đ§ EAP Welcomes the Updated Declaration of Helsinki
The European Academy of Paediatrics (EAP) has issued a formal statement in response to the 2024 update of the Declaration of Helsinki, the foundational international document outlining ethical principles for medical research involving human participants.
EAP welcomes the enhanced focus on participant involvement, transparency, and fairnessâparticularly the updated provisions on ongoing consent, protection of vulnerable populations, diversity in research ethics committees, and environmental sustainability.
However, EAP also urges greater nuance and inclusion in future revisions, especially regarding paediatric research, where rigid consent processes and assumptions about vulnerability may hinder vital studies.
đ Read the full EAP response here
EAP remains committed to promoting ethical, inclusive, and impactful research that advances the health of all children across Europe and beyond.
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. COREâMD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patientsâ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
