Risk Assessment as a Paradox: When Actions of an IRB Become Incompatible with Ethical Principles

Abstract

As anecdotal evidence mounts up of Institutional Review Boards becoming an impediment to research, I share a personal experience in this article to argue how the conduct of an Institutional Review Board was incompatible with a number of ethical principles such as Respect for Persons, Deception, Informed Consent, and Justice. I conclude by promoting Evidence-Based Ethical Problem Solving to facilitate and enhance risk assessments through empirical evidence.

Keywords:

• Institutional Review Boards
• Ethics Committees
• ethical risk assessment
• ethical principles
• Evidence-Based Ethical Problem Solving

ACKNOWLEDGMENTS

I would like to thank the anonymous reviewers and those present during my talk at the CAPPE conference for their useful comments on this article.

Notes

Note from the editor: The editor has authenticated the excerpts included in this commentary.

1. Note that the IRB under discussion is not an IRB based at The University of Edinburgh.

2. The article is in fact based on a talk I gave at the Centre for Applied Philosophy, Politics, and Ethics (CAPPE) Annual Conference, Brighton, UK, September 2010, albeit revised.

3. First, this correspondence was not claimed to be confidential. Second, in order to hold IRBs accountable for the decisions they make and their underlying reasoning, IRB communication needs to be transparent.

4. Given the implications of sexual violence on health and health services (see, for example, Resnick et al., 2000) empirical evidence on the topic is crucial for addressing population health as well as public resources.