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Secretary's Advisory Committee on Human Research Protections - SACHRP - July 2015 (Day 1)

Tuesday, July 21, 2015, 8:30:00 AM, 8 hours, 30 minutes.

Description: 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 July 2015 meeting will include reports from both subcommittees, including discussion of the following topics: the Newborn Screening Saves Lives Reauthorization Act of 2014; the draft NIH Policy on the Use of a Single IRB for Multi-site Research; the draft FDA guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products”; CLIA and HIPPAA issues surrounding the return of research results; and informed consent. Time is allotted on both days for public

For more information go to http://www.hhs.gov/ohrp/sachrp
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Author: Secretary's Advisory Committee on Human Research Protections, HHS
Runtime: 8 hours, 30 minutes
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Event ID: 16582