Are there exceptions or situations where a signed, informed consent form is not acceptable?
Yes. The IRB Committee may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds 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 • 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. For most anonymous surveys and other exempt applications, no informed consent form is required. In fact, an application that requires a signed consent form in this situation may be rejected since it compromises the anonymity of the research subjects. In this case, however, researchers still have an ethical responsibility to ensure that informed consent
