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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Revised FAQ Regarding Engagement in Research

Oct 14, 2010 at 10:34am

In the FWA frequently asked questions (FAQs), at http://answers.hhs.gov/ohrp/categories/1563, OHRP has revised the answer to Question #4: When is an institution considered to be "engaged in research"? The revisions include:

  • Adding "obtaining informed consent" as an activity that can make an institution engaged;
  • Removing the statement that pertained to awardee institutions bearing the ultimate responsibility for protecting human subjects, even when all human subjects activities are carried out by other institutions; and
  • Correcting the link at the end of the FAQ to link to the current guidance document.

This FAQ was revised to be consistent with OHRP's October 16, 2008 guidance document on the Engagement of Institutions in Human Subjects Research. Specifically, consistent with OHRP's 2008 engagement guidance document, the FAQ was modified to clarify that an institution is generally considered to be engaged in human subjects research when its employees or agents obtain the informed consent of human subjects. OHRP also removed the statement in the FAQ that pertained to awardee institutions bearing the ultimate responsibility for protecting subjects involved in the research conducted under the award, even when all human subjects activities are carried out by other institutions. OHRP removed this statement to be consistent with OHRP's 2008 engagement guidance, which reflects OHRP's broader goal of directing communication about noncompliance to the institution or IRB most directly involved in any regulatory noncompliance with 45 CFR part 46 as appropriate. For an example of the application of this concept, see OHRP's recent determination letter at: http://www.hhs.gov/ohrp/detrm_letrs/YR10/sep10b.pdf.