Ethics Committee
What is Ethics Committee?
A body within an organisation responsible for reviewing ethical issues, establishing ethical guidelines, and ensuring that business practices align with the organisation's values and ethical standards.
Terms that appear alongside ethics committee
Each of these is named in at least one of the same controls as ethics committee. The number is how many controls name both.
- consent 5 shared controls
- confidentiality 3 shared controls
- nist 3 shared controls
- compliance 3 shared controls
- governance 3 shared controls
- transparency 2 shared controls
- pseudonymisation 2 shared controls
- authorisation 2 shared controls
Frameworks that govern ethics committee
What the standards actually require on ethics committee
Requirements naming ethics committee across 6 standards, quoted from the control text.
Accountability (Sekinin 責任) is the seventh of 10 Principles per Japan AI Guidelines for Business + addresses organisational governance + clear responsibility allocation + stakeholder engagement + regulatory compliance across AI lifecycle.
JP-AIG-Accountability-Governance-AI-Inventory-Stakeholder-Engagement-Board-Reporting-Tone-at-Top · Japan AI Guidelines Accountability + Governance + AI Inventory + Stakeholder Engagement + Board Reporting + Tone at Top + AI Ethics Committee + DPO + AI Officer + Regulatory Compliance + Multi-Stakeholder →Section 3 establishes Institutional Review Board (IRB) and Independent Ethics Committee (IEC) responsibilities. IRB/IEC composition + qualifications + procedures + meeting documentation + records; protocol review + initial + continuing + amendment review;
ICH-E6-IRB-IEC-EthicsCommittee-InformedConsent-Vulnerable · ICH E6 Section 3 - Institutional Review Board (IRB) + Independent Ethics Committee (IEC) + Informed Consent + Vulnerable Populations →Article 70 sets the application procedure for clinical investigations through EUDAMED + Member State competent authority. Article 74 covers clinical investigations on CE-marked devices used outside the intended purpose.
MDR-Art.70_74_75_80_82 · Clinical-investigation application + CE-marked-device studies + substantial modifications + adverse events + records (Articles 70, 74-75, 80, 82) →Human Research Ethics Committees and other review bodies are properly constituted and review research against the National Statement.
NHMRC-NS-5.2 · Responsibilities of HRECs and other ethics review bodies →Article 56 requires manufacturers to plan + conduct + document a performance evaluation per Annex XIII covering scientific validity + analytical performance + clinical performance, and to update it throughout the device lifecycle (including via post-market per...
IVDR-Art.56_57_58 · Performance evaluation, performance studies and additional requirements (Articles 56-58) →Personal data may be processed for scientific and historical research and for official statistics, including processing of sensitive personal data, subject to appropriate safeguards including data minimisation, pseudonymisation, and ethics committee assessment...
EST-IKS-§6 · Processing for scientific and historical research and official statistics →Questions people ask about ethics committee
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