RD239 - State Fiscal Year 2008 Annual Report of the Human Research Review Committee, Department of Rehabilitative Services


Executive Summary:
The Human Research Review Committee (HRRC) reviews applications for all human research activities involving DRS clients and/or employees.(*1) The purpose of the review is to ensure compliance with state and federal requirements for the conduct of research that involves human volunteers. Annually, the HRRC must submit to the Governor, the General Assembly, and the DRS 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 (regulatory oversight not required), Expedited Review (application reviewed and approved by one or more HRRC members) and Full Committee Review (a quorum of members in attendance). Three new applications were reviewed during the State Fiscal Year 2008 and one was approved by Full Committee Review. One study was approved by Exempt Review. DRS entered into a Cooperative Agreement (45 CFR 46.114) with Virginia Commonwealth University for the third study. The HRRC has no evidence suggesting that there have been any significant deviations from study procedures as approved for applications initially approved during State Fiscal Year 2008. The HRRC also received study closure documents for four studies that continued beyond the initial approval period and had received continuing annual review. One other study was withdrawn by the investigators prior to HRRC approval.

During the fiscal year, DRS began the standard regulatory process (Code of Virginia, Sections 2.2-4007 to 4017) to revise the Protection of Participants in Human Research regulations (22 VAC 30-40-10 et seq.). On August 6, 2007 the Notice of Intended Regulatory Action (NOIRA) was published in the Virginia Register to allow 30 days for public comment. There were no public comments during the first stage of the process. As of June 30, 2008 the “Proposed Stage” of the Human Research Regulations had passed review by the Department of Planning and Budget and the Secretary of Health and Human Resources. The regulations are currently pending review by the Governor’s Office. Once approved by the Governor’s Office, the proposed regulations will be published for public comment. Following the 60 days public comment period, the proposed regulations will proceed through the final stage.
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(*1) The regulatory guidance for federally-funded or sponsored human research is provided in 45 CFR 46.