01 November 2023
Open Access to Research Data
The Data Access Committee of the Faculty of Medicine (MF-DAC) supports research groups in publishing and obtaining sensitive research data
Why open access to research data?
Open access to research data improves integrity and transparency in research and enables wider use of research data. Public funding bodies for research projects, such as the Swiss National Science Foundation (SNSF), have for some time required that the publications of funded research projects be freely accessible. In turn, more and more of the medical journals used for the publications require that the research data underlying the publications also be made available in public data archives suitable for this purpose. This can be a difficult task for researchers to accomplish when dealing with sensitive research data that may not be published in its entirety for free access.
Requirement for publication of research data: the FAIR guiding principles.
Research data are subject to certain requirements and must be specially prepared. Open access to research data should follow the FAIR Guiding Principles for the Management of Scientific Data. FAIR stands for Findable, Accessible, Interoperable, and Re-usable. This means that data should not only be easy to find and understand, but also accessible under clearly defined and comprehensible conditions.
Open access is not synonymous with publishing the entire dataset
Research data and associated metadata with unique identifiers should be stored in an openly accessible, non-commercial data repository. Legal requirements and regulations must be observed. Especially for sensitive data, the following applies: access must be as open as possible, but as secure as necessary. In particular, the legal and ethical rights of data donors (e.g. patients) must be respected. Thus, open access does not mean that all data of a study are publicly stored and anyone can access them. The preparation and publication of data and metadata is complex and requires expertise from various disciplines. Supporting researchers in this process is one of the tasks of the newly founded MF-DAC.
The mission of the MF-DAC
When sensitive research data are to be published, the MF-DAC can be commissioned by the researchers of the Faculty of Medicine as a Data Access Committee. ("Data Submission Process"). Third parties, for example researchers from other institutions, who wish to access these sensitive research data for their own research, can then contact the MF-DAC with their request ("Data Access Request"):
Data Submission Process
Researchers at the Medical Faculty of the University of Basel/USB are planning a research project in which sesnible data will also be published.
- The MF-DAC will assess under which conditions the consent of the participants, the ethics votes and the provisions of the applicable data protection laws allow the storage of the research data in external data repositories or how they can best be made accessible.
- Subsequently, the data and metadata are uploaded by the researchers to external and secure repositories as agreed with the MF-DAC and referenced with a DOI.
- The MF-DAC then verifies compliance with the FAIR guiding principles and registers the data upload in the MF-DAC community of external data repositories.
Data Access Request
Third parties, so-called "Data Requesters" submit a request to the MF-DAC for access to sensitive research data produced by researchers of the USB and/or the Faculty of Medicine.
- The MF-DAC reviews the request for ethical and legal aspects, among others, and decides on access to the data.
- After approval and signing of a Data Transfer and Use Agreement, the MF-DAC organizes the secure transfer of the requested research data to the Data Requesters.
Reminder for researchers
For researchers, this means that they must not only publish and disseminate "their own" data, but that data from other studies can also be used for their own analyses. Until now, such reuse of research data was mostly possible only for their own studies or in the context of collaborations. This opens up opportunities for researchers to conduct their own analyses on further questions using existing data sets from external institutions.
GO FAIR is an international initiative to make health data FAIR (Findable, Accessible, Interoperable, and Re-usable).
The Faculty of Medicine Data Access Committee (MF-DAC).
Composition
- Claudia Saupper, DKF-Operations (specialist for data processing and coordination MF-DAC)
- Claudia Becherer, DKF-Operations(Regulatory Affairs)
- Dr. Thomas Gruberski (USB Legal Service)
- Prof. Dr. Matthias Briel (Clinical Epidemiology) and Dr. Robert Ivanek (Department of Biomedicine) (Independent Medical Experts)
If necessary, further experts can be consulted, e.g. persons from:
- Ethics Committees
- other disciplines
- Legal Services of the University of Basel
- Research and Analysis Services of the USB D&ICT
- Data Protection Officer of the University of Basel
Further information
GO FAIR Initiative: https://www.go-fair.org
Wilkinson et al, 2016: The FAIR Guiding Principles for scientific data management and stewardship
Contactmed-dac@clutterunibas.ch