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
OHRP has posted draft guidance on “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.”
The draft reiterates the distinctions made in the January 2017 Federal Register announcement of the new Common Rule, stating:
It is not the particular field that removes the activity from the definition, but rather that the purpose and design of the particular activity is to focus on specific individuals and not to extend the activity’s findings to other individuals or groups.
Unlike the June 22 video, the draft guidance offers no examples of projects that would or would not be regulated. We are left with a video that offers examples inconsistent with the Federal Register announcement and the official draft guidance from OHRP.
On June 22, OHRP posted a video to YouTube, dated March 2018 and entitled “When Does the Common Rule Apply?,” featuring Misti Ault Anderson, Senior Advisor for Public Health Education at OHRP. The video includes a passage stating that while an oral history interview of “one individual” will no longer be considered research under the new Common Rule, a project about “specific leaders” would still be regulated.
I consider this statement to be at odds with the 18 January 2017 Federal Register announcement of the revised rule. However, Anderson tells me the video is an “education tool,” not official guidance, and that “we will be seeking public comment for consideration before developing the final guidance.”
In a new notice of proposed rulemaking, published in the Federal Register on April 20, HHS and other Common Rule Agencies identify three provisions of the new Common Rule as “burden-reducing.” Among them is the redefinition of research to exclude historical research. Yet the notice gives institutions either three or nine months to implement the reforms.
[“Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period,” 83 Federal Register 17595 (April 20, 2018).
The “burden-reducing” label correctly implies that the corresponding provisions of the current Common Rule are unnecessarily burdensome. Yet rather than reducing the burdens immediately, the new NPRM gives institutions the choice of eliminating them in July 2018 or January 2019.
The notice presents this as a recognition of “entities’ possible inclinations to make all transitions at once.” To be sure, federal agencies seem to favor massive, comprehensive, and infrequent change to incremental improvement, but I wonder if research institutions feel the same. And it’s telling that the notice considers “entities” as the primary stakeholders in the decision. Recall that the 2011 ANPRM aimed at “Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” (Emphasis added.) The new notice does not speculate how investigators might feel about the pace of transition.
The notice also states,
We note that we intend to publish guidance on the carve-outs from the definition of research prior to July 2018, which may also impact an institution’s decision to elect to implement the three burden-reducing provisions or not.
In February 2007, OHRP promised such guidelines “by the end of the year.”
The new Common Rule was supposed to go into effect today, but OHRP has declared a six month delay in the implementation of most of its parts. This apparently includes a delay in the redefinition of research and the liberation of oral history.
The Oral History Review has posted my review of Simon Whitney’s 2016 book, Balanced Ethics Review: A Guide for Institutional Review Board Members. (I think that’s three distinct uses of “review,” right?)
[Zachary M. Schrag, “Balanced Ethics Review: A Guide for Institutional Review Board Members. By Simon N. Whitney,” Oral History Review, accessed May 30, 2017, doi:10.1093/ohr/ohx030.]
I note,
Whitney’s approach is basically utilitarian, arguing that the good research creates outweighs its harms. In this vein, he values social science research as the equivalent of medical research . . but what of research that, like much humanities research and a fair amount of social science, aims only to increase human knowledge?
I conclude:
As Whitney well understands, IRB members face considerable pressure to overregulate. The universities or medical schools in which they work may ask them to review research (including oral history) beyond the scope of regulations, or to protect institutions from lawsuits. They will learn that they themselves are far more likely to be sued for letting one controversial study (like SUPPORT) proceed than for needlessly impairing dozens of less risky projects. And if they do receive training from the dominant institutions, they are likely to hear that “efficiency itself is not a moral imperative or an ethical value” (25). Whitney pushes back against this pressure. His book is well crafted to promote its stated goal: balance.
Oxford University Press asks that I not post a link to a free-access version of the review here, but it does allow me to post that link on my personal website.
It’s been three months since the announcement of the new Common Rule. Some reactions so far:
This winter, the Institutional Review Blog passed two milestones. In December it turned 10 years old, and in January it reported on the largest reform in U.S. human subjects regulations since 1981. This seemed like a good time to archive another batch of postings, so I have deposited a second PDF with the the Mason Archival Repository Service. Now all postings from the start of the blog through the end of January 2017 can be found at http://hdl.handle.net/1920/8642. Many thanks to Wally Grotophorst, Associate University Librarian, George Mason University, for making this possible.
I am less sure about the future of this blog. In ten years I have posted about 445,000 words, a considerable investment of time and effort. I see no reason to formally close the blog, but I may be posting a good deal less frequently as I focus on completing my book about the Philadelphia riots of 1844.
On 19 January 2007, Inside Higher Ed reported the launch of this blog. Here is the kicker from that story:
Schrag said that the problems with IRBs will probably remain for some time. “I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended,” he said. “Perhaps until then, I’m going to have to keep up the blog.”
Ten years later, to the day, the amended regulations are in the Federal Register.
Should I consider piracy?
Inside Higher Ed reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.
[Scott Jaschik, “U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans,” Inside Higher Ed, January 19, 2017.]
[Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]
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