Administrative Code

Virginia Administrative Code
10/2/2022

Chapter 170. Regulation Governing Juvenile Data Requests and Research Involving Human Subjects

6VAC35-170-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Aggregate data" means statistics that relate to broad classes, groups, or categories so that it is not possible to distinguish the properties of individuals within those classes, groups, or categories.

"Case-specific data" means nonaggregated data that provides information about individuals within a group.

"Coordinator of external research" means the department employee designated by the director to receive research proposals and data requests from external entities and to ensure that the proposals are reviewed in accordance with this chapter and related department procedures.

"De-identified data" means data with common identifiers, such as names, phone numbers, social security numbers, and addresses removed in order to eliminate the ability of an individual viewing the data to determine the identity of an individual.

"Department" means the Department of Juvenile Justice.

"Director" means the director of the department or the director's designee.

"External research" means research conducted at or using the resources of a facility, program, or organization that is owned, operated, or regulated by the department or the Board of Juvenile Justice by researchers who are not part of the department or under contract with the department, or who are not employees of another state agency conducting a study at the direction of the General Assembly.

"Human research" means a systematic investigation, including research development, testing, and evaluation, utilizing human subjects that is designed to develop or contribute to generalized knowledge. Human research shall not be deemed to include research exempt from federal research regulation pursuant to 45 CFR 46.101(b).

"Human Research Review Committee" or "HRRC" means the committee established by the department to oversee human research proposals and activities in accordance with 6VAC35-170-130 and § 32.1-162.19 of the Code of Virginia.

"Human subject" means an individual who is under the department's care, custody, or supervision; under the care, custody, or supervision of a facility or program regulated by the department or the Board of Juvenile Justice; or a member of the family of such an individual and who is, or who is proposed to be, a subject of human research. For purposes of this definition, human subject also means an individual who is employed in or provides contractual services to a juvenile correctional center or other facility or program regulated by the department or the Board of Juvenile Justice and who is or who is proposed to be a subject of human research.

"Informed consent" means the knowing and voluntary agreement without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion of a person who is capable of exercising free choice. The basic elements necessary for informed consent regarding human research include:

1. A reasonable and comprehensible explanation to the person of the proposed procedures and protocols to be followed; their purposes, including descriptions of attendant discomforts; and the risks and benefits reasonably to be expected;

2. A disclosure of alternative procedures or therapies that might be helpful to the person;

3. An instruction that the person may withdraw his consent and stop participating in the human research at any time without prejudice to him;

4. An explanation of costs or compensation that may accrue to the person and whether third party reimbursement is available for the proposed procedures or protocols; and

5. An offer to answer, and answers to, questions by the person about the procedures and protocols.

"Internal committee" means the committee established by the department pursuant to 6VAC35-170-65 to oversee de-identified case specific data.

"Legally authorized representative" means the parent having custody of a prospective subject; the legal guardian of a prospective subject; or any person or judicial or other body authorized by law to consent on behalf of a prospective subject to such subject's participation in the particular human research, including an attorney in fact appointed under a durable power of attorney, provided the power grants the authority to make such a decision . For purposes of this chapter, "legally authorized representative" shall not include an official or employee of the institution or agency conducting or authorizing the research.

"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 unit head" means the person in charge of a juvenile correctional center, court service unit, or other organizational unit of the department or a Board of Juvenile Justice-regulated facility, program, or service.

"Principal researcher" means the individual who is responsible for the research design, research implementation, supervision of research staff, and research findings.

"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, the statement of those problems in researchable format, the design of methodologies appropriate to the problems, and the application of statistical techniques to organize and analyze data.

"Researcher" means an individual conducting research.

"Research project" means the systematic collection of information, analysis of the data, and the preparation of a report of findings.

"Sensitive data" means data, the compromise of which, with respect to confidentiality, integrity, or availability, could have a material adverse effect on agency programs or the privacy to which individuals are entitled.

"Virginia Longitudinal Data System" or "VLDS" means a data system that provides de-identified case-specific data from participating agencies to qualified researchers through a process that involves submission of requests and approval or denial by each sponsoring agency from which data are sought in an effort to create usable information for policy and generate cross-agency research.

"Written" means the required information is communicated in writing either in hard copy or electronic form.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-20. General requirements of external researchers.

A. 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. The principal researcher shall be responsible for (i) the conduct of the research staff, (ii) the protection of the rights of subjects involved in the project, and (iii) the provision of information required by the coordinator of external research, organizational unit heads, and the HRRC.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-30. Professional ethics.

All research shall conform to the standards of ethics of professional societies such as the American Correctional Association, the American Psychological Association, the American Sociological Association, the National Association of Social Workers, the American Evaluation Association, or their equivalent.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016.

6VAC35-170-40. Confidentiality requirements of all research.

A. Research findings shall not identify individual subjects.

B. All records and all information given by research subjects or employees of the department shall be kept confidential in accordance with § 16.1-300 of the Code of Virginia and applicable rules and regulations regarding confidentiality of juvenile records.

C. Persons who breach confidentiality shall be subject to sanctions in accordance with applicable laws, regulations, policies, and procedures.

D. Confidentiality does not preclude reporting results utilizing de-identified data or giving raw data to the department for possible further analysis.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016.

6VAC35-170-50. Conditions for department approval of external research and data requests.

The department may approve research and data requests only when it determines, in its sole discretion, that the following conditions have been met:

1. The department has sufficient financial and staff resources to support the request and that, on balance, the benefits of the request justify the department's involvement;

2. The request will not interfere significantly with department programs or operations, particularly those of the operating units that would participate in the proposed research; and

3. The request is compatible with the purposes and goals of the juvenile justice system and with the department's organization, operations, and resources.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-55. Review and approval of aggregate data requests.

A. The department shall determine the following prior to approving aggregate data requests:

1. That the request meets the conditions for department approval of research identified in 6VAC35-170-30 and 6VAC35-170-50;

2. That the data requested is accessible;

3. An estimate of the time required to process the data request; and

4. Based on staff workload, whether staff resources are available to process the request.

B. The department may approve and coordinate the provision of data.

C. The department shall provide the principal researcher with a written notification of the approval or denial of the data request within 20 business days of the department’s receipt of the proposal.

1. If the department denies the data request, documentation of the rationale for the denial shall accompany the proposal.

2. If the department approves the data request, it shall provide the principal researcher with a written estimated timeline for receipt of the data.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-60. Formal agreement required.

No case-specific data request or human research request shall begin until all reviews required by this chapter have been completed and the principal researcher receives a copy of the research agreement signed by the director.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-62. (Repealed.)

Historical Notes

Derived from Virginia Register Volume 33, Issue 5, eff. December 1, 2016; repealed, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-65. External case-specific data requests.

A. External case-specific data requests shall be submitted to the department using the Confidentiality Agreement Form, the Research Proposal Form, and the Research Agreement Form.

B. The Research Agreement Form shall be signed by the principal researcher and the student researcher, if applicable, at the time of submission.

C. The coordinator of external research shall determine the following within 10 business days of receiving the data request:

1. That the request meets the conditions for department approval of research identified in 6VAC35-170-30 and 6VAC35-170-50;

2. That the proposal is not a human research proposal and is not required to be reviewed by the HRRC; however, requests that include sensitive data shall be reviewed by the HRRC;

3. That the principal researcher has appropriate academic or professional standing or job-related experience in the area to be studied;

4. That the proposal is in the required format and includes all required information;

5. That the proposal complies with basic research standards and applicable laws;

6. That the data requested is accessible;

7. That department resources are available to process the data request; and

8. An estimate of the time required to compile the data request.

D. Except as provided in subsection E of this section, the following identifiers are considered sensitive data and shall be removed from the data provided to researchers:

1. Names;

2. Dates of birth;

3. Postal street addresses;

4. Telephone numbers;

5. Email addresses;

6. Social security numbers;

7. Medical record numbers;

8. Biometric identifiers, including finger and voice prints; and

9. Full face photographic images and any comparable image.

E. The director may on a case-by-case basis approve the dissemination of data containing a limited number of the identifiers listed in subsection D of this section for research benefiting the department provided the researcher agrees that any such information shall be kept confidential in accordance with 6VAC35-170-40 or released or published only in aggregate form.

F. The human research review process shall be followed when the data requested by a researcher are such that a reasonable person could identify the research participants.

G. Industry standard levels of encryption shall be required to protect all juvenile record information provided to researchers.

H. Upon determining the requirements in subsection C of this section are met, the director shall designate an internal committee , which shall meet within 20 business days of receiving the proposal. The internal committee shall:

1. Review the data requested and determine if it is necessary to restrict the scope of the information provided. The scope of information may be restricted for any reason.

2. Determine the research is beneficial to the department.

3. Ensure juvenile confidential information will be protected adequately.

4. Make a written recommendation to the director to approve or disapprove the request.

I. The director shall approve or deny the proposal within 10 business days of receiving the recommendation.

J. The department shall notify the researcher of the director's decision within five business days of the director making the decision.

1. If the director denies the proposal, the notification shall include a written rationale for the denial.

2. If the director approves the proposal, the notification shall include the research agreement containing the director's signature. The agreement shall outline the respective responsibilities of the parties and shall specify:

a. When progress reports shall be required. If the external research request also involves human research, this schedule of progress reports shall be developed in consultation with the HRRC;

b. That the department shall have unrestricted permission to use the research findings in accordance with professional standards of research;

c. That a final report shall be submitted electronically to the department;

d. That unless waived by the director or the director's designee, all external articles, reports, and presentations made from the data collected shall be submitted electronically to the department and shall include the statement "The findings of this study are the responsibility of the researchers, and cooperation by the Virginia Department of Juvenile Justice in facilitating this research should not be construed as an endorsement of the conclusions drawn by the researchers;" and

e. That the research agreement shall not be effective until signed by both the principal researcher and the director.

K. The department shall provide the principal researcher, by first class mail, electronic mail, or facsimile, a final copy of the research agreement containing the director's signature .

L. External case-specific data requests submitted through the VLDS shall not be subject to the requirements of this section. Researchers submitting such requests shall adhere to the provisions of 6VAC35-170-67.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 33, Issue 5, eff. December 1, 2016; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-67. VLDS requests.

A. External case-specific data requests submitted through the VLDS shall be submitted to the department using the VLDS portal.

B. The researcher shall comply with all VLDS procedures in order to access data through the VLDS.

C. The chair of the HRRC shall have primary responsibility for reviewing and approving requests submitted through the VLDS portal. The chair of the HRRC may not approve an external case-specific data request unless the request meets the following requirements:

1. The request satisfies the conditions for department approval of research identified in 6VAC35-170-30 and 6VAC35-170-50;

2. The request is not a human research proposal and does not require the HRRC's review;

3. The request is in the required format and includes all required information;

4. The request complies with basic research standards and applicable laws; and

5. The data requested are accessible and available in the VLDS.

D. Upon reviewing the data request, the chair of the HRRC may restrict the scope of the data, provided the data requested are unrelated to the purpose of the research study.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-69. Minor amendments to data requests.

If the researcher offers a minor amendment to an external data request that the director previously approved in accordance with the provisions of this chapter, the chair of the HRRC may conduct an expedited review of the amendment, provided the amendment does not alter the scope of the request. Additional review or approval by the internal committee or director shall not be required.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-70. Requirements specific to human research.

A. All human research shall comply with Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia and all other applicable laws regarding human research.

B. Human research involving known and substantive physical, mental, or emotional risk to subjects, including the withholding of any prescribed program of treatment, and all experimental medical, pharmaceutical or cosmetic research, are specifically prohibited.

C. Offering incentives to participate in research is discouraged but not prohibited. Incentives shall be appropriate to the juveniles' custodial status and proportionate to the situation.

D. If sensitive data are provided, the researchers must comply with appropriate security and non-disclosure requirements.

E. No human research shall be conducted without the approval of the HRRC.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-80. Informed consent required for human research.

A. Except as provided elsewhere in this chapter, no researcher may involve a human subject in human research without first obtaining the informed consent of the human subject or his legally authorized representative. A researcher shall seek such consent only under circumstances that provide the human subject or the legally authorized representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence.

B. If a human subject is competent, informed consent shall be given in writing by the subject and witnessed.

C. If a human subject is not competent, informed consent shall be given in writing by the subject's legally authorized representative and witnessed.

D. If a human subject is a minor who is otherwise capable of giving informed consent, informed consent shall be given in writing by both the minor and his legally authorized representative.

E. If two or more persons who qualify as legally authorized representatives with decision-making authority inform the researcher that they disagree as to the participation of the human subject, the subject shall not be enrolled in the human research that is the subject of the consent.

F. Notwithstanding consent by a legally authorized representative, no person who is otherwise capable of giving informed consent shall be forced to participate in human research.

G. A legally authorized representative may not consent to nontherapeutic research unless the HRRC determines that the research will present no more than a minimal risk to the human subject.

H. The informed consent form shall not include any language through which the human subject waives or appears to waive any legal right, including the release of an individual, institution, or agency or any agent thereof from liability for negligence .

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-90. Exemptions from the requirements governing human research.

A. The following categories of human research are not subject to this chapter's provisions governing human research. Except as otherwise provided by law or regulation, these activities shall be subject to the nonhuman research review and approval process established by the department.

1. Activities of the Virginia Department of Health conducted pursuant to § 32.1-39 of the Code of Virginia.

2. Research or student learning outcomes assessments conducted in educational settings involving regular or special education instructional strategies; the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; or the use of educational tests, whether cognitive, diagnostic, aptitude, or achievement, if the data from such tests are recorded in a manner so that subjects cannot be identified, directly or through identifiers linked to the subject.

3. Research involving solely the observation of public behavior, including observation by participants, or research involving survey or interview procedures unless subjects can be identified from the data either directly or through identifiers linked to the subjects, and either:

a. The information about the subject, if it became known outside the research, reasonably could place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability; or

b. The research deals with sensitive aspects of the subject's own behavior, such as sexual behavior, drug or alcohol use, or illegal conduct.

4. The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the subjects cannot be identified from the information either directly or through identifiers linked to the subjects.

5. Medical treatment of an experimental nature intended to save or prolong the life of the subject in danger of death, to prevent the subject from becoming disfigured or physically or mentally incapacitated, or to improve the quality of the subject's life.

B. Pursuant to 45 CFR 46.101, the exemptions outlined in this section shall not apply to research conducted upon individuals involuntarily confined in a penal institution, including individuals committed to a juvenile correctional center or juvenile secure detention center.

C. Pursuant to 45 CFR 46.101, the exemptions outlined in subdivision A 3 of this section shall not apply to research conducted on children who have not attained age 18 years.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-100. Proposal for external research.

A. If the external research is proposed to take place in a particular organizational unit, the principal researcher shall present a preliminary research proposal to the organizational unit head and get the organizational unit head's endorsement .

B. The principal researcher shall submit to the coordinator of external research a complete research proposal describing the research project and containing:

1. Name, address, telephone number, email address, title, and affiliation of the principal researcher;

2. Name, telephone number, and email address of the person who will coordinate the project, if different from the principal researcher;

3. Funding source, if any;

4. Date of the proposal's submission to the department;

5. Title or descriptive name of the proposed research project;

6. Statement of the specific purpose of the proposed research project with anticipated results, including benefit to the department;

7. A concise description of the research design and techniques for data collection and analysis and of the likely effects of the research methodology on existing programs and institutional operations;

8. Timeframes indicating proposed beginning and ending dates for (i) data collection, (ii) analysis, (iii) preliminary report, and (iv) final report;

9. A list of resources the researcher will require from the department or its units, such as staff, supplies, materials, equipment, work spaces, or access to clients and files;

10. The written endorsement from the organizational unit head in accordance with subsection A of this section;

11. A written endorsement from the institutional review board of the institution or organization with which the researcher is affiliated; and

12. A signed and dated statement that the principal researcher and research staff have read, understand, and agree to abide by these regulations.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-110. Initial review by coordinator of external research.

The coordinator of external research shall receive all research proposals from external researchers and shall:

1. Ensure that the proposals are in the required format and include all required information;

2. Confirm that the proposal complies with basic research standards and applicable laws; and

3. Refer the proposals to appropriate department personnel for review, which , for all proposed human research shall include the department's HRRC.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-120. (Repealed.)

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; repealed, Virginia Register Volume 33, Issue 5, eff. December 1, 2016.

6VAC35-170-130. Human Research Review Committee.

A. The department shall establish an HRRC composed of persons of various backgrounds to ensure the competent, complete, and professional review of human research activities conducted or proposed to be conducted or authorized by the department. No member of the HRRC shall be directly involved in the proposed human research or have administrative approval authority over the proposed research except in connection with his role on the HRRC.

B. The HRRC may ask persons with pertinent expertise and competence to assist in the review of any research proposal or ongoing human research activities.

C. The HRRC may require additional information from the researcher before making a recommendation to the director.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-140. Timeline for review of human research proposals.

A. The HRRC shall review proposals involving human research within 30 business days of receiving a complete research proposal.

B. At the request of the researcher, the HRRC may conduct an expedited review when the proposed research involves no more than minimal risk to the human subjects and:

1. The proposal has been reviewed and approved by another agency's HRRC; or

2. The review involves only minor changes to a previously approved research project .

C. A proposal that undergoes expedited review pursuant to subdivision B 2 of this section shall be approved in writing by the chair of the HRRC before the researcher may proceed. Additional review or approval by the director shall not be required.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-150. HRRC review of human research proposals.

In reviewing the human research proposal, the HRRC shall consider the potential benefits and risks to the human subjects and shall recommend approval only when :

1. The benefits to the human subjects outweigh the risks;

2. The methodology is adequate for the proposed research;

3. The research, if nontherapeutic, presents no more than a minimal risk to the human subjects;

4. The rights and welfare of the human subjects are adequately protected;

5. Appropriate provisions have been made to get informed consent from the human subjects, as detailed in 6VAC35-170-160;

6. The researchers are appropriately qualified;

7. The criteria and means for selecting human subjects are valid and equitable; and

8. The research complies with the requirements set out in this chapter.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-160. HRRC review of informed consent provisions.

A. The HRRC shall review and approve the consent process and all required consent forms for each proposed human research project before recommending approval to the director.

B. The committee may approve a consent procedure that omits or alters some or all of the basic elements of informed consent or waives the requirement to get informed consent if the HRRC finds and documents that:

1. The research involves no more than a minimal risk to the subjects;

2. The omission, alteration, or waiver will not adversely affect the rights and welfare of the subjects;

3. The research could not be performed practicably without the omission, alteration, or waiver; and

4. After participation, the subjects will be given additional pertinent information when appropriate.

C. The HRRC may waive the requirement that the researcher get written informed consent for some or all subjects if the principal risk would be potential harm resulting from a breach of confidentiality, and the only record linking the subject and the research would be the consent document. The HRRC may require the researcher to give the subjects and legally authorized representatives a written statement explaining the research. Further, the researcher shall ask each subject whether he wants documentation linking him to the research, and the subject's wishes shall govern.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-170. Recommendation to director and final action.

A. The HRRC shall make a recommendation to the director to deny, approve, or conditionally approve the proposed human research.

B. The director shall approve or deny the proposal within 10 business days of receiving the committee's recommendation.

C. The research agreement shall become effective only after all reviews required by this chapter are completed and the director signs the agreement on behalf of the department. The coordinator of external research shall send a copy of the signed research agreement to the principal researcher before the project may begin.

D. The coordinator of external research shall notify the principal researcher of the director's final decision.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-180. Annual review of human research activities.

The HRRC shall review all human research activities at least annually to ensure that they are conducted in conformance with the proposals as approved by the director.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-185. Researcher noncompliance.

A. The researcher shall report noncompliance with the approved research proposal to the HRRC and the institutional review board.

B. If the HRRC determines that the research activities fail to comply with the approved proposal or violate the Code of Virginia or the Virginia Administrative Code, the department may (i) restrict or terminate further research , (ii) prohibit the researcher from presenting or publishing the research results, or (iii) bar the researcher from conducting future studies.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 33, Issue 5, eff. December 1, 2016; amended, Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-190. Committee reports required.

A. In accordance with § 66-10.1 of the Code of Virginia, the HRRC shall submit to the Governor, the General Assembly, and the director at least annually a report on human research projects approved by the HRRC and the status of such research, including any significant deviation from the proposals as approved.

B. The HRRC also shall submit annually to the Board of Juvenile Justice the same report as required by subsection A of this section.

C. The HRRC shall ensure that an overview of the report required in subsection A of this section, containing a summary of approved human research projects and the results of such projects, is posted on the department's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-200. Progress reports.

A. The department may require periodic reports on the progress of any research project. The principal researcher shall be responsible for providing such reports and any supplementary information requested by the department in a timely manner.

B. The researcher shall submit an annual progress report to the coordinator of external research when the research is not completed within one year of approval.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-210. Department permission to use research findings.

The research agreement shall specify that the department has unrestricted permission to use, as they are published, all data, summaries, charts, graphs or other illustrations resulting from the research project.

Statutory Authority

§ 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005.

6VAC35-170-220. Final report.

A. The department shall require the principal researcher to submit a formal final report to the coordinator of external research and may require up to 10 copies of the report.

B. The report shall contain, unless waived by the director or designee, the following statement:

"The findings of this study are the responsibility of the researchers, and cooperation by the Virginia Department of Juvenile Justice in facilitating this research should not be construed as an endorsement of the conclusions drawn by the researchers."

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

6VAC35-170-230. Written procedures.

A. The department shall establish written procedures regarding the process for obtaining the organizational unit head's endorsement for any external research proposal, as required in 6VAC35-170-100.

B. The department may establish written procedures that outline additional requirements for the submission, approval, and review of research projects and data requests authorized in this chapter. The written procedures also may identify additional data elements that the department deems to be sensitive data.

C. The department shall ensure that any written procedures established pursuant to this chapter are posted on the agency website.

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 37, Issue 14, eff. April 15, 2021.

FORMS (6VAC35-170).

Research Agreement Form (rev. 4/2021)

Research Proposal Summary (rev. 4/2021)

Confidentiality Agreement (eff. 4/2021)

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