PERIODIC REVIEWS AND SMALL BUSINESS IMPACT REVIEWS
Vol. 41 Iss. 2 - September 09, 2024

TITLE 22. SOCIAL SERVICES

DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES

Report of Findings

Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Department for Aging and Rehabilitative Services (DARS) conducted a periodic review and a small business impact review of 22VAC30-40, Protections of Participants in Human Research, and determined that this regulation should be retained as is. The department is publishing its report of findings dated August 16, 2024, to support this decision.

The Protections of Participants in Human Research regulation (22VAC30-40) establishes protocols to ensure adequate safeguards for the rights and welfare of individuals participating in human subject research. DARS, the Wilson Workforce and Rehabilitation Center (WWRC), the area agencies on aging (AAAs), sheltered workshops (or employment services organizations), and centers for independent living (CILs) that conduct or participate in human subject research are subject to these provisions as required by federal and state law. Universities and other external research organizations that partner with DARS, WWRC, AAAs, sheltered workshops, and CILs in conducting human subject research would also be subject to these provisions. DARS, WWRC, and the agency's affiliated providers conduct human subject research projects that involve older adults and individuals with disabilities, including youth with disabilities. The regulation is clearly written and understandable. The regulation is necessary to comply with § 51.5-132 of the Code of Virginia and to protect the health, welfare, and safety of older adults and individuals with disabilities, including youth with disabilities, who participate in research projects conducted by DARS, WWRC, and the agency's affiliated providers.

DARS has not received any complaints or concerns about the regulation.

Following the promulgation of the federal "Common Rule" in 2018, DARS updated the regulatory chapter to align with federal requirements in 2020. The regulation does not conflict with any federal laws or regulations or state laws. As a result of Chapter 728 of the 2020 Acts of Assembly, the regulation was revised in 2020 to include AAAs under the scope of the regulation.

There is no anticipated economic impact on these entities for this regulation. DARS does not charge fees for Homeless and Housing Resource Center (HHRC) reviews or oversight. Through this regulation, DARS aligns the agency's requirements with those that are expected through the Common Rule for all research conducted using federal funding.

This alignment streamlines the review and approval process for researchers. Further, DARS is often able to defer to institutional review boards within universities as the primary reviewer and approver of human subject research, which minimizes burden and eliminates redundancy for the DARS HRRC as well as for researchers.

Contact Information: Charlotte Arbogast, Senior Policy Analyst, Department for Aging and Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone (804) 662-7093, FAX (804) 662-7663, TDD (800) 464-9950, or email charlotte.arbogast@dars.virginia.gov.