Title of Regulation: 6VAC35-170. Regulation Governing Minimum Standards for Juvenile Information Requests from and Research Involving Human Subjects within the Department of Juvenile Justice (amending 6VAC35-170-10, 6VAC35-170-20, 6VAC35-170-50, 6VAC35-170-60, 6VAC35-170-65, 6VAC35-170-70 through 6VAC35-170-110, 6VAC35-170-130 through 6VAC35-170-200, 6VAC35-170-220; adding 6VAC35-170-55, 6VAC35-170-67, 6VAC35-170-69, 6VAC35-170-230; repealing 6VAC35-170-62).

Statutory Authority: §§ 66-10 and 66-10.1 of the Code of Virginia.

Public Hearing Information: No public hearings are currently scheduled.

Public Comment Deadline: March 31, 2021.

Effective Date: April 15, 2021.

Agency Contact: Kristen Peterson, Regulatory Coordinator, Department of Juvenile Justice, P.O. Box 1110, Richmond, VA 23218-1110, telephone (804) 588-3902, FAX (804) 371-6497, or email kristen.peterson@djj.virginia.gov.

Basis: The Board of Juvenile Justice is entrusted with general, discretionary authority to promulgate regulations by § 66-10 of the Code of Virginia, which authorizes the board to promulgate such regulations as may be necessary to carry out the provisions of this title and other laws of the Commonwealth. Section 66-10.1 of the Code of Virginia imposes upon the board the duty to promulgate regulations for human research conducted or authorized by the department in accordance with Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia.

Purpose: During the last periodic review and amendment of this chapter, which took effect on December 1, 2016, the board revised the regulation to address how external data requests and research proposals within the Commonwealth's juvenile justice system would be coordinated, reviewed, and approved or denied. Rather than providing clarity and enhancing compliance, some of these changes generated additional confusion among the regulated community or created an unsustainable process for department staff and researchers. The proposed changes are intended to clarify the processes applicable for individuals or organizations seeking to conduct research on or requesting data regarding youth under the authority of the department or a department-regulated facility. These amendments provide the regulated community with needed guidance regarding the requirements for submitting data requests and research proposals and the process for handling and approving or denying these requests. New provisions that further protect sensitive data regarding these youth and that allow for more severe consequences for researchers who fail to comply with approved proposals or laws or regulations are needed to ensure the protection of youth under the care of the Department of Juvenile Justice (DJJ) or a DJJ-regulated facility or program and will be essential to protect their safety and welfare.

In addition, the department's participation in the Virginia Longitudinal Data System (VLDS) has generated inquiries among staff and researchers as to whether the existing regulatory requirements apply when external data requests for DJJ-maintained data are submitted through the VLDS. VLDS is a data system that seeks to create usable information for policy and generate cross-agency research by providing de-identified case-specific data from various participating agencies to qualified researchers. Researchers submit data requests through the VLDS portal and work with participating agencies to access whatever data the participating agency elects to make available to the researcher on a case-by-case basis. As the number of requests submitted through VLDS increase, DJJ and researchers should have clear guidance regarding the rules and expectations for submitting such requests.

Rationale for Use of Fast-Track Rulemaking Process: The department does not expect the changes to generate controversy. The amendments seek to simplify the process for external researchers to obtain requested data, protect information deemed sensitive, create a separate process for data requests submitted through the Virginia Longitudinal Data System, and provide additional clarity and guidance to the regulated community.

Substance: The proposed language clarifies the scope of the regulatory provisions regarding human research and specifies that individuals under the care, custody, or supervision of a facility or program regulated by the department or the Board of Juvenile Justice, as well as under the care or supervision of the department, may constitute a human subject for purposes of the regulation. A conforming change is made in the definition of organizational unit head to demonstrate that the head of facilities or programs regulated by the department also may endorse human research conducted on residents or youth under their supervision or care.

The amendments:

Add the Confidentiality Form that must be submitted to the department for external case-specific data requests, remove a few of the identifiers currently required to be removed from case-specific data before the department or department-regulated facility or program provides this information to researchers, and place restrictions on the director's existing authority to allow the dissemination of data with some of these identifiers.

Exempt external-case specific data requests submitted through the VLDS from the requirements applicable to other such data requests and establishes new rules for these requests.

Allow for an expedited review conducted by the chair of the Human Research Review Committee when minor amendments are made to previously approved data requests.

Add two exceptions to the categories of research exempt from the requirements governing human research to conform to federal regulatory provisions contained in 45 CFR 46.101(b).

Remove provisions directing the researcher, as part of the required proposal mandated for external research, to include the endorsement of an academic advisor for student research and the appropriate juvenile and domestic relations judge for records involving juveniles at state and local court service units.

Insert an additional potential consequence for researchers who fail to comply with the approved proposal or who violate state statutes or regulations. In addition to restricting or terminating further research and prohibiting the researcher from presenting or publishing the research results, as authorized under the existing regulation, the proposal allows the department to bar the researcher from conducting studies in the future.

Require an overview of the annual report currently mandated in the regulation be completed and posted on the department's website unless the information is exempt from disclosure under the Freedom of Information Act.

Remove provisions requiring the regulant to comply with various mandates in accordance with department procedures. These provisions violate the Virginia Code Commission's 2016 regulation (1VAC7-10-140) prohibiting state agencies from incorporating into their regulations documents established by that agency. To alert regulants to department-developed procedures pertaining to data requests and research proposals, the amendments add a new section that allows the department to establish written procedures to comply with the regulatory requirements contained in this chapter and that requires the department to place such procedures on its website.

Make minor changes intended to promote clarity including, for example, establishing a new term (internal committee), to distinguish between the human research review committee and the committee that oversees de-identified case specific data.

Issues: Advantages of the action include (i) promoting uniformity for department-regulated facilities and programs seeking to respond to external data requests and research proposals for youth under such facilities' care; (ii) protecting sensitive data and ensure that protected records and information concerning court-involved youth remain confidential; (iii) ensuring that the department's regulations more closely reflect federal and state statutes and regulations; and (iv) removing several needless, impractical, and burdensome requirements that tend to delay or hamper research efforts. These changes may help to advance research that ultimately could reduce recidivism and otherwise benefit the public and court-involved youth in the Commonwealth. A disadvantage to the public is that allowing the department to bar the researcher from conducting studies in the future, however, could quell such research efforts, which ultimately may harm the public.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. External researchers seeking data on incarcerated minors under the supervision or custody of the Department of Juvenile Justice (DJJ) must adhere to the application and review process established in 6 VAC 35-170. The Board of Juvenile Justice (Board) proposes to amend this regulation to remove provisions that are no longer valid, address data requests submitted through the Virginia Longitudinal Data System (VLDS), and impose additional data security requirements. The Board also seeks to make a number of amendments to simplify the language and clarify existing requirements to reduce confusion amongst regulants.

Background. The Board proposes to make several changes to this regulation at the recommendation of DJJ staff; in particular, the coordinator of external research maintained a log of frequently asked questions and issues raised by researchers who sought access to DJJ data. The most substantive changes are summarized as follows:

1. In the interest of simplicity, the Board wishes to shorten the title of the regulation to Regulation Governing Juvenile Data Requests and Research Involving Human Subjects;

2. The Board seeks to amend two existing definitions to clarify existing policy. First, the definition of "human subject" would be amended to also include an individual who is "under the care, custody or supervision of a facility or program regulated by [DJJ or the Board]," as well as an individual who is "employed in or provides contractual services to a juvenile correctional center or other facility or program regulated by [DJJ or the Board] and who is or who is proposed to be a subject of human research." That is, any research that directly involves DJJ staff or contractors and any youth under their authority at any facility either directly run by or contracted by DJJ would be considered "human research."

The Board also seeks to amend the definition of "legally authorized representative" to fully clarify that "for the purposes of this chapter, "legally authorized representative" shall not include an official or employee of the institution or agency conducting or authorizing the research." Although the current definition includes the statement, "No official or employee of the institution or agency conducting or authorizing the research shall act as a legally authorized representative," DJJ reported that "Some researchers believed that this definition meant that DJJ could provide consent on behalf of juveniles, as if they were a "ward of the state."

1. The Board also seeks to clarify 6 VAC 35-170-65 (section 65), which lays out the process for external researchers to use when seeking case specific data, by adding two new definitions and updating procedural language. First, the Board proposes to add a definition of "internal committee" to mean "the committee established by the department pursuant to 6 VAC 35-170-65 to oversee de-identified case specific data." Second, the Board would add a definition of "sensitive data" to mean "data, the compromise of which, with respect to the confidentiality, integrity, or availability, could have a material adverse effect on agency programs or the privacy to which individuals are entitled."

These definitional changes, when used in conjunction with certain identifying information listed in section 65, would clarify which data elements would be considered sensitive data and would therefore have to be removed for the data to be considered de-identified. These identifiers include names, dates of birth, postal street addresses, telephone numbers, email addresses (a proposed addition to the list), social security numbers, and medical record numbers. Thus, the amendments serve to clarify the existing process: that once the coordinator of external research ascertains that the data request does not include any sensitive data, the director would then designate an internal committee to review the proposal and make a written recommendation to the director.

The Board seeks to further amend section 65 to specify that any request for sensitive data would require a review by the Human Research Review Committee (HRRC). Once again, the Board is not amending the process so much as explaining the circumstances that would warrant HRRC review. Further the Board seeks to clarify that the director could make an exception if the request was for only a limited number of the identifiers listed above, provided the researchers agree to the confidentiality requirements as stated in 6 VAC 35-170-40.

1. DJJ is one of several agencies that participates in the Virginia Longitudinal Data System (VLDS), which has prompted questions from researchers using the VLDS portal as to how requests submitted via the VLDS are evaluated vis-a-vis the existing regulation. Hence, the Board proposes to add a new section explicitly addressing VLDS requests.

The Board seeks to add a definition of "Virginia Longitudinal Data System or VLDS" to mean "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."

The new section 6 VAC 35 170-67 titled "VLDS requests" would essentially require researchers using the portal to comply with the same requirements as they would for a request directly submitted to DJJ. However, rather than go through review and approval by the director or an internal committee, the chair of the HRRC would have the primary responsibility for reviewing and approving requests made through the VLDS portal. Moreover, the data being requested would need to already be available in the VLDS database. By addressing the requirements and process in a separate section, the Board seeks to provide clear and simple directions for researchers choosing to adopt this route for accessing data.

1. The Board proposes to repeal 6 VAC 35-170-62 (Review and approval of aggregate data requests) and replace it with 6 VAC 35-170-55 with the same title. This change is intended to clarify how this process works in relationship to section 60, which prohibits any research involving a case specific data request or human research request from beginning 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. Moving the section regarding aggregate data before section 60 is intended to distinguish between aggregate data requests in the proposed section 55, and case specific data requests or human research requests in section 60, and to clarify that aggregate data requests fall outside the requirements in section 60. The actual process of reviewing and approving aggregate data requests would not be changed.

2. The Board proposes to add a new section 6 VAC 35-170-69 titled "Minor amendment to data requests" to allow researchers to submit amendments to existing data requests as long as the scope of the original data request or research proposal remains unchanged. DJJ staff offered the following examples of minor amendments: revising the recruitment method due to low enrollment (e.g. putting up a recruitment poster in a court service unit office when that method was not previously used), revising the wording of a question previously considered confusing, or changing the order of questions on a survey for better flow. The section would allow the chair of the HRRC to conduct an expedited review of the amendment, and would not require the director or internal committee to review the amendment.

3. The Board proposes to add a new section 6 VAC 35-170-230 titled "Written procedures" that requires DJJ to establish written procedures for requesting approval of a research proposal by a DJJ unit head. DJJ may also use written procedures to provide additional guidelines for the submission, approval, and review of research proposals or data requests. The proposed section also serves to notify regulants that these procedures may be accessed through DJJ's website.¹ Compliance with these procedures would not be required, but they would serve to streamline the process for researchers who choose to use them.

4. The Board seeks to add a subsection to section 190 "Committee reports required," which would require that the HRRC post a summary of approved human research projects, unless the research is explicitly protected under the Virginia Freedom of Information Act.

5. Throughout the regulation, the Board proposes to make explicit exactly which parties within DJJ would be responsible for making decisions regarding data requests and for communicating those decisions in writing to the principal investigators making the request.

Estimated Benefits and Costs. The proposed amendments would help streamline the process for different types of data and research requests, clarify the requirements for each type of request, and identify the relevant DJJ personnel who would be responsible for reviewing and approving each type of request. The proposed amendments would not create new costs for researchers requesting data or human research, while continuing to safeguard the privacy and protection of incarcerated juveniles and/or staff at DJJ facilities. Since the requirements themselves are no more onerous or restrictive than they were before, and to the extent that researchers seeking data are able to better understand and follow DJJ procedures, both the researchers and DJJ staff stand to benefit.

Businesses and Other Entities Affected. The proposed amendments would affect researchers at universities or private non-profit organizations or foundations that conduct social science research in facilities operated (or sub-contracted) by DJJ. The proposed amendments do not introduce any additional costs to conducting such research.

Small Businesses² Affected. Small businesses are unlikely to be affected by the proposed amendments. The proposed amendments create no new costs.

Localities³ Affected.⁴ The proposed amendments do not disproportionately affect any specific localities, nor do they introduce new costs for local governments.

Projected Impact on Employment. The proposed amendments are unlikely to affect employment.

Effects on the Use and Value of Private Property. To proposed amendments would not affect the value of private property. Real estate development costs would not be affected.

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¹See http://www.djj.virginia.gov/pages/admin/data-research-requests.htm for details.

²Pursuant to § 2.2-4007.04 of the Code of Virginia, 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."

³"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.

⁴§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The Board of Juvenile Justice agency representatives have reviewed the Department of Planning and Budget's economic impact analysis and are in agreement with the analysis.

Summary:

The amendments (i) remove invalid provisions consistent with recent regulatory amendments, (ii) add provisions addressing external case-specific data requests submitted through the Virginia Longitudinal Data System, (iii) impose additional requirements to ensure that sensitive data disseminated to external entities are protected from unauthorized access, and (iv) make changes to clarify and simplify existing requirements.

6VAC35-170-10. Definitions.

Unless the context clearly indicates otherwise, the The following words and terms when used in this chapter shall have the following meanings, consistent with the definitions offered in § 32.1-162.16 of the Code of Virginia 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" is 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, etc., 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 director of the Department of Juvenile Justice department or the director's designee.

"Encrypted" means the transformation of data through the use of an algorithmic process into a form in which there is a low probability of assigning meaning without the use of a confidential process or key or the securing of the information by another method that renders the data elements unreadable or unusable.

"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 to 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 any 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 any an individual who is: under the department's care, custody, or supervision, or; 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 or parents 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 and the attorney in fact is not employed by the person, institution, or agency conducting the human research. No official or employee of the institution or agency conducting or authorizing the research shall act as a legally authorized representative. 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, the conduct of research implementation, supervision of research staff, and the 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. Research findings should provide valuable information to management for policy options.

"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. Such writing may be available in either in hard copy or electronic form.

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 is 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) providing the provision of information required by the coordinator of external research, organizational unit heads, and the Human Research Review Committee HRRC.

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

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

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

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

4. The proposed research requests for aggregate data or de-identified data, and the human research proposals, comply with all department procedures, which shall be posted on the department's website.

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.

6VAC35-170-60. Formal agreement required.

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

6VAC35-170-62. Review and approval of aggregate data requests. (Repealed.)

A. Aggregate data requests shall be submitted to the department in accordance with procedures posted on the department's website.

B. The department shall determine the following prior to approving the request:

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

2. The data requested is accessible;

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

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

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

D. The principal researcher shall be notified in writing of the approval or denial of the data request within 20 business days of the department receiving the proposal.

1. The department shall provide the principal researcher with documentation of the rationale for the denial of the request when applicable.

2. The department shall provide the principal researcher with a written estimated timeline for receipt of the data when applicable.

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

A. External case-specific data requests shall be submitted to the department via using the Confidentiality Agreement Form, the Research Proposal Form, and the Research Agreement Form, and any attachment required by department procedures.

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 research proposal data request:

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

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

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

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

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

6. The That the data requested is accessible;

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

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

D. The 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 (date of birth, date of admission, date of release, etc.) Dates of birth;

3. Postal address information, other than town or city, state, and zip code street addresses;

4. Telephone numbers;

5. Email addresses;

6. Social security numbers;

6. 7. Medical record numbers;

7. Account numbers (Juvenile Tracking System, Direct Care, etc.);

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

9. Full face photographic images and any comparable image.

E. The director or his designee 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 or his designee shall designate a an internal committee to, 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 adequately protected adequately.

4. Make a written recommendation to the director or his designee 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. Notification of the denial of a proposal shall include a written rationale.

L. Notification of the approval of a proposal shall include the research agreement. The research agreement shall outline the respective responsibilities of the parties and will specify:

1. When progress reports shall be required. If the external research also involves human research, this schedule of progress reports shall be developed in consultation with the Human Research Review Committee;

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

3. A final report shall be submitted electronically to the department;

4. Unless waived by the director or 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

5. The research agreement is not effective until signed by both the principal researcher and the director or his designee.

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

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.

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.

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.

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

A. All human research shall comply with all applicable laws, particularly 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. Research 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 offered shall be appropriate to the juveniles' custodial status and shall be proportionate to the situation.

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

D. E. No human research shall be conducted without the approval of the Human Research Review Committee HRRC.

6VAC35-170-80. Informed consent required for human research (§ 32.1-162.18 of the Code of Virginia).

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.

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

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

C. 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.

D. 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 prospective subject in human research subject, the subject shall not be enrolled in the human research that is the subject of the consent.

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

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

G. No H. The informed consent form shall not include any language through which the human subject waives or appears to waive any legal right, including any the release of any an individual, institution, or agency or any agent thereof from liability for negligence (see § 32.1-162.18 of the Code of Virginia).

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

In accordance with § 32.1-162.17 of the Code of Virginia, the A. The following categories of human research are not subject to this regulation's chapter's provisions governing human research. Except when as otherwise provided for by law or regulation, these activities may 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 become became known outside the research, could 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.

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 head of that organizational unit head and get the organizational unit head's endorsement of the proposal, in accordance with procedures established by the department.

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 numbers number, email address, title, and affiliation of the principal researcher;

2. Name, telephone number, and email address of the person who will immediately supervise 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 or purposes 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 listing 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. A The written endorsement from the head of the organizational unit where the research will be conducted, if applicable head in accordance with subsection A of this section;

11. For student research, endorsement from the researcher's academic advisor or other appropriate persons;

12. For research involving records of juveniles at state and local court service units, a written endorsement from the appropriate juvenile and domestic relations judge or judges;

13. For human research, a 11. A written endorsement from the institutional review board of the institution or organization with which the researcher is affiliated; and

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

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 shall include, for all proposed human research, shall include the department's human research review committee HRRC.

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

A. In accordance with § 32.1-162.19 of the Code of Virginia, the The department shall establish a human research review committee 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 committee 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 committee HRRC.

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

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

A. The Human Research Review Committee will HRCC shall review proposals involving human research within 30 business days of receiving a complete research proposal.

B. At the request of the researcher, the Human Research Review Committee 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 human research review committee HRRC; or

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

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.

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

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

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

2. The methodology is adequate for the proposed research;

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

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

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

5. 6. The researchers are appropriately qualified;

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

7. 8. The research complies with the requirements set out in this regulation and in applicable department policies and procedures chapter.

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

A. The committee 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 committee HRRC finds and documents that:

1. Research 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 practicably 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 committee 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 committee 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 shall be asked whether he wants documentation linking him to the research, and the subject's wishes shall govern.

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

A. The Human Research Review Committee 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 regulation and department procedures chapter are completed and the director signs the agreement on behalf of the department. The coordinator of external research must 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.

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

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

6VAC35-170-185. Researcher noncompliance.

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

B. Research If the HRRC determines that the research activities identified by the department or the Human Research Review Committee as failing fail to comply with the approved proposal or in violation of violate the Code of Virginia or the Virginia Administrative Code, the department may result in the department restricting (i) restrict or terminating terminate further research and the department may, (ii) prohibit the researcher from presenting or publishing the research results, or (iii) bar the researcher from conducting future studies.

6VAC35-170-190. Committee reports required.

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

B. The Human Research Review Committee HRRC also shall also annually 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).

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.

6VAC35-170-220. Final report.

A. The department shall require that the principal researcher to submit a formal final report be submitted 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, contain 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."

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.

FORMS (6VAC35-170)

Research Agreement (rev. 1/2016)

Research Proposal Summary (rev. 1/2016)

Confidentiality Agreement (eff. 2/2021)