Research with 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, and in a recommendation they stress the rights of children to engage with decisions affecting them. UN likewise has its Convention on the Rights of the Child.
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. In certain cases, the research might be about private matters of children which may not obviously be the concern of parents.
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.
Research on a vulnerable population such as children shall never be performed if it is possible to carry out on another population less vulnerable.
Medical research on children is governed by the provisions on clinical trials involving humans (LVFS 2011:19) and by the Medical products act.
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.
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 medical research. Otherwise, the Helsinki Declaration is taken to apply in parts to children as well, and in guideline no 17 CIOMS discusses research with children in their International Ethical Guidelines for Health-related Research Involving Humans. We can also note the Monaco Statement: Considerations on Bioethics and the Rights Of The Child (2000).
- The Ethical Conduct of Clinical Research Involving Children (report from The Institute of Medicine)
- Personal data on children (Data Inspection Board)
- Society for Research in Child Development