Independent ethics committee (IEC) – is independent body comprised of medical professionals, scientists, ethicists, and community members who review and oversee the ethical aspects of clinical trials conducted at institution. The primary responsibility of the IEC is to ensure the safety, rights, and well-being of human participants involved in clinical research.
Definitions
ICH E6(R2)
- 1.27 Independent Ethics Committee (IEC): [1]
- An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.
Role of Independent Ethics Committee
Independent ethics committee role includes assessing the scientific validity of the study, the potential risks and benefits to participants, the informed consent process, and the protection of vulnerable populations.
Independent Ethics Committee evaluates proposed study protocols before a clinical trial begins. Additionally, the IEC monitors ongoing trials to ensure compliance with ethical standards and regulatory requirements.
See also
Another relevant pages
Links to this page
- Independent Ethics Committee (redirect page) (← links)
- Abbreviations (← links)
- Ethics committee (← links)
- Institutional review board (← links)
- Opinion (in relation to Independent Ethics Committee) (← links)
- Well-being (← links)
- Comparison of IRB and IEC requirements (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
External links