Ethical Principles, Constraints, and Opportunities in Clinical Proteomics

Abstract

Recent advances in MS-based proteomics have vastly increased the quality and scope of biological information that can be derived from human samples. These advances have rendered current workflows increasingly applicable in biomedical and clinical contexts. As proteomics is poised to take an important role in the clinic, associated ethical responsibilities increase in tandem with impacts on the health, privacy, and well-being of individuals. We conducted and here report a systematic literature review of ethical issues in clinical proteomics. We add our perspectives from a background of bioethics, the results of our accompanying article extracting individual-sensitive results from patient samples, and the literature addressing similar issues in genomics. The spectrum of potential issues ranges from patient reidentification to incidental findings of clinical significance. The latter can be divided into actionable and unactionable findings. Some of these have the potential to be employed in discriminatory or privacy-infringing ways. However, incidental findings may also have great positive potential. A plasma proteome profile, for instance, could inform on the general health or disease status of an individual regardless of the narrow diagnostic question that prompted it. We suggest that early discussion of ethical issues in clinical proteomics can ensure that eventual health care practices and regulations reflect the considered judgment of the community and anticipate opportunities and problems that may arise as the technology matures.

iProX in 2021: connecting proteomics data sharing with big data

“…At present, all PX resources are committed to completely open data, which means there are currently no limitations for data reuse by the community ( 19 ). One increasingly relevant topic is whether proteomics data from human samples can be used to identify individuals and whether proteomics data may be considered personally identifiable information ( 19 , 20 ). The privacy risks of proteomics data may emerge, and this issue will need to be properly assessed and managed.…”

Advances and Utility of the Human Plasma Proteome

“…Mann et al introduced the four core principles of bioethics: autonomy, justice, nonmaleficence, and beneficence. 191 From a systematic literature review of "ethics and clinical proteomics", they identified 10 normative themes: standards and QC, integration of new laboratory and computer technologies, privacy, discrimination, conflicting rights and duties, beneficence and justice, incidental findings, regulation, international guidance, and clarity of goals. They emphasize a dichotomy between actionable and nonactionable test results.…”

Artificial intelligence for proteomics and biomarker discovery

“…That said, we have noted an increasing tension between the imperatives for data accessibility, as formalized in the FAIR principles (Wilkinson et al, 2016), and the desire for data privacy, such as embodied in the GDPR regulation of the European Union (Ducato, 2020) (Figure 5). This has only recently become an issue in proteomics as data quality has increased to an extent that it potentially allows (re)identification of individuals, which now raises ethical and philosophical questions (Geyer et al, 2021;Mann et al, 2021). It is important that the different stakeholders and authorities recognize these challenges and deal with them in a way that does not prevent scientific and medical progress.…”