The Ethical Problems of Medical Research in Eastern Europe (Focus: Biotechnology) (duration 1.10.2006 - 28.2.2008)

Contact: Hans-Jörg Ehni

This project addressed ethical issues in biomedical research that have arisen as a result of international cooperation. This topic and further key aspects constitute the current state of relevant research in Eastern Europe, especially in the area of biotechnologically produced active substances. The tragic study involving the monoclonal antibody TG1412 provides the basis for this project. Important ethical problems here are the varying acceptance of risks and the permissibility of incentives.

The focus of other unresolved international debates lies on the use of placebo, the level of the standard of care in the experiment subject to the respective local infrastructure, the benefits to the participants and the relation to the health priorities of the country in which the clinical trial takes place.

A workshop with Eastern European experts was held in Tübingen on this topic:

Workshop on Ethical Problems in International Research Cooperations – Focus Biotechnology and Eastern Europe, 5.5.2007, Tübingen, Castle, Fürstenzimmer

9:15- 9:30 Welcome Address (Urban Wiesing , Tübingen)

Session I: Trials of biomedical innovations (Moderation: Urban Wiesing)

9:30 – 10:00 The failure of the TGN 1412-Trial in London (Hans-Jörg Ehni , Tübingen)

10.00 – 10:30 Phase I trials of anticancer drugs (Andres Soosaar, Tartu)

10:30 – 11:00 Recent developments in Gene-therapy (Oana Iftime Bucharest)

Break 30 min

Session II: Legal aspects (Moderation: Josef Kure)

11:30 – 12:00 Is data protection a hindrance to medical research? (David Townend, Sheffield)

12:00 – 12:30 Legal protection of human rights in clinical trials in Bulgaria (Darina Zinovieva, Plovdiv)

12:30 – 1:00pm The acts of competent authorities in clinical trials in Bulgaria (Konstantin Pehlivanov, Plovdiv)

Lunch Break 1.5 hours

Session III: International and intercultural aspects (Moderation: David Townend)

3:00pm – 3:30pm Public morals behind closed door. Some thoughts about the concept, role, and authority of (Research) Ethics Committees (Josef Kure, Brno)

3:30pm – 4:00pm Research ethics in Romania (Beatrice Ioan, Iasi)

4:00pm – 4:30pm Possibility of global bioethics (Peter Sykora, Trnava)

Session IV: Research Ethics in FP7 (Moderation: Urban Wiesing )

5:15pm – 6:30pm Possibilities for future proposals (Hans-Jörg Ehni )