Additional Information — and Potential Changes for the Second Edition

I am grateful to readers who let me know where the manual is incomplete or in error. My hope is, in time, to collect enough material to justify a new edition. For now, this page will serve as a resource to help you look beyond the manual’s limitations.


Charles Lidz W. et al, “The Participation of Community Members on Medical Institutional Review Boards,” Journal of Empirical Research on Human Research Ethics 7:1-6 (2012). DOI: 10.1525/jer.2012.7.1.1.

This carefully-done survey provides an in-depth look at the roles that community members typically play. The authors conclude that they “did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.” If you are a community member, or an IRB chair who wants to help your community members function effectively, the paper is worth a closer read.

Candilis, Philip J. et al, “The Silent Majority: Who Speaks at IRB Meetings?” IRB: Ethics & Human Research 34(4):15-20 (2012). Stable URL:

Candilis and his coauthors analyzed discussions of the IRBs at 10 academic medical centers. They found that many IRB members contribute little or nothing to the discussion, and argue that “many IRBs may simply be larger than they need to be.” They suggest that smaller IRBs can conduct review that is as effective, and more efficient, than larger panels. Food for thought for IRB chairs and for institutional officials.

Lidz, Charles W. et al, “How Closely to Institutional Review Boards Follow the Common Rule?” Academic Medicine 87:969-974 (2012). DOI: 10.1097/ACM.0b013e3182575e2e.

This study of 20 IRB meetings at 10 academic medical centers found a surprising failure to discuss elements that are specified in the regulations: “These findings suggest that essential elements of human subjects protection are not implemented uniformly across IRBs.” This paper might provoke your IRB to ask: are you doing your job?