The NPRM proposes “to explicitly exclude oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information or biospecimens is collected.” Not listed is another scholarly discipline that also focuses on specific individuals: folklore. Why?
Thursday, September 24, 2015
Writing in the Journal of Academic Freedom, law student James Nichols presents Canada’s TCPS2 as a model of balance “that promotes intuitive and promising research without sacrificing human integrity and protection.” However, his conclusion is largely speculative, since we still lack studies of how the document is working in practice.
[James Nichols, “The Canadian Model: A Potential Solution to Institutional Review Board Overreach,” Journal of Academic Freedom 6 (2015)]
Sunday, September 20, 2015
Two scholars from the University of South Africa claim that more than one in four articles they sampled in two journals of public administration involved “research of a more than minimal risk level.” This claim appears to be based on a misunderstanding of U.S. regulations.
[Jacobus S. Wessels and Retha G. Visagie, “The Eligibility of Public Administration Research for Ethics Review: A Case Study of Two International Peer-Reviewed Journals,” International Review of Administrative Sciences, September 3, 2015, 0020852315585949, doi:10.1177/0020852315585949.]
Friday, September 18, 2015
Friday, September 11, 2015
While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.
[This post will be cross-posted to the Petrie-Flom Center's Bill of Health, which is conducting an online NPRM Symposium.]
Friday, September 4, 2015
The notice of proposed rulemaking (NPRM) promises long-sought relief for historians, journalists, and biographers. For these groups, the goal will be to ensure that the proposed rules are enacted as currently written.
[This post has been cross-posted to the Petrie-Flom Center's Bill of Health, which is conducting an online NPRM Symposium.]
11 September 2015: See update at the bottom of this post.
Thursday, September 3, 2015
Just in time for the NPRM comment period, Society has published my review of Robert Klitzman’s book, The Ethics Police?: The Struggle to Make Human Research Safe (New York: Oxford University Press, 2015). I note that “By offering the subjective worldview of IRB members, Klitzman shows how good intentions combine with ethical ineptitude to produce arbitrary decisions.”
Per my agreement with Springer, what follows is the accepted manuscript of the review. The final publication is available at Springer via http://dx.doi.org/10.1007/s12115–015–9935-x.
Wednesday, September 2, 2015
The long awaited Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects, released today, suggests the complete deregulation of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.”
In the coming 90-day comment period, historians will need to insist that this remains an unqualified exclusion. Still, despite this last peril, we have much to celebrate.