RD137 - Annual Report of the Human Research Review Committee on Human Research Projects


Executive Summary:
The Human Research Review Committee (HRRC) must review applications for all human research activities involving DRS clients and/or employees not covered by policies and regulations for the protection of human participants promulgated by any federal government agency. (*1) The purpose of the review is to ensure compliance with state-mandated research guidelines. Annually, DRS must submit to the Governor, the General Assembly, and the Commissioner a report on the human research projects reviewed and approved by the HRRC ("Code of Virginia" Section 51.5-14.01).

There are three types of reviews: Exempt Review, Expedited Review and Full Committee Review. Four new applications were reviewed during the state fiscal year and three were approved by Expedited Review. The fourth application was later withdrawn by the investigator before a review decision could be made. The HRRC also reviewed seven studies that continued beyond the initial approval period. The HRRC has no evidence suggesting that there have been any significant deviations from study procedures as approved for either new studies or studies that continued beyond the initial one-year approval.

During State Fiscal Year 2006, the Office for Human Research Protections (OHRP), United States Department of Health and Human Services (HHS) approved the DRS application to conduct federally-funded or sponsored research in accordance with the Code of Federal Regulations (CFR) 45 CFR 46. If not renewed, this Federal wide Assurance will expire on August 11, 2008.

Also during State Fiscal Year 2006, DRS requested that Centers for Independent Living (CILs) and Employment Services Organizations (ESOs) provide updated information about which of the three options they elected to satisfy the requirement for designation of a human research review committee. Specifically, CILs and ESOs were asked to do one of the following:1) establish their own human research review committee, 2) collaborate with one or more other CIL and/or ESO covered by the regulations (22 VAC 30-40-10 et seq.) to establish a human research review committee, or 3) affiliate with the DRS Human Research Review Committee.
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(*1) The regulatory guidance for federally-funded or sponsored human research is provided in 45 CFR 46.