Informed Consent
Generally, investigators must obtain written informed consent from each research participant before conducting human subjects research.
See Informed Consent Guidance for more information.
The informed consent process should not end with an individual's initial agreement to participate in a research study. Researchers should be sensitive, throughout the conduct of the research, to participants' understanding of the project and willingness to participate.
Please refer to the Research Protocol and Consent Procedure Checklist before submitting your consent forms for review.
Waiver of Informed Consent
Sometimes the requirements for obtaining informed consent can be altered or waived.
Waiver of Informed Consent Guidance
45 CFR 46.116: General requirements for informed consent
Waiver of Documentation of Infomed Consent/Oral Consent
Waiver of documentation of Informed Consent/Oral Consent may be approved by the IRB when it is impossible or undesirable to obtain written consent.
Waiver of Documentation of Informed Consent/Oral Consent Guidance
45 CFR 46.117: Documentation of informed consent
Consent Form Wizard
This program has been developed to help researchers draft a consent form by asking relevant questions to ensure the required elements of an informed consent document are included, and compiling the answers into a consent form format.
Other Informed Consent Resources
OHRP Informed Consent Requirements
NIH Guidelines for Writing Informed Consent Documents
Web-Based Instruction on Informed Consent - University of Minnesota