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Requests for Waivers of Informed Consent

The Board will review requests for alteration or waiver of informed consent. An alteration or waiver of informed consent can be requested for a consent procedure which does not include, or which alters, some or all of the elements of informed consent as defined by 45 CFR 46.116(d) and TCPS. Informed consent cannot be altered or waived for research that is regulated as clinical research by the FDA or HPFB.

The Board will review requests for waiver of documentation of informed consent, which waives the requirement to obtain a signed informed consent for some or all subjects.

A waiver of documentation of informed consent can be requested for research that is non-FDA regulated and complies with 45 CFR 46.117(c) or for FDA regulated research that complies with 21 CFR 56.109(c).

Schulman provides forms for requesting an Alteration Or Waiver Of Informed Consent and for requesting a Waiver of Documentation of Informed Consent.