Tuesday, November 24, 2015
Sunday, November 22, 2015
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.
Monday, November 9, 2015
I am sorry to learn of the death of Clifford M. Kuhn, executive director of the Oral History Association. Among his many other contributions to the study of the past, Cliff was concerned with freeing oral historians from inappropriate regulation while championing ethical standards for their work. In recent weeks I had the pleasure to talk with him about our hopes for regulatory reform, and I deeply regret that those conversations cannot continue.
Sunday, November 8, 2015
Simon Whitney, critic of conventional handbooks for IRB members, is about to publish his own. Should be interesting.
[Simon N. Whitney, Balanced Ethics Review: A Guide for Institutional Review Board Members, (Springer, 2015).]
Thursday, November 5, 2015
Though I could not attend the October 20 Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects (Common Rule) Notice of Proposed Rulemaking (NPRM), I’ve now watched the whole thing on YouTube. Much of the day was spent discussing procedures for biospecimens, which is outside the scope of this blog. But I was interested to see Julia Gorey of OHRP reply to questions that had been sent in by two anthropologists, Lise Dobrin, co-author of the American Anthropological Association’s 2011 comment on the ANPRM, and Edward Liebow, the AAA’s executive director. Gorey frankly admitted OHRP’s lack of expertise on ethnography but held out hope that ethnography may be exempt or even excluded under the NPRM’s proposals.
Wednesday, November 4, 2015
Fifteen scholarly organizations, including the American Council of Learned Societies, the American Historical Association, the American Political Science Association, the Oral History Association, and the Organization of American Historians, have signed a letter endorsing the NPRM’s proposed exclusion of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected."
The letter (whose authors kindly consulted me in its early stages) is unequivocal:
We concur with this recommendation of full exclusion of such activities from IRB oversight. It reflects an appreciation that these activities should not be evaluated under frameworks originally designed with the sciences in mind. It recognizes the value and attributes of these forms of scholarship. It eliminates any ambiguity about review, regulation and enforcement, and thus removes an enormous and contentious burden for both scholars and IRBs.
Don’t change a thing!
Tuesday, November 3, 2015
Friday, October 30, 2015
In its response to the 2011 ANPRM, PRIM&R denied that an exclusion for “certain fields of study” was “even worth considering.”
Now, in comments on the NPRM, PRIM&R Executive Director Elisa Hurley writes, “some of the exclusions proposed in the NPRM will likely be widely welcomed, such as the explicit exclusion of journalism, oral history, biography, and historical scholarship activities.”
As Ellen Bresler Rockmore reminds us, passive constructions (“will … be widely welcomed”) can disguise meaning, and that is the case here; is Hurley among those who will welcome the change?
I hope so. But in any case, PRIM&R seems to be finally acknowledging the grievances of historians and journalists and the need for reform.
Thursday, October 22, 2015
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.]
Thursday, September 24, 2015
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?