Ethics Police Read and Answer Questions

The Ethics Police?: IRBs’ Views Concerning Their Power Robert Klitzman*

Department of Psychiatry, Columbia University, New York, New York, United States of America

Abstract

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]

Introduction

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,’’ [5] 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’’ [10] and that IRBs

are even unconstitutional in impeding academic freedom [11].

IRBs have power as gatekeepers [3], 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 [4]. PIs also tend to value IRBs treating researchers

fairly more than protecting subjects per se [3]. PIs who feel they

have been unfairly treated by IRBs may be more likely to feel

justified in avoiding IRB regulations [12].

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

continue.

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

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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 [17], conflicts of interest [18], CIRBs

[19], unaffiliated and nonscientific members [20], research in the

developing world [21], and variations between IRBs [22].

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.

Methods

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 [23] 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

‘‘thick description.’’

In the methods, I have adapted elements from Grounded

Theory [24]. 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

theories.

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%

Gender

Male 27 58.70%

Female 19 41.30%

Institution Rank

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%

Region

Northeast 21 45.65%

Midwest 6 13.04%

West 13 28.26%

South 6 13.04%

Total # of Institutions Represented 34

doi:10.1371/journal.pone.0028773.t001

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.

Results

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

chair reported,

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

PI concerns.

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

appropriately. IRB19

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

fundamental ways.

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 [22].

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

protocol.’’ (IRB35)

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

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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

justified.

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

regulations differently.

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

continued,

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

me. IRB13

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

administrator said:

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

truth…’’ IRB22

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.

Discussion

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

protected.

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

valuable research.

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

regulations subjectively.

While prior research has explored researcher views of the

‘‘fairness’’ of IRBs [3,12], the present data highlight another

aspect of these views – that IRBs have power that can incur

resentment.

Much of IRB work occurs behind closed doors, which can

aggravate these tensions. Minutes are not publicly accessible, but

arguably attempts should be make these available, at least in part,

to whatever degree may be reasonable and possible. IRBs keep

minutes private, along with all correspondence and decisions

(except to the PI involved). Yet increasing transparency could

potentially help improve perceptions of IRBs among PIs. Given

concerns about proprietary information, redaction of details at any

institution may be hard for certain studies, particularly those that

are industry-funded. Yet transparency may not be as difficult for

many other, non-industry funded protocols. IRBs could, for

instance, post examples, with details redacted, of the types of

concerns they have had about issues that arise in various protocols.

Such an approach could yield many benefits. Yet IRBs may

themselves prefer the lack of transparency, as it may reduce

questions about their processes and decisions – which presumably

is not the intended goal of the current practice of non-

transparency. These interviews thus highlight key questions of

how much lack of transparency is, or should be permitted.

Educational efforts and shifts in attitudes can thus be helpful.

IRBs and PIs should both be encouraged to strive to understand

more clearly the nature of tensions between them, the underlying

causes, and possible ways to address these. IRBs should recognize

these subjective elements more fully, and weigh this awareness

more in decisions. Many IRBs try to respond to PIs’ complaints,

improve relationships, and ‘‘not be the ethics police,’’ but vary

widely in how.

From Aristotle [25] to Madison and Hamilton in the Federalist

Papers [26], theorists have argued that power can play vital roles

in political and social structures, but can be used well or poorly.

So, too, IRBs will invariably, it seems, have a modicum of

authority and thus power, but can use it in ways that are more or

less justified and effective. More recently, ‘‘discretionary power’’

has been described with regard to police, who can choose when

and how to employ it [27]. Yet unlike the police and many other

entities with power in a democratic civil society, with IRBs, no

appeals process exists. Citizens can readily file complaints about

police officers, and have these grievances addressed by higher

administrative authorities that can correct or remedy perceived

wrongs. But for researchers, no such processes have yet been

systematically established.

IRBs should realize that the absence of an appeals process gives

them de facto considerable power. To ignore this fact can

exacerbate tensions between IRBs and PIs, while increased

acknowledgement of this perceived power can help IRBs facilitate

interactions with PIs, and thus in the end best help protect human

subjects.

Concomitantly, PIs may also unfairly ‘‘blame the messenger,’’

resisting federal regulations, exacerbating conflicts [17]. Research-

ers should realize that IRBs, while subjectively implementing these

regulations, are in fact also constrained in many ways by these

policies, and fears of governmental audits, and generally appear to

be trying their best.

Needs thus exist, too, to further enhance education about IRB

regulations and the underlying principles and processes of review

among medical faculty and trainees, to help reduce these tensions

in the future. While existing educational mandates may foster

resentment among some researchers, such education can none-

theless be extremely important. Requirements among physicians

for board certification, and continuing medical education may also

be perceived burdensome, but have been accepted as important to

optimize the standards and quality of care. Further questions

about research ethics could be included, for instance, in board

examinations. Improved understanding of the broader context of

IRBs and IRB regulations can ultimately enhance compliance and

protection of human subjects.

A critic might dismiss these educational and attitudinal efforts as

unimportant, or as too aspirational to be attainable through policy.

However, increased awareness of these issues through discussions

in peer-reviewed journals, at academic meetings, and in other fora

can heighten awareness of these issues in ways that can enhance

the system. Indeed, policy changes, as now being recommended

through the ANPRM, may have unintended consequences, and

may not be able to wholly solve all of the tensions and differing

perspectives that these interviewees describe. Hence, such

education and attitudinal shifts can be vital.

These data also have several critical implications for policy, and

can aid discussions concerning possible changes in policies that are

raised in the ANPRM. For instance, these data suggest needs for

an appeals process. The ANPRM asks whether institutions should

all be required to provide an appeals mechanism, and if so, what

type. The present data are thus important in highlighting reasons

why such an appeals process can be advantageous. These data,

highlighting the role of IRB power, suggest that such an appeal not

be made to the same IRB that made the initial decision, but rather

to an independent body. The details involved would have to be

determined. For example, as one possibility, the researcher could

send a memo documenting the reasons for his or her appeal, to

which the IRB could respond. Both documents could then be

submitted as an appeal (e.g., to another IRB at that or another

institution).

In addition, having one committee serve as the IRB of record in

multi-site studies, as proposed in the ANPRM, could potentially

decrease the power of other, local IRBs. This committee of record

would, however, then assume considerable clout. IRBs having to

report to OHRP if they deviate from aspects of the proposed new

regulations, as raised as a possibility in the ANPRM, can also

prompt IRBs to curb any idiosyncrasies that may exist, and may

serve to create checks and balances, and decrease these

committees’ power.

These data have actual implications for research as well.

Research is critical to explore more fully how IRBs and PIs each

view and respond to these tensions, what factors are involved, and

what interventions might help. Future studies can probe these

areas further with larger samples, examining, for instance, how

factors (such as federal audits at an institution) may affect views of

IRB power, and whether differences in these views correlate with

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differing perceptions and practices among PIs. For instance, those

chairs who see themselves as having power, but try to minimize its

use, may result in PIs who feel less resentful of IRBs, value

research ethics more, follow regulations more closely, and violate

research integrity less.

These findings have several potential limitations. These

interviews explored subjects’ views at present and in the past,

but not prospectively over time, to examine possible changes. This

study did not interview researchers as well at these institutions, but

future studies can do so as well. Further studies can collect and

analyze these additional sources of data. The response rate among

regular members was not as high as among chairs and

administrators, since I did not contact regular members directly,

but relied on chairs and administrators disseminating information

about the study to these regular members, and then having these

regular members contact me. I do not know whether the chairs

and administrators in fact distributed this information, and if so,

did so once or more than once. Hence, the response rate was

lower. These findings are also based on in-depth interviews with

individual IRB chairs and members, and did not include direct

observations of IRBs as a whole, or examination of written IRB

records. Future research can, however, observe IRBs. Yet, such

added data may be hard to procure since, anecdotally, IRBs have

generally required researchers to obtain consent from all IRB

members and the relevant PIs, and protocol funders. This study is

qualitative, and thus is designed to reveal, in many ways that

quantitative data cannot, beliefs, attitudes, views, and relationships

between these phenomena, generating research questions and

hypotheses that future investigations can examine in further detail

among larger samples, employing both qualitative and quantita-

tive approaches. Qualitative research is not designed to measure

responses quantitatively. But future investigations can address

these questions.

These points may be controversial, but as science, and hence

needs for adequate subject protection, further advance, addressing

these conflicts and their underlying sources is essential.

Supporting Information

Appendix S1 Sample questions from semi-structured interview. Note: Additional follow-up questions were asked, as appropriate, with each participant.

(DOC)

Acknowledgments

The author would like to thank Meghan Sweeney, Daniel Marcus-Toll,

Jason Keehn, Renée Fox, and Paul Appelbaum for their assistance with

this manuscript.

Author Contributions

Conceived and designed the experiments: RK. Performed the experiments:

RK. Analyzed the data: RK. Contributed reagents/materials/analysis

tools: RK. Wrote the paper: RK.

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