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Patient Advocate, 3 With Drug Cos. Among Incoming SACHRP Members

When the highest ranking committee advising the government on human subjects research meets later this month, it will mark the first time this year and will bring together seven new members with four current ones. Three of the new members hail from pharmaceutical firms, which a watchdog organization told RRC is concerning.

The 11-member Secretary’s Advisory Committee on Human Subjects Research Protections (SACHRP) will have a full complement for the first time in a few years when members meet later this month. Typically meeting three times a year, SACHRP’s March 27-28 event could not be held because of fears of a lack of a quorum; some members’ whose terms had expired in October were held over, but no new appointments were made in time (“Vacancies Force Cancelation Of March SACHRP Meeting,” RRC 16, no. 4).

On June 13, the Office for Human Research Protections (OHRP) sent a message to its Listserv announcing the new members. SACHRP’s next meeting is scheduled for July 30-31 to be held outside Washington, D.C. It will be webcast. As of RRC’s deadline, the agenda had not yet been posted.

SACHRP helps the research compliance community by developing recommendations addressing a range of issues such as types of studies that could qualify for exempt and expedited review procedures. Members have been working on strategies to aid with implementing the revised Common Rule. OHRP has been criticized for not acting to formally accept and issue SACHRP’s recommendations, although it does post them online.

The seven members, who mark the first new appointees since 2016, won’t have much time to get up to speed or learn from their longer-serving colleagues. Two more SACHRP members will rotate off later this year and two others in mid-2020, including chair Stephen Rosenfeld, M.D. This means within a year the entire panel will have turned over from October 2018.

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