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1 Large research and medical databases in clinical and research multi-centres trials A Swiss Perspective June 19, 2012 European Commission International.

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Presentation on theme: "1 Large research and medical databases in clinical and research multi-centres trials A Swiss Perspective June 19, 2012 European Commission International."— Presentation transcript:

1 1 Large research and medical databases in clinical and research multi-centres trials A Swiss Perspective June 19, 2012 European Commission International Dialogue on Bioethics Prof. Dr. Dr. h.c. mult. Otfried Höffe President of the Swiss National Advisory Commission on Biomedical Ethics

2 2 1. The Swiss context (I) The topic of todays meeting is of particular interest within the current regulation in Switzerland. The legal and political system of Switzerland is highly characterized by federalism. Research on human beings is one of the fields in which federalism has until now been particularly tangible: Except of regulation on clinical trials, there has not yet been a national law on research on human being. This legal situation leads to a significant extent of uncertainties, both among researchers and potential research subjects.

3 1. The Swiss context (II) This has been particularly debated with regard to the standards and the procedures applied by the research ethics committees and with regard to the decisions they take. Reason: research ethics committees in Switzerland are under cantonal authority. Multi-centre trials have to deal with the fact that review procedures, time limits and standards applied may vary and that the decision taken by one committee may be inconsistent with the decision taken by another one. A process of harmonization is under way in Switzerland. The Swiss Association of Ethics Committees for Clinical Trials (AGEK) has started to implement a "leading committee system". 3

4 2. The federal Act on research on human beings (I) The Swiss legislation on research on human beings has been characterized until now by a strong federalism, including the fact that research ethics committees act under cantonal authority. -> This picture will change soon. September 2011: adoption of a national act on research on human beings by the parliament (the act will come into force at the beginning of 2014). -> With regard to today's topic, Switzerland is in a transitory phase. In such a transitory phase, it can be of particular interest to examine which issues are matter of regulation – and which topics have not been included in the new legal dispositions. 4

5 2. The federal Act on research on human beings (II) Regulated: –general principles to be applied to research projects involving human beings; –requirements to be fulfilled in the realm of information and consent; –criteria applying to research on vulnerable subjects, namely children, pregnant women and persons unable to consent; –introduction of national regulation on the activity of the cantonal research ethics committees; –incentives for RECs: permanent secretariat, bigger and more experienced committes. Goal: easier process in multi-centre trials; increased reliability and consistency of committees decisions. 5

6 2. The federal Act on research on human beings (III) Not regulated in the federal act on research on human beings: –There is no research subjects' register introduced. –The act does not address the issue of large databases, in particular, it does not contain an explicit and comprehensive regulation of biobanks. –The act contains only implicit indications regarding biobanks: requirement of an informed consent necessary for the removal (Art. 16) and the reutilization (Art. 32) of biological material and health data. –In addition, there remains an indirect approval by the competent REC, insofar as it can check whether the relevant general consent (or, if needed, the informed consent) has been obtained at the moment when the data were gained. 6

7 2. The federal Act on research on human beings (IV) Reasons: –Weak support of the draft regulation in the public consultation process. –Diversity of existing biobanks; –diversity of collections; –lack of an appropriate authority capable of monitoring and surveillance. -> The consent rule, together with the existing data protections laws, may ensure a sufficient protection of the sensitive data stored in and provided by biobanks. Evaluation of the act will be of major significance as it will show whether the protection of personal data can be guaranteed in a sufficient way. 7

8 3. Conclusion The significance of cooperation and of attempts of further harmonizing the requirements, standards and procedures RECs apply must be highlighted. Given increased harmonization, a "leading committee system", such as it is currently implemented in Switzerland, may also be a promising option on the international level. Thank you for your attention! 8

9 9 Large research and medical databases in clinical and research multi-centres trials A Swiss Perspective June 19, 2012 European Commission International Dialogue on Bioethics Prof. Dr. Dr. h.c. mult. Otfried Höffe President of the Swiss National Advisory Commission on Biomedical Ethics


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