A distributed infrastructure for life-science information
Re-using life-science data ethically
ELIXIR adopts overarching policy for ethical and legal aspects of accessing and re-using sensitive life-science data
Clear ELSI governance is an integral part of the provision of ELIXIR Services, so it is a major milestone that ELIXIR’s ELSI Policy was approved by the ELIXIR Board this week. The policy, which covers so-called Ethical, Legal and Societal Issues (ELSI) around the provision of sensitive human data for use in research, provides guidance on key principles and clarifies how these will be handled in the context of ELIXIR Services.
ELIXIR Services offer data for secondary use - they do not produce data and, in the case of human data, are not involved in getting informed consent from research participants. Their role centres around data stewardship as a service to both data generators and researchers.The ELIXIR ELSI Policy supports the process of making scientific data available in an ethically and legally sound manner by consolidating requirements that are shared across all ELIXIR Members and Services.
ELIXIR is a distributed infrastructure with organisationally independent Nodes; ELIXIR Services are delivered by institutes associated with the Nodes in ELIXIR’s Member countries. Each ELIXIR Service must have its own ethics and regulatory oversight in place as the complexity and diversity of regulations around data can vary significantly between or even within individual countries. This means that the necessary knowledge and expertise concerning these requirements must sit locally with the Service provider.
The ELIXIR ELSI Policy, which was developed in consultation with the ELIXIR Heads of Nodes and technical personnel, Ethics Experts on the ELIXIR Scientific Advisory Board and external experts, addresses the concerns of key stakeholders such as ethics committees and ethics advisory boards (e.g. of large projects), funders, data providers, data users and patients or patient groups.
As it defines a model that clarifies the specific responsibilities of databases or services offering human data for secondary use, the ELIXIR Ethics Policy is likely also to be of interest to other research infrastructures and database providers currently going through the process of assessing or developing their own policies.