Administrative Code

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Virginia Administrative Code
Title 12. Health
Agency 35. Department of Behavioral Health And Developmental Services
Chapter 180. Regulations to Ensure the Protection of Subjects in Human Research

12VAC35-180-60. Composition of research review committees.

A. Each research review committee shall have at least five members, appointed by the head of the institution or agency, with varying backgrounds to ensure the competent, complete, and professional review of human research activities commonly conducted by the institution or agency. The committee shall be sufficiently qualified through the maturity, experience, and diversity of its members, including consideration of race, gender, and cultural background, to promote respect for its advice and counsel in safeguarding the rights and welfare of individuals who are the subjects of human research. In addition to possessing the professional competence necessary to review specific human research activities, the committee must be able to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. If a committee regularly reviews human research that has an impact on individuals who are institutionalized or are otherwise vulnerable, including individuals who reside in state facilities, the committee shall have in its membership one or more persons who are primarily concerned with the welfare of these individuals and who have appropriate experience to serve in that capacity.

B. No committee shall consist entirely of members of one profession, and at least one member shall be a person whose primary concerns are in nonscientific areas (e.g., lawyers, ethicists, members of the clergy).

C. Each committee shall include at least one member who is not otherwise affiliated with the institution or agency and who is not part of the immediate family of a person who is affiliated with the institution or agency.

D. No member of a committee shall participate in the committee's initial or continuing review of any project in which the member is directly involved or for which he has administrative approval authority, except to provide information requested by the committee. The committee shall be responsible for determining whether a member has a conflicting interest. The committee member shall be replaced if the conflicting interest results in a decrease of the committee below five persons.

E. A committee 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 committee. These individuals may not vote with the committee.

F. A quorum of the committee shall consist of a majority of its members including at least one member whose primary concerns are in nonscientific areas.

G. The committee and the institution or agency shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.

Statutory Authority

§§ 37.2-203 and 37.2-402 of the Code of Virginia.

Historical Notes

Derived from VR470-06-01:1 § 6, eff. May 15, 1993; amended, Virginia Register Volume 20, Issue 9, eff. February 11, 2004; Volume 26, Issue 2, eff. November 12, 2009; Volume 36, Issue 11, eff. March 15, 2020.

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