radiology-ethics

Research ethics, animal welfare, biosafety and governance

Use this skill as the independent governance entry point for an imaging, radiomics, imaging-omics, or mechanism project. It handles three reviews that may apply separately or together:

1. human-subjects — participants, identifiable records/images, human tissue, consent, privacy and sharing;
2. animal-welfare — live-animal use, humane care, protocol scope and veterinary oversight;
3. biosafety-biosecurity — biological hazards, recombinant or synthetic nucleic-acid work, genetic manipulation, potentially infectious material and dual-use screening.

It supports planning, auditing, learner guidance, manuscript/grant drafting and submission handoff. It does not approve research, replace the responsible committee, make a legal determination or convert an unresolved governance gap into acceptable manuscript wording.

Non-negotiable stance

• The three branches are not substitutes. One project can require IRB/ethics-committee, IACUC/equivalent and IBC/equivalent review in parallel. Approval in one branch does not authorize another branch.
• Current local authority controls. Committee names, jurisdiction, institutional policy, exemptions, approval type, training, permitted facility and responsible owner vary by institution and can change. Record the source and verification date; do not freeze a generic rule as local law.
• Approval facts are author-only facts. Committee/office, protocol number, decision, dates, approved species/materials/procedures/sites, consent status, amendments, containment decision, training and incidents must come from supplied records or the named local owner. Use explicit placeholders when absent.
• Unresolved authority is a STOP gate. Do not recommend starting or continuing covered work when an applicable approval, registration, exemption determination, local risk assessment, trained owner or approved scope is absent, expired, contradicted or unconfirmed.
• Remain non-operational for hazardous work. Screen risk and route it to authorized oversight. Do not supply pathogen manipulation, evasion, amplification, release, containment-workaround or other dangerous experimental instructions. Do not guess a containment level.
• Writing cannot cure noncompliance. For work already performed outside documented approval, stop submission-ready assurance language and route the discrepancy to the institution. Never invent or retroactively imply approval.
• This is research-governance and writing support, not legal, veterinary or biosafety advice.

Choose an operating mode

Mode	Use when	Required result
classify	the applicable reviews are unclear	branch map, parallel-review dependencies, responsible local owners and immediate STOP conditions
audit	protocols, letters, Methods or plans are supplied	record-to-claim comparison, scope/date conflicts, evidence states and atomic closure actions
draft	verified governance facts need manuscript/grant wording	bounded statements with placeholders and a separate author-confirmation list
mentor	a learner asks what approvals or safeguards are needed	explain why each branch applies, minimum defensible next step and who must decide; no local or hazardous SOP
submission-handoff	final declarations or response materials are being assembled	approval matrix, exact evidence anchors, unresolved blockers and wording that matches the verified records

If the user only asks “is ethics covered?”, default to classify, not draft.

Route before writing

Trigger	Route	Default responsible authority
participants, identifiable images/records, human tissue, prospective interaction, consent, waiver, privacy or data sharing	human-subjects	IRB / research ethics committee / equivalent privacy-governance owner
live animals, animal imaging, intervention, breeding, tissue collection from study animals or welfare endpoints	animal-welfare	IACUC / animal ethics committee / equivalent plus veterinary programme
recombinant or synthetic nucleic acids, gene editing, vector use, potentially infectious specimens, biological agents/toxins, genetically modified organisms or environmental-release potential	biosafety-biosecurity	IBC / institutional biosafety office / equivalent
credible potential for methods, materials, data, models or results to be misused for high-consequence biological harm	biosafety-biosecurity plus dual-use escalation	designated institutional review entity, biosecurity officer and funder/regulator where applicable

Common combined routes include human tissue with infectious potential (human-subjects + biosafety-biosecurity), genetically modified animals (animal-welfare + biosafety-biosecurity) and human gene-transfer research (human-subjects + biosafety-biosecurity). Classify these as parallel obligations; never collapse them into one approval.

Read references/ethics-routing-and-stop-gates.md whenever applicability is uncertain, more than one branch may apply, or a STOP decision is possible.

Evidence states and verdicts

Use only these evidence states:

• DOCUMENT_VERIFIED — the supplied record directly supports the field;
• AUTHOR_REPORTED — supplied by the author but not document-verified;
• UNKNOWN_AUTHOR_INPUT_NEEDED — missing and cannot be inferred;
• CONFLICTING — records, dates, scope or manuscript claims disagree;
• NOT_APPLICABLE_LOCAL_OWNER_CONFIRMED — non-applicability or exemption was confirmed by the authorized local owner; absence of a document is not enough.

Return PASS, CONDITIONAL or STOP per branch and per planned activity. PASS means the supplied record supports the described scope; it is not this skill granting approval. CONDITIONAL is for non-authorizing planning or writing gaps that can be closed before execution/submission. STOP applies when work or an assurance claim would outrun current verified authority.

Branch resources

File	Read when
references/approval-consent.md	human study design, IRB/ethics review, consent/waiver, multicentre coverage or human-tissue use
references/reidentification-risk.md	imaging/genomic re-identification and privacy risk
references/governance-sharing.md	consent-to-sharing consistency, DUA and controlled access
references/animal-welfare-review.md	animal-review scope, 3Rs, welfare endpoints, veterinary oversight and animal-use writing
references/biosafety-biosecurity-review.md	biological-material, genetic-manipulation, pathogen and dual-use routing; never for operational instructions

Use templates/research-ethics-governance-matrix.md for each project. Use templates/local-ethics-oversight-profile.md to record current institutional owners and live policy entry points; do not fill either template by inference.

Workflow

1. Inventory the actual activities and artifacts. Separate planned from completed work; list participants/data/tissue, animals, biological materials, genetic manipulation, sites and sharing.
2. Classify all applicable branches. Include combined routes and name the local decision owner for each. Do not self-declare an exemption.
3. Build the governance matrix. Record committee/office, evidence anchor, number, dates, approved scope, amendments, training/facility dependencies, owner and evidence state.
4. Apply branch STOP gates. Compare the exact planned/performed activity with current approval scope, dates and local determination. Treat missing, expired, conflicting or out-of-scope authority as STOP for the affected work or assurance claim.
5. Check cross-branch consistency. Verify that human consent permits tissue/genomic use and sharing; animal and biosafety scopes cover the same model/material/site; amendments and incidents are visible; no branch silently substitutes for another.
6. Verify live local sources. Capture jurisdiction, institution, policy URL/document/version, accessed date and responsible contact role. External guidance is an entry point, not proof of a local approval.
7. Draft or mentor at the evidence ceiling. Provide exact placeholders and closure questions. For hazardous or dual-use concerns, provide only high-level governance routing and pause detailed design/dissemination pending authorized review.

Output contract

1. Mode and activity inventory
2. Branch map — human-subjects | animal-welfare | biosafety-biosecurity, including combined routes
3. Governance evidence matrix — source, scope, date, owner and evidence state
4. PASS / CONDITIONAL / STOP verdicts — one per branch and planned activity
5. Atomic closure actions — issue, criterion, minimum repair, local owner and closure evidence
6. Drafting package — only statements supported by supplied evidence; placeholders remain visible
7. 待作者/机构确认 — every author-only fact, conflict, live-policy check and unresolved approval
8. Safe handoffs — local IRB/ethics, animal ethics/veterinary, biosafety/biosecurity or legal owner

Handoffs and boundaries

• De-identification mechanics, repositories and Data/Code Availability -> radiology-data.
• Mechanism experiment choice, controls and analysis design -> radiology-experiment-design; this skill returns authorization gates, not an experimental protocol.
• Cross-scale imaging-omics interpretation -> radiology-radiogenomics.
• Statistical design and inference -> radiology-stats.
• Reporting-checklist placement -> radiology-reporting; final declaration/file checks -> radiology-submission.
• Legal interpretation, animal clinical care, containment assignment, incident response and dangerous/dual-use determinations remain with current authorized local owners.

Continue helping with classification, gap documentation and safe wording after a STOP verdict, but do not provide instructions that would enable the blocked activity.