MSU HRPP Manual Section 6-4-B

6-4-B, Informed Consent: Waiver or Alteration of Informed Consent

"(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the 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 or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives 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.

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) the research involves no more than minimal risk to the subjects;”

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

(3) the research could not practicably be carried out without the waiver or alteration; and”

(4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.” 45 CFR 46.116

An investigator may request a waiver of the requirement to obtain informed consent from subjects or may request a consent procedure which does not include or which alters some or all of the elements of informed consent. Waiver of consent may apply to the use of existing private identifiable data. Alteration of consent may apply when the research involves incomplete disclosure or deception. See the Human Research Protection Program (HRPP) Manual 6-3-A “Incomplete Disclosure/Deception” for additional review requirements on projects that involve incomplete disclosure. The Institutional Review Board (IRB) may waive or alter the consent procedure by determining that the regulatory criteria for a waiver or alteration of the consent procedure are met. All the criteria have to be met for the IRB to grant a waiver or alteration of informed consent. When consent is waived, the IRB may require that the researchers provide subjects with a written statement regarding research when appropriate.

The U.S. Department of Health and Human Services (45 CFR 46.116) waiver criteria cannot be used for projects subject to U.S. Food and Drug Administration (FDA) regulations and policies. FDA regulated research does not allow waivers unless for emergency use. See HRPP Manual 7-3 “Emergency Use of Investigational Drugs and Devices” for the requirements for emergency use.

Review and Documentation
Review and approval of waiver or alteration of consent follows the procedures as required by the level of review. See HRPP Manual 8-2 “Expedited Review Procedure” and/or 8-3 “Full Board Review Procedure” for policies and procedures on review and documentation required to waive or alter consent.

Additional Considerations
For research studies involving children, see HRPP Manual 6-4-C “Informed Consent: Parental Permission and Child Assent” for waiver of parental permission criteria.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 7-21-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 12-11-2015. Revision 4 approved by Assistant VP Regulatory Affairs on 6-30-2016.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 6-4-B, Informed Consent: Waiver or Alteration of Informed Consent.