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 European Parliament in its Resolution of 16 January 2008: Towards an EU strategy on the rights of the child, and the UN in its Convention on the Rights of the Child. The European Social Charter also mentions children's rights.

European 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 EMEA's Guideline on the investigation of medicinal products in the term and preterm neonate. These documents should be in accord with each other. Concerning personal data, see Opinion 2/2009 on the protection of children's personal data from Article 29 Data Protection Working Party.

International organizations

The Council of Europe has a Recommendation strongly promoting the participation by children in decisions affecting them. 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: 2010-01-01