David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
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Science and Engineering Ethics 10 (1):167-178 (2004)
The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials.
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References found in this work BETA
Benjamin Freedman, Charles Weijer & Kathleen Cranley Glass (1996). Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths. Journal of Law, Medicine & Ethics 24 (3):243-251.
Robert J. Levine (1986). Ethics and Regulation of Clinical Research. Urban & Schwarzenberg.
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