Clinical trials in Finland
In Finland, clinical trials including pediatric trials involving children aged 0 to 17 years are considered medical research on human subjects and governed by strict, specific regulations. Clinical trials are supervised by competent authorities.
Before starting a clinical trial in Finland, the trial must be notified to the Finnish Medicines Agency, Fimea that gives the ultimate approval for a trial. The trial plan must also be submitted to the National Committee on Medical Research Ethics (TUKIJA) for ethical evaluation and opinion. Clinical trials need to be evaluated by both authorities before study start. In addition, the Sponsor must apply for permission from all those organizations (clinics/hospital departments) where the trial will be conducted. Trial agreements are signed between the Sponsor funding the trial and the organization in question.
Before the trial can be started in practice, participants (children and/or guardians, depending on the age of the child) need to sign voluntary Informed Consent documents to confirm study participation. Informed Consent is based on the provided Patient Information that needs to be understood and approved before signing the Informed Consent. The child's own opinion and supposed will must be obeyed taking into account his/her age and level of understanding.
In Finland, authorities' processes and processing timelines are regulated by law and related standard operating procedures. Research permissions and trial agreement processing periods in hospitals / clinics vary depending on respective administrative procedures and requirements.
More information about clinical trials, processing times, and research organizations in Finland: Clinical Trials in Finland.