Virginia Law

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 a facility licensed by the Virginia Department of Social Services.

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

"Commissioner" means the Commissioner of the Virginia Department of Social Services or the commissioner's designee.

"Committee" means the human research review committee, also known as the Institutional Review Board (IRB), 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 department, including foster 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 person, as defined in § 63.2-1701 A of the Code of Virginia, licensed by the department.

"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 department, or contractor.

"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 does not include research exempt from federal research regulations in accordance with 45 CFR § 46.104(d), as determined by the U.S. Secretary of Health and Human Services (HHS) and published as a notice in the Federal Register.

"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 power of choice. For the purposes of human research, the basic elements of information necessary to such consent include:

1. A reasonable and comprehensible explanation to the person of the proposed procedures or protocols to be followed, the purpose of those procedures or protocols, including descriptions of any attendant discomforts, and the risks and benefits reasonably to be expected;

2. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the person;

3. An instruction that the person may withdraw consent and discontinue participation in the human research at any time without prejudice to the person;

4. An explanation of any costs or compensation that may accrue to the person and, if applicable, the availability of third-party reimbursement for the proposed procedures or protocols; and

5. An offer to answer and answers to any inquiries by the person concerning the procedures and protocols.

"Legally authorized representative" means, in the following specified order of priority, (i) the parent having custody of a prospective subject who is a minor; (ii) the agent appointed under an advance directive, as defined in § 54.1-2982 of the Code of Virginia, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research; (iii) the legal guardian of a prospective subject; (iv) the spouse of a prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final; (v) the adult child of a prospective subject; (vi) the parent of a prospective subject when the subject is an adult; (vii) the adult brother or sister of a prospective subject; or (viii) any person or judicial or other person or body authorized by law or regulation to consent on behalf of a prospective subject to such subject's participation in the particular human research. For the purposes of this chapter, any person authorized by law or regulation to consent on behalf of a prospective subject to such subject's participation in the particular human research includes an attorney in fact appointed under a durable power of attorney, to the extent the power grants the authority to make a decision. The attorney in fact shall not be employed by the entity conducting the human research. No official or employee of the entity conducting or authorizing the research shall be qualified to act as a legally authorized representative.

"Local department" means the local department of social services of any county or city in the 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.