The widespread existence of Institutional Review Boards (IRBs) at educational and professional institutions across the country has brought to the surface a lively debate regarding ethical concerns in research involving human participants. Dennis J. Mazur captures the main themes of this debate in Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members. 

            Mazur cleverly dissects the key functions that an IRB is expected to fulfill and the challenges that it is likely to face, while he highlights the responsibilities of both researchers and IRB members in ensuring that the rights of research participants are protected.  His work brings to the surface the fundamental ambiguities of the terrain upon which an IRB is expected to navigate and the controversies that unmistakably follow. At the core of all the ambiguities appears to be the contentious issue of what qualifies as "research" and thus of what constitutes the target (some would say "the victim") of the work of an IRB.   The Code of Federal Regulations Title 45 describes research involving human subjects as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". This definition appears innocuously unambiguous until it is interpreted by the actual "users", that is, individuals involved in some form of data collection, analysis, and dissemination (either directly as researchers or indirectly as IRB members evaluating research prior to its implementation).  For instance, would a systematic investigation of the paintings of some living artists constitute research? Would this type of investigation require IRB review if no interviews are planned with the artists?  Interestingly, even if the investigator might reasonably argue that this form of "research" is "exempt" under Title 45, the IRB is still entrusted with determining the "exempt" status of the project, thereby forcing the investigator to complete an IRB proposal and the IRB to screen the proposal.

            The ambiguities surrounding the real-life applications of the term "research" bring to life the essential conundrum faced by IRBs across the country and the grumbling that envelops their work. In a nutshell, it is not the function of protecting subjects that makes many investigators uneasy with IRBs, but the fact that they are a regulatory body requiring "unnecessary" work in areas where human participants are unlikely to be at risk.  Many of these investigators angrily ask why they could not be entrusted with the task of determining whether their research involves minimal risk (i.e., research that does not harm or produce discomfort to participants greater than that ordinarily experienced in every day life or during routine physical or psychological examinations).  They argue that they, the investigators, are, de facto, those who are ultimately responsible for all the research activities and outcomes. Unfortunately, the controversy regarding who should be entrusted with the task of evaluating a research project's risks and benefits finds fertile ground in what investigators perceive as the frequent lack of consistency in the evaluations produced by IRBs. Most notably, some argue that changes in the membership of an IRB can mysteriously make the criteria used to evaluate proposals more or less stringent, magically transform the appeal procedures from burdensome to trouble-free (or vice versa), and, overall, change the duration and quality of the review process in ways that are difficult to describe as objective.    

            For the most part, the fact that IRBs have the authority to approve research projects before such projects can be undertaken, and the perceived lack of standardization of the review process (across time within an IRB and across IRBs at different institutions) conspire to create the perception of IRBs as imposing an unfair burden to honest and hard-working investigators whose main goal is to advance knowledge in their field of expertise.  Of course, this perception is magnified by stories of unreasonable requests made by a few, clearly malfunctioning, IRBs.  One blatant example of such requests is the one recently reported in a New York Times article by Patricia Cohen (February 28^th) regarding an investigator asked to have his subjects, who were members of a preliterate tribe, sign an informed consent form.  The isolated nature of these episodes cannot compete with the vividness with which they are remembered, and they help foster in the minds of many investigators negative images of IRBs as committees prone to overreaching and abuse of power.

            Undeniably, perceptions of unfairness based on lack of uniformity in the review process combined with vivid references to unreasonable (albeit isolated) requests make the work of IRBs across the country controversial. This is one good reason for reading Evaluating the Science and Ethics of Research on Humans.  It provides a detailed and impartial description of the functions of the IRB to those who are (or will soon be) members and to those who plan to submit proposals. While exposing possible areas of conflict, it offers a way of reconciling the view of applicants and IRB members under one set of reasonable and practical guiding principles. Even though there is no denying that IRB proposals demand additional labor from investigators, they are portrayed as a valuable exercise for determining the benefits and perils of research endeavors.  As a result, the burden that writing IRB proposals places on investigators is overshadowed by the role that they can play as educational tools within the review process. Indeed, IRB proposals, by forcing investigators to explain to others their research plans, demand that investigators meticulously examine the motives behind their research and the ways in which it is conducted. As such, the review process offers investigators an outside skeptical audience, largely removed from the investigators' research community, and, by doing so, it performs a constructive (rather than disruptive) role in the development and implementation of research projects.

            If IRBs are not to be feared or despised because they serve a useful function within the research enterprise, one might ask whether some changes in the review process should be introduced to make reviewing less cumbersome and its outcomes more uniform. Mazur does not dwell much on these possibilities and mostly focuses on the status quo.  Furthermore, although Mazur's extensive experience in medical research on human participants inspires and enriches his examination of the relationship between the practice of research and the need to protect the rights of research volunteers, it also limits the breath of his examination.

            Notwithstanding the focus on medical research and the limited attempt to envision a future of more functional and less error-prone IRBs, Evaluating the Science and Ethics of Research on Humans is a well-written and informative narrative of the inner workings of IRBs.  It is a must-read for those who are (or will be) members of an IRB and for those who need to submit a proposal.  Arguably, changes in the ways IRBs function are needed, and IRB members have the possibility of developing more efficient, practical guidelines for the review process.  Mazur's book provides an exceptional opportunity for acknowledging the current functional problems of IRBs and for considering solutions that are mindful of the basic principle of academic freedom.

© 2007 Maura Pilotti

Maura Pilotti, Ph.D., Department of Psychology, Dowling College, New York.  Dr. Pilotti is Chair of the Dowling College IRB.

Categories: Ethics