A. No human
subjects research shall be conducted by a covered entity without the informed
consent of the subject or the subject's legally authorized representative. The
required elements of informed consent are provided in
22VAC30-40-100. The consent of the
human subject or the human subject's legally authorized representative to
participate in the research shall be documented in writing and supported by the
signature of a witness not involved in the conduct of the research, except as
provided for in
22VAC30-40-100 L.
The investigator shall ensure that a knowledgeable member of the research team
signs and provides human subjects of a research project with a copy of the
written, informed consent document as defined in
22VAC30-40-100 B.
The investigator shall make arrangements for those who need special assistance
in understanding the consequences of participating in the research.
B. Each human subjects research project shall
be approved by the HRRC as provided by this chapter.
C. Nontherapeutic research shall be
prohibited unless the HRRC determines that such nontherapeutic research will
not present greater than minimal risk to human subjects.
D. The investigator shall be required to
notify all human subjects of the risks caused by the research that are
discovered after the research has concluded.
E.22VAC30-40-160 shall apply to all
research involving minors as subjects conducted or supported by the covered
entity. In addition to other responsibilities assigned to the HRRC under
22VAC30-40-160, the HRRC shall
review research covered by
22VAC30-40-160 and approve only
research that satisfies the conditions of all applicable sections of this
chapter. Notwithstanding this subsection, some projects involving minors may
qualify as exempt research as outlined in
22VAC30-40-80 and as approved by
the HRRC. Such qualifications are described in the following table:
|
Exempt Category
|
Potential Qualification
|
|
Category 1
|
May qualify as exempt
|
|
Category 2 and the project involves observation of
public behavior when the investigators do not participate in the activities
being observed
|
May qualify as exempt
|
|
Category 2 and the project involves:
(i) Surveys or interviews;
(ii) The investigator's participation in the
activities being observed; or
(iii) Educational testing, sensitive information,
and identifiers collected with responses
|
Cannot qualify as exempt
|
|
Category 3
|
Cannot qualify as exempt
|
|
Category 4
|
May qualify as exempt
|
|
Category 5
|
May qualify as exempt
|
|
Category 6
|
May qualify as exempt
|
|
Category 7
|
May qualify as exempt
|
|
Category 8
|
May qualify as exempt
|
F.
Cooperative research projects shall be those projects covered by this chapter
that involve a covered entity in conjunction with an institution. In the
conduct of cooperative research projects, the covered entity and each
institution shall be responsible for safeguarding the rights and welfare of
human subjects and for complying with this chapter. With the approval of the
commissioner, a covered entity participating in a cooperative project may enter
into a joint review arrangement, rely upon the review of another qualified IRB,
or make similar arrangements for avoiding duplication of effort.
G. In the event research is undertaken
without the intention of involving human subjects, but it is later proposed to
involve human subjects in the research, the research first shall be reviewed
and approved by the HRRC, as provided in this chapter, a certification
submitted by the covered entity to the commissioner, and final approval of the
proposed change shall be given by the commissioner.
H. With respect to any research project or
any class of research projects, the commissioner may impose additional
conditions prior to or at the time of approval when, in the judgment of the
commissioner, additional conditions are necessary for the protection of human
subjects.
I. In reviewing proposed
research projects, the HRRC shall consider the requirements of review stated in
22VAC30-40-70.
Notes
22 Va. Admin. Code §
30-40-40
Derived from Virginia
Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register
Volume 25, Issue 21, eff. July 22, 2009; Amended,
Virginia
Register Volume 36, Issue 17, eff.
5/14/2020.
Statutory Authority: §§
51.5-131 and
51.5-132 of the Code of
Virginia.
