Office for Human Research Protections (OHRP)

Request for Public Comment on OHRP's Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others

Background: The Office for Human Research Protections (OHRP) is soliciting public comment on a draft guidance document for Institutional Review Boards (IRBs), investigators, research institutions, Department of Health and Human Services (HHS) agencies that conduct or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 The draft guidance can be viewed by clicking on the links below at the bottom of this page.

For many years the IRB and research communities have requested that federal regulatory agencies provide harmonized guidelines and requirements for reporting adverse events in the context of research involving human subjects. Most recently, the Secretary's Advisory Committee on Human Subjects Protections (SACHRP) at its March 2004 meeting approved a resolution recommending to HHS that OHRP and the Food and Drug Administration (FDA) promptly issue clear and consistent joint guidance on IRB review of both internal and external adverse event reports that will best serve to protect human subjects and effectively reduce regulatory burden.

As an initial step in responding to SACHRP's recommendation, OHRP has developed draft guidance regarding the reporting and handling of adverse events and unanticipated problems involving risks to subjects and others. In preparing this draft guidance, OHRP received comments from members of the Federal Adverse Events Task Force (FAET). FAET was formed in the wake of SACHRP's March 2004 resolution and includes representatives from the National Institutes of Health (Chair), the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, FDA, OHRP, the Department of Defense, and the Department of Veterans Affairs, all of which are ex officio members of SACHRP.

OHRP expects that its guidance on this topic will be the first of many initiatives in a cooperative effort by the major federal agencies that regulate, conduct, or sponsor human subjects research to develop a comprehensive and harmonized approach to the reporting and handling of adverse events and unanticipated problems. The ultimate goal of these efforts is to ensure that the reporting and analysis of adverse events and unanticipated problems occur in a timely, meaningful way so that human subjects can be protected from avoidable harms. OHRP anticipates that its guidance may evolve in conjunction with future initiatives of FAET and its member agencies. In particular, OHRP will continue to work with FDA to ensure that FDA and OHRP guidance regarding the reporting and handling of adverse events and unanticipated problems are harmonized to the maximum extent possible.

The draft guidance is consistent with OHRP's long-standing views regarding the reporting and handling of adverse events under the requirements of the HHS regulations for the protection of human subjects (45 CFR part 46), as articulated by OHRP staff in multiple venues. The draft guidance does not represent any change in OHRP's position on this topic.

Comments should be submitted by 1/13/06 to OHRP by email at ohrp@osophs.dhhs.gov. Please include the term "Draft guidance on reporting adverse events" in the subject field. Alternatively, comments may be submitted by mail to:

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

October 11, 2005 Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others [HTML | PDF]