Human Genome Editing Science, Ethics, and Governance (2017) / Chapter Skim
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8 Summary of Principles and Recommendations
8 Summary of Principles and Recommendations
Pages 181-194
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From page 181... ...
Such research is proceeding rapidly within existing oversight systems. Genome editing is already entering clinical testing for somatic treatment of certain genetic diseases, subject to regulatory systems designed to oversee human somatic cell gene therapy research.
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From page 182... ...
Due care: The principle of due care for patients enrolled in research studies or receiving clinical care requires proceeding carefully and deliberately, and only when supported by sufficient and robust evidence. Responsibilities that flow from adherence to this principle include proceeding cautiously and incrementally, under appropriate supervision and in
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From page 183... ...
EXISTING U.S. OVERSIGHT MECHANISMS FOR HUMAN GENOME EDITING In the United States, existing laws and funding policies at the state and federal levels will govern human genome editing at all stages, from laboratory research through preclinical testing and clinical trials to clinical
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From page 184... ...
Human Embryo Research Panel; the National Academies of Sciences, Engineering, and Medicine's Guidelines for Human Embryonic Stem Cell Research; and the guidelines of the International Society for Stem Cell Research guidelines continue to shape research practices in this area. The ethical and regulatory considerations posed by genome-editing research using human embryos in the laboratory have been explored in the past: the moral status of the embryo, the acceptability of making embryos for research or using embryos that would otherwise be discarded, and legal or voluntary limits that apply to the use of embryos in research.
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From page 185... ...
Conclusions and Recommendation: Fundamental Laboratory Research Laboratory research involving human genome editing -- that is, research that does not involve contact with patients -- follows regulatory pathways that are the same as those for other basic laboratory in vitro research with human tissues, and raises issues already managed under existing ethical norms and regulatory regimes. This includes not only work with somatic cells but also the donation and use of human gametes and embryos for research purposes, where this research is permitted.
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From page 186... ...
But in utero genome editing would also require special attention to issues surrounding consent and to any increased risk of on-target or off-target modifications to fetal germ cells or germ cell progenitors. Recommendations for regulating somatic cell genome editing are informed by several of the overarching principles.
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From page 187... ...
Regulatory assessments associated with clinical trials of somatic cell genome editing will be similar to those associated with other medical therapies, encompassing minimization of risk, analysis of whether risks to participants are reasonable in light of potential benefits, and determining whether participants are recruited and enrolled with appropriate voluntary and informed consent. Regulatory oversight also will need to include legal authority and enforcement capacity to prevent unauthorized or premature applications of genome editing, and regulatory authorities will need to continually update their knowledge of specific technical aspects of the technologies being applied.
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From page 188... ...
The prospect of heritable genome editing also triggers concerns similar to those raised earlier by preimplantation and prenatal genetic screening, that is to say that purely voluntary, individual decisions might collectively change social norms about the acceptance of disabilities. Conclusions and Recommendations: Heritable Genome Editing In some situations, heritable genome editing would provide the only or the most acceptable option for parents who desire to have genetically related children while minimizing the risk of serious disease or disability in a prospective child.
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From page 189... ...
A robust public discussion about the values to be placed on the benefits and risks of heritable genome editing is needed now so that these values can be incorporated as appropriate into the risk/benefit assessments that will precede any decision about whether to authorize clinical trials. But the FDA does not have a statutory mandate to consider public views on the intrinsic morality of a technology when deciding whether to authorize clinical trials.
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From page 190... ...
If, indeed, it is not possible to satisfy the criteria in the recommendation, the committee's view is that heritable genome editing would not be permissible. The committee calls for continued public engagement and input while the basic science evolves and regulatory safeguards are developed to satisfy the criteria set forth here.
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From page 191... ...
authorities to review proposals for clinical trials of heritable genome editing, and therefore to drive development of this technology to other jurisdictions, some regulated and others not. Genome Editing for Purposes Other Than Treating or Preventing Disease or Disability Both the ongoing development of therapeutic uses of somatic genome editing, and possible future development of therapeutic uses of heritable genome editing, raise the issue of defining disease and disability, and the question of how and where to set appropriate boundaries for treatment and prevention of these conditions.
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From page 192... ...
There is significant public discomfort with the use of genome editing for so-called enhancement of human traits and capacities beyond those typical of adequate health.Therefore, a robust public discussion is needed concerning the values to be placed upon the individual and societal benefits and risks of genome editing for purposes other than treatment or prevention of disease or disability. These discussions would include consideration of the potential for introducing or exacerbating societal inequities, so that these values can be incorporated as appropriate into the risk/benefit assessments that will precede any decision about whether to authorize clinical trials.
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From page 193... ...
Weighing the technical and societal benefits and risks of applications of future uses of heritable genome editing will require more formalized efforts to solicit broad public input and encourage public debate than are currently in place. Furthermore, the complex issues surrounding enhancement will require an ongoing public debate to inform regulators and policy makers about the individual and societal values to be placed on the benefits and risks before clinical trials for such enhancement interventions could be authorized.
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From page 194... ...
RECOMMENDATION 7-2. Ongoing reassessment of both health and societal benefits and risks, with broad ongoing participation and input by the public, should precede consideration of any clini cal trials of heritable germline genome editing.
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