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2.
Eur J Hum Genet ; 32(6): 725-730, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38355962

RESUMEN

This study investigates changes in the social valuation of the human genome over the more than 30 years since the establishment of the Human Genome Project. It offers a descriptive sociological analysis of the three waves of this valuation, mainly by considering three key UNESCO declarations and a relevant report. These waves represent a shifting balance between collectivism and individualism, starting with a broadly constructed valuation of the human genome as common human heritage and moving toward a valuation of dynamic applications within various social and medical contexts (e.g., personalized genomic medicine and genome editing). We seek to broaden the analytical perspective by examining how the declarations' ethical foci are framed within the context of rapidly evolving genetic technologies and their social applications. We conclude by discussing continuity and change in value balancing vis-à-vis changing genomic technologies.


Asunto(s)
Genoma Humano , Humanos , Proyecto Genoma Humano/ética , Genómica/ética , Genómica/métodos , Técnicas Genéticas/ética , Técnicas Genéticas/economía , Edición Génica/ética
3.
Front Genet ; 14: 1170794, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38098474

RESUMEN

In the 20 years since the completion of the Human Genome Project, the gap between scientific development and public understanding of genome research has been widening. While genome research has been increasingly utilized for social and clinical purposes in a multifaceted manner, this has resulted in an increase in the potential risks associated with genomic data. In this context, our study aims to consider the nature of public perceptions of genome research, primarily by using as a case study the results of previous public surveys relevant to donations for social benefits in Japan. We explored certain types of awareness, attitude, and intention (A-A-I) in such surveys and discussed the resultant key findings through the cultural transmission framework. Reframing the public's response toward genome research based on A-A-I analysis and behavioral science may contribute to developing more systematic communication approaches with the public. With a view to establishing such approaches, our perspective suggests some new insights to discuss the science-society gap in genome research internationally.

4.
Pathog Glob Health ; : 1-10, 2023 Oct 04.
Artículo en Inglés | MEDLINE | ID: mdl-37791645

RESUMEN

Governing dual-use research of concern (DURC) in the life sciences has become difficult owing to the diversification of scientific domains, digitalization of potential threats, and the proliferation of actors. This paper proposes three approaches to realize bottom-up governance of DURC from laboratory operation to institutional decision-making levels. First, a technological approach can predict and monitor the dual-use nature of the research target pathogens and their information. Second, an interactive approach is proposed in which diverse stakeholders proactively discuss and examine dual-use issues through research practice. Third, a personnel approach can identify the right persons involved in DURC. These approaches suggest that, going beyond self-governance by researchers, collaborative and networked governance involving diverse actors should become essential. This mode of governance can also be seen in light of the management of research use. Therefore, program design by funding agencies and publication screening by journal publishers continuously contribute to governance at the meso-level. Bottom-up governance may be realized by using an appropriately integrated design of these three approaches at the micro-level, such as dual-use prediction and monitoring, stakeholder dialogue, and background checks. Given that the term 'open science' has been promoted to the research community as part of top-down governance, paying due attention on site to research subjects, research practices, and persons involved in research will provide an opportunity to develop a more socially conscious open science.

6.
Regen Ther ; 24: 294-297, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37609523

RESUMEN

This article examines the influence of social media posts on clinical trials involving stem cell-based interventions. Based on the literature review, we identified three potential risks associated with social media posts regarding clinical trials that involve stem cell-based interventions: (1) threats to scientific validity, (2) amplification of excessive expectations, and (3) breaches of confidentiality. Additionally, preliminary recommendations are provided to safeguard the value of stem cell clinical trials for future patients in the age of social media. Our approach aims to safeguard the well-being of forthcoming participants and ensure the scientific validity of stem cell research, as well as possibly aid in the further development of shared guidelines for posting stem cell clinical trial information on social media platforms.

9.
Stem Cell Reports ; 17(12): 2582-2584, 2022 12 13.
Artículo en Inglés | MEDLINE | ID: mdl-36368328

RESUMEN

This forum describes an exploratory approach for assisting individuals with visual impairment during the informed consent (IC) process to participate in a cutting-edge trial. Our approach has been developed to focus on potential participants' preparedness to give IC, along with the creation of supporting audio material.


Asunto(s)
Consentimiento Informado , Trastornos de la Visión , Humanos , Trastornos de la Visión/terapia
10.
Front Genet ; 13: 927721, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36267404

RESUMEN

Despite its promising future, the application of artificial intelligence (AI) and automated decision-making in healthcare services and medical research faces several legal and ethical hurdles. The European Union (EU) is tackling these issues with the existing legal framework and drafting new regulations, such as the proposed AI Act. The EU General Data Protection Regulation (GDPR) partly regulates AI systems, with rules on processing personal data and protecting data subjects against solely automated decision-making. In healthcare services, (automated) decisions are made more frequently and rapidly. However, medical research focuses on innovation and efficacy, with less direct decisions on individuals. Therefore, the GDPR's restrictions on solely automated decision-making apply mainly to healthcare services, and the rights of patients and research participants may significantly differ. The proposed AI Act introduced a risk-based approach to AI systems based on the principles of ethical AI. We analysed the complex connection between the GDPR and AI Act, highlighting the main issues and finding ways to harmonise the principles of data protection and ethical AI. The proposed AI Act may complement the GDPR in healthcare services and medical research. Although several years may pass before the AI Act comes into force, many of its goals will be realised before that.

11.
Front Bioeng Biotechnol ; 10: 966586, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36091454

RESUMEN

The dual-use risk of infectious disease research using enhanced potential pandemic pathogens (ePPP), particularly gain-of-function (GOF) research, has been debated since 2011. As of now, research is supported on the condition that the research plan is reviewed and the actual experiment is supervised. However, the kinds of research conducted and what benefits they have brought to our society have not been adequately verified. Nevertheless, due to the COVID-19 pandemic that began at the end of 2019 and caused numerous deaths and wide economic disruption, the importance of infectious disease control from an international perspective has been recognized. Although complete control of the pandemic is still far off, positive signs include generating epidemiological trends based on genome analysis, therapeutic drug and vaccine development, clinical patient management, and public health policy interventions. In this context, the time has come to reconsider the true significance of GOF research on ePPP and the state of research governance in the post-COVID-19 era. In particular, the risks of such research are clearer than before, whereas its benefits seem less apparent. In this paper, we summarize the history of discussions on such GOF research, its significance in the light of the current COVID-19 pandemic, and the direction we shall take in the future.

12.
Genet Med ; 24(9): 1814-1820, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35657379

RESUMEN

Although still in the early stages of development, the advent of fast, high-output, and cost-effective next-generation DNA sequencing technology is moving precision medicine into public health. Before this shift toward next-generation sequencing in public health settings, individual patients met geneticists after showing symptoms and through limited family screening. In the new era of precision public health, everyone is a possible participant in genetic sequencing, simply by being born (newborn screening), by donating blood (biobanking), or through population screening. These initiatives are increasingly offered to individuals throughout their life and more individuals are encountering opportunities to use DNA sequencing. This article raises awareness of these growing areas and calls for different models of public engagement and communication about genomics, including screening asymptomatic populations, obtaining consent for unspecified and unforeseen future uses of genomic data, and managing variants of uncertain significance. Given that such communication challenges loom large, established norms of practice in genomic medicine and research should be reconsidered.


Asunto(s)
Comunicación en Salud , Salud Pública , Bancos de Muestras Biológicas , Medicina Genómica , Humanos , Recién Nacido , Medicina de Precisión
13.
Genet Med ; 24(5): 1120-1129, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35125311

RESUMEN

PURPOSE: The aim of this study was to determine how attitudes toward the return of genomic research results vary internationally. METHODS: We analyzed the "Your DNA, Your Say" online survey of public perspectives on genomic data sharing including responses from 36,268 individuals across 22 low-, middle-, and high-income countries, and these were gathered in 15 languages. We analyzed how participants responded when asked whether return of results (RoR) would motivate their decision to donate DNA or health data. We examined variation across the study countries and compared the responses of participants from other countries with those from the United States, which has been the subject of the majority of research on return of genomic results to date. RESULTS: There was substantial variation in the extent to which respondents reported being influenced by RoR. However, only respondents from Russia were more influenced than those from the United States, and respondents from 20 countries had lower odds of being partially or wholly influenced than those from the United States. CONCLUSION: There is substantial international variation in the extent to which the RoR may motivate people's intent to donate DNA or health data. The United States may not be a clear indicator of global attitudes. Participants' preferences for return of genomic results globally should be considered.


Asunto(s)
Actitud , Genómica , ADN , Genómica/métodos , Humanos , Intención , Encuestas y Cuestionarios , Estados Unidos
14.
Genome Med ; 13(1): 92, 2021 05 25.
Artículo en Inglés | MEDLINE | ID: mdl-34034801

RESUMEN

BACKGROUND: Public trust is central to the collection of genomic and health data and the sustainability of genomic research. To merit trust, those involved in collecting and sharing data need to demonstrate they are trustworthy. However, it is unclear what measures are most likely to demonstrate this. METHODS: We analyse the 'Your DNA, Your Say' online survey of public perspectives on genomic data sharing including responses from 36,268 individuals across 22 low-, middle- and high-income countries, gathered in 15 languages. We examine how participants perceived the relative value of measures to demonstrate the trustworthiness of those using donated DNA and/or medical information. We examine between-country variation and present a consolidated ranking of measures. RESULTS: Providing transparent information about who will benefit from data access was the most important measure to increase trust, endorsed by more than 50% of participants across 20 of 22 countries. It was followed by the option to withdraw data and transparency about who is using data and why. Variation was found for the importance of measures, notably information about sanctions for misuse of data-endorsed by 5% in India but almost 60% in Japan. A clustering analysis suggests alignment between some countries in the assessment of specific measures, such as the UK and Canada, Spain and Mexico and Portugal and Brazil. China and Russia are less closely aligned with other countries in terms of the value of the measures presented. CONCLUSIONS: Our findings highlight the importance of transparency about data use and about the goals and potential benefits associated with data sharing, including to whom such benefits accrue. They show that members of the public value knowing what benefits accrue from the use of data. The study highlights the importance of locally sensitive measures to increase trust as genomic data sharing continues globally.


Asunto(s)
Genómica , Difusión de la Información , Confianza , Genómica/métodos , Genómica/normas , Humanos , Sistemas en Línea , Investigación , Encuestas y Cuestionarios
16.
Stem Cell Reports ; 16(6): 1425-1434, 2021 06 08.
Artículo en Inglés | MEDLINE | ID: mdl-34019814

RESUMEN

Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM's origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.


Asunto(s)
Medicina Clínica/legislación & jurisprudencia , Política de Salud/legislación & jurisprudencia , Guías de Práctica Clínica como Asunto , Medicina Regenerativa/legislación & jurisprudencia , Seguridad/legislación & jurisprudencia , Trasplante de Células Madre/legislación & jurisprudencia , Tratamiento Basado en Trasplante de Células y Tejidos/ética , Tratamiento Basado en Trasplante de Células y Tejidos/normas , Ética Clínica , Regulación Gubernamental , Humanos , Japón , Medicina Regenerativa/ética , Trasplante de Células Madre/ética
17.
EMBO Rep ; 21(11): e51773, 2020 11 05.
Artículo en Inglés | MEDLINE | ID: mdl-33085180

RESUMEN

The COVID-19 crisis has further highlighted the challenges for open science and data sharing in biomedical research and the need for more traceability and transparency.


Asunto(s)
COVID-19 , Difusión de la Información , Trazado de Contacto , Privacidad Genética , Política de Salud , Humanos , Medidas de Seguridad
18.
Am J Hum Genet ; 107(4): 743-752, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-32946764

RESUMEN

Analyzing genomic data across populations is central to understanding the role of genetic factors in health and disease. Successful data sharing relies on public support, which requires attention to whether people around the world are willing to donate their data that are then subsequently shared with others for research. However, studies of such public perceptions are geographically limited and do not enable comparison. This paper presents results from a very large public survey on attitudes toward genomic data sharing. Data from 36,268 individuals across 22 countries (gathered in 15 languages) are presented. In general, publics across the world do not appear to be aware of, nor familiar with, the concepts of DNA, genetics, and genomics. Willingness to donate one's DNA and health data for research is relatively low, and trust in the process of data's being shared with multiple users (e.g., doctors, researchers, governments) is also low. Participants were most willing to donate DNA or health information for research when the recipient was specified as a medical doctor and least willing to donate when the recipient was a for-profit researcher. Those who were familiar with genetics and who were trusting of the users asking for data were more likely to be willing to donate. However, less than half of participants trusted more than one potential user of data, although this varied across countries. Genetic information was not uniformly seen as different from other forms of health information, but there was an association between seeing genetic information as special in some way compared to other health data and increased willingness to donate. The global perspective provided by our "Your DNA, Your Say" study is valuable for informing the development of international policy and practice for sharing genomic data. It highlights that the research community not only needs to be worthy of trust by the public, but also urgent steps need to be taken to authentically communicate why genomic research is necessary and how data donation, and subsequent sharing, is integral to this.


Asunto(s)
Genoma Humano , Genómica/ética , Difusión de la Información/ética , Análisis de Secuencia de ADN/ética , Confianza/psicología , Adulto , Américas , Asia , Australia , Europa (Continente) , Femenino , Conocimientos, Actitudes y Práctica en Salud , Secuenciación de Nucleótidos de Alto Rendimiento , Humanos , Masculino , Salud Pública/ética , Encuestas y Cuestionarios
19.
J Empir Res Hum Res Ethics ; 15(3): 175-186, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-31729900

RESUMEN

Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher-participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.


Asunto(s)
Bancos de Muestras Biológicas , Investigación Biomédica , Consentimiento Informado , Comunicación , Humanos , Investigadores
20.
J Hum Genet ; 64(5): 397-407, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30842598

RESUMEN

Japan has been proactively promoting genomic medicine initiatives as national policy. With rapid pace developments in genomic medicine, an increasing number of patients and their families will be able to access genomic information. In such circumstances, a consideration of public interests and an assessment of the general knowledge about genomic research and genomic medicine are becoming imperative. This study aims to elucidate public attitude to the handling of genetic information during research and general medicine. The results of the questionnaire survey of 3000 people have revealed the following points: (1) older participants were likely to have better knowledge of genetic information than younger ones; (2) people with better understanding of genetic information tended to care more strongly about technical issues; (3) respondents with higher literacy regarding genetic issues favored stricter rules for handling of genetic information compared to handling of ordinary medical data; and (4) research community and funding agencies should preserve and develop public trust in genomic research and medicine. These results suggest the importance of education for younger people, the need of different types of explanation and transparency aimed at individuals with different levels of knowledge about the genome, and indicate the adequacy of the current governmental guidelines.


Asunto(s)
Investigación Biomédica , Genética Médica , Conocimiento , Femenino , Humanos , Japón , Masculino
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