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IRB Cases: Comment

The IRB and the Community

Robert J. Levine, MD

IRB’s generally have no individual members properly designated as ‘community representatives.’ According to the common rule they must have “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.” (§46.107d)  This individual is commonly but incorrectly referred to as the ‘community representative’. Further, the “IRB shall be sufficiently qualified through the experience and expertise …and the diversity of the members…, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes… to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.”

The common rule, then, does not call for community representation; rather it calls for ”sensitivity to community issues.” That is another matter entirely, one which I believe is attainable. If true community representation were required it would be most difficult to accomplish. Even in a city as small as New Haven, CT, where I live and work, there are many distinct communities; to name a few: Polish, Italian, African-American, Chinese, Muslim, Jewish, Cuban, Puerto Rican and Chicano. I could name others but I believe the point is made.

If the IRB wants to know of the interests and attitudes of a community, it has various methods to do so. These include community consultation, community engagement, several deliberative poll techniques and community advisory boards.

The case study makes reference to ”…community members (who) are truly knowledgeable concerning community norms and (who) contribute such information to IRB discussions…” and asserts that “…they are providing an important service to the IRB and the community.” I agree that such individuals would be extremely valuable if they could be found. Even if they could be found, one would have to decide how to accommodate sufficient numbers of them to represent the interests of all of the communities within the IRB’s catchment area. I believe it is more common to find so-called “…community members, (who) as in this case, vote according to…personal beliefs not representative of the community….”  Moreover, I agree with the case’s author that the other IRB members (scientists, physicians, lawyers, clergy) are often influenced powerfully in their decisions by strongly-held personal beliefs that are unrelated to their role on the IRB. The oncologist, for example, might be a covert racist or have a strong bias against palliative care.   

 

If not community representation, what is the purpose of requiring the IRB to have “…at least one member who is not otherwise affiliated with the institution…? One purpose of this member is, I believe, to mitigate the effect of the academics’ tendency to place an extremely high value on knowledge for its own sake. The “not otherwise affiliated” member is there to remind the academics that there are other values that should be balanced against the pursuit of knowledge. In a certain sense, then, it is to guard against a certain type of conflict of interest.

Conflict of interest

The common rule’s requirement is clear that no member having a conflicting interest in a project may participate in the IRB’s review of that project except to provide information requested by the IRB (§46.107(e)) . It does not specify what counts as a conflict; whether the individual with a conflict should abstain or be recused or whether the recused or abstaining member should leave the meeting room during discussion of the project.

Should the abstaining or recused IRB member be required to leave the room? Temporary dismissal of this member might seem to be advantageous if it would not result in disqualifying the IRB meeting by virtue of loss of either its quorum or its only “non-scientist” member; by reducing the number of voters present, a majority vote could be achieved and the project would be approved. It is worth considering, however, that this might be regarded by some as exploiting the letter of the law in order to circumvent its intent. It is difficult to discern what the regulations’ authors meant by requiring “the approval of a majority of those members present at the meeting.” (§ 46.108(b)) But it strains the imagination to believe they intended to say that a decision to disapprove a protocol, presumably on either ethical or scientific grounds, could plausibly be reversed simply by removal of an abstaining member (by stipulation, a negative voter) from the meeting room. (I concede the possibility that I may be reading the regulation more carefully than it was written.)

The case’s author argues “it is…critical that the [recused] member physically leave the room as their continued presence may inappropriately influence the discussion or the vote nonverbally through body and facial language or even intimidation-by-presence.” I disagree, particularly if he or she intends that this removal apply as well to abstainers. I believe that IRB members have ample experience in resisting the persuasive power of body and facial language and sufficient moral fortitude to stand up to intimidation-by-presence of an abstaining or recused member. They have garnered the necessary experience and fortitude through their past dealings with actual negative voters.

What counts as a conflict of interest? As noted by the author, there are several varieties of conflict that should be considered – financial, professional and personal. I suggest that involuntary recusal be imposed only for reasons that can be specified clearly and unambiguously. For financial considerations it is easy to specify grounds for recusal in dollar amounts as do various funding and regulatory agencies as well as many research institutions. ‘Bright lines’ can also be drawn regarding conflicting relationships – eg, siblings, spouses, teacher-student, coinvestigators, etc.

For other types of conflict it is preferable to rely on voluntary abstention. The case author has carefully described the subtleties of the matter. Conflicts of varying degrees are ubiquitous and sometimes inapparent even to the ‘conflicted” individual.

The ethical principle of publicity requires that individuals or institutions must be willing to state publicly the grounds for their ethical decision-making.1 That entails specification of the criteria for making various types of ethical decisions. This principle is closely related to the contemporary demand for transparency in decision-making. The institution is (or should be) required, for example, to publish in its policies the grounds for recusal of one of its IRB members from discussion of or voting on protocols. Such policy documents are or ought to be available to the public. It is easy to communicate clear and unambiguous criteria such as those published by NIH for limits on financial involvement (paraphrased here as greater than a $10,000 equity interest in the sponsor of the protocol under review). Consider, by contrast the following: “Religious belief that one cannot approve a study of ART.” I ask the reader to consider the consequences of making such a criterion available for public scrutiny.

It may be correct to assume that, among academic faculty, only a very small minority oppose ART on moral grounds. In the general population of the US, however, this position is held by a much more substantial minority. Older members of the Yale Human Investigation Committee (HIC) may recall that when it approved a study of preserving human embryos by freezing them, the headline on page 1 of the next day’s New Haven Register was “Callous Disregard for Human Life.”

In the days that the Yale HIC took this decision on cryopreservation, one of its most respected members, a professor in a clinical department, believed  that most research connected with ART or abortion was proscribed by Jewish Law. Thus, he abstained from voting on all such protocols. 

A concluding remark on objectivity: I seriously doubt that humans are capable of pure objectivity. Every decision taken by a human being is influenced by his or her experiences, by his or her situation in a particular life-world. Although the case author provides considerable commentary supporting this doubt, he or she asserts: “There is…an expectation, by dint of serving on an IRB, that each member is committed to reviewing research based solely on the objective merits of  the study.”

Consider an IRB reviewing a protocol to evaluate intensive chemotherapy with substantial side effects. Patients with cancer will accept enrollment in such a protocol if it offers a 1% chance of cure; physicians would require a 10% chance and oncology nurses a 50% chance.2 Let us imagine that one of each of these groups is an IRB member; which of them should be recused from voting on the protocol on grounds of insufficient objectivity?

The case author recognizes that scientific members of the IRB have professional and personal biases which cannot be eliminated. He or she accepts this, albeit grudgingly, and offers this reassurance: “Additional protections are afforded by the structure of the IRB in that it is likely that a number of other voting members on the IRB will not share the same biases.” I agree with this and would apply the same reasoning to most personal biases held by the non-scientist members.

Reference 

1. The principle does not necessarily apply to all individuals. It applies most strongly to individuals acting in roles in which their decisions will influence the rights or interests of others. As Kant put it in his treatise, To Perpetual Peace: ‘All actions that affect the rights of other men are wrong if their maxim is not consistent with publicity.’

2. Agrawal, M and Emanuel, EJ: ML: Phase I Oncology Research. In The Oxford Textbook of Clinical Research Ethics, edited by E.J. Emanuel, C. Grady, R.A. Crouch, R. K. Lie, F.M.Miller and D. Wendler, Oxford University Press, Oxford,  2008, Chapter 33, pp. 356-366.

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