[Clinical research ethics in respiratory medicine].
Clinical research plays an increasingly strong role in the development of respiratory medicine. Familiarity with issues that affect research on human subjects is therefore essential, particularly so with regard to the conduct of clinical trials of medical with medications. This paper begins with a brief introduction to the ethics of clinical research. We highlight the importance of directives on ethics and the need to understand and comply with them when any type of experiment is conducted on humans. Following is a brief description of historical codes of bioethics and an account of their underlying principles, origins, and consequences. Finally, we discuss Spanish Royal Decree 23/2004 of February 6, 2004 which came into force on May 1 that year; we outline its general principles and analyze 2 types of problem that have emerged: those that result from the article requiring a single central opinion and those of investigators who act independently of the pharmaceuticals industry. The situation of clinical research in respiratory medicine at our hospital is then described. Finally, the 7 requirements of ethical research listed by Emanuel and colleagues are proposed as a tool that pneumologists can use to analyze and assess whether or not a specific trial meets minimum ethical requirements.
Secretaría Técnica del CEIC, Hospital Universitario La Paz, Madrid, Spain.
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Fernández de Uzquiano
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Alvarez-Sala
D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D015272:Pulmonary Medicine / Q000941:ethics* / Q000331:legislation & jurisprudence; D013030:Spain