Perhaps 2016 will be the year when OHRP makes good on its 2007 promise to “give more guidance on how to make the decision on what is research and what is not,” in the form of a promulgated revision to the Common Rule. If so, Happy New Year, OHRP!
Wth these hopes, I have submitted my own comments on the NPRM. I have posted a copy of the PDF I submitted, and below is a web version with links.
In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.
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.
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.
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.
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