The role of scientific self‐regulation for the control of genome editing in the human germline

Gregorowius, Daniel; Biller‐Andorno, Nikola; Deplazes‐Zemp, Anna

doi:10.15252/embr.201643054

Cited by 14 publications

(11 citation statements)

References 9 publications

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“…We hope this discussion can serve as a first step toward serious scientific self-regulation in the proteomic community, which is acceptable to regulators and society, as has happened with recombinant DNA techniques at the Asilomar conference already in 1975 ( 48 ), and as is currently being attempted in the context of editing the human germline ( 49 ).…”

Section: Discussionmentioning

confidence: 99%

Plasma Proteomes Can Be Reidentifiable and Potentially Contain Personally Sensitive and Incidental Findings

Geyer

Mann

Treit

et al. 2021

Molecular & Cellular Proteomics

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The goal of clinical proteomics is to identify, quantify, and characterize proteins in body fluids or tissue to assist diagnosis, prognosis, and treatment of patients. In this way, it is similar to more mature omics technologies, such as genomics, that are increasingly applied in biomedicine. We argue that, similar to those fields, proteomics also faces ethical issues related to the kinds of information that is inherently obtained through sample measurement, although their acquisition was not the primary purpose. Specifically, we demonstrate the potential to identify individuals both by their characteristic, individual-specific protein levels and by variant peptides reporting on coding single nucleotide polymorphisms. Furthermore, it is in the nature of blood plasma proteomics profiling that it broadly reports on the health status of an individual—beyond the disease under investigation. Finally, we show that private and potentially sensitive information, such as ethnicity and pregnancy status, can increasingly be derived from proteomics data. Although this is potentially valuable not only to the individual, but also for biomedical research, it raises ethical questions similar to the incidental findings obtained through other omics technologies. We here introduce the necessity of—and argue for the desirability for—ethical and human-rights-related issues to be discussed within the proteomics community. Those thoughts are more fully developed in our accompanying manuscript. Appreciation and discussion of ethical aspects of proteomic research will allow for deeper, better-informed, more diverse, and, most importantly, wiser guidelines for clinical proteomics.

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Section: Discussionmentioning

confidence: 99%

Plasma Proteomes Can Be Reidentifiable and Potentially Contain Personally Sensitive and Incidental Findings

Geyer

Mann

Treit

et al. 2021

Molecular & Cellular Proteomics

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“…The genomics world has learned that it is important to engage patients and patient advocates and their organizations, not just rely on health professionals to determine what is presumed to be best for the patients ( 86 ). Moreover, the experience of genomics demonstrates that professional discussions of ethical issues in clinical proteomics can benefit from the perspectives of social scientists, lawyers, ethicists, and humanists ( 87 ). We believe the gap in the extant literature represents an opportunity for participation by our community.…”

Section: Discussionmentioning

confidence: 99%

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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“…That remains an option for human gene editing, and indeed, as discussed below, there is already at least one existing treaty that applies to heritable genome editing. Generally, though, international governance has moved away from treaties as the primary instrument of harmonization, due to the major commitments of time, resources, and efforts needed to negotiate, implement, and enforce treaties (51,75). A variety of other instruments, such as principles, codes of conduct, private standards, guidelines, public-private partnerships, and certification requirements, have been used across a wide variety of technologies and industries; these instruments are collectively referred to as soft law, because unlike treaties and statutes, they are not directly enforceable by governments (20,51,75).…”

Section: International Governance: Whether Why and How?mentioning

confidence: 99%

Global Governance of Human Genome Editing: What Are the Rules?

Marchant

2021

Annu. Rev. Genom. Hum. Genet.

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Human gene editing, particularly using the new CRISPR/Cas9 technology, will greatly increase the capability to make precise changes to human genomes. Human gene editing can be broken into four major categories: somatic therapy, heritable gene editing, genetic enhancement, and basic and applied research. Somatic therapy is generally well governed by national regulatory systems, so the need for global governance is less urgent. All nations are in agreement that heritable gene editing should not proceed at this time, but there is likely to be divergence if and when such procedures are shown to be safe and effective. Gene editing for enhancement purposes is not feasible today but is more controversial with the public, and many nations do not have well-developed regulatory systems for addressing genetic enhancement. Finally, different nations treat research with human embryos very differently based on deeply embedded social, cultural, ethical, and legal traditions. Several international governance mechanisms are currently in operation for human gene editing, and several other governance mechanisms have been proposed. It is unlikely that any single mechanism will alone be effective for governing human gene editing; rather, a polycentric or ecosystem approach that includes several overlapping and interacting components is likely to be necessary. Expected final online publication date for the Annual Review of Genomics and Human Genetics Volume 22 is August 2021. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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The role of scientific self‐regulation for the control of genome editing in the human germline

Cited by 14 publications

References 9 publications

Plasma Proteomes Can Be Reidentifiable and Potentially Contain Personally Sensitive and Incidental Findings

Plasma Proteomes Can Be Reidentifiable and Potentially Contain Personally Sensitive and Incidental Findings

Ethical Principles, Constraints, and Opportunities in Clinical Proteomics

Global Governance of Human Genome Editing: What Are the Rules?

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