A waiver of the requirement for documentation of informed consent may be granted when:

The investigator has no convenient place to store signed consent forms separate from the research data.

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

The subjects are literate in their own language; however, they do not read, write, or speak English.

Potential subjects might find some of the research questions embarrassing, personal, or intrusive.