Framework conditions for clinical studies involving vulnerable groups – conference on the Declaration of Helsinki revision process

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 involving 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), and with support from the Bavarian Chamber of Physicians (Bayerische Landesärztekammer, BLÄK), will take place in Munich/Germany on Tuesday, 14 and Wednesday, 15 May and examine this contradiction.

International conference
“Research with vulnerable people – A targeted interdisciplinary discussion within the scope of the WMA Declaration of Helsinki revision”
Tuesday, 14 May 2024, 2:00 p.m. to 5:45 p.m. and Wednesday, 15 May 2024, 9:00 a.m. to 12:30 p.m.
Bayerische Landesärztekammer
Mühlbaurstraße 16, 81677 Munich/Germany and online

The conference is part of the broader Declaration of Helsinki revision process, which takes place every ten years. Following welcome addresses by Dr Gerald Quitterer, President of the Bavarian Chamber of Physicians, Dr Lujain Alqodmani, President of the World Medical Association, Leopoldina President Professor (ETHZ) Dr Gerald Haug, and Dr 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 Professor Dr 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 Professor Dr Samia Hurst from the University of Geneva/Switzerland and the physician Dr 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, Professor Dr Olaf Witt from Heidelberg University Hospital/Germany will discuss clinical studies involving children, while Professor Dr 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.

Dr Ramin Parsa-Parsi, Head of the German Medical Association’s Department of International Affairs, is the medical director of the conference. The Leopoldina Members Professor Dr Stefan Pfister and Professor Dr 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. The link to the livestream and other information can be found here:

Journalists who would like to attend should register by email at presse@leopoldina.org. We will happily organise interviews with the participating scientists.

About the German National Academy of Sciences Leopoldina
As the German National Academy of Sciences, the Leopoldina provides independent science-based policy advice on matters relevant to society. To this end, the Academy develops interdisciplinary statements based on scientific findings. In these publications, options for action are outlined; making decisions, however, is the responsibility of democratically legitimized politicians. The experts who prepare the statements work in a voluntary and unbiased manner. The Leopoldina represents the German scientific community in the international academy dialogue. This includes advising the annual summits of Heads of State and Government of the G7 and G20 countries. With around 1,700 members from more than 30 countries, the Leopoldina combines expertise from almost all research areas. Founded in 1652, it was appointed the National Academy of Sciences of Germany in 2008. The Leopoldina is committed to the common good.

The Leopoldina on X: www.twitter.com/leopoldina

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”.

Further information is available at: