Section 30. Policy

A. No human research may be conducted without informing the participant or his legally authorized representative in writing of the risks, procedures, and discomforts of the research. The voluntary informed consent of the participant or his legally authorized representative to participate in the research must be documented in writing and supported by signature of a witness not involved in the conduct of the research, except as provided in 6VAC15-26-102. Arrangements shall be made for those who need special assistance in understanding the consequences of participating in the research.

B. No offender shall be subjected to experimentation or participation in research against his will.

C. Nontherapeutic research using institutionalized participants is prohibited unless it is determined by the HSRRC that such nontherapeutic research will not present greater than minimal risk.

D. Research involving known and substantive physical, mental, or emotional risk to the participants, including the withholding of any prescribed program or treatment, is specifically prohibited.

E. Medical research shall only be conducted in accordance with Department of Corrections Operating Procedure 701.1, Health Services Administration, which is incorporated by reference with this chapter.

F. Research shall not interfere with the rights of offenders or Department of Corrections' employees.

G. Proper precautions must be exercised for the protection of the research participant's rights and for the overall safety and security of the public, the researcher, and the Department of Corrections.

H. Research shall not interfere significantly with ongoing programs or operations of the Department of Corrections.

I. The research findings shall not identify individual participants. The confidentiality and anonymity of all offenders and other parties engaged in the research will be maintained.

J. Researchers are required to notify all participants of risks caused by the research that are discovered after the research has concluded.

K. Each human research activity shall be reviewed and approved by the HSRRC.

L. No human research activity involving the Department of Corrections shall be initiated without a research proposal reviewed and approved by the HSRRC.

M. Each submitted research proposal must be accompanied by a research agreement signed by the principal researcher, or research project supervisor or advisor.

N. All research proposals, research agreements, and accompanying documentation must be submitted to the HSRRC electronically via email.

O. The burden of proof for review by the HSRRC shall be with the principal researcher.

P. Research shall not commence until all procedural and applicable human research reviews and approvals are completed and the Director of the Department of Corrections or designee signs an approval memorandum on behalf of the department. This approval memorandum and necessary information describing the project shall be sent to the appropriate Department of Corrections organizational unit head, regional operations chief, and principal researcher.

Q. This chapter does not apply to Department of Corrections studies, program evaluations, and routine data analyses for management purposes.

Historical Notes

Derived from VR230-01-004 § 1.3, eff. January 12, 1995; amended, Volume 30, Issue 07, eff. January 1, 2014.

Statutory Authority

§§ 53.1-5 and 53.1-5.1 of the Code of Virginia.