Department for Aging and Rehabilitative Services

 

GDForum ID: 2596

Description of Proposed Guidance Document Changes

As mandated by federal law and regulation (45 CFR Part 46 and 34 CFR Part 97) and state law (see § 51.5-132 of the Code of Virginia), the Protections of Participants in Human Research regulation (22VAC30-40) establishes protocols to approve research proposals involving the Department for Aging and Rehabilitative Services (DARS), including Wilson Workforce and Rehabilitation Center (WWRC), and DARS’ affiliated providers, specifically the area agencies on aging (AAAs), sheltered workshops (i.e., employment services organizations or ESOs) and centers for independent living (CILs). These required protocols ensure adequate safeguards for the rights and welfare of individuals participating in human subject research and ensure such safeguards are consistent with federal requirements and state laws. Last fiscal year, the DARS Human Research Review Committee (HRRC) reviewed nine research projects, of which one was approved, four were amended or continued, and the remaining four were completed. During fiscal year 2022-23, the HRRC reviewed eleven projects, of which three were approved, four were amended or continued, and four were completed. The purpose of this guidance document update is to clarify that in situations when a joint review arrangement is not possible for a cooperative research project, the covered entity (DARS, WWRC, AAAs, sheltered workshops or CILs) may submit to the DARS HRRC a research application prepared for the other IRB institution and the DARS HRRC will follow the applicable review protocol to determine if it complies with DARS’ research requirements. Providing this option, streamlines the review process by eliminating the need for the covered entity to prepare two separate and different applications when participating in a cooperative research project.

 

Guidance Document(s) for this Comment Forum

Document ID	Document Title	Current Document	Proposed Document
4531	Human Research Procedures Manual	Document	Proposed Document	Posted with original changes on 12/19/2024

 

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