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1.
BMC Med Ethics ; 22(1): 147, 2021 11 06.
Artigo em Inglês | MEDLINE | ID: mdl-34742278

RESUMO

BACKGROUND: Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. METHODS: We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. RESULTS: 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. CONCLUSION: LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.


Assuntos
COVID-19 , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , América Latina , Pandemias , SARS-CoV-2
2.
Ethics Hum Res ; 43(6): 2-18, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34676693

RESUMO

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness to share those decisions together represent a missed opportunity for IRBs to learn from one another and advance debates about challenging ethical issues. The concept of IRB precedent, modeled upon the system of legal precedent, has been proposed as a potential solution to these problems. In theory, an IRB faced with a review decision could look back at previous IRB decisions, either its own or those of other boards, made in similar studies or circumstances to guide the present decision. Some IRBs attempt this informally within their institution, but few examples of a structured system of IRB precedent have been described in the literature, and none has been widely adopted. This article describes a pilot project to summarize IRB decisions in a way that could facilitate their use as precedent by creating a documentation tool that meets four criteria-comprehensiveness, validity, searchability, and efficiency. Though this process turned out to be more challenging than expected, we identified key features of such a tool that holds promise for future development and could promote more consistent, robust IRB decision-making and advance discourse in human research ethics.


Assuntos
Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Projetos Piloto , Pesquisadores
6.
BMC Med Ethics ; 22(1): 117, 2021 09 04.
Artigo em Inglês | MEDLINE | ID: mdl-34481506

RESUMO

BACKGROUND: Engagement of people with lived experience and members of the public is an ethically and scientifically essential component of health research. Authentic engagement means they are involved as full partners in research projects. Yet engagement as partnership is uncommon in practice, especially during priority-setting for research projects. What is needed for agenda-setting to be shared by researchers and people with lived experience and/or members of the public (or organisations representing them)? At present, little ethical guidance exists on this matter, particularly that which has been informed by the perspectives of people with lived experience and members of the public. This article provides initial evidence about what they think are essential foundations and barriers to shared decision-making in health research priority-setting and health research more broadly. METHODS: An exploratory, qualitative study was conducted in 2019. 22 semi-structured interviews were performed with key informants from the UK and Australia. RESULTS: Three main types of foundations were thought to be essential to have in place before shared decision-making can occur in health research priority-setting: relational, environmental, and personal. Collectively, the three types of foundations addressed many (but not all) of the barriers to power sharing identified by interviewees. CONCLUSIONS: Based on study findings, suggestions are made for what researchers, engagement practitioners, research institutions, and funders should do in their policy and practice to support meaningful engagement. Finally, key international research ethics guidelines on community engagement are considered in light of study findings.


Assuntos
Prioridades em Saúde , Pesquisadores , Austrália , Ética em Pesquisa , Humanos , Pesquisa Qualitativa
7.
Am J Bioeth ; 21(10): 1-4, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34554060
9.
Am J Bioeth ; 21(10): 20-21, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34554063
10.
BMJ Open ; 11(9): e054213, 2021 09 27.
Artigo em Inglês | MEDLINE | ID: mdl-34580104

RESUMO

In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.


Assuntos
Ética em Pesquisa , Projetos de Pesquisa , Comitês de Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido , Ensaios Clínicos Controlados Aleatórios como Assunto , Pesquisadores
11.
Ethics Hum Res ; 43(5): 18-25, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34496156

RESUMO

This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional-needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long-term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address.


Assuntos
Consultoria Ética , Ética em Pesquisa , Humanos
12.
Ethics Hum Res ; 43(5): 42-44, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34496160

RESUMO

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.


Assuntos
COVID-19 , Comitês de Ética em Pesquisa/normas , Ética em Pesquisa , Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Humanos , Consentimento Livre e Esclarecido
13.
Nature ; 597(7875): 153, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34493844
14.
Rinsho Ketsueki ; 62(8): 1343-1348, 2021.
Artigo em Japonês | MEDLINE | ID: mdl-34497225

RESUMO

Medical ethics are important for medical professionals and can be classified into two subcategories, which are: "Research Ethics," referring to the norms that researchers should follow when engaging in research activities, and "Clinical Ethics," which are mainly norms that should be followed in routine clinical practice. Rules are the basic component of ethics and are an agreement that is enacted after the fact. On the other hand, the development of new medical care strategies requires novelty and originality. Research includes unknown and unpracticed topics; therefore, new problems arise, which are often not possible to deal with by simply following the established rules. Medical professionals need to be ethical so that they can anticipate new problems and make decisions without the rules. This can be done by understanding the background against which the rules have been formed and its preamble.


Assuntos
Ética Médica , Ética em Pesquisa , Humanos
15.
Washington, D.C.; PAHO; 2021-09-22. (PAHO/HSS/BIO/21-0009).
em Inglês | PAHO-IRIS | ID: phr-54869

RESUMO

In 2018, the Member States of the Pan American Health Organization (PAHO) evaluated their progress on integrating ethics in distinct areas of health, and deemed it essential that a systemic approach be promoted so that research is always conducted ethically. To strengthen research ethics systemically, PAHO has developed research ethics indicators that address the core components of a national research ethics system. The indicators allow to identify advances on each component, evaluate progress toward strengthening systems, and develop a plan of action for each country based on the indicators not yet reached. This indicator-based strategy could be useful beyond the Region and be a model for other countries and regions to strengthen their national research ethics systems and catalyze research ethics.


Assuntos
Ética , Bioética , Ética em Pesquisa , Comitês de Ética em Pesquisa , Pesquisa , Sistemas de Saúde , Sistemas Nacionais de Saúde
16.
Washington, D.C.; OPS; 2021-09-22. (OPS/HSS/BIO/21-0009).
em Espanhol | PAHO-IRIS | ID: phr-54868

RESUMO

En el 2018, los Estados Miembros de la OPS evaluaron los avances en la integración de la ética en los distintos ámbitos de la salud y destacaron la importancia de impulsar un enfoque sistémico con vistas a que la investigación siempre se realice de manera ética. En esta publicación, la OPS presenta un conjunto de indicadores que abordan los componentes centrales de un sistema nacional de ética de la investigación. Estos permiten identificar los avances en cada componente, evaluar el progreso en el fortalecimiento de los sistemas y elaborar un plan de acción para cada país sobre la base de los indicadores que estén pendientes de alcanzarse. Esta estrategia basada en indicadores podría ser de utilidad más allá de la Región y constituir un modelo para que otros países y regiones fortalezcan sus sistemas nacionales de ética de la investigación y catalicen la investigación ética.


Assuntos
Bioética , Ética , Pesquisa , Ética em Pesquisa , Comitês de Ética em Pesquisa , Sistemas de Saúde , Sistemas Nacionais de Saúde
17.
Narrat Inq Bioeth ; 11(1): 1-6, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34334454

RESUMO

This symposium is separated into two sections. The first includes twelve personal stories from IRB members, administrators, or staff about their experiences during the COVID-19 pandemic. The second section includes twelve personal stories from researchers. Six commentaries on these narratives are offered by experts in research ethics, regulatory oversite, IRB administration, the logistics of clinical research, and investigator responsibilities. These narratives and commentaries offer an inside look at how the COVID-19 pandemic affected the physical logistics of clinical research already underway, demanded immediate investment in scientific investigation of vaccines and treatments, and rerouted the usual decision pathways that guide ethical practice.


Assuntos
Pesquisa Biomédica/ética , COVID-19 , Comitês de Ética em Pesquisa , Pandemias , Vacinas contra COVID-19 , Membro de Comitê , Ética em Pesquisa , Humanos , Narração , Pesquisadores , SARS-CoV-2
18.
Narrat Inq Bioeth ; 11(1): 39-45, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34334467

RESUMO

The SARS-CoV-2 pandemic has affected practically every aspect of life across the globe for the past year or more; the practice of clinical research not the least. Clinician scientists attempting to start or continue work both related and unrelated to the disease itself have faced ethical, oversight, or regulatory challenges. No aspect of the clinical trial enterprise was unaffected. These narratives detail some of the barriers encountered and how the investigators coped (or didn't cope). Common themes emerged, ranging from a need to contribute, which drove the researchers to frustration with real and perceived obstructions (both old and new). The narratives disclose common ethical issues related to research during a pandemic: issues both qualitatively and quantitatively different from other human subject research; challenges both new and novel, as well as those previously seen, but writ large in the face of the crisis. The narratives also offer words of advice from the trenches and speak to successes, both large and small, and to the value of teamwork and focus on a common goal.


Assuntos
Atitude do Pessoal de Saúde , Pesquisa Biomédica/ética , COVID-19 , Pandemias , Pesquisadores/ética , Ética em Pesquisa , Humanos , Narração , Pesquisadores/psicologia , SARS-CoV-2
19.
Narrat Inq Bioeth ; 11(1): 47-53, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34334468

RESUMO

The researchers' stories collected here demonstrate how many ethical and practical challenges routinely associated with conducting human research were amplified during the COVID-19 pandemic. These challenges include designing studies to minimize risks and maximize potential benefits, working with institutional review boards (IRBs), recruiting and enrolling participants, obtaining valid informed consent, promoting data integrity, managing budget constraints, and finding time to fulfill research obligations along with other duties. By offering insights about not only the barriers and challenges researchers encountered but also the creative solutions they and their colleagues found to conduct research, this behind-the-scenes peek at researchers' experiences helps us to identify barriers and potential lasting improvements for human subjects research even in the best of times.


Assuntos
Pesquisa Biomédica/ética , COVID-19 , Pandemias , Pesquisadores/ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Narração , Projetos de Pesquisa , SARS-CoV-2
20.
Narrat Inq Bioeth ; 11(1): 55-59, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34334469

RESUMO

The COVID-19 pandemic disrupted and displaced the old normal, necessitating adaptation. The narratives in this issue of NIB give us a glimpse into the experience of conducting research during a pandemic. The authors were on a mission to pursue research despite the challenges the pandemic imposed. They described difficulties of the Institutional Review Board process and the necessity of asking for accelerated IRB approval. The authors also discussed challenges they faced with research participant recruitment during a pandemic and concerns about keeping staff safe from the risk of transmission. The authors adapted and adjusted to the personal and professional restraints the COVID-19 pandemic placed upon them. Despite these difficulties, the authors remained committed to maintaining the integrity of their research.


Assuntos
Atitude do Pessoal de Saúde , Pesquisa Biomédica , COVID-19 , Pandemias , Pesquisadores , Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Narração , Seleção de Pacientes , SARS-CoV-2 , Segurança
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