Human Research Protection Program: Guidance

Oral Consent/Waiver of Consent Documentation

Unless the IRB waives the requirement for obtaining informed consent, all human subjects research approved by a UW-Madison IRB must include procedures for obtaining informed consent from participants through the use of either a written consent form or an alternative oral procedure.

 

An oral consent procedure may be approved by the IRB when it is impossible or undesirable to obtain written consent. For example, oral consent may be approved when an investigator is conducting field research in another culture, especially a culture with little or no local experience with scientific research, or when the research participants are illiterate. There are others situations that may call for an oral consent procedure instead of written consent.

 

The federal Common Rule authorizes the IRB to approve the use of an oral consent procedure rather than a written consent form for some or all research participants if it finds either: [45 CFR 46.117(c)]

 

1. That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern; or
2. That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

 

FDA regulations also authorize the IRB to approve the use of an oral consent procedure rather than a written consent form for some or all research participants if it finds either: [21 CFR 56.109(c)]

 

1. 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 the research context; or
2. That the requirements in 21 CFR 50.24 for an exception from informed consent for emergency research are met.

 

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research. [45 CFR 46.117(c); 21 CFR 56.109(d)]

 

For more information, see UW-Madison’s Informed Consent Policy.