The Implementation of Directive 2001/20/EC into Belgian Law and the Specific Provisions on Pediatric Research

in European Journal of Health Law
No Access
Get Access to Full Text
Rent on DeepDyve

Have an Access Token?



Enter your access token to activate and access content online.

Please login and go to your personal user account to enter your access token.



Help

Have Institutional Access?



Access content through your institution. Any other coaching guidance?



Connect

Abstract

The European Clinical Trial Directive (2001/20/EC) was implemented into the Belgian legal system by the Law of 7 May 2004 concerning experiments on the human person (LEH). Apart from implementing the European Directive, this law also broadens the scope of the Directive from interventional clinical trials to all medical experiments involving human persons. This article offers an overview of the requirements for involving minors in medical experiments that are captured in the LEH, illustrates the process of protocol review by an ethics committee, and discusses the dissimilarities between the LEH and the European Directive.

The Implementation of Directive 2001/20/EC into Belgian Law and the Specific Provisions on Pediatric Research

in European Journal of Health Law

Sections

Information

Content Metrics

Content Metrics

All Time Past Year Past 30 Days
Abstract Views 15 15 5
Full Text Views 45 45 28
PDF Downloads 6 6 1
EPUB Downloads 0 0 0