Title of Regulation: 6VAC16-20. Regulations for Human Subject Research (adding 6VAC16-20-10 through 6VAC16-20-120).

Statutory Authority: § 53.1-10 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: February 1, 2023.

Effective Date: March 1, 2023.

Agency Contact: Annie Morgan, Hearing Legal Services Officer II, Department of Corrections, 6900 Atmore Drive, Richmond, VA 23225, telephone (804) 887-8436, or email annie.morgan@vadoc.virginia.gov.

Basis: Section 53.1-10 of the Code of Virginia specifies that the Director of the Department of Corrections shall promulgate regulations for human research, as defined in §32.1-162.16 of the Code of Virginia, to be conducted or authorized by the department.

Purpose: The regulation regarding human research exists for the protection of individuals participating in any sort of research 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. Moving the regulation to the agency with regulatory authority to enforce the regulation protects the public health, safety, or welfare.

Rationale for Using Fast-Track Rulemaking Process: Due to the changes in the Code of Virginia regarding regulatory authority for certain Department of Corrections responsibilities, the regulation must be moved from the State Board for Local and Regional Jails (6VAC15) to the Department of Corrections (6VAC16). The regulation must be promulgated under 6VAC16 and repealed under 6VAC15. No substantial changes have been made in the regulation beyond corrections to the regulatory authority, clarification in the prior use of offenders, and removal of an agency incorporated document (to comply with current regulatory guidance). For these reasons, the action is expected to be noncontroversial and the fast-track rulemaking process has been determined as the best approach to ensure that the regulation is put in place under the correct agency and available for use as quickly as possible.

Substance: The primary purpose of the change is to move the regulation from 6VAC15, regulations for the State Board of Local and Regional Jails, to 6VAC16, regulations for the Department of Corrections. No substantial changes are made to the regulation, except to move the chapter. Nonsubstantive changes to the regulation being added at 6VAC16-20 include (i) removing references to the Board of Corrections; (ii) changing "offenders" to a more specific term of "inmate," "probationer," "parolee," or "other individual" under supervision of the Department of Corrections; (iii) removing internal documents unnecessarily incorporated by reference; (iv) requiring training to comply with the federal Prison Rape Elimination Act of 2003; and (v) updating forms.

Issues: The primary advantage to the public of the regulation is for the protection of a group of individuals who may be part of a research project. These are prevalent in agencies responsible for services and supervision, as well as universities. The regulation protects those involved in the research and provides those conducting the research with clarity and guidance. There is no disadvantage to the public.

The primary advantage to the agency of placing this regulation under 6VAC16 is to ensure the regulation is in effect and in the appropriate regulatory authority. Having the regulation under 6VAC15, where the board has no regulatory authority to enforce the regulation, creates a problem for the public seeking to conduct research and for the individuals who may be subject to such research. There is no disadvantage to the agency or Commonwealth.

Department of Planning and Budget's Economic Impact Analysis: The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia (Code) and Executive Order 19. The analysis presented represents DPB's best estimate of these economic impacts.¹

Summary of the Proposed Amendments to Regulation. Following a legislative change in the authority for this regulation, the Director of the Department of Corrections (DOC) proposes to establish rules governing human research, which are substantially the same as prior regulations, under a new Virginia Administrative Code (VAC) Chapter for DOC.

Background. This action would establish rules governing human research for DOC. Regulations regarding human research are for the protection of individuals participating in any sort of research 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.

Chapter 759 of the 2020 Acts of Assembly, renamed the Board of Corrections as the State Board of Local and Regional Jails.² As a result, the location in Title 6 of the VAC where the Board of Corrections resided (6VAC15) was renamed for the State Board of Local and Regional Jails. This regulation currently exists under 6VAC15. Chapter 759 also changed the authority for this regulation from the prior Board of Corrections to the Director of DOC. Hence, the Registrar assigned a new location for DOC regulations within Title 6 of the VAC (6VAC16). This action would establish substantially the same human research rules under the new Virginia Administrative Code 6VAC16 for DOC.³

Estimated Benefits and Costs. The prior rules for human research and the proposed new rules are substantially the same, except for adding the training requirement mandated by the federal Prison Rape Elimination Act (PREA) National Standards.⁴ According to DOC, the new regulation addresses PREA training which is required for all DOC personnel and its contractors, including entities authorized to conduct human research. DOC notes, however, that the training is free and takes limited time to complete. Furthermore, DOC is currently enforcing this training requirement as mandated by federal law. Thus, the primary effect of this action is to change the Virginia Administrative Code to reflect the statutory change in authority for this regulation and an existing requirement for PREA training under federal law. As a result, no economic impact is expected.

Businesses and Other Entities Affected. The regulations governing human subject research apply to any entity (private, public, nonprofit) that would propose research involving inmates, probationers, parolees, or other individuals under the supervision of DOC or its employees. DOC receives approximately eight proposals on average per year, and issues approximately three approvals which may include extensions of ongoing projects.

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁵ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As noted above, the proposed regulation is substantially the same as the prior regulation. Thus, no adverse impact is indicated on any entity.

Small Businesses⁶ Affected.⁷ The proposed regulation does not adversely affect small businesses.

Localities⁸ Affected.⁹ The proposed regulation does not introduce costs for local governments.

Projected Impact on Employment. The proposed regulation does not affect total employment.

Effects on the Use and Value of Private Property. The proposed regulation does not affect the use and value of private property or the real estate development costs.

__________________________

¹Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

²https://lis.virginia.gov/cgi-bin/legp604.exe?201+ful+CHAP0759

³This action does not repeal existing rules from the Virginia Administrative Code. According to DOC staff, the repeal will be done through a separate regulatory action.

⁴Title 28, Chapter I, Part 115; 5 USC 301; 28 USC 509, 510; 42 USC 15601-15609.

⁵Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁶Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁷If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁸"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁹Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Chapter 20

Regulations for Human Subject Research

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.

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.

6VAC16-20-30. Policy.

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.

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.

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.

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.

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.

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.

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.

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.

Part III

Role of the department and director

6VAC16-20-110. Role of the department and director.

A. The Director of the Department of Corrections or the director's 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 the director's designee shall review communications from the HSRRC reporting violations of research protocols that 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.

Part IV

Applicability of state and federal policies

6VAC16-20-120. Applicability of state and federal policies.

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.

FORMS (6VAC16-20)

Research Agreement, Form 020_F2_5-22 (rev. 5/2022)

Research Proposal, Form 020_F14_9-21 (rev. 9/2021)

Voluntary Informed Consent to Participate in Research, Form 020_F3_9-21 (rev. 9/2021)