SACHRP to Meet in Person Next Week
For the first time since the start of the pandemic, the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold an in-person two-day meeting next week. As has been its policy, the meeting will also be webcast. On the agenda for July 20 is a “discussion of the impact of social media use by research subjects,” according to a notice in the July 1 Federal Register. SACHRP will then conduct a “final review of draft recommendations on the ethical and regulatory considerations for the use of artificial intelligence in human subjects research, and commentary on the Request for Public Comments on DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data.”
On July 21, SACHRP will consider “current HHS policy of engagement and the interpretation of HHS support” in 45 C.F.R. § 46, and review draft guidance on the use of a single institution review board of record for cooperative research. The committee may also discuss unfinished topics from the first day. On the issue of engagement, the Council on Governmental Relations (COGR) on July 8 urged SACHRP to take action to clarify this concept, saying “the time is right” to consider “tightening the focus of the ‘engagement’ standard to cases in which a subrecipient’s filing of FWA [federalwide assurance] is truly necessary for protection of human subjects.” COGR called for an exception to the definition of engagement “for parties who do not play a ‘key role’ in designing/conducting the research or analyzing its results and whose ‘participation in the research is so substantively similar to its regular activities, or otherwise of such a nature, that [the participation] presents no significantly heightened risks to subjects.’”