It could not be missed the last months; the introduction of the new General Data Protection Regulation (GDPR) or in Dutch ‘Algemene Verordening Gegevensbescherming (AVG)’. Many fields, including our medical research field, are impacted by this regulation. Since the introduction of this regulation at the 25th of May, we have to be much more careful with our patient data.
In this new regulation, privacy rights are strengthened and extended, and organizations have more responsibilities in the collection and processing data. The GDPR is all about ‘personal data’ and in medical research, we collect a lot of this type of data. All data that can be traced to a person is categorized as personal data. Also, patient data that is encrypted, for example with study number, is personal data as it is indirectly traceable to the patient. The GDPR does not apply on personal data that is completely anonymized and therefore no longer traceable to a person. But high demands are placed on anonymization and most of the research is therefore not anonymized and thus contains personal data.
But what kind of measures do we have to take for our research to make it GDPR-prove? Most important is that the patient is well informed about the research project and specific about data processing and his/her privacy rights. So, if you work on a research project or going to start a new research project: take some time to investigate the implications of all (new) regulations for your research. The website of AMC and VUmc medical ethical committee is very helpful. Also www.ccmo.nl provides you a lot of information.
Do not let all the regulations keep you away from doing research. Performing and publishing research is still possible! In this new AMSj edition, S. Verhaart published a second part about the safety and efficacy of checkpoint inhibitors in the treatment of cancer. In continuation to the previous published part about CTLA-4 checkpoint inhibitors, she now reviewed the safety and efficacy of PD-1 checkpoint inhibitors. Three subject 101’s about respectively Amyotrophic Lateral Sclerosis, the HELLP syndrome and Calcium and phosphate homeostatis are included in this edition. Furthermore, we present you an extra comprehensive radiology image. We hope you enjoy reading this 12th edition of AMSj.