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)
Max Planck Institute for Comparative Public Law and International Law
University of Basel - Faculty of Law
October 1, 2010
Zeitschrift für Schweizerisches Recht, Vol. 129, No. 4, pp. 367-390, 2010
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
Date posted: November 2, 2010 ; Last revised: December 14, 2011