                                 CODE OF VIRGINIA

HUMAN RESEARCH REVIEW COMMITTEES (§ 32.1-162.19)

A. 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.

B. 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 (i) the adequacy of the description of
the potential benefits and risks involved and the adequacy of the methodology of
the research; (ii) if the research is nontherapeutic, whether it presents more
than a minimal risk to the human subjects; (iii) whether the rights and welfare
of the human subjects involved are adequately protected; (iv) whether the risks
to the human subjects are outweighed by the potential benefits to them; (v)
whether the risks to subjects are minimized by using procedures that are
consistent with sound research design and that do not unnecessarily expose
subjects to risk and, whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes; (vi) when some
or all of the subjects are likely to be incapable of making an informed decision
regarding consent or are otherwise vulnerable to coercion or undue influence,
such as children, prisoners, pregnant women, mentally disabled persons, or
economically or educationally disadvantaged persons, whether additional
safeguards have been included in the study to protect the rights and welfare of
these subjects; (vii) 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; (viii) whether the persons proposing to conduct the particular human
research are appropriately competent and qualified; and (ix) 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.

C. 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 (i) another institution&#8217;s or
agency&#8217;s human research review committee has reviewed and approved the
project or (ii) the review involves only minor changes in previously approved
research and the changes occur during the approved project period.

D. 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.

E. Each human research review committee of a state institution or agency shall
ensure that an overview of approved human research projects and the results of
such projects are made public on the institution&#8217;s or agency&#8217;s
website unless otherwise exempt from disclosure under the Virginia Freedom of
Information Act (&#xA7; 2.2-3700 et seq.).

HISTORY: 1979, c. 38, § 37.1-236; 1986, c. 274; 1992, c. 603; 2002, c. 754;
2007, c. 413.