Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 4.764
Filtrar
2.
BMC Med Ethics ; 22(1): 6, 2021 01 25.
Artículo en Inglés | MEDLINE | ID: mdl-33494754

RESUMEN

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.


Asunto(s)
Investigación Biomédica/ética , Códigos de Ética , Ética , Infecciones por VIH/prevención & control , Pandemias , /epidemiología , Ética en Investigación , Salud Global , Servicios de Salud , Investigación sobre Servicios de Salud/ética , Humanos , Salud Pública , Investigadores , Características de la Residencia , Riesgo
3.
Mol Cell ; 81(2): 213-217, 2021 01 21.
Artículo en Inglés | MEDLINE | ID: mdl-33482088

RESUMEN

As part of our commitment to amplifying the voices of underrepresented scientists, we are publishing the insights and experiences of a panel of underrepresented scientists. Here they tell us about behaviors that can lead underrepresented scientists to feel that they do not belong and what the scientific community can do to provide better support. These are the personal opinions of the authors and may not reflect the views of their institutions.


Asunto(s)
Investigación Biomédica/ética , Diversidad Cultural , Investigadores/psicología , Adulto , Selección de Profesión , Femenino , Humanos , Masculino
5.
Mayo Clin Proc ; 96(1): 165-173, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33413815

RESUMEN

Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response. Appropriate institutional review board oversight and bioethics guidance for COVID-19 biospecimen research must maintain their focus on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and the threat it poses to communities and nations.


Asunto(s)
Investigación Biomédica/ética , Eticistas , Comités de Ética en Investigación , Ética en Investigación , Bancos de Muestras Biológicas , Humanos , Pandemias
6.
Vaccine ; 39(4): 633-640, 2021 01 22.
Artículo en Inglés | MEDLINE | ID: mdl-33341309

RESUMEN

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.


Asunto(s)
Investigación Biomédica/ética , /prevención & control , Experimentación Humana/ética , Consentimiento Informado/ética , /patogenicidad , Antivirales/administración & dosificación , /inmunología , Comités de Ética en Investigación/organización & administración , Voluntarios Sanos , Experimentación Humana/legislación & jurisprudencia , Humanos , Selección de Paciente/ética , Vacunación/ética , Organización Mundial de la Salud
7.
PLoS One ; 15(12): e0241783, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33382683

RESUMEN

BACKGROUND: Biomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies. METHODS: An online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined. RESULTS: Seventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants' rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study's scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19]. CONCLUSIONS: An understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.


Asunto(s)
Investigación Biomédica/ética , Comités de Ética en Investigación/ética , Investigadores/psicología , Percepción Social/psicología , Adulto , Ética en Investigación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Singapur , Encuestas y Cuestionarios
15.
PLoS One ; 15(9): e0239283, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32946521

RESUMEN

Both sharing and using open research data have the revolutionary potentials for forwarding scientific advancement. Although previous research gives insight into researchers' drivers and inhibitors for sharing and using open research data, both these drivers and inhibitors have not yet been integrated via a thematic analysis and a theoretical argument is lacking. This study's purpose is to systematically review the literature on individual researchers' drivers and inhibitors for sharing and using open research data. This study systematically analyzed 32 open data studies (published between 2004 and 2019 inclusively) and elicited drivers plus inhibitors for both open research data sharing and use in eleven categories total that are: 'the researcher's background', 'requirements and formal obligations', 'personal drivers and intrinsic motivations', 'facilitating conditions', 'trust', 'expected performance', 'social influence and affiliation', 'effort', 'the researcher's experience and skills', 'legislation and regulation', and 'data characteristics.' This study extensively discusses these categories, along with argues how such categories and factors are connected using a thematic analysis. Also, this study discusses several opportunities for altogether applying, extending, using, and testing theories in open research data studies. With such discussions, an overview of identified categories and factors can be further applied to examine both researchers' drivers and inhibitors in different research disciplines, such as those with low rates of data sharing and use versus disciplines with high rates of data sharing plus use. What's more, this study serves as a first vital step towards developing effective incentives for both open data sharing and use behavior.


Asunto(s)
Investigación Biomédica/ética , Ética en Investigación , Investigadores/ética , Adulto , Femenino , Humanos , Difusión de la Información/ética , Masculino , Persona de Mediana Edad , Publicaciones/ética , Confianza
17.
Am J Trop Med Hyg ; 103(3): 976-985, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32748773

RESUMEN

Gene drive technologies represent powerful tools to develop vector control strategies that will complement the current approaches to mitigate arthropod-borne infectious diseases. The characteristics of gene drive technologies have raised additional concerns to those for standard genetically engineered organisms. This generates a need for adaptive governance that has not been met yet because of the rapid rate of progress in gene drive research. For the eventual release of gene drive insects into wild populations, an international governance network would be helpful in guiding scientists, stakeholders, public opinion, and affected communities in its use. We examined the current institutions and governing bodies among various continents that could have an impact on gene drive governance or the potential to adapt to its future use. Possible governance strategies also are proposed that seek to bridge gaps and promote an ethically sound policy framework. Ideally, governance strategies should be developed before or at the same pace as gene drive research to anticipate field releases and maximize their impact as a public health tool. However, this is not likely to happen as it takes years to develop global accords, and some countries may choose to move ahead independently on the new technology.


Asunto(s)
Culicidae/genética , Tecnología de Genética Dirigida/legislación & jurisprudencia , Cooperación Internacional/legislación & jurisprudencia , Control de Mosquitos/legislación & jurisprudencia , Mosquitos Vectores/genética , Agricultura/ética , Agricultura/métodos , Animales , Animales Modificados Genéticamente , Investigación Biomédica/ética , Investigación Biomédica/métodos , Tecnología de Genética Dirigida/ética , Humanos , Control de Mosquitos/organización & administración , Salud Pública , Carácter Cuantitativo Heredable
20.
Vaccine ; 38(41): 6381-6387, 2020 09 22.
Artículo en Inglés | MEDLINE | ID: mdl-32826103

RESUMEN

BACKGROUND: A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms. METHODS: Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks. RESULTS: Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust. CONCLUSION: Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.


Asunto(s)
Betacoronavirus/inmunología , Investigación Biomédica/ética , Infecciones por Coronavirus/prevención & control , Desarrollo de Medicamentos/ética , Pandemias/prevención & control , Neumonía Viral/prevención & control , Humanos , Vacunación/ética , Vacunas Virales/inmunología
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA
...