Wednesday, July 2, 2008

OHRP Seeks Comment on Training and Education Programs

Rob Townsend kindly alerted me to the July 1 announcement in the Federal Register that OHRP is seeking comments on its requirements for human subjects training for investigators and IRB members. The summary follows; the full text for the announcement is online at The deadline for comments is September 29.

[Federal Register: July 1, 2008 (Volume 73, Number 127)] [Notices] [Page 37460-37463] From the Federal Register Online via GPO Access [] [DOCID:fr01jy08-43] -----------------------------------------------------------------------
Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office for Human Research Protections.

ACTION: Notice.


SUMMARY: 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.

DATES: Submit written or electronic comments by September 29, 2008.

ADDRESSES: You may submit comments by any of the following methods: E-mail: Include ``Human Subjects Protection Training and Education'' in the subject line. Fax: 301-402-2071. 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 made available to the public upon request.

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

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