Section 60. Composition of the HRRC

A. The HRRC shall have at least five members, appointed by the commissioner, with varying backgrounds to promote complete and adequate review of research projects commonly conducted by covered entities. The HRRC shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural background, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research projects, the HRRC shall be able to ascertain the acceptability of proposed research in terms of the department's commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. If the HRRC regularly reviews research that involves a vulnerable category of subjects, such as children, pregnant women, or persons with mental disabilities, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. Additional membership requirements may be imposed on the HRRC by 34 CFR 350.4(c) and 356.3(c) for research sponsored by the National Institute on Disability and Rehabilitation Research. When minors with disabilities or persons with mental disabilities are purposefully included as research subjects, the HRRC's membership must include at least one person who is primarily concerned with the welfare of these research subjects.

B. Every nondiscriminatory effort will be made to ensure that the HRRC does not consist entirely of men or entirely of women, including the department's consideration of qualified persons of both sexes, so long as no selection is made to the HRRC on the basis of gender. The HRRC may not consist entirely of members of one profession.

C. The HRRC shall include:

1. At least one member whose primary concerns are in nonscientific areas;

2. At least one member who is not otherwise affiliated with any covered entity and who is not part of the immediate family of a person who is affiliated with the covered entity; and

3. At least one member whose primary concerns are in the scientific areas.

D. The HRRC shall not have a member participate in the HRRC's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the HRRC. The HRRC has responsibility for determining whether a member has a conflicting interest. The HRRC member shall be replaced in the case of conflicting interest resulting in a decrease of the HRRC below five members.

E. The HRRC may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the HRRC. These individuals may not vote.

F. A quorum of the HRRC shall consist of a majority of its members including at least one member whose primary concerns are in nonscientific areas. Except when exempt or expedited review procedures are used, proposed research shall be reviewed at convened meetings at which a majority of members is present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

G. The HRRC and the department shall establish procedures and rules of operation necessary to fulfill the requirements of these regulations.

Historical Notes

Derived from Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009.

Statutory Authority

§§ 51.5-131 and 51.5-132 of the Code of Virginia.