Scientists require the vote of an ethics committee to conduct medical research projects or studies involving human subjects in other disciplines.
Medical research projects must be advised or approved in accordance with various legal requirements. This task is performed by the medical specialist group of the ethics committee, established over 40 years ago. It acts on the basis of the Declaration of Helsinki of the World Medical Association and other regulations as well as applicable law. It takes into account scientific standards and relevant national and international recommendations. In accordance with the legal requirements, the medical specialist group of the ethics committee is composed of physicians, pharmacology specialists, persons with experience in the field of experimental design and statistics as well as computer science, persons with experience in the field of ethics, laypersons and lawyers qualified to hold judicial office.
In 2023, TUM was the first university in Germany to additionally establish a non-medical specialist group of the ethics committee due to an increasing number of requests from the non-medical area. The non-medical expert group reviews research projects primarily with regard to methodology and possible impacts on humans, animals and the environment. It is composed of experienced scientists from all schools of TUM in order to adequately assess the various research projects.
Current meeting dates of the ethics committee, important information on how to submit requests for various types of studies, especially from the medical area, as well as links to legal and ethical principles are provided by the office of the ethics committee.
The medical ethics committee is responsible for medical research projects submitted by scientists from TUM and the university hospital, including e.g. proposals in accordance with the German Arzneimittelgesetzt (AMG) or if an assessment by physicians is required by law.
Prof. em. Dr.
Former Head of Biometry at the Institute for Medical Statistics and Epidemiology
Klinikum rechts der Isar
Details on how to submit different types of medical research proposals, such as studies under the Arzneimittelgesetz (AMG) / Clinical Trial Regulation (CTR), or also Medical Device Regulation (MDR), and In-vitro Diagnostics Regulation (IVDR).
An ethics vote is also required for non-medical research activities, surveys and studies involving subjects. The submission portal provides clear guidance on the classification of the request (medical vs. non-medical).
- As a rule, requests may only be submitted before the starting date of the research project.
- Only in justified exceptional cases, especially if the funding conditions were changed after the research project started or new scientific findings prompted a new expert assessment, may an evaluation be undertaken after the starting date of the research project.
- When the publication of the project’s findings depends on the position statement of the non-medical specialist group, the group may issue a subsequent position statement limited only to the intended publication up until the publication’s approval. This position statement expresses at most that there are no objections to the publication and does not replace an ethics vote.
- The individuals who have the authority to submit requests are all full-time TUM employees whose job-related tasks include independently performing research work for the scientific research or teaching projects they are responsible for.
- In the case of doctoral projects or bachelor’s and master’s theses, only the supervisor or the first advisor who is employed full-time at TUM and is responsible for the planned research project may submit a request to the non-medical specialist group. Students are not entitled to submit requests.
- The position statement on the research project is undertaken by way of an ethical expert opinion with respect to the proposed methodical implementation and an impact assessment, especially for humans, animals and the environment.
- The ethical review is carried out primarily with regard to the planned methodological implementation and the impact assessment, in particular on humans, nature and the environment.
- In particular, the non-medical specialist group will assess whether, according to the protocol of the scientific project and the further information to be attached to the application,
- all appropriate precautionary measures have been taken for minimizing the risk to study participants, animals and the environment,
- the project is designed for providing reliable and robust data or findings,
- an appropriate ratio between benefits and risks of the project exists,
- a suitable form for the information and consent declaration for study participants or their legal representatives is available,
- implementation of the project takes the relevant position statements mentioned under § 1 (3) of the statutes of the non-medical specialist group (PDF 460 KB) into account
- implementation of the project complies with the relevant legal requirements.
- Requests submitted to the ethics committee must include all information required for the expert opinion. For detailed information, please refer to the regulations of the non-medical specialist group (PDF 460 KB).
- The non-medical specialist group works and makes its decisions on the basis of applicable law, particularly the German Constitution with the protection of the right to privacy of the individual and the right to control personal data (Art. 2 (1) in conjunction with Art. 1 (1) GG), German data privacy law, the Bavarian Higher Education Innovation Act.
- The committee takes relevant recommendations in their currently valid version into account from the German state and federal government, as well as the European Union, particularly the “German Research Foundation”, the German Academy for Natural Scientists and Leopoldina”, the “German Society for Psychology” and the “German Society for Education”.
- The work of the non-medical specialist group is undertaken in the context of the ethical responsibility of the individual researchers and while observing their constitutionally protected academic freedom.
- The members of the non-medical specialist group are to remain independent when performing their duties and are not bound by instructions. They will perform their duties to the best of their knowledge and belief.