Read the section on the Ethics Police and discuss what is the problem with IRB university reviews.
the blocking of research creativity?
Another bureaucracy that has good intentions but stifles research?
Researchers looking at ethical rules originally targeted for medical abuses being hoisted on social sciences?
Make sure and read the article on the Ethics Police as well as the issues involved in the Pathology of Imprisonment to understand some of the challenges in research among social scientists. Obviously there are reasons for an IRB review but there are also issues that hinder or prevent research from occurring.
The Ethics Police?: IRBs’ Views Concerning Their Power Robert Klitzman*
Department of Psychiatry, Columbia University, New York, New York, United States of America
Background: In recent years, tensions between IRBs and principal investigators (PIs) have risen, posing the needs to understand these conflicts, their underlying causes, and possible solutions. Researchers frequently complain about IRBs, but how IRBs perceive and respond to these criticisms is unclear.
Methods: I conducted in-depth, semi-structured interviews of two hours each with 46 chairs, administrators, and members. I contacted the leadership of 60 IRBs around the country (every fourth one in the list of the top 240 institutions by NIH funding) and interviewed IRB leaders from 34 of these institutions (response rate = 55%).
Results: Interviewees suggest that IRBs and PIs may view the nature and causes of these conflicts very differently and misunderstand each other, exacerbating tensions. Interviewees often recognized that they were seen by PIs as having power, but many IRBs saw themselves as not having it (e.g., because they are ‘‘merely following the regulations,’’ and their process is ‘‘open,’’ impersonal and unbiased, and they are themselves subject to higher administrative agencies), or as having it, but feeling it is small, and/or justified (e.g., because it is based on overriding goals and ‘‘the community values,’’ and IRBs are trying to help PIs). Questions emerge as to whether IRBs do or should have power, and if so, what kind, how much, and when. Several factors may affect these tensions.
Conclusions: This study, the first to explore how IRBs perceive and understand conflicts and power relationships with PIs, suggests how IRBs and PIs may differ in viewing their respective roles and relationships, exacerbating tensions. These issues have critical implications for IRBs and PIs—to enhance their awareness and understanding of these conflicts (e.g., that IRBs may have discretionary power) and the underlying causes involved, and for increasing attention to research, practice, and policy concerning these areas of IRB functioning and interactions with PIs.
Citation: Klitzman R (2011) The Ethics Police?: IRBs’ Views Concerning Their Power. PLoS ONE 6(12): e28773. doi:10.1371/journal.pone.0028773
Editor: Colin Allen, Indiana University, United States of America
Received July 29, 2011; Accepted November 15, 2011; Published December 13, 2011
Copyright: � 2011 Robert Klitzman. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: The NIH (R01-NG04214) and the National Library of Medicine (5-G13-LM009996-02) funded this work. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The author has declared that no competing interests exist.
* E-mail: [email protected]
In recent years, tensions between institutional review boards
(IRBs) and researchers have increased, posing needs to understand
these conflicts and their underlying causes, and possible solutions.
Many principal Investigators (PIs) have complaints about IRBs [1–
4], and IRBs have been called the ‘‘Ethics Police,’’  but little is
known about how IRBs themselves perceive and respond to these
criticisms. Debates persist as to whether IRBs do or should have
power, and if so, what kind, how much, when, and why.
IRBs can approve, disapprove, delay, or require changes in
studies; and frustrate academic researchers – e.g., because of
postponements, and adversarial stances [2,5–6]. Discrepancies have
also been documented between IRBs in their decisions [7–9]. Some
critics have argued that the system is ‘‘broken’’  and that IRBs
are even unconstitutional in impeding academic freedom .
IRBs have power as gatekeepers , and researchers have been
found to generally accept the rationale for ethical oversight, but
often feel that IRBs focus on unimportant details [1,2], and are
bureaucratic . PIs also tend to value IRBs treating researchers
fairly more than protecting subjects per se . PIs who feel they
have been unfairly treated by IRBs may be more likely to feel
justified in avoiding IRB regulations .
In response to criticisms of IRBs by PIs and others, proposals for
increased central IRB (CIRB) reviews in multi-site studies have
been made for almost two decades [13,14]. Recently, the US
Office of Management and budget issued an Advanced Notice of
Proposed Rule Making (ANPRM) to alter the federal regulations
governing IRBs (45-CFR-46 – the so-called ‘‘Common Rule’’).
[15,16]. But given that 15 separate federal departments and
agencies are involved with the Common Rule, the ultimate fate of
such proposals is unclear, and changes, if any, could take years to
become effective. CIRB reviews can also be controversial and
disputed because of inherent uncertainties in current regulations
(e.g., definitions of ‘‘minimal risk’’), and new technologies and
methodologies. Moreover, in most CIRB models, local IRBs can
accept, reject, or amend CIRB recommendations. Hence, ultimate
control will presumably remain local; and regardless of whether,
and to what degree centralization occurs, tensions will doubtlessly
Thus, crucial questions remain of how IRBs see and respond to
these increasing complaints and conflicts, and what else, if
anything, can be done. Surprisingly, little, if any, research has
examined these issues.
In a recent in-depth semi-structured interview study I conducted
of views and approaches toward research integrity (RI) among
PLoS ONE | www.plosone.org 1 December 2011 | Volume 6 | Issue 12 | e28773
IRB chairs, directors, administrators, and members, issues
concerning relationships between IRBs and PIs repeatedly arose.
Participants defined ‘‘RI’’ very broadly, and varied in how they
viewed and approached RI , conflicts of interest , CIRBs
, unaffiliated and nonscientific members , research in the
developing world , and variations between IRBs .
Importantly, they varied, too, in how they saw and approached
the roles and responsibilities of IRBs and PIs; viewed, interacted
with, and responded to PIs and perceived these relationships.
These issues are crucial as they can potentially affect the degree to
which PIs adhere to IRB regulations and protect study participants
as much as possible. The study, since it used qualitative methods,
allowed for detailed explorations of these domains.
Ethics Statement The Columbia University Department of Psychiatry Institu-
tional Review Board approved the study, and participants all gave
informed consent. As approved by the IRB, the consent was
verbal, not written, since the interviews with this sample of IRB
chairs, members, and staff from across the US were conducted
over the telephone, rather than in person. I sent all study
participants an informed consent information sheet that they read
before being interviewed. They then consented to the interview
over the phone, prior to initiating the interview; and I then
documented their consent.
Study Design and Procedures As described elsewhere [17–22], I conducted in-depth telephone
interviews of 2 hours each with 46 chairs, directors, administra-
tors, and members. I contacted the leadership of 60 IRBs around
the country, representing every fourth one in the list of the top 240
institutions by NIH funding, and interviewed IRB leaders from 34
of these institutions (response rate = 55%). At times, I interviewed
both a chair/director and an administrator from an institution
(e.g., if the chair thought the administrator might be better
positioned to answer certain questions). Thus, from these 34
institutions, I interviewed in all 39 chairs/directors and adminis-
trators. The institutions range in location, size, and public/private
status. Sampling IRBs from a wide range of institutions allows for
illumination of the roles of different social and institutional
contexts concerning these issues. I also asked half of these leaders
(every other one whom I interviewed on the list by amount of NIH
funding [n = 17]) to distribute information about the study to
members of their IRBs, in order to recruit 1 member of each of
these IRBs to be interviewed as well. Thus, in addition to the 39
chairs/directors and administrators, I interviewed 7 other
members (6 regular members and 1 nonscientific/unaffiliated
member), yielding a response rate of 41.2% (7/17).
As shown on Table 1, the 46 individuals include 28 chairs/co-
chairs; 1 IRB director; 10 administrators (including 2 directors of
compliance offices); and 7 members, and they varied in gender,
ethnicity, and location.
The interview explored participants’ views of RI, broadly
defined, and IRB responses and factors involved in decisions, but
elucidated many other, wider issues that emerged regarding IRBs’
interactions and relationships with researchers. Several relevant
portions of the interview guide appear in Appendix S1. From a
theoretical perspective, Geertz  has advocated exploring
people’s lives, decisions, and milieu by trying to grasp their own
experiences, through their own words and perspectives to obtain a
In the methods, I have adapted elements from Grounded
Theory . This approach is thus informed by techniques of
‘‘constant comparison’’ in which data from different contexts are
compared for similarities and differences, to see if they suggest
hypotheses. This ‘‘constant comparison’’ yields new analytic
categories and questions, and checks them for reasonableness.
During the ongoing process of in-depth interviewing, I examined
how participants resemble or differ from each other, and the
social, cultural, and medical contexts and factors that contribute to
variations. Grounded theory involves deductive as well as
inductive thinking, building inductively from the data to an
understanding of themes and patterns within the data, and
deductively, drawing on frameworks from prior research and
I drafted the questionnaire, drawing on prior research I
conducted and published studies. Transcriptions and initial
analyses of interviews occurred during the period in which the
interviews were being conducted, enhancing validity, and these
analyses helped shape subsequent interviews.
After the full set of interviews was completed, subsequent
analyses were conducted in two phases, by a trained research
assistant (RA) and myself. In phase I, we independently examined
a subset of interviews to assess factors that shaped participants’
experiences, identifying categories of recurrent themes and issues
that were subsequently given codes. We read each interview,
systematically coding blocks of text to assign ‘‘core’’ codes or
categories (e.g., instances of tensions with PIs; beliefs that IRBs had
power, or did not have power). While reading the interviews, a
topic name (or code) was inserted beside each excerpt of the
Table 1. Subject Characteristics.
Total % (N = 46)
Type of IRB Staff
Chairs/Co-Chairs 28 60.87%
Directors 1 2.17%
Administrators 10 21.74%
Members 7 15.22%
Male 27 58.70%
Female 19 41.30%
1–50 13 28.26%
51–100 13 28.26%
101–150 7 15.22%
151–200 1 2.17%
201–250 12 26.09%
State vs. Private
State 19 41.30%
Private 27 58.70%
Northeast 21 45.65%
Midwest 6 13.04%
West 13 28.26%
South 6 13.04%
Total # of Institutions Represented 34
IRBs’ Views Concerning Their Power
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interview to indicate the themes being discussed. We then worked
together to reconcile these independently developed coding
schemes into a single scheme. We then prepared a coding manual,
defining each code and examining areas of disagreement until
reaching consensus between them. New themes that did not fit
into the original coding framework were discussed, and modifi-
cations were made in the manual when deemed appropriate.
In phase II of the analysis, we then independently content
analyzed the data to identify the principal subcategories, and
ranges of variation within each of the core codes. The sub-themes
identified by each coder were reconciled into a single set of
‘‘secondary’’ codes and an elaborated set of core codes. These
codes assess subcategories and other situational and social factors.
Such subcategories included, for example, specific reasons why
IRBs were thought to have power or not have power, and types of
tensions with PIs (e.g., related to PIs’ misperceptions of IRBs).
Codes and sub-codes were then used in analysis of all of the
interviews. To maximize coding reliability, two coders analyzed all
interviews. Where necessary, multiple codes were used. The coders
assessed similarities and differences between participants, exam-
ining categories that emerged, ranges of variation within
categories, and variables that may be involved.
We examined areas of disagreement through closer analysis
until consensus was reached through discussion. Overall, disagree-
ments were minimal and generally concerned only subtle
refinements of sub-codings, at time necessitating use of dual
codes, and were in no cases significant. We checked regularly for
consistency and accuracy in ratings by comparing earlier and later
coded excerpts. Figure 1 reflects the codes and sub-codes used.
To ensure that the coding schemes established for the core
codes and secondary codes are both valid (i.e., well grounded in
the data and supportable) and reliable (i.e., consistent in meaning),
they were systematically developed and well-documented.
As summarized in Figure 1, and described more briefly below,
many interviewees recognized that they may be seen by PIs as
having power; but these interviewees generally thought that they
did not have it, or that it was minimal or justified, because they
were ‘‘merely following the regulations,’’ had an ‘‘open,’’
impersonal, and unbiased process, and were themselves subject
to higher administrative agencies. To the degree that they do have
power, IRBs appear to feel that it is legitimate because it is based
on ‘‘the community’s values’’ and overriding goals. Yet IRBs may
misperceive PI complaints.
Several factors may shape these views, including the political
position of the chair and the IRB.
Differing Views of the Nature and Causes of PI Complaints
IRBs as Having Power. Interviewees all acknowledged
tensions between themselves and researchers, but suggested that
they and researchers often saw the nature and causes of these
conflicts very differently. At times, interviewees described how they
and PIs disagree in how they seem themselves and each other in
critical ways, exacerbating tensions.
Several interviewees acknowledged that their IRB had power,
but may focus on only particular aspects of it. As one member said,
My IRB is pretty darn powerful. I’ve been amazed at how
many consent forms they will actually send back. We’re
really hard on the inform consent form. IRB41
But the basis of this statement – that the IRB can force changes in
consent forms – refers to only one, relatively small potential
manifestation of IRBs’ potency.
Some interviewees saw their IRBs as having power, but felt that
it was legitimate and deserved, even if tensions ensued. A former
We respected the PIs as scientists, but they are going to have
to do things our way. In two or three instances, they thought,
‘‘Who the hell are you…to tell me that?’’ IRB7
Other IRB chairs agree they have power, but feel that it’s
warranted because of overriding goals – protecting subjects and
optimizing the quality of protocols.
PIs think the IRB has a lot of power because they can’t
proceed without approval. But we’re there to help you get your
protocol up to snuff. And the consent form and all the elements
of the consent are now templated on the website. PIs just
have to fill things out. IRB27
But definitions of ‘‘up to snuff,’’ and whether this term refers to
the science or the ethics involved, can vary. This chair also
suggests that the straightforward nature of these forms means that
the IRB does not have power – again seemingly misapprehending
IRBs may dismiss the notion that they have power because they
see themselves as helping PIs – e.g., navigating the regulations.
The IRB has power in the sense that we can tell someone
they can’t do a study, but we’ve never done that. We can
certainly tell them that they need to do it in a certain way.
So the IRB has certain power, but on the other hand, we’re
just trying to help the PI navigate through – to do good
research, but to do it in a way that navigates the federal rules
Yet she is a social science IRB chair who reviews almost all
minimal risk research. In contrast, IRBs that review more invasive
research may be more likely to alter or block studies in more
Chairs may agree they have power, but feel it is legitimate
because it is based on ‘‘community standards.’’ However,
discrepancies between IRBs may reflect differences in institutional
histories (e.g., having been audited and/or ‘‘shut down’’ by
OHRP) and in personalities (e.g., a chair being ‘‘nitpicky’’ vs.
‘‘user-friendly’’), more than variations in community values .
The absence of an external appeals process can bolster such
authority, facilitating subjectivity.
Others feel that they have power, but only a small amount,
though some realize that scientists may disagree. ‘‘I believe the
IRB has power, but not too much power. But scientists would
probably disagree with that. We have the power to stop a
In interacting with PIs, some interviewees recognized that they
may be seen by PIs as harsh and potentially insensitive. IRBs may
‘‘grill’’ PIs, making them nervous, yet these committees may seek
to justify these approaches.
We have a little bit of a reputation of grilling the investigators
when they come in, and I think they’re a little bit nervous when
IRBs’ Views Concerning Their Power
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they walk in. But I don’t think that’s necessarily bad, because I
don’t think everybody should feel like it’s a cake walk – that
everything’s going to get passed. IRB41
At times, IRBs recognized that PIs may, as a result of the IRB,
decide not to pursue certain studies because of fears of rejection from
the IRB. IRBs may see this trend as unfortunate, but nonetheless
maintain it, seeing it as inevitable under the current system.
Some faculty have learned to become strategic about
projects, to avoid IRB review, and don’t study vulnerable
populations. But then people don’t study children. For
instance, one couldn’t do a naturalistic study of bullying in
the schoolyard. IRB22
Several factors may affect the extent of an IRB’s power. For
instance, the IRB chair may also be a department head, who thus
has additional clout. Such institutional authority appears very
important – i.e., in backing the IRB.
…our IRB chair is also the department chair. So we are dealing
with someone who is in a position of authority outside of the IRB,
so as a result of his position we get less flack from PIs. IRB9
IRBs Not Having Power. Yet IRB chairs and members may
see themselves as not having power, or as having it, but feeling it’s
Several interviewees said they did not understand these claims
that they possess power. Several types of reasons arose in defense
Figure 1. Themes concerning differing views of power and PI complaints among IRBs. doi:10.1371/journal.pone.0028773.g001
IRBs’ Views Concerning Their Power
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of these views. IRBs may think that they lack power because they
are ‘‘merely following the regulations.’’
I don’t really get it when the FDA says the IRB has so much
power. It’s only through regulations. And if things are
designed according to the regulations, then it’s not a matter
of power. IRB13
Yet ‘‘merely following the regulations’’ does not necessarily
preclude the existence of power. Given discrepancies in how
committees interpret and apply these regulations, IRBs appear to
have discretionary power – i.e., abilities to interpret and apply
IRBs may think they lack power, too, because they themselves
feel besieged, disrespected, and disliked. IRBs can themselves be
audited and criticized by federal agencies. (‘‘Where are IRBs very
powerful, and not the objects of scorn?’’ IRB13)
Additionally, IRBs may feel that they lack power because they
follow logical, fairly impersonal processes, and are not biased
against any particular researchers. The interviewee above
We don’t have the power to say, ‘‘That doctor was really
rude to us last year: he complained at the faculty meeting
about how the IRB was slow, and lost studies. OK, we’ll fix
him! We’ll put him on the July agenda.’’ IRB13
But in suggesting that IRBs lack power because they do not use
their role to pursue illegitimate, personal vendettas, this admin-
istrator may in fact be creating a ‘‘straw dog,’’ unfairly
characterizing PI criticisms of IRBs.
IRBs may also dismiss claims that they have power because
their processes are transparent, and IRBs are ‘‘open.’’ This
interviewee added, further explaining her views,
We’re real visible here. At some hospitals, researchers
submit stuff to the IRBs, and it’s a closed door. They can’t
enter the sanctum. At our IRB, all the staff are available all of
the time without appointment. You just come in. PIs know
She sees her IRB as ‘‘open’’ and thus not powerful, suggesting several
issues concerning the definition, perception, and legitimacy of power.
Yet openness can reduce power, but not necessarily eliminate it.
IRBs’ Perceptions of PIs’ Views. Yet IRBs also see PIs
misunderstanding IRBs. PIs may unfairly hold the IRB responsible
for other difficulties, unjustifiably blaming the IRB after turning in
late, incomplete, or sloppy forms, exacerbating tensions. As one
People want to blame something. If a PI can’t start a study –
a sponsor was unable to, or decided not to use the site – the
IRB is always a good place to blame: ‘‘If it hadn’t been for the
IRB!…We lost that study because the IRB didn’t act quickly
enough.’’ OK, well, let’s see the protocol: it says it was issued
last July, and it’s coming over here in February…We can be
the source of all joy or all sorrow, depending on how their
grant funding worked out. IRB13
To a degree, PIs may thus at times ‘‘blame the messenger’’ –
i.e., the IRB – for needs to follow federal regulations. Yet the
ability to thwart another’s desires can be seen as representing
power. Power may thus partly be in the eyes of the beholder, and
two parties may disagree. Nonetheless, IRBs emerge here as, in
effect, ‘‘caught in the middle’’ between federal regulations and
agencies on the one hand serving as their local interpreter,
enforcer, and ‘‘face,’’ and local PIs on the other.
Some felt PIs may unfairly blame IRBs as an easy target. PIs
may fault these committees for delays and complain to institutional
leaders who then pressure IRBs or send protocols to for-profit
CIRBs. One chair, at an institution that recently began also using
such a CIRB, said,
A lot of the political pressure, or frustration with our whole
review system was directed at the IRB when, in reality, I
think we were doing pretty good with our turnarounds.
Other steps, or reviews – the scientific advisory committee,
and the grants and contracts office – were becoming
problematic. Maybe we can turn it around a little quicker.
But I don’t think studies are necessarily starting any quicker
– because of budget issues, or the hospital representative has
a problem with an injury compensation statement that we’re
just fine with. It was a PR problem. Many times the IRB was
the fall guy. It’s easy and quick to say, ‘‘It’s their fault.’’
Rather than really doing a process analysis and figuring out
where all the other delays are, it was easier to say, ‘‘Let’s
take this to WIRB [Western IRB – an independent, for-
profit IRB] and get our turnaround times approved.’’ IRB6
An IRB’s position may be complicated by the fact that it cannot
publicly respond if PIs vocally fault the committee within an
institution. Such limited communication can aggravate strains.
People assume the IRB is the big-evil-regulating-snooty-
bureaucracy, and that the researcher did everything right.
But we can’t say, ‘‘The PI might have said this, but here’s the
Chairs may also misperceive or underappreciate PI complaints,
as well as underlying tensions, and potential responses. ‘‘PIs are
primarily concerned with how quickly a project can be approved
with minimal comments. So, IRBs need additional staff to absorb
the workload’’ (IRB9). Yet IRB attitudes, not only resources, may need to change.
This study, the first to explore how IRBs view power
relationships with PIs, suggests that IRBs and researchers may
differ in how they view their respective roles and relationships,
exacerbating tensions between them. While PIs may see IRBs as
having power, IRBs themselves can disagree, and deny that they
have it, or seek to justify it.
One can argue that these tensions are inevitable and
unavoidable, given the different institutional roles of PIs and
IRBs, and may even be desirable to some degree. After all, if
relationships are too cozy, human subjects may not be adequately
The key questions, though, are not whether such power should
exist, but how much. Specifically, these data highlight questions of
how much power IRBs should have and in what ways, who should
decide, what the costs are of these committees having too much
power, and what checks and balances should exist. Clearly,
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disagreements can occur here. IRB chairs may know that they are
seen as ‘‘obstructionistic’’ by PIs, but differ in how much they are
troubled by, or try to alter these perceptions.
IRBs appear to try to justify their power, arguing that it helps
PIs and human subjects, though that claim may not be based on
empirical evidence, and may actually cause harms that the IRB
may not sufficiently acknowledge or weigh, delaying or impeding
These conflicting views of IRB power may partly reflect larger
social structures and tensions within complex, hierarchical
academic medical institutions. Yet both sides can, ideally, work
to ameliorate these conflicts.
IRBs’ power may be legitimate, but discretionary and
subjective. An IRB’s ability to interpret and apply regulations as
it thinks best confers an important degree of authority. A
committee can follow specified processes, but still interpret
While prior research has explored researcher views of