Obtaining and Documenting Informed Consent/Assent Standard Practice Guideline

A guide to the consent process ensuring compliance with IRBMED, FDA, ICH GCP, and specific sponsor requirements

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This resource may be used by anyone at U-M.


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What is this resource?

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 Keeping consent templates in file cabinets or offices could lead to using an outdated version, which can result in a host of problems.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.

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