MDHHS IRB Guidance on Requesting a Waiver of Informed Consent Requirements

As described in the section of this site: MDHHS IRB Guidance on Informed Consent, the Belmont principles require in most circumstances that research subjects understand research they are asked to participate in, and that subjects voluntarily consent to participate in that research. This guidance discusses the circumstances where the MDHHS IRB may be permitted to waive the requirements for informed consent. A researcher should not involve human subjects in research without having obtained the informed consent of those subjects without first obtaining documentation from the IRB that a waiver or alteration of informed consent requirements has been approved. Where information in this guidance is new per the 2018 Common Rule, that information is presented in bold.

An IRB may waive the requirement to obtain informed consent for certain research involving public benefit and service programs conducted by or subject to the approval of state or local officials. The IRB may do so if the researcher documents to the IRB 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:
   1. Public benefit or service programs;
   2. Procedures for obtaining benefits or services under those programs;
   3. Possible changes in or alternatives to those programs or procedures; or
   4. 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.

An IRB may waive the requirement to obtain informed consent for research in general if the researcher documents to the IRB that:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver;
3. 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;
4. The waiver will not adversely affect the rights and welfare of the subjects; and
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

With implementation of the 2018 Common Rule (anticipated January 21, 2019) an IRB may approve of certain research in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective subjects without the informed consent of the prospective subjects or the subjects’ legally authorized representative. The IRB may approve this research if the researcher documents that:

1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

If a researcher wishes to use or disclose Health Insurance Portability and Accountability Act (HIPAA) covered Protected Health Information (PHI) about subjects for research purposes without obtaining the authorization of subjects to do so, a separate request may need to be made for a waiver of the requirements for authorization. The documentation necessary for a privacy panel to waive the requirements for authorization under the HIPAA Privacy Rule are similar, but distinct from those described here. Please contact the IRB office (MDHHS-IRB@michigan.gov) for additional information.