Virginia Administrative Code › Title 22 - SOCIAL SERVICES › Agency 30 - DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES › Chapter 40 - PROTECTIONS OF PARTICIPANTS IN HUMAN RESEARCH › Section 22VAC30-40-70 - Elements of the HRRC's review process

Current through Register Vol. 40, No. 24, July 15, 2024
A. The HRRC shall review and have authority
				to approve, require modifications in, or disapprove all research activities
				covered by this chapter.
B. The
				HRRC shall require that information given to prospective subjects as part of
				the informed consent process is in accordance with 22VAC30-40-100. The HRRC may
				require that information, in addition to that specifically mentioned in
				22VAC30-40-100, be given to prospective subjects when in the HRRC's judgment
				the information would meaningfully add to the protection of the rights and
				welfare of subjects.
C. The HRRC
				shall require documentation of informed consent or may waive documentation in
				accordance with 22VAC30-40-100 L.
D. The HRRC shall consider research proposals
				within 45 days after submission of a complete application to the HRRC's
				chairperson. The HRRC shall notify investigators and the covered entity in
				writing of its decision to approve or disapprove the research, or of
				modifications required to secure HRRC approval.
E. The HRRC shall develop written complaint
				procedures to be followed by a human subject who has a concern about a research
				project in which he is participating or has participated.
F. Any participant who has a complaint about
				a research project in which he is participating or has participated shall be
				referred to the chairperson of the HRRC, who shall refer the complaint to the
				HRRC to determine if there has been a violation of the research protocol as
				approved by the HRRC.
G. The HRRC
				shall require periodic reports, the frequency of which should reflect the
				nature and degree of risk of each research project.
H. If the HRRC decides to disapprove a
				research application, the HRRC shall include in its written notification a
				statement of the reasons for its decision and give the investigator an
				opportunity to respond in person or in writing.
I. The HRRC shall conduct continuing review
				of research covered by this chapter at intervals appropriate to the degree of
				risk, but not less often than once per year, and shall have authority to
				observe or have a third party observe the consent process and the research.
				Unless the HRRC determines otherwise, continuing review of research shall not
				be required in the following circumstances:
1.
				Research eligible for expedited review in accordance with
				22VAC30-40-90;
2. Research reviewed
				by the HRRC in accordance with the limited IRB review described in
				22VAC30-40-80 B 3, 22VAC30-40-80 C 1 c, and 22VAC30-40-80 G and H; or
3. Research that has progressed to the point
				that it involves only one or both of the following, which are part of the
				HRRC-approved study:
a. Data analysis,
				including analysis of identifiable private information; or
b. Accessing follow-up clinical data from
				procedures that subjects would undergo as part of clinical care.