Guidelines for Written Consent Form
In accord with 45 CFR 46.117(c), an IRB may waive the requirement for a signed consent document for some or all participants, if the IRB determines that:
- The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern; or
- The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.
State your justification for requesting an exemption from the use of written informed consent.