Alterations & Waiver of Informed Consent

PROCEDURES FOR SUBMISSION OF RESEARCH PROPOSALS FOR IRB REVIEW

H. ALTERATIONS AND WAIVER OF INFORMED CONSENT

Under special circumstances, the IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent. The investigator must justify in writing any request to waive the elements of informed consent. Before a waiver can be issued, the IRB must determine that all of the following conditions exist: 1) the project involves minimal risk, 2) the rights of the subject will not be significantly infringed upon, 3) if possible, the subject will be fully informed after the project has been completed, and 4) obtaining standard written informed consent would constitute a potential risk resulting from a breach of confidentiality.
(45 CFR 46.117)