Office for Human Research Protections (OHRP)

Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity

Background:

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research, as announced in Federal Register Vol. 72, No.171, page 50966-50970, dated September 5, 2007. This request for information and comments stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission entitled "Research Involving Persons With Mental Disorders That May Affect Decision-making Capacity" (December 1998), and from subsequent recommendations by the National Human Research Protections Advisory Committee and the current work of the Secretary’s Advisory Committee for Human Research Protections.

Submit written or electronic information and comments by December 4, 2007. Written comments may be sent to REQUEST FOR INFORMATION ON RESEARCH THAT INVOLVES ADULT INDIVIDUALS WITH IMPAIRED DECISION-MAKING CAPACITY, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to impairedcapacityohrp@hhs.gov, or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request. The notice can be accessed at: http://archive.hhs.gov/ohrp/documents/20070905.htm or http://archive.hhs.gov/ohrp/documents/20070905.pdf.

Notice! The Office for Human Research Protections (OHRP), Office of Public Health and Science, is extending the public comment period for the previously announced REQUEST FOR INFORMATION ON RESEARCH THAT INVOLVES ADULT INDIVIDUALS WITH IMPAIRED DECISION-MAKING CAPACITY. Written or electronic information and comments should be received by January 14, 2008.