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Rev. bioét. derecho ; (50): 407-423, nov. 2020. tab, graf
Artigo em Português | IBECS | ID: ibc-191365


O processo de consentimento informado para participação de pesquisa com seres humanos visa fornecer as informações adequadas ao indivíduo possibilitando que este tome a decisão de participar de maneira voluntária, livre de pressões externas. A possibilidade de remuneração poderia interferir na voluntariedade deste processo de consentir. O presente estudo objetivou avaliar percepção de influência da remuneração monetária por meio de simulações de pesquisa que variam em nível de risco (Bioequivalência e de Fase I) e tipo de remuneração monetária (com e sem). Participaram do estudo 80 voluntários. Os resultados sugerem que a remuneração não constituiu uma interferência na voluntariedade do processo de consentimento, visto que participantes aceitaram convite para participar da primeira pesquisa para a qual foram convidados e não se sentiram influenciados indebidamente

El proceso de consentimiento informado para la participación de sujetos humanos en investigación tiene por objeto dar la información adecuada al individuo, permitiendo que tome la decisión de participar de manera voluntaria y libre de presiones externas. La posibilidad de remuneración podría interferir en la voluntariedad de este proceso de consentir. El presente estudio evalúa la percepción de la influencia de la remuneración monetaria a través de simulaciones de investigación que varían en nivel de riesgo (Bioequivalencia y de Fase I) y tipo de remuneración monetaria (con y sin). Participaron del estudio 80 voluntarios. Los resultados sugieren que la remuneración no constituyó una interferencia en la voluntariedad del proceso de consentimiento, ya que los participantes aceptaron una invitación para participar en la primera encuesta a la que fueron invitados y no se sintieron influenciados incorrectamente

The process of informed consent for research participation with human beings aims to provide appropriate information to individuals enabling him or her to make the decision to participate voluntarily, free of external pressures. The possibility of remuneration could interfere in the willingness to consent. The present study aims to evaluate the perception of influence of the monetary payment through research simulations that vary in the level of risk (Bioequivalence and Phase I) and type of monetary payment (with and without). Eighty volunteers participated in the study. The results suggest that remuneration did not interfere with the willingness of the consent process, as participants accepted an invitation to participate in the first research option to which they were invited to and did not feel undue influence

El procés de consentiment informat per a la participació de subjectes humans en recerca té per objecte donar la informació adequada a l'individu, permetent que prengui la decisió de participar de manera voluntària I lliure de pressions externes. La possibilitat de remuneració podria interferir en la voluntarietat d'aquest procés de consentir. El present estudi avalua la percepció de la influència de la remuneració monetària a través de simulacions de recerca que varien en nivell de risc (Bioequivalencia I de Fase I) I tipus de remuneració monetària (amb I sense). Van participar de l'estudi 80 voluntaris. Els resultats suggereixen que la remuneració no va constituir una interferència en la voluntarietat del procés de consentiment, ja que els participants van acceptar una invitació per a participar en la primera enquesta a la qual van ser convidats I no es van sentir influenciats incorrectament

Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Pesquisa Biomédica/economia , Remuneração , Decisões , Consentimento Livre e Esclarecido , Ética em Pesquisa , Fatores Socioeconômicos
Bull World Health Organ ; 98(9): 625-631, 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-33012862


While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended entirely because of either COVID-19-related legal restrictions or logistical, staffing or operational concerns. Billions of people globally are currently affected by lockdowns or curfews. Since the timescale of such restrictive measures is unknown and subject to change, many studies are now in limbo and the welfare of tens of thousands of study participants is at risk. These circumstances have introduced complex ethical challenges that merit urgent attention from international sponsors, researchers and regulators. Certain sponsors and regulators have published guidelines on how the COVID-19-related disruptions to clinical research should be managed. Although these guidelines provide a good starting point in navigating the challenges of the evolving pandemic, they only apply to those researchers funded or governed by these bodies. Here, we provide guidelines on managing such disruptions that apply beyond these specific settings. We highlight some of the effects of the COVID-19 pandemic on other ongoing research projects that are unrelated to COVID-19 and provide practical guidance on how the welfare of affected study participants should be managed. We conclude that policy-makers, sponsors, researchers and regulators must adopt a more flexible approach to ensure participant safety, while maintaining data integrity and complying with good clinical practices.

Pesquisa Biomédica/economia , Pesquisa Biomédica/legislação & jurisprudência , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Betacoronavirus , Humanos , Pandemias , Pesquisadores , Sujeitos da Pesquisa
Rev Soc Bras Med Trop ; 53: e20200522, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32965457


INTRODUCTION: This study investigated the role of early public research funding regarding the COVID-19 pandemic in Brazil. METHODS: We examined the budget for research projects relating to the number of cases and deaths and the relationship between each federal unit, gross domestic product (GDP) per capita, and the national GDP per capita. RESULTS: Using data from the websites of official funding agencies and the Brazilian government, we found that, in the first four months since the first case in Wuhan, China (December 31, 2019), around US$ 38.3 million were directed to public funding for scientific investigations against the COVID-19 pandemic. However, only 11 out of 27 federal units provided funding during the initial stages of the outbreak, and those that did provide financing were not necessarily the units having the most inhabitants, highest GDP, or the greatest number of cases. The areas of research interest were also identified in the funding documents; the most common topic was "diagnosis" and the least common was "equipment for treatment." CONCLUSIONS: Brazilian researchers had access to funding opportunities for projects against COVID-19. However, strategies to minimize the economic impacts of COVID-19 are crucial in mitigating or avoiding substantial financial and social shortcomings, particularly in terms of an emerging market such as Brazil.

Pesquisa Biomédica/economia , Infecções por Coronavirus/economia , Apoio Financeiro , Pandemias/economia , Pneumonia Viral/economia , Betacoronavirus , Brasil , Humanos
Lancet Glob Health ; 8(10): e1295-e1304, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32971052


BACKGROUND: Each year, billions of US$ are spent globally on infectious disease research and development. However, there is little systematic tracking of global research and development. We present research on investments into infectious diseases research from funders in the G20 countries across an 18-year time period spanning 2000-17, comparing amounts invested for different conditions and considering the global burden of disease to identify potential areas of relative underfunding. METHODS: The study examined research awards made between 2000 and 2017 for infectious disease research from G20-based public and philanthropic funders. We searched research databases using a range of keywords, and open access data were extracted from funder websites. Awards were categorised by type of science, specialty, and disease or pathogen. Data collected included study title, abstract, award amount, funder, and year. We used descriptive statistics and Spearman's correlation coefficient to investigate the association between research investment and disease burden, using Global Burden of Disease 2017 study data. FINDINGS: The final 2000-17 dataset included 94 074 awards for infectious disease research, with a sum investment of $104·9 billion (annual range 4·1 billion to 8·4 billion) and a median award size of $257 176 (IQR 62 562-770 661). Pre-clinical research received $61·1 billion (58·2%) across 70 337 (74·8%) awards and public health research received $29·5 billion (28·1%) from 19 197 (20·4%) awards. HIV/AIDS received $42·1 billion (40·1%), tuberculosis received $7·0 billion (6·7%), malaria received $5·6 billion (5·3%), and pneumonia received $3·5 billion (3·3%). Funding for Ebola virus ($1·2 billion), Zika virus ($0·3 billion), influenza ($4·4 billion), and coronavirus ($0·5 billion) was typically highest soon after a high-profile outbreak. There was a general increase in year-on-year investment in infectious disease research between 2000 and 2006, with a decline between 2007 and 2017. Funders based in the USA provided $81·6 billion (77·8%). Based on funding per 2017 disability-adjusted life years (DALYs), HIV/AIDS received the greatest relative investment ($772 per DALY), compared with tuberculosis ($156 per DALY), malaria ($125 per DALY), and pneumonia ($33 per DALY). Syphilis and scabies received the least relative investment (both $9 per DALY). We observed weak positive correlation (r=0·30) between investment and 2017 disease burden. INTERPRETATION: HIV research received the highest amount of investment relative to DALY burden. Scabies and syphilis received the lowest relative funding. Investments for high-threat pathogens (eg, Ebola virus and coronavirus) were often reactive and followed outbreaks. We found little evidence that funding is proactively guided by global burden or pandemic risk. Our findings show how research investments are allocated and how this relates to disease burden and diseases with pandemic potential. FUNDING: Bill & Melinda Gates Foundation.

Pesquisa Biomédica/economia , Doenças Transmissíveis/economia , Saúde Global/economia , Apoio à Pesquisa como Assunto/estatística & dados numéricos , Humanos , Cooperação Internacional
An Acad Bras Cienc ; 92(4): e20200700, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32844986


The Brazilian scientific community and health care workers are working hard to provide support for the political health measures to deal with this unprecedented crisis of the COVID-19 pandemic. Paradoxically, while the society is looking forward for an immediate response of the scientific community, Brazilian scientists are facing a dramatic reduction in financial support for research and graduate programs.

Pesquisa Biomédica/economia , Infecções por Coronavirus/epidemiologia , Apoio Financeiro , Pneumonia Viral/epidemiologia , Betacoronavirus , Brasil , Humanos , Pandemias
Dis Model Mech ; 13(6)2020 06 23.
Artigo em Inglês | MEDLINE | ID: mdl-32764155


The outbreak of COVID-19 has stalled both the basic, clinical and non-COVID medical research. The scientific community has shown extraordinary flexibility and resilience in responding to the pandemic. However, funding restructuring, risk of infection, cancelation of scientific conferences and delayed experiments have already proven detrimental to the career opportunities of early-career scientists. Moreover, school closures and a lack of systematic support for childcare have been additional challenges for early- and mid-career researchers who have young children. This Editorial describes an early-career researcher's experience and highlights how after efficiently contributing to 'flattening the curve' of COVID-19 infections, the research community has an opportunity for growth and re-structuring.

Betacoronavirus , Pesquisa Biomédica , Infecções por Coronavirus/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Pesquisa Biomédica/economia , Criança , Cuidado da Criança/economia , Cuidado da Criança/provisão & distribução , Pré-Escolar , Humanos , Pessoal de Laboratório Médico , Cidade de Nova Iorque/epidemiologia , Pesquisadores
Value Health ; 23(8): 1072-1078, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32828220


Although it is generally accepted that human tissue biobanks are important to facilitate progress in health and medical research, many academic biobanks face sustainability challenges. We propose that biobank sustainability is challenged by a lack of available data describing the outputs and benefits that are produced by biobanks, as reflected by a dearth of publications that enumerate biobank outputs. We further propose that boosting the available information on biobank outputs and using a broader range of output metrics will permit economic analyses such as cost-consequence analyses of biobank activity. Output metrics and cost-consequence analyses can allow biobanks to achieve efficiencies, and improve the quality and/or quantity of their outputs. In turn, biobank output measures provide all stakeholders with explicit and accountable data on biobank value, which could contribute to the evolution of biobank operations to best match research needs, and mitigate some threats to biobank sustainability.

Bancos de Espécimes Biológicos/organização & administração , Pesquisa Biomédica/organização & administração , Modelos Econométricos , Bancos de Espécimes Biológicos/economia , Pesquisa Biomédica/economia , Custos e Análise de Custo , Humanos
PLoS One ; 15(8): e0238026, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32834005


This study aims to analyze the formation of the frame of breast cancer research. To test our hypothesis that the research frame depends on the funding sources, we collected the abstracts of 48,448 breast cancer research papers from PubMed and applied structural topic modeling, word network analysis, and LASSO logistic regression to the data. In particular, we analyzed the relationship between funding sources and the molecularization of breast cancer knowledge. The results show that government-funded research is likely to have molecular objects or population as the unit of interest, whereas the research not funded by the government is likely to have individual patients as the unit of interest in relation to specific treatments. This phenomenon is attributed to the different interests of government institutions and the private sector. This study improves our understanding of molecularization and medical knowledge production.

Pesquisa Biomédica/economia , Neoplasias da Mama , Modelos Logísticos , PubMed
Ann Surg ; 272(4): 539-546, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32740237


OBJECTIVE: The aim of this study was to assess the contemporary trends in National Institutes of Health (NIH) grants awarded to surgical investigators, including potential disparities. BACKGROUND: The NIH remains the primary public funding source for surgical research in the United States; however, the patterns for grants and grantees are poorly understood. METHODS: NIH RePORTER was queried for new grants (R01, -03, -21) awarded to Departments of Surgery (DoS). Principal investigators' (PIs) data were extracted from publicly available information from their institutions' websites and/or professional social media accounts. RESULTS: The NIH awarded 1101 new grants (total: $389,006,782; median: $313,030) between 2008 and 2018. Funding to DoS has doubled in the last 10 years ($22,983,500-2008 to $49,446,076-2018). Midwest/Southeast institutions and surgical oncologists accounted for majority of the grants (31.9% and 24.5%, respectively). Only 24.7% of the projects were led by female PIs, who were predominantly nonphysician PhD scientists (52% vs 37.7% PhD-only male PIs; P = 0.002). During this time, there was a significant increase from 12.4% to 31.7% in grants awarded to PIs with >15 years of experience. These grants were associated with 8215 publications; however, only 13.2% were published in high-impact journals (impact factor ≥10). 4.4% of the grants resulted in patents, and these were associated with higher award amounts ($345,801 vs $311,350; P = 0.030). On multivariate analysis, combined MD/PhD degree [odds ratio (OR) 5.98; 95% confidence interval (CI) 2.18-16.39; P < 0.001] was associated with improved odds of patent creation; conversely, practicing surgeon PIs affected patent creation negatively (OR 0.31; 95% CI 0.11-0.85; P = 0.024). CONCLUSION: In the last decade, a greater proportion of NIH grants in DoS were awarded to more experienced investigators. Disparities exist among grantees, and female investigators are underrepresented, especially among practicing surgeons.

Pesquisa Biomédica/economia , Financiamento Governamental/estatística & dados numéricos , Cirurgia Geral , National Institutes of Health (U.S.)/economia , Editoração/economia , Editoração/estatística & dados numéricos , Apoio à Pesquisa como Assunto , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Estados Unidos
Heart Lung Circ ; 29(11): 1588-1595, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32839116


BACKGROUND: Cardiovascular disease is the leading cause of death in Australia. Investment in research solutions has been demonstrated to yield health and a 9.8-fold return economic benefit. The sector, however, is severely challenged with success rates of traditional peer-reviewed funding in decline. Here, we aimed to understand the perceived challenges faced by the cardiovascular workforce in Australia prior to the COVID-19 pandemic. METHODS: We used an online survey distributed across Australian cardiovascular societies/councils, universities and research institutes over a period of 6 months during 2019, with 548 completed responses. Inclusion criteria included being an Australian resident or an Australian citizen who lived overseas, and a current or past student or employee in the field of cardiovascular research. RESULTS: The mean age of respondents was 42±13 years, 47% were male, 85% had a full-time position, and 40% were a group leader or laboratory head. Twenty-three per cent (23%) had permanent employment, and 82% of full-time workers regularly worked >40 hours/week. Sixty-eight per cent (68%) said they had previously considered leaving the cardiovascular research sector. If their position could not be funded in the next few years, a staggering 91% of respondents would leave the sector. Compared to PhD- and age-matched men, women were less likely to be a laboratory head and to feel they had a long-term career path as a cardiovascular researcher, while more women were unsure about future employment and had considered leaving the sector (all p<0.05). Greater job security (76%) and government and philanthropic investment in cardiovascular research (72%) were highlighted by responders as the main changes to current practices that would encourage them to stay. CONCLUSION: Strategic solutions, such as diversification of career pathways and funding sources, and moving from a competitive to a collaborative culture, need to be a priority to decrease reliance on government funding and allow cardiovascular researchers to thrive.

Pesquisa Biomédica , Doenças Cardiovasculares , Infecções por Coronavirus/epidemiologia , Administração Financeira , Pneumonia Viral/epidemiologia , Pesquisadores , Apoio à Pesquisa como Assunto , Recursos Humanos , Adulto , Austrália , Betacoronavirus , Pesquisa Biomédica/economia , Pesquisa Biomédica/organização & administração , Pesquisa Biomédica/tendências , Emprego/economia , Emprego/psicologia , Feminino , Administração Financeira/métodos , Administração Financeira/organização & administração , Administração Financeira/estatística & dados numéricos , Financiamento Governamental , Humanos , Masculino , Cultura Organizacional , Pandemias , Técnicas de Planejamento , Pesquisadores/economia , Pesquisadores/psicologia , Pesquisadores/estatística & dados numéricos , Apoio à Pesquisa como Assunto/organização & administração , Apoio à Pesquisa como Assunto/tendências , Inquéritos e Questionários , Recursos Humanos/estatística & dados numéricos