Independent ethics committees IECs

An IRB or an independent ethics committee (IEC) is an administrative body that has been formally designated to review and monitor biomedical... 

Since many trials are being conducted around the world and submitted to a US IND application, the FDA is working on a separate type of 1572 form to be used for these sites. The reason for this is that an ethical committee (EC), (the international version of our IRB), reviewing the research protocols and informed consents, is composed slightly differently from IRBs in the US. Independent ethical committees (IECs) follow ICH GCP guidelines, which differ slightly from CFR regulations. 

Good Clinical Practice (GCP) regulations in the United States and the ICH guidelines, which meet safety, ethical and efficacy requirements, are comprehensively covered in the clinical research development chapters. Investigator, sponsor, and monitor obligations are detailed and applied practically. Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Informed Consent (IC) will be discussed fully along with the... 

Independent Review Board/Independent Ethics Committee (IRB/IEC)... 

The goal of the IRB (known also as the Independent Ethics Committee, or IEC) is the protection of the rights, safety, and welfare of human subjects involved in clinical research investigations. The review board is, therefore, primarily responsible for the evaluation of the proposed research. All evaluations should have the following objectives (a) to determine that the research is properly designed (b) to determine that the benefit of the intended therapy will outweigh the potential risk and (c) to determine that the patient will be provided with adequate information to enable him or her to make an informed decision regarding participation in the clinical trial. 

The responsibilities and obligations include knowledge of the elements of informed consent, the role and responsibilities of Institutional Review Boards/Independent Ethics Committees (IRB/ IEC) and the importance of Clinical Study Quality Assurance. 

ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IEC Independent Ethics Committee IMP investigational medicinal product IND investigational new drug (USA)... 

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