There are numerous calls for building health care delivery systems that are more patient centered. The focus on patient-centered care has increasingly begun to rely upon, and even merge with, the ...concept of patients as consumers. Early references to patients as consumers were made by patient advocates who were attempting to challenge professional and corporate dominance in health care. Today, "consumer-driven" health care has become associated with neoliberal efforts to emphasize market factors in health reform and deemphasize government regulation and financing. In our view, a narrow focus on consumerism is conceptually confused and potentially harmful. The consumer metaphor wrongly assumes that health care is a market in the usual understanding of that term, that the high cost of US health care is a function of excessive consumer demand, and that price transparency and competition can deliver on the promise of reducing costs or ensuring quality. Furthermore, a consumer metaphor places disproportionate burdens on patients to reduce health care costs, and it could erode professional obligations to provide appropriate and effective care.
Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to ...manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using "biobank" here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence.
In “Human‐Animal Chimeras: The Moral Insignificance of Uniquely Human Capacities,” Julian Koplin argues against the views that all uniquely human traits have moral significance or that all the traits ...humans have in common with other animals “are morally insignificant.” He recommends instead the adoption of “a better framework for thinking about the moral status of part‐human beings,” one that emphasizes the “phenomenal value (or disvalue)” chimeric animals are likely “to enjoy (or suffer).” If the moral status of these chimeric animals is grounded in the phenomenal value of their interests—that is, their interests as nonhuman animals—current protections for animals used in research may be inadequate to protect those interests.
Evidence and Human Genome Editing Maschke, Karen J.
The Hastings Center report,
September/October 2018, 2018-Sep, 2018-09-00, 20180901, Letnik:
48, Številka:
5
Journal Article
Recenzirano
In July, the United Kingdom's Nuffield Council on Bioethics issued a report on human genome editing in which it said that editing a human embryo's genome to reduce the possibility that the future ...child will inherit a genetic disorder could be ethically acceptable when certain conditions are met: the intended use of genome‐editing interventions secures and is consistent with the “welfare of the future person” and does not “increase disadvantage, discrimination or division in society.” Yet the Council noted that if current legal restrictions on the use of heritable genome‐editing interventions were lifted, the interventions should be used only in the context of “well‐designed and supervised studies” to ensure that they are safe and effective. Some people might contend that it is premature to talk about what kind of evidence—and how much—will be needed to gauge the safety and effectiveness of genome‐editing interventions since the United Kingdom, the United States, and several other countries currently prohibit clinical trials that involve transferring into a woman an embryo whose genome was edited. Yet based on an analysis of evidentiary disputes involving several medical technologies (an analysis that I conducted with my Hastings colleague Michael Gusmano for a forthcoming book, Debating Modern Medical Technologies: The Politics of Safety, Effectiveness, and Patient Access), I suggest that now is the time to start the conversation about evidentiary standards for the use of genome editing in reproductive medicine.
Engaging patients and the public with evidence is an ethical imperative because engagement is central to respect for persons and will likely improve health outcomes, facilitate the stewardship of ...resources, enhance prospects for justice, and build public trust. However, patient and public engagement is also morally complex, because evidence alone is never definitive. As patients and the public engage with evidence, value conflicts will arise and must be managed to achieve trustworthy decision making. We outline value conflicts likely to emerge in the following five settings: clinical care, health care organizations, public health, the regulatory context, and among payers. Using a variety of examples, we offer suggestions about how such conflicts may be managed, including providing more opportunities for democratic deliberation and having more explicit community discussion of how to balance personal choice and community well-being, transparent discussions of cost and quality outcomes, and greater patient engagement in community-based participatory research and the governance of learning health systems.
The release of genetically engineered organisms into the shared environment raises scientific, ethical, and societal issues. Using some form of democratic deliberation to provide the public with a ...voice on the policies that govern these technologies is important, but there has not been enough attention to how we should connect public deliberation to the existing regulatory process. Drawing on lessons from previous public deliberative efforts by U.S. federal agencies, we identify several practical issues that will need to be addressed if relevant federal agencies are to undertake public deliberative activities to inform decision‐making about gene editing in the wild. We argue that, while agencies may have institutional capacity to undertake public deliberative activities, there may not be sufficient political support for them to do so. Advocates of public deliberation need to make a stronger case to Congress about why federal agencies should be encouraged and supported to conduct public deliberations.
Over the past year media outlets and scientific and bioethics journals have reported about several medical and scientific innovations touted as having the potential to fundamentally change not only ...how diseases and disorders are diagnosed and treated but even how to alter the genomes of future generations. The purported "miracle" blood-testing technology of Theranos and the potential use of the genome editing technology CRISPR-Cas9 to modify human and nonhuman organisms reflect dramatic advances in scientific understanding about the biological mechanisms of humans and other living organisms. Yet evidence about whether these and other innovative biomedical technologies are safe and effective and lead to improved health outcomes for patients young and old is often in dispute. How to assess the safety and effectiveness of innovative biomedical technologies, who should be involved in that effort, and how to define risks and benefits of those technologies are questions at the intersection of values, interests, and politics.
Over the past year media outlets and scientific and bioethics journals have reported about several medical and scientific innovations touted as having the potential to fundamentally change not only ...how diseases and disorders are diagnosed and treated but even how to alter the genomes of future generations. The purported “miracle” blood‐testing technology of Theranos and the potential use of the genome editing technology CRISPR‐Cas9 to modify human and nonhuman organisms reflect dramatic advances in scientific understanding about the biological mechanisms of humans and other living organisms. Yet evidence about whether these and other innovative biomedical technologies are safe and effective and lead to improved health outcomes for patients young and old is often in dispute. How to assess the safety and effectiveness of innovative biomedical technologies, who should be involved in that effort, and how to define risks and benefits of those technologies are questions at the intersection of values, interests, and politics.
Patients As Partners: The Authors Reply Gusmano, Michael K; Maschke, Karen J; Solomon, Mildred Z
Health Affairs,
06/2019, Letnik:
38, Številka:
6
Journal Article
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