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2.
BMC Med Ethics ; 22(1): 22, 2021 03 03.
Artículo en Inglés | MEDLINE | ID: mdl-33658019

RESUMEN

BACKGROUND: The COVID-19 pandemic has presented extraordinary challenges to worldwide healthcare systems, however, prevalence remains low in some countries. While the challenges of conducting research in high-prevalence countries are well published, there is a paucity from low COVID-19 countries. METHODS: A PRISMA guided systematic review was conducted using the databases Ovid-Medline, Embase, Scopus and Web of Science to identify relevant articles discussing ethical issues relating to research in low prevalence COVID-19 countries. RESULTS: The search yielded 133 original articles of which only 2 fit the inclusion criteria and aim, with neither specific to low prevalence. Most of the available literature focused on clinical management and resource allocation related to high prevalence countries. These results will be discussed under the ethical dimensions of equity, individual liberty, privacy and confidentiality, proportionality, public protection, provision of care, reciprocity, stewardship and trust.. CONCLUSIONS: A systematic review failed to identify articles relating to COVID-19 research ethics, specific to low prevalence countries. It shows that there is a significant gap in the literature that warrants further investigation. Common ethical principles were used to present a distinct set of challenges experienced by a country with a low prevalence of COVID-19. This unique perspective of some of the common ethical problems surrounding research, may help guide further discussion and guide research in similar countries.


Asunto(s)
/epidemiología , Ética en Investigación , Humanos , Pandemias , Prevalencia
3.
Artículo en Español | PAHO-IRIS | ID: phr-53321

RESUMEN

[RESUMEN]. Se está llevando a cabo un número considerable de ensayos clínicos en todo el mundo en respuesta a la pandemia de COVID-19, incluso en países de ingresos bajos y medios como los de América Latina y el Caribe. Sin embargo, la abundancia de estudios no necesariamente acorta el camino para encontrar intervenciones seguras y eficaces frente a la COVID-19. Se analizaron los ensayos para el tratamiento y la prevención de la COVID-19 de los países de América Latina y el Caribe que están registrados en la Plataforma de Registros Internacionales de Ensayos Clínicos de la Organización Mundial de la Salud, y se identificó una tendencia hacia la realización de estudios pequeños, repetitivos y no rigurosos que duplican los esfuerzos y merman recursos limitados sin producir conclusiones significativas sobre la seguridad y la eficacia de las intervenciones evaluadas. Se evaluaron asimismo los desafíos que plantea la realización de investigaciones científicamente sólidas y socialmente valiosas en América Latina y el Caribe a fin de brindar recomendaciones que alienten la realización de ensayos clínicos que tengan más probabilidades de producir evidencia sólida durante la pandemia.


[ABSTRACT]. A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.


Asunto(s)
Infecciones por Coronavirus , Coronavirus , Betacoronavirus , Infecciones por Coronavirus , Ensayo Clínico , Ética en Investigación , Políticas Públicas de Salud , América Latina , Región del Caribe , Infecciones por Coronavirus , Ensayo Clínico , Ética en Investigación , Políticas Públicas de Salud , América Latina , Región del Caribe
5.
J Law Med ; 28(2): 311-322, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33768743

RESUMEN

COVID-19 has generated a new and distinctive focus on the use of human challenge studies, also known as controlled human infection trials. The first such trial was authorised in England in February 2021. Although vaccines are now available for COVID-19, there remain multiple deficits in knowledge in respect of treatment and prevention of the infection and a powerful impetus for solutions given the level of its global morbidity and mortality. Thus, there are potent incentives for unorthodox acceleration of medical knowledge but against these must be balanced ethical and pragmatic considerations. This editorial adds to the literature on such issues by reflecting on the ethical principles that are applicable and identifying the arguments that have been mustered for and against human challenge studies in relation to COVID-19. It argues that, given the limited state of knowledge about the diverse and longer term risks from contraction of COVID-19, considerable care needs to be devoted to any assessment of the appropriateness of human challenge trials to test treatments for the disease or measures to prevent contracting the virus.


Asunto(s)
Inglaterra , Ética en Investigación , Humanos , Proyectos de Investigación
9.
Am J Bioeth ; 21(3): 11-31, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33541252

RESUMEN

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.


Asunto(s)
Ética en Investigación , Humanos , Motivación , Proyectos de Investigación
10.
PLoS One ; 16(2): e0245793, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33544777

RESUMEN

Remote in-home infant monitoring technologies hold great promise for increasing the scalability and safety of infant research (including in regard to the current Covid-19 pandemic), but remain rarely employed. These technologies hold a number of fundamental challenges and ethical concerns that need addressing to aid the success of this fast-growing field. In particular, the responsible development of such technologies requires caregiver input. We conducted a survey of the opinions of 410 caregivers on the viability, privacy and data access of remote in-home monitoring technologies and study designs. Infant-friendly wearable devices (such as sensing body suits) were viewed favourably. Caregivers were marginally more likely to accept video and audio recording in the home if data was anonymised (through automated processing) at point of collection, particularly when observations were lengthy. Caregivers were more open to international data sharing for anonymous data. Caregivers were interested in viewing all types of data, but were particularly keen to access video and audio recordings for censoring purposes (i.e., to delete data segments). Taken together, our results indicate generally positive attitudes to remote in-home monitoring technologies and studies for infant research but highlight specific considerations such as safety, privacy and family practicalities (e.g. multiple caregivers, visitors and varying schedules) that must be taken into account when developing future studies.


Asunto(s)
Actitud , Desarrollo Infantil , Ética en Investigación , Tecnología de Sensores Remotos , Cuidadores , Femenino , Humanos , Lactante , Masculino , Padres , Privacidad , Tecnología de Sensores Remotos/ética , Teléfono Inteligente/ética , Grabación en Video/ética
11.
Clin Trials ; 18(2): 226-233, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33530721

RESUMEN

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.


Asunto(s)
/terapia , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/organización & administración , Investigación Biomédica/ética , Investigación Biomédica/organización & administración , Comités de Ética en Investigación , Ética en Investigación , Prioridades en Salud , Recursos en Salud , Humanos , Proyectos de Investigación
12.
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
14.
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
15.
Artículo en Alemán | MEDLINE | ID: mdl-33377989

RESUMEN

In medical research, it is established practice to discuss ethical issues, usually based on the criteria informed consent and voluntary participation, protection from harm, confidentiality, and anonymity. The discussion of ethical questions is also gaining importance in social science research. The same applies to participatory research, which is not yet very widespread in Germany. Because this approach is based on equality between all those involved, it results in relationships uncommon in nonparticipatory research. Therefore, ethical questions are raised in a different way. Partly based on an analysis of documents, a case study from participatory health research will be used to illustrate how the principle of harm reduction can be recognized. The case study shows this from the perspective of both the researchers and the peer-researchers.From the peer-researchers' perspective, there are different challenges in participatory teamwork, which can bring impairments and consequently result in a risk of harm. This can lead to disappointments, for example, when from the peer-researchers' perspective individual support during a research process is insufficient.Conclusions for dealing with ethical aspects in participatory research projects will be derived from the gathered experiences. The application of the criteria used in nonparticipatory research can be an opportunity to strengthen the discussion of ethical issues as part of participatory processes. It can also be a chance to combine the ethical discourse in participatory and qualitative social science research.


Asunto(s)
Investigación Participativa Basada en la Comunidad , Ética en Investigación , Confidencialidad , Alemania , Humanos , Consentimiento Informado
17.
Methods Mol Biol ; 2197: 307-316, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-32827145

RESUMEN

Several experimental human DNA vaccines are currently undergoing Phase I, II, and III clinical trials in order to investigate their efficacy and safety. Human clinical trials must follow guidelines and procedures that have been approved by the regulatory authorities and ethics committees. Ethical clinical research is much more than applying an informed consent to participants. In this chapter we will review the ethical standards and provide a framework to evaluate and design ethical clinical research. Despite being universal standards supported by universal guidelines, they must be adapted to the conditions in each country where the clinical research is being conducted.


Asunto(s)
Estudios Clínicos como Asunto , Ética en Investigación , Vacunas de ADN/administración & dosificación , Estudios Clínicos como Asunto/ética , Estudios Clínicos como Asunto/legislación & jurisprudencia , Conflicto de Intereses , Revisión Ética , Humanos , Consentimiento Informado , Selección de Paciente/ética , Medición de Riesgo , Vacunas de ADN/efectos adversos , Vacunas de ADN/genética , Vacunas de ADN/inmunología , Vacunología/ética , Vacunología/legislación & jurisprudencia
18.
20.
Science ; 370(6523): 1423-1424, 2020 12 18.
Artículo en Inglés | MEDLINE | ID: mdl-33335058
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