Research governance in placebo-controlled trials: Is the EMA/ICH position consistent in itself and in accordance with the declaration of helsinki?

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Lenk, C.; Hoppe, N.: Research governance in placebo-controlled trials: Is the EMA/ICH position consistent in itself and in accordance with the declaration of helsinki?. In: Medical Law International 14 (2014), Nr. 3, S. 115-132. DOI: https://doi.org/10.1177/0968533214547119

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Sum total of downloads: 65




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Abstract: 
The European Medicines Agency and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use are powerful international institutions for the regulation of biomedical research. Although not directly concerned with the ethical aspects of research, both institutions have disseminated position papers on ethical issues relating to the use of placebos in clinical trials. What appears initially to be guidance on the methodology of placebo-controlled trials (with very technical content) clearly has some far-reaching implications for the extent of risk patients can be expected to be subjected to in such trials. On the basis of this guidance, this article questions how much additional harm to patients would be acceptable in placebo-controlled trials in comparison with active-control trials. The article will show that the instruments provided in the guidance are unsuitable, remaining unclear on vital points and thereby leaving patients, researchers and research ethics committees without appropriate direction. In conclusion, placebo-controlled trials urgently need more. © The Author(s) 2014.
License of this version: Es gilt deutsches Urheberrecht. Das Dokument darf zum eigenen Gebrauch kostenfrei genutzt, aber nicht im Internet bereitgestellt oder an Außenstehende weitergegeben werden. Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
Document Type: article
Publishing status: publishedVersion
Issue Date: 2014
Appears in Collections:Philosophische Fakultät

distribution of downloads over the selected time period:

downloads by country:

pos. country downloads
total perc.
1 image of flag of Germany Germany 25 38.46%
2 image of flag of United States United States 14 21.54%
3 image of flag of Singapore Singapore 3 4.62%
4 image of flag of France France 3 4.62%
5 image of flag of Russian Federation Russian Federation 2 3.08%
6 image of flag of Israel Israel 2 3.08%
7 image of flag of United Kingdom United Kingdom 2 3.08%
8 image of flag of Denmark Denmark 2 3.08%
9 image of flag of China China 2 3.08%
10 image of flag of Hong Kong Hong Kong 1 1.54%
    other countries 9 13.85%

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