Abstract

http://ssrn.com/abstract=1701206
 


 



The Law on Research with Humans – The Emergence of Norms in the Context of Soft Law, International Agreements and Statutes (Recht der Forschung am Menschen – Normgenese im Kontext von Soft Law, internationalen Abkommen und Gesetz) (in German)


Anne Peters


Max-Planck-Institute for Comparative Public Law and International Law; University of Basel - Faculty of Law

Peter Bürkli


University of Basel - Faculty of Law

October 1, 2010

Zeitschrift für Schweizerisches Recht, Vol. 129, No. 4, pp. 367-390, 2010

Abstract:     
The legal landscape on research with humans is characterised by a mixture of norms of differing nature. Besides statutory provisions, we find self-regulation of professional associations and guidelines of private organisations. On the international level, besides the CoE Convention on Human Rights and Biomedicine, a great number of normative frameworks issued by diverse standard-setting institutions exist.

Many of those norms might be qualified as soft law. As such, these are legally relevant even if not strictly legally binding. Because the state occupies a position which is both in factual and in normative terms special, the quality of state-made norms as 'law' should be presumed. In contrast, non-state made norms are presumably not 'law,' but may be so under certain conditions.

State-authored and non-state made soft law fulfills various functions in relation to hard law. It has a pace-making function, it can complement and make more concrete hard law, and it can even substitute hard law. The fulfillment of these functions is however accompanied by legitimacy deficits.

After the entry into force of the Swiss statute on research with humans (Humanforschungsgesetz, Loi relative à la recherche sur l’être humain), non-state norms will probably remain significant, mainly because of the transnational character of scientific activity and the rapid progress of medical research. As long as constitutional basic principles are respected, an orderly interplay between hard and soft law in the field of research with humans is not only effective but also legitimate.

Note: Downloadable document is in German.

Number of Pages in PDF File: 12

Keywords: Emergence of Norms, Law on Research with Humans, Soft Law, Legitimacy of Soft Law, Legal Pluralism, Human Rights and Biomedicine

JEL Classification: K33

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Date posted: November 2, 2010 ; Last revised: December 14, 2011

Suggested Citation

Peters, Anne and Bürkli, Peter, The Law on Research with Humans – The Emergence of Norms in the Context of Soft Law, International Agreements and Statutes (Recht der Forschung am Menschen – Normgenese im Kontext von Soft Law, internationalen Abkommen und Gesetz) (in German) (October 1, 2010). Zeitschrift für Schweizerisches Recht, Vol. 129, No. 4, pp. 367-390, 2010. Available at SSRN: http://ssrn.com/abstract=1701206

Contact Information

Anne Peters (Contact Author)
Max-Planck-Institute for Comparative Public Law and International Law ( email )
Im Neuenheimer Feld 535
69120 Heidelberg, 69120
Germany
University of Basel - Faculty of Law ( email )
Peter Merian-Weg 8
CH-4002 Basel
Switzerland
HOME PAGE: http://www.ius.unibas.ch/peters_anne
Peter Bürkli
University of Basel - Faculty of Law ( email )
Switzerland
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