Institutional review boards (IRBs) regularly vote to resolve conflict. This article argues that voting minimizes protections for human subjects and violates moral order. Rather than vote, IRBs should be mediating disputes, which respects the moral difference and integrity of IRB members

Dubler, Nancy Neveloff

Institutional review boards (IRBs) regularly vote to resolve conflict. This article argues that voting minimizes protections for human subjects and violates moral order. Rather than vote, IRBs should be mediating disputes, which respects the moral difference and integrity of IRB members.El consejo de revisión institucional (IRB) regularmente lleva a cabo votaciones para resolver desacuerdos. Este artículo sostiene que el voto viola el orden moral y minimiza la protección de los participantes humanos. En lugar de hacer una votación, el consejo de revisión institucional (IRB), se debería mediar con disputas, que respeten la diferencia moral y la integridad de los miembros del IRB.

Social Medicine / Medicina Social (E-Journal)

 Social Medicine (www.socialmedicine.info)	   - 143 -	   Volume 7, Number 3, October 2013 FESTSCHRIFT IN HONOR OF DR. VICTOR SIDEL  Deliberation and decisions in the IRB process  Nancy Neveloff Dubler, LLBAbstract Institutional review boards (IRBs) regularly vote to resolve conflict. This article argues that voting min-imizes protections for human subjects and violates moral order. Rather than vote, IRBs should be me-diating disputes, which respects the moral difference and integrity of IRB members. •    •    • It is my honor and pleasure to be a participant in this Festschrift honoring Victor W. Sidel, MD. Vic Sidel was my mentor, guide, benefactor, editor, co-author, and friend for many years in the Department of Social Medicine and in the world of protecting human subjects. He has shown the way for genera-tions of medical students and the occasional lawyer. He has set a standard of excellence in moral leader-ship. I can think of no better way to honor his achievement than to continue a discussion that we engaged in for years, whose goal, ending the process of voting on contentious matters in the Montefiore Medical Center Institutional Review Board (IRB), eluded us. However, given my own work in media-tion,1 with which some of you are familiar, and giv-en new voices in the discussion, I plan to expand my dissent, which I regularly offered in the Montefiore IRB, with hoped-for future agreement that voting is not a useful tool for promoting and protecting the interests and rights of human subjects.  The intellectual architecture of the regulations governing research with human subjects2 appears to anticipate the full range of ethical dilemmas that IRBs might face in attempting to review protocols within the specific regulatory standards and guided by a set of moral principles. The regulations stipu-late, among other things, membership in the IRB, categories of protocols receiving more or less inten-sive review, processes for notification of investiga-tors, special protections for vulnerable populations, and even the specific logic of review for research involving specific populations, i.e., prisoners and children who exhibit compromised or developing abilities to provide legally and ethically adequate informed consent.1 Surprisingly, the regulations are silent on any process to be used to resolve disputes over any particular protocol. As a result, most IRBs use some system of majority vote, an approach that, I would argue, is not suited to the resolution of complex moral matters. Nor is voting, by extension, helpful to the identification and protection of the rights and interests of potential human subjects, which should be the sole focus of IRB deliberation. I suggest, in these brief remarks, that voting may actually distort deliberation when an IRB addresses ethically complex issues. A word about the gold standard for voting before moving on: first, to an argument about moral com-plexity and, second, to an examination of two cases illustrating the dangers of the voting process. Ac-cording to Wikipedia (as of March 28, 2012):  Robert’s Rules of Order is the short title of a book containing rules of order intended to be adopted as a parliamentary authority for use by a deliberative assembly written by Brig. Gen. Henry Martyn Robert. The first edition of the book, whose full title was Pocket Manual of Rules of Order for Deliberative Assemblies, was published in February 1876 by then U.S. Army Colonel Henry Martyn Robert (1837–1923) with the short title Robert’s Rules of Order placed on its cover. The procedures prescribed by the book were loosely modeled after those used in the United States House of Representatives, with  Nancy Neveloff Dubler, LLB Consultant for Ethics New York City Health and Hospitals Corporation 125 Worth Street New York, NY 10013 Email: nancyadubler@gmail.com   Social Medicine (www.socialmedicine.info)	   - 144 -	   Volume 7, Number 3, October 2013 such adaptations as Robert saw fit for use in or-dinary societies.3  Interestingly, Robert’s notion was that delibera-tive bodies should decide, as part of their organizing process, whether to adopt these rules to govern de-liberations. (Note that the U.S. House of Repre-sentatives is no longer seen as that ideal deliberative body whose process should be duplicated for the benefit of humankind.) What Robert’s Rules do is: keep order, move the agenda, and facilitate domina-tion by the majority. None of these supposed virtues is sympathetic to the exploration of moral complexi-ty. In a 2011 article, Autumn M. Fiester defines an “aporetic case” as “a case in which the moral per-missibility (or correctness) of opposing positions can both be justified on moral grounds (that is, using moral reasons)—as opposed to grounds of pure self-interest.”4 Feister argues that in aporetic cases, vot-ing is not a morally supportable structure and that only a consensus process should be used to resolve differences. Feister goes on to argue that a dispute among members of a clinical ethics committee (or by ex-tension an IRB) on the proper resolution of a case indicates not just disagreement but a state of moral uncertainty or perplexity. Where such disagreement exists, not on a verifiable issue—Did this investiga-tor meet a deadline?—but on a matter that is ethical-ly significant, then what is at stake is a “clash be-tween moral considerations, values, or principles, or significant disagreement about which moral consid-eration ought to trump the others in the case.”4 Feister, who opposes voting in these circum-stances, concludes that:  Mediation, as a process, honors the validity of both sides in a dispute. It works towards consen-sus about outcome, even when consensus about principles or values is not possible. This ap-proach provides a built-in safeguard against choosing between incommensurable values be-cause it takes no stand on which moral princi-ples or claims ought to trump in a disputed case. It does not claim moral authority when there is none to be had. It does not prioritize one set of values over another in the absence of any access to the moral knowledge or expertise needed to anchor such claims. And mediation levels the playing field in an arena with clear power and status differentials that can artificially (and ille-gitimately) grant priority to the values of the powerful. Because it includes the voices of all af-fected by the outcome, it legitimizes and safe-guards the moral claims of all of the partici-pants.4  These observations apply similarly to clashes of moral judgment among IRB members. Consider two cases that illustrate disagreement: the first is an actual case and the second is a hypo-thetical. The first involved the approval of synthetic growth hormone to replace human growth hormone to avoid the spread of Creutzfeldt-Jakob disease; the second involved the creation of scars on the skin of African American subjects in order to test various interventions to lessen the scarring.  In the first case, the molecular structure of the synthetic hormone was identical to that of the hu-man growth hormone, but of chemical and not hu-man origin. The study protocol required all children enrolled in the protocol to receive weekly injections for two years, one year with and one year without the active agent. Although the synthetic material was already available for clinical use, it was hugely expensive and often not reimbursed by insurance companies. In this case, there was a vote and, over vociferous objection, the protocol was approved by the IRB.  Consider some of the arguments offered for en-rolling children in trials of synthetic growth hor-mone: without FDA approval, insurance companies would not cover treatment; poor children enrolled in the study would receive state-of-the-art care that would be beyond their families’ means; the process would make growth hormone available to greater numbers of children who needed it; and the burden of placebo injections was outweighed by the benefit of treatment. (Although it is generally inappropriate to assert that the there will be a benefit from a re-search intervention, in this case, given the identical molecular structure, the intervention could appropri-ately be described as treatment.) The counter argu-ments noted the abuse of poor children whose lives would be adversely affected for one year by the pla- Social Medicine (www.socialmedicine.info)	   - 145 -	   Volume 7, Number 3, October 2013 cebo injections; the fact that no parent who could afford the treatment would ever accept placement of her child in the protocol; and the clear class bias of the study. The vote disposed of the matter, but did nothing to reconcile the opposing moral claims or claimants.  The hypothetical, which I created for a law school class, hypothesized a protocol that sought to identify remedies for scarring in the African Ameri-can population. The danger in the protocol was that scars created to test interventions might not be re-mediable. In the course of a classroom discussion, it became clear that there was a huge difference of opinion about the approvability of the study. Those in favor argued that it targeted a problem about which little was known and for which few treat-ments were clinically efficacious. Advocates for rejection of the study cited the Tuskegee syphilis study5,6 and the Retin A prison experiments7 as dis-positive. A consensus process sharpened the issues and adjourned the discussion until members of the affected community could be invited to participate.  Voting, especially under Robert’s Rules: limits discussion; declares certain lines of reasoning out of order; permits those disgruntled, uncomfortable, or just plain bored to push toward a vote; and, “moves the agenda” of a long and possibly tedious meeting. What these rules and voting procedures do not do is: encourage discussion of underlying moral princi-ples; help level the playing field distorted by power differentials between investigators and human sub-jects; surface individual biases against populations affected by the proposed research; and permit and facilitate intellectual “horse trading” that might modify a protocol to minimize moral hazard. In contrast, a consensus process: assumes that all will offer reasons for their espousal of one or anoth-er position and attempt to convince others to accept their logic; supports open discussion, leading to the minimization of differences; and seeks a common moral and intellectual ground that identifies an out-come not as morally superior but as morally possi-ble. Most IRB proposals are neither so complex nor so contentious as the ones referenced here. Howev-er, mediating disputes rather than outvoting the ob-jectors respects moral difference and the integrity of IRB members.  References 1. Dubler NN, Liebman CB. Bioethics mediation: a guide to shaping shared solutions. Nashville (TN): Vanderbilt University Press; 2011. 2. Code of Federal Regulations. Title 45. Public Wel-fare. Department of Health and Human Services. Part 46: Protection of Human Subjects. Revised January 15, 2009. Effective July 14, 2009 [cited 2013 Mar 17]. Available from: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf 3. Wikipedia. Robert’s Rules of Order [cited 2012 Mar 28]. Available from: http://en.wikipedia.org/wiki/Robert%27s_Rules_of_Order 4. Fiester AM. Ill-placed democracy: ethics consulta-tions and the moral status of voting, J Clin Ethics. 2011 Winter;22(4):363-72.  5. Rockwell DH, Yobs AR, Moore MB Jr. The Tuskeg-ee Study of Untreated Syphilis: the 30th year of ob-servation. Arch Intern Med. 1964 Dec;114:792-8. 6. Reverby SM. Tuskegee’s truths: rethinking the Tuskegee syphilis study. Chapel Hill: University of North Carolina Press; 2000. 7. Gostin LO. Biomedical research involving prisoners: ethical values and legal regulation. JAMA. 2007 Feb 21;297(7):737-40.     

Deliberation and decisions in the IRB process

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