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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. bioét. derecho ; (49): 173-189, jul. 2020.
Artigo em Espanhol | IBECS | ID: ibc-192101


El uso de animales para obtener conocimiento y desarrollar tratamientos para enfermedades humanas, se justifica argumentando que son similares a nosotros, pero, al mismo tiempo sus intereses se ignoran enfatizando que ellos son diferentes de nosotros, lo que se considera un doble estándar moral en la ciencia. Millones de animales son sometidos a dolor y sufrimiento cuando no siempre hay certeza de que se obtendrá un beneficio real, en ocasiones la extrapolación no es exitosa, los resultados no son aplicables o nunca se publican. ¿Qué tan éticos y válidos son los métodos que utilizamos para alcanzar nuestros objetivos? Los animales deberían ser considerados un grupo vulnerable a los que se extiendan algunos principios éticos establecidos en la Declaración de Helsinki

The use of animals to obtain knowledge and develop treatments for human diseases is justified by arguing that they are like us, yet their interests are ignored by emphasizing that they are not similar to us, which is considered a double moral standard in science. Millions of animals are subjected to pain and suffering, even when there is no certainty that a real benefit will be obtained. Sometimes extrapolation is not successful, results are invalid, not applicable or even never published. Then, how ethical and valid are the methods we use to achieve our goals? We propose animals should be considered as a vulnerable group and to extend them some of the ethical principles stated in the Declaration of Helsinki

L'ús d'animals per obtenir coneixement I desenvolupar tractaments per a malalties humanes es justifica argumentant que són similars a nosaltres, però, al mateix temps els seus interessos s'ignoren emfatitzant que ells són diferents de nosaltres, el que es considera un doble estàndard moral en la ciència. Milions d'animals són sotmesos a dolor I sofriment quan no sempre hi ha la certesa de que s'obtindrà un benefici real, de vegades l'extrapolació no és exitosa, els resultats no són aplicables o mai es publiquen. Què tan ètics I vàlids són els mètodes que utilitzem per assolir els nostres objectius? Els animals haurien de ser considerats un grup vulnerable als que afecten alguns principis ètics establerts en la Declaració d'Hèlsinki

Animais , Conhecimento , Pesquisa Biomédica/ética , Experimentação Animal/ética , Direitos dos Animais/legislação & jurisprudência , Pesquisa Biomédica/legislação & jurisprudência , Declaração de Helsinki , Direitos dos Animais/normas
Am J Law Med ; 46(2-3): 275-296, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32659196


Corporate influence is one of the most pressing issues in public health. It cuts across many of our most intractable problems-from obesity to the opioid epidemic. Companies develop close relationships with public health agencies, research universities, academic medical centers, professional societies, and patient advocacy organizations-often funding medical research and public health interventions intended to address the very challenges these corporations are creating or exacerbating. How we view relationships with industry, including how these relationships are framed in ethical discourse, shapes our legal and policy responses to them. In recent years, fueled in part by the opioid epidemic, the ethical framing of industry relationships has begun to evolve in significant ways. But legal and policy responses have not yet caught up. In this article, I develop a temporal account of corporate influence, and legal and policy responses to corporate influence. This account clarifies the limitations and adverse effects of conflicts of interest disclosure, especially when implemented as the sole legal or policy response. Disclosure can illuminate corporate influence-but policymakers cannot and should not rely on disclosure to eliminate corporate influence or its effects. Nor should we allow disclosure to crowd out structural and systemic responses to corporate influence-including sequestration of and separation from private-sector entities.

Pesquisa Biomédica/legislação & jurisprudência , Revelação/legislação & jurisprudência , Ética nos Negócios , Formulação de Políticas , Saúde Pública/legislação & jurisprudência , Conflito de Interesses , Humanos , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Estados Unidos
Cancer Radiother ; 24(4): 306-315, 2020 Jul.
Artigo em Francês | MEDLINE | ID: mdl-32499188


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.

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
Am J Trop Med Hyg ; 103(1): 38-40, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32228776


In the most recent Brazilian yellow fever (YF) outbreak, a group of clinicians and researchers initiated in mid-January 2018 a considerable effort to develop a multicenter randomized controlled clinical trial to evaluate the effect of sofosbuvir on YF viremia and clinical outcomes (Brazilian Clinical Trials Registry: RBR-93dp9n). The approval of this protocol had urgency given the seasonal/short-lived pattern of YF transmission, large number of human cases, and epidemic transmission at the outskirts of a large urban center. However, many intricacies in the research regulatory and ethical submission systems in Brazil were indomitable even under such pressing conditions. By April 2018, we had enrolled 29 patients for a target sample size of 90 participants. Had enrollment been initiated 3 weeks earlier, an additional 31 patients could have been enrolled, reaching the prespecified sample size for the interim analysis. This recent experience highlights the urgent need to improve local preparedness for research in the setting of explosive outbreaks, as has been seen in the last few years in different countries.

Pesquisa Biomédica/legislação & jurisprudência , Doenças Transmissíveis Emergentes/epidemiologia , Surtos de Doenças , Ensaios Clínicos Controlados Aleatórios como Assunto/legislação & jurisprudência , Viremia/epidemiologia , Febre Amarela/epidemiologia , Vírus da Febre Amarela/patogenicidade , Aedes/virologia , Animais , Antivirais/uso terapêutico , Pesquisa Biomédica/ética , Brasil/epidemiologia , Doenças Transmissíveis Emergentes/tratamento farmacológico , Doenças Transmissíveis Emergentes/virologia , Regulamentação Governamental , Hospitalização/estatística & dados numéricos , Humanos , Mosquitos Vetores/virologia , Seleção de Pacientes/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Sofosbuvir/uso terapêutico , Viremia/tratamento farmacológico , Febre Amarela/tratamento farmacológico , Febre Amarela/virologia , Vírus da Febre Amarela/efeitos dos fármacos , Vírus da Febre Amarela/fisiologia
Anaesthesia ; 75(9): 1229-1235, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32329902


In the last decade, research in transplant medicine has focused on developing interventions in the management of the deceased organ donor to improve the quality and quantity of transplantable organs. Despite the promise of interventional donor research, there remain debates about the ethics of this research, specifically regarding gaining research consent. Here, we examine the concerns and ambiguities around consent for interventional donor research, which incorporate questions about who should consent for interventional donor research and what people are being asked to consent for. We highlight the US and UK policy responses to these concerns and argue that, whereas guidance in this area has done much to clarify these ambiguities, there is little consideration of the nature, practicalities and context around consent in this area, particularly regarding organ donors and their families. We review wider studies of consent in critical care research and social science studies of consent in medical research, to gain a broader view of consent in this area as a relational and contextual process. We contend a lack of consideration has been given to: what it might mean to consent to interventional donor research; how families, patients and health professionals might experience providing and seeking this consent; who is best placed to have these discussions; and the socio-institutional contexts affecting these processes. Further, empirical research is required to establish an ethical and sensitive model for consent in interventional donor research, ensuring the principles enshrined in research ethics are met and public trust in organ donation is maintained.

Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Doadores de Tecidos/ética , Doadores de Tecidos/legislação & jurisprudência , Humanos , Reino Unido , Estados Unidos
FEMS Microbiol Lett ; 367(5)2020 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-32149346


The European Culture Collections' Organisation presents two new model documents for Material Deposit Agreement (MDA) and Material Transfer Agreement (MTA) designed to enable microbial culture collection leaders to draft appropriate agreement documents for, respectively, deposit and supply of materials from a public collection. These tools provide guidance to collections seeking to draft an MDA and MTA, and are available in open access to be used, modified, and shared. The MDA model consists of a set of core fields typically included in a 'deposit form' to collect relevant information to facilitate assessment of the status of the material under access and benefit sharing (ABS) legislation. It also includes a set of exemplary clauses to be included in 'terms and conditions of use' for culture collection management and third parties. The MTA model addresses key issues including intellectual property rights, quality, safety, security and traceability. Reference is made to other important tools such as best practices and code of conduct related to ABS issues. Besides public collections, the MDA and MTA model documents can also be useful for individual researchers and microbial laboratories that collect or receive microbial cultures, keep a working collection, and wish to share their material with others.

Biodiversidade , Pesquisa Biomédica/legislação & jurisprudência , Manejo de Espécimes , Transferência de Tecnologia , Europa (Continente) , Humanos