Section 50. Informed consent

A. No human research may be conducted without voluntary informed consent signed by the participant or by the participant's legally authorized representative, except as provided for in subsection C of this section. If the participant is a minor otherwise capable of rendering voluntary informed consent, the consent shall be signed by both the minor and his legally authorized representative. A researcher shall seek such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the participant or the representative shall be in language understandable to the participant or the representative.

B. The committee may approve a consent procedure which omits or alters basic elements of informed consent or may waive the requirements to obtain informed consent, provided the committee finds and documents that:

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

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

3. The research could not practicably be carried out without the waiver or alteration of the informed consent; and

4. Whenever appropriate, the participants will be provided with additional pertinent information after participation.

C. The committee may waive the requirement for the researcher to obtain a signed consent form for some or all participants if it finds that the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. The committee may require the investigator to provide participants with a written statement explaining the research. Each participant shall be asked whether he wants documentation linking him to the research and the subject's wishes shall govern.

Historical Notes

Derived from VR615-80-01 § 5, eff. August 11, 1993.

Statutory Authority

§§ 63.2-217 and 63.2-218 of the Code of Virginia.