22VAC30-40-40. General provisions for conducting human subjects research.
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.
Historical Notes
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009; Volume 36, Issue 17, eff. May 14, 2020.