Part I. General Provisions
6VAC16-20-10. Definitions.
The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:
"Department" means the Department of Corrections.
"Director" means the Director of the Department of Corrections.
"Human research" means any systematic investigation utilizing human subjects that may expose such human subjects to physical or psychological injury as a consequence of participation as subjects and that departs from the application of established and accepted therapeutic methods appropriate to meet the subject's needs.
"Human Subject Research Review Committee" or "HSRRC" means the Department of Corrections committee responsible for (i) reviewing all submitted research projects for completeness and compliance with the Regulations for Human Subject Research, with all applicable Department of Corrections operating procedures, and with all applicable state and federal regulations pertaining to human subject research; (ii) approving or denying submitted research proposals; (iii) monitoring all approved research projects for adherence to the scope of the research that was approved; and (iv) reporting on all research projects approved, all research projects denied, and the findings of all approved research projects. The composition of the HSRRC and its responsibilities shall be as stated in Part II (6VAC16-20-40 et seq.) of this chapter.
"Legally authorized representative" means (i) any parent having custody of a prospective subject, (ii) the legal guardian of a prospective subject, or (iii) any person or judicial body authorized by law or regulation to consent on behalf of a prospective subject to such subject's participation in the particular human research. For the purposes of this definition, any person authorized by law or regulation to consent on behalf of a prospective participant to the prospective participant's participation in the particular human research shall include an attorney-in-fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney-in-fact shall not be employed by the person, organizational unit, or agency conducting the human research and shall not be authorized to consent to nontherapeutic medical research. No official or employee of the organizational unit or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.
"Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
"Nontherapeutic research" means human research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the human subject.
"Organizational work unit" means any unit, facility, office, or district within the Department of Corrections, such as prisons, correctional centers, correctional field units, correctional work centers, probation and parole districts or offices, community corrections alternative programs, or units supervised by a manager who reports directly to a deputy director. Each organizational work unit is managed by an organizational unit head such as a warden, superintendent, chief probation and parole officer, or manager.
"Participant" or "human participant" means a living individual whether employee, inmate, probationer, parolee, or other individual under supervision of the Department of Corrections, about whom a researcher, whether professional or student, conducting research obtains (i) data through intervention or interaction with the individual or (ii) identifiable private information. "Intervention" includes both physical procedures by which data are gathered and manipulations of the participant or the participant's environment that are performed for research purposes. "Interaction" includes communication or interpersonal contact between researcher and participant.
"Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public. Private information must be individually identifiable in order for obtaining the information to constitute research involving human participants.
"Research" means the systematic development of knowledge essential to effective planning and rational decision making. It involves the assessment of current knowledge on conceptual problems selected, statement of those problems in researchable format, design of methodologies appropriate to the problems, and the application of appropriate analytical techniques to the data. Research findings should provide valuable information to management for policy options.
"Research agreement" means the document signed by the principal researcher, research project supervisor, or advisor and the HSRRC indicating the principal researcher and research project supervisor or advisor agree to conduct their research project in the manner in which the research project was approved by the HSRRC, including compliance with this chapter, all applicable Department of Corrections operating procedures, all applicable state and federal laws and regulations, the research project timeline, and any conditions imposed by the HSRRC. The research agreement is governed by and must comply with the provisions of this chapter.
"Researcher" means an individual who has professional standing in the pertinent field or is supervised directly by such an individual.
"Research project" means the systematic collection of information, analysis of data, and preparation of a report of findings.
"Research proposal" means the document completed by the principal researcher outlining (i) information about the researchers, including contact information, affiliations, and funding sources; (ii) the human research to be performed, including purpose, methodology, informed consent, timeframe, and Department of Corrections resources required; and (iii) any endorsements. The research proposal must be submitted to and approved by the HSRRC. Research proposals are to be limited to 20 pages, not including bibliographies, curriculum vitae, letters of endorsement, copies of surveys or instruments to be used, copies of external institutional review board approvals, and voluntary informed consent forms.
"Voluntary informed consent" means the knowing consent of an individual so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. Voluntary informed consent forms shall not include any language through which the human subject waives or appears to waive any of the human subject's legal rights, including any release of any individual, facility, agency, or agents thereof, from liability or negligence. The human participant shall sign all voluntary informed consent forms confirmed by an acceptable witness. With regard to the conduct of human research, the basic elements of information necessary to such voluntary informed consent shall include:
1. A fair explanation to the individual of any procedures to be followed and their purposes, including identification of any procedures which are experimental;
2. A description of any attendant discomforts and risks reasonably to be expected;
3. A description of any benefits reasonably to be expected;
4. A disclosure of any appropriate alternative procedures that might be advantageous for the individual;
5. An offer to answer any inquiries by the individual concerning the procedure; and
6. An instruction that the individual is free to withdraw the individual's voluntary informed consent and to discontinue participation in the human research at any time without prejudice.
Statutory Authority
§ 53.1-10 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.
6VAC16-20-20. Applicability.
This chapter shall apply to any individual, group, or agency conducting research that uses human participants within the Virginia Department of Corrections, including any facility, program or organization owned, operated, funded, or licensed by the department.
Statutory Authority
§ 53.1-10 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.