Documents/HHSFACA9492/1: Recommandations/1: Make, Accept, Implement/Indicator:2

Indicator: 2

[Outcome]

Measurements in/of Recommendations Fully Accepted

Relationships:

Department of Health and Human Services - Narrower_Than

Other Information:

Secretary's Advisory Committee on Human Research Protections

Type Target Actual
StartDate 2010-10-01 2010-10-01
EndDate 2011-09-30 2011-09-30
Percentage n/a 11
Description For a variety of its own reasons not applicable to the Committee, the agency may implement all/most of the recommendations, but few times recommendations are not implemented. Among the fully implemented recommendations were recommendations pertaining to: IRB acountability, the formation of a subcommittee to examine harmonization of Federal regulations and guidance affecting human subjejcts research; the addition of ex-officio representation from the Office of Civil Rights; the 45 CFR 46.407 review process for research involving children as subjects; the accreditation of human research protection programs; the interpretation of 45 CFR subpart C (protections for prisoners involved as subjects in human subjects research); a recommendation that a workshop be convened focusing issues pertaining to central IRB review; various FAQs on parental permission, child assent, and documentation of informed consent; IRB accoutability; and continuing review.