PSC – Part III of IV Series: Waivers – Documentation & Consent

01/13/2026

Written by Jamie Saunders, M.S., Research Program Manager, MaineHealth Cancer Care Network NCORP

 Informed consent is a fundamental part of the research process. However, there are circumstances when an IRB may waive the requirement for documentation of consent or may waive the requirement of consent completely.

When an IRB allows for a waiver of consent, this removes the requirement of consent completely. A waiver of consent removes the need for the consent discussion and for the documentation of consent. Waivers of consent allows human subject research to be conducted without consent of the participant. Participants will not be informed they are in a research study, nor will they be able to opt out of participation.

Waivers of consent may be possible in certain circumstances:

• Research involves no more than minimal risk to participants
• Research could not practically be carried out without a waiver of consent
• Research will not adversely affect the rights and welfare of the participants
• When applicable, participants will be made aware of relevant information after their participation has ended

Alternatively, the IRB can waive the requirement for documentation of consent. This means that documentation of consent (i.e., signatures) is not needed as part of the consent process. However, in this circumstance the participant is aware of their participation, and they can opt out of participation. Additionally, the participant must still be provided all the same information that would have been provided if a waiver of documentation was not in place.

IRBs may waive the requirement for consent documentation when specific criteria are met. The following guidance provided by CFR 46.117 allows for waivers of consent when:

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. 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; 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.

Unlike with a waiver of consent, when a waiver of documentation of consent is in place, the consent discussion (as outlined in Part 1 of this series) must still occur and verbal consent from the participant must be obtained.

In all circumstances (except for those when a full waiver of consent is in place), a record of the informed consent process is needed. This record is the source documentation that all necessary components of the informed consent process occurred.

Stay tuned for Part IV, which will review how to document the informed consent process.

Missed Part I and Part II? You can catch up here:

Part I of IV Part Series: Informed Consent Discussion & Documentation – NRG Oncology

Part II of IV Part Series: Informed Consent Discussion & Documentation Options – NRG Oncology