Ethics Diversity Persists

The extremely patchy and diverse nature of Europe's ethical approval system is evident from an updated report from the European Forum for Good Clinical Practice (EFGCP).

Wide variations between different countries continue to exist, in spite of many years of harmonization efforts, according to the document, "The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe," which is now available free-of-charge from the EFGCP Web site (www.efgcp.be).

A sub-group of the EFGCP's Ethics Working Party has studied over 30 aspects of the ethical review process in each country. It has brought the information together in its report, which is designed to serve as a reference tool for any company, academic department or CRO that wishes to conduct clinical research across Europe.

Ethics Presence

Differences by country

As the table shows, the number of committees in each nation varies greatly, as do the ethical procedures. For instance, for studies in Germany conducted by an investigator not attached to a university, regional medical associations are responsible for establishing and supervising ethics committees. For studies conducted by an investigator attached to a university, the faculty of medicine has responsibility for ethical aspects. There is no central ethics committee for the review of individual biomedical projects. The German Ethics Council (Deutscher Ethikrat) was established in April 2007 and gives nonbinding recommendations, and the Central Ethics Committee of the German Medical Association also gives opinions on general ethical issues.

In France, on the other hand, sponsors have to submit their protocols both to the competent regional ethics committee (CPP) and the competent authority. No trial can start without the approval of one of the 40 CPPs. The CPP evaluates the different parts of the protocol and sends its written advice to the sponsor within 35 days. This advice is also sent for information to the competent authority.

EFGCP events

As part of its education campaign, the EFGCP organized a workshop, held at the end of May in Rome, about complex cases handled by ethics committees across Europe. This event, which was the fourth in a series, explored the differences between ethics committees on the one hand and investigators and sponsors of research projects on the other. It included three case-based discussions by people closely involved in the cases. There was also a presentation on cases of fraud and misconduct in research projects that have involved ethics committees.

EFGCP was founded with the support of the European Commission in 1993, and is a nonprofit organization that aims to encourage the practice of common, high-quality standards in all stages of research throughout Europe and globally. It promotes contact and partnership between pharmaceutical companies, CROs, academics, investigators, ethics committees, regulatory authorities, patient organizations, and suppliers of services, systems, and equipment.

Next year's EFGCP Annual Conference will focus on "Certified GCP Training—Needs and Expectations," and will take place in Budapest, Hungary, from February 1 to February 2, 2011. It is also supporting a pediatric forum, "Current & Future Medical Child Care: Visions, Daily Challenges, Ways Forward," to be held in London from September 28 to 29, 2010.