Research involving children
Research using children as subjects is, from an ethical perspective, problematic. It is, quite naturally, more difficult to obtain adequate informed consent from children, as their ability to judge risks and assess consequences is limited or nonexistent, and they can more easily be influenced by others. At the same time, repudiation of research on children entails exposing them to other risks. For example, letting children use medicine that has been tested on adults means that sick children, whether or not they want to, become in practice those who test the medicine's effect. It is not surprising that people have felt the need for specific guidelines to protect children's rights. Thus in its European Convention of 25 January 1996, the Council of Europe addresses children's rights, as do the UN in its Convention on the Rights of the Child. The European Social Charter also mentions children's rights.
European & Swedish regulation
In the EU, Regulation No 1901/2006 and Regulation No 1902/2006 on medicinal products for paediatric use have addressed these issues. The main regulation concerning clinical trials is Ethical considerations for clinical trials on medicinal products conducted with the pediatric population. See also ICH's Clinical investigation of medical products in the pediatric population and EMA's Guideline on the investigation of medicinal products in the term and preterm neonate. These documents should be in accord with each other.
In 2005 The Swedish Medical Products Agency [Läkemedelsverket] established provisions on clinical investigations of medical products in children (now updated to LVFS 2011:19). These are based on the European guidelines which include some binding rules. These have now been incorporated into Swedish law and are thus legally binding. However, the provisions mostly stresses important aspects that should be considered in clinical trials with children. The basic regulation for such studies is to be found in Läkemedelslagen.
The WMA's Declaration
of Ottawa on the Rights of the Child to Health Care discusses,
among other things, children's right to refuse to participate in
research. Otherwise, the Helsinki
Declaration is taken to apply in parts to children as well. We can also
note the Monaco
Statement: Considerations on Bioethics and the Rights Of The
Child (2000) and the policy document Rights
of young people to information and informed consent, by the
Standing Committee of European Doctors.
Last updated: 2016-02-05