News Discussion about clinical studies on vulnerable groups

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”.

The Leopoldina uses cookies

We use cookies on our website. Some of them are necessary (functional cookies), while others are not necessary but help us to improve our online offering and operate it economically.

You can consent to the use of non-essential cookies by clicking on the "Accept all" button or by clicking on individual settings and agreeing to them by clicking on "Accept selection".

You can access these settings at any time and deselect cookies at a later date.

Functional

These cookies are technically necessary in order to provide the following core functionalities of the website:

  • Display of the website
  • Anonymisation of IP addresses within log files
  • Status cookie consent
Comfort

In addition to necessary cookies, we also use cookies to make your use of the website more pleasant. If you accept these cookies, external media will be loaded without your further consent.

Tracking

With the help of statistics cookies, we can better customise the content and services of our website to your interests and needs. For statistics and analyses, we use the product Matomo for statistics and analyses.

External link warning

Die Nutzung dieses Teildienstes erfordert ihre Einwilligung in die Verarbeitung zusätzlicher personenbezogener Daten durch einen selbständigen Verantwortlichen: Matterport Inc., 352 E. Java Drive, Sunnyvale, CA 94089, USA. Es gelten folgende Datenschutzhinweise: https://matterport.com/de/node/44. Mit der Einwilligung durch Klick auf „Ok“ kann auch eine Übermittlung von personenbezogenen Daten in ein Land außerhalb der Europäischen Union erfolgen. Die Einwilligung ist freiwillig. Eine Ablehnung führt zu keinen Nachteilen. Eine erteilte Einwilligung kann jederzeit mit Wirkung für die Zukunft widerrufen werden.

Ich bin damit einverstanden, dass bei Nutzung dieses Teildienstes zusätzliche personenbezogene Daten verarbeitet werden. Dabei verarbeitete Datenkategorien: technische Verbindungsdaten des Serverzugriffs (IP-Adresse, Datum, Uhrzeit, abgefragte Seite, Browser-Informationen), Daten zur Erstellung von Nutzungsstatistiken und Daten über die Nutzung der Website sowie die Protokollierung von Klicks auf einzelne Elemente. Zweck der Verarbeitung: Auslieferung von Inhalten, die von Dritten bereitgestellt werden. Rechtsgrundlage für die Verarbeitung: Ihre Einwilligung nach Art. 6 (1) a DSGVO, Art. 49 DSGVO. Verantwortlicher für die Datenverarbeitung Matterport Inc., 352 E. Java Drive, Sunnyvale, CA 94089, USA. Es gilt die Datenschutzerklärung von Matterport Inc.: https://matterport.com/de/node/44.

Visit page ▸