On November 9, I will join other scholars to discuss the revised Common Rule at a one-day conference hosted by Seton Hall University: Reimagining Human Subject Protection for the 21st Century: A Critical Assessment of the Revised Common Rule.
The agenda is online at https://law.shu.edu/docsnoncommonspot/images/events/human-subject-agenda.pdf
This morning sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects, effective 19 January 2018. The final rule preserves and clarifies the NPRM’s deregulation of oral history. This is a great victory for freedom of speech and for historical research.
Patricia Aufderheide, University Professor of Communication Studies at American University, reports her satisfaction with the IRB at that institution. It’s great to hear some good news, and Aufderheide’s essay points to the importance of having the right people in positions of power. But it also raises questions about how good and how replicable AU’s experience is.
[Patricia Aufderheide, “Does This Have to Go Through the IRB?,” Chronicle of Higher Education, August 17, 2016.]
In her contribution to the PS symposium, Melissa Michelson argues that “real-world practitioners” will often know more about relevant ethics and law than will the members of an IRB.
[Melissa R. Michelson, “The Risk of Over-Reliance on the Institutional Review Board: An Approved Project Is Not Always an Ethical Project,” PS: Political Science & Politics 49, no. 02 (April 2016): 299–303, doi:10.1017/S104909651600024X.]
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.
What do we know about interview research under the NPRM?
Whatever its final provisions, the new Common Rule seems bound to be much harder to follow than, say, Canada’s TCPS2. The proposed rule is full of cross references from one section to the next, and often to other documents, such as Subpart D or the Belmont Report. This makes it hard to figure out what it says about any given form of research.
Here’s what I’ve been able to figure out about one form: interview research. My sense is that the NPRM proposes to eliminate IRB review for the vast majority of conversations between consenting adults, but it may unintentionally impose review on projects that do not merit it.
Virignia universities, including the University of Virginia, Virginia Tech, and Virginia Commonwealth University, want to reform Virginia’s human subjects laws, which in theory impose IRB requirements on all research in the state, even constitutionally protected speech like surveys conducted by news organizations and political polling firms.
[Derek Quizon, “New UVa Rector Discourages Post-Vote Dissent, Use of Email,” Richmond Times-Dispatch, August 17, 2015.]
The NPRM cites 42 U.S.C. 289 as its statutory authority, but it does not seem to care much about following the language of the statute.
In an interview about his new book, The Censor’s Hand: The Misregulation of Human-Subject Research, law professor Carl Schneider charges that IRB abuses are inherent to the design of the system.
[Scott Jaschik, “‘The Censor’s Hand’,” Inside Higher Ed, June 3, 2015.]
Contrary to the self-aggrandizing story bioethicists like to tell about how IRBs arose out of concern for human subjects of research, Stark shows that, when you dig into this history, it is lawyers all the way down . . . She argues that IRB work was decentralized not to make it more ethical, but to protect the NIH from lawsuits. Stark convincingly concludes that IRBs today do not primarily enact ethical principles; they manage procedures.
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