Uncertainty about ethical and legal requirements with respect to sensitive data – such as personally identifiable data – is one of the most important barriers to data sharing. Aimed at researchers with limited or no background or experience with these formal requirements, this tool aims to clarify if and how sensitive data can be shared, or when additional actions or expert advice are needed.
The requirements relate to regulations in the following areas applicable in the European Union:
- data protection
- data security
- intellectual property
- biosample security
The tool aims to raise awareness of formal requirements when sharing data with Ethical, Legal and Societal Implications (ELSI). It highlights areas that need further action from the researcher making the data available (the “data provider”) or issues alerts when further expert advice may be needed.
The tool covers the current legal framework in the European Union concerning four areas: data protection, data security, intellectual property and biosample security.
How to use this tool
Users are guided through a series of multiple choice questions where they are asked for example about the type of data they want to share (metadata, text data, images, genetic data, biosamples or biosample associated data), the form in which the data is provided (data from which individuals can be identified or pseudonymised/anonymised data), or possible limitations on the wider use of the data (e.g. intellectual property requirements). After providing the necessary information, the user is shown the applicable rules and regulations for their specific case and the tool recommends possible solutions or necessary further steps to make their data shareable.
- Tool for assessment of regulatory and ethical requirements
- USER GUIDE and DESCRIPTION: Tool for assessment for legal and ethical requirements
- WORKSHOP REPORT: Supporting researchers using sensitive data
- Sariyar Murat, Schluender Irene, Smee Carol, and Suhr S. (2015) Sharing and Reuse of Sensitive Data and Samples: Supporting Researchers in Identifying Ethical and Legal Requirements. Biopreservation and Biobanking, doi:10.1089/bio.2015.0014