Obtaining and Documenting Informed Consent/Assent


Research teams must recognize and understand their roles and responsibilities for all aspects of the consent and/or assent (if required) process. These responsibilities may include, but are not limited to, the following:

  • Managing consent/assent development, approval, and revisions (i.e. amendments)
  • Identifying team members qualified and trained to obtain informed consent/assent
  • Completing and maintaining the U-M eResearch application regarding processes for obtaining consent/assent
  • Documenting that consent/assent processes have taken place (including re-consent when applicable)
  • Including the required elements in the consent/assent per the U-M Institutional Review Board Medical School (IRBMED), Food and Drug Administration (FDA), International Council for Harmonisation (ICH) Good Clinical Practice (GCP) (if applicable), or per sponsor specifications
  • Adhering to additional policies which pertain to special populations or groups such as children, prisoners, foreign-speaking subjects, etc.
  • Identifying and adhering to regulations that apply to consenting/assenting subjects requiring specialized informed consent (e.g. biorepository, compassionate use, humanitarian use, etc.) when applicable

To ensure the correct (IRB-approved) version of the consent is being used, it is recommended that research teams print the consent/assent directly from eResearch before consenting subjects. Keeping consent templates in file cabinets or offices could lead to using an outdated version, which can result in a host of problems.

Related Resources

U-M Institutional Review Board Medical School (IRBMED): Informed Consent Templates

U-M Institutional Review Board Medical School (IRBMED): Specialty Informed Consent Templates

FDA: Exception from Informed Consent for Studies Conducted in Emergency Settings

FDA: CFR - Code of Federal Regulations Title 21

FDA: CFR - Code of Federal Regulations Title 45

International Conference on Harmonisation (ICH) Good Clinical Practice (GCP): 4.8 Informed Consent of Trial Subjects

HRPP Operations Manual (OM)

Standard Practice Guideline (SPG) Templates for Clinical Trials

Downloadable Templates and Appendices

Informed Consent.docx


Contact us at MICHR-SPGSupport@umich.edu .

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