32.1-162.16 - Definitions.
§ 32.1-162.16. Definitions.
As used in this chapter, unless the context requires a different meaning:
"Human research" means any systematic investigation, including researchdevelopment, testing and evaluation, utilizing human subjects, that isdesigned to develop or contribute to generalized knowledge. Human researchshall not be deemed to include research exempt from federal researchregulation pursuant to 45 C.F.R. § 46.101(b).
"Informed consent" means the knowing and voluntary agreement, without undueinducement or any element of force, fraud, deceit, duress, or other form ofconstraint or coercion, of a person who is capable of exercising free powerof choice. For the purposes of human research, the basic elements ofinformation necessary to such consent shall include:
1. A reasonable and comprehensible explanation to the person of the proposedprocedures or protocols to be followed, their purposes, includingdescriptions of any attendant discomforts, and risks and benefits reasonablyto be expected;
2. A disclosure of any appropriate alternative procedures or therapies thatmight be advantageous for the person;
3. An instruction that the person may withdraw his consent and discontinueparticipation in the human research at any time without prejudice to him;
4. An explanation of any costs or compensation which may accrue to the personand, if applicable, the availability of third party reimbursement for theproposed procedures or protocols; and
5. An offer to answer and answers to any inquiries by the person concerningthe procedures and protocols.
"Institution" or "agency" means any facility, program, or organizationowned or operated by the Commonwealth, by any political subdivision, or byany person, firm, corporation, association, or other legal entity.
"Legally authorized representative" means, in the following specified orderof priority, (i) the parent or parents having custody of a prospectivesubject who is a minor, (ii) the agent appointed under an advance directive,as defined in § 54.1-2982, executed by the prospective subject, provided theadvance directive authorizes the agent to make decisions regarding theprospective subject's participation in human research, (iii) the legalguardian of a prospective subject, (iv) the spouse of the prospectivesubject, except where a suit for divorce has been filed and the divorcedecree is not yet final, (v) an adult child of the prospective subject, (vi)a parent of the prospective subject when the subject is an adult, (vii) anadult brother or sister of the prospective subject or (viii) any person orjudicial or other body authorized by law or regulation to consent on behalfof a prospective subject to such subject's participation in the particularhuman research. For the purposes of this chapter, any person authorized bylaw or regulation to consent on behalf of a prospective subject to suchsubject's participation in the particular human research shall include anattorney in fact appointed under a durable power of attorney, to the extentthe power grants the authority to make such a decision. The attorney in factshall not be employed by the person, institution, or agency conducting thehuman research. No official or employee of the institution or agencyconducting or authorizing the research shall be qualified to act as a legallyauthorized representative.
"Minimal risk" means that the risks of harm anticipated in the proposedresearch are not greater, considering probability and magnitude, than thoseordinarily encountered in daily life or during the performance of routinephysical or psychological examinations or tests.
"Nontherapeutic research" means human research in which there is noreasonable expectation of direct benefit to the physical or mental conditionof the human subject.
(1979, c. 38, § 37.1-234; 1986, c. 274; 1992, c. 603; 2002, c. 754.)