Protecția datelor cu caracter personal ale participanților la studiile clinice
Protection of the personal data of the participants in clinical trials

Summary/Abstract: Given that the new General Data Protection Regulation has influenced most of the industrial sectors, new challenges in life science area have also been generated, particularly those regarding the effective protection of the personal data of the patients – subjects to clinical trials. The new changes focus mainly on how data and the rights of the data subjects are perceived by these persons, as well as the controllers and processors. This study aims to identify and determine the impact of this regulation on clinical trials and patient engagement policies, having also into consideration the derogations from the rights of data subjects for the purpose of scientific research. Also, we seek to define concepts such as sensitive data, health data, clinical trial data, the obtained results following the clinical trials, data processing, as well as notions related to the parties involved – either the patients or CROs (contract research organizations) understood through the meaning of the terms of natural person or controller, processor, recipient respectively. We want to clarify to what extent the clinical trials can be included in the scientific research that the Regulation refers to and whether its application in this area makes a distinction between the goals of the research: either the one of profit-making or the one of developing the medical knowledge. Another issue that we are pursuing in this study is the processing of personal data in the aforementioned field having in mind the data processing principles, the rights of the data subject and the derogations that apply in the case of scientific research. The present analysis will be carried out by taking into account the following four steps: the time of the selection of the participants in the clinical trial, the time after the completion of the list of subjects, the stage of the clinical trial itself and the moment of the study results. Under no circumstances should the General Data Protection Regulation become an impediment to technological advances in the medical field and the initiation of scientific research in the pharmaceutical area. The general and imperative nature of this regulation must be adapted to the primary public interest for public health at the European level.

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