Office for Human Research Protections (OHRP)

Request for Public Comment on OHRP Draft Guidance Document on Engagement of Institutions in Human Subjects Research

Background:

On December 8, 2006, the Office for Human Research Protections (OHRP) announced, in the Federal Register, the availability of a draft guidance document entitled “OHRP Guidance on Engagement of Institutions in Human Subjects Research.” The draft guidance would revise and replace two existing OHRP guidance documents on engagement of institutions in human subjects research: (1) the January 26, 1999 document on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.” To facilitate public review of the draft guidance document, OHRP has developed a table presenting a side-by-side comparison of OHRP’s draft guidance document with the current guidance documents on the engagement of institutions in human subjects research.

The draft guidance document can be accessed at: [HTML][PDF].
The side-by-side comparison table can be accessed at: [PDF].
A copy of the Federal Register notice can be accessed at: [PDF]

OHRP requests that written comments on the revised draft guidance document be submitted by February 6, 2007 to: ENGAGEMENT GUIDANCE COMMENTS, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent to engagementohrp@hhs.gov or via facsimile at 301-402-2071.