Title of Regulation: 6VAC35-170. Minimum Standards for Research Involving Human Subjects or Records of the Department of Juvenile Justice (amending 6VAC35-170-10, 6VAC35-170-30, 6VAC35-170-40, 6VAC35-170-50, 6VAC35-170-80, 6VAC35-170-100, 6VAC35-170-140, 6VAC35-170-170, 6VAC35-170-190, 6VAC35-170-200, 6VAC35-170-220; adding 6VAC35-170-62, 6VAC35-170-65, 6VAC35-170-185; repealing 6VAC35-170-120).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 28, 2016.

Agency Contact: Janet P. Van Cuyk, Legislative and Research Manager, Department of Juvenile Justice, 600 East Main Street, 20th Floor, P.O. Box 1110, Richmond, VA 23218, telephone (804) 588-3879, FAX (804) 371-6490, or email janet.vancuyk@djj.virginia.gov.

Basis: Section 66-10.1 of the Code of Virginia directs the Department of Juvenile Justice's State Board of Juvenile Justice to promulgate regulations pursuant to the Administrative Process Act to effectuate the provisions of Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia for human research to be conducted or authorized by the department. Thus, the regulation is mandatory.

The board is empowered with general authority to promulgate regulations by § 66-10 of the Code of Virginia that states the board may "promulgate such regulations as may be necessary to carry out the provisions of this title and other laws of the Commonwealth administered by the Director or the Department."

Purpose: The Minimum Standards for Research Involving Human Subjects or Records of the Department of Juvenile Justice (6VAC35-170) establishes the regulatory requirements and minimum standards for research on human subjects who are under the care or supervision of department or other board regulated programs or facilities. The regulation became effective February 1, 2005, and is intended to protect the safety, rights, and confidentiality of human research subjects.

The board approved the submission of a Notice of Intended Regulatory Action (NOIRA) for 6VAC35-170, Minimum Standards for Research Involving Human Subjects or Records of the Department of Juvenile Justice, on September 13, 2013, and it was submitted on February 18, 2014. The Executive Branch review for this stage was completed on March 13, 2014. The NOIRA was published in the Virginia Register of Regulations on April 21, 2014. The public comment period ended on May 21, 2014. The board approved the proposed amendments to the regulatory language on November 12, 2014.

The proposed amendments to the regulation provide the public information on the requirements and the decision process for research proposals involving only data requests. Additionally, the proposed amendments require researchers to report noncompliance with the conditions of the signed research agreements and authorize the department and Human Research Review Committee to prohibit further research or restrict the publication and use of the data research results.

Substance: The proposed language describes how all external data requests and research proposals within the Commonwealth's juvenile justice system will be coordinated, reviewed, and approved or denied. The proposed language provides the process for the review and approval of two new types of external data requests. These are (1) external aggregate data requests (new section: 6VAC35-170-62) and (2) external case-specific data requests (new section: 6VAC35-170-65). Proposed language also addresses researcher noncompliance (new section: 6VAC35-170-185). Additional revisions have been proposed to bring the current language in the regulation related to human research in line with the requirements of Title 32.1 of the Code of Virginia.

Issues: The primary advantage of the proposed amendment to the public is providing the public with the requirements and decision process for research proposals involving only data requests. Additionally, language has been proposed requiring an additional layer of review to ensure juvenile information is adequately protected when providing de-identified data. The current timeline for the decision process for research proposals not involving human research is 40 days. The proposed timeline for the decision process for aggregate data requests has been shortened to 20 days. The primary advantage to the department and the Commonwealth is proposed language allowing the department the discretion to approve or deny research projects to ensure selected projects align with the current department needs and priorities. Finally, proposed language allows the department or the Human Research Review Committee to restrict or terminate the work of researchers who fail to comply with the approved conditions of a research proposal. There are no disadvantages to the public, the department, or the Commonwealth in adopting the proposed changes to the regulation.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Juvenile Justice proposes 1) to reduce the time allotted for decisions for aggregate data requests and 2) to require researchers to submit an annual progress report.

Result of Analysis. There is insufficient data to accurately compare the magnitude of the benefits versus the costs.

Estimated Economic Impact. These regulations establish procedures for coordination, review, approval, and denial of data requests and research proposals involving juveniles within the Commonwealth's juvenile justice system.

One of the proposed changes will reduce the time to make decisions for aggregate data requests from 30 days to 20 days. With this change, researchers will be informed of a decision regarding their request sooner than it is currently.

Another proposed change will require researchers to submit an annual progress report to the Department of Juvenile Justice (DJJ). DJJ reports that the majority of projects are completed within one year and expects to receive only 3-4 annual reports from researchers. Furthermore, DJJ states that the type of information that will be included in the annual report is already required by the Institutional Review Boards and should require minimal to no extra work on the researchers part to comply.

The remaining proposed changes are formatting and clarifying changes reflecting the practices currently followed and are not expected to create any significant economic impact other than improving the clarity of the regulations.

Businesses and Entities Affected. These regulations primarily apply to researchers wishing to analyze data involving juveniles within the Commonwealth's juvenile justice system. In fiscal year 2014, DJJ received six research proposals and approved five of those proposals. In the same timeframe, the average daily population in three juvenile correctional centers was 599 and the average daily population in 25 juvenile detention centers was 735. There were also 1,366 placements in 19 juvenile group homes/shelter care facilities.

Localities Particularly Affected. The regulations apply throughout the Commonwealth.

Projected Impact on Employment. The proposed amendments are not expected to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are not expected to affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments are not expected to affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are not expected to adversely affect small businesses.

Real Estate Development Costs. The proposed amendments are not expected to affect real estate development costs.

Agency's Response to Economic Impact Analysis: The responsible Virginia Board of Juvenile Justice agency representatives have reviewed the Department of Planning and Budget's (DPB) economic impact analysis of 6VAC35-170, Minimum Standards for Research Involving Human Subjects or Records of the Department of Juvenile Justice. The agency is in agreement with DPB's analysis.

Summary:

The proposed action addresses how all external data requests and research proposals within the Commonwealth's juvenile justice system will be coordinated, reviewed, and approved or denied. The proposed amendments provide the process for the review and approval of (i) external aggregate data requests, (ii) external case specific data requests, and (iii) human research proposals. The proposed amendments also require researchers to report noncompliance with the conditions of the signed research agreements and authorize the Department of Juvenile Justice and the Human Research Review Committee to prohibit further research or restrict the publication and use of the data research results.

CHAPTER 170
REGULATION GOVERNING MINIMUM STANDARDS FOR JUVENILE INFORMATION REQUESTS FROM AND RESEARCH INVOLVING HUMAN SUBJECTS OR RECORDS OF WITHIN THE DEPARTMENT OF JUVENILE JUSTICE

6VAC35-170-10. Definitions.

Unless the context clearly indicates otherwise, the following words and terms when used in this regulation chapter shall have the following meanings, consistent with the definitions offered in § 32.1-162.16 of the Code of Virginia:

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

"De-identified data" means data with common identifiers, such as names, phone numbers, social security numbers, 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 of the Department of Juvenile Justice, or his 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 the department, or who are not employees of another state agency conducting a study at the direction of the General Assembly.

"Human subject" means any individual who is under the department's care, custody or supervision, or a member of the family of such an individual, who is or who is proposed to be a subject of human research.

"Human research" means any systematic investigation using human subjects, that may expose those subjects to physical or psychological injury, and that departs from the application of established and accepted therapeutic methods appropriate to meet the subject's needs 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" 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 individual who is under the department's care, custody, or supervision, or a member of the family of such an individual, 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 any attendant discomforts, and risks and benefits reasonably to be expected;

2. A disclosure of any 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 any 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, any questions by the person about the procedures and protocols.

"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.

"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, halfway house, court service unit, regional office or other organizational unit of the department.

"Principal researcher" means the individual who is responsible for the research design, the conduct of research, supervision of any 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, statement of those problems in researchable format, 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.

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

6VAC35-170-30. Professional ethics.

The 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.

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 in a consolidated form that protects the identity of individuals, utilizing de-identified data or giving raw data to the department for possible further analysis.

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

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

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

2. The proposed research 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 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.

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

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

B. The coordinator of external research 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 coordinator of external research 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 the Research Proposal Form, 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:

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

2. The proposal is not a human research proposal and is not required to be reviewed by the Human Research Review Committee;

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

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

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

6. The data requested is accessible;

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

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

D. The following identifiers shall be removed from the data provided to researchers:

1. Names;

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

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

4. Telephone numbers;

5. Social security numbers;

6. 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.

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 committee to meet within 20 business days of receiving the proposal. The 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.

4. Make a 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.

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. The department shall provide a final signed copy of the research agreement to the principal researcher by first class mail, electronic mail, or facsimile.

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

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

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

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

D. E. 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.

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

F. G. No informed consent form shall include any language through which the human subject waives or appears to waive any legal rights right, including any release of any individual, institution, or agency or any agents agent thereof from liability for negligence (see § 32.1-162.18 of the Code of Virginia).

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

A. If the 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 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, title and affiliation of the principal researcher;

2. Name of the person who will immediately supervise 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. Time frames Timeframes indicating proposed beginning and ending dates for (i) data collection, (ii) analysis, (iii) preliminary report, and (iv) final report;

9. A listing of any 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. Endorsement A written endorsement from the head of the organizational unit where the research will be conducted, if applicable;

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

6VAC35-170-120. Research proposals not involving human research. (Repealed.)

Designated department staff shall review research proposals that do not involve human research and make a recommendation to the director within 20 days of receiving the proposal. The director shall approve or deny proposals within 10 days of receiving the staff recommendation.

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

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

B. At the request of the researcher, the committee Human Research Review Committee 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; or

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

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

A. The committee Human Research Review Committee 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 are completed and the director signs the agreement on behalf of the department. The coordinator of external research must send a copy of the signed Research Agreement research agreement to the researcher before the project may begin.

6VAC35-170-185. Researcher noncompliance.

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

B. Research activities identified by the department or the Human Research Review Committee as failing to comply with the approved proposal or in violation of the Code of Virginia or the Virginia Administrative Code may result in the department restricting or terminating further research and the department may prohibit the researcher from presenting or publishing the research results.

6VAC35-170-190. Committee reports required.

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

B. The committee Human Research Review Committee shall also annually submit to the Board of Juvenile Justice the same report as required by subsection A of this section. The report to the board shall also include a summary of human research proposals that were not approved.

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 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 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, 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."

FORMS (6VAC35-170)

Research Proposal Summary (undated; filed 12/2015)

Research Agreement (undated; filed 12/2015)