Virginia Administrative Code › Title 6 - CRIMINAL JUSTICE AND CORRECTIONS › Agency 16 - DEPARTMENT OF CORRECTIONS › Chapter 20 - REGULATIONS FOR HUMAN SUBJECT RESEARCH › Part I - General provisions › Section 6VAC16-20-30 - Policy

Current through Register Vol. 40, No. 24, July 15, 2024
A. No human
				  research may be conducted without informing the participant or the
				  participant's legally authorized representative in writing of the risks,
				  procedures, and discomforts of the research. The voluntary informed consent of
				  the participant or the participant's 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
				  6VAC16-20-100. Arrangements shall
				  be made for those who need special assistance in understanding the consequences
				  of participating in the research.
B. No inmate, probationer, parolee, or other
				  individual under the supervision of the Department of Corrections 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.
				  Research shall not interfere with the rights of inmates, probationers,
				  parolees, and other individuals under the supervision of the Department of
				  Corrections or employees of the Department of Corrections.
F. 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.
G. Research shall not
				  interfere significantly with ongoing programs or operations of the Department
				  of Corrections.
H. The research
				  findings shall not identify individual participants. The confidentiality and
				  anonymity of all inmates, probationers, parolees, other individuals under the
				  supervision of the Department of Corrections, and other parties engaged in the
				  research will be maintained.
I.
				  Researchers are required to notify all participants of risks caused by the
				  research that are discovered after the research has concluded.
J. Each human research activity shall be
				  reviewed and approved by the HSRRC.
K. No human research activity involving the
				  Department of Corrections shall be initiated without a research proposal
				  reviewed and approved by the HSRRC.
L. Each submitted research proposal must be
				  accompanied by a research agreement signed by the principal researcher or
				  research project supervisor or advisor.
M. All research proposals, research
				  agreements, and accompanying documentation must be submitted to the HSRRC
				  electronically via email.
N. The
				  burden of proof for review by the HSRRC shall be with the principal
				  researcher.
O. 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
				  the director's 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 organizational unit head, regional
				  operations chief, and principal researcher at the Department of
				  Corrections.
P. This chapter does
				  not apply to Department of Corrections studies, program evaluations, and
				  routine data analyses for management purposes.
Statutory Authority: § 53.1-10 of the Code of
						Virginia.