Section 40. General provisions for conducting human subjects research

A. No human subjects research may 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 must 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 J. 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 department's HRRC.

C. Nontherapeutic research is 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 applies 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. Exemptions in subdivisions 1 and 3 through 6 of 22VAC30-40-80 are applicable to 22VAC30-40-160. The exemption in subdivision 2 of 22VAC30-40-80 regarding educational tests is also applicable to 22VAC30-40-160. However, the exemption in subdivision 2 of 22VAC30-40-80 for research involving survey or interview procedures or observations of public behavior does not apply to research covered by 22VAC30-40-160, except for research involving observation of public behavior when the investigator or investigators do not participate in the activities being observed.

F. Cooperative research projects are those projects covered by this chapter that involve a covered entity in conjunction with an institution(s). In the conduct of cooperative research projects, the covered entity and each institution are 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 institutional review board (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 shall first 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 given to the proposed change 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.

Historical Notes

Derived from Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009.

Statutory Authority

§§ 51.5-131 and 51.5-132 of the Code of Virginia.