Virginia Regulatory Town Hall
Agency
Department for Aging and Rehabilitative Services
Board
Department for Aging and Rehabilitative Services

General Notice
Small Business Impact Analysis for 22 VAC 30-40 Protection of Participants in Human Research
Date Posted: 10/17/2011
Expiration Date: 12/7/2011
Submitted to Registrar for publication: YES
No comment forum defined for this notice.

Pursuant to § 2.2-4007.1 E and F of the Code of Virginia, the Department of Rehabilitative Services has conducted a review on 22 VAC 30-40 Protection of Participants in Human Research to determine whether the regulation should be continued without change, amended, or repealed, consistent with the stated objectives of applicable law, to minimize the economic impact of regulations on small businesses.   A public notice of this was review was issued, but no public comment was received by the department. This regulation provides a basis for the Department of Rehabilitative Services to oversee human subjects research involving the Department of Rehabilitative Services, the Woodrow Wilson Rehabilitation Center, sheltered workshops, and independent living centers.  The regulation is needed to protect the health and welfare of humans that receive services from the stated entities who also may become subjects in human research. Although federal regulations exist to provide these protections, this regulation is required to ensure that oversight for these protections is provided at the state level.   The regulation is written to ensure consistency with 45 CFR 46.101 et seq.  The existing regulation was last reviewed in July 2009.  Technology has resulted in existing research data being easily accessible by those who intend to conduct secondary data research. In addition, economic conditions make such data that can be acquired inexpensively more desirable to researchers.  Research is typically conducted by those in academic, medical, or government settings.  Small businesses do not usually engage in research using human subjects from the Department of Rehabilitative Services, the Woodrow Wilson Rehabilitation Center, sheltered workshops, and independent living centers.  However, if a small business is interested in conducting such research, this regulation provides a protocol for the small business to follow.  Thus, this regulations remains an important process in the protecting the welfare of human subjects.


Contact Information
Name / Title: Vanessa S. Rakestraw  / Policy Analyst
Address: 8004 Franklin Farms Drive
Richmond, 23229
Email Address: Vanessa.Rakestraw@drs.virginia.gov
Telephone: (804)662-7612    FAX: (804)662-7663    TDD: (800)464-9950