IRB Policy: Guidance for Protocols involving Oral Consent

Guidance from the Cornell IRB on developing an oral consent script, for those studies where a written and signed informed consent form is not appropriate.

For protocols involving oral consent, following the standard informed consent template may not be practical or appropriate for assuring informed consent. A shorter, more conversational consent script may be more appropriate.

In such cases, the following minimum information must be communicated to the participant:

  • Introduction- who is the caller/interviewer, affiliation, organization
  • Statement that the study involves research
  • Study purpose
  • What will participant be asked to do - as well as the amount of time participant will spend (include any follow ups that you plan to do)
  • Any compensation, and any information that you will need to collect in order to make that payment (mailing address, email address, etc.)
  • The voluntary nature of participation in the study
  • Any risks or benefits associated with participating (leave this out if there are none)
  • That you are taking notes or recording the data.
  • Whether the information collected will remain confidential or if you plan to keep identifiers with the research data (if address is collected, will that be kept separate from the survey responses)
  • Provide contact information for the researcher and/or the IRB
  • Ask if the participant has any questions that you can answer
  • Ask explicitly- do you agree to participate in this research? And record the response.

Depending on the nature of the study and the participant pool, the researcher may offer other pertinent information to assure that participants are fully informed about the study and any risks or benefits from participating in it.