PROTECȚIA DATELOR CU CARACTER PERSONAL ALE PARTICIPANȚILOR LA STUDIILE CLINICE

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.