General-Purpose Privacy Regulation and Translational Genomics

McGeveran, William; Schmitz, Caroline

doi:10.1177/1073110520917002

Cited by 3 publications

(3 citation statements)

References 6 publications

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“…The GDPR serves as the basis for similar legislation in other countries, including Israel, Brazil, and Japan ( 61 ). Although frequently not observed in practice, in principle, US regulations also provide for an individual right to access ( 62 ).…”

Section: Additional Perspectives On Bioethics and Clinical Proteomicsmentioning

confidence: 99%

“…Although frequently not observed in practice, in principle, US regulations also provide for an individual right to access ( 62 ). National and US state laws and regulations vary and may provide greater or lower levels of protection depending on the national implementation of European Union and federal regulations ( 61 , 63 ). Table 1 lists several relevant regional, international, and professional instruments ( 64 ).…”

Section: Additional Perspectives On Bioethics and Clinical Proteomicsmentioning

confidence: 99%

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Ethical Principles, Constraints, and Opportunities in Clinical Proteomics

Mann

Treit

Geyer

et al. 2021

Molecular & Cellular Proteomics

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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.

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Section: Additional Perspectives On Bioethics and Clinical Proteomicsmentioning

confidence: 99%

Section: Additional Perspectives On Bioethics and Clinical Proteomicsmentioning

confidence: 99%

Ethical Principles, Constraints, and Opportunities in Clinical Proteomics

Mann

Treit

Geyer

et al. 2021

Molecular & Cellular Proteomics

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“…In the absence of widely accessible genomics services via national healthcare systems, DTC companies have generated a market and grown rapidly, leading to decreased costs and increased access to genetic tests [67]. However, governments today remain unable to monitor or quantify DTC testing effectively and are limited in their ability to regulate it [27].…”

Section: Snir (2020)mentioning

confidence: 99%

The implementation of large-scale genomic screening or diagnostic programmes: A rapid evidence review

et al. 2022

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Genomic healthcare programmes, both in a research and clinical context, have demonstrated a pivotal opportunity to prevent, diagnose, and treat rare diseases. However, implementation factors could increase overall costs and affect uptake. As well, uncertainties remain regarding effective training, guidelines and legislation. The purpose of this rapid evidence review was to draw together the available global evidence on the implementation of genomic testing programmes, particularly on population-based screening and diagnostic programmes implemented at the national level, to understand the range of factors influencing implementation. This review involved a search of terms related to genomics, implementation and health care. The search was limited to peer-reviewed articles published between 2017–2022 and found in five databases. The review included thirty articles drawing on sixteen countries. A wide range of factors was cited as critical to the successful implementation of genomics programmes. These included having policy frameworks, regulations, guidelines; clinical decision support tools; access to genetic counselling; and education and training for healthcare staff. The high costs of implementing and integrating genomics into healthcare were also often barriers to stakeholders. National genomics programmes are complex and require the generation of evidence and addressing implementation challenges. The findings from this review highlight that there is a strong emphasis on addressing genomic education and engagement among varied stakeholders, including the general public, policymakers, and governments. Articles also emphasised the development of appropriate policies and regulatory frameworks to govern genomic healthcare, with a focus on legislation that regulates the collection, storage, and sharing of personal genomic data.

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