Vulnerable groups including Children

Biomedical research, in which the participation of children is necessary, is subject to special conditions. This is in agreement with international ethical codes of the medical professions in which there is a general agreement that children shall enjoy protection and privilege.

The conditions limiting the participation of children in biomedical studies apply as well to the participation of other vulnerable groups.

The following conditions for involving children in biomedical research shall apply without exception when assessing research proposals:

  1. The participation of children in a biomedical study is indispensable when information available from research on grownup individuals cannot answer the question posed in relation to children.
  2. As a general principle the participation of a child in a biomedical study is that participation will directly benefit the health and wellbeing of the child. There are however exceptions, following condition one above. In addition it must be envisaged that the conclusions drawn from the research in question, in the end will be of benefit to the child involved or to other children or to those suffering from the same disease or similar health distraction. Furthermore participating in such a study shall carry with it a minimum of risk and suffering for the child.
  3. The informed consent shall be sought from the parent or guardian of the child. Pending the age and maturity of children, their assent to participate shall also be sought. The participation of a child in a biomedical study against its expressed will is not allowed.
  4. The child and its parent/guardian shall be informed about the biomedical study in question in accordance with the provisions of applicable regulations and Acts of Law. The information for the child shall take into account linguistic ability and skills as adjusted to their age.
  5. When participating in a biomedical study is a part of a treatment at a hospital, the relation of the anticipated benefit to the risk shall be at least as favourable to the child as that presented by the best available approach to treatment.

The conditions restricting the participation of children in biomedical studies are in line with internationally accepted approach to bioethics.

In general these conditions apply as well when the participants are members of vulnerable groups, including the elderly, mentally inparied, prisoners, those who have got a legal guardian, pregnant women, people in mourning, etc.