Publications by authors named "Amy L McGuire"

187 Publications

Patient, Caregiver, and Decliner Perspectives on Whether to Enroll in Adaptive Deep Brain Stimulation Research.

Front Neurosci 2021 7;15:734182. Epub 2021 Oct 7.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, United States.

This research study provides patient and caregiver perspectives as to whether or not to undergo adaptive deep brain stimulation (aDBS) research. A total of 51 interviews were conducted in a multi-site study including patients undergoing aDBS and their respective caregivers along with persons declining aDBS. Reasons highlighted for undergoing aDBS included hopes for symptom alleviation, declining quality of life, desirability of being in research, and altruism. The primary reasons for not undergoing aDBS issues were practical rather than specific to aDBS technology, although some persons highlighted a desire to not be the first to trial the new technology. These themes are discussed in the context of "push" factors wherein any form of surgical intervention is preferable to none and "pull" factors wherein opportunities to contribute to science combine with hopes and/or expectations for the alleviation of symptoms. We highlight the significance of study design in decision making. aDBS is an innovative technology and not a completely new technology. Many participants expressed value in being part of research as an important consideration. We suggest that there are important implications when comparing patient perspectives vs. theoretical perspectives on the choice for or against aDBS. Additionally, it will be important how we communicate with patients especially in reference to the complexity of study design. Ultimately, this study reveals that there are benefits and potential risks when choosing a research study that involves implantation of a medical device.
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http://dx.doi.org/10.3389/fnins.2021.734182DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8529029PMC
October 2021

Conceptualization of utility in translational clinical genomics research.

Am J Hum Genet 2021 11 22;108(11):2027-2036. Epub 2021 Oct 22.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX 77030, USA.

Prior to integration into clinical care, a novel medical innovation is typically assessed in terms of its balance of benefits and risks, often referred to as utility. Members of multidisciplinary research teams may conceptualize and assess utility in different ways, which has implications within the translational genomics community and for the evidence base upon which clinical guidelines groups and healthcare payers make decisions. Ambiguity in the conceptualization of utility in translational genomics research can lead to communication challenges within research teams and to study designs that do not meet stakeholder needs. We seek to address the ambiguity challenge by describing the conceptual understanding of utility and use of the term by scholars in the fields of philosophy, medicine, and the social sciences of decision psychology and health economics. We illustrate applications of each field's orientation to translational genomics research by using examples from the Clinical Sequencing Evidence-Generating Research (CSER) consortium, and we provide recommendations for increasing clarity and cohesion in future research. Given that different understandings of utility will align to a greater or lesser degree with important stakeholders' views, more precise use of the term can help researchers to better integrate multidisciplinary investigations and communicate with stakeholders.
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http://dx.doi.org/10.1016/j.ajhg.2021.08.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8595895PMC
November 2021

Perceived Utility of Genomic Sequencing: Qualitative Analysis and Synthesis of a Conceptual Model to Inform Patient-Centered Instrument Development.

Patient 2021 Oct 18. Epub 2021 Oct 18.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA.

Background And Objectives: Successful clinical integration of genomic sequencing (GS) requires evidence of its utility. While GS potentially has benefits (utilities) or harms (disutilities) across multiple domains of life for both patients and their families, there is as yet no empirically informed conceptual model of these effects. Our objective was to develop an empirically informed conceptual model of perceived utility of GS that captures utilities and disutilities for patients and their families across diverse backgrounds.

Methods: We took a patient-centered approach, in which we began with a review of existing literature followed by collection of primary interview data. We conducted semi-structured interviews to explore types of utility in a clinically and sociopolitically diverse sample of 60 adults from seven Clinical Sequencing Evidence-Generating Research (CSER) consortium projects. Interviewees had either personally received, or were parents of a child who had received, GS results. Qualitative data were analyzed using thematic analysis. Findings from interviews were integrated with existing literature on clinical and personal utility to form the basis of an initial conceptual model that was refined based on expert review and feedback.

Results: Five key utility types that have been previously identified in qualitative literature held up as primary domains of utility and disutility in our diverse sample. Interview data were used to specify and organize subdomains of an initial conceptual model. After expert refinement, the five primary domains included in the final model are clinical, emotional, behavioral, cognitive, and social, and several subdomains are specified within each.

Conclusion: We present an empirically informed conceptual model of perceived utility of GS. This model can be used to guide development of instruments for patient-centered outcome measurement that capture the range of relevant utilities and disutilities and inform clinical implementation of GS.
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http://dx.doi.org/10.1007/s40271-021-00558-4DOI Listing
October 2021

Behavioral and psychological impact of genome sequencing: a pilot randomized trial of primary care and cardiology patients.

NPJ Genom Med 2021 Aug 24;6(1):72. Epub 2021 Aug 24.

Center for Medical Ethics and Health Policy at Baylor College of Medicine, Houston, TX, USA.

Many expect genome sequencing (GS) to become routine in patient care and preventive medicine, but uncertainties remain about its ability to motivate participants to improve health behaviors and the psychological impact of disclosing results. In a pilot trial with exploratory analyses, we randomized 100 apparently healthy, primary-care participants and 100 cardiology participants to receive a review of their family histories of disease, either alone or in addition to GS analyses. GS results included polygenic risk information for eight cardiometabolic conditions. Overall, no differences were observed between the percentage of participants in the GS and control arms, who reported changes to health behaviors such as diet and exercise at 6 months post disclosure (48% vs. 36%, respectively, p = 0.104). In the GS arm, however, the odds of reporting a behavior change increased by 52% per high-risk polygenic prediction (p = 0.032). Mean anxiety and depression scores for GS and control arms had confidence intervals within equivalence margins of ±1.5. Mediation analyses suggested an indirect impact of GS on health behaviors by causing positive psychological responses (p ≤ 0.001). Findings suggest that GS did not distress participants. Future research on GS in more diverse populations is needed to confirm that it does not raise risks for psychological harms and to confirm the ability of polygenic risk predictions to motivate preventive behaviors.
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http://dx.doi.org/10.1038/s41525-021-00236-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8384838PMC
August 2021

Psychosocial Effect of Newborn Genomic Sequencing on Families in the BabySeq Project: A Randomized Clinical Trial.

JAMA Pediatr 2021 Nov;175(11):1132-1141

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas.

Importance: Newborn genomic sequencing (nGS) may provide health benefits throughout the life span, but there are concerns that it could also have an unfavorable (ie, negative) psychosocial effect on families.

Objective: To assess the psychosocial effect of nGS on families from the BabySeq Project, a randomized clinical trial evaluating the effect of nGS on the clinical care of newborns from well-baby nurseries and intensive care units.

Design, Setting, And Participants: In this randomized clinical trial conducted from May 14, 2015, to May 21, 2019, at well-baby nurseries and intensive care units at 3 Boston, Massachusetts, area hospitals, 519 parents of 325 infants completed surveys at enrollment, immediately after disclosure of nGS results, and 3 and 10 months after results disclosure. Statistical analysis was performed on a per-protocol basis from January 16, 2019, to December 1, 2019.

Intervention: Newborns were randomized to receive either standard newborn screening and a family history report (control group) or the same plus an nGS report of childhood-onset conditions and highly actionable adult-onset conditions (nGS group).

Main Outcomes And Measures: Mean responses were compared between groups and, within the nGS group, between parents of children who received a monogenic disease risk finding and those who did not in 3 domains of psychosocial impact: parent-child relationship (Mother-to-Infant Bonding Scale), parents' relationship (Kansas Marital Satisfaction Scale), and parents' psychological distress (Edinburgh Postnatal Depression Scale anxiety subscale).

Results: A total of 519 parents (275 women [53.0%]; mean [SD] age, 35.1 [4.5] years) were included in this study. Although mean scores differed for some outcomes at singular time points, generalized estimating equations models did not show meaningful differences in parent-child relationship (between-group difference in adjusted mean [SE] Mother-to-Infant Bonding Scale scores: postdisclosure, 0.04 [0.15]; 3 months, -0.18 [0.18]; 10 months, -0.07 [0.20]; joint P = .57) or parents' psychological distress (between-group ratio of adjusted mean [SE] Edinburgh Postnatal Depression Scale anxiety subscale scores: postdisclosure, 1.04 [0.08]; 3 months, 1.07 [0.11]; joint P = .80) response patterns between study groups over time for any measures analyzed in these 2 domains. Response patterns on one parents' relationship measure differed between groups over time (between-group difference in adjusted mean [SE] Kansas Marital Satisfaction Scale scores: postdisclosure, -0.19 [0.07]; 3 months, -0.04 [0.07]; and 10 months, -0.01 [0.08]; joint P = .02), but the effect decreased over time and no difference was observed on the conflict measure responses over time. We found no evidence of persistent negative psychosocial effect in any domain.

Conclusions And Relevance: In this randomized clinical trial of nGS, there was no persistent negative psychosocial effect on families among those who received nGS nor among those who received a monogenic disease risk finding for their infant.

Trial Registration: ClinicalTrials.gov Identifier: NCT02422511.
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http://dx.doi.org/10.1001/jamapediatrics.2021.2829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8383160PMC
November 2021

Genetic testing in ambulatory cardiology clinics reveals high rate of findings with clinical management implications.

Genet Med 2021 Dec 6;23(12):2404-2414. Epub 2021 Aug 6.

Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, Houston, TX, USA.

Purpose: Cardiovascular disease (CVD) is the leading cause of death in adults in the United States, yet the benefits of genetic testing are not universally accepted.

Methods: We developed the "HeartCare" panel of genes associated with CVD, evaluating high-penetrance Mendelian conditions, coronary artery disease (CAD) polygenic risk, LPA gene polymorphisms, and specific pharmacogenetic (PGx) variants. We enrolled 709 individuals from cardiology clinics at Baylor College of Medicine, and samples were analyzed in a CAP/CLIA-certified laboratory. Results were returned to the ordering physician and uploaded to the electronic medical record.

Results: Notably, 32% of patients had a genetic finding with clinical management implications, even after excluding PGx results, including 9% who were molecularly diagnosed with a Mendelian condition. Among surveyed physicians, 84% reported medical management changes based on these results, including specialist referrals, cardiac tests, and medication changes. LPA polymorphisms and high polygenic risk of CAD were found in 20% and 9% of patients, respectively, leading to diet, lifestyle, and other changes. Warfarin and simvastatin pharmacogenetic variants were present in roughly half of the cohort.

Conclusion: Our results support the use of genetic information in routine cardiovascular health management and provide a roadmap for accompanying research.
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http://dx.doi.org/10.1038/s41436-021-01294-8DOI Listing
December 2021

Challenges to Building a Gene Variant Commons to Assess Hereditary Cancer Risk: Results of a Modified Policy Delphi Panel Deliberation.

J Pers Med 2021 Jul 8;11(7). Epub 2021 Jul 8.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77005, USA.

Understanding the clinical significance of variants associated with hereditary cancer risk requires access to a pooled data resource or network of resources-a "cancer gene variant commons"-incorporating representative, well-characterized genetic data, metadata, and, for some purposes, pathways to case-level data. Several initiatives have invested significant resources into collecting and sharing cancer gene variant data, but further progress hinges on identifying and addressing unresolved policy issues. This commentary provides insights from a modified policy Delphi process involving experts from a range of stakeholder groups involved in the data-sharing ecosystem. In particular, we describe policy issues and options generated by Delphi participants in five domains critical to the development of an effective cancer gene variant commons: incentives, financial sustainability, privacy and security, equity, and data quality. Our intention is to stimulate wider discussion and lay a foundation for further work evaluating policy options more in-depth and mapping them to those who have the power to bring about change. Addressing issues in these five domains will contribute to a cancer gene variant commons that supports better care for at-risk and affected patients, empowers patient communities, and advances research on hereditary cancers.
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http://dx.doi.org/10.3390/jpm11070646DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305920PMC
July 2021

Effects of participation in a U.S. trial of newborn genomic sequencing on parents at risk for depression.

J Genet Couns 2021 Jul 26. Epub 2021 Jul 26.

Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.

Much emphasis has been placed on participant's psychological safety within genomic research studies; however, few studies have addressed parental psychological health effects associated with their child's participation in genomic studies, particularly when parents meet the threshold for clinical concern for depression. We aimed to determine if parents' depressive symptoms were associated with their child's participation in a randomized-controlled trial of newborn exome sequencing. Parents completed the Edinburgh Postnatal Depression Scale (EPDS) at baseline, immediately post-disclosure, and 3 months post-disclosure. Mothers and fathers scoring at or above thresholds for clinical concern on the EPDS, 12 and 10, respectively, indicating possible Major Depressive Disorder with Peripartum Onset, were contacted by study staff for mental health screening. Parental concerns identified in follow-up conversations were coded for themes. Forty-five parents had EPDS scores above the clinical threshold at baseline, which decreased by an average of 2.9 points immediately post-disclosure and another 1.1 points 3 months post-disclosure (both p ≤ .014). For 28 parents, EPDS scores were below the threshold for clinical concern at baseline, increased by an average of 4.7 points into the elevated range immediately post-disclosure, and decreased by 3.8 points at 3 months post-disclosure (both p < .001). Nine parents scored above thresholds only at 3 months post-disclosure after increasing an average of 5.7 points from immediately post-disclosure (p < .001). Of the 82 parents who scored above the threshold at any time point, 43 (52.4%) were reached and 30 (69.7%) of these 43 parents attributed their elevated scores to parenting stress, balancing work and family responsibilities, and/or child health concerns. Only three parents (7.0%) raised concerns about their participation in the trial, particularly their randomization to the control arm. Elevated scores on the EPDS were typically transient and parents attributed their symptomatology to life stressors in the postpartum period rather than participation in a trial of newborn exome sequencing.
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http://dx.doi.org/10.1002/jgc4.1475DOI Listing
July 2021

Psychological Distress Among the U.S. General Population During the COVID-19 Pandemic.

Front Psychiatry 2021 22;12:642918. Epub 2021 Jun 22.

Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.

The COVID-19 pandemic is taking a significant global toll on emotional well-being, but evidence of mental health impacts in the United States remains limited. In April 2020, we conducted an exploratory survey of U.S. residents to understand prevalence of and factors associated with psychological distress during the pandemic. Data collection was conducted using Qualtrics, an online survey platform, and U.S. adult respondents were recruited via Amazon's Mechanical Turk platform. Among 1,366 respondents, 42% ( = 571) reported clinically significant anxiety and 38% ( = 519) reported clinically significant depression. Factors associated with anxiety and depressive symptoms included Hispanic/Latino ethnicity; younger age; lower income; employment as or living with a health care worker-first responder; caregiver status; SARS-CoV-2 infection status; decreased frequency of engagement in healthy behaviors; and changed frequency of engagement in unhealthy behaviors. That some of these factors are associated with elevated distress during the pandemic is not yet widely appreciated and might be useful in informing management of mental health care resources.
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http://dx.doi.org/10.3389/fpsyt.2021.642918DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8258251PMC
June 2021

Pediatric Oncologists' Experiences Returning and Incorporating Genomic Sequencing Results into Cancer Care.

J Pers Med 2021 Jun 18;11(6). Epub 2021 Jun 18.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX 77030, USA.

Pediatric oncologists' perspectives around returning and incorporating tumor and germline genomic sequencing (GS) results into cancer care are not well-described. To inform optimization of cancer genomics communication, we assessed oncologists' experiences with return of genomic results (ROR), including their preparation/readiness for ROR, collaboration with genetic counselors (GCs) during ROR, and perceived challenges. The BASIC3 study paired pediatric oncologists with GCs to return results to patients' families. We thematically analyzed 24 interviews with 12 oncologists at two post-ROR time points. Oncologists found pre-ROR meetings with GCs and geneticists essential to interpreting patients' reports and communicating results to families. Most oncologists took a collaborative ROR approach where they discussed tumor findings and GCs discussed germline findings. Oncologists perceived many roles for GCs during ROR, including answering families' questions and describing information in lay language. Challenges identified included conveying uncertain information in accessible language, limits of oncologists' genetics expertise, and navigating families' emotional responses. Oncologists emphasized how GCs' and geneticists' support was essential to ROR, especially for germline findings. GS can be successfully integrated into cancer care, but to account for the GC shortage, alternative ROR models and access to genetics resources will be needed to better support families and avoid burdening oncologists.
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http://dx.doi.org/10.3390/jpm11060570DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8235493PMC
June 2021

Four misconceptions about investigative genetic genealogy.

J Law Biosci 2021 Jan-Jun;8(1):lsab001. Epub 2021 Apr 13.

University of Washington School of Medicine, Department of Bioethics and Humanities, Seattle, WA 98195, USA.

Investigative genetic genealogy (IGG) is a new technique for identifying criminal suspects that has sparked controversy. The technique involves uploading a crime scene DNA profile to one or more genetic genealogy databases with the intention of identifying a criminal offender's genetic relatives and, eventually, locating the offender within the family tree. IGG was used to identify the Golden State Killer in 2018 and it is now being used in connection with hundreds of cases in the USA. Yet, as more law enforcement agencies conduct IGG, the privacy implications of the technique have come under scrutiny. While these issues deserve careful attention, we are concerned that their discussion is, at times, based on misunderstandings related to how IGG is used in criminal investigations and how IGG departs from traditional investigative techniques. Here, we aim to clarify and sharpen the public debate by addressing four misconceptions about IGG. We begin with a detailed description of IGG as it is currently practiced: what it is and-just as important-what it is not. We then examine misunderstood or not widely known aspects of IGG that are potentially confusing efforts to have constructive discussions about its future. We conclude with recommendations intended to support the productivity of those discussions.
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http://dx.doi.org/10.1093/jlb/lsab001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8043143PMC
April 2021

Hospital-Based Education for Hospitalized Children: Current Practice and Future Direction.

Hosp Pediatr 2021 05 14;11(5):e75-e77. Epub 2021 Apr 14.

Center for Child Health Policy and Advocacy, and

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http://dx.doi.org/10.1542/hpeds.2020-004556DOI Listing
May 2021

Family-level impact of genetic testing: integrating health economics and ethical, legal, and social implications.

Per Med 2021 05 17;18(3):209-212. Epub 2021 Mar 17.

Center for the Evaluation of Value & Risk in Health (CEVR), Institute for Clinical Research & Health Policy Studies, Tufts Medical Center, Boston, MA 02111, USA.

Tweetable abstract Health economics and ELSI can be better integrated to consider the family impacts of genetic and genomic testing.
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http://dx.doi.org/10.2217/pme-2021-0016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8488502PMC
May 2021

Researcher Perspectives on Data Sharing in Deep Brain Stimulation.

Front Hum Neurosci 2020 17;14:578687. Epub 2020 Dec 17.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, United States.

The expansion of research on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that they were either sharing their data or would share in the future and that doing so was important for advancing the field. However, those who are sharing reported a variety of sharing partners, suggesting heterogeneity in sharing practices and lack of the broad sharing that would reflect principles of open science. Researchers described several concerns and barriers related to sharing, including privacy and confidentiality, the usability of shared data by others, ownership and control of data (including potential commercialization), and limited resources for sharing. They also suggested potential solutions to these challenges, including additional safeguards to address privacy issues, standardization and transparency in analysis to address issues of data usability, professional norms and heightened cooperation to address issues of ownership and control, and streamlining of data transmission to address resource limitations. Researchers also offered a range of views on the sensitivity of neural activity data (NAD) and data related to mental health in the context of sharing. These findings are an important input to deliberations by researchers, policymakers, neuroethicists, and other stakeholders as they navigate ethics and policy questions related to aDBS research.
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http://dx.doi.org/10.3389/fnhum.2020.578687DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7793701PMC
December 2020

Essential, not peripheral: Addressing health care workers' mental health concerns during the COVID-19 pandemic.

J Occup Health 2020 Jan;62(1):e12169

Baylor College of Medicine, Houston, TX, USA.

In this Opinion, we synthesize recent evidence regarding the mental health impacts of the pandemic with an emphasis on health care workers. Departing from the literature that has already been published on this topic, we focus on health care workers with mental health concerns that preexisted the pandemic and discuss evidence suggesting that this population has suffered disproportionately from pandemic conditions.
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http://dx.doi.org/10.1002/1348-9585.12169DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532262PMC
January 2020

Direct-to-Consumer Drug Advertisement and Prescribing Practices: Evidence Review and Practical Guidance for Clinicians.

J Gen Intern Med 2021 05 15;36(5):1390-1394. Epub 2020 Sep 15.

Center for Biomedical Ethics and Health Policy, Baylor College of Medicine, , Houston, TX, USA.

Direct to consumer advertising (DTCA) of prescription drugs has increased dramatically in the past two decades. The effect of this increase in advertising on the frequency of inappropriate prescribing is poorly understood, as are the factors that may underly inappropriate prescribing. A review of existing observational and experimental studies that address advertising-related prescription requests and contain some measure of prescription appropriateness demonstrate that DTCA increases prescription requests, increases the likelihood of prescription, and increases both appropriate and inappropriate prescribing. Patient expectations, insufficient information sharing, and patient satisfaction surveys are proposed contributors to potentially inappropriate prescribing in response to DTCA.
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http://dx.doi.org/10.1007/s11606-020-06218-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8131444PMC
May 2021

The road ahead in genetics and genomics.

Nat Rev Genet 2020 10 24;21(10):581-596. Epub 2020 Aug 24.

Center for Genome Engineering, Institute for Basic Science, Daejon, Republic of Korea.

In celebration of the 20th anniversary of Nature Reviews Genetics, we asked 12 leading researchers to reflect on the key challenges and opportunities faced by the field of genetics and genomics. Keeping their particular research area in mind, they take stock of the current state of play and emphasize the work that remains to be done over the next few years so that, ultimately, the benefits of genetic and genomic research can be felt by everyone.
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http://dx.doi.org/10.1038/s41576-020-0272-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444682PMC
October 2020

Airmen and health-care providers' attitudes toward the use of genomic sequencing in the US Air Force: findings from the MilSeq Project.

Genet Med 2020 12 18;22(12):2003-2010. Epub 2020 Aug 18.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA.

Purpose: The use of genomic sequencing (GS) in military settings poses unique considerations, including the potential for GS to impact service members' careers. The MilSeq Project investigated the use of GS in clinical care of active duty Airmen in the United States Air Force (USAF).

Methods: We assessed perceived risks, benefits, and attitudes toward use of GS in the USAF among patient participants (n = 93) and health-care provider participants (HCPs) (n = 12) prior to receiving or disclosing GS results.

Results: Participants agreed that there are health benefits associated with GS (90% patients, 75% HCPs), though more HCPs (75%) than patients (40%) agreed that there are risks (p = 0.048). The majority of both groups (67% HCPs, 77% patients) agreed that they trust the USAF with genetic information, but far fewer agreed that genetic information should be used to make decisions about deployment (5% patients, 17% HCPs) or duty assignments (3% patients, 17% HCPs). Despite their hesitancy, patients were supportive of the USAF testing for nondisease traits that could impact their duty performance. Eighty-seven percent of patients did not think their GS results would influence their career.

Conclusion: Results suggest favorable attitudes toward the use of GS in the USAF when not used for deployment or assignment decisions.
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http://dx.doi.org/10.1038/s41436-020-0928-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7710566PMC
December 2020

Direct-to-Consumer Genetic Testing: Value and Risk.

Annu Rev Med 2021 01 31;72:151-166. Epub 2020 Jul 31.

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas 77030, USA; email:

Although the explosive growth of direct-to-consumer (DTC) genetic testing has moderated, a substantial number of patients are choosing to undergo genetic testing outside the purview of their regular healthcare providers. Further, many industry leaders have been expanding reports to cover many more genes, as well as partnering with employers and others to expand access. This review addresses continuing concerns about DTC genetic testing quality, psychosocial impact, integration with medical practice, effects on the healthcare system, and privacy, as well as emerging concerns about third-party interpretation services and non-health-related uses such as investigative genetic genealogy. It concludes with an examination of two possible futures for DTC genetic testing: merger with traditional modes of healthcare delivery or continuation as a parallel system for patient-driven generation of health-relevant information. Each possibility is associated with distinctive questions related to value and risk.
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http://dx.doi.org/10.1146/annurev-med-070119-114727DOI Listing
January 2021

Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force.

Am J Bioeth 2020 07 8;20(7):15-27. Epub 2020 Jun 8.

Emory University.

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient's ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities.
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http://dx.doi.org/10.1080/15265161.2020.1764138DOI Listing
July 2020

Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.

J Law Med Ethics 2020 03;48(1):69-86

Susan M. Wolf, J.D., is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine at the University of Minnesota. She is also Chair of the University's Consortium on Law and Values in Health, Environment & the Life Sciences. She is a Principal Investigator on an NIH-supported project on "LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application" (NHGRI/NCI # R01HG008605; Wolf, Clayton, Lawrenz, PIs). Pilar N. Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin-Madison, where she is on the faculties of the Law School and the Department of Medical History and Bioethics at the Medical School. She is Ethics Scholar-in-Residence at the Morgridge Institute for Research, Co-Director of UW's Law and Neuroscience Program, a faculty member in the UW Masters in Biotechnology Studies program, and Program Faculty in the Graduate Program in Population Health. Susan A. Berry, M.D., is Division Director for Genetics and Metabolism in the Department of Pediatrics at the University of Minnesota. She is a Professor in the Departments of Pediatrics, Ophthalmology and Genetics, Cell Biology and Development. She is a member of the Minnesota Department of Health Newborn Screening Advisory Committee, a Fellow of the American Academy of Pediatrics, and a Fellow of the American College of Medical Genetics. Henry T. Greely, J.D., is the Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics at Stanford University. He chairs the California Advisory Committee on Human Stem Cell Research and the steering committee of the Stanford University Center for Biomedical Ethics, and directs the Stanford Center for Law and the Biosciences and the Stanford Program in Neuroscience and Society. Amy L. McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at the Baylor College of Medicine. She served on the National Advisory Council for Human Genome Research 2011-15 and is immediate past-President of the Association of Bioethics Program Directors. Michelle A. Penny, Ph.D., is Head of the Translational Genome Sciences Group at Biogen. She is Co-Chair of the National Academy Roundtable on Genomics and Precision Health and the Industry Pharmacogenomics Working Group. Sharon F. Terry, M.A., is President and Chief Executive Officer of Genetic Alliance and co-founder of the Genetic Alliance Registry and Biobank. She has served in a leadership role on organizations including the Precision Medicine Initiative Cohort Advisory Panel; Cures Acceleration Network Review Board and Advisory Council, National Center for Accelerating Translation Science, NIH; National Academy Roundtable on Genomics and Precision Health; Global Alliance for Genomics and Health; and International Rare Disease Research Consortium Executive Committee. Organizations are listed here for author identification only.

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.
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http://dx.doi.org/10.1177/1073110520916996DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447150PMC
March 2020

A Right to Privacy and Confidentiality: Ethical Medical Care for Patients in United States Immigration Detention.

J Law Med Ethics 2020 03;48(1):161-168

Amanda M. Gutierrez, M.P.H., is a Research Assistant at the Baylor College of Medicine Center for Medical Ethics and Health Policy in Houston, Texas. Jacob D. Hofstetter, M.G.P.S., is a Research and Policy Associate at the Massachusetts Appleseed Center for Law and Justice in Boston, Massachusetts. Emma Dishner, M.D., M.P.H., recently graduated from her Infectious Diseases fellowship from Baylor College of Medicine in Houston, Texas and will soon begin working with North Texas Infectious Diseases Consultants. Elizabeth Chiao, M.D., M.P.H., is a Professor of Medicine at Baylor College of Medicine in Houston, Texas. Dilreet Rai, M.D., is a hospitalist at the Michael E. Debakey VA Medical Center in Houston, Texas. Amy L. McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Dr. McGuire serves on the program committee for the Greenwall Foundation Faculty Scholars Program in Bioethics and is immediate past president of the Association of Bioethics Program Directors.

Recently, John Doe, an undocumented immigrant who was detained by United States Immigration and Customs Enforcement (ICE), was admitted to a hospital off-site from a detention facility. Custodial officers accompanied Mr. Doe into the exam room and refused to leave as physicians examined him. In this analysis, we examine the ethical dilemmas this case brings to light concerning the treatment of patients in immigration detention and their rights to privacy. We analyze what US law and immigration detention standards allow regarding immigration enforcement or custodial officers' presence in medical exams and documentation of detainee health information. We describe the ethical implications of the presence of officers in medical exam rooms, including its effects on the quality of the patient-provider relationship, patient privacy and confidentiality, and provider's ability to provide ethical care. We conclude that the presence of immigration enforcement or custodial officers during medical examination of detainees is a breach of the right to privacy of detainees who are not an obvious threat to the public. We urge ICE and the US Department of Homeland Security to clarify standards for and tighten enforcement around when officers are legally allowed to be stationed in medical exam rooms and document detainees' information.
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http://dx.doi.org/10.1177/1073110520917004DOI Listing
March 2020

Data Sharing in the Context of Health-Related Citizen Science.

J Law Med Ethics 2020 03;48(1_suppl):167-177

Mary A. Majumder, J.D., Ph.D., is an Associate Professor of Medicine at the Center for Medical Ethics and Health Policy, Baylor College of Medicine. Amy L. McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Dr. McGuire serves on the program committee for the Greenwall Foundation Faculty Scholars Program in Bioethics and is immediate past president of the Association of Bioethics Program Directors.

As citizen science expands, questions arise regarding the applicability of norms and policies created in the context of conventional science. This article focuses on data sharing in the conduct of health-related citizen science, asking whether citizen scientists have obligations to share data and publish findings on par with the obligations of professional scientists. We conclude that there are good reasons for supporting citizen scientists in sharing data and publishing findings, and we applaud recent efforts to facilitate data sharing. At the same time, we believe it is problematic to treat data sharing and publication as ethical requirements for citizen scientists, especially where there is the potential for burden and harm without compensating benefit.
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http://dx.doi.org/10.1177/1073110520917044DOI Listing
March 2020

Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated With Members of the Association of Bioethics Program Directors.

Ann Intern Med 2020 08 24;173(3):188-194. Epub 2020 Apr 24.

Albert Gnaegi Center for Health Care Ethics, Saint Louis University, St. Louis, Missouri (J.T.E.).

Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies.

Objective: To characterize the development of ventilator triage policies and compare policy content.

Design: Survey and mixed-methods content analysis.

Setting: North American hospitals associated with members of the Association of Bioethics Program Directors.

Participants: Program directors.

Measurements: Characteristics of institutions and policies, including triage criteria and triage committee membership.

Results: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend that those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations.

Limitation: The results may not be generalizable to institutions without academic bioethics programs.

Conclusion: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation.

Primary Funding Source: None.
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http://dx.doi.org/10.7326/M20-1738DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7207244PMC
August 2020

The case for implementing sustainable routine, population-level genomic reanalysis.

Genet Med 2020 04 12;22(4):815-816. Epub 2019 Dec 12.

Center for Genomic Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1038/s41436-019-0719-3DOI Listing
April 2020

Donors, authors, and owners: how is genomic citizen science addressing interests in research outputs?

BMC Med Ethics 2019 11 21;20(1):84. Epub 2019 Nov 21.

Baylor College of Medicine, Center for Medical Ethics and Health Policy, 1 Baylor Plaza, Houston, TX, 77030, USA.

Background: Citizen science is increasingly prevalent in the biomedical sciences, including the field of human genomics. Genomic citizen science initiatives present new opportunities to engage individuals in scientific discovery, but they also are provoking new questions regarding who owns the outputs of the research, including intangible ideas and discoveries and tangible writings, tools, technologies, and products. The legal and ethical claims of participants to research outputs become stronger-and also more likely to conflict with those of institution-based researchers and other stakeholders-as participants become more involved, quantitatively and qualitatively, in the research process. It is not yet known, however, how genomic citizen science initiatives are managing the interests of their participants in accessing and controlling research outputs in practice. To help fill this gap, we conducted an in-depth review of relevant policies and practices of U.S.-based genomic citizen science initiatives.

Methods: We queried the peer-reviewed literature and grey literature to identify 22 genomic citizen science initiatives that satisfied six inclusion criteria. A data collection form was used to capture initiative features, policies, and practices relevant to participants' access to and control over research outputs.

Results: This analysis revealed that the genomic citizen science landscape is diverse and includes many initiatives that do not have institutional affiliations. Two trends that are in apparent tension were identified: commercialization and operationalization of a philosophy of openness. While most initiatives supported participants' access to research outputs, including datasets and published findings, none supported participants' control over results via intellectual property, licensing, or commercialization rights. However, several initiatives disclaimed their own rights to profit from outputs.

Conclusions: There are opportunities for citizen science initiatives to incorporate more features that support participants' access to and control over research outputs, consistent with their specific objectives, operations, and technical capabilities.
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http://dx.doi.org/10.1186/s12910-019-0419-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6868686PMC
November 2019

Learning Health System - Moving from Ethical Frameworks to Practical Implementation.

J Law Med Ethics 2019 09;47(3):454-458

Stephanie R. Morain, M.P.H, Ph.D., is an Assistant Professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine. She received an A.B. in Biology and History, Government, and Law from Lafayette College, an M.P.H. from Columbia University, and a Ph.D. from Harvard University. Mary A. Majumder, J.D., Ph.D.,is an Associate Professor of Medicine at the Center for Medical Ethics and Health Policy, Baylor College of Medicine. She received an A.B. from Bryn Mawr College, a J.D. from Yale Law School, and a Ph.D. from Rice. Amy L. McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. She received a B.A. in psychology from the University of Pennsylvania, a J.D. from the University of Houston, and a Ph.D. from the Institute for Medical Humanities at the University of Texas Medical Branch.

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http://dx.doi.org/10.1177/1073110519876180DOI Listing
September 2019

Device Removal Following Brain Implant Research.

Neuron 2019 09;103(5):759-761

Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA. Electronic address:

The development of implanted neural devices to manage neurological and psychiatric disorders or to restore loss of physiological function is a rapidly advancing area of neuroscience research. We consider whether investigators of brain implant studies have an obligation to facilitate device explantation for participants who request it at study conclusion.
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http://dx.doi.org/10.1016/j.neuron.2019.08.024DOI Listing
September 2019
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