Title of Regulation: 22VAC40-890. Human Subject Research Regulations (amending 22VAC40-890-10).

Statutory Authority: §§ 63.2-217 and 63.2-218 of the Code of Virginia.

Effective Date: November 1, 2011.

Agency Contact: Todd Areson, Institutional Review Board Administrator, Department of Social Services, 801 East Main Street, Richmond, VA 23219, telephone (804) 726-7490, FAX (804) 726-7946, or email todd.areson@dss.virginia.gov.

Summary:

The amendment replaces the definition of "local agency" with the definition of "local department" in conformance with § 63.2-100 of the Code of Virginia.

22VAC40-890-10. Definitions.

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

"Affiliated with the department" means any individual employed, either on a paid or volunteer basis, by the Virginia Department of Social Services, by a local department of social services, or by an agency licensed by the Virginia Department of Social Services.

"Authorized" means to permit the implementation or conducting of research.

"Board" means the Virginia State Board of Social Services.

"Commissioner" means the Commissioner of the Virginia Department of Social Services or his designee.

"Committee" means the human research review committee which reviews and approves human research activities related to this chapter.

"Contractor" means agencies, organizations, or individuals providing goods or services, receiving funds, or under contract with the department or a local agency including, but not limited to, foster homes and day-care homes.

"Department" means the Virginia Department of Social Services.

"Discomforts, risks, and benefits" means the expected advantages and disadvantages to the participant for participating in the research.

"Facility" means any agency licensed by the department including, but not limited to, adult and child day and residential facilities.

"Human participant" or "participant" means any individual, customer, volunteer, or employee who is the subject of research conducted or authorized by the department, facility, local agency, or contractor.

"Human research" or "research" means any formal and structured evaluation involving individuals in a special project, program, or study.

"Informed consent" means the knowing and voluntary agreement of the participant exercising free choice, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

"Legally authorized representative" means a person with authority to consent on behalf of a prospective participant to include (i) the parent or parents having custody, (ii) the legal guardian, or (iii) any person or judicial or other person or body authorized by law or regulation, including an attorney in fact appointed under a durable power of attorney, to the extent the power grants the authority to make a decision related to human research. The attorney in fact shall not be employed by the person or department conducting the human research. No official or employee of the department, facility or local agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.

"Local agency department" means any the local department of social services or department of welfare of any county or city in this Commonwealth.

"Minimal risk" means that the risks of harm to the prospective participant 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.