Ethical, legal, and social implications of learning health systems.
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ABSTRACT:
SUBMITTER: Platt J
PROVIDER: S-EPMC6508801 | biostudies-literature | 2018 Jan
REPOSITORIES: biostudies-literature
Publications
Ethical, legal, and social implications of learning health systems.
Platt Jodyn J Spector-Bagdady Kayte K Platt Tevah T De Vries Raymond R Markel Dorene D Hutchinson Raymond R Manion Frank F Ziegler Georgiann G Rubin Joshua J Kardia Sharon S
Learning health systems 20180103 1
Similar Datasets
Project description:Employers have begun to offer voluntary workplace genomic testing (wGT) as part of employee wellness benefit programs, but few empirical studies have examined the ethical, legal, and social implications (ELSI) of wGT. To better understand employee perspectives on wGT, employees were surveyed at a large biomedical research institution. Survey respondents were presented with three hypothetical scenarios for accessing health-related genomic testing: via (1) their doctor; (2) their workplace; and 3) a commercial direct-to-consumer (DTC) genetic testing company. Overall, 594 employees (28%) responded to the survey. Respondents indicated a preference for genomic testing in the workplace setting (70%; 95% CI 66-74%), followed by doctor's office (54%; 95% CI 50-58%), and DTC testing (20%; 95% CI 17-24%). Prior to participating in wGT, respondents wanted to know about confidentiality of test results (79%), existence of relevant laws and policies (70%), and privacy protection (64%). Across scenarios, 92% of respondents preferred to view the test results with a genetic counselor. These preliminary results suggest that many employees are interested and even prefer genetic testing in the workplace and would prefer testing with support from genetic health professionals. Confirmation in more diverse employer settings will be needed to generalize such findings.
| S-EPMC8010177 | biostudies-literature
Project description:Advances in genomics are contributing to the development of more effective, personalized approaches to the prevention and treatment of infectious diseases. Genetic sequencing technologies are furthering our understanding of how human and pathogen genomic factors - and their interactions - contribute to individual differences in immunologic responses to vaccines, infections and drug therapies. Such understanding will influence future policies and procedures for infectious disease management. With the potential for tailored interventions for particular individuals, populations or subpopulations, ethical, legal and social implications (ELSIs) may arise for public health and clinical practice. Potential considerations include balancing health-related benefits and harms between individuals and the larger community, minimizing threats to individual privacy and autonomy, and ensuring just distribution of scarce resources. In this Opinion, we consider the potential application of pathogen and host genomic information to particular viral infections that have large-scale public health consequences but differ in ELSI-relevant characteristics such as ease of transmission, chronicity, severity, preventability and treatability. We argue for the importance of anticipating these ELSI issues in advance of new scientific discoveries, and call for the development of strategies for identifying and exploring ethical questions that should be considered as clinical, public health and policy decisions are made.
| S-EPMC4295297 | biostudies-other
Project description:BackgroundSymptom checker apps (SCAs) are accessible tools that provide early symptom assessment for users. The ethical, legal, and social implications of SCAs and their impact on the patient-physician relationship, the health care providers, and the health care system have sparsely been examined. This study protocol describes an approach to investigate the possible impacts and implications of SCAs on different levels of health care provision. It considers the perspectives of the users, nonusers, general practitioners (GPs), and health care experts.ObjectiveWe aim to assess a comprehensive overview of the use of SCAs and address problematic issues, if any. The primary outcomes of this study are empirically informed multi-perspective recommendations for different stakeholders on the ethical, legal, and social implications of SCAs.MethodsQuantitative and qualitative methods will be used in several overlapping and interconnected study phases. In study phase 1, a comprehensive literature review will be conducted to assess the ethical, legal, social, and systemic impacts of SCAs. Study phase 2 comprises a survey that will be analyzed with a logistic regression. It aims to assess the user degree of SCAs in Germany as well as the predictors for SCA usage. Study phase 3 will investigate self-observational diaries and user interviews, which will be analyzed as integrated cases to assess user perspectives, usage pattern, and arising problems. Study phase 4 will comprise GP interviews to assess their experiences, perspectives, self-image, and concepts and will be analyzed with the basic procedure by Kruse. Moreover, interviews with health care experts will be conducted in study phase 3 and will be analyzed by using the reflexive thematical analysis approach of Braun and Clark.ResultsStudy phase 1 will be completed in November 2021. We expect the results of study phase 2 in December 2021 and February 2022. In study phase 3, interviews are currently being conducted. The final study endpoint will be in February 2023.ConclusionsThe possible ethical, legal, social, and systemic impacts of a widespread use of SCAs that affect stakeholders and stakeholder groups on different levels of health care will be identified. The proposed methodological approach provides a multifaceted and diverse empirical basis for a broad discussion on these implications.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00022465; https://tinyurl.com/yx53er67.International registered report identifier (irrid)DERR1-10.2196/34026.
| S-EPMC9152714 | biostudies-literature
Project description:More than thirty years ago in the United States, the National Center for Human Genome Research (NCHGR) at the National Institutes of Health (NIH) and its partner in the Human Genome Project (HGP), the Department of Energy (DOE), called for proposals from social scientists, ethicists, lawyers, and others to explore the ethical, legal, and social implications (ELSI) of mapping and sequencing the human genome. Today, nearly twenty years after the completion of the HGP, the ELSI Research Program of the National Human Genome Research Institute (NHGRI) continues this support. It has fostered the growth of ELSI research into a global field of study, uniquely positioned at the nexus of many academic disciplines and in proximity to basic and applied scientific research. We examine the formation of the first ELSI program and consider whether science policy in the public interest can exist within the confines of a set-aside from the NHGRI budget.
| S-EPMC9352173 | biostudies-literature
Project description:Gene-environment interactions play a key role in how psychiatric disorders manifest and develop. Psychiatric genetics researchers are making progress in identifying genomic correlates of many disorders. And recently, the field of genetics has given rise to a technology that many claim will revolutionize the biological sciences and propel the field into a transformative phase: the powerful gene-editing tool known as CRISPR-Cas9. This Article illustrates which psychiatric conditions are likely to make an attractive target for CRISPR as the technology evolves and CRISPR therapies becomes a viable tool to manage or prevent disorders in a clinical setting. We examine the potential scientific and clinical challenges of applying CRISPR in the mental health context, along with the regulatory, ethical, and legal issues that might arise as a consequence of these applications.
| S-EPMC6927684 | biostudies-literature
Project description:Background: The fields of stroke genomics, biobanking, and precision medicine are rapidly expanding in sub-Saharan Africa. However, the ethical, legal, and social implications (ELSI) of emerging neurobiobanking and genomic data resources are unclear in an emerging African scientific landscape with unique cultural, linguistic, and belief systems. Objective: This article documents capacity-building experiences of researchers during the development, pretesting, and validation of data collection instruments of the African Neurobiobank for Precision Stroke Medicine-(ELSI) Project. Methods: The African Neurobiobank for Precision Stroke Medicine-ELSI project is a transnational, multicenter project implemented across seven sites in Ghana and Nigeria. Guided by the Community-Based Participatory Research framework, we conducted three workshops with key stakeholders to review the study protocol, ensure uniformity in implementation; pretest, harmonize, and integrate context-specific feedback to ensure validity and adaptability of data collection instruments. Workshop impact was assessed using an open-ended questionnaire, which included questions on experience with participation in any of the workshops, building capacity in Genetic and Genomic Research (GGR), level of preparedness toward GGR, the genomic mini-dictionary developed by the team, and its impact in enhancing understanding in GGR. Data were analyzed qualitatively using a thematic framework approach. Results: Findings revealed the usefulness of the workshop in improving participants' knowledge and capacity toward GGR implementation. It further identified local, context-specific concerns regarding quality data collection, the need to develop culturally acceptable, genomic/biobanking data collection tools, and a mini-dictionary. Participants-reported perceptions were that the mini-dictionary enhanced understanding, participation, and data collection in GGR. Overall, participants reported increased preparedness and interest in participating in GGR. Conclusion: Capacity-building is a necessary step toward ELSI-related genomic research implementation in African countries where scholarship of ELSI of genomics research is emerging. Our findings may be useful to the design and implementation of ELSI-GGR projects in other African countries.
| S-EPMC10125390 | biostudies-literature
Project description:BackgroundHealthcare is a rapidly expanding area of application for Artificial Intelligence (AI). Although there is considerable excitement about its potential, there are also substantial concerns about the negative impacts of these technologies. Since screening and diagnostic AI tools now have the potential to fundamentally change the healthcare landscape, it is important to understand how these tools are being represented to the public via the media.MethodsUsing a framing theory approach, we analysed how screening and diagnostic AI was represented in the media and the frequency with which media articles addressed the benefits and the ethical, legal, and social implications (ELSIs) of screening and diagnostic AI.ResultsAll the media articles coded (n = 136) fit into at least one of three frames: social progress (n = 131), economic development (n = 59), and alternative perspectives (n = 9). Most of the articles were positively framed, with 135 of the articles discussing benefits of screening and diagnostic AI, and only 9 articles discussing the ethical, legal, and social implications.ConclusionsWe found that media reporting of screening and diagnostic AI predominantly framed the technology as a source of social progress and economic development. Screening and diagnostic AI may be represented more positively in the mass media than AI in general. This represents an opportunity for health journalists to provide publics with deeper analysis of the ethical, legal, and social implications of screening and diagnostic AI, and to do so now before these technologies become firmly embedded in everyday healthcare delivery.
| S-EPMC7725880 | biostudies-literature
Project description:BackgroundNeurological disorders are the leading cause of disability and the second leading cause of death worldwide. Teleneurology (TN) allows neurology to be applied when the doctor and patient are not present in the same place, and sometimes not at the same time. In February 2021, the Spanish Ministry of Health requested a health technology assessment report on the implementation of TN as a complement to face-to-face neurological care.MethodsA scoping review was conducted to answer the question on the ethical, legal, social, organisational, patient (ELSI) and environmental impact of TN. The assessment of these aspects was carried out by adapting the EUnetHTA Core Model 3.0 framework, the criteria established by the Spanish Network of Health Technology Assessment Agencies and the analysis criteria of the European Validate (VALues In Doing Assessments of healthcare TEchnologies) project. Key stakeholders were invited to discuss their concerns about TN in an online meeting. Subsequently, the following electronic databases were consulted from 2016 to 10 June 2021: MEDLINE and EMBASE.Results79 studies met the inclusion criteria. This scoping review includes 37 studies related to acceptability and equity, 15 studies developed during COVID and 1 study on environmental aspects. Overall, the reported results reaffirm the necessary complementarity of TN with the usual face-to-face care.ConclusionsThis need for complementarity relates to factors such as acceptability, feasibility, risk of dehumanisation and aspects related to privacy and the confidentiality of sensitive data.
| S-EPMC9962592 | biostudies-literature
Project description:For the past several years, the implementation of pharmacogenetic (PGx) testing has become widespread in several centers and clinical practice settings. PGx testing may be ordered at the point-of-care when treatment is needed or in advance of treatment for future use. The potential benefits of PGx testing are not limited to adult patients, as children are increasingly using medications more often and at earlier ages. This review provides some background on the use of PGx testing in children as well as mothers (prenatally and post-natally) and discusses the challenges, benefits, and the ethical, legal, and social implications of providing PGx testing to children.
| S-EPMC6800463 | biostudies-literature
Project description:ObjectivesThe objective was to identify and describe the published guidance and current academic discourse of ethical issues and standards related to the use of Social Media Research for generating patient insights for the use by health technology assessment (HTA) or health policy decisions.MethodsA scoping review of the literature was conducted in PubMed and Embase and identified 935 potential references published between January 2017 and June 2021. After title and abstract screening by three reviewers, 40 publications were included, the relevant information was extracted and data were collected in a mind map, which was then used to structure the output of the review.ResultsSocial Media Research may reveal new insights of relevance to HTA or health policies into patient needs, patient experiences, or patient behaviors. However, the research approaches, methods, data use, interpretation, and communication may expose those who post the data in social media channels to risks and potential harms relating to privacy, anonymity/confidentiality, authenticity, context, and rapidly changing technologies.ConclusionsAn actively engaged approach to ensuring ethical innocuousness is recommended that carefully follows best practices throughout planning, conduct, and communication of the research. Throughout the process and as a follow-up, there should be a discourse with the ethical experts to maximally protect the current and future users of social media, to support their trust in the research, and to advance the knowledge in parallel to the advancement of the media themselves, the technologies, and the research tools.
| S-EPMC11570170 | biostudies-literature