The Ethical Imperialism of the NAS

The National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements has released the second part of its report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The new part includes a chapter on “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” While presenting valid critiques of the NRPM, the chapter ignores the voices of scholars in social sciences and the humanities. Its proposals are unlikely to be adopted, and if they were they would continue the half-century history of marginalizing those disciplines.

My NPRM Response. Draft 1.

Though the deadline for commenting on the NPRM has been extended until January 6, I post here a draft of my comments in the hopes that they may help others craft theirs and send me feedback on mine.

NRC Report: Where's the Freedom?

My biggest disappointment with the new NRC report is its silence on the question of academic and personal freedom.

NRC Report: Assess Risk Empirically

One theme running throughout the NRC report is the need to replace the worthless gut reactions decried by Ezekiel Emanuel with a system that would base its judgments on the latest empirical evidence. But the report does not present a clear set of reforms that would effect this change without scrapping the current system of local IRB review.

NRC Report: Liberate Oral History

For historians, the most exciting passage in the new National Research Council report—the passage that had me cheering out loud—is the recommendation that the Common Rule be amended to explicitly exclude historical interviews, as well as other forms of information gathering that do not constitute “human-subjects research specifically in the biomedical, behavioral, and social sciences.”

National Research Council Issues IRB Report

The National Research Council has issued its long awaited report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.

[National Research Council. Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, D.C.: The National Academies Press, 2014.]

Report from the National Academies Workshop

Last week I attended the Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop sponsored by the National Academies.

I live-tweeted the event on my @IRBblog account, and I have collected those tweets on Storify.

What follows are what I consider some of the key messages from selected presenters. The statements following each name represent my summary of the remarks, not necessarily a quotation or paraphrase.

National Academies Post Workshop Agenda

The National Academies has posted the agenda for their Workshop on Proposed Revisions to the Common Rule in Relation to Behavioral and Social Sciences, to be held tomorrow and Friday in Washington, D.C.

I plan to attend and to post comments to this blog. If I can establish WiFi, I may also live tweet at @IRBblog.

National Academies Run Workshops on Common Rule Revisions

The National Academies are running workshops on "Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences." I was unaware of the first two meetings in January, but I hope to attend the upcoming meetings on March 21 and 22.