WP8 will map the critical ethical, legal and social issues which arise from creating a real-world evidence platform, re-using the existing health data and pooling data from different data sources. WP8 also addresses ethical concerns and topics arising during the course of the project.

Overall objective: Develop an ELSI framework with extensive patient involvement for the development and application of RWE in AD (WP8)
Read more about the work of our Ethical, Legal and Social Implication team here.

Objectives

• Map the requirements and critical issues for an ELSI framework for an RWE platform for AD.
• Establish and manage an Ethics Advisory Board (EAB) to identify ethical and legal issues embedded in data integration tools developed by ROADMAP, and the recommendations for an RWE platform for phase 2 of the ROADS call.
• Review of ethical issues in sensitive medical data re‐purposing and pooling for UC1, UC2 and UC3, including assessment and integration of prior work on the ethical and legal governance of biobanks and other biomedical Big Data platforms, as well as empirical studies of AD patient and carer attitudes towards an RWE approach and ethics and privacy challenges for an RWE approach in AD introduced by the EU General Data Protection Regulation.
• Conduct stakeholder focus groups on ELSI issues arising in a RWE approach to inform UC1, UC2 and UC3.
• Provide input on WP2, WP5 and WP7 stakeholder engagement activities concerning ethical dimensions of social outcomes (e.g. quality of life measurements) arising in developing the preference matrix.