Publications by authors named "Karen M Meagher"

Bipolar disorder is a chronic disease that imposes a lifelong burden on those that suffer from it. Lithium is still considered both gold standard treatment and first-line maintenance treatment, and access to treatment with lithium is paramount to improving patient outcomes. However, access to adequate treatment is not only contingent on symptom recognition, accurate diagnosis, and individualization of treatment, but also affected by racial and ethnic disparities at each stage of patient experience.

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We demonstrate the fruitfulness of using card sort activities as an engagement method by detailing community consultation for ethical, legal, and social implications of sociogenomics. Readers are provided with a user-guide for card sort engagement through: (1) an overview of the card sort activity and its merits for engagement, (2) detailed methods of sorting for values-elicitation and prioritization goals, and (3) strategies to design this approach for other participatory research designs. Our intent is to add to meaningful exchanges between community engaged researchers and empirical bioethicists.

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Economics is the primary discipline used to understand supply chain design, scale-up, and management. For example, antibiotics can be compared to other forms of "tragedy of the commons," whereby a common good (effective treatment of infections) is jeopardized by individual consumption and lack of community oversight and stewardship. While economic analysis can explain innovation decline in terms of market failure, one pitfall of an early-stage focus on research and development is a failure to challenge the discovery narrative.

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One Health-a holistic approach to health that brings the moral status of animals and environments into consideration-is understood as a "professional imperative," a value-laden obligation that flows from the scope and objectives of professional roles. In this article, antimicrobial resistance provides a case study to demonstrate the fruitfulness of public health and bioethics collaborations by applying One Health key concepts of interconnection and interdependence. Moving toward an ethics of One Health requires a more nuanced analysis of ecological relationships, including humans' connections to other species as hosts, vectors, domestic companions, meat-eaters' food, and farmers' livelihood.

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The precision health era is likely to reduce and respond to antimicrobial resistance (AMR). Our stewardship and precision efforts share terminology, seeking to deliver the "right drug, at the right dose, at the right time." Already, rapid diagnostic testing, phylogenetic surveillance, and real-time outbreak response provide just a few examples of molecular advances we dub "precision stewardship.

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Article Synopsis
  • The study explores how biobank participants understand pharmacogenomic (PGx) results, specifically regarding drug-gene interactions that affect their health.
  • Conducted through focus groups, the research reveals participants' themes around health implications, drugs, and genetics, indicating they generally grasp their PGx results.
  • Findings suggest the need for improved communication strategies in PGx disclosure, recognizing participants' understanding while addressing misunderstandings about drug interactions and genetics.
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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.

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Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response.

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Article Synopsis
  • The study aimed to investigate how returning unexpected pharmacogenomic (PGx) results affects biobank participants and their perspectives on improving communication about these results.
  • Researchers conducted focus groups with 54 biobank participants who received unexpected notifications about increased risks related to the cancer drug 5-fluorouracil.
  • Findings revealed participants had questions about sharing the information, valued the results personally and for future medicine, and their understanding of risk was influenced by their health identity and experiences with others' chemotherapy reactions.*
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Introduction: To address ethical concerns about the of future research authorization, biobanks employing a broad model of consent can design ongoing communication with contributors. Notifying contributors at the time of sample distribution provides one form of communication to supplement broad consent. However, little is known about how community-informed governance might anticipate contributor responses and inform communication efforts.

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Before population screening of 'healthy' individuals is widely adopted, it is important to consider the harms and benefits of receiving positive results and how harms and benefits may differ by age. Participants in a preventive genomic screening study were screened for 17 genes associated with 11 conditions. We interviewed 11 participants who received positive results.

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In November 2018, the announcement that genetically edited human embryos had been used for reproductive purposes caused international uproar; many observers argued that editing the human germline was unethical, particularly given the early stage of the science and the absence of appropriate oversight. We provide an overview of the implications of these events, focusing on the relevant ethical considerations for physicians addressing patient questions and concerns. The editing of the human germline for reproductive purposes should be understood against an historic backdrop of clinical research in assisted reproduction, as well as other exemplars of translational investigation.

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In this special issue, we solicited three commentators to discuss issues specific to the responsible conduct of research as it relates to the birth of gene-edited children. We explore the ethics of prevention and its ties to the responsible conduct of gene-editing research to introduce three commentaries addressing: (1) the relevance of cultural and regulatory context in China, (2) how to actualize calls for greater public engagement, and (3) where we might improve graduate education of genomic researchers.

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New gene-editing tools challenge conventional policy proscriptions of research aimed at either human germline gene editing or human enhancement by potentially lowering technical barriers to both kinds of intervention. Some recent gene-editing reports have begun to take up the prospect of germline editing, but most experts are in broad agreement that research should prioritize medical applications over attempts to enhance human traits. However, there is little consensus about what counts as human enhancement in this context, or how to deal with the issues it flags.

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In addition to genetic data, precision medicine research gathers information about three factors that modulate gene expression: lifestyles, environments, and communities. The relevant research tools-epidemiology, environmental assessment, and socioeconomic analysis-are those of public health sciences rather than molecular biology. Because these methods are designed to support inferences and interventions addressing population health, the aspirations of this research are expanding from individualized treatment toward precision prevention in public health.

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