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Virginia Administrative Code
Title 12. Health
Agency 35. Department of Behavioral Health And Developmental Services
Chapter 180. Regulations to Ensure the Protection of Subjects in Human Research

12VAC35-180-70. Elements of each committee's review process.

A. No human research shall be conducted or authorized by an institution or agency unless a research review committee has reviewed and approved the proposed human research project giving consideration to:

1. The adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the human research;

2. The degree of the risk, and, if the human research is nontherapeutic, whether it presents greater than minimal risk;

3. Whether the rights and welfare of the individuals who are the subjects of the human research are adequately protected;

4. Whether the risks to the individuals who are the subjects of human research are outweighed by the potential benefits to them;

5. Whether the risks to individuals are minimized by using procedures that are consistent with sound human research design and that do not unnecessarily expose individuals to risk and, whenever appropriate, by using procedures already being performed on individuals for diagnostic or treatment purposes;

6. When some or all of the individuals are likely to be incapable of providing informed consent or are otherwise vulnerable to coercion or undue influence, whether additional safeguards have been included in the study to protect the rights and welfare of these individuals;

7. Whether the informed consent is to be obtained by methods that are adequate and appropriate and whether the written consent form is adequate and appropriate in both content and language for the particular human research and for the individuals who are the particular subjects of the human research;

8. Whether the persons proposing to supervise or conduct the particular human research are appropriately competent and qualified;

9. Whether criteria for selection of individuals to participate as human research subjects are equitable; and

10. Whether the human research conforms with such other requirements of the department, where applicable.

B. When cooperating institutions conduct some or all of the human research involving some or all of the individuals, each cooperating institution is responsible for safeguarding the rights and welfare of the individuals and for complying with this chapter, except that in complying with this chapter institutions may enter into joint review, rely upon the review of another qualified committee, or come to similar agreements aimed at avoiding duplication of effort. These agreements must be in writing and designate a lead institution, which shall be the institution responsible for reporting and dealing with possible misconduct in human research. Such agreements may be made by the committee chair with the approval of a majority of the members present at a meeting of the committee. If a given institution or agency does not have a research review committee, this arrangement shall be approved by the chief executive officer of the institution, or his designee.

C. The committee shall consider human research proposals within 45 days after submission to the committee's chair. In order for the human research to be approved, it shall receive the approval of a majority of those members present, including one nonscientific person, at a meeting in which a quorum exists. A committee shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed human research project, or of modifications required to secure committee approval.

D. The committee shall develop a written description of the procedure to be followed by an individual who has a complaint about a human research project in which he is participating or has participated.

E. Any individual who has a complaint about a human research project in which he is participating or has participated shall be referred to the chairperson of the committee who shall refer it to the committee to determine if there has been a violation of the protocol.

F. The committee shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the committee requirements or that has been associated with unexpected serious harm to any individuals. Any suspension or termination of approval shall include a statement of the reasons for the committee's action and shall be reported promptly to the investigator, appropriate institutional officials, the department or agency head, and the commissioner.

G. The chair of the committee shall provide a written report as soon as possible to the head of the institution of any violation of the human research protocol that led the committee to either suspend or terminate the human research.

H. The committee shall require periodic written reports to ensure that the project is being carried out in conformity with the proposal. The frequency of such reports should reflect the nature and degree of risk of each human research project, but shall be at least annually.

I. Prior to participation by individuals in any human research project, the institution or agency shall inform and provide a copy of the research review committee approval to the local human rights committee established pursuant to 12VAC35-115. Once the research has been initiated, the institution or agency shall update the local human rights committee periodically on the status of an individual's participation.

J. The committee shall ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191) and federal and state regulations regarding the use and disclosure of PHI created for human research. In particular, authorization shall be obtained for the use and disclosure of PHI created for the purpose of human research, except as otherwise permitted by 45 CFR 164.512(i).

Statutory Authority

§§ 37.2-203 and 37.2-402 of the Code of Virginia.

Historical Notes

Derived from VR470-06-01:1 § 7, eff. May 15, 1993; amended, Virginia Register Volume 20, Issue 9, eff. February 11, 2004; Volume 26, Issue 2, eff. November 12, 2009; Volume 36, Issue 11, eff. March 15, 2020.

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