OHRP seeks comment on draft guidance for reporting adverse events and unanticipated risks

OHRP seeks comment on draft guidance for reporting adverse events and unanticipated risks

The national Office for Human Research Protections (OHRP) is soliciting public comment on a draft guidance document for Institutional Review Boards (IRBs), investigators, research institutions, Department of Health and Human Services (DHHS) agencies that conduct or sponsor human subjects research, and other interested parties, entitled "Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others." The draft guidance can be viewed on the OHRP website at http://www.hhs.gov/ohrp/requests/com101105.html.

Comments should be submitted by January 13, 2006, via email at ohrp@osophs.dhhs.gov. Respondents should include the term <Draft guidance on reporting adverse events> in the subject field. Alternatively, comments may be submitted by snail mail to:

Capt. Michael Carome, M.D.
US Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852