HRPP Manual Section 6-4-B

Informed Consent: Waiver or Alteration of Informed Consent

Excerpt of Regulatory Requirements Relevant to Waiver or Alteration of Informed Consent

Revised Common Rule (2018 Requirements)

“(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—

(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.

(2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (e)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.

(3) 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:

(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;

(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.

(f) General waiver or alteration of consent—

(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.

(2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.

(3) 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:

(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.” 45 CFR 46.116(2018 Requirements)

Pre-2018 Common Rule Requirements

“(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(Pre-2018 Requirements)

U.S. Food and Drug Administration Requirements

“Exception from informed consent requirements for minimal risk clinical investigations.

The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b), or may waive the requirement to obtain informed consent, provided the IRB finds and documents the following:

(a) The clinical investigation involves no more than minimal risk to the subjects;

(b) The clinical investigation could not practicably be carried out without the requested waiver or alteration;

(c) If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format;

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

(e) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.” 21 CFR 50.22 (FDA)

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.

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.

Applicability of the Revised Common Rule (2018 Requirements)

See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements),” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.

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. Revision 5 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 6 approved by Associate VP Research Regulatory Support on 9-25-2024.

Human Research Protection Program Office of Research Regulatory Support