Skip to content

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.

Governance

Each of these is named in at least one of the same controls as ethics committee. The number is how many controls name both.

What the standards actually require on ethics committee

Requirements naming ethics committee across 6 standards, quoted from the control text.

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 →

Seventeenth additional provision: listed health statutes provide the GDPR 9.2 g to j basis for health and genetic data; for health research, consent may cover general areas of a speciality;

spain-organic-law-32018-on-data-protection-and-digital-rights-lopdgdd::DA 17 · Health research: follow the rules on broad consent, compatible reuse, pseudonymisation separation and ethics committee review →

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) →

Practitioners involved in designing, organising, conducting or reporting human health research: (a) give participants due respect and protection; (b) are honest and act with integrity;

ahpra-shared-code-of-conduct-2022::11.1 · 11.1 Research ethics →

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 →

When a lawyer knows that another lawyer has broken the rules in a way that raises a substantial question about honesty, trustworthiness or fitness to practise, the lawyer must inform the appropriate professional authority, and may not make non-reporting of suc...

connecticut-rules-of-professional-conduct-connecticut-practice-book::8.3 · Report professional misconduct of lawyers and judges; never trade silence for settlement →

Questions people ask about 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.
Why is Ethics Committee important for compliance?
Ethics Committee is a key concept in Governance. Understanding ethics committee helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 1,016 frameworks with 316K cross-framework control mappings.
Which compliance frameworks address Ethics Committee?
Ethics Committee appears in the requirement text of ICH E6(R3) - Good Clinical Practice, Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD), EU Medical Devices Regulation (MDR 2017/745), Ahpra Shared Code of Conduct (2022), Australia NHMRC National Statement on Ethical Conduct in Human Research. Across these standards we have identified 7 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Ethics Committee?
Explore our compliance framework pages to see how ethics committee applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 1,016 frameworks.

See how Ethics Committee applies across compliance frameworks

Our platform maps 1,016 frameworks with 316K cross-framework control mappings. Explore how this concept is addressed across standards.

Written and maintained by Gerard Blokdyk, The Art of Service.