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. 2018 Sep;124:46-48.
doi: 10.1016/j.earlhumdev.2018.04.022. Epub 2018 Jun 4.

WASP (Write a Scientific Paper): Ethics Approval for a Research Study (1)

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WASP (Write a Scientific Paper): Ethics Approval for a Research Study (1)

Pierre Mallia. Early Hum Dev. .

Abstract

Past experience in science has thought us the importance of ethics in research. Research is important to the advancement of medicine and therefore good clinical practice in research maintains public trust which otherwise is not only lost but may cause science to seem negative. The rights of participants in the research trial are discussed. This includes knowledge and information about the research itself, the obligations of the researchers and the rights of participants during the research. The EU Directive on Good Clinical Practice in research trials is reviewed, including the twelve principles of the directive. The function and composition of Research Ethics Committees is discussed in the context of protecting patients and participants, asserting quality and monitoring of the research, qualifications of the scientists and liability.

Keywords: EU directive; Ethics approval; Information; Obligations; Research ethics committees; Rights.

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