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Documenting Consent

The federal regulations require that consent is documented through a written document that is provided by the researcher and signed by each participant or a legally authorized representative. If your study is exempt, such documentation will not be required. Documentation in a specifically written form can also be waived, and an oral substitute accepted, if there are good reasons for doing so. For example, for some participants it may not be culturally acceptable to sign a document. Some participants may not be literate enough to read and sign a form.  In some cases, signing the form may be the only information that links the participant to the study and that link may even be a risk to the participant if confidentiality is lost.

There are three options for documenting consent:

Signed Consent Form: This option follows the classic model outlined in Basic Consent Scenario where the participant is given a written consent form, the researcher reviews the form with the participant, and the participant is given the option to sign if they agree to participate.

Oral presentation with documentation: In this option, the researcher presents the consent information to the participant, either referring to the bullet points listed on the Oral Consent Card or using a modified version of the Oral Consent Script Template, and answers any questions the participant has. If the participant gives consent, it is either recorded on a digital recorder/tape recorder or in the researcher’s notes, depending on the amount of identifying information that is collected. This option is more appropriate for participants who are illiterate or who may be unlikely to sign a form because of cultural reasons. If you think this option is appropriate for your participants, it is necessary that you provide adequate justification in the protocol when describing your consent procedures. 

Oral presentation without documentation: In this option, the researcher presents the consent information to the participant, referring to the bullet points listed on the Oral Consent Card or as described in a modified version of the Oral Consent Script Template and answers any questions the participant has. Consent is not documented because the research meets one of the following requirements:

  • That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
  • 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.

In order to waive documentation of consent, your research must meet one of the above bullet points; the Board is obligated to document that these items are satisfied according to federal regulations. Regardless of whether your participants officially document their consent or not, it is important that you keep accurate record of the participants from whom you obtain consent. In your notes, you should indicate that you presented the consent information and obtained consent. 

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. For example, if you are studying multiple populations where some of the populations are literate and some are not, it would be appropriate to provide the literate populations with a written consent form where the illiterate populations will need an oral presentation. 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.

Additonal Topics

Oral Consent
Modifying Consent for Ethnography

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