The Question of Method in Ethics Consultation: The IRB Frontier

Our society must weather a series of critical challenges in plish that purpose. Reports of deaths occurring in biomedreexamining, defining, and enacting the practice of the ical research inject an element of apprehension into the ethics of research over the next few years. There is growing mounting number of inquiries and investigations of seri-concern that the systemof protections for individuals par-ous failures to follow procedures to ensure an appropriate ticipating in research, which has evolved over the past 35 review of proposed research and adequate informed con-years (MacKay 1995), can no longer be relied on to accom-sent of individuals. Major criticism, focusing now on the inherent potential for conflict of interest in a review process that was intended to be independent, disinterested, and balanced, asks whether the present systemcan be trusted at all in the light of these problems. In response, government and private organizations have initiated reforms and proposed steps intended to promote uniform and objectively verifiable standards through programs of accreditation, certification, education, and training.

However, the role of ethics consultation in the research setting has not received great attention. In my view, this is an area of enormous potential to be developed to ensure substantive gains in safeguarding the rights of individuals who become involved as subjects in research activities. The scrupulous and meticulous adherence to procedural elements of review, record keeping, oversight, and education may well improve the performance of institutional review boards (IRBs), sponsors, researchers and the organizations that are involved in carrying out research. But reliable evidence and documentation of adequate performance of IRBs (Bell, Whiton, and Connelly 1998), provided little reassurance that an adequate job is to be considered a successful job.

Consequently, the opportunity for ethics consultation in the research setting seems unparalleled and strategically valuable. As distinguished fromethics consultation in the clinical setting, research ethics offers a well-developed framework that has been codified into regulations and international codes and standards. Although many IRBs have included ethicists among their members, ethicists have not been prominent in commentary, analysis, and resolution of the routine topics of IRB deliberations and determinations. The contributions of bioethicists, whatever their original education and training, have been an invaluable part of policy formulations and commentary on salient and controversial issues. Nevertheless, apart fromoften superb analyses in the journal IRB: Ethics and Human Research, the literature does not reflect any great amount of commentary on specific protocols or types of protocols. Ethicists have not appeared to publish accounts of their views about the adequacy of safeguards for subjects or what constitutes acceptable levels of risk in the protocols most commonly reviewed by IRBs. Their contributions about the basic principles, concepts, and methods of research have, of course, enriched the thinking and practice of clinical researchers and IRB members. (Freedman 1987; see also the "Ethics of Clinical Trials—General" section of Clinical Trials Research Group 2000). Paradigmcases and cutting-edge ethical issues in research have been the targets of choice for ethicists.

Integrating the role of the bioethicist as an IRB consultant and as a consultant in patient-relevant ethical issues in research and clinical care in the research setting has been carried out systematically in the Clinical Center Research programat the National Institutes of Health for approximately 25 years. Most recently, with the establishment of the Department of Clinical Bioethics in 1996, the roles have become more formalized. Ethicists take part in the rounds of the clinical research staff and also respond to requests for consults on the ability of individuals to comprehend and provide voluntary consent. Other individuals, with clinical and ethical expertise, serve as consultants/ members of the several IRBs in the NIH intramural research program, helping the IRBs maintain an overall consistency in applying ethical norms and making determinations about the adequacy of protections for subjects in the intramural program.¹ Similar arrangements can be...