HHS Office of Human Research Protections Finalizes Documentation on Engagement of Human Subjects in Research

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The HHS Office of Human Research Protections (OHRP) has posted on its Web site a finalized guidance document entitled, “Guidance on Engagement of Institutions in Human Subjects Research.”  The public comments submitted on the draft document were very helpful as this guidance document. The finalized guidance is on the OHRP Web site.  This new guidance document replaces two prior OHRP guidance documents on the engagement of institutions in human subjects research:  (1) the January 26, 1999, document on “Engagement of Institutions in Research,” and (2) the December 23, 1999, document on “Engagement of Pharmaceutical Companies in HHS Supported Research.”   The Federal Register notice announcing the
availability of this new guidance document can be found at http://edocket.access.gpo.gov/2008/E8-25177.htm or http://edocket.access.gpo.gov/2008/pdf/E8-25177.pdf.

OHRP has also posted a revised version of the “Guidance on Research Involving Coded Private Information or Biological Specimens” that includes minor changes that were made for consistency with the new guidance document on the engagement of institutions in human subjects research.