There are three situations where the regulatory requirement may be waived for written documentation of consent:
- The principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research (e.g., studies on sensitive topics such as drug abuse or sexual deviance); and (2) the consent document is the only record linking the subject with the research, OR
- The research presents no more than minimal risk and involves no procedures for which written consent is normally required when they are performed outside of a research setting, OR
- If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research involves no more than minimal risk, and there is an alternative method for documenting that consent was obtained.
If the documentation requirement is waived, the investigator should provide subjects with a written statement regarding the research.