Waiver of Documentation of Informed Consent

{45 CFR 46.117(c)}

An IRB may waive the requirement for the investigator to obtain a signed consent form for some

or all subjects if it finds either:

1. 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

2. 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, the IRB must determine if the investigator is required to provide subjects with a written statement regarding the research.

FDA difference

Unlike HHS, FDA does not provide that an IRB may waive the requirement for signed consent when the principal risk is a breach of confidentiality because FDA does not regulate studies which would fall into that category of research.

Both regulations allow for waiver of documentation of informed consent in instances of minimal risk.