22VAC40-890-60. Human research review committee.
A. The department shall establish a department committee, consisting of seven members, appointed by the commissioner. The department committee is authorized (i) to determine if a proposed project is human subject research; and (ii) to review and approve any human research proposed, authorized, or conducted by the department, by any local agency, by any facility, or by any contractor.
B. All human research conducted or authorized by the department, local agency, facility, or contractor must be reviewed and approved by the department committee, except local agencies, facilities, or contractors collaborating with another organization on a research project may instead elect to utilize that organization's research review committee.
C. Members of the committee will be appointed to ensure the competent, complete, and professional review of human research. No member of the committee shall be directly involved in the proposed human research project or have administrative approval authority over the proposed research, except in connection with his responsibilities as a member of the committee. At least two members of the committee must be individuals whose primary concerns are in nonscientific or ethical areas (e.g., the clergy, lawyers).
D. The committee shall include at least two members who are not affiliated with and are not immediate family members of persons who are affiliated with the department.
E. No member of the committee shall participate in the committee's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the committee. The committee has responsibility for determining whether a member has a conflict of interest. If necessary, the committee size shall be maintained by the appointment of a substitute representative to review a project where a member has a conflicting interest.
F. 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.
G. A quorum of the committee shall consist of a majority of its members.
H. The committee shall establish procedures and rules of operations necessary to fulfill the requirements of this chapter.
Statutory Authority
§§ 63.2-217 and 63.2-218 of the Code of Virginia.
Historical Notes
Derived from VR615-80-01 § 6, eff. August 11, 1993.