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 › Section 12VAC35-180-60 - Composition of research review committees

Current through Register Vol. 40, No. 24, July 15, 2024
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.