Duty to report unexpected events

     The principal investigator of a study shall immediately submit to the monitoring body under paras. 2 and 3, art. 29, and to the Data Protection Authority if applicable, written notification of unexpected events which have, or could have, adversely affected participants, and are believed to be attributable to the study. 

     The principal investigator, other investigators and staff shall, on their own initiative, disclose to monitoring bodies information on factors which could pose a risk to the security of participants in the study. An unexpected death shall immediately be notified to the police in accord with the provisions of the Act on Death Certificates, Autopsies etc.