Guide :: Informed Consent :: Special Consent :: Oral Consent
Oral Consent
As a general rule, the Board requires that all literate adults receive a consent form as part of their participation in a study. However, there are situations where this may not be appropriate. For example, in some cultures, individuals may not be willing to participate in a study if they have to sign a form. Forms are considered suspicious and thus may prevent a researcher from enrolling participants. Some participants may not be literate enough to read and sign a form. In ethnographic studies, a researcher may be interested in engaging in conversation with individuals and this information will be used as part of the study. However, the conversation does not rise to the level of a full interview. The researcher can use an abbreviated version of the oral consent to inform the participant that he or she is a researcher collecting data for a study and ask permission of the participant to use their conversation in the study. If the conversation moves to a full interview, the researcher would then do a complete consent process, either using a form or doing a full oral consent (depending on the participant).
Only certain types of studies qualify for using oral consent procedures. The IRB can approve oral consent procedures when the research poses no more than minimal risk and is conducted under circumstances where a written consent procedure is not normally required, or when the only risk to the participants is a breach of confidentiality resulting from the documentation of identity on the consent document.
What forms should I use?
Oral consent is a waiver of the documentation of consent; however, it is not a waiver of consent. Although a participant may not sign a form, federal regulations still require that they are informed of the study and that they provide consent to participate. Where appropriate, the IRB may require investigators to provide subjects with a written statement regarding the research. Please see Waiver of Documentation of Consent for more information. For model oral consent scripts and instructions about including this information in your protocol, please see Alternative Consent document.
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Guide :: Informed Consent :: Special Consent :: Oral Consent |
