6 Va. Admin. Code § 35-170-160

Current through Register Vol. 41, No. 4, October 8, 2024

Section 6VAC35-170-160 - HRRC review of informed consent provisions

A. The HRRC shall review and approve the consent process and all required consent forms for each proposed human research project before recommending approval to the director.

B. The committee may approve a consent procedure that omits or alters some or all of the basic elements of informed consent or waives the requirement to get informed consent if the HRRC finds and documents that:

1. The research involves no more than a minimal risk to the subjects;

2. The omission, alteration, or waiver will not adversely affect the rights and welfare of the subjects;

3. The research could not be performed practicably without the omission, alteration, or waiver; and

4. After participation, the subjects will be given additional pertinent information when appropriate.

C. The HRRC may waive the requirement that the researcher get written informed consent for some or all subjects if the principal risk would be potential harm resulting from a breach of confidentiality, and the only record linking the subject and the research would be the consent document. The HRRC may require the researcher to give the subjects and legally authorized representatives a written statement explaining the research. Further, the researcher shall ask each subject whether he wants documentation linking him to the research, and the subject's wishes shall govern.

6 Va. Admin. Code § 35-170-160

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; Amended, Virginia Register Volume 37, Issue 14, eff. 4/15/2021.

Statutory Authority: §§ 66-10 and 66-10.1 of the Code of Virginia.