Informed consent and the use of placebo in Poland: ethical and legal aspects

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 pharm...

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Bibliographic Details
Published in:Science and engineering ethics 2004-01, Vol.10 (1), p.167-178
Main Authors: Zaborowski, Piotr, Górski, Adam
Format: Article
Language:English
Subjects:
Bioethics
Clinical trials
Controlled Clinical Trials as Topic - ethics
Controlled Clinical Trials as Topic - legislation & jurisprudence
Double-Blind Method
Humans
Informed consent
Informed Consent - ethics
Informed Consent - legislation & jurisprudence
Legal aspects
Medical ethics
Pharmaceutical industry
Physician-Patient Relations - ethics
Placebo effect
Placebos
Poland
Therapeutic Human Experimentation - ethics
Therapeutic Human Experimentation - legislation & jurisprudence
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Summary: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.
ISSN:1353-3452
1471-5546
DOI:10.1007/s11948-004-0074-9