Both the handling of data foreseen within RD-Connect and the broader environment of large-scale omics research in rare diseases has a substantial ethical component. In collaboration with patient and patient organisations, RD-Connect is developing and implementing best ethical practices for balancing patient-related interests associated with rare disease research using registries, biobanks and omics databases in global networks of clinicians and researchers. This includes:
- developing guidelines and standards for informed consent procedures
- producing standards for protection of personal data
- producing guidelines for effective and ethical data and sample sharing
As omics technologies change and develop rapidly it is vital to ensure there is a two-way dialogue between researchers and patients. RD-Connect will therefore include patients and patient organisations in all stages of the discussion:
- Patient Advisory Committee (PAC): will act to inform partners from RD-Connect, NeurOmics and EURenOmics of issues important to patients.
- Rare Disease Patient and Ethics Council (RD-PEC): will identify and examine ethical and social aspects of the work taking place in the context of RD-Connect, NeurOmics and EURenOmics to ensure that practical ethical issues are handled in a carefully planned process. The RD-PEC will work to address issues, concerns or dilemmas brought forth by the PAC as well as project partners.
The PAC and RD-PEC will seek to ensure that scientists incorporate into their work an understanding of patients’ hopes and expectations for the technologies and that those patients receive up-to-date information about the scope of RD-Connect. Such communication and inter-understanding should increase uptake and acceptance by providing technologies that meet patients’ needs.