The federal regulations require that the consent process includes an IRB approved written document that is provided by the study team and signed by each participant as part of the consent discussion.
However, the IRB recognizes that there are situations when a consent discussion between the study team and the participant is the best method of obtaining informed consent. "Oral Consent" or "Verbal Consent" are terms that are both used for this method of obtaining informed consent from participants, and either term is acceptable. If you would like to use an oral/verbal consent process to enroll participants into your study, then you will need to describe this consent plan in your study protocol so that the IRB may review and approve it.
If your study is determined to be exempt from the federal regulations, a consent discussion may be sufficient, and a formal signature on a consent form may not be required.
Additionally, if the study receives expedited approval, and the study team provides a good reason in the protocol to justify not collecting signature, then the IRB may be able to waive the requirement for signature to be collected on a consent form.
Finally, if the study is determined to be more than minimal risk and reviewed by the full board, then a signature from the participant on the study's consent form will need to part of the consent process.
In this option, the researcher provides the IRB approved Study Information Sheet (consent without signature) to the potential participant to review. Then the potential participant and the researcher discuss the study and the researcher answers any questions that the potential participant may have about the study. Finally, the researcher askes the potential participant directly if the individual would like to participate in the study.
If the participant agrees to participate in the study, the participant's oral/verbal consent should be recorded on an audio recorder or in the researcher’s notes. Please note, it may be appropriate to only record the participant's subject number or pseudonym with the researcher's note or the audio recording depending on the privacy plan for study participants that was included in the IRB approved protocol.
If you think this option is appropriate for your participants, please include this as part of the study plan in the protocol when describing your consent procedures and include the rationale for use of an oral/verbal consent method.
In this alternative option, the researcher does not provide written documentation about the study to the potential participant. The consent process begins with the potential participant and the researcher discussing the study, and the researcher answers any questions that the potential participant may have about the study. Finally, the researcher askes the potential participant directly if the individual would like to participate in the study.
If the participant agrees to participate in the study, the participant's oral/verbal consent should be recorded on an audio recorder or in the researcher’s notes. Please note, it may be appropriate to only record the participant's subject number or pseudonym with the researcher's note or the audio recording depending on the privacy plan for study participants that was included in the IRB approved protocol.
The IRB offers tools to help with the oral/verbal consent process when conducted without the Study Information Sheet. For example, if the research is conducted entirely over the phone, an IRB approved consent script should be used by the researcher calling the potential participant. For an example of a different tool, commonly used by anthropology studies, the Oral Consent Card may be the best option to help ensure the elements of consent are covered verbally during the consent discussion while still being sensitive to cultural norms.
If you think this option is appropriate for your participants, please include this as part of the study plan in the protocol when describing your consent procedures and include the rationale for use of an oral/verbal consent method.
Please note: Depending on the nature of your project and the needs of your participants, it may be necessary for you to use multiple consent methods. When you are describing this information in the protocol, make sure that you clearly distinguish the different groups and describe the consent method for each group.