Administrative Code

Creating a Report: Check the sections you'd like to appear in the report, then use the "Create Report" button at the bottom of the page to generate your report. Once the report is generated you'll then have the option to download it as a pdf, print or email the report.

Virginia Administrative Code
Title 22. Social Services
Agency 30. Department For Aging And Rehabilitative Services
Chapter 40. Protections of Participants in Human Research

22VAC30-40-60. 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, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. When minors with disabilities or persons with intellectual or developmental disabilities are purposefully included as research subjects, the HRRC's membership shall include at least one person who is primarily concerned with the welfare of these research subjects.

B. Every nondiscriminatory effort shall 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 shall 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 a covered entity and who is not part of the immediate family of a person who is affiliated with a 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 to fewer than five members.

E. The HRRC, at its discretion, may invite individuals with competence in special areas to assist in the review of complex issues that 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 this chapter.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009; Volume 36, Issue 17, eff. May 14, 2020.

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.