18. November 2021

How are children protected in a clinical study and which rights/obligations are involved?


The protection of participants in a clinical study is ensured by numerous laws and guidelines.

How is the protection of participating children ensured?


Before a study is initiated in a medical facility, not only medical safety but also compliance with ethical guidelines is reviewed.

A so-called clinical investigation plan is carefully reviewed by the responsible ethics committee and the competent authority in Austria, which is then approved. More stringent protective measures apply for studies with children and adolescents. The clinical investigation plan provides information on how the safety of participants will be ensured over the course of the study.

When a study of a medicinal product in children is commissioned by the pharmaceutical industry, it is reviewed in advance by the Paediatric Committee of the European Medicines Agency. This will help determine the likelihood that the medicinal product being studied is able to achieve progress in the treatment of children.

What is the role of an ethics committee in medicinal product studies?


An ethics committee for clinical research consists of physicians, scientists, lawyers, theologians and patient representatives.

The aim is to evaluate research projects from an ethical, legal and social point of view and to assess the potential risk for children and adolescents. The ethics committee also controls whether the medical facilities and the responsible study physicians meet the respective requirements. The information sheets for the study must also be comprehensible and complete.

If studies are conducted with participants who are minors, it must be ensured that the resultant stress is kept as low as possible. All approved studies are also monitored on an ongoing basis by the ethics committee, which can also decide to prematurely terminate a study if necessary.


What safeguards exist for participants?

As part of a clinical study, insurance is provided for all participants.

If, despite all precautions, health impairments occur during the treatment or during the follow-up phase, these are covered by the insurance. Participation in a study can also be terminated at any time.

What rights do the parents of study participants have?


Parents of study participants have a right to:

  • Information and counselling
  • A second medical opinion
  • Appropriate and qualified care for their child
  • Self-determination and confidentiality
  • Disclosure of the patient file
  • Documentation
  • Compensation


Which obligations must be complied with?


Participation in a study results in the following obligations:

  • By signing the informed consent form, consent is granted for the child to be treated. The agreed treatment dates and control dates must be adhered to.
  • The attending physicians must be informed about any health changes and abnormalities occurring in the child.
  • There is an obligation to report whether the participating child takes any additional medication or participates in therapies that are not part of the study plan.
  • Any questionnaires must be completed conscientiously.
  • In the event of an emergency or hospital admission of the child, the study physicians must be informed immediately.
  • Any adverse reactions that occur that may be caused by the investigational product must be reported immediately.
  • All physicians not involved in the study must be informed about participation in the clinical study.
  • Depending on the study, parents may be requested to keep a diary of the child’s experiences of the treatment.