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Request for Public Comment on OHRP Draft Guidance Document on Human Subjects Research

Comparison Table: OHRP Draft Guidance Versus 1999 Guidance Documents (PDF)

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Overview
A number of AABB members are engaged in ongoing research in the transfusion medicine and cellular therapies field. Any research being conducted or supported by the U.S. Department of Health and Human Services (HHS) must follow specific guidelines concerning the use of human subjects, intervention and private information.

Recent Actions

12/8/06
The HHS Office for Human Research Protections (OHRP) announces the availability of a draft guidance document, “OHRP Guidance on Engagement of Institutions in Human Subjects Research.” The draft guidance would revise and replace two existing OHRP guidance documents on engagement of institutions in human subjects research: the “Engagement of Institutions in Research” document from Jan. 26, 1999, and the “Engagement of Pharmaceutical Companies in HHS-Supported Research” document from Dec. 23, 1999. Public comments are due Feb. 6, 2007.

Last modified on 3/6/2008 12:27:09 PM
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