Under Federal regulations, investigators must obtain documented informed consent from a subject before the subject may begin participation in research. Documentation is most commonly through a signed Consent Form that has been approved by the IRB. An IRB may waive the need for written documentation of informed consent only in very limited circumstances, such as if the only record linking the subjects and the research is the consent form and the principal risk to participants is the potential harm resulting from a breach of confidentiality. In such cases, the UCAIHS will nonetheless expect the investigator to provide detailed information about how he will obtain consent in the absence of a written form.

Alternatively, the investigator may create a Project Summary statement for subjects which includes all of the information normally contained in and informed consent form, merely eliminating the signature line.

The investigator will also be expected to assess the subjects' understanding of the explanation given, to make all elements of informed consent clear to them, and to ensure their voluntary participation.