Ethical, Legal and Social Issues (ELSI)

Sharing sensitive health and genomic data for research reuse raises many ethical, legal and social questions.

To address them, RD-Connect ELSI experts in collaboration with patients and patient organisations, have developed best ethical practices that protect patient privacy without hindering research. This includes:

  • guidelines and standards for informed consent procedures
  • standards for protection of personal data
  • guidelines for effective and ethical data and sample sharing

As omics technologies develop rapidly, researchers and patients must work together to find optimal solutions that protect patient privacy without creating obstacles for research, diagnostics and therapy development. Therefore, RD-Connect and its partnering research projects NeurOmics and EURenOmics include patients and patient organisations in all stages of the discussion:

Within RD-Connect, the work on ELSI is led by the team at the Uppsala University in Sweden.

Patient Advisory Council (PAC)

Informs partners from the three projects of issues important to patients.

Rare-Disease Patient and Ethics Council (RD-PEC)

Identifies and examines ethical and social aspects of the work of the three projects to ensure that practical ethical issues are handled in a carefully planned process. The RD-PEC addresses issues, concerns or dilemmas brought forth by the PAC and by project partners.

The PAC and RD-PEC aim 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.

To provide guidance for effective legally and ethically grounded sharing, RD-Connect has developed the International Charter of Principles for Sharing Bio-specimens and data as well as a template for general Material and Data Transfer Agreement (MTA and DTA). The RD-Connect Code of Practice ensures that all data on the RD-Connect Platform are shared according to legal requirements, ethical principles as well as patient and scientific needs.