Office for Human Research Protections (OHRP)
Secretary's Advisory Committee on Human Research Protections (SACHRP)
Each SACHRP subcommittee is composed of experts in their respective fields. Based on their review and assessment of topics selected by the full committee, the subcommittee develops recommendations for consideration by SACHRP. The full committee then votes on all final recommendations and forwards them to the Secretary of Health and Human Services.
Currently Active Subcommittees
Subcommittee on Harmonization
- Charge: The Subcommittee will identify and prioritize areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination. The Subcommittee will then develop recommendations, for consideration and possible adoption by SACHRP, to harmonize and simplify these guidelines and regulations. The goal of this subcommittee effort is to reduce unnecessary burdens on research efforts, thus resulting in better allocation of research resources and promoting the safety and welfare of human subjects.
Subcommittee on Federal Policy for the Protection of Human Subjects (Subpart A)
- Charge: To review and assess all provisions of subpart A of 45 CFR part 46 and relevant OHRP guidance documents. Based on its review and assessment, the Subcommittee will develop recommendations for consideration by SACHRP on the following topics and the goals of enhancing protection of human subjects and of reducing regulatory burdens that do not contribute to the protection of human subjects: (1) recommendations on the interpretation of specific Subpart A provisions; (2) recommendations for the development of new, or modification of existing OHRP guidance; and (3) recommendations regarding possible revisions to subpart A.
Subcommittee on Inclusion of Individuals with Impaired Decision-Making in Research (SIIIDR)
- Charge: The Subcommittee will develop recommendations for consideration by SACHRP about whether guidance and/or additional regulations are needed for research involving individuals with impaired decision-making capacity. In making its assessment, the Subcommittee will review the relevant provisions of subpart A, 45 CFR part 46, including the provisions at 45 CFR 46.111(b) (and 21 CFR 56.111(b) for FDA), and will seek additional information to formulate its decision as it deems necessary. The Subcommittee will develop either one or both of the following products, depending on its conclusions: (1) recommendations on the interpretation of specific Subpart A provisions that will enhance protections for this population; and (2) recommendations for a new subpart under 45 CFR part 46 (and FDA's human subject protection regulations) that would provide additional regulatory protections for this population.
Subcommittee on Research Involving Children (Subpart D)
- Charge: Provide recommendations for consideration by SACHRP on interpretations of the requirements of 46.404, 46.405, and 46.406 under Subpart D in order to help ensure that children who participate in research are neither under protected, nor overprotected. This Subcommittee submitted final recommendations to SACHRP at its July 31, 2006 meeting.
Subcommittee on Research Involving Prisoners (Subpart C)
- Charge: To provide recommendations for guidance on the current Subpart C; and to consider whether or not Subpart C is adequate; if not, provide recommendations on how Subpart C should be revised. This Subcommittee completed its work with a final report that was submitted to and approved by SACHRP at its April 2005 meeting.
Subcommittee on Accreditation
- Charge: The HRPP Accreditation Working Group should consider the following: certification of HRPP accreditation organizations; incentives that could/should be in place to motivate organizations to achieve HRPP accreditation and potential impact of accreditation. The subcommittee completed its work and submitted recommendations to SACHRP during their March 2004 meeting.