Section 10. Definitions

Unless the context clearly indicates otherwise, 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:

"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 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.

"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 research" means any 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" 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 attendant discomforts, and 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.

"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, court service unit, 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 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.

Historical Notes

Derived from Volume 21, Issue 09, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 05, eff. December 1, 2016.

Statutory Authority

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