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

  • 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
  • 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.

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