                                 CODE OF VIRGINIA

DEFINITIONS (§ 32.1-162.16)

As used in this chapter, unless the context requires a different
meaning:		&#8220;Human research&#8221; 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 C.F.R. § 46.101(b).		&#8220;Informed
consent&#8221; 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 shall include:

1. A reasonable and comprehensible explanation to the person of the proposed
procedures or protocols to be followed, their purposes, including descriptions
of any attendant discomforts, and 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 his consent and discontinue
participation in the human research at any time without prejudice to him;

4. An explanation of any costs or compensation which 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.
			&#8220;Institution&#8221; or &#8220;agency&#8221; 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.			&#8220;Legally authorized representative&#8221; means, in the
following specified order of priority, (i) the parent or parents having custody
of a prospective subject who is a minor, (ii) the agent appointed under an
advance directive, as defined in &#xA7; 54.1-2982, executed by the prospective
subject, provided the advance directive authorizes the agent to make decisions
regarding the prospective subject&#8217;s participation in human research, (iii)
the legal guardian of a prospective subject, (iv) the spouse of the prospective
subject, except where a suit for divorce has been filed and the divorce decree
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) an adult brother
or sister of the prospective subject or (viii) any person or judicial or other
body authorized by law or regulation to consent on behalf of a prospective
subject to such subject&#8217;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&#8217;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.			&#8220;Minimal risk&#8221; means that the risks of harm
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.			&#8220;Nontherapeutic research&#8221; means human research in which
there is no reasonable expectation of direct benefit to the physical or mental
condition of the human subject.

HISTORY: 1979, c. 38, § 37.1-234; 1986, c. 274; 1992, c. 603; 2002, c. 754.