Preventive Human Genome Editing and Enhancement: Candidate Criteria for Governance.

While somatic cell editing to treat disease is widely accepted, the use of human genome editing for "enhancement" remains contested. Scientists and policy-makers routinely cite the prospect of enhancement as a salient ethical challenge for human genome editing research. If preventive genome editing projects are perceived as pursuing human enhancement, they could face heightened barriers to scientific, public, and regulatory approval.

Blurring Boundaries: A Proposed Research Agenda for Ethical, Legal, Social, and Historical Studies at the Intersection of Infectious and Genetic Disease.

Contemporary understanding of the mechanisms of disease increasingly points to examples of "genetic diseases" with an infectious component and of "infectious diseases" with a genetic component. Such blurred boundaries generate ethical, legal, and social issues and highlight historical contexts that must be examined when incorporating host genomic information into the prevention, outbreak control, and treatment of infectious diseases.

Governing with public engagement: an anticipatory approach to human genome editing.

In response to calls for public engagement on human genome editing (HGE), which intensified after the 2018 He Jiankui scandal that resulted in the implantation of genetically modified embryos, we detail an anticipatory approach to the governance of HGE. By soliciting multidisciplinary experts' input on the drivers and uncertainties of HGE development, we developed a set of plausible future scenarios to ascertain publics values-specifically, their hopes and concerns regarding the novel technology and its applications. In turn, we gathered a subset of multidisciplinary experts to propose governance recommendations for HGE that incorporate identified publics' values.

Challenging the Boundaries Between Treatment, Prevention, and Enhancement in Human Genome Editing.

Traditional distinctions between treatment and enhancement goals for human genome editing (HGE) have animated oversight considerations, yet these categories have been complicated by the addition of prevention as a possible target for HGE applications. To assess the role these three categories might play in continued HGE governance efforts, we report on interviews with genome editing scientists and governance group members. While some accepted traditional distinctions between treatment and enhancement and rejected the latter as unacceptable, others argued that the concept of enhancement is largely irrelevant or not as morally problematic as suggested.

The Promise and Reality of Public Engagement in the Governance of Human Genome Editing Research.

This paper analyses the activities of five organizations shaping the debate over the global governance of genome editing in order to assess current approaches to public engagement (PE). We compare the recommendations of each group with its own practices. All recommend broad engagement with the general public, but their practices vary from expert-driven models dominated by scientists, experts, and civil society groups to citizen deliberation-driven models that feature bidirectional consultation with local citizens, as well as hybrid models that combine elements of both approaches.

Improving the Continuity of Care for People Living with HIV Experiencing Incarceration in North Carolina Jails: Stakeholder Perspectives.

Jail detention can disrupt the continuity of care for people living with HIV/AIDS (PLWH). Using a state's "Data to Care" (D2C) program might help overcome this barrier, but raises important questions of data security, personal privacy, resource allocation, and logistics. As part of a study involving in-depth expert stakeholder interviews, a 1-day workshop was convened to identify and discuss potential ethical challenges in extending North Carolina's D2C program to jail settings.

Public health research using cell phone derived mobility data in sub-Saharan Africa: Ethical issues.

The movements of humans have a significant impact on population health. While studies of such movements are as old as public health itself, the COVID-19 pandemic has raised the profile of mobility research using digital technologies to track transmission routes and calculate the effects of health policies, such as lockdowns. In sub-Saharan Africa, the high prevalence of cell phone and smartphone use is a source of potentially valuable mobility data for public health purposes.

Scientists' Views on Scientific Self-Governance for Human Genome Editing Research.

As research on human gene editing has grown, a variety of prominent international organizations are considering how best to govern such research. But what role do scientists engaged in genome editing think they should have in developing research governance? In this study, we present results from a survey of 212 U.S.

Polygenic embryo screening: four clinical considerations warrant further attention.

Recent advances in developing polygenic scores have made it possible to screen embryos for common, complex conditions and traits. Polygenic embryo screening (PES) is currently offered commercially, and though there has been much recent media and academic coverage, reproductive specialists' points of view have not yet been prominent in these discussions. We convened a roundtable of multidisciplinary experts, including reproductive specialists to discuss PES and its implications.

Advancing a Data Justice Framework for Public Health Surveillance.

Background: Bioethical debates about privacy, big data, and public health surveillance have not sufficiently engaged the perspectives of those being surveilled. The data justice framework suggests that big data applications have the potential to create disproportionate harm for socially marginalized groups. Using examples from our research on HIV surveillance for individuals incarcerated in jails, we analyze ethical issues in deploying big data in public health surveillance.

A New Governance Approach to Regulating Human Genome Editing.

For years, genomic medicine-medicine based on the growing understanding of the genetic contribution to many diseases and conditions-has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate goal of genomic medicine has always been the ability not just to identify dangerous gene mutations, but to fix them. Now CRISPR and related genome-editing technologies may have the potential to provide a safe and effective way to repair dangerous mutations.

The View from the Benches: Scientists' Perspectives on the Uses and Governance of Human Gene-Editing Research.

The advent of human gene editing has stimulated international interest in how best to govern this research. However, research on stakeholder views has neglected scientists themselves. We surveyed 212 scientists who use gene editing in their work.

Anticipating the ethical, legal, and social implications of human genome research: An ongoing experiment.

Dr. Victor McKusick was a founding member of the joint NIH-DOE working group that designed the federal effort to address the ethical, legal, and social implications of the US Human Genome Project in 1989. A key feature of this effort was its commitment to anticipating genomics-driven questions before they became urgent practical dilemmas, by complementing the scientific effort to map and sequence the human genome with projects by a wide range of social scientists, humanities scholars, legal experts, and public educators designed to equip society with the foresight required to optimize the public welfare benefits of new genomic information.

"Prevention" and Human Gene Editing Governance.

The Holocaust and the racial hygiene doctrine that helped rationalize it still overshadow contemporary debates about using gene editing for disease prevention. In part, this is because can mean 3 different things, which are often conflated. involves modifying the expression of pathogenic DNA variants to forestall their clinical effects in at-risk patients.

Toward better governance of human genomic data.

In this Commentary, we argue that in line with the dramatic increase in the collection, storage, and curation of human genomic data for biomedical research, genomic data repositories and consortia have adopted governance frameworks to address the dual objectives of enabling wide access while protecting against possible harms. However, there are ongoing debates in the scientific community about the merits and limitations of different governance frameworks in achieving these twin aims; and indeed, best practices and points for consideration are notably absent when it comes to devising a governance framework for genomic databases. Based on our collective experience of devising and assessing governance frameworks, our Commentary identifies five key functions of “good governance” (or what makes “better governance”) and three areas where trade-offs should be considered when specifying policies within those functions.

Corrigendum: Scraping the Web for Public Health Gains: Ethical Considerations from a 'Big Data' Research Project on HIV and Incarceration.

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Transparency, trust, and community welfare: towards a precision public health ethics framework for the genomics era.

Infectious disease control is experiencing a paradigm shift, as pathogen sequencing technologies and digital applications are increasingly implemented for control of diseases such as tuberculosis, Ebola, and COVID-19. A new ethical framework should be a critical part of this emerging paradigm to ensure that the benefit of precision public health interventions based on advances in genomics research is not outweighed by the risks they pose to individuals, families, and vulnerable segments of the population. We suggest that the ethical framework guiding practice in this domain combines standard precepts from public health ethics with emerging ethics principles from precision medicine.

Practical and Ethical Concerns in Implementing Enhanced Surveillance Methods to Improve Continuity of HIV Care: Qualitative Expert Stakeholder Study.

Background: Retention in HIV care is critical to maintaining viral suppression and preventing further transmission, yet less than 50% of people living with HIV in the United States are engaged in care. All US states have a funding mandate to implement Data-to-Care (D2C) programs, which use surveillance data (eg, laboratory, Medicaid billing) to identify out-of-care HIV-positive persons and relink them to treatment.

Objective: The purpose of this qualitative study was to identify and describe practical and ethical considerations that arise in planning for and implementing D2C.

Scraping the Web for Public Health Gains: Ethical Considerations from a 'Big Data' Research Project on HIV and Incarceration.

Web scraping involves using computer programs for automated extraction and organization of data from the Web for the purpose of further data analysis and use. It is frequently used by commercial companies, but also has become a valuable tool in epidemiological research and public health planning. In this paper, we explore ethical issues in a project that "scrapes" public websites of U.

Do Groups Have Moral Standing in Unregulated mHealth Research?

Biomedical research using data from participants' mobile devices borrows heavily from the ethos of the "citizen science" movement, by delegating data collection and transmission to its volunteer subjects. This engagement gives volunteers the opportunity to feel like partners in the research and retain a reassuring sense of control over their participation. These virtues, in turn, give both grass-roots citizen science initiatives and institutionally sponsored mHealth studies appealing features to flag in recruiting participants from the public.

Expert stakeholders' perspectives on a Data-to-Care strategy for improving care among HIV-positive individuals incarcerated in jails.

Data-to-Care (D2C) uses surveillance data (e.g., laboratory, Medicaid billing) to identify out-of-care HIV-positive persons to re-link them to care.

Genomic Essentialism: Its Provenance and Trajectory as an Anticipatory Ethical Concern.

Since the inception of large-scale human genome research, there has been much caution about the risks of exacerbating a number of socially dangerous attitudes linked to human genetics. These attitudes are usually labeled with one of a family of genetic or genomic "isms" or "ations" such as "genetic essentialism," "genetic determinism," "genetic reductionism," "geneticization," "genetic stigmatization," and "genetic discrimination." The psychosocial processes these terms refer to are taken to exacerbate several ills that are similarly labeled, from medical racism and psychological fatalism to economic exploitation and social exclusion.