Reproducibility of research results in medicine and biomedicine

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Researchers carry out each step of the research process lege artis. When research findings are made publicly available (in the narrower sense of pub- lication, but also in a broader sense through other communication channels), the quality assurance mechanisms used are always explained. This applies especially when new methods are developed.

Continuous quality assurance during the research process includes, in particular, compliance with subject-specific standards and established methods, processes such as equipment calibration, the collection, processing and analysis of research data, the selection and use of research software, software development and programming, and the keeping of laboratory notebooks.

If researchers have made their findings publicly available and subsequently become aware of inconsistencies or errors in them, they make the necessary corrections. If the inconsistencies or errors constitute grounds for retracting a publication, the researchers will promptly request the publisher, infrastructure provider, etc. to correct or retract the publication and make a corresponding announcement. The same applies if researchers are made aware of such inconsistencies or errors by third parties.

The origin of the data, organisms, materials and software used in the research process is disclosed and the reuse of data is clearly indicated; original sources are cited. The nature and the scope of research data generated during the research process are described. Research data are handled in accordance with the requirements of the relevant subject area. The source code of publicly available software must be persistent, citable and documented. Depending on the particular subject area, it is an essential part of quality assurance that results or findings can be replicated or confirmed by other researchers (for example with the aid of a detailed description of materials and methods).

Researchers take into account and acknowledge the current state of re- search when planning a project. To identify relevant and suitable research questions, they familiarise themselves with existing research in the public domain. HEIs and non-HEI research institutions ensure that the necessary basic framework for this is in place.

Methods to avoid (unconscious) distortions in the interpretation of findings, e.g. the use of blinding in experiments, are used where possible. Researchers examine whether and to what extent gender and diversity dimensions may be of significance to the research project (with regard to methods, work programme, objectives, etc.). The context in which the research was conducted is taken into consideration when interpreting findings.

Researchers document all information relevant to the production of a re- search result as clearly as is required by and is appropriate for the relevant subject area to allow the result to be reviewed and assessed. In general, this also includes documenting individual results that do not support the research hypothesis. The selection of results must be avoided. Where subject-specific recommendations exist for review and assessment, re- searchers create documentation in accordance with these guidelines. If the documentation does not satisfy these requirements, the constraints and the reasons for them are clearly explained. Documentation and re- search results must not be manipulated; they are protected as effectively as possible against manipulation.

An important basis for enabling replication is to make available the information necessary to understand the research (including the research data used or generated, the methodological, evaluation and analytical steps taken, and, if relevant, the development of the hypothesis), to ensure that citations are clear, and, as far as possible, to enable third parties to access this information. Where research software is being developed, the source code is documented.

This statement(externer Link) was prepared in 2018 by the DFG Permanent Senate Commission on Key Questions in Clinical Research in consultation with the DFG Permanent Senate Commission on Animal Protection and Experimentation and the DFG Permanent Senate Commission on Genetic Research. The statement makes recommendations to the research community, institutions and funding agencies to help improve the reproducibility of research results in medicine and biomedicine.

Reproducibility of research results in medicine and biomedicine

Cross-phase quality assurance

Research design

Documentation

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Reproducibility of research results in medicine and biomedicine

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