radiology-ethics

name

radiology-ethics

description

Write compliant, non-overstated Ethics, Informed-Consent, and privacy/governance text for imaging and imaging+omics studies — study-type framing (retrospective, prospective, registered, multi-center), IRB/ethics-committee approval and numbers, consent vs documented waiver, re-identification risk (DICOM metadata, rare-disease small cohorts, genomic data), and the human-subjects governance behind data sharing (HIPAA/GDPR/PIPL, data-use agreements, controlled access). Use when the user mentions ethics, IRB, ethics committee, informed consent, consent waiver, "伦理", "知情同意", "隐私", HIPAA, GDPR, PIPL, data-use agreement, or needs the Ethics/Consent statement for a manuscript or grant. Produces submission-ready statements and a re-identification risk read. Never fabricates approval numbers, dates, or consent status.

Research Ethics, Consent & Privacy

Use this skill to write the Ethics, Informed Consent, and privacy/governance parts of an imaging (or imaging+omics) manuscript or grant so they are compliant and honestly bounded. This is the governance counterpart to radiology-data (which handles the mechanics of de-identification, repositories, and availability statements). This skill frames the human- subjects side: approvals, consent, re-identification risk, and what may lawfully be shared.

Core stance

• State the approval, don't invent it. Ethics-committee/IRB name, approval number, and date, plus the consent status, come from the author. Use placeholders; never fabricate them.
• Consent must match the design. Retrospective studies often have a documented waiver of consent; prospective studies need consent (and a consent process described). Say which, and on what basis the waiver was granted.
• Re-identification is a spectrum. DICOM metadata, dates, rare-disease small cohorts, facial reconstruction from head imaging, and genomic data each raise risk; address them specifically.
• Sharing is governed, not automatic. Imaging may be openly shareable after de-identification; genomic/clinical data are often controlled access. The Ethics/consent must permit whatever the Data Availability statement promises (keep them consistent with radiology-data).
• Jurisdiction matters. HIPAA (US), GDPR (EU), PIPL (China) and local rules differ; name the framework that applies and defer specifics to the institution.
• Integrity & scope. This is drafting and risk-flagging support, not legal advice; approval numbers, consent terms, and DUAs must be confirmed with the institution/IRB.

When to use

• "Write the Ethics / Informed Consent / privacy statement / 帮我写伦理与知情同意表述。"
• "Retrospective multi-center study — how do I word the consent waiver?"
• "We have genomic + imaging data — what's the re-identification risk and how do I share it?"
• "Which approval/consent text does a grant or Radiology submission need?"
• "Is 'available on reasonable request' acceptable, and what governance must back it?"

When to open extra files

File	Open when
references/approval-consent.md	Study-type framing, IRB/ethics approval, consent vs waiver, multi-center approvals, registration
references/reidentification-risk.md	Assessing/мitigating re-identification: DICOM metadata, dates, small cohorts, defacing, genomic data
references/governance-sharing.md	HIPAA/GDPR/PIPL framing, data-use agreements, controlled access, aligning consent ↔ Data Availability

Workflow

1. Classify the study — retrospective / prospective / registered / multi-center; secondary use of existing data; involvement of imaging, clinical records, pathology, genomics.
2. Establish approvals & consent (approval-consent.md) — committee, number, date (placeholders if unknown), consent obtained vs documented waiver and its basis; per-center approvals.
3. Assess re-identification risk (reidentification-risk.md) — what in the data could re-identify a participant, and the mitigations (de-id, defacing, aggregation, controlled access). Coordinate de-id mechanics with radiology-data.
4. Set governance for sharing (governance-sharing.md) — what may be public vs controlled vs restricted, the applicable framework, DUA needs; ensure it matches the Data Availability statement.
5. Draft statements — Ethics, Informed Consent, and (if needed) a privacy/governance note, in submission-ready English, with a 待确认 list of author-only facts.

Output contract

1. Study/ethics classification — design, data types, jurisdiction/framework.
2. Ethics statement — committee, approval number, date (placeholders where unknown).
3. Consent statement — consent obtained or documented waiver + basis; prospective process if applicable.
4. Re-identification risk read — risks + mitigations; defacing/controlled-access decisions.
5. Governance/sharing note — what can be shared and how, consistent with radiology-data.
6. 待确认（中文） — approval numbers, dates, consent terms, DUA details to confirm with the IRB.

Quality bar

A good ethics section is specific, consistent with the data-sharing plan, and never claims an approval, consent, or shareability the study does not actually have. It reads like an investigator who knows the governance — and flags exactly what only the IRB can confirm.

Handoffs

• De-identification mechanics, repositories, Data/Code Availability statements → radiology-data.
• Controlled-cohort design (dbGaP/EGA), matched imaging+omics governance → radiology-radiogenomics.
• Ethics/open-science checklist items (CLAIM/TRIPOD+AI) → radiology-reporting.
• Grant ethics/feasibility framing → radiology-grant.
• Not legal advice — confirm all approvals, consent, and DUAs with your institution/IRB.