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Munich/Berlin The Declaration of Helsinki (DoH), first adopted by the World Medical Association 60 years ago, is currently in the process of being revised. It formulates globally applicable ethical principles for medical research on humans and protects vulnerable groups.

These vulnerable groups are currently the focus of considerations and considerations by experts from all over the world: children, young people and adults unable to consent. In order to give them special protection in accordance with the applicable DoH, they are usually not included in clinical studies.

But this special protection can also become a problem for members of vulnerable groups. Because at the same time it means less or no access to therapeutic innovations for them. They usually only gain access to innovative therapies after new medications have been tested on a sufficient number of adults.

Yesterday and today in Munich, the debate at the international conference of the National Academy of Sciences Leopoldina and the Federal Medical Association (BK) in cooperation with the World Medical Association (WMA) and the American Medical Association (AMA), supported by the Bavarian State Medical Association, was devoted to this contradiction.

At the conference, the extent to which the intended protection of vulnerable groups becomes a disadvantage for them was discussed from various perspectives. It became clear that delays in the availability of new treatments can be very problematic, especially for children and young people with cancer.

Based on the data and discussions, working groups now want to present well-founded recommendations for revising the paragraphs of the Declaration of Helsinki that relate to vulnerability.

Such a revision is essential so that the declaration always remains current, Lujain Al-Qodmani, President of the World Medical Association, praised the ongoing efforts. The Declaration of Helsinki has a global claim and is one of the few available guidelines for research on humans in many countries, said the doctor.

In addition to the World Medical Association, the Working Group on Framework Conditions for Clinical Studies on Vulnerable People at the National Academy of Sciences Leopoldina is also dedicated to this topic. Under the leadership of Stefan Pfister and Urban Wiesing, it is currently in the process of identifying ethically based improvements to the framework conditions for clinical studies on vulnerable people, especially children and adolescents.

The Leopoldina brings together scientists from all disciplines and acts completely independently of politics and industry, emphasized dermatologist Thomas Krieg, Vice President of the Leopoldina, at the conference in Munich.

The academy chooses its own topics that it considers important for society, he said. The current conference to revise the Declaration of Helsinki is an example of good interdisciplinary and international cooperation in an area that is being discussed worldwide.

The relevance of independence from ethical considerations was also emphasized in Munich by the President of the Federal Medical Association, Klaus Reinhardt. Unfortunately, there is currently a political development in Germany that threatens the independence of the ethical assessment of clinical studies. This development contacts the Declaration of Helsinki and we will do everything we can to counter it, he stressed.

The recently concluded 128th German Medical Association in Mainz passed a resolution for democracy and human rights with a large majority. He also called on the legislature to maintain the independence of the ethical assessment of clinical trials.

Background: The draft of the Medical Research Act planned in Germany provides for the establishment of a Specialized Ethics Committee at the Federal Institute for Drugs and Medical Devices (BfArM), which will be responsible for the assessment of complex research projects, including those involving vulnerable patient groups.

Reinhardt made it clear that this state authority, which is subordinate to the Federal Ministry of Health and is bound by instructions, fundamentally questions the independence in the ethical assessment of study projects.

According to the President of the Federal Medical Association, the latter is a central cornerstone of the protection of test subjects in the context of clinical trials. For many years in Germany, the ethics committees formed under state law, which are located both at the state medical associations and at the universities, have taken on this task. They are interdisciplinary and completely independent institutionally, he emphasized. The Declaration of Helsinki also stands for this independence.

The Declaration, adopted in 1964 at the 18th General Assembly of the World Medical Association (WMA) in Helsinki, is actually one of the most important documents of the WMA. It is considered a living document and, like all WMA papers, undergoes regular revisions, explained Jack Resneck, past president of the American Medical Association.

With seven revisions and two clarifications over the past 50 years, the WMA ensured that the normative requirements of the Declaration were adapted to the constant changes in science and ethics.

In 2013, the 64th WMA General Assembly adopted the latest version of the Declaration. Working groups have been working on the topic of vulnerability since 2020, said Resnack. For everyone, this is both a privilege and a responsibility. It is necessary to find the right balance between protection and participation in research.

Currently, the paragraphs on vulnerability in the DoH are very general and require special attention to protection.” That raises questions, said Wiesing. The main question of the Leopoldina working group is therefore: What does the protection of endangered people or groups mean specifically for development helpful therapies for these vulnerable people or groups, especially children?

There is empirical data that shows a delay in new interventions for these groups, said the doctor and medical ethicist. Some authors have shown that helpful interventions for children, for example, have a delay of six years in approval.

The main reason for this is the delayed start of research with children. Whether there is an imbalance between protection and opportunities should be examined as closely as possible for children and other vulnerable groups, he said. © ER/aerzteblatt.de