Section 70. Review and approval process

A. Prior to the initiation of a human research project, a description of the proposed human research project shall be submitted to the department committee for review and approval, except for projects which are exempt or those reviewed by another organization's committee. The description shall include a statement of the purpose of the proposed project and justification of it, the criteria for inclusion of a participant in the research project, a description of what will be done to the participants, and the proposed informed consent statement.

B. No human research shall be conducted or authorized by the department unless the department committee has reviewed and approved the proposed human research project giving consideration to:

1. The necessity and utility of the research;

2. The adequacy of the description of potential benefits and risks involved and the appropriateness of the research methodology;

3. Whether the research presents more than a minimal risk to the subject;

4. Whether the risks to the participants are outweighed by the potential benefits to them;

5. Whether the rights and welfare of the participants involved are adequately protected;

6. Whether the voluntary informed consent is obtained by methods (including the written consent form) that are adequate and appropriate considering the participants' educational level and language of greatest fluency;

7. Whether the people proposing to supervise or conduct the research are competent and qualified; and

8. Whether the criteria for selection of participants is equitable.

C. Except for the research referenced in 22VAC40-890-80, the committee shall consider research proposals within 30 days after submission to the committee. In order for the research to be approved, it shall receive the approval of a majority of those members present at a meeting in which a quorum exists. The committee shall notify investigators in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure committee approval.

D. During the committee review of research projects, no personal identifiers of present or potential participants shall be presented or discussed.

E. The committee shall require a written description of the procedure to be followed when a participant has a complaint about a research project in which he is participating or has participated. All complaints shall be referred to the committee to determine if there has been a violation of the established protocol.

F. The committee shall require reports from approved research projects at least annually to ensure conformity with the approved proposal. The frequency of such reports shall be consistent with the nature and degree of risk of each research project. The committee shall also require a report from the research project at the conclusion of the project.

Historical Notes

Derived from VR615-80-01 § 7, eff. August 11, 1993.

Statutory Authority

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