Clinical data reuse for research purposes is relevant to address the unmet clinical needs, but at the same time, secondary use of personal data is particularly challenging, especially in the case of research involving vulnerable populations, such as children.
As a human being, a child must also be guaranteed all the rights of a person, including the right to the protection of personal data!
The EU General Data Protection Regulation (GDPR) enables a new legal framework for the data protection and personal data processing.
In this framework, the article “The Secondary Use of Paediatric Data Under the EU General Data Protection Regulation: Looking for New Safeguards for Research“ was published on the European Pharmaceutical Law Review by Annagrazia Altavilla, from Espace Éthique PACA CORSE – France, in collaboration with Jean Herveg from Namur University, Viviana Giannuzzi, Annalisa Landi and Adriana Ceci from Fondazione Gianni Benzi.
The work analyses the GDPR provisions with the aim to verify if paediatric specificities are taken into account by the Regulation and if GDPR provides adequate and clear rules to favour the secondary use of paediatric data for research purpose in international contexts.
The analysis points out the lack of specific provisions covering paediatric peculiarities in the rules introduced by the GDPR, particularly for the secondary use of data in international research projects. For this reason, it underlines the importance to develop new overall governance of personal data processing for health research in order to reduce the risk of infringements of fundamental and child’ rights.
Fondazione Gianni Benzi has already addressed this topic and the results of this study were discussed in the article “A Review on Impact of General Data Protection Regulation on Clinical Studies and Informed Consent” that you can read here.
Considering the children vulnerability, all the activities addressed to them shall receive specific attention, including also the data processing!
You can find the article here.