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Stop submitting related material, preserve the facts, and contact your institution’s information-security, privacy, and research-compliance teams immediately. If the material was NIH controlled-access human genomic data, the applicable Data Use Certification requires notification to the appropriate Data Access Committee (DAC) within 24 hours after identifying a qualifying unauthorized sharing, breach, or inadvertent release, followed by a detailed written report within three business days. Those deadlines apply to the covered NIH agreement—not automatically to every dataset, institution, country, or AI service.

First actions when sensitive data may have entered an AI tool

1. Stop the exposure from growing

Do not paste more records, genomic sequences, images, laboratory notes, prompts, outputs, screenshots, or copied excerpts into the tool. Do not forward the conversation to colleagues or create a second ticket containing the same sensitive material. Tell the authorized incident-response team what happened and ask what evidence it wants preserved before you delete, edit, or reset anything.

Stopping further submissions does not prove that an earlier prompt was deleted. Treat the event as a possible external disclosure until your institution has assessed the service, account, data, and applicable agreements.

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2. Notify the people who can make the report

Use your institution’s emergency information-security or privacy route, then notify the principal investigator and research-compliance office. Involve the privacy office when human participants, identifiable information, consent restrictions, or confidentiality commitments may be involved. Your institution may require an internal report immediately even when an external notification is not ultimately required.

For NIH controlled-access genomic data, the requester and PI have a specific duty to notify the appropriate DAC after identifying a covered event. The controlling requirement is in the NIH Data Use Certification Agreement.

Capture the facts without spreading the data

Give responders a concise, access-controlled incident record. Record the date and time, AI service and account type, the files or fields submitted, whether the tool generated an output containing sensitive material, who could view the conversation, and any retention, sharing, workspace, or administrator settings shown in the account. Include whether the prompt was sent from a personal account, an institutional workspace, an API, a plug-in, or another connected application.

Keep the record itself free of unnecessary participant identifiers or full sequences. If a ticketing system is not approved for restricted information, describe the category and location of the data and provide the evidence through the institution’s authorized secure channel. Limit access to the incident record to personnel assigned to investigate or report it.

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These fields are practical triage information, not a universal checklist imposed by NIH. The purpose is to let authorized responders determine what was exposed, under which account, to whom, and under which rules.

Classify the data and identify the rule set

The reporting path depends on the data category, the agreement under which it was obtained, and what the AI service did with it. An external AI submission is not automatically a reportable breach in every circumstance, but it can violate a data-use restriction even when no public disclosure is confirmed.

Situation Primary authority to consult Key trigger or question Timing and report content
NIH controlled-access human genomic data or derivatives Data Access Committee, Data Use Certification, institutional security and compliance offices Was data shared, breached, or inadvertently released to a party or service not covered by the approved Data Access Request? For a qualifying event, notify the DAC within 24 hours of identification; submit a detailed report within three business days after notification. Include the event date and nature, remediation, and prevention plans with anticipated timelines.
Other human-participant or confidential research data Institutional privacy, security, IRB or research-compliance office; consent, contract, and applicable law Do consent terms, a confidentiality commitment, a data-use agreement, or institutional policy restrict disclosure to an external AI provider? Deadlines and required recipients vary. Follow the institution’s incident procedure and the governing agreement rather than importing NIH deadlines.
Laboratory exposure, pathogen release, loss of containment, or another biosafety event Institutional biosafety officer, Institutional Biosafety Committee (IBC), and relevant NIH or other authorities Did a physical or biological safety incident occur in addition to a data disclosure? Use the biosafety reporting rules for the incident type. A data disclosure and a containment incident are separate questions and may require parallel reports.

NIH’s March 28, 2025 notice states that controlled-access genomic and associated data, including derivatives, must not be distributed to parties not identified in the Data Access Request without appropriate written NIH approval. The notice specifically warns that sharing data with AI tools can cause inadvertent disclosure.

NIH controlled-access genomic data: exact deadlines

The NIH Data Use Certification Agreement says: “The Requester and PI agree to notify the appropriate DAC(s) of any unauthorized data sharing, breaches of data security, or inadvertent data releases that may compromise data confidentiality within 24 hours of when the incident is identified.”

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That 24-hour period starts when the qualifying incident is identified, not necessarily when the original prompt was sent. After notifying the DAC, the agreement requires a detailed written report within three business days. The report should cover:

  • When the event occurred and when it was identified.
  • What data or derivatives were involved and the nature of the unauthorized sharing, breach, or release.
  • Which AI service, account, application, or recipient had access.
  • Actions taken or planned to contain and remediate the event.
  • Prevention measures, responsible processes, and anticipated completion timelines.

Coordinate the DAC notification through your institution’s authorized channel. Do not wait for a provider to confirm retention or model use before making a required notice; uncertainty about those details belongs in the report.

A practical response sequence

Step 1: Freeze related activity

  1. Stop using the AI tool for the affected project and pause automated workflows that could continue sending data.
  2. Do not test the service by submitting additional sensitive examples.
  3. Preserve the original conversation, timestamps, account identifiers, settings, and outputs only as directed by the response team.

Step 2: Activate institutional response

  1. Contact information security or incident response using the institution’s emergency procedure.
  2. Notify privacy and research-compliance contacts when human data, controlled-access data, consent, or contractual restrictions may apply.
  3. Inform the PI or data steward and identify the person authorized to communicate with the DAC, IRB, sponsor, or provider.

Step 3: Map the exposure

  1. List the exact files, fields, sequences, images, metadata, or notes submitted.
  2. Determine whether the AI tool returned any of that material, transformed it, or exposed it to collaborators or connected applications.
  3. Identify all possible viewers, including workspace administrators, shared-project members, API operators, or unintended recipients.
  4. Record account type, retention notices, training controls, export options, plug-ins, and integrations shown at the time.

Step 4: Check authorization

Compare the service and environment with the approved Data Access Request, data-use agreement, consent language, institutional policy, and contract. For NIH data, verify whether the AI provider or cloud environment was named or otherwise approved. Controlled-access data and derivatives cannot be distributed outside the approved request without appropriate written NIH approval.

Step 5: Make required notifications

For a qualifying NIH event, notify the appropriate DAC within 24 hours of identification and deliver the detailed report within three business days after that notification. Other datasets may have different deadlines, such as immediate institutional escalation or sponsor-specific notice. Let the responsible compliance office determine which obligations run in parallel.

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Step 6: Contain and remediate with authorization

Ask the response team whether it should request account suspension, access revocation, provider-side preservation or deletion, removal of shared links, or restrictions on connected applications. Do not independently delete evidence or contact an external provider if that could compromise an investigation. Document each action, owner, and completion time.

Can deleting the prompt remove every copy?

Not necessarily, and no universal provider-side outcome is established by the NIH materials. A conversation may have account, workspace, backup, logging, moderation, or security copies, and an output may have been exported or shared. Whether a provider retains prompts, uses them for service improvement, or can remove associated records depends on the specific product, account terms, configuration, and applicable law.

Ask your authorized response team to review the provider’s current terms and settings and to coordinate any containment request. Do not promise participants, colleagues, or sponsors that deletion has occurred until the responsible authority has verified what can be verified.

NIH’s Office of Science Policy warns: “Investigators should be cognizant that research data used as input or training for AI could result in their unintentional disclosure if the data is sent to an AI provider external to NIH.” Read the full NIH Artificial Intelligence policy overview for its discussion of participant protections and external providers.

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Do model-training and memorization risks change the response?

They can change the questions responders ask, but they do not create a single universal probability of leakage. NIH’s May 30, 2025 request for information discusses the possibility that generative AI systems may memorize and leak underlying data and asks about privacy-preserving mitigation. It is evidence of an acknowledged research concern and ongoing policy development, not a breach-rate statistic or a step-by-step incident protocol.

The March 28, 2025 NIH notice also described an interim pause on sharing generative AI models and their parameters based on NIH human genomic controlled-access data, and on retaining those tools beyond project closeout. That was the notice’s stated posture on that date; later policy updates, award terms, or DAC instructions may change the position. Check the current terms governing your project.

Keep biosafety reporting separate

Sending a genomic file or laboratory note to an AI service is a confidentiality and governance issue. It is not, by itself, proof of pathogen release, researcher exposure, or loss of physical containment. Conversely, a laboratory accident can require biosafety reporting even when no AI tool was involved.

If the same event includes an exposure, accident, unauthorized possession, shipment problem, or containment failure, contact the biosafety officer and IBC as well as privacy and security teams. NIH’s Biosafety and Biosecurity Policy overview describes reporting for significant problems, violations, accidents, and illnesses; the trigger and timing depend on the incident type and applicable guidance.

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Preventing a repeat disclosure

  • Maintain a project-level list of approved AI services, accounts, environments, and prohibited data classes.
  • Require a privacy, security, and data-use review before connecting an AI tool to a research repository, electronic lab notebook, sequencing pipeline, or cloud drive.
  • Train researchers to treat prompts, uploaded files, generated outputs, and conversation histories as potential disclosures.
  • Use de-identification or synthetic examples only when the method has been approved and the residual re-identification risk is understood; removing names alone may not satisfy a genomic or consent restriction.
  • Document who may authorize external processing and how staff can reach incident response outside business hours.
  • Recheck provider terms, retention controls, administrator visibility, and connected-app permissions when the service or project changes.

These controls reduce risk but do not replace the obligation to report a suspected incident under the agreement that governs the data.

What to tell participants, sponsors, or collaborators

Do not send an improvised explanation containing more sensitive data. Route communications through the institution’s privacy, legal, research-compliance, and communications leads. A factual notice should distinguish what is confirmed from what is still being investigated, identify the affected data category, state which authority is coordinating the response, and avoid claiming that a provider retained, trained on, or deleted data unless that fact has been established.

Frequently Asked Questions

Do I have to report every use of an external AI tool?

No universal rule makes every use reportable. The answer depends on the data category, consent and confidentiality terms, data-use agreement, institutional policy, approved environment, and what was actually shared. NIH controlled-access genomic data have specific notification duties when a qualifying unauthorized sharing, breach, or inadvertent release is identified.

Are NIH’s 24-hour and three-business-day deadlines universal?

No. They are requirements in the NIH Data Use Certification Agreement for covered controlled-access data incidents. Other institutions, sponsors, countries, and agreements may impose different recipients or deadlines.

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Is an AI data disclosure the same as a biosafety incident?

No. A confidentiality disclosure concerns information access and data governance. A biosafety incident concerns physical or biological exposure, release, or containment. One event can involve both, so assess the two reporting paths separately.

Should I delete the conversation immediately?

First ask the authorized incident-response team what evidence to preserve. Deleting a prompt may not remove provider-side, workspace, backup, or exported copies, and it can destroy evidence needed for investigation.

What if I do not know whether the AI provider retained the data?

Report the known facts and the uncertainty to your institutional responders. They can review the specific account terms and settings and decide whether to request containment or preservation from the provider.

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