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Stop sending related material, preserve the facts, and contact your institution’s information-security, privacy, and research-compliance teams immediately. If NIH controlled-access human genomic data may be involved, the applicable Data Use Certification requires notice to the appropriate Data Access Committee within 24 hours of identifying a qualifying incident, followed by a detailed report within three business days.
1. Stop the exposure from growing
Do not paste additional files, sequences, participant details, screenshots, prompts, or outputs into the AI service. Do not forward the conversation to colleagues or create a new ticket that reproduces the sensitive content. Tell your institution’s authorized incident-response team what happened and ask how it wants evidence preserved.
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Record the basic facts while they are fresh, but keep the record in an approved, access-controlled system:
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- The AI service, workspace, account type, and sign-in identity used.
- The files, fields, sequences, metadata, or other material entered.
- Whether the tool returned an output containing the material, and whether anyone else saw or downloaded it.
- Any retention, sharing, training, workspace, or administrator settings visible at the time.
This is a practical triage record, not a universal legal checklist. Do not copy the underlying sensitive data into an unapproved email, chat, ticket, or incident document merely to describe the event.
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2. Identify which rule set applies
The response depends on the data category, the agreement under which it was obtained, and what the AI service was authorized to receive. An external AI submission is not automatically a reportable breach in every setting, but it can violate a data-use agreement, consent restriction, contract, institutional policy, or privacy law.
| Situation | Primary authority to involve | Trigger to assess | Timing or report detail established by the cited sources |
|---|---|---|---|
| NIH controlled-access human genomic data or derivatives | Appropriate NIH Data Access Committee (DAC), institutional security, privacy, research-compliance office, and principal investigator | Unauthorized sharing, security breach, or inadvertent release that may compromise confidentiality | DAC notice within 24 hours after identification; detailed written report within 3 business days after that notice under the Data Use Certification Agreement |
| Other identifiable human-participant or restricted research data | Institutional privacy office, information security, research-compliance office, IRB or equivalent where applicable, and the data owner | Exposure contrary to consent, confidentiality commitments, contract, approved protocol, or institutional rules | No single deadline is established here; follow the governing agreement, institutional incident procedure, and applicable law |
| Laboratory safety, pathogen, or containment event in addition to a data disclosure | Institutional biosafety committee (IBC), biosafety officer, incident response, and any required NIH or other regulator contact | Accident, illness, significant problem, policy violation, or loss of containment | Requirements vary by incident type and applicable biosafety guidance; a data disclosure alone is not proof of a biological release |
The table separates questions that are often wrongly merged. A genomic privacy incident concerns confidentiality and authorized access. A biosafety incident concerns exposure, containment, or laboratory operations. One event can require both assessments, but neither category should be assumed from the other.
3. If NIH controlled-access genomic data are involved
Check the approved request and certification
NIH’s March 28, 2025 notice on controlled-access human genomic data says that the Genomic Data Sharing Policy and Data Use Certification prohibit distributing controlled-access genomic or associated data, or derivatives, to parties not identified in the Data Access Request without appropriate written NIH approval. Read the notice at NIH NOT-OD-25-081.
Compare the AI service, account, cloud environment, and named collaborators with the approved request. A provider being used for ordinary work does not by itself establish that it was an approved recipient of controlled-access data. Ask the research-compliance contact to determine whether an amendment or written approval is possible; do not attempt to cure the problem by sending more data or by deleting evidence.
Meet the two reporting deadlines
The NIH Data Use Certification Agreement states: “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.” The agreement is available at NIH’s Data Use Certification Agreement page.
- Within 24 hours of identification: notify the appropriate DAC of a qualifying unauthorized sharing, breach, or inadvertent release. The requester and principal investigator have obligations under the agreement; your institution may require an even faster internal report.
- Within 3 business days after DAC notification: submit the detailed written report required by the agreement. Include the event’s date and nature, actions taken or planned to remediate it, prevention plans or process changes, and anticipated timelines.
These are requirements for incidents covered by that NIH agreement, not universal deadlines for every AI service, dataset, country, or institution. If classification is uncertain, escalate immediately and let the authorized office determine whether the agreement’s trigger is met.
Understand the 2025 model-sharing posture
NOT-OD-25-081 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 statement reflects the notice’s posture and publication date, March 28, 2025; it should not be treated as a complete statement of every later policy change. Ask the DAC or institutional compliance office which current rule applies to your project.
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The response team needs enough information to determine what was exposed and to whom. Give investigators the service name, account and workspace identifiers, timestamps, file names, data categories, prompts, outputs, recipients, and screenshots or export files when approved. Restrict the incident record to personnel with a need to know.
Classify the material precisely:
- Direct identifiers: names, contact details, medical-record numbers, or other fields that identify a person.
- Quasi-identifiers: dates, rare conditions, locations, demographic combinations, or linkage keys that could enable re-identification.
- Genomic information: raw sequence, variant calls, associated phenotypes, or derivatives covered by a controlled-access agreement.
- Operational or unpublished science: protocols, screening results, proprietary methods, or data restricted by contract or sponsor terms.
Then determine what the tool actually did. Was the material submitted only in a prompt, uploaded as a file, included in an image, or copied into a plug-in or connected workspace? Did the service return a quotation or transformation that reveals the input? Did the account permit sharing with administrators, collaborators, or third-party integrations? The answers affect containment and notification, and they must come from the provider’s current account records and terms rather than assumptions about AI products in general.
5. Do not assume deletion or non-retention
Closing a browser tab, deleting a prompt, or closing an account does not establish that every copy has disappeared. NIH materials discuss unintentional disclosure, retention, and the possibility that generative AI can memorize and leak underlying data, but they do not prescribe one provider-side deletion result for all services.
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 policy overview at NIH Office of Science Policy: Artificial Intelligence.
Ask the authorized response team to coordinate any preservation, deletion, account-freeze, or access-revocation request with the provider under institutional procedure. The team should first preserve the evidence needed for reporting and then decide what containment request is lawful and technically possible. Do not promise colleagues or participants that the provider has erased the data unless the responsible office has verified that outcome under the applicable terms.
6. Review participant protections and contracts
External AI processing can intersect with informed-consent language, confidentiality commitments, Certificates of Confidentiality, institutional review-board approvals, sponsor agreements, and data-use contracts. NIH’s AI overview identifies human-subject protections and Certificates of Confidentiality as relevant considerations; it does not declare every external AI service prohibited.
Have the privacy or research-compliance office compare the event with:
- The consent form and protocol language governing secondary use or disclosure.
- The Data Use Agreement, Data Access Request, or sponsor contract.
- Institutional rules for cloud services, generative AI, and incident notification.
- Applicable privacy, breach-notification, export-control, or professional obligations.
If the data came from another institution or consortium, notify the designated data owner through the approved channel. Avoid independently contacting participants, funders, or regulators until the institution’s response lead confirms the communication plan; inconsistent or premature notices can expose additional information or conflict with required reporting.
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7. Assess biosafety separately
An AI prompt containing a pathogen sequence or laboratory protocol is a data-governance issue even when no organism was released. Conversely, a spill, accidental exposure, illness, or containment failure may require biosafety reporting even when no digital data left the institution.
Ask the biosafety officer and IBC whether the facts implicate a separate safety event. NIH’s biosafety and biosecurity policy overview describes reporting for significant problems, violations, accidents, and illnesses, with triggers and timing depending on the incident. Consult NIH’s Biosafety and Biosecurity Policy and your institution’s emergency procedures. Keep the biosafety investigation and the privacy investigation coordinated, but do not substitute one report for the other.
8. Prepare the written incident report
A useful report distinguishes confirmed facts from unknowns. State when the submission occurred, how it was discovered, what categories of data were involved, which account and service were used, and who may have received the content. Explain immediate containment, evidence preservation, access restrictions, and provider contact. For NIH-covered data, add the remediation actions, prevention measures, and implementation timelines required by the Data Use Certification.
If a fact is not known, label it as unknown and assign an owner and deadline for checking. Do not estimate a probability of model memorization or provider retention: the cited official sources acknowledge those risks but provide no prevalence rate or universal measurement.
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After the incident is stabilized, update the controls that failed. Practical measures include:
- Maintain an approved-tools register that names permitted AI services, account types, regions, integrations, and data classes.
- Use de-identification, aggregation, synthetic examples, or locally controlled processing only when those methods satisfy the governing protocol and do not create a false sense of safety.
- Train investigators that prompts, uploaded files, images, plug-ins, and generated outputs can all be disclosure routes.
- Require principal-investigator or data-steward approval before controlled-access data enters a new computational environment.
- Keep an incident playbook with current security, privacy, research-compliance, DAC, IBC, and provider contacts.
- Review account retention, sharing, administrator access, and model-use settings whenever a service or contract changes.
NIH’s May 30, 2025 request for information discusses the possibility that generative AI may memorize and leak underlying data and seeks views on privacy-preserving mitigations. It is evidence of an acknowledged concern and continuing policy development, not a universal checklist or a measured estimate of how often leakage occurs. The request is at NIH NOT-OD-25-118.
Use this decision checklist
- Have all related submissions stopped?
- Is the evidence stored only in an approved, access-controlled location?
- Have information security, privacy, research compliance, and the principal investigator been contacted?
- Is the data classified as NIH controlled-access genomic, other human-participant, restricted institutional, or unrelated to those categories?
- Does the approved request name the AI provider or environment?
- If NIH controlled-access data are involved, has the DAC been notified within the agreement’s 24-hour window?
- Has the detailed report been scheduled for completion within three business days after that notification?
- Have biosafety personnel assessed whether a separate containment or exposure incident exists?
- Has anyone avoided promising deletion or confidentiality that has not been verified?
The safest response is prompt escalation with disciplined evidence handling. Treat the AI submission as a possible external disclosure until the authorized security, privacy, and research-compliance teams establish what happened, which rules govern it, and what notifications and remediation are required.
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