||SACHRP provides expert advice and recommendations to the Secretary, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects. The committee is composed of 11 appointed voting members, with additional ex-officio members from Common Rule government agencies. SACHRP presently has two working subcommittees, the Subpart A Subcommittee (SAS) and the Subcommittee on Harmonization (SOH). The March 16, 2017 meeting will include reports from both subcommittees, including recommendations concerning the expedited review list, .110, under the new final rule. There will also be continued discussion of two SOH recommendations carried over from the previous SACHRP meeting, one on the Return of Incidental Findings and the other on the FDA Draft Guidance “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” Time is allotted for public comment.
For more information go to http://www.hhs.gov/ohrp/sachrp