RD170 - Annual Report of the Human Research Review Committee on Human Research Projects


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, 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 (compliance with regulations not required), Expedited Review (application reviewed and approved by one or HRRC members) and Full Committee Review. Three new applications were reviewed during the State Fiscal Year 2007, and two were approved by Full Committee Review. By unanimous vote of the Full Committee, a third application was tabled because the Committee determined that the application materials were not adequate for the review process to take place. Subsequently, the investigator withdrew the application. 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 2007.

The HRRC also reviewed two studies that continued beyond the initial approval period; thus, required annual continuing review. However, one of these studies continued for almost five years beyond the one-year approval authority granted to the HRRC by 22 VAC 30-40-70(G) and 45 CFR 46.109(e). The lapse in continuing HRRC oversight of the research was, in part, associated with the fact that the HRRC was still establishing operating procedures at the time the study was initially approved on January 8, 2001. Also, at the time of initial approval, the research database had not been developed to track research studies and to facilitate ongoing HRRC follow-up with research investigators. By unanimous vote of the Full Committee, this study was closed to enrollment of new volunteers and to any further contact with volunteers ready enrolled in the study. In accordance with 45 CFR 46.1 03(b)(5), a report of continuing noncompliance was filed with the U.S. Department of Health and Human Services, Office for Human Research Protection.

On August 6, 2007, the DRS Notice of Intended Regulatory Action (NOIRA) will he published in the Virginia Register to allow for public comment on revisions to Protection of Participants in Human Research regulations (22 VAC 30-40-10 et seq.). These regulations were revised to ensure that state regulations are in compliance with federal Protections of Human Subjects regulations at 45 CFR 46. Additionally, the revised regulations require that independent living centers and sheltered workshops affiliate with the DRS Human Research Review Committee as intended in the Code of Virginia § 51.5-14.01. The existing regulations gave these two organizations the options to establish their own human research review committee, to affiliate with other independent living centers and sheltered workshops to establish a central human research review committee, or to 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. On August 15, 2005, 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 Federalwide Assurance will expire August 11, 2008.