PRIN 2022 - A Legal Framework and Feasibility Study for Open Access Biobanks
Advances in biomedical sciences and hygiene have caused a huge increase in longevity and well-being. People are living longer, but the corresponding increase in healthy life expectancy is significantly lower, which means that ill people are living with their disease for longer.
Despite the unprecedented insights provided by the use of animals for the advancement of biomedical studies, there are fundamental species-specific differences in architecture, metabolism, and susceptibility to exogenous compounds, which explains why such studies often fail to translate into human relevant data or clinical trials. Research on human-derived cells and tissue (HDCTR) is indisputably a mine of information to understand how our bodies work and how they get sick, to guide and validate translational research, to develop new models. But there are three main obstacles to surmount before HDCTR develops its full potential: i) a fragmented and inadequate legal framework; ii) the lack of common ground for supporting technical and public understanding of HDCTR applications and implications; iii) obstacles to the accessibility of data and samples.
The sharing of knowledge to speed up the response to COVID-19 has highlighted the importance of biobanks as common research infrastructures, along with a balanced approach between individual and collective health. Medical research would immensely benefit from a harmonised approach to the collection and preservation of HDCT, based on qualified OA to samples and data. At the same time, this approach would have an enormous impact also in social terms, encouraging the public empathy for sharing and collaboration in research for the benefit of humanity: A Legal Framework and Feasibility Study for Open Access Biobanks and Organoids (ALeF) is conceived as a contribution to this effort.
ALeF is an applied Law and Bioengineering Technology research project that brings together medical, legal and scientific expertise to enhance the development of new human-relevant models and institutional solutions to protect the interests of patients and create new knowledge. Its general object is the design of an overarching legal and scientific framework for the legitimate, safe, reliable, and sufficient supply of human-derived cells and tissue (HDCT) to research, based on the principle of non-discriminatory and qualified open access (OA). To reach this goal, ALeF will (A) identify the legal and ethical obstacles to human tissue research and biobanking; (B) design an appropriate scientific and regulatory framework; (C) conduct a feasibility study for OA brain biobanking.
ENTE PROMOTORE: Unione Europea - MUR
NOME PROGETTO: PRIN 2022 A Legal Framework and Feasibility Study for Open Access Biobanks; COD MUR: 2022TNRRT9
PERIODO E DURATA: 28/09/2023 – 27/09/2025
FINANZIAMENTO: Missione 4 “Istruzione e Ricerca” del Piano Nazionale di Ripresa e Resilienza ed in particolare la componente C2 – investimento 1.1, Fondo per il Programma Nazionale di Ricerca e Progetti di Rilevante Interesse Nazionale (PRIN) – del Piano Nazionale di Ripresa e Resilienza, dedicata ai Progetti di ricerca di Rilevante Interesse Nazionale - CUP J53D23005960006
COORDINATORE: Università degli Studi di Pisa
REFERENTI SSSA: Prof.ssa Erica Palmerini, Dott.ssa Viola Cappelli