Disclosure in research ethics

The issue of disclosure of decisions made by research ethics boards (REBs) is worthy of extended debate.¹ The US Food and Drug Administration (FDA) is soliciting public comments concerning the issue of institutional review board (IRB) “shopping” in anticipation of formulating a rule to address this issue.²

Disclosure of REB decisions should be made public through mandatory registration of trials in a publicly accessible register. In the US, for example, trial registration may involve Web-accessable registers such as www.clinicaltrials.gov. This kind of register should contain a hyperlink to a page where REB decisions would be recorded.

If the decision of an REB is one of disapproval, it should provide the reasons for the decision in one or more of the following categories: social and scientific value, scientific validity, fair subject selection, favourable risk–benefit ratio, informed consent and respect for potential and enrolled participants.³ Entries in a category may be limited to a specified number of words.

Accessible information will enable REBs to consider the decisions of other committees at the time of initial or continuing review of clinical trial protocols, and such disclosure will also serve the interests of potential trial participants and the general public. The case for trial registration has been summarized by Tonks.⁴

Howard Mann Program Associate Division of Medical Ethics School of Medicine University of Utah Salt Lake City, Utah