Table 2.

Topics that should be covered by ELSI rare diseases funding calls, as indicated by IRDiRC funders. The topics are subdivided in categories, but many of the topics interact with different categories

Topics for ELSI rare diseases funding calls	Category
Data collection	• Privacy regulations (GPDR) and impact data collection for rare disease clinical studies • Integration of multiple sources of data • Data management plans • Access to rights
Data sharing	• Privacy • Equity of access • Quality of information and how it is disseminated • Best practices for cross-border data sharing compliant with ethics requirements and data protection laws
Challenges of living with a rare disease	• Economic analysis on burden of rare diseases • Compensation strategies put in place by the person with a RD and/or relative • Evaluation of the direct/indirect costs of living with a RD • Social life and citizenship • Decision making of people affected with RD • Health literacy • Knowledge/perception of disability by third party • Impact of a RD on siblings or the family • Impact of rarity of disease on life plan (including parenthood) • Assessment of specific situations of disruption in the health follow-up • Access to care
Consent and patient information	• Disclosure of information to family members • Informed consent • Protection of patient information • Protection of people in relation to specific vulnerabilities
Patient engagement	• Patient inclusion in design of research programs and their evaluation • Role of Patient Organizations in supporting families, supporting social participation • Collaboration of different stakeholders in health/social/medico-social fields • Access to learning