Switzerland

Concerning research with humans, the legal situation in Switzerland is comparatively confusing and inconsistent due to the fact that it is regulated cantonally. Some cantonal regulations do apply the medical-ethical guidelines of the Swiss Academy of Medical Sciences (SAMS) regarding research examinations on the human being. Not all cantons do, however, possess specific regulations for research on the human being.
A constitutional article, which has been developed by the federal council of Switzerland (Bundesrat), together with its accompanying law on human research are to counteract this condition. So far, the most important conditions at the federal level can be found in the federal law concerning pharmaceuticals and medical devices (law on remedies) of 15th December 2000. Article 55 sets the conditions for approvable research on persons being underage, placed under disability or unable to form a judgment. Accordingly, clinical trials are allowed to take place only if comparable results cannot be obtained with persons that are of age and able to form a judgment (subsidiarity principle), if the legal representative of the test subject has given his or her consent, and if there are no signs of resistance or unwillingness on the part of the persons unable to form a judgment concerning the testing.
By way of exception, clinical research that is of no direct benefit to the child is allowed to be conducted if "the trials are expected to render important results as regards the condition, the illness or the sufferings of the test persons, which have the test persons or other persons of the same age group or persons suffering from the same disease or show the same symptoms, profit in the long term." (unofficial translation). Furthermore, only low risks are allowed to be connected with the trials. These regulations will be to be found in the law on human research but will, indeed, be extended to further fields of research on humans, such as surgery, psychiatry and psychology.
The final version of the constitutional article is currently being discussed; it is, at this moment, in the state of settling differences. The small chamber (also called Council of States representing the cantons with 46 members) is, for instance, debating whether observing the freedom of research should be mentioned explicitly in the constitutional article on research on the human being or whether it is sufficient that it is already fixed in the basic right somewhere else in the constitution under the term of "academic freedom". It is known that the term of dignity of man is assigned a major role: "The federal government enacts regulations regarding research on the human being insofar as is required by the protection of his dignity and personality." (unofficial translation) As regards research with minors, the new constitutional article reads: "With persons unable to form a judgment, a research project is allowed to be carried out only if equivalent insights cannot be gained through research with persons able to form a judgment. If the research project is not in for a direct benefit for the persons unable to form a judgment, the risks and stress are only allowed to be minimal."
The completed constitutional article is being decided upon by means of a referendum. On the occasion of the discussion regarding the federal legislation, Switzerland's National Ethics Commission in the field of human medicine (NEK-CNE) has published a statement on research on minors. In this statement, the Commission argues for an augmented research on minors in order to extent the medical knowledge within this field; this, in turn, is for the benefit of the minors themselves insofar as ethically-demanded preventive measures are being adhered to. These preventive measures include the necessity that therapeutic research with minors balance the benefit and the stress, as well as the chances and risks, on a case-to-case basis, and that the child's legal representatives as well as, if possible, the child itself, are being included in the process of a voluntary consent. The Ethic Commission criticizes the phrasing "minimal risk" as a precondition for research benefitting others, which entails a certain risk as well as a certain stress. Since risks, according to the Commission, are no measurable variable, the Commission suggests to use the phrasing "reasonability/harmlessness of the risk" instead. The revision of the reasonability or the stress guarantees the judgment of the individual case; general standards cannot be existent as regards the evaluation. The statement further reads that, sometimes, even a long-time therapeutic experience in practice can justify the application of pharmaceuticals on minors.

Federal Law of 15th December 2000 regarding drugs and medical devices (law on remedies). Online Version (German)

Draft of the constitutional article concerning research on the human being. Online Version (German)

Statement by the NEK-CNE (2009). Online Version 

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