Virginia Administrative Code › Title 6 - CRIMINAL JUSTICE AND CORRECTIONS › Agency 35 - DEPARTMENT (BOARD) OF JUVENILE JUSTICE › Chapter 170 - REGULATION GOVERNING MINIMUM STANDARDS FOR JUVENILE INFORMATION REQUESTS FROM AND RESEARCH INVOLVING HUMAN SUBJECTS WITHIN THE DEPARTMENT OF JUVENILE JUSTICE › Section 6VAC35-170-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
The following words and terms when used in this chapter
				  shall have the following meanings unless the context clearly indicates
				  otherwise:
"Aggregate data" means statistics that relate to broad
				  classes, groups, or categories so that it is not possible to distinguish the
				  properties of individuals within those classes, groups, or categories.
"Case-specific data" means nonaggregated data that provides
				  information about individuals within a group.
"Coordinator of external research" means the department
				  employee designated by the director to receive research proposals and data
				  requests from external entities and to ensure that the proposals are reviewed
				  in accordance with this chapter and related department procedures.
"De-identified data" means data with common identifiers, such
				  as names, phone numbers, social security numbers, and addresses removed in
				  order to eliminate the ability of an individual viewing the data to determine
				  the identity of an individual.
"Department" means the Department of Juvenile Justice.
"Director" means the director of the department or the
				  director's designee.
"External research" means research conducted at or using the
				  resources of a facility, program, or organization that is owned, operated, or
				  regulated by the department or the Board of Juvenile Justice by researchers who
				  are not part of the department or under contract with the department, or who
				  are not employees of another state agency conducting a study at the direction
				  of the General Assembly.
"Human research" means a systematic investigation, including
				  research development, testing, and evaluation, utilizing human subjects that is
				  designed to develop or contribute to generalized knowledge. Human research
				  shall not be deemed to include research exempt from federal research regulation
				  pursuant to
				  45 CFR
				  46.101(b).
"Human Research Review Committee" or "HRRC" means the
				  committee established by the department to oversee human research proposals and
				  activities in accordance with
				  6VAC35-170-130
				  and §
									32.1-162.19
				  of the Code of Virginia.
"Human subject" means an individual who is under the
				  department's care, custody, or supervision; under the care, custody, or
				  supervision of a facility or program regulated by the department or the Board
				  of Juvenile Justice; or a member of the family of such an individualand who is,
				  or who is proposed to be, a subject of human research. For purposes of this
				  definition, human subject also means an individual who is employed in or
				  provides contractual services to a juvenile correctional center or other
				  facility or program regulated by the department or the Board of Juvenile
				  Justice and who is or who is proposed to be a subject of human research.
"Informed consent" means the knowing and voluntary agreement
				  without undue inducement or any element of force, fraud, deceit, duress, or
				  other form of constraint or coercion of a person who is capable of exercising
				  free choice. The basic elements necessary for informed consent regarding human
				  research include:
1. A reasonable and comprehensible explanation to the person
				  of the proposed procedures and protocols to be followed; their purposes,
				  including descriptions of attendant discomforts; and the risks and benefits
				  reasonably to be expected;
2. A disclosure of alternative procedures or therapies that
				  might be helpful to the person;
3. An instruction that the person may withdraw his consent
				  and stop participating in the human research at any time without prejudice to
				  him;
4. An explanation of costs or compensation that may accrue to
				  the person and whether third party reimbursement is available for the proposed
				  procedures or protocols; and
5. An offer to answer, and answers to, questions by the
				  person about the procedures and protocols.
"Internal committee" means the committee established by the
				  department pursuant to
				  6VAC35-170-65
				  to oversee de-identified case specific data.
"Legally authorized representative" means the parent having
				  custody of a prospective subject; the legal guardian of a prospective subject;
				  or any person or judicial or other body authorized by law to consent on behalf
				  of a prospective subject to such subject's participation in the particular
				  human research, including an attorney in fact appointed under a durable power
				  of attorney, provided the power grants the authority to make such a decision.
				  For purposes of this chapter, "legally authorized representative" shall not
				  include an official or employee of the institution or agency conducting or
				  authorizing the research.
"Minimal risk" means that the risks of harm anticipated in
				  the proposed research are not greater, considering probability and magnitude,
				  than those ordinarily encountered in daily life or during the performance of
				  routine physical or psychological examinations or tests.
"Nontherapeutic research" means human research in which there
				  is no reasonable expectation of direct benefit to the physical or mental
				  condition of the human subject.
"Organizational unit head" means the person in charge of a
				  juvenile correctional center, court service unit, or other organizational unit
				  of the department or a Board of Juvenile Justice-regulated facility, program,
				  or service.
"Principal researcher" means the individual who is
				  responsible for the research design, research implementation, supervision of
				  research staff, and research findings.
"Research" means the systematic development of knowledge
				  essential to effective planning and rational decision-making. It involves the
				  assessment of current knowledge on conceptual problems selected, the statement
				  of those problems in researchable format, the design of methodologies
				  appropriate to the problems, and the application of statistical techniques to
				  organize and analyze data.
"Researcher" means an individual conducting research.
"Research project" means the systematic collection of
				  information, analysis of the data, and the preparation of a report of
				  findings.
"Sensitive data" means data, the compromise of which, with
				  respect to confidentiality, integrity, or availability, could have a material
				  adverse effect on agency programs or the privacy to which individuals are
				  entitled.
"Virginia Longitudinal Data System" or "VLDS" means a data
				  system that provides de-identified case-specific data from participating
				  agencies to qualified researchers through a process that involves submission of
				  requests and approval or denial by each sponsoring agency from which data are
				  sought in an effort to create usable information for policy and generate
				  cross-agency research.
"Written" means the required information is communicated in
				  writing either in hard copy or electronic form.
Statutory Authority: §§
											66-10
					 and
					 66-10.1
					 of the Code of Virginia.