Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 20 - REGULATIONS FOR THE CONDUCT OF HUMAN RESEARCH › Section 12VAC5-20-10 - 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:
"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.