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Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs

July 2, 2008

Background:

The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments from affected entities and individuals about (a) whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research, or (b) whether HHS should develop a regulation requiring the implementation of such training and education programs. This request for information and comment stems from the 1998 report from the HHS Office of Inspector General (OIG) recommending that Federal requirements be enacted to help ensure that investigators and institutional review board (IRB) members be adequately educated about, and sensitized to, human subjects protections. More recently, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended that OHRP require institutions to ensure that initial and continuing training is provided for IRB members and staff, investigators, and certain institutional officials. The implementation of such training and education programs might help to ensure that individuals involved in the conduct or review of human subjects research at institutions holding OHRP-approved Federalwide Assurances (FWAs) understand and meet their regulatory responsibilities for protecting human subjects.

Submit written or electronic comments by September 29, 2008. Comments may be submitted by any of the following methods: (1) E-mail: humansubjectstraining@hhs.gov. Include “Human Subjects Protection Training and Education” in the subject line; (2) Fax: 301-402-2071; (3) Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Comments received within the public comment period, including any personal information, will be make available to the public upon request. The notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2008-07-01/html/E8-14917.htm or http://www.hhs.gov/ohrp/documents/fedreg20080701.pdf.

FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov