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How do I document consent or assent (permission)?

Use the signature sections on the stamped consent form approved by the IRB. Ensure all items are completed, including dates and optional elements.

The following are the requirements for long form consent documents:

  • The participant or representative signs and dates the consent document.
  • The individual obtaining consent signs and dates the consent document.
  • Whenever the IRB or the sponsor requires a witness to the oral presentation, the witness signs and dates the consent document. The person obtaining consent also may serve as the witness if appropriate.
  • For participants who cannot read, write, talk, or are blind, and whenever required by the IRB or the sponsor, a witness to the oral presentation signs and dates the consent document. The witness must be an impartial individual (not a member of the study team) and not the individual obtaining consent.
  • A copy of the signed and dated consent document is made available to the participant.

The following are the requirements for short form consent documents:

  • The participant or their legally authorized representative signs and dates the short form consent document and the summary.
  • The person obtaining consent signs and dates the summary.
  • The witness is an impartial individual and is not the individual obtaining consent. The witness should be fluent in both English and the language of the participant. When a translator assists the person in obtaining consent, the translator may serve as the witness.
  • The witness to the oral presentation signs and dates the short form consent document and the summary.
  • Copies of the signed and dated short form consent document and summary are made available to the participant or their legally authorized representative.

 

The IRB may require separate signatures for the assent of adults incapable of providing consent or for children. The template consent documents provided by the IRB Office include compliant signature sections for use by the Investigator. If research includes adults incapable of providing consent or children who do not sign the consent document, then incorporate the appropriate assent documentation signature sections from the templates in the consent documents you submit for review. Please see templates here: https://irb.northwestern.edu/resources-guidance/consent-templates-hipaa-requirements/biomedical-social-behavioral-consent-templates/

 

How do I document the Consent Process?

Documenting the informed consent process usually occurs after the person obtaining consent and the potential participant have discussed the research study. The person obtaining consent must document the consent process within the participant’s research record or within the participant’s medical record. The IRB Office provides templates to document consent on the Office’s website.