The European Network of Research Ethics Committees (EUREC) has issued a position paper addressing the ethical considerations surrounding the compensation of research participants. This important document, adopted in June 2024, outlines the principles and guidelines to...
The European Commission has released new guidance, namely “Clinical evaluation of orphan medical devices”, aimed at facilitating the clinical evaluation of orphan medical devices. Orphan devices are designed to treat rare diseases affecting no more than 12,000...
On 3 May 2024, the European Medicines Agency (EMA) has issued a "Reflection Paper on Use of Real-World Data in Non-Interventional Studies to Generate Real-World Evidence". It explores opportunities to harmonise the use of real-world data (RWD) to generate real-world...
Privacy protection in scientific research is a crucial issue that is constantly evolving due to technological advances and new ethical challenges. In Italy, Article 110 of Legislative Decree 101/2018, which transposes the GDPR, has undergone recent amendments that...
Two new papers featuring our researcher Annalisa Landi as one of the authors and released in the framework of the European Joint Programme on Rare Diseases (EJP RD), have been published in the journal Nature. These papers propose a new way to responsibly share...
On 13 March the European Parliament adopted the world’s first binding law on artificial intelligence (AI). This legislation sets out clear guidelines for the use of AI technologies, aiming to ensure their responsible and ethical deployment. More specifically, the law...
On 10 April 2024 , the European Parliament has adopted its position on the EU pharmaceutical reform. The new pieces of EU law come from the "pharmaceutical package" proposed by the European Commission in April 2023 to amend EU pharmaceutical laws. This package aimed...
On 18 January, the World Health Organization (WHO) has released a new guidance document aimed at governing the ethical utilisation of Large Multi-modal Models (LMMs) in healthcare. Unlike conventional AI models, LMMs can process various forms of data inputs and...
The article “The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries” has been published in the journal Frontiers in Medicine on April 17,...
The conference “La salute nel tempo della malattia”, organised by APS Bottega del Sorriso, will be held in Bari on Saturday, April 13, 2024 at the IRCCS Istituto dei Tumori "Giovanni Paolo II" conference room. The event represents the end of the project “Tumore ma non...
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