Research with Minors

Posted: 26 Sep 2012

See all articles by Benedikt Buchner

Benedikt Buchner

University of Bremen - Faculty of Law

Dieter Hart

University of Bremen - Faculty of Law

Date Written: 2008

Abstract

The European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called “group benefit”. Particularly the latter possibility of conducting clinical trials on minors even if no individual benefit can be expected is not a matter of course in Germany since due to historical experiences a sceptical attitude towards clinical research on humans prevailed for a long time. German legislature has availed itself of the option granted by Article 3 of the GCP Directive to establish a higher level of protection of clinical trial subjects than the European level.

Keywords: Benefit/Risk Assessment, Clinical Trial, Consent, Ethic Committees, GCP Directive, Group Benefit, Minors

Suggested Citation

Buchner, Benedikt and Hart, Dieter, Research with Minors (2008). European Journal of Health Law, Vol. 15, No. 127, 2008, Available at SSRN: https://ssrn.com/abstract=2152334

Benedikt Buchner (Contact Author)

University of Bremen - Faculty of Law ( email )

PO Box 330440
Bremen, 28334
Germany

Dieter Hart

University of Bremen - Faculty of Law ( email )

PO Box 330440
Bremen, 28334
Germany

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