Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 8.626
Filtrar
1.
Nature ; 597(7875): 153, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34493844
2.
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
12.
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
13.
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
14.
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
15.
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
16.
Narrat Inq Bioeth ; 11(1): 101-105, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34334484

RESUMO

In early 2020, clinicians and researchers rushed to understand the SARS-CoV-2 virus and how to go about treating and preventing it. Caring for patients while simultaneously learning about a disease not seen before created challenges on several levels. Much of the spotlight was on the researchers doing this critical work; however, these narratives remind us of the enormous effort and commitment shown by IRB members and research administrators responsible for research infrastructure. Despite the sense of urgency and obligation to plan and conduct clinical research during the pandemic, IRBs guaranteed that researchers still adhered to the core ethical principles that protect the rights and welfare of human subjects so that critical research could continue. Many themes emerge in these stories, including the need for flexibility in processes for both staff and research participants and the perception that IRB members serve as "research gatekeepers." With approaches to clinical research evolving, the SARS-CoV-2 pandemic may be the catalyst needed to make sustainable improvements to our research processes, roles, and goals.


Assuntos
Pesquisa Biomédica/ética , COVID-19 , Comitês de Ética em Pesquisa , Pandemias , Ética em Pesquisa , Controle de Acesso , Humanos , Narração , Pesquisadores , Sujeitos da Pesquisa , SARS-CoV-2
17.
J Postgrad Med ; 67(3): 134-138, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34414930

RESUMO

Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.


Assuntos
COVID-19 , Consentimento Livre e Esclarecido , Seleção de Pacientes/ética , Ensaios Clínicos Controlados Aleatórios como Assunto , COVID-19/epidemiologia , COVID-19/prevenção & controle , COVID-19/terapia , Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , SARS-CoV-2
18.
BMC Med Ethics ; 22(1): 96, 2021 07 19.
Artigo em Inglês | MEDLINE | ID: mdl-34281535

RESUMO

BACKGROUND: In the course of the COVID-19 pandemic, the biomedical research community's attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees (RECs). METHODS: We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. RESULTS: We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk-benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) respect for study participants (e.g. data security). Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. CONCLUSIONS: RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies.


Assuntos
COVID-19 , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Pandemias , SARS-CoV-2
19.
Cancer Epidemiol Biomarkers Prev ; 30(8): 1455-1458, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34233916

RESUMO

Since the start of the COVID-19 pandemic, Asian Americans have been subjected to rising overt discrimination and violent hate crimes, highlighting the health implications of racism toward Asian Americans. As Asian Americans are the only group for whom cancer is the leading cause of death, these manifestations of anti-Asian racism provoke the question of the impact of racism across the cancer continuum for Asian Americans. In this Commentary, we describe how the myth of the "model minority" overlooks the diversity of Asian Americans. Ignoring such diversity in sociocultural trends, immigration patterns, socioeconomic status, health behaviors, and barriers to care masks disparities in cancer risk, access to care, and outcomes across Asian American populations. We recommend cancer epidemiologists, population science researchers, and oncology providers direct attention toward: (i) studying the impacts of structural and personally mediated racism on cancer risk and outcomes; (ii) ensuring studies reflect the uniqueness of individual ethnic groups, including intersectionality, and uncover underlying disparities; and (iii) applying a critical race theory approach that considers the unique lived experiences of each group. A more nuanced understanding of cancer health disparities, and how drivers of these disparities are associated with race and differ across Asian American ethnicities, may elucidate means through which these disparities can be alleviated.


Assuntos
Americanos Asiáticos/estatística & dados numéricos , Ética em Pesquisa/educação , Disparidades em Assistência à Saúde , Neoplasias/terapia , Racismo/prevenção & controle , Americanos Asiáticos/psicologia , Comportamentos Relacionados com a Saúde , Humanos , Racismo/etnologia , Racismo/psicologia , Classe Social
20.
BMJ Open ; 11(7): e047076, 2021 07 23.
Artigo em Inglês | MEDLINE | ID: mdl-34301656

RESUMO

OBJECTIVES: In response to the COVID-19 pandemic there have been significant developments in research, its conduct and the supporting ethical framework. While many protocols have been delayed, halted or modified, other research efforts have been accelerated, generating controversy. The goal of this paper is to determine the rates of references surrounding the ethical oversight of research as reported in current COVID-19-related research publications. DESIGN: Scoping review. SETTING: Population-based observational or interventional studies from December 2019 to May 2020 with sample size of two or more. Studies were searched through electronic databases including Medline, EMBASE, and Cochrane CENTRAL Register of Controlled Trials. PARTICIPANTS: Eligibility criteria included participants within published studies who tested positive for COVID-19. MAIN OUTCOMES AND MEASURES: Data were extracted and charting methods included taking note of references to ethical frameworks, institutional review board (IRB), ethics committee (EC) or research ethics board (REB) involvement, consent processes, and other variables. RESULTS: 11 556 articles were screened, with 656 included in the final analysis. References to ethics were present in 530 (80.8%) studies, with 491 (74.8%) involving IRB/ECs/REBs and 126 (19.2%) not referencing ethics. Consent processes were outlined in 201 (30.6%) studies, with 198 (30.2%) reporting that they obtained consent waivers, however, 257 (39.2%) did not mention consent at all. Differences (p<0.001) in ethics-related references were apparent when analysed by continent, publication type, sample size and IF. CONCLUSIONS: The majority of published articles pertaining to COVID-19 research made mention of ethical considerations, however, national and regional variations in research ethics review requirements introduce heterogeneity between studies and raise important questions about the conduct of scientific research during global public emergencies. TRIAL REGISTRATION NUMBER: Open Science Framework: https://osfio/z67wb.


Assuntos
COVID-19 , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Pandemias , SARS-CoV-2
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...