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| Zanini GM, Marone C. |
Swiss Med Wkly 2005;135:315317
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| Original article Peer reviewed article |
| Summary We report three years of experience with a newly introduced register for healthy research volunteers in Canton Ticino, Southern Switzerland. The aim of the register was to encourage responsible participation in medical research, and to detect fraud due to volunteers taking part in more than one study at the same time. All healthy volunteers participating in drug studies approved by the Research Ethics Committee were included in the register and given a special code. During three years, in a population of 1436 volunteers involved in 152 studies, 192 subjects (13.4%) were identified as habitual or regular volunteers (they participated regularly, limiting the pause between studies to the minimum of three months as required by the regulations of the Research Ethics Committee). Among them, only three subjects gave false information and were identified. Most volunteers participated in studies only sporadically (54% in one, 21% in two over three years) and 82.4% of the volunteers were involved, on average, in only one study per year. Our register permits fraud detection as well as analysis of the research population from an epidemiological point of view. It has been well accepted from both volunteers and research organisations. It is simple and represents a substantial contribution especially for organisations, which need to recruit a large number of subjects for their research. |
Health Department of Canton Ticino, Bellinzona, Switzerland Department of Internal Medicine, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland G. M. Zanini and C. Marone are President resp. past President of the Research Ethics Committee of Canton Ticino, Southern Switzerland |
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Copyright © 2005 EMH Swiss Medical Publishers Ltd. |