D1.3 Ethics and Gender Guidelines

The CARAMEL (CArdiovascular Risk Assessment via multimodal data analysis enabling personalised prevention strategies targeting MEnopausaL women) project aims to address the urgent clinical need for improved CVD prevention in women, particularly around menopause when the risk significantly increases. The "Ethics and Gender Guidelines" present the legal, ethical, and gender considerations crucial for the project's implementation. This document provides practical guidance to ensure compliance with legal obligations, promote ethical conduct, and integrate best practices in gender and research integrity. The guidelines cover key areas including GDPR, AI Act, Medical Device Regulation, European Health Dataspace Regulation, ethical research frameworks, data management, and gender considerations in research, including addressing sex and gender bias. A Gender, Legal, Ethics, Data (GLED) Committee will monitor and report on relevant issues throughout the project's duration.
The drafting of the Ethics and Gender Guidelines has been coordinated by DCU as Task Leader of Task 1.4 within WP1, devoted to “Legal, privacy and ethics compliance”, co-authored by TLX (Legal Guidelines) and TCD (Gender Guidelines), with the contributions from all partners including the members of the Gender, Legal, Ethics and Data (GLED) Committee.
CARAMEL’s Ethics and Gender Guidelines represent Deliverable 1.3 as described in the Description of the Action (DoA).
The objective of this deliverable is to provide legal, ethical and gender guidelines that will define simple and practical pointers during the implementation of the project, support compliance with underlying legal obligations and promote the adoption of best ethical, gender and research integrity practices. 

DISCLAIMER

This deliverable has been submitted to the European Commission for review. The content of this document reflects only the author's view and the Commission is not responsible for any use that may be made of the information it contains.