Skip to main content
OpenIRB

Evidence Packets

Review begins with evidence.

An evidence packet is the structured submission that allows reviewers to understand what a system is, what it claims, what it can affect, what evidence supports it, and what safeguards exist.

Minimum packet structure

An evidence packet at the center, connected to its component modules.
Evidence packets make review specific, comparable, and auditable.
  1. Executive summary

    Plain-language description of the object of review and requested decision.
  2. Intended use

    What the system is designed to do, where, for whom, and under what limits.
  3. System description

    Architecture, model type, agent capabilities, workflow, dependencies, and external tools.
  4. Human impact statement

    Affected people, groups, decisions, rights, safety, welfare, access, opportunity, or dignity.
  5. Claims and evidence

    What is being claimed, and what evidence supports each claim.
  6. Data provenance

    Data sources, permissions, representativeness, sensitivity, retention, and limitations.
  7. Consent posture

    What consent applies, how it was obtained, what scope it covers, and how revocation is handled.
  8. Authority and delegation

    Who is allowed to act, what authority has been delegated, and what scope constraints apply.
  9. Risk-benefit-impact analysis

    Foreseeable harms, benefits, affected populations, uncertainty, alternatives, and mitigation.
  10. Validation and evaluation

    Testing, benchmark limitations, field validation, bias assessment, robustness, and human-AI team performance.
  11. Human oversight

    Who can intervene, override, pause, audit, suspend, or revoke operation.
  12. Monitoring and incident response

    Drift detection, adverse events, complaints, escalation, remediation, and re-review triggers.
  13. Change management

    How updates are reviewed, versioned, approved, and communicated.
  14. Disclosure and transparency

    What users, participants, patients, workers, students, or citizens are told.
  15. Attestations

    Sponsor attestations about completeness, accuracy, conflicts, and known limitations.

Evidence packets make disagreement productive. Without a structured packet, review often collapses into opinion. With one, reviewers can identify precisely what is known, what is uncertain, what is missing, and what must change.