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1.
Rev. bioét. derecho ; (50): 407-423, nov. 2020. tab, graf
Artigo em Português | IBECS | ID: ibc-191365

RESUMO

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


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


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


Assuntos
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
7.
Washington, D.C.; OPS; 2020-09-29. (OPS/HSS/BIO/COVID-19/20-0034).
em Espanhol | PAHO-IRIS | ID: phr-52767

RESUMO

La transparencia es un componente central de la gobernanza ética de la investigación. En el contexto de la pandemia de COVID-19, la transparencia es fundamental para promover la confianza pública en la investigación y en la respuesta a la pandemia. Si la sociedad y todos los actores involucrados conocen qué investigaciones se están realizando y qué mecanismos se tienen para asegurar que esas investigaciones se realicen de manera ética, estarán más dispuestos a contribuir a los esfuerzos de investigación y confiar en los resultados de las investigaciones. Por ello, la Organización Panamericana de la Salud (OPS) recomienda a las autoridades nacionales competentes tomar acción para fortalecer la transparencia de la investigación durante la pandemia.


Assuntos
Infecções por Coronavirus , Coronavirus , Pandemias , Bioética , Ética em Pesquisa
8.
Rom J Morphol Embryol ; 61(1): 277-281, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32747923

RESUMO

PURPOSE: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014∕536, the Directive 2001∕20∕EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. BACKGROUND: The Directive 2001∕20∕EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.


Assuntos
Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/legislação & jurisprudência , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Revisão Ética , Ética em Pesquisa , Política de Saúde , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Comissão de Ética , União Europeia , Humanos , Consentimento Livre e Esclarecido , Pandemias , Segurança do Paciente , Saúde Pública , Projetos de Pesquisa
9.
Pediatrics ; 146(Suppl 1): S93-S98, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32737240

RESUMO

A central tension in pediatric research ethics arises from our desire to protect children from harm while also allowing progress toward discoveries that could improve child health. A prime example of this tension is research on a controversial yet increasingly common practice: the use of cannabis by women to treat nausea and vomiting of pregnancy. Studies of cannabis use in pregnancy face a combination of ethical hurdles because of the inclusion of pregnant women and involvement of a schedule I controlled substance. Given the growing need for research on the safety and efficacy of cannabis for nausea and vomiting of pregnancy, we reflect on the multiple historical contexts that have contributed to the challenge of studying cannabis use during pregnancy and make a case for the ethical rationale for such research.


Assuntos
Ética em Pesquisa , Maconha Medicinal/uso terapêutico , Êmese Gravídica/terapia , Pediatria/ética , Gestantes , Sujeitos da Pesquisa , Antieméticos/efeitos adversos , Diciclomina/uso terapêutico , Doxilamina/uso terapêutico , Aprovação de Drogas , Combinação de Medicamentos , Feminino , Humanos , Maconha Medicinal/efeitos adversos , Ondansetron/uso terapêutico , Gravidez , Piridoxina/uso terapêutico , Teratogênios , Talidomida/efeitos adversos
10.
PLoS One ; 15(8): e0235618, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32756563

RESUMO

BACKGROUND: This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders. METHODS: This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis. RESULTS: Results are arranged under the following themes: consent; balancing the social value of the research with consent requirements; and harm. Our findings demonstrate different perspectives on the review process, styles of ethical reasoning and issues of concern. First, researchers and RECs disagreed about whether the cost of re-consenting patients satisfied the criterion of impracticability for consent waivers. Second, most researchers were skeptical that secondary research with already collected tissue and data could harm patients. Researchers often pointed to the harm arising from a failure to use existing material for research. RECs were concerned about the potential for secondary research to stigmatize communities. Third, researchers adopted a more consequentialist approach to decision-making, including some willingness to trade off the benefit of the research against the cost of getting consent; whereas RECs were more deontological and typically considered research benefit only after it had been established that re-consent was impractical. CONCLUSION: This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.


Assuntos
Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido/ética , Comitês de Ética em Pesquisa/ética , Ética em Pesquisa , Grupos Focais , Humanos , Pesquisa Qualitativa , Projetos de Pesquisa , Pesquisadores/ética , Bancos de Tecidos/ética
11.
Am J Bioeth ; 20(8): 7-18, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32757931

RESUMO

The distinction between germline and somatic gene editing is fundamental to the ethics of human gene editing. Multiple conferences of scientists, ethicists, and policymakers, and multiple professional bodies, have called for moratoria on germline gene editing, and editing of human germline cells is considered to be an ethical "red line" that either never should be crossed, or should only be crossed with great caution and care. However, as research on germline gene editing has progressed, it has become clear that not all germline interventions are alike, and that these differences make a significant moral difference, when it comes to ethical questions about research, regulation, clinical application, and medical justification. In this paper, I argue that, rather than lumping all germline interventions together, we should distinguish between revising, correcting, and transferring genes, and I assess the consequences of this move for the ethics of gene editing.


Assuntos
Edição de Genes/ética , Terapia Genética/ética , Células Germinativas , Ética Clínica , Ética em Pesquisa , Humanos , Princípios Morais , Políticas
12.
PLoS One ; 15(8): e0237875, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32853218

RESUMO

While emerging digital health technologies offer researchers new avenues to collect real-time data, little is known about current ethical dimensions, considerations, and challenges that are associated with conducting digital data collection in research with minors. As such, this paper reports the findings of a scoping review which explored existing literature to canvass current ethical issues that arise when using digital data collection in research with minors. Scholarly literature was searched using electronic academic databases for articles that provided explicit ethical analysis or presented empirical research that directly addressed ethical issues related to digital data collection used in research with minors. After screening 1,156 titles and abstracts, and reviewing 73 full-text articles, 20 articles were included in this review. Themes which emerged across the reviewed literature included: consent, data handling, minors' data rights, observing behaviors that may result in risk of harm to participants or others, private versus public conceptualizations of data generated through social media, and gatekeeping. Our findings indicate a degree of uncertainty which invariably exists with regards to the ethics of research that involves minors and digital technology. The reviewed literature suggests that this uncertainty can often lead to the preclusion of minors from otherwise important lines of research inquiry. While uncertainty warrants ethical consideration, increased ethical scrutiny and restricting the conduct of such research raises its own ethical challenges. We conclude by discussing and recommending the ethical merits of co-producing ethical practice between researchers and minors as a mechanism to proceed with such research while addressing concerns around uncertainty.


Assuntos
Coleta de Dados , Ética em Pesquisa , Menores de Idade , Comportamento , Gerenciamento de Dados , Humanos , Consentimento Livre e Esclarecido/ética , Publicações , Risco , Mídias Sociais
13.
Rev. argent. salud publica ; 12(Suplemento Covid-19): 1-4, 23 de Julio 2020.
Artigo em Espanhol | LILACS, BINACIS, ARGMSAL | ID: biblio-1104046

RESUMO

Realizar investigaciones para dar respuestas a la pandemia de COVID-19 es un deber moral. Con el objetivo de acelerar la evaluación de las investigaciones y asegurar su rigurosidad científica y ética, el Ministerio de Salud aprobó un documento de pautas éticas y operativas. El documento aborda los aspectos a los cuales se debe prestar especial atención durante la pandemia y brinda orientación a los Comités de Ética en Investigación para la elaboración de procedimientos operativos que acorten los plazos de la evaluación. Este artículo describe los puntos clave del documento


Assuntos
Infecções por Coronavirus , Revisão Ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Política de Pesquisa em Saúde
14.
Niger Postgrad Med J ; 27(3): 250-258, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32687128

RESUMO

Research misconduct policy (RMP) is a legal document that shows the definitions of the various types of misconduct, describes the inquiry and investigation of allegations, and the appropriate penalties that should be imposed. The presence of the adopted RMP on the website of a university or postgraduate college is an indication of the level of commitment to promote the proper handling of misconduct cases. Perusal of the websites of top universities in developing countries revealed that many do not have RMP on their websites. The probable starting point for combating research misconduct at the national or institutional level is by acquisition of RMP. The purpose of this article is to propose a modern, structured and cost-effective RMP for universities and postgraduate colleges in developing countries. The bibliographic database, PubMed, was searched using the terms 'research misconduct' and 'research misconduct policy'. All relevant articles from the search and some RMPs of universities, national agencies and global health organisations available on the Internet were carefully studied. A formulated RMP, based on the Final Rule of the United States, Public Health Services Policies on Research Misconduct of 2005 and the Regulations of the University Grants Commission of India of 2018, is hereby presented. In the proposed RMP, plagiarism was stratified into four levels in ascending order of severity so that imposed penalties are commensurate with the seriousness of misconduct. The zero tolerance for plagiarism in the core work areas was adopted. The proposed RMP was designed to act as a template. It should be modified as required based on the prevailing local circumstances and made fit for purpose. Universities, postgraduate colleges and journals should have RMP on the homepage of their websites.


Assuntos
Autoria/normas , Pesquisa Biomédica/ética , Plágio , Editoração/ética , Pesquisadores/ética , Má Conduta Científica/ética , Academias e Institutos , Países em Desenvolvimento , Ética em Pesquisa , Humanos , Revisão por Pares/normas , Editoração/normas , Universidades
15.
PLoS Biol ; 18(7): e3000737, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32673304

RESUMO

For knowledge to benefit research and society, it must be trustworthy. Trustworthy research is robust, rigorous, and transparent at all stages of design, execution, and reporting. Assessment of researchers still rarely includes considerations related to trustworthiness, rigor, and transparency. We have developed the Hong Kong Principles (HKPs) as part of the 6th World Conference on Research Integrity with a specific focus on the need to drive research improvement through ensuring that researchers are explicitly recognized and rewarded for behaviors that strengthen research integrity. We present five principles: responsible research practices; transparent reporting; open science (open research); valuing a diversity of types of research; and recognizing all contributions to research and scholarly activity. For each principle, we provide a rationale for its inclusion and provide examples where these principles are already being adopted.


Assuntos
Ética em Pesquisa , Pesquisadores , Hong Kong , Humanos , Tutoria , Revisão da Pesquisa por Pares , Pesquisa , Relatório de Pesquisa
16.
mSphere ; 5(4)2020 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-32669462

RESUMO

Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak. Calls for challenge studies, however, rely on the expected social value of these studies. This value represents more than the simple possibility that a successful study will lead to the rapid development and dissemination of vaccines but also some expectation that this will actually occur. I show how this expectation may not be realistic in the current political moment and offer potential ways to make sure that any challenge trials that arise actually achieve their goals.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/métodos , Ensaios Clínicos como Assunto/ética , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/prevenção & controle , Betacoronavirus , Ética em Pesquisa , Humanos , Valores Sociais , Vacinas Virais/uso terapêutico
18.
Proc Natl Acad Sci U S A ; 117(32): 18948-18950, 2020 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-32719133

RESUMO

We resolve a controversy over two competing hypotheses about why people object to randomized experiments: 1) People unsurprisingly object to experiments only when they object to a policy or treatment the experiment contains, or 2) people can paradoxically object to experiments even when they approve of implementing either condition for everyone. Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Pesquisa/normas , Ética em Pesquisa , Humanos , Distribuição Aleatória , Ensaios Clínicos Controlados Aleatórios como Assunto/ética
19.
Recurso na Internet em Português | LIS - Localizador de Informação em Saúde | ID: lis-47637

RESUMO

Durante a pandemia das síndromes da angústia respiratória aguda grave e a Doença por COVID-19, o isolamento social é a medida mais eficaz no enfrentamento do agravo (NUSSBAUMER-STREIT et al., 2020). Desde que a World Health Organization (WHO) declarou estado de pandemia (WHO, 2020), esforços mundiais vêm sendo envidados em busca de vacina e de tratamento eficaz para a doença (YI et al., 2020; WHO, 2020). É crescente a necessidade de realizar pesquisas com seres humanos para se obter respostas clínicas, epidemiológicas, farmacológicas e sociais. Estratégias de obtenção de assinaturas em documentos obrigatórios, que compõe o protocolo de pesquisa a ser submetido ao Sistema CEP (Comitê de Ética em Pesquisa) /CONEP (Comissão Nacional de Ética em Pesquisa), representam um desafio, devido a vulnerabilidade do participante de pesquisa.(AU)


Assuntos
Ética em Pesquisa , Pesquisa sobre Serviços de Saúde , Comitês de Ética em Pesquisa , Quarentena , Documentação
20.
Cancer Radiother ; 24(4): 306-315, 2020 Jul.
Artigo em Francês | MEDLINE | ID: mdl-32499188

RESUMO

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol. This issue of categorisation is central and must be taken into account by researchers from the beginning of the research process. Researches considered as not involving human beings also require a set of ethical precautions focused on patients' information and the collection of their non-opposition (due to the application of the General Data Protection Regulation adopted by the European Parliament). Thus, many regulations exist and they require a real work for researchers to meet these requirements in research ethics. This article aims to summarise French regulations. Selected examples are specifically taken into the field of radiation oncology research.


Assuntos
Ética em Pesquisa , Regulamentação Governamental , Radioterapia (Especialidade)/ética , Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , França , Humanos , Segurança do Paciente/legislação & jurisprudência , Radioterapia (Especialidade)/legislação & jurisprudência , Sujeitos da Pesquisa/legislação & jurisprudência
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