Section 160. Committee review of informed consent provisions

A. The committee 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 committee finds and documents that:

1. 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 practicably be performed without the omission, alteration or waiver; and

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

C. The committee 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 committee may require the researcher to give the subjects and legally authorized representatives a written statement explaining the research. Further, each subject shall be asked whether he wants documentation linking him to the research, and the subject's wishes shall govern.

Historical Notes

Derived from Volume 21, Issue 09, eff. February 9, 2005.

Statutory Authority

§ 66-10.1 of the Code of Virginia.