Abstract
Abstract
Background
Europe’s General Data Protection Regulation, or GDPR, is a set of data protection rules on the acquisition, storage, use, and access of personal data. GDPR came into effect in May 2018 when it was introduced across all 27 European Union (EU) member states and the European Economic Area (EEA). Maintaining compliance with this legislation has presented significant new challenges for ongoing clinical research.
Aims
To evaluate the knowledge and expectations of patients and doctors regarding GDPR and implications for future clinical research.
Methods
An anonymous 12-item questionnaire was circulated to patients and doctors at a University Teaching Hospital. Data analysis included descriptive statistics.
Results
Five hundred nine participants were included: 261 females (51.3%) and 248 males (48.7%). Three hundred fifty were patients (68.8%) and 159 were doctors (31.2%). Three hundred thirty-four participants were aware of GDPR (65.7%): 116 doctors (73.0%) and 218 patients (62.3%, P = 0.018). 71.1% of doctors were willing to allow their personal data to be processed anonymously as part of a clinical research project compared to 43.4% of patients (P < 0.001). 80.2% of patients believed explicit consent is needed before using personal data in clinical research in comparison to 60.4% of doctors (P < 0.001). Level of education impacted awareness of GDPR (P < 0.001); a higher level of education among patients increased GDPR familiarity (P < 0.001), however failed to impact doctor familiarity (P = 0.117).
Conclusion
GDPR has introduced complexity to the processing and sharing of personal data among researchers. This study has identified differences in the perception of GDPR and willingness to consent to data being used in clinical research between doctors and patients. Measures to adequately inform prospective research participants on data processing and the evolving landscape of data protection regulation should be prioritised.
Funder
National University Ireland, Galway
Publisher
Springer Science and Business Media LLC
Reference28 articles.
1. Union E (2019) The EU General Data Protection Regulation (GDPR) is the most important change in data privacy regulation in 20 years. [Available from: https://eugdpr.org/
2. Regulation EU (2016) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing. Directive 95/46/EC (General Data Protection Regulation)
3. Chico V (2018) The impact of the general data protection regulation on health research. Br Med Bull 128(1):109–118
4. Clarke N, Vale G, Reeves EP et al (2019) GDPR: an impediment to research? Ir J Med Sci 88(4):1129–35
5. Dale H (1950) Scientific method in medical research. BMJ 2(4690):1185
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
1. EU Legislation and Health Data Protection;GDPR Requirements for Biobanking Activities Across Europe;2023