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Former SACHRP Chair Has Pride Over Efforts, But Sees 'Reckoning,' Need to Restore Trust

When the highest-ranking federal committee on human subject protections meets later this month for its first gathering of 2021, it will be led by a new chair who reflects a return to academia. In January, Stephen Rosenfeld, MD, formerly executive review board chair of a commercial institutional review board (IRB) concluded four-and-a-half years as head of the HHS Secretary’s Advisory Committee on Human Research Protections, which followed his three years of service as a SACHRP member.

Douglas Diekema, MD, who became chair in early January following his appointment to SACHRP in July, is a professor in the Department of Pediatrics and an adjunct professor in the Departments of Bioethics & Humanities and Emergency Medicine at the University of Washington School of Medicine. Diekema will lead the 11-member committee[1] that includes officials from three pharmaceutical firms, and from Yale, Duke and Vanderbilt universities, among others.

Rosenfeld’s final meeting as chair was in October. At the time, Jerry Menikoff, director of the HHS Office for Human Research Protections (OHRP) to which SACHRP reports, praised Rosenfeld,[2] saying one of his “incredible strengths” among many was his ability to “bridge divides,” leading to a “very productive period” for SACHRP, despite a move to online meetings and other adjustments due to the pandemic. Now head of the IRB consulting firm Freeport Research Systems LLC, Rosenfeld will remain active with SACHRP as a member of one of its two subcommittees, which he hopes will enable completion of recommendations on ensuring justice in human subjects research.

In an interview with RRC about his tenure on SACHRP, Rosenfeld addressed a variety of topics, including what was left undone, the long-standing complaints about OHRP’s “failure” to issue necessary guidance, the “reckoning” he thinks is coming for a certain type of research, and why it’s vital for SACHRP to urge that systemic injustice be confronted within the research context.

RRC: At the time of your appointment as chair in December 2016, RRCpointed out that you were the first person from a nonacademic background to hold this position.[3] Did that matter at all as your tenure moved forward?

SR: It never bothered me. I never felt like I had to prove anything. I just went blithely along because I felt like I understood things pretty well and could articulate things well.

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