Institutional Review Board Community Members: Who Are They,
What Do They Do, and Whom Do They Represent?
Dr. Robert Klitzman, MD [professor]
Department of Psychiatry, and director, Master of Science in Bioethics program, Columbia
University College of Physicians and Surgeons, New York, New York.
Abstract
Purpose—The roles of nonaffiliated and nonscientific institutional review board (IRB) members
at academic medical centers have received some attention, but questions remain—Who are they,
what do they do, and whom, if anyone, do they represent?
Method—The author interviewed 46 IRB chairs, directors, administrators, and members in 2007–
2009. He contacted the leadership of 60 IRBs (every fourth one in the list of the top 240
institutions by National Institutes of Health funding), interviewed IRB leaders from 34 of these
institutions, then recruited 7 additional members from these IRBs to interview.
Results—Regular IRB members often called these individuals community members and were
confused as to who these members were, or should be, and whether they did, or should, represent
anyone and, if so, whom. IRBs encountered challenges in finding, training, and retaining these
community members. Tensions emerged because nonscientific members, by definition, have no
scientific training, so they have difficulty understanding key aspects of protocols, making them
feel unempowered to contribute to reviews. IRBs varied in how much they encouraged these
members to participate, in what ways, and with what success.
Conclusions—At academic medical centers, IRBs struggled with how to view, choose, employ,
and retain nonaffiliated and nonscientific members, and they varied widely in these regards. Some
IRBs had these members review entire protocols, others only limited parts (particularly reading
consent forms for comprehension), pro forma. Yet, at times, these members’ input proved very
important. These findings have critical implications for policy, practice, and research.
The roles of nonaffiliated and nonscientific institutional review board (IRB) members at
academic medical centers have received some attention in the literature, but many questions
about them remain. For instance, whom, if anyone, do they represent, how are they selected,
and what do they do? This report describes how IRB chairs, directors, administrators, and
members view a range of issues concerning nonaffiliated and nonscientific IRB members,
and it examines a series of questions and decisions that IRBs confront regarding these
individuals.
Section XXXXXXXXXXa) of the federal regulations governing the protection of human subjects
equires IRBs to “be sufficiently qualified through the experience and expertise of its
members, and the diversity of the members, including consideration of race, gender, and
Co
espondence should be addressed to Dr. Klitzman, 1051 Riverside Dr., Unit 15, New York, NY 10032; telephone: XXXXXXXXXX;
fax: XXXXXXXXXX; XXXXXXXXXX..
Other disclosures: None.
Ethical approval: The New York State Psychiatric Institute/Columbia University Department of Psychiatry institutional review board
granted ethical approval for this research.
Editor’s Note: A commentary by M.A. Speers and S. Rose appears on page 842.
NIH Public Access
Author Manuscript
Acad Med. Author manuscript; available in PMC 2013 January 20.
Published in final edited form as:
Acad Med. 2012 July ; 87(7): 975–981. doi:10.1097/ACM.0b013e3182578b54.
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cultural backgrounds and sensitivity to such issues as community attitudes.” Sections 46.107
(c) and (d) of the same regulations state that IRBs will include “at least one member whose
primary concerns are in nonscientific areas” and “at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate family of a person who is
affiliated with the institution.”1 For review of research concerning prisoners, 45 CFR §46
specifically requires that this population be represented.
Important principles underlie these mandates. The views of nonscientists and of those
outside an academic medical center are valuable and, presumably, reflect the concerns of
potential research subjects and the
oader community. They also are less affected by the
possibility of financial and nonfinancial conflicts of interest (COIs), which may arise with
someone who works at an institution or is a close family member of an employee. Yet, the
egulations do not address who exactly these nonscientific and nonaffiliated members should
e, how they should be chosen, and what roles and functions they should fill. The National
Institutes of Health (NIH) Office of Human Subjects Research (OHSR) determined that a
single person could fit both these roles.2 Yet, such a determination may, arguably, counte
the intent of the regulations.
Surprisingly, prior studies of such members have usually combined the nonscientific and
nonaffiliated IRB members. Anderson3 found that 16 “nonaffiliated/nonscientific” IRB
members from 11 institutions were unclear whom they represented, and these members felt
that they should receive more respect from the rest of the IRB. Porter,4,5 also not
differentiating between the two groups, found that these individuals saw themselves playing
a variety of roles and valuing several traits as ideals (e.g., assertiveness and communication).
Allison and colleagues6 also combined the two groups, as “nonscientists,” in examining how
they viewed their specific functions and found that they were also more likely than scientists
to think that their major role was to review informed consent documents. In one question,
however, Allison and colleagues compared affiliated and nonaffiliated nonscientific
members and found that nonaffiliated members were more likely, in general, to see
themselves as laypersons. Sengupta and Lo7 surveyed 32 nonaffiliated and nonscientific
members from 11 IRBs. These participants had been on IRBs for a mean of 8.4 years, 71.9%
held advanced degrees, 88% had occasionally felt intimidated and disrespected by the
scientists on the IRB, and 78% wanted more education. Yet, it is not clear whether these
members included those (e.g., nurses and social workers) who are clinicians even if they are
not scientists per se. Affiliated clinicians may also vary markedly from nonaffiliated
nonclinicians because of training. Additionally, nurses and social workers may have
experience conducting research, raising questions about the definition of nonscientists.
Rothstein and Phuong8 analyzed three groups (physicians, nurses, and nonaffiliated
members) and found certain differences in what was very important to them personally, with
nonaffiliated members being less likely to list protecting confidentiality and privacy and
ensuring IRB oversight postapproval as concerns. It is unclear whether these nurses are
scientific or not (i.e., they have clinical training but may not be researchers). Still, this study
suggests that nonaffiliated and other IRB members differ. Critical questions thus remain
about how IRB chairs and other members view the roles and functions of these nonscientific
and nonaffiliated members.
I conducted an in-depth, semistructured interview study of the views and approaches among
IRB chairs, directors, administrators, and members toward research integrity (RI), which
these participants define very
oadly.9 Interviewees revealed how they viewed and
addressed RI, how they responded to RI violations in various ways related to how they saw
and approached their roles and responsibilities, and how they interpreted and applied federal
egulations. IRBs were affected by their members’ personal views and psychological and
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personality issues and also by institutional factors. Issues frequently arose concerning
differences between nonscientific, nonaffiliated, and other IRB members’ roles, functions,
contributions, work, and identities. Because my study used qualitative methods, I was able
to further explore these domains and shed light on these issues. I have reported elsewhere on
other, distinct sets of issues regarding interviewees’ views and approaches concerning
COIs,10 central IRBs,11 perceptions of variations between IRBs,12 and research conducted
in the developing world.13 But other distinct and important sets of issues and decisions arose
as well concerning nonscientific and nonaffiliated members, which I have analyzed and
explored in this report.
Method
As described elsewhere,9–13 I conducted in-depth telephone interviews of approximately
two hours each with 46 IRB chairs, directors, administrators, and members in 2007–2009. I
contacted the leadership of 60 IRBs around the United States, representing every fourth
institution on the list of the top 240 by NIH funding, and interviewed IRB leaders from 34 of
these 60 institutions (response rate of 56.7%). In some cases, I interviewed both a chair and
or a director as well as an administrator from the institution (e.g., the chair thought that the
administrator might be better able to answer certain questions). From these 34 institutions,
then, I interviewed a total of 39 chairs/directors and administrators. I also asked half of these
leaders (every other one interviewed on the list by amount of NIH funding [n = 17]) to
distribute information about my study to members of their IRBs to recruit 1 member from
each of these IRBs to interview as well. I interviewed 7 additional members (1 nonscientific
and 6 regular members), for a response rate of 41.2% (7 of 17 potential additional
members).
My interview guide (see List 1) included questions to elicit detailed descriptions of
participants’ views of RI, COIs, and related realms, probing how IRBs viewed and made
decisions about these areas, and the factors involved in those decisions. My method was
informed by grounded theory.14
I drafted the questionnaire, drawing on prior research that I conducted and on published
literature. I transcribed and performed my initial analyses of the interviews during the same
period in which I conducted the interviews, and these analyses helped shape subsequent
interviews. The Columbia University Department of Psychiatry IRB approved the study, and
all participants gave informed consent.
Once I completed the full set of interviews, a trained research assistant and I conducted
subsequent analyses in two phases.
In phase I, we independently examined a subset of interviews to assess factors that shaped
the participants’ experiences, identifying recu
ent themes and issues that were then given
codes. We read each interview, systematically coding blocks of text to assign core codes o
categories (e.g., comments about so-called community or other members). We inserted a
topic name (or code) beside each excerpt of the interview. We then worked together to
econcile these independently developed coding schemes into a single scheme and prepared
a coding manual, defining each code and examining areas of disagreement until reaching
consensus. We discussed new themes that did not fit into the original coding framework and
modified the manual when appropriate.
In phase II of the analysis, we independently performed content analysis of the data to
identify the principal subcategories and ranges of variation within each of the core codes.
We reconciled the subthemes identified by each coder into a single set of secondary codes
and an elaborated set of core codes. These codes assess subcategories and other situational
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and social