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1.
Hastings Cent Rep ; 51(3): 3-4, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-34028820

RESUMO

The Covid-19 pandemic has exposed four myths in bioethics. First, the flood of bioethics publications on how to allocate scarce resources in crisis conditions has assumed authorities would declare the onset of crisis standards of care, yet few have done so. This leaves guidelines in limbo and patients unprotected. Second, the pandemic's realities have exploded traditional boundaries between clinical, research, and public health ethics, requiring bioethics to face the interdigitation of learning, doing, and allocating. Third, without empirical research, the success or failure of ethics guidelines remains unknown, demonstrating that crafting ethics guidance is only the start. And fourth, the pandemic's glaring health inequities require new commitment to learn from communities facing extraordinary challenges. Without that new learning, bioethics methods cannot succeed. The pandemic is a wake-up call, and bioethics must rise to the challenge.


Assuntos
Temas Bioéticos/normas , COVID-19/epidemiologia , Alocação de Recursos para a Atenção à Saúde/organização & administração , Pesquisa Biomédica/ética , Pesquisa Biomédica/organização & administração , Alocação de Recursos para a Atenção à Saúde/ética , Alocação de Recursos para a Atenção à Saúde/normas , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde/ética , Disparidades em Assistência à Saúde/normas , Humanos , Pandemias , Saúde Pública , SARS-CoV-2
2.
J Nepal Health Res Counc ; 19(1): 148-153, 2021 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-33934150

RESUMO

BACKGROUND: Public health emergency is vulnerable time where maintaining ethical principles is obligatory while doing research, on the other hand, it is the same time when breach in ethics is much likely whenever a researcher is unaware, unprepared or hastens to do research. The aim of this study was to assess ethical issues of the coronavirus disease 2019 (COVID-19) related research proposals submitted during the early stages of pandemic in Nepal. METHODS: Retrospective analysis of COVID-19 related research proposals and their informed consent document submitted to the ethical review board at Nepal Health Research Council was done for the study. The analysis was done as per the National Ethical Guidelines, Standard Operating Procedure for Health Research in Nepal and World Health Organization guidelines for infectious disease outbreak, 2016 under ethically relevant headings. Descriptive data were analyzed in SPSS v24. RESULTS: The major issues were observed in the informed consent documents where 55% were lacking principal investigator's contact information, 68% not having participant selection criteria, 70% without clear informed consent taking process, 57% without explanation of possible risks. Similarly, 68% of the interventional studies' consent form didn't mention possible adverse events and mitigation mechanisms. CONCLUSIONS: Most of the research proposals related to COVID-19 were devoid of major ethical elements which took longer time for receiving approval and eventually delayed the opportunity for evidence generation in critical time. More attention is needed to increase awareness and to develop capacity of researchers, reviewers, ethics committees and relevant stakeholders at the time of health emergencies.


Assuntos
Pesquisa Biomédica/ética , COVID-19/epidemiologia , Revisão Ética , Humanos , Nepal/epidemiologia , Pandemias , Projetos de Pesquisa , Estudos Retrospectivos , SARS-CoV-2
3.
Indian J Med Ethics ; VI(2): 1-4, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33908357

RESUMO

The initial trials of SARS-CoV-2 vaccines were randomised control trials (RCT) with a placebo as control. The use of a placebo was ethically justified because, as with any new and emerging infectious disease, there was no known vaccine. There are now at least eight vaccines that have been shown to be effective and approved for emergency use, so the use of a placebo in the control group is no longer ethically justified. This article discusses why ethical guidelines should be continually evaluated in a changing landscape and why trust is so important.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Vacinas contra COVID-19/normas , COVID-19/prevenção & controle , Ética Médica , Guias como Assunto , Placebos/normas , Humanos , Pandemias , SARS-CoV-2 , Estados Unidos
4.
Indian J Med Ethics ; VI(2): 1-8, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33908358

RESUMO

A World Health Organization (WHO) Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation recently recommended placebo-controlled trials (PCT) of Covid-19 vaccines. PCTs are ethically acceptable when there is no proven effective and safe treatment for a certain condition. However, there are already some vaccines that have been approved and which have high levels of efficacy and safety. Any new vaccine under development must be tested against the most effective vaccines available. PCTs go against the participants' best interests, by putting them in a position of disadvantage while taking part in a trial, compared with people who are not in the trial and who could get vaccinated. Particularly in high-income countries, many people are getting vaccinated. This means that, following a recent trend in clinical trials, PCTs would have to be conducted in low- and middle-income countries, where there a number of advantages for drug companies, but where fatality rates of Covid-19 are, in many cases, much higher. For this and other reasons having to do with equal rights, participants in control groups should be protected with the most effective vaccines available.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Vacinas contra COVID-19/normas , COVID-19/prevenção & controle , Ética Médica , Guias como Assunto , Placebos/normas , Humanos , Pandemias , SARS-CoV-2
7.
Mol Cell ; 81(5): 885-888, 2021 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-33667376

RESUMO

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. In this segment, we asked about support systems-the types of support that are most helpful (and less helpful), how to find a supportive network, and how institutions can better support underrepresented scientists. These are the personal opinions of the authors and may not reflect the views of their institutions.


Assuntos
Pesquisa Biomédica/ética , Grupos Minoritários/psicologia , Pesquisadores/psicologia , Adulto , Pesquisa Biomédica/organização & administração , Diversidade Cultural , Feminino , Humanos , Masculino , Relações Raciais/psicologia , Apoio Social , Estados Unidos
8.
Hastings Cent Rep ; 51(2): 10-16, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33755216

RESUMO

Covid-19 has infected thousands and killed hundreds in prisons, jails, and immigration detention facilities across the United States. Responding to this crisis, leading medical researchers have called for expanding opportunities for people in prison to participate in vaccine trials. These calls, like current regulations, focus on individualized risk assessments around consent, coercion, and harm, while ignoring the unnaturalness of deprivation conditions in U.S. prisons. We need new frameworks of analysis that refocus on structural, rather than individual, risk assessments. Integrating structural perspectives-including skepticism of claims of scarcity, avoidance of representational distortions, and attention to institutional agency-into our existing, overly individualistic frameworks might permit the design of more ethical research projects involving people who are incarcerated. Still, the unnatural deprivations of incarceration might be so great that research subjects might need to be removed from prison entirely in order to ethically participate in research.


Assuntos
COVID-19 , Estabelecimentos Correcionais , Emigrantes e Imigrantes/estatística & dados numéricos , Prisioneiros/estatística & dados numéricos , Vacinação/métodos , Pesquisa Biomédica/ética , Pesquisa Biomédica/métodos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Estabelecimentos Correcionais/organização & administração , Estabelecimentos Correcionais/normas , Humanos , Controle de Infecções/normas , Seleção de Pacientes/ética , Medição de Risco , Fatores de Risco , SARS-CoV-2 , Estados Unidos/epidemiologia , Populações Vulneráveis
9.
Clin Trials ; 18(2): 226-233, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33530721

RESUMO

Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution's research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors' experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.


Assuntos
COVID-19/terapia , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/organização & administração , Pesquisa Biomédica/ética , Pesquisa Biomédica/organização & administração , Comitês de Ética em Pesquisa , Ética em Pesquisa , Prioridades em Saúde , Recursos em Saúde , Humanos , Projetos de Pesquisa , SARS-CoV-2
11.
BMC Med Ethics ; 22(1): 6, 2021 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-33494754

RESUMO

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.


Assuntos
Pesquisa Biomédica/ética , COVID-19 , Códigos de Ética , Ética , Infecções por HIV/prevenção & controle , Pandemias , COVID-19/epidemiologia , COVID-19/prevenção & controle , Ética em Pesquisa , Saúde Global , Serviços de Saúde , Pesquisa sobre Serviços de Saúde/ética , Humanos , Saúde Pública , Pesquisadores , Características de Residência , Risco , SARS-CoV-2
12.
Mayo Clin Proc ; 96(1): 165-173, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33413815

RESUMO

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.


Assuntos
Pesquisa Biomédica/ética , COVID-19/virologia , Eticistas , Comitês de Ética em Pesquisa , Ética em Pesquisa , Bancos de Espécimes Biológicos , Humanos , Pandemias , SARS-CoV-2
14.
Mol Cell ; 81(2): 213-217, 2021 01 21.
Artigo em Inglês | MEDLINE | ID: mdl-33482088

RESUMO

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.


Assuntos
Pesquisa Biomédica/ética , Diversidade Cultural , Pesquisadores/psicologia , Adulto , Escolha da Profissão , Feminino , Humanos , Masculino
16.
Vaccine ; 39(4): 633-640, 2021 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-33341309

RESUMO

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.


Assuntos
Pesquisa Biomédica/ética , Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Experimentação Humana/ética , Consentimento Livre e Esclarecido/ética , SARS-CoV-2/patogenicidade , Antivirais/administração & dosagem , COVID-19/tratamento farmacológico , COVID-19/imunologia , COVID-19/virologia , Comitês de Ética em Pesquisa/organização & administração , Voluntários Saudáveis , Experimentação Humana/legislação & jurisprudência , Humanos , Seleção de Pacientes/ética , SARS-CoV-2/efeitos dos fármacos , Vacinação/ética , Organização Mundial da Saúde
18.
Rev. med. cine ; 16(4): 255-260, dic. 2020. ilus
Artigo em Espanhol | IBECS | ID: ibc-199491

RESUMO

Los documentales El peligroso negocio con la salud (2018) y Salud a la venta (2018) ponen de manifiesto el riesgo de corrupción que puede existir en el proceso de investigación biomédica, específicamente con el desarrollo y posterior aprobación de dispositivos médicos. Esta industria mueve millones de euros al año y por esto puede resultar gobernada por la lógica del lucro a expensas de lesiones, sufrimiento y muerte de pacientes que, con necesidad de utilizar dispositivos, reciben los que son rentables y no necesariamente los más eficaces o seguros. Este material audiovisual recopila casos que obligan a reflexionar sobre el sentido de la invención de dispositivos que debe ser el de mejorar el proceso de salud y enfermedad de las personas y no los bolsillos de los fabricantes. En ese sentido, las denuncias desde los medios de comunicación deben favorecer una autocrítica para que cada individuo sea capaz de reflexionar sobre sus acciones y se desarrolle en un futuro cercano un espíritu colectivo nuevo: sin corrupción


The documentaries The dangerous health business (2018) and The Bleeding Edge (2018) highlight the risk of corruption that may exist in the biomedical research process, specifically in the development and subsequent approval of medical devices. This industry moves millions of euros per year and therefore can be governed by the logic of profit at the expense of injuries, suffering and death of patients who, with the need to use devices, receive those that are profitable but not effective and safe. This audiovisual material collects cases that require a reflection on the sense of devices invention that should be to improve the health-illness process of people and not the pockets of manufacturers. In that sense, complaints from the media should favor a self-criticism for each individual became capable of reflecting on their own actions and, in a near future, a new collective spirit without corruption be developed


Assuntos
Humanos , Filmes Cinematográficos , Corrupção/ética , Ética Médica , Equipamentos e Provisões/ética , Setor de Assistência à Saúde/ética , Medicina nas Artes , Pesquisa Biomédica/ética
19.
PLoS One ; 15(12): e0241783, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33382683

RESUMO

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.


Assuntos
Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa/ética , Pesquisadores/psicologia , Percepção Social/psicologia , Adulto , Ética em Pesquisa , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Singapura , Inquéritos e Questionários
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