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Increasingly, pharmaceutical phase III clinical trials are coordinated across multiple centers and clinical research organizations worldwide (Annas 2009). In line with this global development, international cooperation has universalized global health standards and has standardized medical bioethics. For the sake of patient protection worldwide, the Declaration of Helsinki was formulated by the World Medical Association during the 1960s. It upholds internationally-recognized principles, guidelines, and norms of medical ethics that serve to protect human subjects during medical research; it also stipulates the three linchpins of high-quality informed consent: the forbidding of coercion, the mandate that patients who volunteer fully comprehend the risks associated with the research in question, and the stipulation that consent must be formally documented and witnessed (Lee 2010). |
