The trial will be reviewed and approved by institutional Ethical Committees warranting the ethical integrity of the project and a favorable risk/benefit ratio in the best interests of the patients. The central Ethical Committee responsible for the international sponsor Charité Berlin will review the annual safetey reports and the recommendation of the Data Safety monitoring Committee and will communicate the conclusions to the other competent Ethical Committees.
Data Safety monitoring Committee (DSMC)
The DSMC includes experts in the field not involved into the trial, who will review the safety data of the trial and exclusively the efficacy data as provided with the interim analysis. They will make recommendations on the further conduction of the trial or termination of the trial, if safety, efficacy or scientific integrity of the trial are substantially affected. The report of the DSMC is reviewed by the sponsor Charité Berlin and the central Ethical Committee.
Independent Ethics Board
In addition, an Ethics Board is implemented for the IntReALL FP7 project, consulting the project partners on the conduct of the project from the view point of parents and patients. The Board consists of parents, patients, parent-group representatives, psychologists, and social scientists. This Board is involved in the development of the protocol and the consent forms; and representatives take part at the regular project meetings. A scientific evaluation of the work of this board is planned leading to conclusions which will be published and made available for other groups. The integration of parents and patients interest is a major goal of the IntReALL consortium.