Question $4$

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

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

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