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 which may expose such human subjects to physical or psychological injury as a consequence of participation as subjects and which departs from the application of established and accepted therapeutic methods appropriate to meet the subjects' 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) the parent or parents 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 his 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 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 which has been provided for specific purposes by an individual and which 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 or documents 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, time frame, 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 his 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.
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.
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 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 Department of Corrections' employees.
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, and 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 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.
P. This chapter does not apply to Department of Corrections’ studies, program evaluations, and routine data analyses for management purposes.
A. The HSRRC shall have at least three members, appointed by the Director of the Department of Corrections or designee, with varying backgrounds to provide complete and adequate review of activities commonly conducted by researchers. The HSRRC shall be sufficiently qualified through the experience and diversity of its members.
1. The HSRRC shall not be comprised entirely of men or of women.
2. The HSRRC shall not be comprised entirely of members from one organizational work unit.
3. The HSRRC shall have at least one member who is not otherwise affiliated with the Department of Corrections and is not an immediate family member of a person who is affiliated with the department.
B. In addition to possessing the professional competence necessary to review research proposals, the HSRRC must be able to ascertain the acceptability of research proposals in terms of organizational work unit commitments, this chapter, applicable Department of Corrections operating procedures, any applicable state and federal law or regulation, standards of professional conduct and practice, and community attitudes.
C. No member of the HSRRC shall participate in the HSRRC's initial or continuing review of any research project in which the member has a conflict of interest, defined as having direct involvement in or department approval authority over the proposed human research or otherwise having a conflict of interest under applicable Virginia law. The HSRRC has responsibility for determining whether a member has a conflicting interest.
D. The HSRRC may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues that require expertise beyond or in addition to that available to the HSRRC. These individuals may not vote with the HSRRC.
E. A quorum of the HSRRC shall consist of a majority of its members. If a quorum cannot be established, or cannot meet within the established time frames, from the existing HSRRC, the director or designee may replace temporarily an active committee member with an alternate to the degree needed to establish a quorum.
A. The HSRRC shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.
B. The HSRRC shall review all submitted research proposals for the following:
1. Completeness, including:
a. Researcher information.
(1) Name of principal researcher,
(3) Mailing address,
(4) Telephone number,
(5) Email address,
(6) Names of all other researchers participating in the research project,
(7) Name of research project supervisor or advisor, if different from principal researcher,
(a) Telephone number,
(b) Email address,
(8) Funding source, and
(9) Curriculum vitae of principal researcher, all persons named as researchers, and research project supervisor or advisor.
b. Research proposal information.
(1) Date research proposal submitted to HSRRC,
(2) Title of research proposal,
(3) Purpose of research proposal,
(a) Research design,
(b) Sampling methods,
(c) Methods of analysis,
(5) Discussion of the research proposal in the context of relevant literature,
(6) Discussion of the benefits to the Department of Corrections as well as the field of study,
(7) Copies of any surveys or instruments to be used,
(8) Voluntary informed consent forms,
(9) Timeline for the research project,
(10) Department of Corrections resources required (e.g., personnel, supplies, materials, equipment, workspace, access to participants and files, etc.), and
(11) External Institutional Review Board (IRB) approval, including academic IRBs, research group IRBs, and government IRBs; all external IRB approvals must be received before the HSRRC will initiate review of a submitted research proposal.
c. Letters of endorsement.
2. Compliance with this chapter, all applicable Department of Corrections operating procedures, and all applicable state and federal laws and regulations. Compliance includes, but is not limited to:
a. The researchers' ability to obtain the appropriate security clearances to enter an organizational work unit.
b. The researchers' adherence to an organizational work unit's standards for appropriate attire, including dress or wardrobe, jewelry, hair, grooming, body piercings and tattoos.
c. The researchers' ability to pass an organizational work unit's security screening process for contraband, including weapons of any kind, alcohol, drugs of any kind, cellular phones, other electronic devices, tobacco products, including lighters and matches, and any other items deemed as potentially adversely impacting the safety and security of the Department of Corrections, organizational work unit, department staff, research participants or other inmates, probationers, parolees, and other individuals under the supervision of the Department of Corrections, the researchers, or the general public.
d. The researchers’ completion of Prison Rape Elimination Act (PREA) training and any other Department of Corrections required training for vendors and volunteers.
3. Adherence to basic research standards, including:
a. Credentials. The principal researcher shall have academic or professional standing in the pertinent field or job-related experience in the areas of study or be directly supervised by such a person.
b. Ethics. The research shall conform to the appropriate standards of ethics of professional societies such as the American Psychological Association, the American Sociological Association, the National Association of Social Workers, or other equivalent society.
c. Protection of rights. The principal researcher is responsible for the conduct of his staff and assumes responsibility for the protection of the rights of participants involved in the research project.
d. Confidentiality or anonymity. Research project information given by participants to the researcher or researchers shall be confidential or anonymous depending on the study design. This does not preclude the reporting of results in aggregated form that protects the identity of individuals, or the giving of raw data to the Department of Corrections for further analysis. The confidentiality of any such raw data shall be monitored by the department. Persons who breach confidentiality or anonymity shall be subject to sanctions in accordance with applicable laws, policies, and procedures.
e. Participant incentives. The opportunity to participate in research is considered sufficient incentive for participation. The offering of additional incentives is prohibited without specific written approval from the Director of the Department of Corrections or designee. Sentence reduction or pecuniary compensation are always prohibited as incentives.
5. Agreement with Department of Corrections’ research procedures.
a. The principal researcher and research project supervisor or advisor must submit a separate, signed written research agreement when submitting their research proposal indicating that the principal researcher, research project supervisor or advisor, and all other researchers and staff under their supervision who are associated with the research project have read, understand, and agree to abide by Department of Corrections research procedures.
b. The research agreement shall establish a timeline for the research project and the specific date when the principal researcher shall submit the final report to the HSRRC.
c. In the case of student research, the student's academic advisor must sign the research agreement indicating endorsement of the research project.
C. After reviewing each submitted, complete research proposal, research agreement and accompanying documentation, the HSRRC will vote to approve or deny the research proposal.
D. A research proposal shall be approved by the HSRRC when a majority of the quorum of the HSRRC votes to approve the research proposal.
E. If a research proposal is denied, the HSRRC shall notify the principal researcher of the reason or reasons for denial and any requested clarifications, edits, updates, or additions that can be made to the research proposal. The principal researcher may resubmit a revised research proposal with these requested clarifications, edits, updates, or additions. The HSRRC will then review the resubmitted revised, complete research proposal in accordance with 6VAC16-20-50 B.
F. Upon approval of a research proposal by the HSRRC, the HSRRC shall prepare a research brief summarizing the research proposal with any comments. The research brief will be provided to the Director of the Department of Corrections or designee for review and approval.
G. Upon approval of the research brief by the Director of the Department of Corrections or designee, the HSRRC shall provide an approval memorandum and necessary information describing the research project to the organizational work unit head, regional operations chief, and principal researcher.
H. The HSRRC shall retain a separate electronic file for each submitted research proposal. Each electronic file shall contain:
1. The original submitted research proposal.
2. The research agreement.
3. Any accompanying documentation.
4. Any resubmitted revised research proposals.
5. The research brief.
6. The approval memorandum.
7. Any progress reports.
8. The final report.
9. All communication between the HSRRC, principal researcher, research project supervisor or advisor, the Director of the Department of Corrections or designee, regional operations chief, and organizational unit head pertaining to the research project.
I. At the time the research agreement is signed, the HSRRC shall establish due dates for progress reports to be provided by the principal researcher. These progress reports will inform the HSRRC of the status of the research project and any difficulties encountered that might delay or preclude completion of the research project.
J. The HSRRC shall establish research priorities consistent with the needs of the Department of Corrections.
K. The HSRRC shall regulate the number and timetable of research projects so as to not disrupt the normal functioning of any Department of Corrections operational work unit.
L. Upon receipt of a complaint from an organizational unit head or participant, the HSRRC will investigate to determine if there has been a violation of these regulations, Department of Corrections operating procedures, the research proposal, the research agreement or any applicable state or federal laws or regulations.
M. If the HSRRC determines that a principal researcher, researcher, research project supervisor or advisor, or staff supervised by them has violated any provisions of this chapter, Department of Corrections operating procedures, the research proposal, the research agreement, or any applicable state or federal laws or regulations, the HSRRC may terminate the research project at any time.
N. The HSRRC shall submit to the Governor, the General Assembly, and the Director of the Department of Corrections or designee, at least annually, a report on the human research projects reviewed and approved by the HSRRC, including any significant deviations from the approved research projects.
A. The principal researcher must submit progress reports to the HSRRC by the dates agreed upon in the research agreement. These progress reports must be submitted electronically via email.
B. The principal researcher must submit a final report to the HSRRC. The final report must be submitted electronically via email.
C. The HSRRC reserves the right to reproduce the final report for official Department of Corrections use only.
A. The principal researcher shall maintain records adequate to enable the Department of Corrections to ascertain the status of the research project at any given time.
B. The principal researcher shall maintain completed voluntary informed consent forms in a secure location for at least three years.
A. Researchers are not permitted to publish beyond the approved research proposal without further review and approval from the HSRRC.
B. The researcher shall furnish the HSRRC with an electronic copy of the published research findings.
C. The Department of Corrections shall be permitted to use the data collected in the research project and to reproduce the materials as they are published.
D. Without the explicit written approval of the researcher, the Department of Corrections should not publicly distribute any dissertation or thesis material that the researcher has not published or presented publicly or professionally.
E. Without prior approval from the HSRRC, research conducted by employees or agents, including but not limited to interns, volunteers, contractors, and vendors, of the Department of Corrections is the property of the department and cannot be published without the approval of the Director of the Department of Corrections or designee.
The following are exempt from HSRRC review:
1. Department of Corrections' studies, program evaluations and routine data analyses for management purposes.
2. Research conducted by the Department of Corrections and any of its organizational units in established or commonly accepted educational settings, involving commonly used educational practices, such as:
a. Research on regular and special education instructional strategies.
b. Research on the effectiveness of, or the comparison among, instructional techniques, curriculum or classroom management methods.
3. Research involving required department survey procedures, unless responses are recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants, and either:
a. The participants' responses, if they become known outside the research, could reasonably place a participant at risk of criminal or civil liability or be damaging to a participant's financial standing, employability, or reputation; or
b. The research deals with sensitive aspects of a participant's own behavior, such as sexual behavior, drug or alcohol use, illegal conduct, or family planning.
4. Research involving solely the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publically available or if the information taken from these sources is recorded in such a manner that participants cannot be identified, either directly or through identifiers linked to the participants.
A. The HSRRC may waive the requirement for the researcher to obtain a signed voluntary informed consent form for some or all participants in a research project if it finds that the only record linking the participant and the research would be the consent form and that the principal risk would be potentially harmful resulting from a breach of confidentiality.
B. Each participant will be asked whether he wants documentation linking him to the research, and the participant's wishes will govern.
C. In cases where the documentation requirement is waived, the HSRRC shall require the researcher to provide participants with a written statement explaining the research.
A. The Director of the Department of Corrections, or designee, shall establish and maintain records of the HSRRC assurances, annual reports, and summary descriptions of research projects.
B. The Director of the Department of Corrections, or designee, shall review communications from the HSRRC reporting violations of research protocols which led to suspension or termination of the research to ensure that appropriate steps have been taken for the protection of rights of human research participants.
C. The Director of the Department of Corrections shall arrange for the printing and dissemination of copies of this chapter.
A. No statement in this chapter shall be construed as limiting in any way the rights of participants in research under regulations promulgated by the director pursuant to §53.1-10 of the Code of Virginia.
B. Human research that is subject to policies and regulations for the protection of human participants promulgated by any agency of the federal government shall be exempted from this chapter. Annual certification shall be made to the Director of the Department of Corrections that exempted projects have complied with the policies and regulations of federal agencies.