Impact of the General Data Protection Regulation on Clinical Proteomics Research

Abstract

The recently implemented General Data Protection Regulation (GDPR) has promising attributes for ensuring the protection of personal data collected and processed for clinical proteomic investigations. However, there exist ever increasing alarming concerns regarding its implications upon the future of clinical proteomics research both within and beyond the European Union. The main issues of concern regard GDPR legislative requirements for informed consent for study subjects' data collection and processing, data anonymization, and data storage and/or sharing, particularly in research areas which readily utilize databanks and biobanks, such as clinical proteomics investigations. The potential impacts of the aforementioned issues upon on-going and future clinical proteomics investigations are detailed, whilst recommendations for potentially resolving these emerging issues are proposed. Consensus between government, legislative, and research stakeholders, as well as impact assessments of final measures to be applied for medical research, is necessary so as to ensure the favorable perpetuation of clinical proteomics investigations and subsequent impact upon optimal patient health.

Ethical Principles, Constraints, and Opportunities in Clinical Proteomics

“…The need to keep up to date with technological and scientific advances in related fields, notably other omics, to facilitate interoperability and efficiency was mentioned in five studies ( 32 , 33 , 34 , 35 , 36 ). One article proposed the use of blockchain technologies for transparent and secure data access management ( 32 ).…”

“…Eight articles noted that duties owed to patients and/or individuals may conflict with duties owed to scientific advancement ( 32 , 36 , 37 , 38 , 39 , 40 , 41 , 42 ). One example is where data anonymization could be employed to maximize the privacy of patients but would also create significant problems for research involving data linkage ( 36 ). Eight of the included studies noted a potential ethically relevant distinction between studies funded by or pursued for the sake of private interests versus publicly funded research.…”

Datasharing: Obsolete? Impossible in times of GDPR ? Or mandatory in science?!

“…This situation has recently substantially worsened, as a result of the introduction of the general data protection rule (GDPR) in Europe, which is echoed by similar yet not as detrimental legal frameworks in other countries. The introduction of GDPR, while theoretically likely starting from the positive aim to protect individuals from exploitation, by now has had a severe negative impact on science (and likely also on other areas, not the topic of this article) 1 . GDPR has been (ab)used to refuse sharing of raw data.…”

Beyond Genes: Re-Identifiability of Proteomic Data and Its Implications for Personalized Medicine

“…One could argue that the remaining SAPs are too few and/or of too poor quality to conclusively pose identification risks, but this remains to be investigated. Critselis E. recently proposed to submit batches of pseudonymized data instead of individual data [49], but this would only work if the relation between the SAPs is removed completely. This means that MS/MS spectra of all experiments would be submitted as a whole (so processed data, not raw data), and the identifications and accompanying FDR estimations are done experiment instead of sample wise.…”