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[Editorial] Indian Journal of Medical Ethics Vol 8,No 4
Thomas, George
Thomas, George
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n194ed202.pdf
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"The ICMR guidelines state: The basic responsibility of an Institutional Ethics Committee (IEC) is to ensure a competent review of all ethical aspects of the project proposals received by it in an objective manner. IECs should provide advice to the researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific soundness of the proposed research through appropriate Scientific Review Committee [emphasis added]. In institutions where this is lacking, the IEC may take up the dual responsibility... (1: 8) The design of clinical research projects has become a complex affair, with much care taken to ensure that chance, bias and other errors do not vitiate the collection of data, and its interpretation. This is an ongoing process and there is much debate still going on as to how best to acquire data that will be true. It is a moot point whether most medical institutions in India have expertise in the design of clinical trials. Even institutions like the All India Institute of Medical Sciences, the Post Graduate Institute of Medical Education and Research, and the Jawaharlal Institute of Postgraduate Medical Education and Research -- all of which have been set up with a research component as part of their mandate -- seem to have inconsistent policies which result in some departments having a high degree of competence in the area and others showing a remarkable ignorance. In the educational institutions managed by various state governments, very few have institutional arrangements for training in research and many researchers learn methodology on their own. These individual efforts, while laudable, need to be replaced by systematic capacity building if we wish to build a strong research fraternity with exemplary ethical values."(pg 200)
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2011-10
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With permission of the license/copyright holder