Virginia USA
Human Research Law
Chapter 5.1
§ 32.1-162.16 Definitions
§ 32.1-162.17 Exemptions
§ 32.1-162.18 Informed consent
§ 32.1-162.19 Human research review
committees
§ 32.1-162.20 Applicability of federal policies
§ 32.1-162.16
Definitions
As used in this chapter, unless the context requires a different meaning:
"Human research" means any systematic investigation utilizing human
subjects which may expose such human subjects to physical or psychological
injury as a consequence of participation as subjects and which departs from
the application of established and accepted therapeutic methods appropriate
to meet the subjects' needs.
"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 shall include:
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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;
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A disclosure of any appropriate alternative procedures or therapies that
might be advantageous for the person;
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An instruction that the person may withdraw his consent and discontinue
participation in the human research at any time without prejudice to him;
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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
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An offer to answer and answers to any inquiries by the person concerning
the procedures and protocols.
"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
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the parent or parents having custody of a prospective subject,
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the legal guardian of a prospective subject, or
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any person or judicial or other 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 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 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.
"Nontherapeutic research" means human research in which there is no
reasonable expectation of direct benefit to the physical or mental condition
of the human subject.
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§ 32.1-162.17
Exemptions
The following categories of human research are exempt from the provisions
of this chapter:
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Activities of the Virginia Department of Health conducted pursuant to §
32.1-39;
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Research or student learning outcomes assessments conducted in educational
settings involving regular or special education instructional strategies,
the effectiveness of or the comparison among instructional techniques, curricula,
or classroom management methods, or the use of educational tests, whether
cognitive, diagnostic, aptitude, or achievement, if the data from such tests
are recorded in a manner so that subjects cannot be identified, directly
or through identifiers linked to the subjects;
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Research involving survey or interview procedures unless responses are recorded
in such a manner that the subjects can be identified, directly or through
identifiers linked to the subjects, and either
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the subject's responses, if they became known outside the research, could
reasonably place the subject at risk of criminal or civil liability or be
damaging to the subject's financial standing or employability or
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the research deals with sensitive aspects of the subject's own behavior,
such as sexual behavior, drug or alcohol use, or illegal conduct;
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Research involving survey or interview procedures, when the respondents are
elected or appointed public officials or candidates for public office;
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Research involving solely the observation of public behavior, including
observation by participants, unless observations are recorded in such a manner
that the subjects can be identified, directly or through identifiers linked
to the subjects, and either
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the observations recorded about the individual, if they became known outside
the research, could reasonably place the subject at risk of criminal or civil
liability or be damaging to the subject's financial standing or employability
or
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the research deals with sensitive aspects of the subject's own behavior,
such as sexual behavior, drug or alcohol use, or illegal conduct; and
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Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly
available or if the information is recorded by the investigator in a manner
so that subjects cannot be identified, directly or through identifiers linked
to the subjects.
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§ 32.1-162.18
Informed consent
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In order to conduct human research in this Commonwealth, informed consent
must be obtained if the person who is to be the human subject is as
follows:
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competent, then it shall be subscribed to in writing by the person and
witnessed;
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not competent at the time consent is required, then it shall be subscribed
to in writing by the person's legally authorized representative and witnessed;
or
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a minor otherwise capable of rendering informed consent, then it shall be
subscribed to in writing by both the minor and his legally authorized
representative.
The giving of consent by a legally authorized representative shall be subject
to the provisions of subsection B of this section. No informed consent form
shall include any language through which the person who is to be the human
subject waives or appears to waive any of his legal rights, including any
release of any individual, institution, or agency or any agents thereof from
liability for negligence.
Notwithstanding consent by a legally authorized representative, no person
who is otherwise capable of rendering informed consent shall be forced to
participate in any human research. In the case of persons suffering from
organic brain diseases causing progressive deterioration of cognition for
which there is no known cure or medically accepted treatment, the implementation
of experimental courses of therapeutic treatment to which a legally authorized
representative has given informed consent shall not constitute the use of
force.
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A legally authorized representative may not consent to nontherapeutic research
unless it is determined by the human research committee that such nontherapeutic
research will present no more than a minor increase over minimal risk to
the human subject.
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The human research review committee may approve a consent procedure which
omits or alters some or all of the basic elements of informed consent, or
waives the requirement to obtain informed consent, if the committee finds
and documents that
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the research involves no more than minimal risk to the subjects;
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the omission, alteration or waiver will not adversely affect the rights and
welfare of the subjects;
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the research could not practicably be performed without the omission, alteration
or waiver; and
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after participation, the subjects are to be provided with additional pertinent
information, whenever appropriate.
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The human research review committee may waive the requirement that the
investigator obtain written informed consent for some or all subjects, if
the committee finds that the only record linking the subject and the research
would be the consent document and the principal risk would be potential harm
resulting from a breach of confidentiality. The committee may require the
investigator to provide the subjects with a written statement explaining
the research. Further, each subject shall be asked whether he wants documentation
linking him to the research and the subject's wishes shall govern.
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§ 32.1-162.19
Human research review committees
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Each institution or agency which conducts or which proposes to conduct or
authorize human research shall establish a human research review committee.
The committee shall be composed of representatives of varied backgrounds
to ensure the competent, complete, and professional review of human research
activities conducted or proposed to be conducted or authorized by the institution
or agency. No member of the committee shall be directly involved in the proposed
human research or have administrative approval authority over the proposed
human research except in connection with his responsibilities as a member
of the committee.
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No human research shall be conducted or authorized by such institution or
agency unless the committee has reviewed and approved the proposed human
research project giving consideration to
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the adequacy of the description of the potential benefits and risks involved
and the adequacy of the methodology of the research;
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if the research is nontherapeutic, whether it presents more than a minimal
risk to the human subjects;
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whether the rights and welfare of the human subjects involved are adequately
protected;
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whether the risks to the human subjects are outweighed by the potential benefits
to them;
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whether the informed consent is to be obtained by methods that are adequate
and appropriate and whether the written consent form is adequate and appropriate
in both content and language for the particular research;
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whether the persons proposing to conduct the particular human research are
appropriately competent and qualified; and
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whether the criteria for selection of subjects are equitable. The committee
shall require periodic reports from each existing human research project
to ensure that the project is being carried out in conformity with the proposal
as approved.
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The regulations of an institution or agency may authorize the committee to
conduct an expedited review of a human research project which involves no
more than minimal risk to the subjects if
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another institution's or agency's human research review committee has reviewed
and approved the project or
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the review involves only minor changes in previously approved research and
the changes occur during the approved project period.
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Every person engaged in the conduct of human research or proposing to conduct
human research shall affiliate himself with an institution or agency having
a research review committee, and the human research which he conducts or
proposes to conduct shall be subject to review and approval by such committee
in the manner set forth in this section.
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§ 32.1-162.20
Applicability of federal policies
Human research which is subject to policies and regulations for the protection
of human subjects promulgated by any agency of the federal government shall
be exempt from the provisions of this chapter.
In lieu of promulgating regulations pursuant to the requirements of this
chapter, an institution or agency may comply with this chapter by promulgating
regulations under the provisions of the Administrative Process Act
(§9-6.14:1 et seq.) governing human research projects which incorporate,
explicitly or by reference, federal policies and regulations for the protection
of human subjects. However, in the case of projects which are not required,
by reason of their nature, the source of their funding, or the lack thereof,
to comply with federal policies and regulations, the institution or agency
may enforce compliance by filing a petition for an injunction in the appropriate
circuit court. This section shall not preclude any other enforcement action
available to the institution or agency.
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