Informed Consent

Overview

These resources provide guidance and support for creating your informed consent documents and for conducting informed consent discussions with potential research participants.


Links

IRBMED

Informed Consent Guidance
IRBMED offers a list of resources regarding informed consent including templates, information about federal regulations, and U-M resources such as a plain language medical dictionary and tips on preparing understandable informed consent documents.

Informed Consent Templates
IRBMED Informed Consent Templates come with detailed instructions to guide and assist you prior to submitting documents to the IRBMED for review.

Checklist of Federally Required Elements of Informed Consent
IRBMED created this informed consent document to ensure all the required elements are included and speed up the review process.

Foreign Language Short Forms
IRBMED offers various foreign language short forms available to download.

FDA

The following links provide information about FDA regulations regarding informed consent.

FDA 21CFR50.25 – Elements of Informed Consent

FDA 21CRFPart 50 Subpart B Section 50.20

FDA 45CFR46.116 (A) – General Requirements for Informed Consent

International Council for Harmonization: Good Clinical Practice (ICH-GCP)

ICH-GCP E6 Section 4.8 – Informed Consent of Trial Subjects 4.8
This guidance relates to informed consent from the International Council for Harmonization: Good Clinical Practice.


Questions and Disclaimer

If you have questions about any of the resources on this page, please contact the sponsoring office directly. MICHR is not responsible for the content of these resources.

Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.

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