ELSI resources

BioMedBridges - Legal Assessment Tool

As part of the BioMedBridge project a Legal Assessment Tool (LAT) was developed to help raise researcher awareness of the formal requirements for data sharing. The tool highlights areas that need further action from the researcher to make their data available, and issues prompts if expert advice is needed. A researcher can use the tool to learn more about requirements that cover the current legal framework for the European Union in the areas of data protection, data security, intellectual property and biosample security. It does not provide legally binding advice.

Figure 1 Legal Assessment Tool survey interface

A researcher is prompted to answer a series of multiple choice questions, including questions 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 his or her specific case and the tool recommends possible solutions or necessary further steps to make the data shareable.

You can learn more about the LAT in the User Guide and Tool Description document.

IPAC

IPAC, the International Policy interoperability and data Access Clearinghouse, is part of the Public Population Project in Genomics and Society (P3G) consortium, based in Montreal, Canada. IPAC provides a 'one stop' screening service for policy interoperability and access authorisation. These non-legal services advise on research policies and protocols for data access; deliver a database of generic clauses and agreements that can be used to build ELSI policy documents; offer assistance in developing documentation, consent forms, code of ethics and policies for data sharing; provide a review service for proposed policies and procedure documents; present services for creating Data Access Compliance Office (DACO) for customised projects.

Figure 2 IPAC homepage

REMS

REMS, the Resource Entitlement Management System, provides a tool for the administration of access rights to research data. It acts as a broker between research scientists and the holders of biomedical data. Users can apply for access to datasets of interest through an application interface. REMS then notifies the data custodian/s, as well as presenting the researcher with the documentation required for access.

Further information on REMS can be found on the REMS website. This includes leaflets, presentations, literature, a demonstration of the tool and information on the REMS software.

BBMRI Legal Wiki

The European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), and BioMedBridges partner, has created a wiki to provide a community resource for disseminating legal materials to the BBMRI community. It includes legal forms and standards, information on navigating legal pathways, and guidance on using legal templates. The BBMRI Legal Wiki is intended to foster discussion and the sharing of experiences by BBMRI members and partners, making it easier to access experience and expertise on a complicated subject.

 

BBMRI