ETHICAL PRINCIPLES AND PRACTICES IN CLINICAL RESEARCH: A BRIEF HISTORY AND GUIDELINES OF CURRENT RELEVANCE

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Abstract :

Ethics is the science of moral values and standards. Scientific experiments, especially those in human subjects, need to be guided by specific ethical values in several aspects. Human experiments of newly discovered medicines or medicines under development, the clinical trials, have a fairly healthy ethical history in ancient and medieval times. However, between World War I and 1970s, the history of clinical trials is very disappointing and has often violated the ethical principles. As a result, several guidelines on ethical conduct of clinical trials have been formulated by various stakeholders covering more or less the same principles of ethics. The Nuremberg code, Declaration of Helsinki, the Belmont report, the ICH GCP guidelines, and the ICMR Guidelines on Ethics are some of the examples. All these documents have covered mainly three aspects of ethics of conducting research in human patients or subjects: a) the patient related aspects (protection, justice and beneficence); b) scientific standard and quality related aspects and c) documentation, publication and promulgation related aspects.