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.
Potential subjects might find some of the research questions embarrassing, personal, or intrusive
The subjects are literate in their own language; however, they do not read, write, or speak English
Answer: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.