Human Subjects Research

Documentation of Informed Consent


  • These templates are intended to assist in documenting the consent discussion and process with potential participants. There are many ways to document the informed consent process.
  • Below are several examples that can be customized to meet your specific study needs/requirements (study populations, optional items etc.).

Best Practice Considerations

  • Documentation of the consent/assent process should be completed as a source document at time of consent.
  • This process should be used throughout the life of the study.
  • It is best to file this type of documentation with the associated consent/assent document.

Verbal Consent

  • Verbal Consent is used only in studies with an IRB-approved waiver of documentation of consent (no written signature required).

Consent Using LAR/PG