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OHRP has posted draft guidance on “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.”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Unlike the June 22 video, the draft guidance offers no examples of projects that would or would not be regulated. We are left with a video that offers examples inconsistent with the Federal Register announcement and the official draft guidance from OHRP.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.”
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