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 Keeping consent templates in file cabinets or offices could lead to using an outdated version, which can result in a host of problems.
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
Contact us at MICHR-SPGSupport@umich.edu .