Ethics

Regulatory Compliance

The SENSOPAD project places a strong emphasis on regulatory compliance, particularly given the sensitive nature of the Point of Care (PoC) device being developed. A comprehensive regulatory strategy will be established, addressing all aspects of the device, including its cartridge, functional components, and associated software application. Project partners will identify the elements subject to the relevant EU regulatory frameworks and develop an adaptive strategy to ensure compliance with the General Safety and Performance Requirements of SENSOPAD. Throughout the project, compliance of all developed systems and components will be monitored meticulously, with special attention paid to AI and software development standards.

Research Ethics & Bioethics

SENSOPAD plans to involve patients, on a voluntary basis, in order to collect menstrual samples that will serve as a means of verifying the functionality of the SENSOPAD. NTUA will oversee the protocols implemented by partners involving human participants, ensuring adherence to international, supranational, and national legal and ethical frameworks. The project will address ethical, social, and legal aspects (ELSA) related to its technological advancements by employing a Health Technology Assessment (HTA) approach, ensuring that the project’s outcomes are aligned with Responsible Research and Innovation (RRI) principles.

Research Integrity

In alignment with its commitment to ethics and open science, SENSOPAD will use a transparent approach to facilitate the reproducibility of its experiments and the reproduction of calculations based on raw data from original studies.

In addition, SENSOPAD has appointed a dedicated Ethics Advisor that will assist the consortium in identifying, organizing, and monitoring all ethics issues and related documents, with special attention to the development of AI.