved in research is at the
forefront of this researcher’s mind. Given that the research pertains to the entity charged with
protecting participants, every measure was taken to ensure the ethical and responsible conduct of
research. Participants were asked to participate in a one-hour interview about their experiences as
IRB insiders. Their identifiable information was collected due to the nature of the online video
data collection over Zoom, so I took the necessary precautions to protect participant data by
ensuring appropriate encryption and password protection on my computer. Relative to risk, there
was a slight possibility of someone feeling uncomfortable recalling their experience with the
IRB. This risk was mitigated by describing the voluntary nature of the study in the information
sheet, provided in Appendix B, and informing participants that they were free to quit the
interview or skip questions at any time. There were not any incentives offered as part of
participation. I am not affiliated with any of the universities from which participants were
recruited, eliminating concern for my undue influence.
Unfortunately, however, although IRB insiders’ participation was necessary to
understand their lived experiences, it is not likely that participants will see any direct benefit
from their participation. These points are addressed from the vantage point of someone who is
both an IRB insider and has traversed the IRB process. This lens allows for a unique perspective
when framing the scope of the research as both an insider and outsider to the topic under study.
43

Summary
This chapter discussed the selected methodology employed to explore this study’s
research questions. The stakeholder group of focus was highlighted and discussed regarding the
data collected from participants. Next, instrumentation and the interview protocol and procedures
were elaborated on to demonstrate how the study was carried out. Additionally, the procedure for
the data analysis was described, along with the credibility, trustworthiness, and ethics of the
research. A discussion on the careful considerations for the protection of human subjects in this
study was presented as well. Finally, Chapter 4 will present and analyze the data.

44

Chapter Four: Findings
The purpose of this study was to understand how IRB insiders balance their role relative
to three primary stakeholder groups: their institution, the researchers they support, and their duty
to protect human subjects in research. More specifically, through interviews with IRB insiders
from a range of SBER institutions, the study sought to create a deeper understanding of whether
and to what degree IRB insiders see any of these forces as competing with one another.
The four research questions that guided this study were as follows:
RQ1. What are the experiences of IRB insiders shepherding researchers through the IRB
process?
RQ2. What are the experiences of IRB insiders related to the protection of human
subjects?
RQ3. What are the experiences of IRB insiders related to interactions with their
institution?
RQ4. What are IRB insiders’ experiences with balancing forces from researchers, their
institution, and their duty to protect human subjects in research?
As discussed in Chapter 3, phenomenology was used to understand phenomena from
individuals who are experiencing it (Creswell & Creswell, 2018). Data were gathered through
semi-structured interviews with IRB insiders at a range of different institutions that review
SBER studies. Once all data had been collected, a thorough review of every interview transcript
was conducted. During that time, reflective notes were taken by the researcher (Creswell &
Creswell, 2018). Data were then coded to indicate meaning of the section of text in the
transcripts. Codes were clustered together to develop the themes for this research.
45

Participating Stakeholders
The 12 stakeholders who participated in this study were at varying institutions across the
United States that review SBER studies in their respective IRBs. Each participant had a
minimum of two years of experience in a decision-making role at her institution. Most
participants were from private or public universities, three worked for independent IRBs, or an
IRB that is not affiliated with an academic institution, and one worked for a research agency.
Interviews were held over Zoom during two weeks between September and October 2021.
Interviews were 35–90 minutes, with the average length being 54 minutes. Additional data about
participants’ institutions were captured to assess the size of their individual IRB. This included
the number of protocols each participant’s institution reviews in a year to the number of full-time
employees (FTE) in their IRB and the reporting structure for academic institutions. Table 1 lists
the participant’s pseudonym that is used to refer to them throughout the remainder of this
dissertation, the type of institution they are currently working for, the longevity within IRB, and
the duration of their interview.

46

Table 1
Participating Stakeholder Descriptions
Participant Type of institution Years in IRB Interview length
Averie Public Academic Institution in U.S. 10 90 minutes
Brooklynn Private Academic Institution in U.S. - 52 minutes
Chloe Public Academic Institution in U.S. 9 37 minutes
Emma Nonprofit Research Agency 15 58 minutes
Heidi Private Academic Institution in U.S. 6 56 minutes
Jody Private Academic Institution in U.S. 10 58 minutes
June Nonprofit Independent Review Board 2 37 minutes
Katie Nonprofit Independent Review Board 2 35 minutes
Lucy Public Academic Institution in U.S. 15 62 minutes
Olivia Public Academic Institution in U.S. 20 48 minutes
Sarah Independent Review Board 6 69 minutes
Summer Private Academic Institution in U.S. 15 48 minutes

Table 2 provides greater detail about the participants and their institution. It lists the
number of protocols processed by participants’ individual institution, the number of employees
47

dedicated to IRB efforts, and the person or office the IRB reports into for those participants who
were in academic institutions.

Table 2
Participants’ Institutional Descriptions and Reporting Structures
Participant Institution
Protocols
processed
per year by
participants’
IRBs
Number of
employees full
time (FTE) or
part time
(PTE) in IRB
Position or
department IRB
reports to
Averie
Public Academic
Institution in U.S.

200

3 FTE

Vice President for
Research and
Innovation

Brooklynn
Private Academic
Institution in U.S.

2000

16 FTE

Vice President for
Research

Chloe
Public Academic
Institution in U.S.
300 2 FTE, 1 PTE
Vice President for
Research and
Graduate Studies

Emma
Nonprofit Research
Agency
120 1 FTE -
Heidi
Private Academic
Institution in U.S.
20 0 FTE
Research Department

Jody
Private Academic
Institution in U.S.
5 1 PTE
The Office of the
Provost

June
Nonprofit Independent
Review Board
650 3 FTE -

48

Table 2 Continued

Participant Institution Protocols
processed
per year by
participants’
IRBs
Number of
employees full
time (FTE) or
part time
(PTE) in IRB
Position or
department IRB
reports to
Katie
Nonprofit Independent
Review Board
400 4 FTE, 2 PTE -
Lucy
Public Academic
Institution in U.S.
300 2 FTE
Research and
Economic
Development

Olivia
Public Academic
Institution in U.S.
500 4 FTE
Vice President for
Research Integrity
and Compliance

Sarah
Independent Review
Board
200 4 FTE -
Summer
Private Academic
Institution in U.S.
900 3 FTE
Vice President for
Academic Affairs

Findings
After analyzing the data, several themes emerged related to how IRB insiders experience
the various forces of their responsibilities. This chapter is organized by individual research
question, which has the supporting codes and themes. Table 3 shows examples of the collapsed
codes that supported the themes.

49

Table 3
Codes and Themes
Research question Codes Themes
1. What are the experiences
of IRB insiders
shepherding researchers
through the IRB process?
- Mentor
- Educator
- Police
- Amount of training
makes a difference
- Gatekeeper
- Underprepared
Researchers
- IRB Insiders as
Mentors and Educators
- IRB Insiders Aim to
Cultivate Trust

2. What are the experiences
of IRB insiders related to
the protection of human
subjects?
- Process
- Interpretation
- Perspective
- Beyond the
regulations

- IRB Insiders as
Protectors
3. What are the experiences
of IRB insiders related to
interactions with their
institution?

- Institutional Structure
- Tone at the Top
- Over documentation
- Support

- Institution as a Barrier
and Support
4. What are IRB insiders’
experiences with balancing
forces from researchers,
their institution, and their
duty to protect human
subjects in research?
- Helping researchers
- Protecting human
subjects
- Balancing priorities

- Complexity in
Navigating the work of
IRB

50

Research Question 1: What Are the Experiences of IRB Insiders Shepherding Researchers
Through the IRB Process?
The following themes emerged after the data were analyzed: (a) IRB insiders act as
mentors and educators, and (b) IRB insiders also act as gatekeepers. Although various roles were
shared during the interviews, these findings were consistent throughout the data analysis.
Finding 1: IRB Insiders as Mentors and Educators
IRB insiders are responsible for knowing and upholding the system of protections in
place for research conducted with human subjects. This requires them to intimately know the
body of regulations around human subjects protection in research, the Belmont Report, important
guidance documents, and a myriad of other information. Because of the depth and breadth of
knowledge required for an IRB insider, they often take on the role of mentoring or educating
researchers. Of the IRB insiders interviewed, 11 out of the 12 (92%) considered mentoring or
educating researchers through the IRB process a significant element of their job. Each of the 11
participants spoke about the mentor and educator role as if it were their primary role when
working with researchers, and they used the phrases “mentor” and “educator” interchangeably.
The participants acknowledged the compliance aspect of their duties, but when talking about
their role relative to the researchers, descriptors such as “mentor,” “educator,” “facilitator,”
“support,” and the like were used to talk about how they see their role. Heidi spoke about being
able to not only help researchers make sense of the IRB process but also assess where they are in
their understanding of the regulations to help them through the submission process:
So I have these two hats, right? I’m a research specialist, mentor, and researcher, and an
IRB chair. So they overlap. Sometimes when I’m very involved in having someone
develop a protocol, I don't review it. And so, you know, I will often give them advice.
51

Sometimes they have everything ready. But it’s kind of like they go to an accountant with
a shoebox full of receipts. So they have everything there, I’ll help them assemble it…
Heidi talked about helping researchers “assemble” their research, meaning that she guides them
through the salient pieces the IRB needs to conduct a complete review. She added that
Once [researchers] are a little more experienced, I give them advice. I will
sometimes give them advice about study design insofar as it protects human
subjects research. And then sometimes, you know, when I’m doing that, it's like,
well, you don’t have to do this, but as a researcher, you might want to do that it’ll
improve your study.
Heidi spoke of being able to gauge the amount and kind of mentoring or education needed to
successfully complete the IRB process. Her parallel to bringing a shoebox full of receipts into an
accountant described the how IRB insiders must navigate researchers who approach the IRB
with an idea for research but have not fully developed their study design or methodology. When
researchers consult the IRB at this point, IRB insiders can leverage their expertise of the
regulations to help the researcher develop an ethical study. Olivia echoes this idea of assessing
the researcher’s needs and helping them develop their research within the regulatory framework:
Honestly, just being available, and being able to able to talk to [researchers] on the
phone, or through Zoom, you know, what I mean, and having FaceTime and, and really
making an effort to understand what they’re trying to do, and not kind of fitting a square
peg in a round hole. And, you know, really talking them through and giving them ideas of
how they can accomplish what they want to accomplish in a way that’s going to be
acceptable to the IRB. And I think people really appreciate that, because most of our
52

training is study specific, meaning when we’re consulting with researchers were talking
about their specific research.
Katie spoke to the importance of cultivating relationships with the researchers and having
transparency in the IRB process for the researchers. She stated, “Typically, when we have a
submission, we're very detailed in letting [researchers] know our process.” This further
demonstrates how IRB insiders take on the mentor or educator role.
Finding 2: IRB Insiders Aim to Cultivate Trust
IRB insiders discussed various ways in which they aim to establish trust inside the IRB.
This happens though their interactions with researchers, and, more broadly, through the reviews
themselves. IRB insiders see themselves as having a role in establishing and maintaining the
public’s trust in the ethical conduct of research.
IRB insiders described instances where being a colleague (meaning that they typically
hold the same level of academic degree) to those submitting to the IRB, either formerly or
currently, makes a difference in their interactions with researchers. In several instances,
participants described how being a colleague has allowed them to better protect human subjects
in research by establishing trust. Summer described how she attends all faculty meetings and
events where the IRB may come up. She had established an IRB presence in the faculty
community as someone who is dependable, reasonable, easy to work with, and results driven.
This, as she described, “is probably more paramount in the protection of human subjects than the
actual review process. Because [researchers] understand that we all have the same goal, which is
to successfully complete a research project the best, most efficient way possible.”
Like Summer, Averie’s experience with building trust is similar:
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I am a researcher. Most of my experience is in research and I still am an active
researcher, so I feel like a colleague. When I talked to researchers I want to understand
where they’re coming from so that I can show them how these things matter to them.
Right? So I would say generally, researchers want to do [research] the right way. But
they also are doing so much that they’re like, if I don't have to do [the IRB], I don't want
to. And so really trying to show them how it matters, in what ways and what aspects of
IRB matter to them, given their standing, epistemologically, and methodologically. So
I'm like a colleague, trying to bring the IRB to them in a way that they can understand it.
She describes how collegiality can help build trust and establish a better working relationship
with IRBs and researchers. When IRBs had individuals who had traversed the IRB from a
researcher perspective, as Averie described, they had better traction with the researchers.
A secondary element of trust described in the interviews was the role IRB insiders play in
establishing the public’s trust in research. Chloe succinctly stated about IRB insiders, “[the]
public has to be able to trust that research is being done correctly. And we’re kind of the
cornerstone of that piece.” Summer echoed Chloe’s notion of IRB insiders being the cornerstone
of public trust in research when she stated, “At the end of the day, the IRB is the mechanism for
upholding trust in research.” Additionally, Chloe talked about the ways in which IRBs help
cultivate that trust by taking steps to ensure researchers are maintaining privacy and
confidentiality or requiring provisions to secure data. To that end, Chloe noted, “we do a lot of
work behind the scenes.” What Chloe described is how the review process is, for the most part,
unseen by those participating in research. But the “behind the scenes” work of IRB insiders helps
to ensure that research participants are protected. Summer agreed with Chloe, stating, “when
IRBs and researchers partner together it’s the best way we have to protect participants.”
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Conversely, when a trusting relationship does not exist between IRB insiders and
researchers, IRB insiders can be labeled or perceived as gatekeepers in the IRB process. How
IRB insiders are thought of by researchers can significantly impact IRB insiders’ lived
experiences. Current research on IRBs discusses the gatekeeping function IRBs have in research
(Emmerich, 2016; Harger & Quintela, 2017); however, IRB insiders described a different
perspective. IRB insiders framed “gatekeeping” through the lens of establishing and maintaining
trust, both with the research community and with the public.
Emma reflected on her experience with trying to counteract the perception of the IRB as
a gatekeeper:
If you were to ask the researchers, they’d say I was a gatekeeper. My perspective on my
role with researchers is I feel like I am I’m there to support their work and I’m there to
support the best that their work can be in the field. And I often really strive to make sure
that there’s a customer service aspect to my role… I really see it as a making sure that
people feel comfortable enough that they could come to me with questions… All the kind
of the compliance, regulatory role scares them, it scares them and makes them feel like
they’re in some way being forced to do something that they're not sure why they have to
do it. And so my goal is often helping them understand why this benefits them, in
addition to why it benefits those that they’re working with.
Emma acknowledged the general perception of IRBs as gatekeepers but reflected on how she
tries to bring a customer-centric approach to her role and responsibilities, which helps to
cultivate trust. Summer talked about counterbalancing the researchers’ perceptions of IRB s as
gatekeepers by encouraging researchers to be open with their inquiries so the IRB can better
support researchers:
55

Well, yeah, we have this gatekeeper role. And yes, we’re very important. But the reality
is I have always been very passionate about having kind of a no penalty box policy, like
if [researchers] come to ask questions, I’m not keeping a secret list and reporting it back
to administration of, you know, faculty that are very problematic.
Conversely, June described how she internalized the gatekeeper role as a means to protect
research participants from poorly constructed research, stating, “I feel like we are the barrier
between bad research and participants.” As June described, there is a conscious effort to maintain
the public trust in research by serving as a barrier to poorly constructed or ill-conceived research
proposals. Lucy described a different type of gatekeeping at her institution, where she is
responsible for looking over protocols to make sure they have everything needed for review. As
she described it, “I’m the gatekeeper in the sense that I don’t want to send poor quality
applications to IRB reviewers [because] I don’t want to waste their time.” As the first point of
contact at her institution, Lucy acts as a gatekeeper between the researchers and the IRB
reviewers. Before she passes on research to be reviewed by members, she ensures protocols are
fully developed. Lucy’s example helps to cultivate internal trust within the IRB team.
Brooklynn discussed how IRB insiders can feel as though they serve in a gatekeeping
role for the institution when she shared, “I think that the IRB in general, including the
committee, is definitely charged with trying to keep the university and the institution safe from
any sort of backlash, whether it be public backlash in the news, or financial issues.” In this
instance, Brooklynn perceived that an element of her position was to maintain trust with her
institution by properly executing the functions of her role. Doing so establishes the institution as
a capable agent of research.
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Though IRB insiders discussed trust in a variety of different ways, they were clear in
their intentions to cultivate trust between a variety of stakeholder groups.
Summary of Findings for Research Question 1: What Are the Experiences of IRB Insiders
Shepherding Researchers Through the IRB Process?
In summary, 11 of the 12 participants identified their role as being a mentor or an educator to
those submitting to the IRB. Five of the 12 (42%) participants described the role trust plays in
their experiences. Additionally, four participants (33%) acknowledged an aspect of IRB insiders
as gatekeepers.
Research Question 2: What Are the Experiences of IRB Insiders Related to the Protection
of Human Subjects?
Data under this research question revealed the following theme: IRB insiders see
themselves as protectors in the landscape of research with human subjects. Insiders described
varying ways in which their role as protector is established. In some cases, IRB insiders enact
protection through interpretation and application of the regulations. In other instances, IRB
insiders discussed feeling that the regulatory framework was not enough to protect research
participants from researchers. Finally, many of the IRB insiders talked about reviewing protocols
as though they were participants in the proposed study to understand how to best protect them.
Finding 1: IRB Insiders as Protectors
When IRB insiders were asked about their role relative to the participants they protect in
research, 12 out of 12 (100%) interviewees described various ways to leverage the IRB
regulations and process for protection. Although IRB insiders rarely, if ever, encounter the
research participants they protect, all the respondents described how the process of IRB review
makes them feel as though they are doing their part to protect research subjects. Each participant
57

described their role as a protector in three distinct ways: (a) beyond process, (c) through
interpretation, and (d) through perspective.
Protection Beyond Process
Twelve out of 12 (100%) described protecting research subjects through the formal IRB
review process. This means that they saw the regulations as a guardrail or bumper, providing
assurances that the subjects they were charged with protecting were being protected through their
procedural review. When participants were asked if they felt that any of the decisions they made
as reviewers could be catastrophic to the research subjects they were charged with protecting in
SBER studies, five of the 12 (42%) indicated they felt their decisions in the review process could
have lasting impacts. They described scenarios where their idea of safeguarding research
subjects went beyond the administrative tasks of executing the regulations. They described a
more visceral response to the role and spoke of their feelings of inadequacy and fear about not
being able to do enough. They provided instances that their own thoughts and feelings went
beyond just the process of protecting participants in research. Jody, for example, whose IRB
serves mostly tribal populations, described a scenario where she was reflective on the review
process and the impact it may have on the research subjects in tribal communities after the
research had taken place:
I think about some of the harms coming up after time has passed. So maybe immediately,
[the consequences of the research are] not felt because, you know, it’s not been
discussed, it’s kind of looked at from the initial presentation as a good study, as a study
that really does bring together important points. But later, as the [participant] reflects, and
has increased interactions with their community, then circumstances or life experiences
come up. And [the participant] applies that question that they were asked in a study, and
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it doesn’t really resonate like it did at the time of the study. It’s that time consideration,
and actually being immersed in your community traditions and ceremony and life, that
caused that question to remain, and cause that question to expand, and then cause that
question to be positioned in various contexts beyond the immediate research study.
Jody’s description highlighted how her practice must reach past the regulations and consider how
time might impact or influence participants beyond their participation.
Summer talked about her concerns relative to staying current in research ethics. In her
interview, she acknowledged there were elements of the regulations that helped IRB insiders
protect participants, but she also described how the field of research could evolve so quickly that
ongoing training is necessary:
I am constantly concerned about how we are protecting subjects and the ways in which
we can best do that beyond just the regulations. Every single week, I carve out time in my
schedule and in my employees’ schedule, to stay on top of whatever professional
development could possibly help us. Because in the end, it’s going to protect the human
subjects.
Averie stated that she “thinks about it all the time, that researchers are putting their
priorities ahead of the protections [for subjects].” She spoke about how sometimes she feels the
IRB is the only line of defense between subjects and researchers who are only interested in
science. Later in her interview, Averie noted the distinction between biomedical studies and
SBER studies. She was explaining how intensely she feels about protecting human subjects
given the historical context in which research malfeasance has occurred through SBER studies:
I would say in general, our participants are not likely to die, for example. So in terms of
catastrophic to a specific individual, I say that that's probably relative compared to
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biomedical where somebody could genuinely lose their life if somebody does something
messed up. But I would say that some of the quintessential unethical experiment
examples historically, are SBER. And it's a researcher with good intentions, fumbling
around and putting their priorities ahead of the people or communities that they’re in.
Averie made a critical distinction between the difficulty IRB insiders face in navigating a body
of regulations mostly written for biomedical studies and applying these to social behavioral
research. Specifically, she noted that the likelihood of death is not typical in SBER studies, but
that is not to say SBER studies are absent of risk. She continued, discussing an older example:
…the linguist professor who was like, I have this theory about the acquisition of
language. So I’m just going to go into this orphanage and I'm gonna, you know,
randomize kids to one group, [and] when they try to talk, I’m going to praise them and
give them positive reinforcement. And the other random group, I’m going to punish and
give negative reinforcement. Well, they genuinely fucked those kids up. Right? And like,
okay, so yes, he proved this theory, but like, at what cost to the people? Did they die? No.
But I’m sure that they had a lot of suffering throughout their lives, right?
In this example, Averie expressly noted the participants did not suffer the worst consequence of
research participation, which is death, but they likely have long-term, if not lifelong, issues
related to their participation as children. In yet another example, Averie described an experiment
with Baby Albert:
Baby Albert is another great example. They’re like, we're just trying to understand
conditioning your baby when you touch this cotton ball, we’re gonna zap you, and now
oh, my god! They’re scared of everything white and soft! Like, of course they are. Right?
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Like they fucked up that kid. Yes, they proved the point from a scientific standpoint, but
was it worth it? And I would say for Baby Albert, that’s fucking catastrophic.
All of Averie’s examples of protections beyond process indicated her awareness of the
magnitude of the role IRB insiders play. She discussed how failure to acknowledge the type of
risk in social behavioral research could have a significant and lasting impact on participants.
Protection Through Interpretation
Four of the 12 (33%) IRB insiders detailed how interpretation of the regulations supports
them in the review process. They learn to adapt and find ways to ensure protection over HS
research, especially in SBER institutions. Averie notes the complexity of navigating this
protection when she described how she finds ways to both adapt within the framework of the
regulations and collaborate with researchers to ensure the best protections for human subjects:
Looking at [the research] from a participant protection standpoint and recognizing that
the regulations don’t always protect participants in different study options. So adapting
the ethical principles and basic IRB expectations to fit various research projects, I think is
incredibly valuable, because then I am, right, a collaborator, with the researcher in
ultimately working to ensure that we have compliant ethical research, instead of as an
arbiter, like, yes, no, yes, no. I'm so working collaboratively with them with my
framework being what is the participant’s experience with this? Rather than how quickly
can we get this through?
Olivia spoke about feeling comfortable interpreting and applying the regulations, but she
pointed out that she was trying to mostly adhere to the regulations with little interpretation when
she first started. As her time in the IRB progressed, she became more comfortable interpreting
and applying regulations:
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I think it does help when you’re starting out to be a rule follower and learn the
regulations and be fairly strict in interpreting them. But a lot of that also depends on the
leadership that you have in the office. [After] 20 years now I have a whole different
perspective on research protections than I did when I started, especially with regards to
issues around privacy and things like that.
Olivia made the distinction between how she felt first starting out as an IRB insider, where she
would adhere closely to the regulations, leaving little room for interpretation, and how she
became more comfortable employing the regulations as time in her role increased. She
continued, “I think that was the big eye opener for me, you go from kind of this very, I don’t
want to say paternalistic… to being more comfortable that the regs are really quite vague for a
reason.” Olivia described how time was an important factor in her becoming more comfortable
executing her role and being able to adequately interpret the regulations when they were
purposefully ambiguous.
Lucy aptly noted that the ability to interpret regulations in various ways can be both
positive and negative:
The other thing I say a lot is like the curse and the joy of the regulations. The curse is that
there is so much flexibility and interpretation, but the joy is that there is so much
flexibility and interpretation. It really is like a double-edged sword.
Emma commented “I’m just doing my job. Thankfully I don’t write the regulations, I’m
just interpreting them and try to make it as painless as possible for [researchers].” Both Lucy and
Emma drew attention to the body of regulations being challenging for an IRB insider attempting
to interpret and execute the regulations in their reviews.
Protection Through Perspective
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Eight of the participants interviewed (67%) said they try to think of themselves as a
participant in the research they are reviewing. IRB insiders described instances when they were
conducting reviews and they purported that the strength of their review came from being able to
place themselves in the proverbial shoes of the participants. Participants described scenarios
where IRB insiders would review consent documents of someone who might participate in the
proposed research. Lucy, for example, explained the following:
So I definitely feel like a lot of times when I'm looking at resources, trying to put myself
in the position of the participant, it’s sort of my practice to really read a consent form
before I kind of look at anything else, just to have some sense of, do I even understand
this? Does any of this make sense to me?
Emma described a similar scenario to Lucy, stating
how would I feel if this were happening to my child? How would I feel if my child, who
is 3 years old, is being asked to come into a room with a researcher and answer questions
for an hour?
In both instances, the IRB insiders described part of the mechanics of conducting
reviews. Placing themselves in the potential participant’s mindset helps them ensure studies are
not only compliant but ethical for the people who are participating. When Averie talked about
reviewing studies, she pointed out that IRB insiders are responsible for considering what it is like
to participate in a study. Although she empathized with what researchers go through, she noted
her primary responsibility was to consider the participant experience:
I understand it’s tough for you as a researcher, which I do understand, but I’m the one in
the relationship who's primarily focused on participant experience, and helping the
researcher think about that, and work toward that and craft their project.
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Brooklynn offered a more concrete anecdote about a study she reviewed where she had to put
herself in the position of minor participants and what they were being asked to do, which helped
her better protect the study participants:
We had a study, maybe a couple of years ago, regarding scoliosis. And the kids were
typically young children, 11, 12, 13 years old. And part of the study was asking kids to
strip down and to be put in this like container of water, you know, how they do like
weight displacement [to measure BMI]? We were concerned that the kids in the actual
ascent weren’t told all of the particulars, [but] the parents were told all of the particulars.
And we were concerned that a 13-year-old girl might not be too keen on being naked for
a research project and stuck in a tank of water.
In her example, Brooklynn pointed out the importance of IRB insiders being able to place
themselves in the proverbial shoes of participants to help ensure protection. In this instance, in
her review of the protocol, Brooklynn understood that although the parents were to be made
aware of how the researchers planned to measure BMI, there was not yet a mechanism in place
to adequately and accurately inform the actual child participants of the requirements. She
discussed how she had the research team adjust the protocol to better reflect how participants
might be experiencing this particular research:
[The IRB] wanted to make sure that the consent didn’t just say, you know, “we’re going
to find out your body fat percentage,” right? That is exactly what you’re going to do, but
you need to explain it to both the parents and the children what the expectation is because
you are asking a teenager… to do something like this without them knowing in advance,
you're putting them psychologically in a bad place. When stuff like that comes up, it’s
okay how can we better explain to the subjects and protect the subjects themselves, so
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that they’re fully aware of what they’re agreeing to? And what they can expect when they
come to a study visit.
Brooklynn’s example highlights the importance of IRB insiders to place themselves in the
position of potential participants. In her case, if the IRB insider had not done so and allowed the
consent and assent documents to simply state something about taking a body fat metric without
explicitly describing how that happens, the potential was high for participants to become upset or
experience other psychological ramifications, especially considering the population.
Summary of Findings for Research Question 2: What Are the Perceptions of IRB Insiders
With Respect to the Protection of Human Subjects? Twelve participants (100%) viewed their
role as protectors of human subjects in research. Additionally, five (42%) of participants
described how they view research participants’ protection beyond the regulations and the IRB
process to protect research participants. Four (33%) described ways in which interpretation of the
regulations supports them in the review process, and eight (67%) use perspective as a means to
protect human subjects in research.
Research Question 3: What Are the Experiences of IRB Insiders Related to Interactions
With Their Institution?
The data around IRB insiders and their role relative to their institution were conflicting.
Some insiders felt highly supported by their institution, but others described a strained
relationship between the IRB and their institution. The following themes emerged: (a) the
institution as a barrier and (b) the institution as a support.
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Finding 1: The Institution as a Barrier
Eight of the 12 participants (67%) described scenarios where the institution acted as a
barrier to the IRB. This was discussed in various ways, such as the reporting structure of the IRB
creating problems or lack of support from high-level administrators for IRB functions.
Sarah described how the tone set by high-level administrators responsible for overseeing
the IRB is pivotal. Reflecting on some of her experiences as a consultant in the IRB world, she
stated
I’ve worked in places mostly where they were, where the IRB was respected. I’ve done
consulting in places that have been really bad. And in one place, I just consulted with the
administrator and said, “find another job, you’re in a no-win situation.”
Sarah continued to talk about how the infrastructure and support for IRB is important in the
functioning of IRBs, and lack of support can leave IRB insiders at a loss:
I think [IRBs] understand [when] they’re supported. When they have a problem, it’s
understood and taken seriously. There is a recognized chain of command I think that’s
often missing in smaller places. It’s not a definite chain of command. Most of the people
in small [institutions] don’t understand research, so they put it up in a temple of some
sort. And [one researcher] could do no wrong, except that he was. And the [IRB]
administrator knew it. It was just a mess. And there was nothing [the IRB administrator]
could do right. Because she was holding up the research, she was always under fire. She
was holding up approval, and it was a no-win situation for her.
Averie echoed the notion that without support from the top, IRBs can be dysfunctional
and be difficult places to work:
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I’ve been a part of IRBs who have been so damaging in their thought process and the way
they treat their people. And this world can be really tough. Especially if you don’t have
the support from your IO, and the tone at the top is all messed up. I think it can be, it can
make all the difference for people like us in these roles.
Olivia, a veteran IRB insider, described a more volatile situation with an Institutional
Official (IO), or the person at the top responsible for the proper support and functioning of an
IRB:
The tone at the top can make a difference to how IRBs are perceived in general or how
they’re approached by researchers. …In the old days, and this was right before I came [to
this institution] the VPR (Vice President for Research) then was allowing researchers to
go to him and complain about the IRB. And then he’d storm into the IRB office and yell
at everybody.
Olivia concluded by saying “…that hurts morale, and morale is something I take very seriously
in my [IRB] office. I’ve been there where I felt pretty beat up by my job.”
Jody referenced high turnover in the IRB due to a lack of infrastructure and support from
the top. She discussed how her IRB still operates through an email submission system, which has
created an untenable situation for IRB insiders:
Yes, we’ve had turnover. I think I probably, I have the longevity mark of 2 years. I think
people typically last 1 year, and they just throw up their hand and say, “this is not okay.”
So I think that, yeah… There have been gaps where the Provost has appointed someone
quickly to fill in because faculty either have left or have had assignments… We’ve had a
huge turnover of staff, and so that makes it a little unwieldy.
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Jody’s description of IRBs not receiving the proper support by their institution demonstrates how
it can impact IRB insiders. In Jody’s case, she indicated she is the IRB insider who has been with
her institution the longest at two years. This means that the IRB must spend a significant amount
of time and resources on hiring and retraining, which ultimately draws resources away from the
protection of human subjects. Not only can IRB insiders experience the institution as a barrier
from a top-down hierarchical perspective, but it can also happen at the researcher level.
Emma described a scenario where a well-funded researcher usurped the IRB and went to
a high-level administrator because they “wanted less oversight on their projects.” As the IRB
insider, she was put into a position to advocate for the IRB to perform the basic function of its
job. She said she “received a full email about how I need to change what I was doing.” When she
reflected on the interaction, she stated she felt like responding with the following:
Should I just change the regulations? [Should I just] make sure we don’t need them to get
an assurance number? [Should I] make sure that nobody needs to do CITI training? And
they say things to us like, “Why are you making everybody get trained?” Well, let's talk
about the assurance. Or they say things like, “our subcontractors or [researchers] who
were also engaged in research, they don’t need to get the IRB approval, they’re not really
doing the research. I mean, we're gonna hold the data.” Or, “well, they’re in the
classrooms, they’re collecting the data, they’re going to do the consent process with
families, and they’re going to also see some of the data, but they’re not really going to do
the analysis.”
As Emma pointed out, she had researchers trying to find ways not to submit to the IRB
because they felt as though they did not need to do so. Emma’s experience indicates how the
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tone set about research at the institution allows certain types of behaviors from researchers.
Emma continued
I was amazed at how this went back and forth. And I think it’s things like that, that make
this work really hard, because I feel like how much effort I put into it. And I really try
and be transparent. And when I when I don’t feel like I'm getting supported from
leadership when they do these things, it’s very obvious that they see this as a low priority
compliance mechanism, as opposed to really thinking about how we protect subjects and
protect even the idea of liability [to the institution]. That was the big way that I got them
sway back the other way. It was a talk about liability to [the institution].
Emma described feeling as though the IRB was a “low-priority mechanism” at her
institution. Her feelings of frustration and resentment toward the institution were palpable in her
example. When the IRB is not well supported, it can leave IRB insiders feeling discouraged.
Lucy spoke about not feeling supported by her department for a number of reasons:
You know, we have this terrible submission system, and half the time researchers can’t
figure it out. And the other half of the time [the IRB reviewers] even struggle to tell
people how to navigate it. And to make matters worse, we can’t pull any data out of it, so
we have to do all of our reporting manually. And that is really taxing on the team. And
quite honestly, it sucks all of our resources from reviews.
Lucy’s example spoke to IRB insiders feeling unsupported by their institution. When the
IRB does not have the proper resources to support their research community, it makes the daily
lived experience of IRB insiders difficult. In this example, the failing IRB submission system
causes strain on both the research community and the IRB insiders. This can create tensions both
internally in the IRB and between the IRB insiders and the research community. Conversely, in
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instances when IRB insiders feel supported by their institution, they describe less of a strain both
internally and externally with the research community.
Finding 2: The Institution as a Support
Eight of the 12 participants (66%) described scenarios where either their institution
served as a support for the IRB or identified mechanisms they would like to see in place to
support it. Three described an environment where their institution’s policies and procedures for
IRB were aligned with the regulations, and that fundamental aspect created a positive culture of
supporting the IRB and their compliance efforts at the highest levels of the institution. Chloe felt
confident about the support her IRB received at her university:
I really know [the policies and procedures] are quite congruent. And I think they really
helped me in giving justification for why I’m asking for things often. And if a researcher
has a question about something that is relevant to a specific policy or specific guidance,
you know, I can easily refer them to that.
Katie had a similar experience with her institution’s policies and procedures:
Now, I feel like our policies and procedures are very detailed. It’s actually something that
we’ve been working on a lot in the last year is really doing a lot of internal audits to make
sure that things aren’t conflicting, things are straightforward and detailed, as far as how to
handle any type of review or situation.
Katie highlighted how her institution engaged in meaningful reflection and allocated resources
toward ensuring their policies and procedures were congruent with one another. She echoed how
the process of changing the policies and procedures helped her IRB carry out the function of
their roles more efficiently. She continued
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And something I actually do for our institution is make a lot of worksheets and checklists
that are based off of SOPs (Standard Operating Procedures). I just did participant
complaints, so taking our procedures for that, [and] putting it into checklist form has been
helpful. So then if we ever have [a participant complaint], we know exactly how to
handle it, how to document it, where it’s all kept.
When internal policies and procedures are clear and well aligned, IRB insiders can
leverage materials to support them in making their regulatory determinations. In Chloe’s case,
the infrastructure around the IRB positively supported her ability to review research. She leaned
upon the backbone of the policies and procedures for IRB to support her decision making. She
went further and reported
I think the institution really has to show that they value [the IRB] and if a researcher is
feeling like this is too much, and they don’t want to submit to the IRB, because they think
that there are no negative implications for the participant, the people who are higher than
me in the institution need to basically back me up and say that [the researchers do] need
to submit, that this is necessary and required, and I do feel like I have that support behind
me.
Chloe’s experience demonstrated how IRB insiders can utilize the support of the
institution to aid in managing difficult scenarios with researchers. She expressed confidence in
her institutional support. Olivia spoke to the idea of fully supporting her staff as a director:
I’m lucky in that I have really good staff too. But you know, sometimes if you don’t have
good staff you can’t be as nimble. But I have very well-trained people, and I feel
confident that any of them could give good advice to anybody. So, I as director, I don’t
feel like I have to weigh in on every decision.
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Olivia asserted how having highly trained IRB insiders is essential to the proper functioning of
her IRB. She also noted how she encourages them to be empowered in their decision making.
She further reported
…[The staff] know the limits of their limits. So, they know when they have a question
[and say] “I just don’t know the answer,” and I may not know either, but we can
brainstorm together. I think people just think we're kind of the friendly IRB, and I think
people really like that.
Olivia’s idea of supporting her IRB seemed to be through an open-door policy. The
environment she established as IRB director seemed to be supportive and understanding of the
IRB insider experience. As she described it, this openness with her staff translated into a greater,
more positive overall feeling from the research community toward the IRB.
Summary of Findings for Research Question 3: What Are the Experiences of IRB Insiders
Related to Interactions With Their Institution? Eleven out of 12 (92%) participants described
scenarios of the institution being either a barrier or support. Eight (73%) described scenarios
where the institution acted as a barrier to the IRB, and eight (73%) described instances where
their institution acted as a support mechanism for the IRB. Five of the 11 (55%) saw instances of
their institution acting as a barrier and support, allowing for crossover between each category.
Research Question 4: What Are IRB Insiders’ Experiences With Balancing Forces from
Researchers, Their Institution, and Their Duty to Protect Human Subjects in Research?
When participants were asked about balancing forces from the various stakeholder
groups, the following theme emerged: IRB insiders experience competing forces from the
various stakeholders.
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IRB Insiders Experience Competing Forces
Ten out of 12 (83%) IRB insiders spoke of experiencing competing forces when
balancing the needs of all three stakeholder groups. Some described the participant stakeholder
group as their primary concern but said they felt pressure from other stakeholder groups for
various reasons. Others described scenarios of being directed to prioritize the institution or
researcher.
Katie detailed a scenario when she was following the regulations and procedures for
reviewing an IRB submission and felt tension and pressure from researchers, stating, “When it
comes to difficult researchers, there’s sometimes that pressure. [Researchers] are wanting to do
things [a certain] way, and they’re not letting up.” She continued to discuss how researchers with
certain expertise will abrasively approach the IRB. She made a point about researchers
navigating the IRB:
It is different than just [the researchers’] daily job. [For me] having that pressure, it’s like
having somebody down your neck, but then [we] also have to be the middleman between
[the IRB Chair and the researchers]. It’s very much like don't shoot the messenger. So I
think that’s probably the hardest part.
Katie outlined how researchers can impact IRB insiders by the way in which they
approach the IRB. Katie went on to discuss how her institution started to combat the kind of
scenario she described with difficult researchers:
So I guess if somebody is going to complain, they want to call and complain rather than
send an email. We’ve really cracked down on making sure people know that we record
our phone calls for quality assurance, and anything can be added to your [IRB] record.
It’s documented, just like in an email, because I think people try to get around the whole
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documentation side of being arrogant. So they don’t want to send an email, they want to
do a phone call. But we’ve made it very clear in all of our phone calls that they are
recorded, and they’re kept in [the IRBs] documentation, just like an email would be. So
that kind of helps, I guess, with the bullying of some researchers.
In this scenario, Katie described wanting to execute her role to protect research subjects.
She noted this feeling of being bullied by researchers over the phone. As a result of the
researchers’ behaviors, the institution put additional protections for the IRB insiders by allowing
them to record and document phone calls. The complexity with this is that recording phone calls
does not necessarily equate to greater protection for human subjects in research but rather greater
protection for the institution. Additionally, this process added extra work for the IRB insiders as
they were required to log each call. Though not explicitly stated, Katie described a tension
between researchers and their institution and IRB insiders.
Later in the interview, Katie identified a definite area where she felt strain between
competing forces. She described her role as being part of a peer review process and an
administrator in the IRB. She talked about having to make sure people follow the rules and
regulations but that she also wanted to ensure researchers were having a positive experience with
both the peer review process and the IRB. She commented, “So I think that kind of where my
juggle comes in is just the administrative side versus the reviewer side. So protecting human
subjects, but also being kind of that customer service and protecting your institution’s
reputation.”
Along the lines of protecting the institution’s reputation, other IRB insiders described
how they struggle with the latest change in regulations. It creates conflict for them in that it has
made the distinction between two different regulatory determinations: exempt, or the most
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benign type of research, and expedited, which carries some risk but not more than experienced in
everyday life, irrelevant. Sarah was asked how the latest change the Common Rule has impacted
her IRB operations:
We’re a regulatory body, and we don’t do follow up more and more, there’s no
continuing review. And most PIs (researchers) don't know enough to know when to
report things. So when [the Feds] cut out continuing review, I think they cut out the trust
angle, we have no way anymore. So, the trust has to be in a in a larger institution. The
IRB contributes to that, but we don’t control [it].
Sarah acknowledged how the new regulations changed an IRB insider’s ability to categorically
distinguish between an exemption versus an expedited review. In the pre-2018 Common Rule the
regulations were written so that determinations could be made based on whether the IRB wanted
to see the protocol within a given time frame, typically one year from approval. The New
Common Rule has no requirement for continuing review. This means that the decision whether
and when to report anything to the IRB is left up to researchers. IRB insiders reported struggling
with giving researchers greater decision-making authority over regulatory decisions.
Averie passionately noted similar frustration with the latest change when she described
an interaction she had at a professional conference where the Secretary’s Advisory Committee
on Human Research Protections (SACHRP) was there to answer questions. Averie asked
What’s the difference between exempt and expedited? Nobody can answer. The Feds
couldn’t answer that question, SACHRP couldn’t answer that question, nobody had
thought of that question. I said, when you’re an SBER IRB, and you're looking at a study
that could either be exempt or expedited, “old school” (meaning pre-2018 Common Rule
change), one of the things you would say is “do I need to look at this again, is this
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something that I want to check the progress on?” And if it is, you would put that in
expedited [category].
Averie started to outline how IRB insiders were impacted by the change in the Common Rule.
She explained that IRB insiders no longer have a clear line between two distinct regulatory
categories, which can cause confusion for not only IRB insiders but also researchers. When IRB
insiders, who are the regulatory experts, do not have a clear explanation or delineation as to why
a protocol was reviewed one way versus another, it can add to the notion that IRBs are too
paternalistic and burdensome (Bledsoe et al., 2007; Miller & Wertheimer, 2007; Mueller, 2007).
Sarah echoed Averie, noting, “…That’s when the regulations become a barrier to us being able
to do our jobs because there isn’t clarity there.” Both Averie and Sarah expressed their
frustrations with the body of regulations themselves causing angst for IRB insiders.
Sarah brought up two significant points about complexity in balancing roles in the work
of IRBs. First, she agreed with other participants in this research about allowing researchers
greater freedoms to make determinations about their research. This, according to IRB insiders,
ultimately decreases clarity for them because not only do the regulators not have clarity on this
issue, but the regulations are written in such a way that interpretation can be difficult for IRB
insiders. This means that people who are highly trained within the framework of the regulations
are now relying on researchers to make these nuanced decisions. Secondly, she pointed out the
debate over whether IRBs are regulatory or ethics committees. Not having continuity across the
field of IRB can create confusion from both researchers and IRB insiders.
Lucy described yet another point of trying to balance stakeholder priorities. She talked
about not compromising the integrity of her work or the work of her team, but doing so may
result in pushback from the institution:
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I’m not going to compromise protections [for research subjects] and what my
expectations are. And I’m not going to rush our IRB to do stuff. I don’t want to give them
an application that is so clearly crap and waste their time and make it more difficult for
[my team] because I really want them to be focused on the human subjects protections
and not how crap the application is and how it’s written poorly or whatever. So I feel like
that difficulty is when I feel the researcher is rushing and demanding and pushing and,
and those [researchers] that will go up the chain to complain to higher ups for things
taking so long or whatever it might be. That’s really where I feel the most force from.
Lucy’s account highlighted how IRB insiders receive complaints because of researchers
who complained to high-level administrators. She described how complaints can negatively
impact IRB insiders. In the same vein, Summer noted the difficulty of her institutional structure
not being set up for the IRB to succeed. She described an extreme scenario where she felt
tremendous pressure from the institution to compromise the integrity of the IRB process:
When you have a structure that’s poorly set up, and administrators who are pressuring
you one way or the other, I’ve been directly pressured to slow the [IRB] process down,
because it will make more money for the institution. I’ve been directly told that by
administration.
Summer described how IRB insiders can experience undue influence from those in their
reporting structure:
So clearly, the institution, and the senior level administrators are where I feel the most
force from because it directly affects me personally, in terms of my employment. So
pissing off the wrong person directly affects my employment and my ability to, you
know, provide for my family. And sometimes that voice can be loud and strong.
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Summer’s account, though extreme, was not unfamiliar to the other participants. The idea
that IRB insiders must uphold a set of federal regulations but a high-level administrator could
attempt to influence their decision demonstrates the severity of the competing forces for IRB
insiders. Similarly, June described external pushback but from researchers. She noted feeling
varying forces from her desire to conduct quality reviews and the demands of researchers:
I’ve had heated conversations with researchers before that didn’t think they should have
to include [the IRB’s] contact information or their contact information in a consent form.
Or researchers sometimes feel they shouldn’t even consent people to begin with. And I’m
like, no, you don’t understand what my job is, and you hired us to provide this service for
you and we are not going to just rubber stamp the study. And I think that there are
institutions out there that do that, and I don’t want to say it ruins our reputation, but it
makes us seem very harsh. When we are just trying to do our job.
Competing forces from various stakeholder groups can cause strain in IRB insiders.
Summer spoke about how she has encountered others who have experienced similar situations
and how she is able to commiserate with colleagues:
The one thing for me, personally, what I’ve noticed about other IRB people, is that it’s a
universal feeling. So having camaraderie and knowing like, I'm not alone in this, and I
can get through it, and this is how other people have gotten through.
As Summer described it, she feels supported by the relationships she has built over the years
with other IRB insiders who have had comparable experiences.
Overall, IRB insiders experience significant forces from various stakeholder groups, but
participants described the greatest forces coming from researchers and the institution.
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Summary of Findings for Research Question 4: What Are IRB I n siders’ Experiences With
Balancing Forces From Researchers, Their Institution, and Their Duty to Protect Human
Subjects in Research? Ten out of 12 (83%) IRB insiders spoke of experiencing competing
forces when balancing the needs of all three stakeholder groups. Analysis of the data revealed six
of the 10 (60%) pointed to feeling the greatest force from researchers, and four of the 10 (40%)
felt the institution was the greatest competing force.
Emergent Finding Unrelated to Research Questions
During the course of the interviews, 10 of the 12 (83%) participants also discussed a
“changing of the guard” moment, which they saw as the department experiencing turnover in key
leadership roles that would allow for a fresh perspective on applying regulations or improving
the IRB process. Participants described how that moment impacted their approach to interpreting
and applying regulations and how they see their role. More specifically, in instances when
tension was ease, they were able to be less rigid in their reviews. For example, Olivia spoke
about becoming the director of her IRB after the director left under extenuating circumstances:
Coming into this job as a director, I was able to develop my own policies and procedures.
There was freedom in kind of loosening up certain interpretations, or just setting a
different culture for how things were reviewed.
Heidi had a similar experience where she started as an IRB administrator at the same time
their academic unit hired a director for research. She noted how the two new changes within the
department allowed them to be on the same page and act concurrently as a department:
When I was hired, the research director had recently been hired too. And the IRB was
kind of in disarray. The research department was reforming and so we started working,
we did a lot of that together. What that means, in terms of advantages, is that the director
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of research is very knowledgeable about human subjects research and IRB issues.
Because of all of the discussions we have about research department policies, which tend
to really conform with the common role, there is an understanding there, that I think just
basically avoids a lot of miscommunications.
Averie discussed her experience from previous IRB work going into an institution that
had recently experienced some changeover. She talked about the idea of coming in with fresh
eyes and trying to understand why things were done the way they were. As she described it, the
best explanation she could get was “because somebody 10 years ago thought this is how it is
supposed to be, and they’ve been stuck with it ever since.”
Brooklynn described a changing of the guard moment at her institution where the first
director who helped establish the IRB was retiring. It afforded their department the opportunity
to bring in new staff. What she mentioned is congruent with one of the previous findings from
this study where the institution can act as a barrier:
Back when I started, our IRB chairs and our IRB director were very old school.
They had been working in the IRB since, honestly, since IRBs had been required. Our
first director was someone that had literally started the IRB. She has since retired, and
we’ve brought in new staff members that see the regs in a different way, and want us to
apply them equally and fairly, to every study, and are not worried as much as long as we
follow the regulations, we’ve done our jobs. And in the past, we had a lot of old school
staff members that felt that everything should be expedited, because it helps the
university stay protected.
Lucy’s experience positively impacted and improved the IRB operations at her institution
by allowing for more accuracy in designating review levels. Lucy described how most of the
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research at her institution would be reviewed under expedited procedures, meaning there were
several more requirements to be met by researchers. When the changing of the guard moment
happened, the new staff applied the regulations so as to allow for research to be properly
categorized rather than deferring to one category for the majority of submissions:
When I first came here, my boss has long since retired. But she had only been in the job
for maybe 5 years. And really, when she came in the IRB was not viewed very favorably.
And she did a lot to really turn things around to try to establish a more customer service,
but also just a collegial kind of environment and relationship with the IRB and
researchers.
Overall, the changing of the guard moment happened to most of the IRB insiders who
participated in this study. All the participants described a positive shift from the “old guard” to
the “new guard.” Participants also expressed feeling thankful for that moment, as it positively
impacted their everyday lives in various ways.
Summary of Findings
This study explored the lived experiences of IRB insiders who work in SBER IRBs. This
chapter presented an analysis of data from 12 interviews of IRB insiders at various institutions
across the United States. The analysis indicated that they are part of a dynamic and complex
ecosystem and many factors contribute to how they experience their role in the IRB. The
majority of IRB insiders’ discussions were framed in the context of their relationship with
researchers. IRB insiders reported feeling like mentors and educators to researchers. They also
reported feeling like a gatekeeping aspect of their role was viewed relative to both the institution
and researchers. IRB insiders saw their main function as protecting human subjects in research.
Although it was described slightly differently by the 12 participants, 100% of them identified
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this as the most critical part of their role. The insiders also pointed to several challenges
surrounding IRB work, mostly tied to their relationship with researchers and institutions. Some
insiders reported feeling bullied or pressured by their institution, and others shared stories of
dealing with problematic researchers. Chapter 5 addresses these findings and will leverage
current literature to support that IRB insiders are part of a dynamic and complex ecosystem.

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Chapter Five: Discussion and Recommendations
This study intended to understand IRB insiders’ lived experiences. Given the lack of
research on IRB insiders, gaining insight into how they manage competing forces from their
complex ecosystem and, in turn, how that influences their role as IRB insiders is important.
Utilizing Bronfenbrenner’s ecological systems theory (1979) and layering it with the concept of
trust in the workplace (Brown et al., 2015), this study sought to identify the various ways in
which IRB insiders understand and navigate the complex ecosystem to which they belong.
Overview of the Study
The topics addressed in this qualitative study were how IRB insiders experience their role
relative to three stakeholder groups: the researchers, their institution, and their duty to protect
human subjects. This research sought to highlight and understand the lived experiences of IRB
insiders as part of a complex and dynamic ecosystem. Chapter 4 focused on the role IRB insiders
played relative to various stakeholders and sought to understand to what extent they experienced
competing forces between stakeholder groups. Understanding the experience of IRB insiders
leads to a greater understanding of the IRB ecosystem. The following sections discuss the five
major themes related to the research questions.
Bronfenbrenner’s system, described in Chapter 2, is a large ecosystem where the
outermost layer portrays the cultural ideologies and beliefs and the various systems move inward
toward the person at the center of the circle. Because this research sought to understand the IRB
insider’s world, Bronfenbrenner’s (1979) model was pared down to fit the ecosystem described
by participants. More specifically, Figure 3 portrays the more targeted and specific ecosystem
impacting the IRB insider. In this research, the application of the macrosystem is the institution
in which the IRB insider works. The institution houses the policies and procedures surrounding
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IRBs, the culture of the institution, and the general tone set toward research, which greatly
impacts how IRB insiders execute their role. The exosystem houses the participants that IRB
insiders are charged with protecting, and the mesosystem, where the researchers can be found, is
the layer closest to IRB insiders. This system is represented in a different color on the figure
because the findings indicated IRB insiders have the most interaction with this stakeholder
group. Finally, the microsystem houses the IRB insider at the center of this ecosystem. Each
system is interconnected, and information and experiences can flow inward toward the IRB
insider, from the IRB insider outward, and between systems, as demonstrated by the bidirectional
arrows in Figure 3. An additional layer of trust was weaved through the various ecosystems, as
trust is a necessary element from system to system.

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Figure 3
IRB Ecosystem

This next section leverages literature on IRBs and the findings from this study to
contextualize the complex and dynamic IRB ecosystem. It frames a greater understanding of the
lived experiences of IRB insiders within the IRB ecosystem through the lenses of ecological
systems.
Summary of the Findings
Each participant had a unique perspective and different experiences, yet the results
reflected common themes supported by research around IRBs. First, IRB insiders felt as though a
large part of their role was in relation to shepherding researchers through the IRB process. IRB
insiders described themselves in both a mentor and an educator role to researchers. Secondly,
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IRB insiders saw themselves as gatekeepers in the research ecosystem. This finding was
supported by current literature on IRBs, discussed in Chapter 2. Next, IRB insiders felt the
researcher stakeholder group was the greatest competing force for them. This finding is
consistent with literature surrounding IRBs: The majority of it is from the researchers’
perspective. The fourth major finding suggests the largest role IRB insiders identify with is their
role as protectors over human subjects. Although IRB insiders do not typically engage with this
population, 100% of participants identified this role as their most important. Finally, IRB
insiders see the institution they belong to as both a barrier and support. Those who described the
institution as a barrier expressed feeling greater pull from the poor practices and structure of their
institution. In several cases, IRB insiders discussed a changing of the guard moment that allowed
the negative pull of the institution to be alleviated in some ways. Table 4 outlines the various
systems within the IRB ecosystem, identifies the stakeholder group of the ecosystem, and lists
the associated theme resulting from this research study.

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Table 4
Research Themes Across the Ecosystem
Ecological system Associated theme
Microsystem
- IRB Insiders

IRB Insider as Mentor and Educator

IRB Insider Aim to Cultivate Trust

Mesosystem
- Researchers
IRB Insiders Experience Competing Forces

Exosystem
- Research participants
IRB Insider as Protector
Macrosystem
- Institution
Institution as a Support and Barrier

IRB Insiders Experience Competing Forces

Discussion for Research Question 1: What Are the Experiences of IRB Insiders
Shepherding Researchers Through the IRB process?
The microsystem is the center of the theoretical framework. It is a setting containing
resources, patterns of activity, roles, and interpersonal relationships experienced by IRB insiders
(Newman & Newman, 2020). Central to the microsystem is how the person at the center of the
circle perceives the setting and their role within that setting (Newman & Newman, 2020). The
application of the microsystem for this research places the IRB insider at the center of the
system. The systems are interactive, meaning that information and experiences can flow from
system to system in any direction. For example, IRB insiders may feel pressure from researchers
in the mesosystem to review their protocols within a certain time frame while trying to manage
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the lack of resources for their department centered in the macrosystem. In this instance, the
pressures from one system may be greater, causing the insider delays in their responsibilities
(Newman & Newman, 2020).
The mesosystem draws connections or relationships between two or more systems for
IRB insiders (Bronfenbrenner, 1979). In the mesosystem, the demands of one setting for IRB
insiders may be competing with expectations from another setting (Newman & Newman, 2020).
In this research, the mesosystem places the researchers firmly within this system, given their
proximity to IRB insiders.
IRB insiders described their role as mentors and educators for researchers. Even though
most institutions require human subjects research (HSR) training for researchers (Klitzman,
2012), IRB insiders still carry a large responsibility for mentoring them through the IRB process.
But this finding had two different connotations. According to Klitzman (2012), some IRB
insiders spend their time educating researchers on appropriate research design, which is not
within their purview. The lack of preparedness on the researchers’ side translates to additional
time and effort for IRB insiders who have to “clean up” IRB protocols prior to submission. In
this sense, IRB insiders seemed frustrated at times with doing these kinds of tasks for
researchers, which begins to weaken their trust in researchers.
Conversely, some IRB insiders embraced the role of mentor and educator when the
purpose is to provide outreach and education to their research community. Whereas the mentor
and educator role were not viewed favorably when it required IRB insiders to have to “clean up”
the work of researchers, IRB insiders who could do broad outreach and education for their
research community enjoyed this role. The tone of frustration from IRB insiders toward
researchers was lifted as insiders shifted their role toward the more traditional mentor and
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educator. This indicates that IRB insiders like to be seen as trustworthy and credible (Fiske &
Dupree, 2014) by the research community.
When IRB insiders spoke of the gatekeeper role, they framed it in the context of how
they perceived researchers to view them. Many of the IRB insiders spoke about counteracting a
negative perception from researchers and maintaining a customer-centric approach. In this sense,
IRB insiders attempt to foster trust with researchers by providing ample information and
justification for requested changes to protocols and making an effort to meet the researchers
where they are. This finding differs from current literature about IRBs serving a gatekeeping
function in that it provides a perspective from within the IRB.
Often, the gatekeeping mechanism perpetuates the perception of IRBs as being overly
burdensome, which means researchers may perceive IRBs as barriers to research rather than
facilitators (Martin & Inwood, 2012). Further evidence suggests the burden of the IRB work
coupled with negative perceptions of IRBs either significantly alters or ultimately deters
researchers from doing research (Silberman & Kahn, 2011). For example, when research with
very little risk involves children (e.g., asking school-age children about their favorite school
subject), IRBs may require so many safeguards and stipulations in their protocol that researchers
forego their attempts to access children and resort to researching their parents or caregivers
(Klitzman, 2015). Although not inherent in the IRB review process, the gatekeepers in these
situations could be silencing children’s voices from participation in research (Harger & Quintela,
2017). This has broader implications for trust outside of the relationship between the researchers
and the IRB insiders. In this sense, IRB insiders are key to fostering public trust in research when
they review protocols. A tendency to over review or review in a way that requires researchers to
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implement unnecessary stipulations can not only strain the trust relationship between IRB
insiders and researchers but deter people who may consider taking part in research studies.
These examples run contrary to the accounts given by IRB insiders in this research. IRB
insiders acknowledged their awareness of the perception of IRBs in the gatekeeping role but
discussed striving to aid researchers in being able to conduct the research they wanted while still
meeting the regulatory requirements. There seemed to be a disconnect between what was in the
literature about IRBs in gatekeeping roles and what IRB insiders have experienced in their role.
Discussion for Research Question 2: What Are the Experiences of IRB Insiders Related to
the Protection of Human Subjects?
The exosystem refers to settings in which IRB insiders are not considered active
participants and includes conditions that may impact other relationships or settings surrounding
the insiders (Newman & Newman, 2020). In applying this research, the exosystem houses the
research participants, which IRB insiders strive to protect but have little to no interaction with.
Although some research has indicated IRBs are too paternalistic (Bledsoe et al., 2007;
Miller & Wertheimer, 2007; Mueller, 2007), other scholars defend that paternalism as necessary
to protect research participants (London, 2012; Resnik, 2015). The notion that IRBs are stifling
creativity (Bledsoe et al., 2007) because the care taken in the review process by IRB insiders
fails to consider the context in which these reviews occur. Participants’ ability to trust in the
research they participate in is partially cultivated through the IRB review process. IRB insiders
described a delicate balance of ensuring the protection of human subjects through IRB review yet
adhering to university policies and procedures, balancing the needs and expectations of
researchers, and maintaining relationships across the IRB ecosystem. Yet, this review process,
coupled with researcher integrity, allows the public to trust the research process (Resnik, 2011).
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Resnik (2011) affirms that the public must have trust that research conducted with human
subjects is done ethically. Trust plays a vital role in the conduct of scientific research in that it
promotes cooperative relationships among researchers, which results in peer reviews, data
sharing, replication of results, teaching, and mentoring (Resnik, 2011). Additionally, as
researchers leverage government funding in many instances, they must utilize resources
appropriately, follow ethical standards, and generate knowledge that helps to advance science
and medicine (Shrader-Frechette, 1994). This is important because when researchers work
together to advance science, it impacts how human subject participants perceive research
(Resnik, 2011). Developing trust between researchers and participants is crucial for recruiting
and retaining participants: people will not agree to participate in a study if they do not trust
researchers (Mastroianni, 2008; Resnik, 2011). Mastroianni (2008) argues that “to create
accountability, the public needs to be assured that processes are in place to protect research
participants” (p. 8). Having the proper processes to ethically conduct research (Mastroianni,
2008) funnels down to the institutions.
Discussion for Research Question 3: What Are the Experiences of IRB Insiders Related to
Interactions With Their Institution?
The macrosystem is the broadest layer of the framework, and it examines cultural factors
impacting IRB insiders. According to Bronfenbrenner (1979), the macrosystem applies to more
abstract influences. In this research, the macrosystem applies to the institution for which the IRB
insider works. The institution is responsible for maintaining the policies and procedures around
research, the culture of research, and the overall tone or attitude taken toward the IRB. All the
beliefs, attitudes, policies, procedures, and general sentiments toward the IRB flow from this
system toward the microsystem.
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Building a culture for research in a university is the role of the Institutional Official (IO)
because they are responsible for establishing and “promoting an institutional culture of respect
and conscience, so that the ethical conduct of HSR is supported at the highest levels of the
organization” (OHRP, 2008). The individual in this position is responsible for setting the tone at
the institution’s top for how IRBs are regarded. The culture established in the macrosystem is
paramount to consider, as it informs how organizations behave as a unit, allocate resources, and
are structured to achieve goals related to producing their deliverables (Schein, 2017).
This research reported interactions within the macrosystem where the tone at the top
highly impacted the IRB insiders’ experience, mostly negatively. IRB insiders described
situations where high-level administrators were pressuring them to push research through the
IRB process or, in one extreme case, to slow down the process so the institution could charge
students for additional semesters. Scenarios where IRB insiders were yelled at because a
researcher complained were described in significant detail by IRB insiders. In these instances,
IRB insiders described the lack of trust they had with their administration and how that
negatively impacted their daily work.
Peckman (2006) asserts that research institutions are uniquely situated to create a culture
whereby ethics are highly valued and the importance of the IRB is honored. This institutional
culture is established through the interconnectedness of the relationships between the systems.
More specifically, IRBs need to be seen within the organizational culture as an independent
entity, acting in the interest of protecting human subjects in research (Peckman, 2006). To this
end, “active institutional support,” according to Peckman “is the foundation for a successful,
ethical human-research program” (2006, p. 18). Peckman (2006) also asserts three major
accountability facets need to be present for a university to build a research culture that actively
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endorses the IRB: institutional accountability, researcher accountability, and IRB accountability.
The university culture needs to ensure these three entities—the university, the researchers, and
the IRB—are seen as partners in the protection of human subjects to have a culture “in which the
importance of IRB review and compliance with regulations is readily acknowledged” (Peckman,
2006, p. 19). Failure to do so leads to the accounts detailed by IRB insiders here.
One way in which universities impact IRB operations is by providing sufficient effort and
resources (Schneider, 2015). Artifacts, organizational structures, and resources at the
macrosystem level demonstrates to the larger university community the value the university
places on research and the system of protections to support it. How the IRB operates is directly
impacted by the effort and resources made available through the university (Schneider, 2015).
Discussion for Research Question 4: What Are IRB Insiders’ Experiences With Balancing
Forces From Researchers, Their Institution, and Their Duty to Protect Human Subjects in
Research?
Each of the systems within the framework of this research is unique, but they are all
interconnected. The discussion on this research question is represented by the bidirectional
arrows in Figure 3. This research found that IRB insiders exist within a complex and dynamic
ecosystem, and they experience the different systems in similar ways.
Role strain refers to the difficulty of fulfilling various and potentially competing role
obligations (Goode, 1960). IRB insiders spoke about feeling role strain when managing the
needs of the three different stakeholder groups. Although they pointed to identifying mostly
with their role as protectors, the scenarios they described around their roles as mentors,
educators, and gatekeepers highlighted how complex their roles can be at times and how they
felt tension between those roles. Klitzman (2011) examined tensions between IRBs and
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researchers, noting that IRBs and researchers differ in how they each perceive their respective
roles and relationships, increasing tensions between the two stakeholder groups.
Discussion for the Emergent Finding
The changing of the guard moment discussed by several participants brought to light how
IRB insiders experience transitions of power. In many instances, they saw positive changes result
from new leadership. They were able to impact or improve processes or functions where space to
do so had been lacking. This means that IRB insiders experience unique power dynamics both
with the “old guard” and with the “new guard” they described.
IRB insiders spoke of being able to make positive changes once new leadership came
into the IRB, implying barriers too great to overcome with the old guard. This could in part be
due to a generational gap in IRBs. According to Kunreuther (2003), more seasoned leaders may
have ignored younger employees who bring fresh ideas to the table. Kunreuther (2003)
additionally suggests that the generational gap is not always a result of the old guard and the new
guard wanting different outcomes but rather having varying approaches to achieving goals. This
leads to power struggles within the IRB, which can sometimes cause a stalemate until a changing
of the guard.
Recommendations for Practice
Recommendations for this study revolve around two major themes: trust and
transparency. The absence of both leaves all stakeholder groups frustrated with one another
(Fleischmann & Wallace, 2005). Organizations which experience tension or friction often result
in overtly calling for greater transparency (Schnackenberg & Tomlinson, 2016). Research points
to the idea that transparency within organizations has an impact on creating, sustaining, or
repairing trust (Schnackenberg & Tomlinson, 2016). This study highlights the need for both trust
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and transparency across the ecosystem of IRBs. More specifically, IRB insiders discussed
wanting greater trust in their relationship with researchers and their institution. Against the
backdrop of the ecological system of the IRB, the recommendations for practice in this study are
informed by the insights drawn from the interviews. Given the accounts derived from this
research, recommendations for the various stakeholder groups have been identified and are
detailed below.
Recommendation 1: Accountability for IRB insiders
Researcher frustrations toward IRBs has been documented in the literature (Klitzman,
2012). Frustrations about ambiguous policies, lack of clear direction or requirements, the amount
of time reviews take, the changes required, and more have been a staple in the literature
surrounding IRBs (Klitzman, 2012; White, 2007). However, very little is documented about what
IRB insiders experience on the receiving end of these frustrations. This research highlights how
IRB insiders similarly experience frustration across various systems in their ecosystem. For
example, they expressed frustration in the lack of preparedness of researchers at times and spoke
of instances where researchers create more work for them by failing to adequately provide
information or documentation. This research additionally provided a space for IRB insiders to
express their frustration with broken submission systems or lack of resources provided to their
department. Each of these concerns can be improved by increasing transparency between the
various stakeholder groups.
Create a Transparency Loop
IRB insiders need to actively engage in creating a transparency loop for their department. This
means they would seek out honest feedback from various stakeholder groups in their ecosystem,
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reflect on the feedback, and generate actionable items to employ. Next, they would implement
the changes and start the loop over again by seeking feedback.
Current research reinforces the notion that researchers do not look favorably upon IRBs,
due to lack of transparent decision making (Florczak & Lockie, 2015; Lynch, 2018; Shoenbill et
al., 2017). Recommendations in the literature point to increasing transparency in the IRB process
(Florczak & Lockie, 2015; Lynch, 2018; Shoenbill et al., 2017). Studies suggest this will
improve researchers’ perception of IRBs, which will improve communication between IRBs and
researchers (Abbott & Grady, 2011; Gunsalus et al., 2007). Increasing transparency leads to
higher performance both from researchers and IRB insiders (Bharucha, 2018).
IRB insiders who are at the director level or have authority to decide how the IRB
operates should engage other IRB insiders within their institution in the formal evaluation of the
IRB process. IRB insiders’ intimate knowledge of their home institution’s review process gives
them firsthand knowledge of potential areas for improvement and bottlenecks in the system
(McGough, 2006) which tend to frustrate researchers. A systematic review of each step of the
IRB process should leverage IRB insiders’ expertise to help reduce redundancies and identify
areas for improvement. The systematic review should also include opportunities for stakeholder
feedback through user-satisfaction surveys that can be provided to researchers immediately
following their IRB review or interactions with the IRB. This survey should include questions
aimed at measuring satisfaction and gauging quality of services (e.g., were the revision requests
clear? Were your questions answered in a timely manner?). This survey should become part of
the metrics collected and evaluated regularly. Some example surveys include the following:
o Georgia State University:
http://ursa.research.gsu.edu/human-subjects/irb-satisfaction-survey/
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o Boston University Medical Campus:
https://www.bumc.bu.edu/irb/bumcirb/irb-review-time/
o Stanford University:
http://humansubjects.stanford.edu/research/documents/survey_results_sum
mary.pdf
This type of end-user feedback can provide IRB insiders with actionable data that they
should leverage and act on in intentional ways. IRB insiders can also use the feedback to explore
particular sticking points and then develop specified outreach and education for the research
community to address the identified issues.
Once the issues have been identified and information is in a sharable state, institutions
should develop or procure procedures and tools for regular information dissemination to
stakeholders. This could include a website, e-newsletter, email listserv, or other format.
Universities could utilize the in-house expertise related to online content delivery to inform the
higher level IRB insiders of best practices for communicating information. Once these
communication strategies are implemented, they should be tested regularly. For instance, IRB
leaders can interview a sample of faculty members to ensure that communications have reached
them to help close the transparency loop.
Engage in Continual Evaluation
Various accounts of IRB insiders’ experiences with their institutions were highlighted in
this research. In their description of the changing of the guard moments, IRB insiders detailed
how leadership changes allowed for them to make improvements to their IRBs. In several
instances, improvements looked like more support from the top or greater trust between
leadership and the IRB team.
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IRBs should not wait for the changing of the guard moment to be reflective on their
operations, communications, tone, and their reputation. Rather, they should take a proactive
approach to look internally at several factors impacting IRB insiders. In larger IRB operations,
IRBs could include a survey about internal trust, job satisfaction, areas for improvement, and
areas of strength within the IRB team, to assess various factors influencing IRB insiders. Further
exploration around IRB insiders’ attitudes and experiences with their institution may help
identify pain points that can be improved.
Recommendation 2: Institutions Need to Properly Support the IRB
Academic institutions have three distinct avenues by which they can actively support
their IRBs: (a) create a culture of trust and research, (b) ensure policies and procedures around
IRB and IRB processes are congruent, and (c) provide adequate resources and support for their
IRBs. Each of these facets aims at increasing transparency within the institution, which in turn
will help to increase trust within the IRB ecosystem.
Create and Foster a Culture of Trust and Research
Universities need to foster a culture of trust and research for IRB insiders. According to Bolman
and Deal (2017), an organization’s efficiency depends on its structure. This can include having
appropriately trained people in decision-making positions to carry out the mission of the
institution. IRBs insiders are responsible for protecting human subjects in research, which
happens mostly through the reviews they conduct on IRB protocols. IRB insiders not only work
autonomously in their decision making but also have a significant amount of personal discretion
when it comes to interpreting and applying the regulations (Klitzman, 2015).
Interview findings from this study showed that IRB insiders felt a culture of research and
tone at the top were paramount to how researchers approached the IRB. In some instances, IRB
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insiders reported feeling undue pressure from high-level administrators. This can lead to
decreased transparency and trust across the institution. As a result, universities need to foster a
culture of research that can evolve through tangible efforts that impact daily practices, policies,
procedures, routines, and resources (Schein, 2017). Universities will need to properly evaluate
their current organizational structures to ensure they align with establishing a culture of trust and
research and to provide sufficient resources which demonstrate to the larger university
community that research, and thus the IRB is valued. Failure to put forth adequate effort and
resources can negatively impact how the IRB operates (Schneider, 2015). Findings from this
study demonstrated how IRB insiders were negatively impacted by lack of institutional support.
Universities need to be prepared to develop a culture of trust and research at the highest
levels and work on demonstrating, both formally and informally, the importance of research
compliance efforts and modeling trust within the system. Cartwright et al. (2013) indicates that
researchers are seeking ways to improve their interactions with IRBs, which include cultivating a
personal relationship, managing bureaucracy, avoiding conflict, and working with various IRBs,
which are all paramount in building and sustaining a culture of trust around the IRB.
Develop and Maintain Congruent Policies and Procedures
Interview findings showed that IRB insiders either had well-developed internal policies
and procedures or their institution’s policies and procedures created significant problems for
them in the review process. Universities need to ensure the policies and procedures around IRB
and IRB processes are congruent. Although sometimes referenced interchangeably, policies and
procedures have two different yet distinct goals. According to Walker and Barnard (2006)
“policies provide overall guidance [to IRBs], but procedures are what an IRB, its administrative
staff, and the institution’s researchers consult every day” (p. 33). This means that the procedures
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need to be robust and well written, as the procedures provide the operationalization of IRBs.
Walker and Barnard (2006) assert that procedures need to provide information in enough detail
so that those unfamiliar with the IRB process can easily follow and understand it. Failure to do
so can lead to misinforming researchers or it can introduce ambiguity, which creates additional
burden for both the IRB and the researchers (Walker & Barnard, 2006).
Universities need to ensure the broad policies accurately encompass the goal of
protecting human subjects in research. From there, three different sets of procedures—for the
IRB staff and administrative office, researchers, and the IRB committee—need to reflect the
operationalization of the policies.
Adequate Resources
IRB insiders in this study described instances where their IRB both was and was not
properly funded by their institution. In the instances where IRB insiders felt they had adequate
staffing and resources, they reported less friction within their teams and with researchers. When
IRBs are not adequately supported by their institution, there could be a lack of one or more of the
following: funding, staffing, materials, or space necessary to do the work. This, according to De
Vries and Forsberg (2002), leads to criticisms about reviewing and monitoring research studies.
Although federal regulations are not so specific that they dictate how an IRB should manage its
office, each IRB is unique in its own demands and resources. However, the Department of
Health and Human Services (2019) does mandate that provisions should be made for sufficient
staff to support the IRB’s review and recordkeeping duties (45 CFR 46, 2019, section
46.108(a)(1)). The importance of an adequately funded, well-trained staff is paramount to
researchers’ experiences (Fitch, 2005). If IRBs are underfunded and have inadequately trained
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staff or insufficient resources, IRBs are being set up to fail. As a result, universities need to
provide adequate support and resources for IRBs and IRB insiders.
Table 5 shows the recommendations for the various stakeholder groups.

Table 5
Recommendations for Stakeholders
Recommendation Actionable items Associated stakeholder
group
Accountability for IRB
insiders

- Create a transparency loop
- Engage in continual evaluation

- IRB Insiders
Institutions need to
properly support the
IRB
- Create and foster a culture of
trust and research
- Develop and maintain
congruent policies and
procedures
- Adequate resources

- Institution
- Researchers

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Limitations and Delimitations
Limitations are obstacles for a study that are beyond the researcher’s control (Creswell &
Creswell, 2018). One limitation of this study was the time frame for interviews and data analysis.
This study had a relatively short window to organize, recruit, interview, and analyze data, which
meant a limited number of participants. Another limitation was how and how truthfully
participants answered the questions. This facet was mitigated by offering participants the
opportunity to review their transcripts for accuracy prior to data analysis. None of the
participants asked to see the transcript data, but three did ask for a final copy of the study.
Delimitations are those elements of the study that are at the discretion of the researcher
(Creswell & Creswell, 2018). One delimitation of this study was the focus on SBER institutions.
Given the complexity of biomedical research, and the additional layers of regulations they must
adhere to, this study strategically endeavored to understand IRB insiders’ experience within
SBER universities. Additionally, because most of the literature focuses on researchers’
experience surrounding IRBs, the target population for this study was those who are on the
reverse end of that narrative. Though the data collected from this study are generalizable, it is an
important voice to add to the current research on this topic.
Recommendations for Future Research
As a result of the findings in this study, future research on the experiences of IRB
insiders is needed. This study identified a large gap in the literature on IRBs (the missing
perspective from within the IRB). Exploring the experiences from IRB insiders more broadly and
through different methodologies will begin to add an important perspective to research around
IRBs. More specifically, this can be done by first expanding this research beyond SBER IRBs to
include biomedical IRBs. It would then be logical to survey the population for a more detailed
102

look into their lived experiences. This would begin to not only create a better understanding of
the experiences of IRB insiders but identify further areas for exploration and research.
A second area that would be worth studying is having IRB insiders develop a survey
based on IRB insiders’ input, knowledge, experience, and expertise. Those interviewed for this
research had a significant amount of experience and expertise that should be utilized to develop a
robust survey instrument for researching this population more broadly. Having their expertise
when creating a survey will aid in the development of a tool that is specific to their experiences.
A third component that would be interesting to study relates to the emergent finding of
the changing of the guard moment that several IRB insiders identified. Research should be done
on this phenomenon to discover how IRBs manage leadership changes and improvements were
made during transition. IRB insiders could leverage this information to make improvements in
their own operations. A follow-up study could include a quantitative component to determine
whether this phenomenon occurs in the broader IRB world. In addition, it would be useful to
employ interviews of IRB insiders who experienced this moment in their institution to gain a
better understanding of how best to leverage the opportunity. A similar study could be performed
with Institutional Officials or someone with broader authority over the IRB. All of these findings
could then be synthesized to provide a detailed and nuanced view of IRBs and how these
changes impact their operations.
A fourth area that would be interesting to study would be power dynamics within the IRB
insiders’ world. This study interviewed people with different levels of authority, from running
the IRB operations and budgets to reviewing research and making determinations. Many of the
insiders touched on internal struggles within their own operations. Studying the power dynamics
within an IRB, separate from the power dynamic associated between the IRB and researchers,
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would add a new layer of complexity to the ecosystem of IRBs. This could be done through
anonymous surveys of IRB insiders across all institutions with IRBs. It would not be limited by
the type of IRB (e.g., SBER versus biomedical) and might provide a unique perspective on how
IRB insiders experience their world.
Conclusion
This qualitative study aimed to understand the lived experiences of IRB insiders who
work within SBER institutions with this qualitative study. The body of research on IRBs is
largely dominated by the researchers’ experience, and the experiences of IRB insiders have
mostly been ignored. This study sought to add a new and important voice to that narrative. Based
on Bronfenbrenner’s (1979) ecological systems theory, this study framed the experiences of IRB
insiders as existing within a complex and dynamic ecosystem. The study situated the IRB insider
at the center of the system and suggested their interactions between the major stakeholder groups
happen within this framework and that trust between the various systems is a necessary
component for success. Twelve IRB insiders from various American institutions were
interviewed, and an analysis of the data revealed the complexity of the IRB insiders’ ecosystem.
The findings from this study highlight the importance of having cohesive,
communicative, and transparent IRBs, which begins with the work of IRB insiders. When these
are lacking, tension is greater between IRB insiders and the research community, which
perpetuates the negative perception of IRBs. This study highlights how passionate IRB insiders
are about their role in the protection of human subjects and in their role as mentors and educators
for researchers. Understanding how IRB insiders experience their roles will be important to
further investigating their lived experiences and how that impacts the overall functioning of IRBs
and the protection of human subjects in research.
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Millions of people take part in research studies every year (Goldstein, 2018). IRB
insiders are pivotal to the operation and function of IRBs, yet very little is known about how they
experience their roles. Being an IRB insider is a great responsibility that requires thoughtful
curiosity, intellectual interest, continued dedication to learning and evolving with the research
landscape, and a genuine desire to support the highest standards in research for the benefit of
society (Rivera, 2022). IRB insiders are a crucial layer in protecting people from the horrific
experiments once conducted on research participants. Their experience upholding the system of
protections for HSR is imperative to understand. Without this perspective, research on IRBs
remains entirely lopsided toward the researchers’ experiences and one of the biggest stakeholders
in the system for the protection of HSR is disregarded. With additional insight into this critical
layer, IRBs can continually evolve to the highest standards in research maximizing the benefit to
everyone in our global community.

105

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120

Appendix A: Recruitment Messages and Email Communications

Online Recruitment Message for IRB Forum and Facebook Group:

Hello Colleagues! I am researching how people working in IRBs experience their roles. I would
like to interview people who have at least two years of experience in a decision-making position
within the IRB. Additionally, at this time, I am only interested in studying people who work in
IRBs that process only SBER studies. If you think you might like to participate in a one-hour
interview, please contact me at mongeon@usc.edu.

To qualify for this study, you must:

· Be at least 18 years old or older
· Have served or currently serve for a minimum of two years in a decision-making role within an
IRB at an institution of higher education which processes only SBER
· Speak and read English
· Have access to a computer with video and audio capabilities

For more information, please email me, Brianne Mongeon, at mongeon@usc.edu.

Email to Confirm Participation

Subject: Confirming participation in interview for individuals working in SBER IRBs
121

Dear [NAME],

Thank you so much for agreeing to participate in my research study! As I mentioned in my initial
message, I would like to interview you about your experiences as an IRB insider, or someone
who works in a decision-making role within a SBER university.

The interview will take place on Zoom and last around an hour. To that end, if you are able to
send me three one-hour slots during which you might be available over the next few weeks, that
would be very helpful. Once we agree on a date and time, I will send you a separate email with
the Zoom meeting details.

In the meantime, I am attaching an Information Sheet for Exempt Research, which formally
summarizes the nature of the research study and describes your involvement in it. If you have
any questions, please contact me (mongeon@usc.edu) or my advisor Dr. Alexandra Wilcox
(amwilcox@usc.edu).

Kind regards,

Brianne Mongeon

122

Appendix B: Information Sheet
INFORMATION SHEET FOR EXEMPT RESEARCH
STUDY TITLE: IRB Insiders: A Qualitative Analysis of Their Complex Ecosystem
PRINCIPAL INVESTIGATOR: Brianne Mongeon
FACULTY ADVISOR: Alexandra Wilcox, JD, MFA, EdD

You are invited to participate in a research study. Your participation is voluntary. This
document explains information about this study. You should ask questions about anything that is
unclear to you.
PURPOSE OF THE STUDY

The purpose of this study is to better understand the experiences of IRB insiders
(researcher’s term used to indicate those working in an IRB in a decision-making capacity).
Current research surrounding IRBs notes how complex and dynamic the IRB system is. I am
interested in understanding how IRB insiders find balance in the complexity of their
environment.
WHAT MY PARTICIPATION ENTAILS

This study is completely voluntary, meaning you have the right at any time and for any
purpose, to withdraw from the study. You will be interviewed as a part of this study. The
interview will be conducted via the Zoom video conferencing platform at a time that is
convenient for you. The interview will last approximately one hour. With your permission, the
interview will be recorded so that it can be transcribed later.
123

CONFIDENTIALITY
The members of the research team, Brianne Mongeon and Dr. Alexandra Wilcox (faculty
advisor), and the University of Southern California Institutional Review Board (IRB) may access
the study data. The IRB reviews and monitors research studies to protect the rights and welfare
of research subjects.
When the results of the research are published, no identifiable information about you or
your institution will be used. All information about your participation will be confidential. You
will have the opportunity to strike anything from the record before the end of the interview.
After the interview is complete, the video recording will be transcribed using a third-
party transcription service. Once the transcript is available, the video recording will be deleted.
You have the right to review the transcript after the interview to determine if there is anything
that you wish to edit, or do not want to be included in the data analysis. The transcript will be
stored in encrypted form on a laptop and it will be destroyed at the end of the study.
INVESTIGATOR CONTACT INFORMATION
If you have any questions about this study, please contact Brianne Mongeon
(mongeon@usc.edu) or Dr. Alexandra Wilcox (amwilcox@usc.edu).
IRB CONTACT INFORMATION
If you have any questions about your rights as a research participant, please contact the
University of Southern California Institutional Review Board at 323-442-0114 or email
irb@usc.edu.

124

Appendix C: Interview Protocol

Introduction (3 minutes)

● Greet the participant and introduce myself
● Express gratitude for their participation
● Confirm they understand the Informed Consent and ask if they have any questions
● Present an outline of the next 57 minutes:
○ confidentiality discussion
○ overview of the interview process
○ asking of questions
○ closing (with opportunity for participant to ask questions)

Confidentiality (2 minutes)

● Emphasize the importance of privacy and confidentiality
● Confirm with the participant that it is OK to record the interview
○ Assert that the only people who will see the recording are the researcher and the
transcription service
○ State that the recording will be deleted after it has been transcribed
○ Assert that no identifying information about the participant or their institution will
appear in the dissertation

125

Overview (2 minutes)

● State that I will be asking a number of questions over a period of 50 minutes
● State that questions will be open-ended
● Explain that I may interrupt the participant to clarify the question or to ask for more detail
● Explain that recording will begin now and press the record button in Zoom

Questions (50 minutes)

Demographic Questions
1. Can you tell me about how many protocols your IRB processes in a year? (D1)
a. Ongoing review
b. Exemptions
c. Expedited
d. Full board
2. Can you tell me how many FTEs your department has? (D2)
3. Where is your IRB housed in the greater university hierarchy? Who does the IRB report
into? (D3)
4. Can you tell me a bit about your background in HSR and how long you’ve been working
in IRBs? (D4)
a. [PROBE] Can you tell me what kind of training you’ve done in your career?
b. [PROBE] How often do you go to these trainings?
126

c. [PROBE] What can you tell me about the support you get from your institution
for training?

RQ1 What are the experiences of IRB insiders shepherding researchers through the IRB
process?

1. Can you describe for me your role relative to researchers who submit to the IRB?
a. [PROBE] If you were to reflect on your interaction with researchers, what works
and doesn’t work when you are communicating with them?
b. [PROBE] How do you think you are perceived by researchers? Can you give me
an example?
c. [PROBE] When you think of your role in IRB, talk to me about getting
researchers successfully through the IRB process. What does that look like for
you? Examples?
2. In thinking about your role in the IRB, can you describe how you feel about your
relationship with researchers?
a. [PROBE] Positive? Negative? Easy? Hard?

RQ2 What are the experiences of IRB insiders related to the protection of human subjects?

3. Can you describe for me your role relative to the protection of human subjects in
research?
127

4. Research has shown that the public needs to trust that research is being done ethically.
When thinking about the broader social context of research, can you describe the role of
public trust?
a. [PROBE] Can you talk to me about whether there are any factors from a broader
cultural aspect which influence how you see your role? Can you provide
examples?
b. [PROBE] To what degree, if at all, do you have a sense that decisions you make
in your reviews could be catastrophic to the participants you are charged with
protecting?
5. Some research on IRBs positions IRBs as overly bureaucratic while other research frames
the bureaucracy as a necessary component to protecting human subjects in research. Can
you talk to me about where you might fall on this continuum?
a. [PROBE] Can you provide examples of that?

RQ3 What are the experiences of IRB insiders related to interactions with their institution?

6. I would like you to think about your role within the IRB. In the broader institutional
culture, how do you see your role?
a. [PROBE] In what ways, if any, do you contribute to the culture around research at
your institution?
7. In thinking about the institution’s role, can you describe, from your perspective, whether
and to what degree the institution plays a role in the protection of human subjects?
128

a. [PROBE] Do you have the opportunity to work directly with your Institutional
Official?
i. YES—Can you describe that relationship relative to both of your
respective roles?
1. [PROMPTS] Supportive? Contentious?
ii. NO—Next question
b. [PROBE] Can you talk to me about the overall feeling or attitude towards the IRB
at your institution? Can you provide examples?
i. How does this impact you, if at all?
c. [PROBE] Can you tell me a bit about the culture of research at your institution?
i. [PROMPTS] Is it highly competitive? Is there a greater focus on teaching
than research? Is it a high-stakes environment? Are researchers well
supported? Examples?
1. [PROBE] Can you provide examples?
d. [PROBE] What is your perception of the resources available to your department
(e.g., funding, staffing, space, equipment)?
e. [PROBE] Can you tell me how—if at all—this impacts you?
f. [PROBE] In thinking about the role of researchers, how are they accountable for
adding to the research culture, if at all?
i. [PROBE] Can you describe how this impacts you in your role? Examples?
8. To what degree, if any, do you have a sense that decisions you make in your reviews
could be catastrophic to your institution?
a. [PROBE] Can you provide examples?
129

RQ4 What are IRB insiders’ experiences with balancing forces from researchers, their
institution, and their duty to protect human subjects in research?

[Transition: Now that we’ve discussed your role with researchers, with HS, and with your
institution, I’d like to try to understand how you balance your role relative to all three entities.]

9. Can you describe for me how you balance your role relative to researchers, the
institution, and to HS?
a. [PROBE] Are there any competing goals you must balance? Walk me through
how that works for you. Can you provide examples?
10. One theory on regulations calls for people who enforce the regulations to exercise
flexibility when they can. Can you provide any examples of being able to exercise
flexibility in your role?
11. Can you talk to me about whether you’ve experienced greater force from one entity than
another (researchers, institution, or protection of HS), and what that looked/felt like?
Examples?
a. [PROBE] Can you estimate how often that happens?
b. [PROBE] How did/do you manage this?
130

Appendix D: Data Collection Crosswalk
Research question Corresponding
ecological system
Data instrument questions
1. What are the
experiences of IRB
insiders shepherding
researchers through
the IRB process?

Microsystem

1. Can you describe for me your role
relative to researchers who submit to
the IRB?
a. [PROBE] If you were to reflect
on your interaction with
researchers, what works and
doesn’t work when you are
communicating with them?
b. [PROBE] How do you think
you are perceived by
researchers? Can you give me
an example?
c. [PROBE] When you think of
your role in IRB, talk to me
about getting researchers
successfully through the IRB
process. What does that look
like for you? Examples?
131

2. In thinking about your role in the IRB,
can you describe how you feel about
your relationship with researchers?
a. [PROBE] Positive? Negative?
Easy? Hard? Examples?

2. What are the
experiences of IRB
insiders related to the
protection of human
subjects?

Mesosystem

3. Can you describe for me your role
relative to the protection of human
subjects in research?
4. Research has shown that the public
needs to trust that research is being
done ethically. When thinking about
the broader social context of research,
can you describe the role of public
trust?
a. [PROBE] Can you talk to me
about whether there are any
factors from a broader cultural
aspect which influence how
you see your role? Can you
provide examples?
b. [PROBE] To what degree, if at
all, do you have a sense that
132

decisions you make in your
reviews could be catastrophic
to the participants you are
charged with protecting?
5. Some research on IRBs positions IRBs
as overly bureaucratic while other
research frames the bureaucracy as a
necessary component to protecting
human subjects in research. Can you
talk to me about where you might fall
on this continuum?
a. [PROBE] Can you provide
examples of that?
3. What are the
experiences of IRB
insiders related to
interactions with their
institution?

Exosystem 6. I would like you to think about your
role within the IRB. In the broader
institutional culture, how do you see
your role?
a. [PROBE] In what ways, if any,
do you contribute to the culture
around research at your
institution?
7. In thinking about the institution’s role,
can you describe, from your
133

perspective, whether and to what
degree the institution plays a role in
the protection of human subjects?
a. [PROBE] Do you have the
opportunity to work directly
with your Institutional
Official?
i. YES—Can you
describe that
relationship relative to
both of your respective
roles?
1. [PROMPTS]
Supportive?
Contentious?
ii. NO—Next question
b. [PROBE] Can you talk to me
about the overall feeling or
attitude towards the IRB at
your institution? Can you
provide examples?
i. How does this impact
you, if at all?
134

c. [PROBE] Can you tell me a bit
about the culture of research at
your institution?
i. [PROMPTS] Is it
highly competitive? Is
there a greater focus on
teaching than research?
Is it a high-stakes
environment? Are
researchers well
supported? Examples?
1. [PROBE] Can
you provide
examples?
d. [PROBE] What is your
perception of the resources
available to your department
(e.g., funding, staffing, space,
equipment)?
e. [PROBE] Can you tell me
how—if at all—this impacts
you?
f. [PROBE] In thinking about the
135

role of researchers, how are
they accountable for adding to
the research culture, if at all?
i. [PROBE] Can you
describe how this
impacts you in your
role? Examples?
8. To what degree, if any, do you have a
sense that decisions you make in your
reviews could be catastrophic to your
institution?
a. [PROBE] Can you provide
examples?
4. What are IRB
insiders’ experiences
with balancing forces
from researchers, their
institution, and their
duty to protect human
subjects in research?

Macrosystem

9. Can you describe for me how you
balance your role relative to
researchers, the institution, and to HS?
a. [PROBE] Are there any
competing goals you must
balance? Walk me through
how that works for you. Can
you provide examples?
10. One theory on regulations calls for
people who enforce the regulations to
136

exercise flexibility when they can. Can
you provide any examples of being
able to exercise flexibility in your
role?
11. Can you talk to me about whether
you’ve experienced greater force from
one entity than another (researchers,
institution, or protection of HS), and
what that looked/felt like? Examples?
a. [PROBE] Can you estimate
how often that happens?
[PROBE] How did/do you
manage this?

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Asset Metadata

Creator Mongeon, Brianne (author)

Core Title IRB insiders: perspectives from within the institutional review board

School Rossier School of Education

Degree Doctor of Education

Degree Program Organizational Change and Leadership (On Line)

Degree Conferral Date 2022-05

Publication Date 05/09/2022

Defense Date 04/13/2022

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

Tag ecological systems theory,Institutional Review Board,interpersonal trust,IRB,IRB insiders,OAI-PMH Harvest

Format application/pdf (imt)

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Wilcox, Alexandra (committee chair), Krop, Cathy (committee member), Tobey, Patricia (committee member)

Creator Email briannemongeon@gmail.com,mongeon@usc.edu

Permanent Link (DOI) https://doi.org/10.25549/usctheses-oUC111296820

Unique identifier UC111296820

Document Type Dissertation

Format application/pdf (imt)

Rights Mongeon, Brianne

Type texts

Source 20220509-usctheses-batch-940 (batch), University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

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