August 2024

1. Waiver or alteration of informed consent elements
2. Justification for changes or waiver of the consent process
3. Waiver of documentation of informed consent
4. FDA Regulated Studies: Different Standards for Waiver of Informed Consent

1. Waiver or alteration of informed consent elements

The JHM IRB has some authority to alter or waive the required elements of informed consent, the consent process, and the documentation of informed consent. 

Under the DHHS regulations (the “Revised Common Rule") and FDA regulations^[1] (the “FDA Final Rule”), numerous variations of elements of consent, the process, and documentation are possible, depending on the nature of the study, the risk to the subjects, and the justification for the alteration or waiver requested. 

In addition to the FDA Final Rule, the FDA will permit waiver of informed consent if the research is FDA-regulated and meets the criteria for “emergency research,”^[2] and the FDA will exercise “enforcement discretion” regarding the requirement for informed consent for certain in vitro diagnostic (IVD) studies which use de-identified tissue samples or specimens but for which all of the elements under Section 2 below are not all met (see Organization Policy FDA 50.1).

2. Justification for changes or waiver of the consent process.

“Alteration or waiver of informed consent” means a departure from the traditional consent process.  Generally speaking, that process includes a thoughtful and thorough discussion of the study with the subject and confirmation that the subject understands the study and will participate voluntarily.  Under the Revised Common Rule and the FDA Final Rule, the JHM IRB may approve alteration or waiver of consent if:

• The research involves minimum risk to subjects;
• The waiver or alteration will not adversely affect the rights and welfare of the participants;
• The research could not practicably be carried out without the alteration or waiver;
• If the clinical investigation involves identifiable private information or identifiable biospecimens, it could not practicably be carried out without using such information or biospecimens in an identifiable format; and
• Whenever appropriate, the subject will be given additional information about the research after it is completed.

3. Waiver of documentation of informed consent.

Waiving the requirement for a participant’s signature to document informed consent is separate from waiver/alteration of consent, with a different set of criteria. 

See Guidance: Waiver of Documentation of Consent

4.  FDA Regulated Studies: Different Standards for Waiver of Informed Consent.

Current FDA guidance (4/25/06) indicates that under some circumstances, when samples taken from excess clinical or research specimens cannot be identified (e.g., all linking codes and identifiers have been removed, or the investigator has no access to the code keys or identifying information), the agency will exercise “enforcement discretion” and permit the IRB to approve the study without requiring informed consent of the sample sources.

To be eligible for approval without a requirement for informed consent, FDA indicates that IVD research must meet the following criteria:

• The research must be conducted under an IRB-approved protocol;
• The research must meet criteria for an IDE exemption (see above);
• The research must use specimens left over from clinical care, specimen repositories, or other research (i.e., the specimens may not be collected specifically for the proposed research, and no additional specimen may be collected for the purpose of research);
• Individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation;
• The specimens are provided for research without identifiers (codes are permissible only if neither the investigator nor anyone associated with the study has access to the code key or can identify the person who was the source of the specimen);
• Any clinical information supplied with the specimen must not be individually identifiable;
• No test results from the research may be reported to any subject or that subject’s health care provider; and
• The supplier of the specimens must have established policies and procedures to prevent the release of identifying information.

PLEASE NOTE: The criteria above overlaps with, but is not identical to, the criteria in the FDA Final Rule. For example, the IVD research guidance does not require IRBs to determine the research could not practicably be carried out without a waiver of informed consent or that it is minimal risk. The FDA stated in the preamble to the FDA Final Rule that it believes that most IVD device investigations, falling within the scope of the IVD guidance, would also meet the criteria for waiver of informed consent under the FDA Final Rule; however, the FDA acknowledges that this may not always be the case and clarifies that the IVD guidance will remain in place to cover such scenarios.^[3]

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[1] Effective January 22, 2024, the FDA Final Rule added a new section 21 C.F.R. § 50.22 to its regulations governing informed consent in FDA-regulated clinical investigations. This rule harmonizes FDA’s requirements for waiver or alteration of informed consent for minimal risk clinical investigations with the Revised Common Rule’s requirements, adopting identical criteria for waiver.

[2] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research

[3] To avoid unnecessary confusion, our current eIRB application does not include an IVD waiver option and studies requesting a waiver or alteration of consent are directed to meet the waiver criteria under Section 2 above.