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

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 Keeping consent templates in file cabinets or offices could lead to using an outdated version, which can result in a host of problems.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