12VAC5-20 Regulations for the Conduct of Human Research

NOTICES OF INTENDED REGULATORY ACTION

Vol. 29 Iss. 3 - October 08, 2012

TITLE 12. HEALTH

STATE BOARD OF HEALTH

Chapter 20

Notice of Intended Regulatory Action

Notice is hereby given in accordance with § 2.2-4007.01 of the Code of Virginia that the State Board of Health intends to consider amending 12VAC5-20, Regulations for the Conduct of Human Research. The purpose of the proposed action is to amend the regulations for clarity, efficiency, and effectiveness relating to (i) the elements that each review committee shall consider in conducting a review of a proposed human research project; (ii) the expedited review process, including the committee's authority to suspend or terminate approval of research; (iii) the informed consent process; and (iv) the elimination of references to repealed Code of Virginia sections and the addition of a reference to the Virginia Immunization Information System. The proposed amendments are the result of a completed periodic review.

The agency does not intend to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: § 32.1-12.1 of the Code of Virginia.

Public Comment Deadline: November 7, 2012.

Agency Contact: Joseph Hilbert, Director of Governmental and Regulatory Affairs, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone [phone], FAX [phone], or email [e-mail].

VA.R. Doc. No. R13-3401; Filed September 17, 2012, 5:15 p.m.