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.

Research ethics

In the Act on ethical review, § 18 states that for research falling under the act, it is so that children 15 years of age who realize what participation entails shall be informed and decide themselves on whether to consent. In other cases, the custodians shall be informed and consent to the research (as the parental code gives both parents a right to make decisions it is usually not sufficient with only one parent consenting). Even so, the child must as far as possible be informed and even if parents consent the research is not allowed if the child understands what the research entails and says no. Research not falling under the act has other age limits to consider, see "Personuppgifter om barn".

In practice, researchers usually tries to get the consent from both the children and custodians to the extent possible. Even when kids cannot consent they should be given information about what participation means for them in a way adapted to their age and their possibilities of understanding. In certain cases, though, the research might be about private matters of children which may not obviously be the concern of parents. If that seems to be the case, a discussion with an ethical review board is important before embarking on the research.

Research on a vulnerable population such as children shall never be performed if it is possible to carry out on another population less vulnerable.

For clinical trials, there are stronger demands for parental consent and the information provided, see further references below.

Research in schools

When research is carried out in schools several different regulations might be applicable, not least the ethical review act as outlined above. If the research involves video recordings, it is good research practice to get consent both from children and custodians. One should also make sure that consent is collected both for the way one plans to use the recording, as well as for doing it in the first place.

Public schools are authorities and must observe the Public Access to Information and Secrecy Act (SFS 2009:400). This means that many documents and records should be considered official and therefore should be disclosed to those wishing to see them, as long as this does not seem to be to the disadvantage of the one who the data is about (could for example be about school welfare decisions). Other documents, for example school medical records, have stronger secrecy, which means that the data should not be released unless it is clear that it can be done without it hurting the data subject. As whether it risk hurting someone is usually best decided by the person considered, it is often a good solution to collect the consent of the pupul/custodian. For private schools, there is instead the Educational act (skollagen) which has statutes on professional secrecy.

To be able to process the personal data released, the demands formulated in the GDPR and the ethical review act must be met. If it is sensitive data that will be processed in research, the researcher needs an ethical approval from the ethical review board. For more on release of data, the GDPR and its relation to ethical review, see this page.

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 Medical Products Act).

International organisations

The major document is Ethical research involving children from the UNICEF. 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: 2018-12-18