Administrative Code

Virginia Administrative Code
6/25/2024

Part II. Human Subject Research Review Committee

6VAC16-20-40. Composition.

A. The HSRRC shall have at least three members, appointed by the Director of the Department of Corrections or the director's 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 timeframes from the existing HSRRC, the director or the director's designee may replace temporarily an active committee member with an alternate to the degree needed to establish a quorum.

Statutory Authority

§ 53.1-10 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.

6VAC16-20-50. Duties and responsibilities.

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;

(2) Affiliation;

(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;

(4) Methodology;

(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); 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:

a. The researcher's ability to obtain the appropriate security clearances to enter an organizational work unit.

b. The researcher's adherence to an organizational work unit's standards for appropriate attire, including dress or wardrobe, jewelry, hair, grooming, body piercings, and tattoos.

c. The researcher's 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 researcher's 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 the principal researcher's 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 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.

4. Determination if the research proposal is subject to the human research review requirements of §§ 32.1-162.16 through 32.1-162.20 of the Code of Virginia.

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 the 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 all 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 the director's designee for review and approval.

G. Upon approval of the research brief by the Director of the Department of Corrections or the director's 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; and

9. All communication between the HSRRC, principal researcher, research project supervisor or advisor, the Director of the Department of Corrections or the director's 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 this chapter, 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 the director's 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.

Statutory Authority

§ 53.1-10 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.

6VAC16-20-60. Reports.

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.

Statutory Authority

§ 53.1-10 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.

6VAC16-20-70. Records maintenance.

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.

Statutory Authority

§ 53.1-10 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.

6VAC16-20-80. Publication rights.

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 the materials 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 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 the director's designee.

Statutory Authority

§ 53.1-10 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.

6VAC16-20-90. Research exempt from HSRRC review.

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. Participant 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.

Statutory Authority

§ 53.1-10 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.

6VAC16-20-100. Waiver of signed voluntary informed consent form.

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 the participant wants documentation linking the participant 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.

Statutory Authority

§ 53.1-10 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 10, eff. March 1, 2023.

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