Virginia Administrative Code › Title 22 - SOCIAL SERVICES › Agency 30 - DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES › Chapter 40 - PROTECTIONS OF PARTICIPANTS IN HUMAN RESEARCH › Section 22VAC30-40-40 - General provisions for conducting human subjects research

Current through Register Vol. 40, No. 24, July 15, 2024
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.
Statutory Authority: §§
											51.5-131
					 and
					 51.5-132
					 of the Code of Virginia.