Bioethical standards

In Part V, we examine research and ethics. Increasingly, clinical research is undertaken in multi-center studies involving numerous countries and jurisdictions. Argentinian bioethicist Florencia Luna, a past president of the International Association of Bioethics, introduces one of the major issues debated in recent years in international research ethics in this context, namely the question of what constitutes appropriate standards of care for participating patients. The line taken by the U.S. National Institutes of Health and many American bioethicists has been that it is acceptable for developed world sponsors of such trials to provide less than the best proven therapeutic means of treatment to the trial participants. Developed world-based bioethicists do not always agree and Luna explains why. 

The minimalist position derives the requirements of justice from the accepted pillars of contemporary bioethics, and of research ethics in particular. A just research initiative is one that faithfully adheres to the standard values of nonmaleficence, beneficence, and respect for autonomy.. .. any research Initiative that satisfies the conditions of... 

Thus, while regulations help ensure minimum ethical standards, they do not necessarily ensure the highest ethical standards. Increasingly, therefore, the medical and pharmaceutical research and practice environments face a growing need for a formal approach to ethics, and particularly to bioethics. 

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