GENETIC DATA IN PUBLIC RESEARCH DATABASES: WHICH GOVERNANCE MECHANISMS SHOULD APPLY?

This workshop aims to 1) explore ethical and legal challenges that may arise when researchers are required to deposit genetic and genomic research data in public research databases, and 2) investigate governance mechanisms that may support ethically and legally compliant data deposit.

Data sharing is necessary to facilitate research on genetic and molecular mechanisms underlying disease. Increasingly, research funders encourage or require that researchers deposit their data (including genotype, phenotype and raw sequence data) in public research databases. The data can then potentially be used for an unlimited number of privately or public-funded research projects, nationally and internationally. Data sharing requests may in some cases be designed as a trade-off. For instance, the funder may agree with a biobank to sequence biological samples at no cost if the data produced are stored in a public research database. Such agreements can be appealing for institutions battling with funding shortages.

Genomic data sharing through public research databases raises ethical and legal questions we aim to explore. Current governance mechanisms and consent procedures primarily rely on the assumption that researchers are able to keep track of how their data is shared and used at any point in time. For instance, researchers have obligations to establish MTAs, DTAs, and inform their research participants about potential uses. However, if the data is deposited in public research databases where the original body loses control over data uses, this may mean that the researchers may not be able to satisfy such obligations and that current governance mechanisms are no longer suitable to protect participants’ rights. Current data deposit practices require clarification regarding a number of issues. For instance, indefinite data sharing for a multitude of purposes poses a legal challenge. Also, few guidelines exist to inform researchers on how to inform research participants about data sharing. Furthermore, accountability mechanisms which address potential issues of data privacy breaches are largely missing, despite recent requirements by the OECD to implement such mechanisms.

What are the ethical and legal aspects such databases pose? Are there mechanisms that may support data sharing while promoting better transparency and accountability? How can the ELSI community contribute to develop such mechanisms? National authorities, funding bodies, research database representatives, and legal and ethical researchers will be invited to explore and address these issues during the workshop.

Programme and further details