Waiver or Alteration of Consent - Saint Mary-of-the-Woods College

Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials—

An IRB may waive the requirement to obtain informed consent for research

Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (A) Public benefit or service programs; (B) Procedures for obtaining benefits or services under those programs; (C) Possible changes in or alternatives to those programs or procedures; or (D) Possible changes in methods or levels of payment for benefits or services under those programs; and
The research could not practicably be carried out without the waiver or alteration.

General waiver or alteration of consent—

Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

The research involves no more than minimal risk to the subjects;
The research could not practicably be carried out without the requested waiver or alteration;
If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
The waiver or alteration will not adversely affect the rights and welfare of the subjects; and

Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.