Informed Consent

Category: Research Subjects

Do all studies require signed informed consent?

No. The IRB may waive the requirement for signed informed consent if any of the following conditions is true:

1. That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
2. 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; or
3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

However, all subjects must be informed of the nature and purpose of the study, what will be asked of them for participation, any risks or benefits of participation, that participation is voluntary, and who to contact for more information, whether or not signed informed consent is required.