§___.116(e) 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: 

The IRB may waive the requirement to obtain informed consent, or approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in §___.116(b) and (c) provided that the following criteria are met:

(i) 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

(ii) The research could not practicably be carried out without the waiver or alteration.

§___.116(f) General waiver or alteration of consent:

The IRB may waive the requirement to obtain informed consent, or approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in §___.116(b) and (c) provided that the following criteria are met:

(i) The research involves no more than minimal risk to the subjects;

(ii) The research could not practicably be carried out without the requested waiver or alteration;

(iii) 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;

(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and

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