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Intensive Care Medicine

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01.02.2004 | Editorial

To consent or not to consent, that is (not) the (sole) question.

“And there is nothing new under the sun”. Kohelet (also known as Ecclesiastes), 1:9. Bible

verfasst von: Didier Dreyfuss

Erschienen in: Intensive Care Medicine | Ausgabe 2/2004

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Excerpt

Nearly 40 years ago, Henry K. Beecher, a professor of research in anaesthesia at the Massachusetts General Hospital and the author of many fundamental clinical research papers, wrote: “There is a belief in certain sophisticated circles that attention to these matters (informed consent) will block progress” [1]. …

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Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348:1383–1386CrossRef

Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31:S153–S160CrossRef

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Evidence-based medicine working group (1992) Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 268:2420–2425CrossRef

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Tobin MJ (2003) The role of a journal in a scientific controversy. Am J Respir Crit Care Med 168:511–515CrossRef

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Dreyfuss, D, Saumon G (2002) Evidence-based medicine or fuzzy logic. What is best for ARDS management? Intensive Care Med 28:230–234CrossRef

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Paasche-Orlow MK, Taylor HA, Brancati FL (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348721–726

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Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zitoun R, Le Gall JR, Dhainaut JF, Schlemmer B, French FAMIREA Group (2001) Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med 29:1893–1897CrossRef

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Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892CrossRef

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Benson K, Hartz AJ (2000) A comparison of observational studies and randomized, controlled trials. N Engl J Med 342:1878–1886CrossRef

20.

Zelen M (1979) A new design for randomized clinical trials. N Engl J Med 300:1242–1245CrossRef

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Truog RD, et al (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 340:804–807CrossRef

22.

Freeman BD, et al (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192CrossRef

23.

Mello MM, Studdert DM, Brennan TA (2003) The rise of litigation in human subjects research. Ann Intern Med 139:40–45CrossRef

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Titel: To consent or not to consent, that is (not) the (sole) question.
“And there is nothing new under the sun”. Kohelet (also known as Ecclesiastes), 1:9. Bible
verfasst von: Didier Dreyfuss
Publikationsdatum: 01.02.2004
Verlag: Springer Berlin Heidelberg
Erschienen in: Intensive Care Medicine / Ausgabe 2/2004
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-003-2064-9

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To consent or not to consent, that is (not) the (sole) question.

“And there is nothing new under the sun”. Kohelet (also known as Ecclesiastes), 1:9. Bible

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