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ethics | BioMedBridges


Supporting researchers sharing sensitive data: identifying requirements

Legal and Ethical Requirements Assessment Tool - LAT

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.

Supporting researchers using sensitive data - BioMedBridges workshop

Organised by the BioMedBridges partners from TMF, technical staff, legal and ethics experts met on 30 June in Berlin to discuss how best to support life science researchers who need to use sensitive data and/or biosamples. Presentations outlined current and proposed EU data regulations, and synergies between existing resources that aid researchers in navigating various local, national, European and international legislation were explored.

ED1: The Ethical Governance Framework for BioMedBridges

The objective of the BioMedBridges project is to better enable researchers to access data, increasing its utility with the ultimate goal of benefiting society, for example by facilitating new discoveries in health research and by allowing re-analysis of expensive, rare or unrepeatable investigations, while continuing to protect the interests of research participants with regard to their privacy and confidentiality. The BioMedBridges Ethical Governance Framework sets out policies for the project that specifically relate to ethical and regulatory issues with regard to the access of data used within the project. The aim of the framework is to enable the BioMedBridges project to operate within agreed terms with respect to participant consent, ethics committee approvals and national regulations, ensuring researchers supply and access data based on a common ethical framework focussing on specific issues that are key to the development and operation of BioMedBridges. As the project evolves, adjustments may be made to this framework. Any adjustments will be developed and agreed by the Ethical Governance Committee and approved by the Executive Steering Committee. Together with the Independent External Ethics Adviser and in the context of deliverable 5.2 "Tool for assessment of ethical and regulatory requirements", project partners have also developed suitable participant information sheets and consent templates.
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