Waiver of Informed Consent in Research
Criteria and Application of Waiver of Informed Consent in Human Subjects Research · Also known as: consent waiver, waived consent, exempt from consent, research without consent
A waiver of informed consent permits research to proceed without obtaining prospective written or verbal consent from participants. This exception to the standard informed consent requirement applies to specific low-risk research scenarios where obtaining consent is impractical, unnecessary, or would compromise research validity. In the U.S., the regulations (45 CFR 46.116) specify four criteria that must be met for an IRB to approve a waiver; similar criteria apply in the UK (Research Ethics Committee) and EU jurisdictions. Waivers are not automatic; researchers must request them explicitly and justify them to the ethics committee, which determines whether the criteria are met.
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When to use it
Request a waiver of informed consent when: (1) your research involves minimal risk to participants (surveys, observational studies, retrospective medical record review without identifiable data), (2) you are using de-identified existing data (medical records, biospecimens, survey datasets), (3) obtaining consent is impractical (studying a deceased population, lost-to-follow-up cohort, large population database), (4) the research involves emergency scenarios where advance consent is impossible (e.g., resuscitation studies), or (5) obtaining consent would compromise research validity (e.g., studies of implicit bias or decision-making where knowing the hypothesis would alter behavior). Do NOT request a waiver if: your research involves more than minimal risk without strong safeguards, you are collecting new identifiable data from participants, or your participants are vulnerable populations (minors, prisoners) without additional justification and protections. If unsure whether your research qualifies, consult your IRB/REC before submitting an application.
Strengths & limitations
- Enables important research that would otherwise be infeasible: retrospective studies of patient outcomes, large epidemiological studies, and public health surveillance could not proceed if consent from every participant were required.
- Protects research validity in behavioral studies where awareness of the research hypothesis would alter natural behavior (e.g., implicit bias testing, decision-making under uncertainty).
- Maintains privacy and confidentiality when research uses de-identified data; participants face no identifying information published or disclosed.
- Allows emergency or time-sensitive research to proceed without delaying potentially life-saving interventions.
- Reduced participant autonomy: participants do not explicitly agree to participate or have opportunity to withdraw in advance; while protections are in place, some argue this diminishes respect for persons.
- Trust and transparency concerns: retrospective waived-consent research may strain public trust if participants later learn their data was used without advance permission (though post-research notification can mitigate this).
- Limited to minimal-risk research: waivers cannot be granted for higher-risk studies (e.g., experimental interventions, medical procedures) even if obtaining consent is difficult; these studies require full consent or significant modifications.
- Potential for data misuse: research conducted under a waiver may be more vulnerable to unauthorized use of data outside the approved protocol if data governance and access controls are weak.
Frequently asked
Is a waiver of informed consent the same as no ethics oversight?
No. A waiver of informed consent means participants do not need to provide prospective written consent; however, the ethics committee still reviews the study, risk-benefit assessment must be sound, and participant protections must be robust. The IRB/REC still exercises oversight, and the protocol must still comply with all other ethical and regulatory requirements (data security, privacy protections, conflict of interest disclosure, etc.). The waiver only exempts the specific requirement for informed consent; it does not waive ethics review.
Can I use a waiver of informed consent if my research involves interviewing participants face-to-face?
Generally, no. If you are conducting interviews or direct interaction with participants where they provide new information, you should obtain informed consent at the start of the interaction. A waiver of informed consent is appropriate for studies using existing data (medical records, de-identified datasets, biological specimens) without new contact with participants. If you plan to contact participants directly, even by phone, you typically must inform them of the research and obtain consent (at minimum verbal consent) before proceeding. If you believe consent is impractical even with direct contact, consult your IRB/REC.
What is the difference between a waiver of consent and a waiver of consent documentation?
A waiver of informed consent (45 CFR 46.116(c)) means the entire consent process is waived; participants do not consent in advance and no consent form is signed. A waiver of documentation of informed consent (46.117(c)) means participants do consent verbally, but no written form is required (e.g., a brief phone interview where verbal consent is obtained and documented by the researcher's notes). The latter is less common. A waiver of consent requires meeting all four criteria and is more restrictive; a waiver of documentation allows verbal consent alone. Ensure you understand which you are requesting.
If I have a waiver of informed consent, do I need a Certificate of Confidentiality?
A Certificate of Confidentiality (CoC) protects against compelled disclosure of identifiable research data to third parties (subpoenas, law enforcement). If your waived-consent research uses identifiable data or data that could be re-identified (even if you have de-identification safeguards), a CoC provides additional legal protection. If your data is truly de-identified with no possibility of re-identification, a CoC is less critical but may still be advisable for administrative data (income, immigration status) or sensitive topics (substance use, HIV status). Consult your IRB/REC and institution's legal counsel.
Sources
- U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.116(c). link ↗
- U.S. Department of Health and Human Services, Office for Human Research Protections. (2019). Waiver or Alteration of Informed Consent. National Institutes of Health. link ↗
- U.S. Food and Drug Administration. (2015). Guidance for Industry: Waiver or Alteration of Informed Consent for in vitro Diagnostic Device Studies Using Leftover Human Specimens. link ↗
- Health Research Authority. (2021). Guidance for Applicants: Research Without Consent. UK Research Ethics Service. link ↗
How to cite this page
ScholarGate. (2026, June 4). Criteria and Application of Waiver of Informed Consent in Human Subjects Research. ScholarGate. https://scholargate.app/en/research-ethics/waiver-of-informed-consent
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