Leopoldina Home Menü

Leopoldina Home

News| Tuesday, 30 April 2024

Discussion about clinical studies on vulnerable groups

Discussion about clinical studies on vulnerable groups

Image: Leopoldina

In Germany, as a rule, clinical studies involve adults between the ages of 18 and 70. The World Medical Association’s “Declaration of Helsinki” policy statement defines ethical principles for medical research involving humans. The principles accord special protection to vulnerable groups, such as children, adolescents, and adults not capable of giving consent. Generally speaking, these groups are therefore not involved in clinical studies. In some cases, however, vulnerable groups could particularly benefit from participation in such studies. An international conference is dedicated to this contradiction.

The conference is part of the broader Declaration of Helsinki revision process, which takes place every ten years and is being organized by the German National Academy of Sciences Leopoldina and the German Medical Association (BÄK) in cooperation with the World Medical Association (WMA) and the American Medical Association (AMA) with the support of the Bavarian Medical Association (BLÄK) on Tuesday, 14 May and Wednesday, 15 May in Munich. Following welcome addresses by Gerald Quitterer, President of the Bavarian Chamber of Physicians, Lujain Alqodmani, President of the World Medical Association, Leopoldina President  Gerald Haug, and Klaus Reinhardt, President of the German Medical Association, the Declaration of Helsinki and the ongoing revision process will be presented. The medical ethics expert and historian Urban Wiesing will report on current discussions in the Leopoldina Working Group “Framework conditions for clinical studies on vulnerable people”, which focuses in particular on clinical studies involving children and adolescents. The bioethics expert Samia Hurst from the University of Geneva/Switzerland and the physician Hilary Marston from the US Food and Drug Administration (FDA) will be among speakers giving keynote lectures on vulnerability. There will also be short lectures focusing on individual vulnerable groups. For example, Olaf Witt from Heidelberg University Hospital/Germany will discuss clinical studies involving children, while Mohammed Ghaly from Hamad Bin Khalifa University in Doha/Qatar will talk about people with disabilities. To conclude the event, a podium discussion will examine the revision of the Declaration of Helsinki’s paragraphs concerning vulnerability.

Ramin Parsa-Parsi, Head of the German Medical Association’s Department of International Affairs, is the medical director of the conference. The Leopoldina Members Stefan Pfister and Urban Wiesing, who are also the spokespersons of the Leopoldina Working Group “Framework conditions for clinical studies on vulnerable people”, are responsible for scientific coordination of the conference.

The conference is registered as a continuing education event at the Bavarian Chamber of Physicians and is aimed at members of the public interested in the topic. It will take place in English, is free of charge, and will also be streamed online.

About the German Medical Association

The German Medical Association (BÄK), as the joint association of Germany’s 17 State Chambers of Physicians, plays an active role in opinion-forming processes with regard to citizen-focused health and social policy. The BÄK supports the work of the Chambers of Physicians and in so doing is indirectly involved in legislative procedures. The BÄK is directly involved in legislative procedures relating to, among other things, quality assurance and transplantation legislation. The German Medical Association arose from the Working Group of West German Medical Associations (Arbeitsgemeinschaft der Westdeutschen Ärztekammern), which was founded in 1947. Today, it is the joint association of the 17 State Chambers of Physicians, which are registered corporations under public law. The annual German Doctors’ Conference (Deutscher Ärztetag) is the German Medical Association’s annual general meeting, also known as the “Parliament of the Medical Profession”.