Administrative Code

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Virginia Administrative Code
Title 12. Health
Agency 5. Department of Health
Chapter 20. Regulations for the Conduct of Human Research

12VAC5-20-10. 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 institution" means employed by or contracting with the institution or directly or indirectly involved in the management thereof.

"Commissioner" means the Commissioner of the Department of Health.

"Committee" means human research committee assembled pursuant to 12VAC5-20-70 of this chapter by any institution defined herein.

"Department" means the Department of Health.

"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).

"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.

"Institution" or "agency" means any facility, program, or organization owned or operated by the Commonwealth, by any political subdivision, or by any person, firm, corporation, association, or other legal entity.

"Legally authorized representative" means, in the following specified order of priority, (i) the parent or parents having custody of a prospective subject of human research 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 person who is the prospective subject of human research, provided the advance directive authorizes the agent to make decisions regarding the person's participation in human research; (iii) the legal guardian of a prospective subject of human research; (iv) the spouse of a prospective subject of human research, except where a suit for divorce has been filed and the divorce decree is not yet final; (v) an adult child of a prospective subject of human research; (vi) a parent of a prospective subject of human research when the individual is an adult; (vii) an adult brother or sister of a prospective subject of human research; or (viii) any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject of human research to such person'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 shall include an attorney-in-fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney-in-fact shall not be 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 be qualified to act as a legally authorized representative.

"Minimal risk" means that the risks of harm or discomfort 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, tests, or treatments.

"Minor increase over minimal risk" means there is only slightly more than minimal risk; potential harms are transient and reversible with respect to any harm; and there is an extremely small probability that the subject will experience severe pain, discomfort, stress, or harm.

"Nontherapeutic research" means human research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the subject.

"Protected health information" or "PHI" means individually identifiable health information that is created or received by or on behalf of the institution or agency that is maintained or transmitted in any medium, including electronic media. PHI excludes individually identifiable health information in:

1. Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 USC § 1232g;

2. Records described at 20 USC § 1232g(a)(4)(B)(iv) (educational records not otherwise covered under the Family Educational Rights and Privacy Act in subdivision 1 of this definition); or

3. Employment records held by a covered entity in its role as an employer.

"Subject" or "human subject" means a living person about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the person or (ii) identifiable private information.

Statutory Authority

§§ 32.1-12 and 32.1-12.1 of the Code of Virginia.

Historical Notes

Derived from VR355-01-400 § 1, eff. July 1, 1993; amended, Virginia Register Volume 32, Issue 8, eff. January 14, 2016.

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