Research Data Policy of Hannover Medical School
Remarks on handling research data at Hannover Medical School.
This is a translation of MHH’s research data policy (last change to translation: 30.06.2023). The official (german) version of this policy was passed in the 608. session of MHH’s senate on May 3rd 2023.
Every scientific activity generates research data of various kinds, e.g. as intermediate result, byproduct or end result of the research process. Research data comprises all data generated in the research process, including metadata and methods for analyzing data to generate new information or higher-value data. Research data is also relevant beyond the end of a research project. It guarantees the reproducibility and reusability of research results and serves as basis for further research activities.
In accordance with the principles of the DFG and the Alliance of Science Organisations in Germany, Hannover Medical school acknowledges the importance of research data for scientific research and commits itself to its responsible use.
Hannover Medical School supports research data management in accordance with the Principles of Good Scientific Practice and the FAIR Principles and supports its scientists in all disciplines in transparent data management by providing suitable infrastructures and services. This ensures that both data and metadata are findable, accessible, interoperable, and reusable.
Scope of application
These guidelines for handling research data address all scientists as well as all members and affiliates of Hannover Medical School who handle research data. Although the concrete realization details of research data management remain the researchers’ personal responsibility, it is mandatory to take these principles into account.
- People producing research data are responsible to ensure that data management obeys ethical guidelines and confidentiality standards as well as applicable rules regarding privacy, security, intellectual property and copyright.
- Researchers of Hannover Medical School decide in their own responsibility which datasets to publish or archive, about format and level of aggregation and whether existing central infrastructures and services for research data management are applicable. Central services consulting and supporting in research data management have to be involved starting with the planning phase of the research project.
- Resources for data storage and management (personnel, project-specific hardware and software, user fees, etc.) are considered in grant applications. This includes required central infrastructures of Hannover Medical School.
- A data management plan describes the planned collection, management, storage, use and publication of research data in the project as well as measures to ensure integrity and confidentiality. It includes the project’s agreements on responsibilities, copyright and authorship, regulations in case of changing project staff and on conditions for data sharing. The data management plan is created early in the research project, reviewed regularly and updated as necessary.
- Relevant metadata (e.g. methods and tools used in data generation, processing and analysis) are documented from the start in each research activity, to ensure reproducibility of data and results.
- In accordance with the FAIR principles, Hannover Medical School encourages its researchers to make research data freely accessible as early as possible in citable and reusable form and under a suitable license (e.g. Creative Commons or comparable). Legitimate interests and constraints have to be respected.
- Users of Research Core Units remain exclusive owners (intellection property) of measurement results, excluding transfer of intellection property from the user to the Research Core Unit. For research and teaching purposes, academic users can make unrestricted use of information and intellectual property of Research Core Units that resulted from the research project („foreground IP“).
Hannover Medical School operates central services and infrastructures supporting researcher data mangement in all phases of the research project.
A central point of contact providing consultation and support for researchers has been established. This support is offered starting from the application stage and includes coordination to the other entities listed below.
Several entities of Hannover Medical School continuously expand their research data management services in close coordination with each other and in dialog with the scientists:
- MHH-IT provides IT tools (e.g. services for the secure exchange of data, version control) and is responsible for the procurement and distribution of standard scientific software (e.g. statistics, laboratory/sample management) and for the provision of technical infrastructure (e.g. storage devices, servers, high performance computing cluster).
- The medical data integration center provides consulting and support with a focus on management of clinical research data and metadata (e.g. planning the (FAIR) management of research data in the proposal phase, semantic annotation using existing metadata and interoperability standards, secondary use of clinical data). This also includes links to national and international research data infrastructures and networks (e.g. Medical Informatics Initiative, Network University Medicine).
- The Hannover Unified Biobank offers all departments, institutes and partners of the Hannover Medical School a comprehensive service for all aspects of storage and management of biological samples.
- Hannover Medical School’s Clinical Research Center Core Facility (CRC CF) consults academic researchers as well as pharmaceutical and medical device companies on the planning and conduct of clinical trials according to AMG, MPDG and BOÄ. In addition, the CRC offers GCP-compliant services in the areas of project management, medical writing, regulatory affairs, data management (eCRF design using Marvin or SecuTrial, data validation) and monitoring. Phase 1 studies can be conducted in the translational infrastructure CRC by the Early Clinical Trial Unit (ECTU) team.
- The library is the point of contact for the publication of research data. A consulting service has been set up. An open access repository managed according to FAIR principles is available.
- Central research infrastructure at Hannover Medical School is organized primarily through the Core Facilities (CFs). The CFs follow the recommendations of the DFG and the European Science Foundation for the operation of research infrastructures. In particular, they aim to provide researchers with efficient access to modern high-performance technologies, which often require the use of costly and high-maintenance large-scale equipment, as well as highly specialized expertise of the operating staff. CFs often generate substantial amounts of research data for researchers - in the form of commissioned work or collaborations. This poses substantial challenges in terms of adequate processing (e.g. HPC technology), storage, and general handling of research data. The CFs have an important role in the development of suitable solutions for these kind of challenges. Furthermore, the CFs play an essential role in general quality assurance and support researchers already in the planning stage in questions regarding research proposals, adequate experimental designs and suitable methodological approaches as well as in the selection of appropriate data processing workflows.
- The Institute of Biometry offers consulting services for all researchers of the Hannover Medical School and thus creates the opportunity to obtain a rough estimate about feasibility and costs (in number of experimental units), the suitable experimental design and the correct analysis strategy for a research project. In cooperation projects, the institute supports the grant application with an elaborated statistical test design. In clinical trials that are subject to the AMG or MPDG, the Institute carries out the necessary analyses in a GCP-compliant manner with appropriately trained staff, taking into account the relevant regulations. The institute maintains a quality assurance system for this purpose. This infrastructure is available to all scientific projects.
- Hannover Medical School’s unit for Research Funding, Knowledge & Technology Transfer supports in the formal application process, in the development and implementation of suitable exploitation strategies, as well as with getting in touch with suitable experts within Hannover Medical School.
- Central contacts for the topics of data privacy and information security provide advice to ensure that research data management at Hannover Medical School is conducted complying with the goals of confidentiality, availability and integrity.
- The ethics committee ensures the mandatory counseling required by the professional code of conduct for physicians, which must precede any data collection and any reuse of non-anonymized data.
Oriented to its researchers’ needs, Hannover Medical School continuously expands its teaching and training opportunities on the topics of research data management and data literacy.
Hannover Medical School cooperates with relevant working groups and infrastructure initiatives in research data management at regional, national and international level in order to ensure up-to-date research data management services compatible with international research networks (e.g. AG FDM Niedersachen, NFDI, Medical Informatics Initiative, Network University Medicine, German Biobank Alliance).