Section 40. Policy

A. Each human research activity, as well as significant changes to approved research proposals, shall be submitted to and approved by a committee composed of representatives of varied backgrounds prior to implementation of the research. The committee shall ensure the competent, complete, and professional review of human research activities conducted, authorized, or proposed to be conducted or authorized by the department, local agencies, facilities, or contractor. The committee shall ensure the participants' rights to privacy are maintained.

B. Every person engaged in the conduct of human research or proposing to conduct human research shall report to an agency having a research review committee, and the human research which he conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in this chapter.

C. Every person or organization engaged in a human research project that requires an allowable variance or other approval related to department regulations must obtain approval for such from the department prior to requesting the committee's review and approval of the proposed research.

D. Prior to the initiation of any human research, each participant or legally authorized representative must be informed in writing of the following:

1. Procedure or procedures to be utilized, their purposes, and any expected discomforts, risks, and benefits;

2. Instruction that the participant may withdraw his consent and discontinue participation in the human research at any time without loss of services or benefits to which the participant is otherwise entitled;

3. Explanation of any costs or benefits which may accrue to the participant or the participant's family;

4. An offer to answer any inquiries by the participant concerning the procedures and use of the results;

5. Statement assuring confidentiality of records and describing the extent to which confidentiality of records identifying the participant will be maintained; and

6. Expected duration of participation.

E. Where the human research activity exposes to risk others not participating, all must give their signed voluntary informed consent.

F. The committee may suspend or terminate research that is in violation of the research protocol.

Historical Notes

Derived from VR615-80-01 § 4, eff. August 11, 1993.

Statutory Authority

§§ 63.2-217 and 63.2-218 of the Code of Virginia.