Book Review

Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members

N Engl J Med 2007; 357:1061-1062September 6, 2007

Article

Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members
By Dennis J. Mazur. 252 pp. Baltimore, Johns Hopkins University Press, 2007. $50 (cloth); $29.95 (paper). ISBN: 978-0-8018-8501-3 (cloth); 978-0-8018-8502-0 (paper).

In the past few years, a handful of books have aimed to help members of institutional review boards (IRBs) fulfill their role of protecting those who participate in approved biomedical and behavioral studies. This book, the latest addition to the list, walks IRB members through the maze of ethical considerations, regulatory requirements, and procedural issues they must attend to during protocol review and their oversight and periodic reviews of approved studies. Mazur covers familiar terrain regarding the tasks of the IRB and the basic terms and concepts that members must understand, including attention to informed consent, the recruitment of research participants, qualitative research, the management of the workload of the IRB, and the continuing review of ongoing research. He also provides an extended discussion of several challenges that IRB members face when they review proposed studies, such as how to assess a study's risk–benefit ratio and review its scientific elements and what to consider in order to protect the privacy of research participants and their associated data.

The chapter about risk provides IRB members with essential information about the nature of risk and how to weigh it and reminds them to ensure that informed-consent documents communicate information about risk in clear language that laypeople can understand. Some observers will disagree with Mazur's view that IRB members should review the medical literature to identify potential research risks, rather than rely on the information in the proposed protocol; few IRB members have the training or time to conduct an exhaustive search of the literature to identify the risk profile of the experimental intervention.

In the chapter on the scientific aspects of a proposed study, Mazur provides a long list of questions that IRB members can ask when they review the scientific aspects of a study. This list of questions establishes a strong case that the IRB's ethical analysis of proposed research should include careful attention to the scientific quality of the study. Yet whether every IRB member needs to know or be willing to learn basic statistics is arguable. Others have recommended that IRBs should have one or more biostatisticians on the committee to assess the design and scientific quality of the study and report their assessment to the full committee.

Privacy is a growing area of concern, especially as researchers begin to mine massive amounts of data about medicine and genetics that were obtained in clinical and research settings. Complicating these efforts is the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which does not regulate research but does regulate access to protected health information that is used and disclosed by covered entities that transmit it electronically. IRB members need to know when and under what conditions the HIPAA Privacy Rule overlaps with federal regulations that govern human research. Mazur fails to note that the only role that is specified for IRBs in the Privacy Rule is to approve or disapprove requests for partial or complete waivers or alteration of the requirement that persons give authorization for research uses and disclosures of their protected health information.

Some notable subjects omitted from the book are how the accreditation of an institution's human research protection program affects its IRB, the review of pediatric studies as well as critical care research in the emergency setting, the relationship between local and central IRBs in multisite studies, and the roles of and challenges faced by members of community IRBs. Despite these missing pieces, Mazur's book provides IRB members with essential questions they should ask when reviewing proposed and ongoing studies so that they may fulfill their obligation to protect the rights and welfare of persons who participate in clinical trials and other research studies.

Karen J. Maschke, Ph.D.
Hastings Center, Garrison, NY 10524
maschkek@thehastingscenter.org