Abstract
Scientists and clinicians are starting to translate genomic discoveries from research labs to the clinical setting. In the process, big data genomic technologies are both a risk to individual privacy and a benefit to personalized medicine. There is an opportunity to address the social and ethical demands of various stakeholders and shape the adoption of diagnostic genome technologies. We discuss ethical and practical issues associated with the networking of genomics by comparing how the European Union (EU) and North America understand and practice notions of privacy and consent in research. An overview of international policy suggests the embedding of genomics within digital networks and the Internet creates conditions that challenge the management of privacy and consent in the age of big data. The risks of re-identification, informational harms, and data security vulnerabilities are issues that need to be better addressed in the clinical setting to reconcile the unpredictable pathway of research and practice in the networked information society.
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Abbreviations
- ACMG:
-
American College of Medical Genetics and Genomics
- CalGINA:
-
California Genetic Information Nondiscrimination Act (2012)
- CLIA:
-
US Clinical Laboratory Improvements Act (1988)
- CMA:
-
Canadian Medical Association
- CMS:
-
US Centers for Medicare and Medicaid Services
- DNA:
-
Deoxyribonucleic acid
- DTC:
-
Direct-to-consumer
- FDA:
-
US Food and Drug Administration
- GE3LS:
-
Genomics and its related Ethical, Environmental, Economic, Legal, and Social aspects
- GINA:
-
US Genetic Information Nondiscrimination Act (2008)
- GWAS:
-
Genome-Wide Association Studies
- HHS:
-
US Department of Health and Human Services
- HIPAA:
-
US Health Insurance Portability Accountability Act (1996)
- ISP:
-
Internet Service Provider
- IVD:
-
In-vitro diagnostics
- LDT:
-
Laboratory-developed test
- NHS:
-
UK National Health Service
- NIH:
-
US National Institute for Health
- PGS:
-
23andMe’s proprietary Personal Genomics Service
- PHG:
-
Public Health Genomics (UK)
- PIPEDA:
-
Canada’s Personal Information Protection and Electronic Documents Act (2000)
- SACHRP:
-
US Secretary Advisory Committee on Human Research Protections
- UNESCO:
-
United Nations Educational, Scientific and Cultural Organization
- WGS:
-
Whole Genome Sequencing
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Chow-White, P.A., MacAulay, M., Charters, A. et al. From the bench to the bedside in the big data age: ethics and practices of consent and privacy for clinical genomics and personalized medicine. Ethics Inf Technol 17, 189–200 (2015). https://doi.org/10.1007/s10676-015-9373-x
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DOI: https://doi.org/10.1007/s10676-015-9373-x