EORTC Legal Aspects

The EORTC is an international association under Belgian law. All trials carried out under the auspices of the EORTC are, by definition, the responsibility of the EORTC. The registered office of the EORTC is at 83, Av. E. Mounier, B-1200 Brussels, Belgium.


The EORTC insurance programme, established in 1993 covers all patients entered into EORTC studies (except patients from the US, Canada and Australia) and for which the EORTC is the sponsor/promotor. For studies conducted in collaboration with the pharmaceutical industry, insurance coverage must be discussed on a case-by-case basis.


In order to fulfill regulatory affairs obligations and to guarantee adequate trial insurance coverage for patients and investigators, according to their national law, the Regulatory Affairs Unit at the EORTC Headquarters must give its permission for each center prior to patient recruitment.


On the other hand, the EORTC plays a major role both at the European and national levels to alert regulators to the need for independent clinical research conducted without commercial aims.

 


Ethical Aspects and Informed Consent/Insurance

All EORTC protocols are written and conducted in accordance with international standards for ethics: the Declaration of Helsinki, Good Clinical Practice guidelines approved by the International Conference on Harmonization. A standard chapter on Ethical Considerations is included in all EORTC protocols.


In accordance with local, regional, and national requirements, written approval from competent ethics committees must be obtained before an institution is given the authorisation to register or randomise a patient into a study. Standard guidelines for obtaining informed consent from patients entered in EORTC protocols have been developed. Investigators must obtain a dated and signed consent form from each patient.


All internal and external people involved in clinical activities need to comply with EORTC policies and procedures. More specifically, investigators and Board members must sign a conflict of interest statement.