Virginia Law

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.

J. In order to approve research covered by this chapter, the HRRC shall determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized:

a. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk; and

b. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the HRRC should consider only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. The HRRC should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

3. Selection of subjects is equitable. In making this assessment, the HRRC should take into account the purposes of the research and the setting in which the research will be conducted. The HRRC should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

4. Informed consent is sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required by 22VAC30-40-100.

5. Informed consent is appropriately documented in accordance with and to the extent required by 22VAC30-40-100.

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

K. For purposes of conducting the limited review required by 22VAC30-40-80-G, the HRRC need not make the determinations at subdivisions J 1 through J 7 of this section and shall make the following determinations:

1. Broad consent for storage, maintenance, and secondary research use of identifiable private information is obtained in accordance with the requirements of 22VAC30-40-100 A and D;

2. Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with 22VAC30-40-100 L; and

3. If there is a change made for research purposes in the way the identifiable private information is stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

L. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, there are additional safeguards in place to protect the rights and welfare of the human subjects.