Federal regulations 45 CFR 46.117c allow an IRB to waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
- That the only record linking the subject and the research would be the consent document AND the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
- That the research presents no more than minimal risk of harm to subjects AND involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived and the study is allowed to proceed on either the subject's oral consent or in the case of online survey research the subject's implied consent by completion of the survey instrument, the IRB requires the investigator to provide subjects with a written informed consent statement regarding the research.
Template 3 - Format for Unsigned Informed Consent Document
Template 4 - Format for Unsigned Informed Consent Document for web-based online surveys