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1.
Am J Nurs ; 120(3): 14, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32079781

RESUMO

One study's pediatric protocol sparks ethical debate.


Assuntos
Revelação/ética , Genômica/ética , Predisposição Genética para Doença , Humanos , Programas de Rastreamento/ética
4.
BMC Med Ethics ; 20(1): 84, 2019 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-31752834

RESUMO

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.


Assuntos
Ciência do Cidadão/ética , Pesquisa em Genética/ética , Genômica/ética , Propriedade/ética , Testes Genéticos/ética , Humanos , Propriedade Intelectual , Políticas
6.
Hum Genet ; 138(11-12): 1237-1246, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31531740

RESUMO

Trust may be important in shaping public attitudes to genetics and intentions to participate in genomics research and big data initiatives. As such, we examined trust in data sharing among the general public. A cross-sectional online survey collected responses from representative publics in the USA, Canada, UK and Australia (n = 8967). Participants were most likely to trust their medical doctor and less likely to trust other entities named. Company researchers were least likely to be trusted. Low, Variable and High Trust classes were defined using latent class analysis. Members of the High Trust class were more likely to be under 50 years, male, with children, hold religious beliefs, have personal experience of genetics and be from the USA. They were most likely to be willing to donate their genomic and health data for clinical and research uses. The Low Trust class were less reassured than other respondents by laws preventing exploitation of donated information. Variation in trust, its relation to areas of concern about the use of genomic data and potential of legislation are considered. These findings have relevance for efforts to expand genomic medicine and data sharing beyond those with personal experience of genetics or research participants.


Assuntos
Bases de Dados Genéticas/normas , Pesquisa em Genética , Genômica/ética , Disseminação de Informação/ética , Confiança , Adolescente , Adulto , Austrália , Canadá , Criança , Estudos Transversais , Feminino , Genômica/métodos , Humanos , Disseminação de Informação/métodos , Masculino , Pessoa de Meia-Idade , Reino Unido , Estados Unidos , Adulto Jovem
8.
Genome Biol ; 20(1): 128, 2019 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-31262363

RESUMO

As the scale of genomic and health-related data explodes and our understanding of these data matures, the privacy of the individuals behind the data is increasingly at stake. Traditional approaches to protect privacy have fundamental limitations. Here we discuss emerging privacy-enhancing technologies that can enable broader data sharing and collaboration in genomics research.


Assuntos
Privacidade Genética , Genômica/ética , Disseminação de Informação/ética , Genoma Humano , Humanos
9.
Eur J Med Genet ; 62(10): 103711, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31265899

RESUMO

Access to active search for actionable secondary findings (SF) in diagnostic practice is a major psychological and ethical issue for genomic medicine. In this study, we analyzed the preferences of patients and their families regarding SF and identified the reporting procedures necessary for informed consent. We interviewed parents of patients with undiagnosed rare diseases potentially eligible for exome sequencing and patients affected by the diseases listed in the ACMG recommendations. Four focus groups (FG) were formed: parents of patients with undiagnosed rare diseases (FG1, n = 5); patients with hereditary cancers (FG2, n = 10); patients with hereditary cardiac conditions (FG3, n = 3); and patients with metabolic diseases (FG4, n = 3). Psychologists presented three broad topics for discussion: 1. Favorable or not to SF access, 2. Reporting procedures, 3. Equity of access. Discussions were recorded and analyzed using simplified Grounded Theory. Overall, 8 participants declared being favorable to SF because of the medical benefit (mainly FG1); 11 were unfavorable because of the psychological consequences (mainly FG2, FG3, FG4); 2 were ambivalent. The possibility of looking for SF in minors was debated. The 4 key information-based issues for participants ranked as follows: explanation of SF issues, autonomy of choice, importance of a reflection period, and quality of interactions between patients and professionals. Examining equity of access to SF led to philosophical discussions on quality of life. In conclusion, individual experience and life context (circumstances) were decisive in participants' expectations and fears regarding access to SF. Additional longitudinal studies based on actual SF disclosure announcements are needed to establish future guidelines.


Assuntos
Ética Médica , Genômica/ética , Sequenciamento de Nucleotídeos em Larga Escala/ética , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças Genéticas Inatas/diagnóstico , Doenças Genéticas Inatas/genética , Doenças Genéticas Inatas/psicologia , Testes Genéticos , Genoma Humano , Humanos , Achados Incidentais , Pessoa de Meia-Idade , Sequenciamento Completo do Exoma
10.
Genet Med ; 21(11): 2431-2438, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31160753

RESUMO

Genomic sequencing and multigene panel tests are moving rapidly into clinical practice for a range of indications, but the evidence to guide appropriate use is currently limited. Well-crafted advice is needed to reduce unjustified practice variation, minimize risk of error and harm to patients, and encourage best practices. In the absence of definitive evidence, provisional advice can be helpful if it clarifies the potential benefits and risks of different courses of action and identifies the knowledge gaps most important to address in future research. This paper proposes an evolutionary process starting with clinical practice advisory documents (CPADs) and culminating in clinical practice guidelines (CPGs), using two case examples to illustrate the need for this process. When evidence is limited, CPADs can clarify current practice options and identify key knowledge gaps. Added evidence can then support updates to the CPADs over time. Ultimately CPADs can provide the foundation for definitive CPGs as the evidence base matures. This approach addresses an important challenge in genomics and may be applicable to other fields in which technology and practice are outpacing evidence generation.


Assuntos
Medicina Baseada em Evidências/métodos , Guias de Prática Clínica como Assunto/normas , Genômica/ética , Genômica/métodos , Humanos
11.
New Bioeth ; 25(2): 153-171, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31130111

RESUMO

The successes of the human genome project and genomics research programs portend great potential to improve upon health and enhance life. As scientific advancements continue, bioethicists and policy makers deliberate over the social and ethical implications of genetic and genomic technologies and information (ggT/I). The application of ggT/I to human reproduction raises conceptual and moral questions about being human and the links between offspring, parents, and society. Given ggT/I's ability to significantly affect the biological constitution of humans and future human generations thinking through such issues is fundamental to ethical and policy analysis. By means of a systematic literature review and accompanying content analysis, this paper highlights the dominant ethical concerns raised within recent bioethics discourse over the use of ggT/I for human reproduction. Based on these findings it aso offers a framework through which, and demarcates where, religious perspectives can add value to genethics debates and policy deliberation.


Assuntos
Pesquisa em Genética/ética , Técnicas Genéticas/ética , Genômica/ética , Religião e Ciência , Reprodução/ética , Humanos , Obrigações Morais
12.
Kennedy Inst Ethics J ; 29(1): 67-95, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31080178

RESUMO

One of the practices that has defined the ethos of genomic research to date is a commitment to open and rapid sharing of genomic data and resources. As genomic research evolves into an international enterprise, this commitment is being challenged by the need to respect the interests of those it involves and implicates, from individual scientists and subjects to institutions and nations. In this essay, we first describe the types of claims that different stakeholders are making about the disposition of genomic data and samples. Next, we illustrate the complexities of these multiple claims by applying them to the case of one ongoing international genomics initiative, the H3Africa Consortium. Finally, in the light of these complexities, we conclude by comparing and contrasting four governance models for future international data-sharing policy and practices in genomics.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Genômica/ética , Genômica/legislação & jurisprudência , Disseminação de Informação/ética , Disseminação de Informação/legislação & jurisprudência , África , Política de Saúde , Humanos , Consentimento Livre e Esclarecido/ética , Cooperação Internacional , Propriedade/ética , Privacidade , Participação dos Interessados , Reino Unido , Estados Unidos
13.
Pac Symp Biocomput ; 24: 427-438, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30963079

RESUMO

The United States' All of Us Research Program is a longitudinal research initiative with ambitious national recruitment goals, including of populations traditionally underrepresented in biomedical research, many of whom have high geographic mobility. The program has a distributed infrastructure, with key programmatic resources spread across the US. Given its planned duration and geographic reach both in terms of recruitment and programmatic resources, a diversity of state and territory laws might apply to the program over time as well as to the determination of participants' rights. Here we present a listing and discussion of state and territory guidance and regulation of specific relevance to the program, and our approach to their incorporation within the program's informed consent processes.


Assuntos
Pesquisa Biomédica , Consentimento Livre e Esclarecido , Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Estudos de Coortes , Biologia Computacional , Testes Genéticos/ética , Testes Genéticos/legislação & jurisprudência , Genômica/ética , Genômica/legislação & jurisprudência , Health Insurance Portability and Accountability Act/ética , Health Insurance Portability and Accountability Act/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Estudos Longitudinais , Estados Unidos
14.
Genet Med ; 21(10): 2364-2370, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-30948857

RESUMO

PURPOSE: African ancestry (AA) individuals are inadequately included in translational genomics research, limiting generalizability of findings and benefits of genomic discoveries for populations already facing disproportionately poor health outcomes. We aimed to determine the impact of stakeholder-engaged strategies on recruitment and retention of AA adult patients into a clinical trial testing them for renal risk variants nearly exclusive to AAs. METHODS: Our academic-clinical-community team developed ten key strategies that recognize AAs' barriers and facilitators for participation. Using electronic health records (EHRs), we identified potentially eligible patients. Recruiters reached out through letters, phone calls, and at medical visits. RESULTS: Of 5481 AA patients reached, 51% were ineligible, 37% enrolled, 4% declined, 7% were undecided when enrollment finished. We retained 93% at 3-month and 88% at 12-month follow-up. Those enrolled are more likely female, seen at community sites, and reached through active strategies, than those who declined. Those retained are more likely female, health-literate, and older. While many patients have low income, low clinician trust, and perceive racism in health care, none of these attributes correlate with retention. CONCLUSION: With robust stakeholder engagement, recruiters from patients' communities, and active approaches, we successfully recruited and retained AA patients into a genomic clinical trial.


Assuntos
Afro-Americanos/psicologia , Ensaios Clínicos como Assunto/métodos , Seleção de Pacientes/ética , Adulto , Feminino , Genômica/ética , Genômica/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Participação dos Interessados/psicologia
18.
Am J Kidney Dis ; 73(6): 837-845, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30879919

RESUMO

DNA is now commonly collected in clinical research either for immediate genomic analyses or stored for future studies. Many genomic studies were previously designed without awareness of the ethical issues that might arise regarding the disclosure of genomic test results. At the start of the Chronic Kidney Disease in Children (CKiD) Cohort Study in 2004, we did not foresee the advent of genomic technology or the associated ethical issues pertaining to genetic research in children. Recent genomic studies and ancillary proposals using genomic technology stimulated the CKiD investigators to reassess the current ethical and policy environment pertaining to genomic testing and results disclosure. We consider the issues pertaining to next generation sequencing and individual results disclosure that may guide current and future research practices.


Assuntos
Testes Genéticos/ética , Sequenciamento de Nucleotídeos em Larga Escala/ética , Pesquisa Qualitativa , Insuficiência Renal Crônica/genética , Adolescente , Criança , Pré-Escolar , Feminino , Previsões , Testes Genéticos/tendências , Genômica/ética , Política de Saúde , Sequenciamento de Nucleotídeos em Larga Escala/tendências , Humanos , Consentimento Livre e Esclarecido , Masculino , Pediatria/métodos , Formulação de Políticas , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/epidemiologia , Projetos de Pesquisa , Revelação da Verdade , Estados Unidos
19.
Pac Symp Biocomput ; 24: 386-390, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30864339

RESUMO

High-throughput technologies for biological data acquisition are advancing at an increasing pace. Most prominently, the decreasing cost of DNA sequencing has led to an exponential growth of sequence information, including individual human genomes. This session of the 2019 Pacific Symposium on Biocomputing presents the distinctive privacy and ethical challenges related to the generation, storage, processing, study, and sharing of individuals' biological data generated by multitude of technologies including but not limited to genomics, proteomics, metagenomics, bioimaging, biosensors, and personal health trackers. The mission is to bring together computational biologists, experimental biologists, computer scientists, ethicists, and policy and lawmakers to share ideas, discuss the challenges related to biological data and privacy.


Assuntos
Big Data , Biologia Computacional/ética , Confidencialidade/ética , Privacidade Genética/ética , Registros Eletrônicos de Saúde/ética , Estudo de Associação Genômica Ampla/ética , Genômica/ética , Sequenciamento de Nucleotídeos em Larga Escala/ética , Humanos , Análise de Sequência de DNA/ética
20.
Health Secur ; 17(1): 62-68, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30724614

RESUMO

Host genomic research on high-consequence infectious diseases is a growing area, but the ethical, legal, and social implications of such findings related to potential applications of the research have not yet been identified. While there is a robust ethical debate about the ethical, legal, and social implications of research during an emergency, there has been less consideration of issues facing research conducted outside of the scope of emergency response. Addressing the implications of research at an early stage (anticipatory ethics) helps define the issue space, facilitates preparedness, and promotes ethically and socially responsible practices. To lay the groundwork for more comprehensive anticipatory ethics work, this article provides a preliminary assessment of the state of the field with a scoping review of host genomic research on a subset of high-consequence infectious diseases of relevance to high-level isolation units, focusing on its ethically relevant features and identifying several ethical, legal, and social implications raised by the literature. We discuss the challenges of genomic studies of low-frequency, high-risk events and applications of the science, including identifying targets to guide the development of new therapeutics, improving vaccine development, finding biomarkers to predict disease outcome, and guiding decisions about repurposing existing drugs and genetic screening. Some ethical, legal, and social implications identified in the literature included the rise of systems biology and paradigm shifts in medical countermeasure development; controversies over repurposing of existing drugs; genetic privacy and discrimination; and benefit-sharing and global inequity as part of the broader ecosystem surrounding high-level isolation units. Future anticipatory ethics work should forecast the science and its applications; identify a more comprehensive list of ethical, legal, and social implications; and facilitate evaluation by multiple stakeholders to inform the integration of ethical concerns into high-level isolation unit policy and practice.


Assuntos
Pesquisa Biomédica/ética , Doenças Transmissíveis , Genômica/ética , Contenção de Riscos Biológicos , Drogas em Investigação/uso terapêutico , Saúde Global , Humanos
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