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, 2024.
This work originated as part of the EJP RD – European Joint Programme on Rare Diseases project, of which Fondazione Gianni Benzi onlus is a partner, and in collaboration with the European Reference Networks (ERNs).
The objective of this work was to develop an adaptable informed consent form for research purposes to be used for ERNs Rare Disease patients’ registries in a heterogeneous regulatory environment and enabling machine readability.
The outcomes of this work not only aim to promote harmonized practices and facilitate the secondary use of health data in general, but also provide adaptable templates. Furthermore, these outcomes can assist the Registry Data Access Committees by offering a more transparent view of patients’ preferences regarding the use of their data. It is highly valuable for the Rare Diseases community and holds potential for extension and application to other disease communities.
The article is available here.