How aware are Instagram users of the existence and functionality of AI algorithms? How do the sleep patterns of students change during the semester and especially in exam situations? Or how much coffee should a biathlon competitor drink to boost overall performance without affecting the steady hand needed for accurate marksmanship? These recent examples show that requests to the TUM Ethics Committee for ethical assessments of research proposals are no longer limited to medical topics. Ethical approval is always needed for research involving people.
Until now these non-medical topics were also handled by the Medical Ethics Committee. But the numbers are increasing with each passing year. Around 150 of the 850 submissions in 2023 were no longer related to medicine. As a result, the Ethics Committee now has a new non-medical subcommittee to address such topics. It will evaluate the technical and societal conditions relevant to research initiatives and will require changes when needed. The up to 10 voting members of the subcommittee will come from TUM schools in such diverse areas as management, social sciences, natural sciences and engineering.
New submissions using the ethics tool: decisions generally ready within a few days
“The main objective is to check whether an experiment can be properly performed from the standpoint of good scientific practice,” explains Prof. Klaus Bengler of the TUM School of Engineering and Design, who will head the new Ethics Commission subcomittee. In general terms, the focus will be on “the methodology and possible consequences of the project for humans, animals and the environment.” This may involve
- projects related to human-technology interactions such as autonomous driving,
- data protection and personality rights,
- personal data used to train AI algorithms,
- social sciences questionnaires that collect personal data.
Ethics Commission: “Opening the door between researchers’ ideas and society.”
In their assessments, the commission members do not intervene in the design and contents of the research: Overarching questions on “dilemma situations”, for example in connection with autonomous driving, are handled by the German Ethics Council. “The TUM Ethics Commission deals with individual projects,” explains Prof. Georg Schmidt of TUM Klinikum rechts der Isar, who heads the ethics committee for the medical field, which was founded more than 40 years ago. “After a detailed assessment, it opens a door, in a sense, between the researchers’ ideas and society and can make it possible for test subjects to take part.”
The eTIC software supports researchers in submitting proposals simply and with a minimum of bureaucracy. “It’s more a ‘four-eyes principle’ than an extra layer of red tape,” says Prof. Bengler, describing the review process, which he sees as a form of support for researchers. In the meantime, ethical approval has become an explicit demand for research activities and publications in the relevant areas. “In the end, rather than producing a new document, researchers only have to upload a study protocol with a cover letter in the tool,” adds Schmidt. It takes an average of 4.5 days for the Ethics Commission to respond to a new submission. The process can take as long as 12 months only in case of missing information or defective research proposals.
Funding providers demand ethical approval
The first Ethics Commission at TUM was established more than 40 years ago as a purely medical body. For example, when the testing of a drug involves a risk to patients taking part in a study, an ethical opinion is required beforehand. The Drug and Medical Product Act now requires studies involving patients to be evidence-based and risks to be demonstrably kept to a minimum. In addition, the professional code of conduct for physicians requires prior consultation with the Ethics Commission before conducting research involving patients. Although it is no longer possible for any type of medical research to be carried out without ethical approval, non-medical research is not as strictly regulated. Personality rights, data protection laws and the Bavarian University Innovation Act provide a general framework for research. However, the pressure to obtain ethical approval before the start of a project is coming especially from grant providers such as the German Research Foundation (DFG), federal ministries and scientific journals, which often expect ethical approval before projects are submitted.
The good news for all researchers: 80–90% of submissions are approved in the first round.
Further information
General information on the TUM Ethics Committee: https://www.tum.de/en/about-tum/organization/ethics-committee
Link to the article on tum.de: https://www.tum.de/en/news-and-events/all-news/press-releases/details/new-ethics-committee-for-ai-and-related-fields-at-tum
Additional editorial information
Photo material: AI and other non-medical topics are becoming increasingly important for the Ethics Committee; https://mediatum.ub.tum.de/652209?show_id=1738127
Contact for scientific information:
Prof. Klaus Bengler
Chair of Ergonomics
Technical University of Munich (TUM)
Klaus.bengler@tum.de
089-289-15388
Prof. Georg Schmidt
Consulting Physician for Internal Medicine and Cardiology
Klinikum rechts der Isar
gschmidt@tum.de
