A Code of Ethics for Institutional Review Boards

A Code of Ethics for Institutional Review Boards

  By Norman M. Goldfarb

Institutional review boards (IRBs) focus on the ethical issues of people and organizations   that conduct clinical research, as defined by applicable laws, regulations, guidelines, etc.   However, the IRB itself, along with its individual members (and staff), have their own   ethical challenges. A concise, common-sense statement of what constitutes ethical conduct   by an IRB and its members — a code of ethics — could improve the quality of IRB reviews.   Since IRBs are only one part, albeit a very important part, of a human subjects protection   program, the code of ethics should be adapted accordingly.   The code of ethics proposed in Figure 1 focuses on ethical conduct, not the conflicts of   interest (COIs) and other potential causes of unethical conduct, which constitute a separate,   very complex topic. The proposed code of ethics assumes that IRBs have instituted COI   policies and procedures.1   Most of the individual items in the proposed code of ethics are   probably followed widely, although perhaps not rigorously and universally.   Is an IRB code of ethics necessary? To the extent that an IRB’s policies and procedures   incorporate the contents of a code of ethics, a separate code of ethics is redundant.   However, even in this case, a separate code of ethics can clarify the ethical responsibilities   of the IRB and its members.   This article is not meant to be the last word on the topic of an IRB code of ethics. Rather, it   is intended to stimulate discussion about what constitutes ethical conduct by IRBs, lead to   the adoption of codes of ethics superior to the one proposed here, and promote ethical   conduct by IRBs and their members.