When Does the FDA Allow Verbal Informed Consent? Emergency Use and IRB Waivers Explained

Verbal Informed Consent Regulations

The FDA’s default is written, signed informed consent. However, the agency permits consent to be obtained verbally in specific circumstances, provided you meet documentation requirements and any IRB conditions. In FDA terms, “verbal” consent typically occurs either through the short-form process with an oral presentation or when an IRB waives the requirement for a signed consent document.

Under the short-form pathway, you deliver the consent information orally, use a written summary, and involve a witness. The subject or legally authorized representative (LAR) signs the short form, the person obtaining consent signs the summary, and the witness signs both. Copies of the short form and the summary are provided to the subject or LAR. When an IRB waives documentation of consent for minimal risk research, you may obtain consent verbally and record it in the study file instead of using signatures.

Separately, for certain minimal risk clinical investigations, an IRB may waive or alter elements of informed consent when specific IRB waiver criteria are satisfied (for example, the study presents no more than minimal risk, the waiver will not adversely affect subjects’ rights and welfare, and the research could not practicably be carried out without it). In these cases, verbal consent or informational scripts may be used in place of a full, signed form.

• Use verbal consent only with IRB approval or under a recognized FDA provision.
• Cover all required consent elements verbally, ensure understanding, and allow time for questions.
• Document the exchange thoroughly, including date/time, who was present, what was discussed, and the decision.

Emergency Use of Investigational Products

Emergency use involves a one-time treatment with an investigational drug, biologic, or device for a patient in a life-threatening situation when no standard acceptable alternative is available and there is not enough time for prospective IRB approval. For an investigational drug emergency use, you may need an Emergency IND; for a device, follow the applicable IDE emergency procedures. Whenever feasible, attempt to obtain informed consent from the subject or LAR before treatment.

If time permits but signatures cannot reasonably be obtained, you may seek verbal consent from the subject or LAR (including by telephone) using an IRB-approved script or short-form process, with a witness, and then complete written documentation as soon as practicable. If consent cannot be obtained because of the subject’s condition and time constraints, the FDA’s informed consent exception for individual emergency use may be applied when its conditions are met, including independent physician certification when required.

After any emergency use without prior IRB approval, submit an emergency use notification to the IRB within the required timeframe, and provide all supporting documentation. Report to the sponsor and FDA as applicable.

IRB Waivers for Emergency Research

Planned emergency research (e.g., cardiac arrest, severe trauma) may proceed without prospective consent only under the FDA’s exception for emergency research in 21 CFR 50.24. This provision allows enrollment when the subject cannot consent due to the medical condition, available treatments are unproven or unsatisfactory, and the research could not practicably be conducted without the exception. The IRB must make and document specific findings before approval.

• Risks are reasonable in relation to what is known about the condition and investigational intervention.
• There is a prospect of direct benefit to enrolled subjects or the research addresses the condition in a way that justifies the risks.
• A therapeutic window is prospectively defined, with a plan to contact a LAR within that window, and to obtain consent to continue participation as soon as feasible.
• Independent data monitoring is in place, and community consultation requirements and public disclosure activities are completed before initiation and after completion of the study.

These IRB approvals are study-wide; they are distinct from individual-patient emergency use and require rigorous advance planning, documentation, and oversight.

Exception from Informed Consent Requirements

FDA regulations recognize limited “informed consent exception” pathways. Choosing the correct pathway depends on the purpose and timing of the activity:

• Individual-patient emergency use: If immediate use is required to save life or prevent serious harm and consent cannot be obtained in time, you may treat under the emergency exception, with the required independent physician determinations and prompt IRB reporting.
• Planned emergency research (21 CFR 50.24): For preapproved studies in life-threatening settings where consent cannot be obtained at enrollment, the IRB may approve an exception after specific findings, community consultation, and public disclosure.
• Minimal risk research: An IRB may waive documentation of consent or, when criteria are met, waive or alter elements of consent; in these cases, verbal consent or an information sheet may replace signed forms.

In every pathway, use the least restrictive approach possible: obtain standard written consent when feasible, obtain verbal consent with appropriate documentation when signatures are impracticable, and use exceptions without consent only when all regulatory conditions are satisfied.

Documentation of Informed Consent

Documentation depends on the pathway used:

• Short-form oral consent: Keep the IRB-approved summary; ensure the subject/LAR signs the short form; ensure the witness signs both the short form and the summary; ensure the person obtaining consent signs the summary; provide copies to the subject/LAR.
• IRB waiver of documentation (minimal risk research): Record in the study file the verbal consent process, including date/time; names and roles of those present (including any witness); the information provided; subject questions; confirmation of voluntary agreement; and that a study information sheet was provided when applicable.
• Individual-patient emergency use without consent: Maintain written certifications showing the life-threatening situation, lack of alternatives, and time constraints; include the independent physician determination if required; and file the emergency use notification with the IRB and sponsor/FDA reports as applicable.
• Emergency research under 21 CFR 50.24: Retain the IRB’s documented findings, community consultation materials, public disclosures, data monitoring plans, and records of attempts to obtain consent from a LAR or the subject as soon as feasible.

IRB Review and Approval

IRBs evaluate whether your consent approach protects subjects’ rights and welfare and complies with FDA regulations. For minimal risk research, the IRB may approve a waiver or alteration of consent or a waiver of documentation when criteria are met. The IRB’s minutes or determination letter should explicitly capture these findings.

For individual-patient emergency use, prior IRB approval is not required when conditions are met, but you must submit an emergency use notification to the IRB within the specified period. Any subsequent use at the institution requires prospective IRB review and approval.

For emergency research under 21 CFR 50.24, the IRB must document each required finding, confirm independent data monitoring, verify community consultation and public disclosure plans, and ensure procedures to seek consent from a LAR or the subject at the earliest feasible opportunity.

Community Consultation and Public Disclosure

Community consultation requirements under 21 CFR 50.24 ensure that people likely to be affected by emergency research can ask questions, voice concerns, and influence study plans before enrollment begins. Effective approaches include engaging patient advocacy groups, EMS leadership, faith and civic organizations, and neighborhood stakeholders in two-way dialogue.

Public disclosure occurs both before and after the study. Before initiation, disclose the study’s purpose, population, risks, potential benefits, and opt-out mechanisms if applicable. After completion, disclose a summary of results, including aggregate outcomes and the demographics of enrolled subjects, in formats accessible to the community.

Keep records of consultation methods, attendance, feedback, and how comments were addressed. These materials support IRB review, strengthen transparency, and build public trust in studies that rely on an informed consent exception.

Summary

In practice, the FDA allows verbal informed consent when an IRB waives documentation for minimal risk research or when you use the short-form oral process. In emergencies, obtain verbal consent from the subject or LAR whenever feasible; if not, apply the informed consent exception appropriately—individual emergency use or emergency research under 21 CFR 50.24—followed by rigorous documentation, IRB oversight, and timely emergency use notification.

FAQs

Under what emergency conditions does the FDA permit verbal informed consent?

When time is critically limited but some discussion is feasible, you may obtain consent verbally from the subject or LAR (including by phone), using an IRB-approved script or short-form process with a witness, and then finalize documentation as soon as possible. If consent is not feasible due to the subject’s condition and time constraints, treatment may proceed under the FDA’s emergency informed consent exception instead of verbal consent.

How must investigators document FDA-approved verbal consent?

Document the date and time; who obtained consent; who was present (and the witness); the information provided; subject/LAR questions; and the verbal agreement to participate. When using the short-form process, ensure signatures and copies are handled as required. When documentation is waived by the IRB for minimal risk research, place a detailed note in the study file and provide an information sheet when appropriate.

What are the IRB notification requirements after emergency use without prior approval?

You must submit an emergency use notification to the IRB within the required timeframe (commonly within five working days), summarizing the clinical circumstances, the regulatory basis for the informed consent exception, determinations by the investigator and independent physician if required, and any sponsor/FDA notifications (e.g., Emergency IND or device reporting).