On 5 August 2025, a new ethics and regulatory study has been published on Health Research Policy and Systems. It derives from the main contribution of Fondazione Benzi to INHERENT, an international network which aims at investigating genetic modifiers in paediatric and adult patients with haemoglobinopathies.

In this new publication, Fondazione Gianni Benzi researchers – namely Antonella Didio, Viviana Giannuzzi, Fedele Bonifazi and Sabina Sblano – collaborated with colleagues from the Boston Children’s Hospital in Boston, Kaduna State University in Nigeria, New York University School of Global Public Health and The Cyprus Institute of Neurology & Genetics. Through a collaborative research, the review of international documents and a survey conducted in 32 countries worldwide, they outline the essential ethical and regulatory framework for conducting multinational, researcher-driven genetic studies on humans.

Building on this, 33 international documents on data processing, clinical research and biospecimen management were identified from grey literature and used as standard references. In addition, the survey gathered national laws, guidelines and recommendations covering the same areas, which revealed notable differences across geographical regions. The paper also highlighted the absence of a unique reference framework for genetic studies without investigational drugs, i.e. outside the scope of Good Clinical Practice, and that there are discordances at national level regarding the requirement to get approval from the ethics committees.

In this framework, authors point out that this fragmentation can challenge the scientific community and slow down the start and implementation of clinical studies, crucial for public health. Hence, their call for greater harmonisation of rules, to facilitate international collaboration while ensuring the protection of participants.

Read the article here.