Request for Waiver of the Requirement to Consent Subjects or to Make Alteration to the Elements of Consent for Projects Conducted by or Subject to the Approval of State or Local Government Officials Important Note: This Request for Waiver of Consent or Alteration to Consent is not applicable to FDA regulated studies involving test articles except for planned emergency research as provided under FDA regulations.

Per 45CFR46.116( c)(1), An IRB may approved a consent procedure which does not include, or which alters, some or all of the elements of informed consent or waive the requirement to obtain informed consent provided that IRB finds and documents that: (1) 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: i. public benefit of service programs; ii. procedures for obtaining benefits or services under those programs; iii possible changes in or alternative to those programs or procedures; or iv. possible changes in methods or levels of payment for benefits or services under those programs; and (2) the research could not practicably be carried out without the waiver or alteration *****************************************************************************************************************

PI Name:

Study Title and/or IRB #:

1. Identify the government agency / officials involved in this study: Response:

2. Identify the role(s) of the agency by placing an x before the appropriate category Involved with conducting the study Must approve the study

3. Explain how the study meets the criteria of one or more elements of 1i –1iv as noted above.

4. Indicate whether a complete waiver of consent or an alteration to the elements of consent is being sought. If an alteration is being sought, provide a description. Waiver of Consent Requested, or Alteration of Consent Elements Requested. If applicable, describe alterations below. Describe the Alteration:

5. Is it practical to conduct the research without the waiver or alteration? If not, explain. YES – No waiver or alteration can be approved by the IRB.

NO – Explain below why waiver or alteration is necessary to this research.

Answer:

*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Note: For waivers or alterations reviewed by the convened board the IRB Coordinator will document determinations for each criteria and the approval outcome in the minutes. For expedited review, information put forth by the PI and determination of reviewer as noted on reviewer form will serve as documentation. The approvals of waivers will be noted on the IRIS outcome page.

Rev 1/15/09, 5/4/074/3/06 10/6/2004, 6/20/05