Guidance on Waiver or Alteration of Informed Consent for Clinical Researchers
This guidance provides clinical researchers with an overview of when an exemption from informed consent requirements may be appropriate and outlines the regulatory conditions that must be met to obtain such an exemption. It is intended to support ethical and compliant study design in accordance with U.S. federal regulations. Keep in mind that the IRB of record may have additional requirements that must be met.
Types of Waivers or Alterations of Informed Consent?
Written informed consent is usually required for a clinical research study. However, what happens when the informed consent is not feasible, may interfere with the aims of the study, or may actually increase the risk of participating in a clinical research study? In certain circumstances, an Institutional Review Board (IRB) may approve a researcher’s request to waive or modify the informed consent process.
Full Waiver: A full waiver of informed consent is a request that no consent is obtained at all from the participant. This may be when obtaining consent is impractical or impossible.
Alteration: Researchers may request an alteration to the informed consent process. Alterations may be used in cases where obtaining an initial informed consent may bias the study. In this, consent is still being obtained, but some required elements of informed consent may be altered.
Waiver of Documentation of Informed Consent: Researchers may request that the IRB waive the requirement for a signed informed consent form. This means that consent is still being obtained, typically verbally, but the participant is not signing an informed consent form.
These types of waivers allow a research study or specific elements of a study to proceed without obtaining informed consent from participants or for the consent to be altered in some fashion. These waivers are granted only under strict regulatory criteria and are subject to Institutional Review Board (IRB) approval.
Regulations That Guide Waivers
The primary U.S. regulations governing informed consent exemptions include:
- 45 CFR 46 (Common Rule) – Applies to federally funded research.
- 46.116 (c): This regulation identifies cases when it is appropriate for the IRB to approve or waive an alteration of informed consent.
- 46.116 (d): This regulation identifies an overview of criteria the IRB may use to waive or approve an alteration of informed consent for research that meets four main criteria.
- 46.117 (c): This regulation outlines requirements for a waiver of documentation of informed consent.
- 21 CFR 50 (FDA regulations) – Applies to FDA-regulated clinical investigations.
Researchers must determine whether their study falls under these regulations and consult with their IRB for guidance.
When Can Informed Consent Be Waived or Altered?
Waiver or Alteration Under the Common Rule (45 CFR 46)
An IRB may approve a full or partial waiver of informed consent if all of the following criteria are met:
- Minimal Risk: The research involves no more than minimal risk to participants.
- Rights and Welfare: The waiver will not adversely affect the rights and welfare of the participants.
- Practicability: The research could not be practicably carried out without the waiver or alteration.
- Debriefing (if appropriate): Whenever appropriate, participants will be provided with additional pertinent information after participation.
Examples: Retrospective chart reviews, certain public health surveillance activities, or studies using anonymized data.
When Can Documentation of Informed Consent be Waived?
Waiver or Alteration Under the Common Rule (45 CFR 46)
An IRB may waive documentation of Informed Consent when:
- The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality.
- The research presents no more than minimal risk and involves procedures that do not normally require written consent in a non-research setting (surveys, interviews).
- Participants of the research are members of a distinct cultural group where signing documents is not the norm or culturally appropriate.
Examples: Anonymized survey studies where the study is not collecting identifiable information.
How to Request an Informed Consent Exemption
- Consult Your IRB Engage early with your Institutional Review Board or ethics committee. They will assess whether your study qualifies for a waiver or exemption.
- Submit a Detailed Justification
Include:- Study objectives and design
- Risk assessment
- Justification for the impracticability of consent
- Procedures for maintaining participant confidentiality
- Plans for debriefing (if applicable)
- Use Templates and Forms Many IRBs have standardized waiver request forms. Use these to streamline the submission process.
Important Considerations
- HIPAA Requirements: A waiver of consent does not automatically waive HIPAA authorization. You may also need a waiver of HIPAA authorization from your Privacy Board or IRB.
- International Research: If conducting research internationally, local laws and ethical guidelines must also be followed. Some countries do not allow consent waivers.
- Transparency: Even when a waiver is granted, researchers should ensure the study is conducted with transparency, respect, and appropriate oversight.
Need Help?
If you have questions about informed consent requirements or waivers, please contact the Rutgers IRB for a pre-submission consultation or request a consultation with the NJ ACTS Regulatory Support Office.
We are here to help you ensure ethical, compliant, and high-quality research!