Prepare an emergency-research informed-consent exception package

What should an emergency-research informed-consent exception package establish?

For planned research under §50.24, connect each eligibility criterion and participant protection to scientific evidence, protocol procedures and documented IRB findings with the required physician concurrence. Use the separate IND/IDE pathway, distinguish consultation from public disclosure and track sponsor communications. A community notice or a sponsor-authored justification alone does not establish the exception.

Before you begin

Planned emergency research under 21 CFR 50.24 and IND sponsor duties under 312.54; not the single-patient emergency exception under 50.23.

What you will prepare: A traceable package connecting protocol criteria, IRB evidence, disclosures and required communications.

1.12.6: establish the planned-research pathway

An EFIC package is not a generic waiver letter. Start with the protocol, life-threatening condition, investigational intervention, therapeutic window, available treatments and evidence supporting the prospect of direct benefit. Explain why subjects cannot consent, why a legally authorized representative cannot feasibly provide consent in the necessary window, and why eligible individuals cannot reasonably be identified prospectively.

Under 50.24(d), the protocol must be conducted under a separate IND or IDE clearly identifying the inability-to-consent context, even when an application for the same product exists. Do not propose simply adding this protocol as an amendment to another existing application. This guide concerns the drug/biologic IND package; the IDE procedure requires its own implementation.

Translate the criteria into an evidence matrix

Create one row per applicable 50.24 criterion and protection: finding to be made, protocol section, scientific evidence, operational procedure, IRB record and unresolved item. Include risk/benefit support, why the research cannot practicably be done with consent, the evidence-based therapeutic window, efforts to reach a representative and the consent procedure when consent is feasible.

Also identify community consultation, pre-study and post-study disclosure, independent data monitoring and attempts to contact a family member about objection when the specified circumstances apply. Show how subjects or representatives will be informed at the earliest feasible opportunity, including the opportunity to discontinue. These are operational protections, not headings satisfied by writing “per protocol.” Preserve the IRB findings and required physician concurrence; a sponsor-authored checklist does not make those findings.

1.12.7: prepare public disclosure as a real communication

Keep public disclosure distinct from community consultation. Consultation obtains community views; disclosure communicates the planned study and, later, study information and results. Prepare accessible descriptions of the purpose, population, intervention, risks, expected benefits, sites and contacts appropriate to the audience. Avoid promotional language or a claim that the community has collectively consented.

Build a disclosure record containing the approved material, audience/community, channel, dates, version and evidence of dissemination. For completion disclosure, include the study and population characteristics and results in the appropriate public form. Under 312.54(a), when the sponsor receives the public-disclosure information from the IRB, it must promptly submit copies of the information disclosed under 50.24(a)(7)(ii) and (iii) to both the IND file and FDA’s public docket, identified by the IND number. The regulation names Docket Number 95S-0158; confirm the current docket submission instructions when preparing the handoff. An empty press-release template is not proof of disclosure.

1.12.8: retain decisions and communicate disapproval

Identify each IRB/FDA communication, the protocol version, the issue and the sponsor's response. If an IRB cannot approve because the exception criteria or other ethical concerns are not satisfied, preserve the written findings and assess the sponsor's prompt disclosure duties to FDA, other participating or invited investigators and reviewing IRBs under the cited provisions.

Do not remove an unfavorable IRB determination from a package simply because another IRB approved a site. Prepare an action log that records who received the finding, what changed and which question remains. This correspondence record is separate from the public-disclosure material.

Worked review: a public notice does not resolve consent feasibility

Fictional editorial exercise: the package contains a community newspaper notice but no evidence supporting a ten-minute therapeutic window and no procedure for reaching a representative. The clinical rationale and consent-attempt process remain incomplete; better publicity cannot supply them.

Change the scenario to an unplanned single-patient treatment emergency. Stop using this planned-research package and establish the applicable emergency-use and consent procedure with the responsible clinicians and regulatory team. If the intervention window is unknown, no author can conclude that obtaining consent is infeasible.

Review the exception as an evidence and operations package

Use a matrix that links the regulatory finding to something the investigator, sponsor and IRB can inspect. This table summarizes preparation tasks; it does not replace the full criteria or the IRB’s determinations.

Operational exercise: a protocol states that representatives cannot be reached within the therapeutic window, but the only evidence is a site's usual staffing pattern. Establish the scientific basis for the window separately from the operational contact process. Describe feasible attempts and how they will be documented. An inconvenient workflow does not by itself demonstrate the regulatory consent-infeasibility findings.

The concurrence required by §50.24(a) comes from a licensed physician who is an IRB member or consultant and is not otherwise participating in the clinical investigation. Preserve that role and the documented findings. A sponsor's clinical reviewer signing the authoring checklist does not necessarily satisfy this requirement.

Keep three communication records distinct. Community consultation records the views sought and considered. Public disclosure records the pre-study information and the subsequent study/population/results communication. Regulatory handoff records what was submitted and where. Under §312.54(a), the sponsor promptly submits the received public-disclosure information to both the IND file and the FDA public docket, identified by IND number. A copy placed only in the eCTD package leaves the separate docket handoff unaccounted for.

Finally, preserve unfavorable IRB findings and their required dissemination. One site's approval does not erase another IRB's inability to approve for exception criteria or ethical concerns. Track recipients and actions under §§50.24(e) and 312.54(b), including the relevant participating or invited investigators and other reviewing IRBs. If the study ends early, the guidance also expects public disclosure of terminated or discontinued studies; early termination is not a reason to hide the results.

For a study-specific closeout, use the discontinuation guide alongside the additional EFIC duties. This planned-research workflow should not be substituted for the distinct assessment of an unplanned individual treatment emergency.

Frequently asked questions

Sources and revisions

Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.

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