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2.
Proc Natl Acad Sci U S A ; 117(48): 30014-30021, 2020 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-33229586

RESUMO

In 1966, Henry Beecher published his foundational paper "Ethics and Clinical Research," bringing to light unethical experiments that were routinely being conducted by leading universities and government agencies. A common theme was the lack of voluntary consent. Research regulations surrounding laboratory experiments flourished after his work. More than half a century later, we seek to follow in his footsteps and identify a new domain of risk to the public: certain types of field experiments. The nature of experimental research has changed greatly since the Belmont Report. Due in part to technological advances including social media, experimenters now target and affect whole societies, releasing interventions into a living public, often without sufficient review or controls. A large number of social science field experiments do not reflect compliance with current ethical and legal requirements that govern research with human participants. Real-world interventions are being conducted without consent or notice to the public they affect. Follow-ups and debriefing are routinely not being undertaken with the populations that experimenters injure. Importantly, even when ethical research guidelines are followed, researchers are following principles developed for experiments in controlled settings, with little assessment or protection for the wider societies within which individuals are embedded. We strive to improve the ethics of future work by advocating the creation of new norms, illustrating classes of field experiments where scholars do not appear to have recognized the ways such research circumvents ethical standards by putting people, including those outside the manipulated group, into harm's way.


Assuntos
Ética em Pesquisa , Experimentação Humana/ética , Experimentação Humana/normas , Humanos , Padrões de Referência , Risco , Mídias Sociais , Ciências Sociais
13.
Biologicals ; 67: 69-74, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32829985

RESUMO

This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).


Assuntos
Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Desenvolvimento de Medicamentos/ética , Experimentação Humana/ética , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/uso terapêutico , Desenvolvimento de Medicamentos/legislação & jurisprudência , Experimentação Humana/legislação & jurisprudência , Humanos , Controle de Qualidade , Padrões de Referência
14.
Daru ; 28(2): 807-812, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32851596

RESUMO

BACKGROUND: The pandemic associated with the new SARS-CoV-2 coronavirus continues to spread worldwide. The most favorable epidemic control scenario, which provides long-term protection against COVID-19 outbreak, is the development and distribution of an effective and safe vaccine. The need to develop a new COVID-19 vaccine is pressing; however, it is likely to take a long time, possibly several years. This is due to the time required to demonstrate the safety and efficacy of the proposed vaccine. and the time required to manufacture and distribute millions of doses. OBJECTIVES: To accelerate this development and associated safety testing, the deliberate infection of healthy volunteers has been suggested. The purpose of this short communication is to describe the ethical aspects of this type of testing, RESULTS: Deliberate infection of volunteers with a dangerous virus such as SARS-CoV-2 was initially considered unethical by researchers; but the current pandemic is so different from previous ones that these studies are considered ethical if certain criteria are met. Participants in human challenge studies must be relatively young, in good health and must receive the highest quality medical care, with frequent monitoring. Tests should also be performed with great caution and specialized medical supervision. Besides, the fact that obtaining vaccines faster through deliberate infection studies of healthy people has greater benefits than risks, has been demonstrated by obtaining other vaccines in other historical pandemics such as: smallpox, influenza, malaria, typhoid fever, Dengue fever and Zika. CONCLUSIONS: One possibility to shorten the time required for the development of COVID-19 vaccines is to reduce clinical phases II and III by using human challenge studies through eliberate infection of healthy volunteers with SARS-CoV-2 after administration of the candidate vaccine. Accelerating the development of a COVID-19 vaccine even for a few weeks or months would have a great beneficial impact on public health by saving many lives.


Assuntos
/administração & dosagem , /imunologia , Animais , /virologia , /imunologia , Ensaios Clínicos como Assunto/ética , Experimentação Humana/ética , Humanos , Fatores de Tempo
16.
Ann Intern Med ; 173(7): 558-562, 2020 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-32687743

RESUMO

Evaluating the quality and effectiveness of the institutional review boards (IRBs) responsible for overseeing research involving human participants is critically important but perpetually challenging. Seemingly common-sense measures, such as the number of proposals approved with and without major modifications and the number of unexpected adverse events occurring in approved protocols, can be misleading indicators of participant protection, and regulatory compliance may not correspond to achieving ethical goals. These measurement challenges make it difficult to assess the validity of concerns about different IRB models. A group of U.S. senators recently raised questions about the increasing use of for-profit IRBs to review research proposals (as opposed to boards typically housed at academic medical centers and health care institutions) and, more specifically, about the growing trend of private equity ownership and consolidation of for-profit IRBs. Although all IRBs face pressure to speed reviews and none are entirely free of conflicts of interest, the private equity model is particularly susceptible to approaches that could undercut the ethical mission of IRBs to protect and promote the rights and welfare of research participants. Ideally, the quality of board oversight could be measured directly, rather than relying on the heuristic of board type; this article describes several current efforts toward this goal. In the meantime, one improvement may be to pursue a new model of IRB oversight: independent nonprofit boards that stand apart from research institutions, take advantage of business approaches to research review, and minimize conflicts of interest.


Assuntos
Experimentação Humana , Setor Privado/ética , Conflito de Interesses , Comitês de Ética em Pesquisa/legislação & jurisprudência , Comitês de Ética em Pesquisa/normas , Regulamentação Governamental , Experimentação Humana/legislação & jurisprudência , Experimentação Humana/normas , Humanos , Setor Privado/organização & administração , Estados Unidos
18.
Hastings Cent Rep ; 50(4): 9-11, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32633816

RESUMO

The Covid-19 crisis has underscored the importance of the collection and analysis of clinical and research data and specimens for ongoing work. The federal government recently completed a related revision of the human subjects research regulations, founded in the traditional principles of research ethics, but in this commentary, we argue that the analysis underpinning this revision overemphasized the importance of informed consent, given the low risks of secondary research. Governing the interests of a community is different from governing the interests of individuals, and here we suggest that, moving forward, the analyses of the risks of secondary research protocols be assessed from the perspective of the former.


Assuntos
Pesquisa Biomédica/ética , Consentimento Livre e Esclarecido/ética , Sujeitos da Pesquisa , Comitês de Ética em Pesquisa , Governo Federal , Regulamentação Governamental , Experimentação Humana/ética , Humanos , Formulação de Políticas , Projetos de Pesquisa
19.
Zhonghua Yi Shi Za Zhi ; 50(1): 15-20, 2020 Jan 28.
Artigo em Chinês | MEDLINE | ID: mdl-32564532

RESUMO

"The Research Report on Epidemic Prevention of Army Medical School Ⅱ: Vol.1, No.36" , the report named "various symptoms and serological responses of human body after receiving ultrasonic cholera vaccine" is one of the declassified materials of Japanese biological warfare. The author is M. D. Watanabe Be. Through detailed analysis of its contents, such as institute of report, test method, test results, and so forth, conclusion is reached that Unit 731 did conduct scientific research based on human-subject experiment to launch biological warfare on human beings. The report mentioned above is one of the most important evidence of crime that Japan conducts biological warfare which violates international convention and contempt bottom line of human basic morals and ethics.


Assuntos
Armas Biológicas/ética , Epidemias/prevenção & controle , Experimentação Humana/ética , Relatório de Pesquisa , Humanos , Japão , Princípios Morais , Faculdades de Medicina
20.
Int J Pediatr Otorhinolaryngol ; 135: 110108, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32480138

RESUMO

OBJECTIVE: Although subject recruitment is one of the most critical aspects of human subject research, there is a lack of studies prospectively examining the recruitment preferences of adults for research involving children. METHODS: This was a cross-sectional study of adults accompanying patients at an otolaryngology clinic in a pediatric medical center. Anonymous questionnaires were distributed in English and Spanish to one adult for every patient. Questions assessed the respondent's preferences for research recruitment including contact method preferences, contact preferences for medical profession type, and whether they would expect a child to receive a small gift for participating in a research study. Fisher's exact tests were used to assess the association between the primary predictor, language, and each outcome. RESULTS: 566 surveys were collected. 505 (89.1%) were completed in English and 61 (10.7%) were completed in Spanish. Spanish-speaking respondents were more likely to prefer talking to a doctor (76.7%) than English-speaking respondents (40.1%, p < 0.05). Spanish-speaking respondents were more likely to prefer talking over the phone (48.3%) than English-speaking respondents (17.3%, p < 0.05). Spanish-speaking respondents were more likely to prefer communicating via text messaging (41.7%) than English-speaking respondents (16.3%, p < 0.05). English-speaking respondents were more likely to prefer communicating through the patient portal of an electronic health record (EHR) (19%) than Spanish-speaking respondents(3.3%, p < 0.05). Mothers were more likely to prefer talking to a nurse/physician's assistant (20%) than fathers (10%, p < 0.05). Mothers were more likely to prefer talking to research staff (20%) than fathers (9%, p < 0.05). Mothers were more likely to prefer communication via text-message (22%) than fathers (6%, p < 0.05). Spanish-speaking respondents were more likely to prefer pediatric patients receiving a small monetary gift for participating in clinical research (70%) than English-speaking respondents (30%, p < 0.05). CONCLUSION: There was a significant association between preference for recruitment method and primary language spoken by the respondent. Further inquiry is required to understand these differences between English and Spanish speakers.


Assuntos
Ensaios Clínicos como Assunto , Pais , Seleção de Pacientes , Adulto , Criança , Comunicação , Estudos Transversais , Grupo com Ancestrais do Continente Europeu/estatística & dados numéricos , Feminino , Hispano-Americanos/estatística & dados numéricos , Experimentação Humana , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Telefone , Envio de Mensagens de Texto
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