Waiver of Informed Consent Form
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Summary
This form should be used when requesting a full Waiver of Informed Consent (no consent) or when requesting an Alteration of Informed Consent (some elements are missing, full information is not disclosed to participants, or deception is used).
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This form should be used if participants do not have a choice about participating in the research or if they are not given full information about the study.
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About the Waiver of Informed Consent
This form should be used when requesting a full Waiver of Informed Consent (no consent) or when requesting an Alteration of Informed Consent (some elements are missing, full information is not disclosed to participants, or deception is used).
The IRB may approve a consent procedure which does not include some or all of the required elements of informed consent provided all of the following are true:
- The research involves no more than minimal risk
- The waiver of informed consent will not adversely affect the rights and welfare of the subjects
- It is not practicable to conduct the research without the waiver or alteration
Who Needs to Complete this Form
If you answered “Yes” to Section 8.9.2) Waiver of Informed Consent Process in the New Study Application for Human Subjects form, you will need to complete this form as part of your application.
If there are participants will not have a choice to participate in your study, and you did not yet select “Yes” in the New Study Application yet, please be sure update the information in that form, and then complete this form for your application.
Additional Details
If the only element missing from the consent document is the signature, but a participant has a choice to participate, use the Informed Consent Process Form and request a Waiver of Documentation of Consent in that form.
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- Forms