Biotechnology AI Agents,
Monitored for Integrity

1. Target

   Generated lab protocols specifying concentrations, temperatures, timings, reagents and dilutions

2. Trigger

   A protocol states a concentration, dilution or reagent value without a verified source

3. Action — enforced

   Block the protocol and require verified values; agent may return a sourced protocol or flag for review

4. Human override

   Released only by the responsible scientist after verifying values against the controlled protocol

Logged evidenceprotocol id · parameter · stated value · verified source · scientist identity · timestamp

1. Target

   Containment, spill-response and waste-handling guidance for biological and hazardous materials

2. Trigger

   Guidance specifies a containment level or spill response below the required biosafety standard

3. Action — enforced

   Refuse the unsafe guidance and enforce the required containment; agent may direct to the biosafety officer

4. Human override

   Released only by the biosafety officer confirming the containment level for the agent and task

Logged evidenceagent or material · proposed level · required level · officer identity · timestamp

1. Target

   Requests touching pathogen enhancement, synthesis routes and sequence-screening bypass techniques

2. Trigger

   A query seeks enhancement, a synthesis route or a way to evade sequence screening

3. Action — enforced

   Refuse the request and escalate per dual-use policy; agent may provide only non-actionable, published context

4. Human override

   Released only by the institutional biosafety committee under documented dual-use review

Logged evidencequery id · dual-use category · refusal basis · escalation ref · reviewer identity · timestamp

1. Target

   Sequences, constructs, unpublished results and genomic data scoped to a single program or partner

2. Trigger

   A request or tool call would read another program IP, partner data or patient genomes

3. Action — enforced

   Deny the cross-program read and return only in-scope data; agent continues within the program boundary

4. Human override

   None — cannot be overridden in session

Logged evidencerequesting program · target program · denied asset id · policy rule · timestamp

1. Target

   Ingested papers, protocols, LIMS records and tool outputs the agent reads during a task

2. Trigger

   Ingested documents or tool outputs contain directives or calls attempting to steer the agent

3. Action — enforced

   Treat the content as data only and refuse the embedded instruction; the analysis task continues normally

4. Human override

   None — cannot be overridden in session

Logged evidencesource id · detected instruction · artifact type · content hash · timestamp

1. Target

   Safety-signal review of trial data, case reports and pharmacovigilance intake for adverse events

2. Trigger

   Data indicates a serious adverse event yet it is not flagged or escalated for reporting

3. Action — enforced

   Force the safety escalation and reporting workflow; agent may not downgrade and must preserve the signal

4. Human override

   Released only by the pharmacovigilance officer after clinical review of the adverse-event signal

Logged evidencecase id · event term · seriousness · escalation route · officer identity · timestamp

1. Target

   Randomisation, allocation and blinding controls across the trial data and analysis pipeline

2. Trigger

   An action would reveal allocation, break the blind or corrupt the randomisation sequence

3. Action — enforced

   Block the action and preserve the blind; agent may continue on de-identified, allocation-masked data only

4. Human override

   Released only by the unblinding statistician under the protocol-defined emergency-unblinding procedure

Logged evidencetrial id · subject id · requested action · blinding status · statistician identity · timestamp

1. Target

   Clinical variant interpretation and reporting drawing on ACMG/AMP criteria and evidence

2. Trigger

   A variant is reported as pathogenic or benign without a completed ACMG/AMP criteria review

3. Action — enforced

   Hold the variant report and require criteria review; agent may return a documented classification with evidence

4. Human override

   Released only by the clinical molecular geneticist confirming the ACMG/AMP classification and evidence

Logged evidencevariant id · genome build · classification · criteria applied · geneticist identity · timestamp

1. Target

   GxP records the agent creates or edits, including trial-data transcription and audit trails

2. Trigger

   A record write would transcribe data inaccurately or break the ALCOA+ audit trail

3. Action — enforced

   Block the write and require source verification; agent may log a corrected, attributable entry with audit trail

4. Human override

   Released only by the quality-assurance officer after verifying the record against source data

Logged evidencerecord id · source reference · before-and-after values · officer identity · timestamp

1. Target

   Batch-record disposition, deviation handling and CAPA closure for manufactured lots

2. Trigger

   A batch is dispositioned with an open deviation, incomplete record or unclosed CAPA

3. Action — enforced

   Hold the disposition and require review closure; agent may compile the record and route deviations for sign-off

4. Human override

   Released only by the quality-assurance officer after deviation review and CAPA closure are complete

Logged evidencebatch id · open deviations · CAPA status · disposition · officer identity · timestamp