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Berlin – The number of research projects on topics such as human-technology interaction and artificial intelligence (AI) is increasing rapidly and with it the need for research ethics advice. The Working Group of Medical Ethics Commissions (AKEK) has reacted to this development and dedicated its 42nd annual meeting in Berlin yesterday to ethics advice on non-medical research on humans.

“While doctors in Germany are obliged by the medical professional regulations to obtain an ethics approval for any research involving humans, there is no such obligation for non-medical researchers – for example in sports science, sociology or engineering,” explained Georg Schmidt, chairman of the AKEK, dem German medical journal (DA).

At the conference, members of medical ethics committees confirmed: They are increasingly being asked by non-medical researchers and, based on their know-how and their established structures, are asked to provide “administrative assistance” also in non-medical research projects. Funding organizations such as the German Research Foundation (DFG), federal ministries or research journals are increasingly demanding ethical approval when funding and publishing study results in the non-medical area.

“This development is important because non-medical research on humans can also have potentially dangerous or ethically and legally sensitive aspects – just think of developments in robotics or artificial intelligence,” says Schmidt.

That is why the medical ethics committee has so far looked at and assessed these topics. But there are more and more every year. “At TUM alone there are now around 150 studies per year in the non-medical area,” says Schmidt. That is why a second, independent arbitration chamber with its own statutes was established under the umbrella of the Medical Ethics Commission.

This new non-medical specialist group of the ethics committee, whose members come from the areas of management, social sciences, natural sciences and engineering, evaluates the technical and social framework conditions of the research approaches and calls for improvements if necessary.

“Our main concern is to check whether an experiment is carried out properly from the point of view of good scientific practice,” explained the head of the non-medical specialist group of the ethics committee at the TUM, Klaus Bengler, at the AKEK annual meeting.

The main focus of considerations is the methodology and possible consequences of a research project for people, animals and the environment, says Bengler. These could be human-technology interaction projects such as autonomous driving, data protection and personal rights, personal data that is used in artificial intelligence to train algorithms or surveys in the social sciences in which personal data is collected will, go.

During its examinations, the commission does not intervene in the content of the research: overarching questions about “dilemma situations”, such as autonomous driving, are the responsibility of the German Ethics Council.

“There is great interest and a great need for clear ethical advice in non-medical research,” said Schmidt on the sidelines of the annual meeting DA. AKEK tries to do justice to this. In order to create standards, a joint working group has already been formed by the German Medical Association (BÄK) and AKEK. “Finding solutions here is a task for the near future,” says Schmidt.

The BÄK has also already discussed developments in the area of ​​research on humans by non-medical professional groups.

She fears that in this research on humans, the protection standards for participants in research studies could fall short of the long-established protection standards of the Declaration of Helsinki. In addition, funding institutions and publication bodies that require the submission of ethics opinions could not require uniform audit quality in non-medical areas.

In addition: The Declaration of Helsinki, amended in October with the participation of the BÄK, stipulates that it should be taken into account by all people, teams and organizations involved in medical research, as it ensures the respect and protection of all research participants, whether patients or healthy ones Volunteers are essential. © ER/aerzteblatt.de