Ethical Standards for Clinical Trials
The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy and privacy. These ethical concerns have been translated into a complex regulatory apparatus, containing specific ethical/legal provisions concerning such matters as participant safety, informed consent and confidentiality. This chapter will deal with main ethical standards adopted in international ethical and legal texts. Debate about the globalization of clinical research will also be addressed taking into account specific ethical concerns related to trials in vulnerable persons/population.
KeywordsEthical Standard European Medicine Agency Distributive Justice Independent Ethic Committee Legal Text
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