Ethics committees (EC) oversee research to ensure ethical standards are met, protecting rights and well-being of study participants. They evaluate study protocols, informed consent procedures, and risks versus benefits, promoting integrity in research conduct.
In the U.S., Institutional Review Boards (IRBs) oversee clinical trials to ensure participant protection, as required by FDA regulations (21 CFR Part 56 [1]). The ICH GCP framework uses the term Independent Ethics Committee (IEC) instead of IRB. While IECs and IRBs serve similar roles, some regulatory differences exist.
Ethics committee terminology
The names and authority levels of Ethics committees vary by region and setting. Common terms include:
- Ethical review board (ERB)
- Independent ethics committee (IEC)
- Institutional review board (IRB)
- Research ethics board (REB)
General requirements and regulations
The ICH GCP (R3) outlines key responsibilities and operations of the EC as follows [2].
Responsibilities of the Ethics committee
The EC ensures the protection of the rights, safety, and well-being of trial participants. It reviews study protocols, informed consent materials, investigator credentials, safety updates, recruitment processes, and compensation plans.
The EC must document and justify its decisions, conduct ongoing trial reviews, and assess ethical considerations for vulnerable populations, such as minors. It also ensures that participant payments are fair and not coercive.
Composition and operations
The EC should have a diverse membership with at least five qualified individuals, including one non-medical expert and one independent member. Meetings must be conducted per documented procedures, ensuring quorum and proper record-keeping. Investigators and sponsors may provide information but cannot participate in decision-making. Only independent members can vote.
Procedures
The EC must establish documented procedures to govern its operations. These procedures include defining the membership structure, meeting schedules, and trial review processes.
They specify the frequency of reviews, the handling of changes and amendments during the trial, and ensure that participants are not enrolled, nor protocol deviations made, without prior approval (except in emergency cases).
Additionally, procedures should be in place for investigators to promptly report safety concerns, deviations, and significant trial changes.
Records
The EC must retain all relevant records, including procedures, membership lists, submitted documents, meeting minutes, and correspondence, in compliance with regulatory requirements. These records must be accessible to regulatory authorities upon request.
Communication
Submissions to the EC may vary by region, sometimes requiring combined filings with regulatory authorities. Depending on local regulations, submissions may be made by the investigator, institution, or sponsor.
See also
Another relevant pages
- Independent ethics committee (IEC)
- Institutional review board (IRB)
- Comparison of IRB and IEC requirements
Links to this page
- Clinical research (← links)
- Phase I clinical trials (← links)
- Phase II clinical trials (← links)
- Protocol Amendment (← links)
- Approval (in relation to Institutional Review Boards) (← links)
- Institution (← links)
- EC (redirect page) (← links)
- Regulatory inspection (← links)
- Protocol (← links)
- Safety (← links)
- Serious adverse event (serious adverse drug reaction) (← links)
- Trial site (← links)
- Comparison of IRB and IEC requirements (← links)
References
- ↑ 21 CFR Part 56, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56 Accessed Feb 2025
- ↑ ICH, 2025, ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3), https://database.ich.org/sites/default/files/ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf Accessed Feb 2025
External links