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 6VAC16-20-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
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.