Virginia Administrative Code › Title 22 - SOCIAL SERVICES › Agency 30 - DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES › Chapter 40 - PROTECTIONS OF PARTICIPANTS IN HUMAN RESEARCH › Section 22VAC30-40-110 - HRRC records

Current through Register Vol. 40, No. 24, July 15, 2024
A. The HRRC
				shall prepare and maintain adequate documentation of HRRC activities, including
				the following:
1. Copies of all research
				applications reviewed, scientific evaluations, if any, that accompany the
				applications, approved consent documents, progress reports submitted by
				investigators, and reports of injuries to subjects;
2. Minutes of HRRC meetings which shall be in
				sufficient detail to show attendance at the meetings; actions taken by the
				HRRC; the vote on these actions including the number of members voting for,
				against, and abstaining; the basis for requiring changes in or disapproving
				research; and a written summary of the discussion of controverted issues and
				their resolution;
3. Records of
				continuing review activities;
4.
				Copies of all correspondence between the HRRC and the investigators;
5. A list of all HRRC members identified by
				name; earned degrees; representative capacity; indications of experience such
				as board certifications, licenses, etc., sufficient to describe each member's
				chief anticipated contributions to HRRC deliberations; and any employment or
				other relationship between each member and the covered entity, for example:
				full-time employee, part-time employee, member of governing panel or board, or
				paid or unpaid consultant;
6.
				Statements of significant new findings provided to participants; and
7. Written procedures for the HRRC that shall
				include:
a. Conducting its initial and
				continuing review of research and for reporting its findings and actions to the
				investigator and the department;
b.
				Determining which projects require review more often than annually and which
				projects need verification from sources other than the investigators that no
				material changes have occurred since previous HRRC review;
c. Ensuring prompt reporting to the HRRC of
				proposed changes in a research activity, and for ensuring that such changes in
				approved research, during the period for which HRRC approval has already been
				given, may not be initiated without HRRC review and approval except when
				necessary to eliminate apparent immediate hazards to the subject; and
d. Ensuring prompt reporting to the HRRC and
				the commissioner of (i) any unanticipated problems involving risks to subjects
				or others or any serious or continuing noncompliance with this policy or the
				requirements or determinations of the HRRC and (ii) any suspension or
				termination of HRRC approval.
8. The rationale for an expedited reviewer's
				determination under
				22VAC30-40-90
				A 1 that research appearing on the expedited review list described in 63 FR
				30364-60367 is more than minimal risk.
9. As applicable, documentation specifying
				the responsibilities that the covered entity and another qualified IRB other
				than the HRRC, each shall undertake to ensure compliance with the requirements
				of this chapter when (i) nonexempt research involving human subjects or (ii)
				exempt research with a limited review is overseen by another qualified IRB
				other than the HRRC. Such documentation may include:
a. A written agreement between the covered
				entity and the qualified IRB that is not the HRRC;
b. Implementation of an institution-wide
				policy directive providing the allocation of responsibilities between the
				covered entity and the qualified IRB that is not the HRRC; or
c. A research protocol.