EORTC Legal Aspects

The EORTC is an international association under Belgian law. The registered office of the EORTC is 83 Av. E. Mounier, B-1200 Brussels, Belgium.

EORTC is the legal sponsor for the majority of the trials run under its auspices, except in US, Canada, and Australia where trials are performed in collaboration with other partners.

The EORTC insurance program, established in 1993, covers all patients entered into EORTC studies and for which the EORTC is the sponsor/ promoter.

For Intergroup trials lead by non-EORTC groups, sponsorship issue is discussed on a case by case basis taking into account applicable legislation. For fully industry supported trials, usually industry is the sponsor.

In order to fulfill the sponsor’s legal obligations and to guarantee compliance with applicable national laws, the Regulatory Affairs Unit at the EORTC Headquarters keeps its legal expertise up to date in more than 30 countries in Europe and other countries.

The EORTC also 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 authorization to register or randomize 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.

Last updated 02-03-2011