While open research data (ORD) is widely considered as a core principle contributing to common knowledge, it raises complex legal issues in the field of sensitive and non-sensitive data alike. SIB has a longstanding role in the ORD landscape for life science data, and has developed legal know-how in this context. A paper published by SIB’s legal experts offers a map of the applicable legal rules in this field in Switzerland. It also provides a checklist of elements to consider before making data open for biomedical research.
From ORD incentives to implementation: a balancing act
Principles of open science, and of open research data in particular, are aimed at ensuring that discoveries resulting from public funding are shared and used in a way that maximizes their benefit to society. Initiatives promoting them are continuously emerging, both at the international (e.g. UNESCO) and national levels (e.g. Swiss National ORD Strategy). They are often implemented using incentive instruments, such as setting ORD goals as a funding condition in research proposals. However, in the context of biomedical data, encouraging ORD implies balancing data-sharing goals with the applicable legal rules. These may include data protection, professional secrecy, and/or intellectual property rights. “To date, little attention has been given to the topic from the Swiss law point of view,” says Frédéric Erard, Head of the Legal and Technology Transfer Office (LTTO) at SIB. “With this map of the applicable legal rules on ORD, we invite the Swiss legal community to continue exploring solutions that will help biomedical research move forward, while guaranteeing respect for participants' rights.”
A checklist for legal teams at research institutions
The paper considers the specific context of biomedical research, where data are often closely linked to individuals, making them “sensitive”. By setting out a series of questions and answers (e.g. “Are the data concerned covered by other legal regimes?”), the authors propose a checklist of elements to consider before opening data for biomedical research in order to adopt the best possible strategy.
Challenges arise for sensitive and non-sensitive data alike
In Switzerland, researchers can generally rely on the General Consent given by participants to reuse and share their health data for research purposes. But this nonetheless requires the adoption of a contractual framework ensuring respect for participants’ rights and data security. In the context of the Swiss Personalized Health Network (SPHN), contractual templates were drafted and made publicly accessible in close cooperation with SIB’s LTTO and Personalized Health Informatics group. This framework is enabling ambitious multicentric biomedical research projects, on paediatric research or oncology, for example.
Despite its less legally sensitive nature, the sharing of non-personal (e.g. anonymized) data for the purpose of medical research also requires a careful sharing strategy. An effective way of doing this is to attach free licences, such as Creative Commons Licences, to the data deposited. This is the case, for instance, with the SIB Resources, a portfolio of essential software and databases for the life sciences, which are aligned with open science goals and support data reuse through appropriate licensing (e.g. CC BY 4.0).
Erard F, Heusghem M, Parisato C, Recherche biomédicale et Open Data, Weblaw 2023.