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1.
J Korean Med Sci ; 39(12): e116, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38565174

RESUMO

BACKGROUND: Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government's pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020-February 2021) and the second phase (March 2021-February 2023) for long-term preparedness. RESULTS: The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). CONCLUSION: As a result of South Korea's commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.


Assuntos
COVID-19 , Humanos , COVID-19/epidemiologia , Pandemias/prevenção & controle , SARS-CoV-2 , República da Coreia/epidemiologia , Ética em Pesquisa , Governo
2.
Artigo em Inglês | PAHO-IRIS | ID: phr-59388

RESUMO

The Pan American Journal of Public Health draws readers' attention to an error in the following article, pointed out by the authors: Saenz C, Carracedo S, Caballero C, Hurtado C, Leite Ribeiro A, Luna F, et al. Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas. Rev Panam Salud Publica. 2024;48:e32. https://doi.org/10.26633/RPSP.2024.32 In article published on March 2024, reference 2 appears as follows: Global Forum on Bioethics in Research. GFBR 2023 Key- note presentation [Internet video]. Youtube. 2024 Feb 01 [cited 2024 Feb 13]. Available from: https://www.youtube.com/ watch?v=HlPgN6n6i8M The correct way to reference 2 is: Millum J. Ethics of health research priority setting [video]. Uploaded by Global Forum on Bioethics in Research, 1 February 2024. [Accessed on 13 February 2024] Available from: https://www.youtube.com/ watch?v=HlPgN6n6i8M.


Assuntos
Política de Pesquisa em Saúde , Ética em Pesquisa , América , Agenda de Prioridades em Saúde
3.
Artigo em Espanhol | PAHO-IRIS | ID: phr-59387

RESUMO

La Revista Panamericana de Salud Pública llama la atención de los lectores sobre un error en el siguiente artículo, señalado por los autores: Saenz C, Carracedo S, Caballero C, Hurtado C, Leite Ribeiro A, Luna F, et al. La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas. Rev Panam Salud Publica. 2024;48:e26. https://doi.org/10.26633/RPSP.2024.26 En el artículo publicado en marzo 2024, la referencia 2 aparece de la siguiente manera: Global Forum on Bioethics in Research. GFBR 2023 Keynote presentation [video en internet]. Youtube. 1 de febrero de 2024 [citado 13 de febrero de 2024]. Disponible en: https://www.youtube.com/watch?v=HlPgN6n6i8M La forma correcta para la referencia 2 debe ser: Millum J. Ethics of health research priority setting [video]. Subido por Global Forum on Bioethics in Research, 1 de febrero de 2024. [citado 13 de febrero de 2024] Disponible en: https://www.youtube.com/ watch?v=HlPgN6n6i8M


Assuntos
Ética em Pesquisa , Política de Pesquisa em Saúde , América , Agenda de Prioridades em Saúde
4.
Rev. bioét. derecho ; (60): 19-34, Mar. 2024. tab
Artigo em Espanhol | IBECS | ID: ibc-230470

RESUMO

La sociedad contemporánea vive la revolución digital y la necesidad de reflexionar sobre la interacción entre los seres humanos y las tecnologías digitales. El auge de las tecnologías de inteligencia artificial y la algoritmización social ha planteado interrogantes sobre la indispensabilidad de la supervisión y el análisis ético de la información y los datos en Internet. Así como la necesidad de verificar la influencia de las plataformas digitales en el ejercicio de la ciudadanía. La bioética posibilita la investigación sobre los principios que se deben respetar en una sociedad democrática y digital. Resaltamos los principios de responsabilidad social y no discriminación con la intención de que los beneficios del uso tecnológico promuevan el bienestar y la calidad de vida de los menos favorecidos. Su objetivo es garantizar la supervivencia de la especie humana y la mejora de la protección de la vida de todos los seres vivos, animales y plantas. La reflexión bioética sobre el uso de la inteligencia artificial podría establecer la brújula moral que oriente el análisis de los conflictos éticos y la defensa de que a todos los seres humanos se les debe garantizar la igualdad de oportunidades y las condiciones para realizar plenamente su proyecto de vida.(AU)


La societat contemporània viu la revolució digital i la necessitat de reflexionar sobre la interacció entre els éssers humans i les tecnologies digitals. L'auge de les tecnologies d'intel·ligència artificial i la algoritmització social ha plantejat interrogants sobre la indispensabilitat de la supervisió i l'anàlisi ètic de la informació i les dades a Internet. Així com la necessitat de verificar la influència de les plataformes digitals en l'exercici de la ciutadania. La bioètica possibilita la recerca sobre els principis que es deuen respectar en una societat democràtica i digital. Destaquem els principis de responsabilitat social i no discriminació amb la intenció que els beneficis de l'ús tecnològic promoguin el benestar i la qualitat de vida dels menys afavorits. El seu objectiu és garantir la supervivència de l'espècie humana i la millora de la protecció de la vida de tots els éssers vius, animals i plantes. La reflexió bioètica sobre l'ús de la intel·ligència artificial podria establir la brúixola moral que orienti l'anàlisi dels conflictes ètics i la defensa que a tots els éssers humans se'ls ha de garantir la igualtat d'oportunitats i les condicionsper realitzar plenament el seu projecte de vida.(AU)


Contemporary society is going through the digital revolution and the need to reflect on the interaction between human beings and digital technologies. The rise of artificial intelligence technologies and social algorithmization has raised questions about the need for ethical monitoring and analysis of information and data on the Internet. As well as the need to verify the influence of digital platforms in the exercise of citizenship. Bioethics enables research on the principles that must be respected in a democratic and digital society. We highlight the principles of social responsibility and non-discrimination with the intention that the benefits of technological use promote the well-being and quality of life of the less favored. Its objective is to guarantee the survival of the human species and the improvement of the protection of the life of all living beings, animals, and plants. Bioethical reflection on the use of artificial intelligence could establish the moral compass that guides the analysis of ethical conflicts and the defense that all human beings must be guaranteed equal opportunities and the conditions to fully carry out their project of life.(AU)


Assuntos
Humanos , Masculino , Feminino , Inteligência Artificial , Bioética , Temas Bioéticos , Ética em Pesquisa
6.
7.
Am J Nurs ; 124(3): 50-54, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38386835

RESUMO

Editor's note: This is the 20th article in a series on clinical research by nurses. The series is designed to be used as a resource for nurses to understand the concepts and principles essential to research. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. To see all the articles in the series, go to https://links.lww.com/AJN/A204.


Assuntos
Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos
10.
J Empir Res Hum Res Ethics ; 19(1-2): 16-27, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38263704

RESUMO

For research purposes, it is generally accepted that experimental ostracism manipulations can lead to a reduction of participants' well-being. To eventually restore participants' well-being, researchers rely on post-experimental debriefings that discredit prior deception. However, evidence suggests that discredited beliefs can persevere. The present research investigates whether a potent debriefing procedure restores participants' well-being after an experimentally induced ostracism experience. In two studies, participants were either excluded or included in a Cyberball game, indicated their well-being, and were debriefed. In two additional conditions, participants were debriefed before indicating their well-being. Ostracism compared to inclusion led to decreased positive and increased negative mood. The debriefing did not counteract this effect (Studies 1 & 2). Unwanted aftereffects of the manipulation persevered for more than one day after the experimental session (Study 2). These findings question the effectiveness of debriefings and raise issues about research ethics.


Assuntos
Afeto , Ostracismo , Humanos , Ética em Pesquisa
11.
BMC Med Educ ; 24(1): 1, 2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-38172860

RESUMO

Research ethics education is critical to developing a culture of responsible conduct of research. Many countries in sub-Saharan Africa (SSA) have a high burden of infectious diseases like HIV and malaria; some, like Uganda, have recurring outbreaks. Coupled with the increase in non-communicable diseases, researchers have access to large populations to test new medications and vaccines. The need to develop multi-level capacity in research ethics in Uganda is still huge, being compounded by the high burden of disease and challenging public health issues. Only a few institutions in the SSA offer graduate training in research ethics, implying that the proposed ideal of each high-volume research ethics committee having at least one member with in-depth training in ethics is far from reality. Finding best practices for comparable situations and training requirements is challenging because there is currently no "gold standard" for teaching research ethics and little published information on curriculum and implementation strategies. The purpose of this paper is to describe a model of research ethics (RE) education as a track in an existing 2-year Master of Public Health (MPH) to provide training for developing specific applied learning skills to address contemporary and emerging needs for biomedical and public health research in a highly disease-burdened country. We describe our five-year experience in successful implementation of the MPH-RE program by the Mbarara University Research Ethics Education Program at Mbarara University of Science and Technology in southwestern Uganda. We used curriculum materials, applications to the program, post-training and external evaluations, and annual reports for this work. This model can be adapted and used elsewhere in developing countries with similar contexts. Establishing an interface between public health and research ethics requires integration of the two early in the delivery of the MPH-RE program to prevent a disconnect in knowledge between research methods provided by the MPH component of the MPH-RE program and for research in ethics that MPH-RE students are expected to perform for their dissertation. Promoting bioethics education, which is multi-disciplinary, in institutions where it is still "foreign" is challenging and necessitates supportive leadership at all institutional levels.


Assuntos
Eticistas , Saúde Pública , Humanos , Saúde Pública/educação , Uganda , Currículo , Ética em Pesquisa
12.
BMC Med Ethics ; 25(1): 9, 2024 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-38238678

RESUMO

BACKGROUND: The conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information about ethical compliance in conflict areas. Valid and ethically informed decision-making is a premier pact with research participants in settling possible ethical issues before commencing the research, which is ensured by gaining informed consent from prospective participants of the research. AIMS: This research aimed to explore compliance with research ethics and consent validity in community-based epidemiological research conducted previously. METHODS: Research participants were recruited in the western part of Ethiopia in three districts subjected to conflicts. A community-based cross-sectional study design was utilized, and 338 residents were enrolled as study participants. All participants had previously been enrolled as research participants in epidemiological studies. Data was collected using a questionnaire that was pilot-tested before the commencement of the main data collection. The questionnaire focused on participants' experiences of the informed consent process followed when they were recruited for an epidemiological study and covered themes such as essential information provided, level of comprehension, and voluntarism of consent. RESULTS: Over half of the study participants, 176 (52%), were not provided with essential information before consenting. And 135 (40%) of them did not comprehend the information provided to them. One hundred and ninety (56%) participants freely and voluntarily agreed to partake in one of these epidemiological studies, with over a quarter (97; 28.7%) of them reporting they were subjected to undue influence. Written consent was obtained from only 32 (9.4%) of the participants.


Assuntos
Compreensão , Consentimento Livre e Esclarecido , Humanos , Estudos Transversais , Etiópia , Estudos Prospectivos , Ética em Pesquisa , Inquéritos e Questionários
13.
Am J Bioeth ; 24(2): 99-102, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38295251
14.
BMC Med Ethics ; 25(1): 3, 2024 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-38172914

RESUMO

BACKGROUND: Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols. METHODS: We followed PRISMA guidelines and Arksey and O'Malley's approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically. RESULTS: We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community. CONCLUSIONS: Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children.


Assuntos
Saúde da Criança , Pesquisa , Adolescente , Criança , Humanos , Canadá , Ética em Pesquisa , Consentimento dos Pais , Pais
15.
17.
AIDS Res Hum Retroviruses ; 40(1): 22-27, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37227023

RESUMO

The concept of vulnerability in bioethics was first referenced in 1979, when the Belmont Report highlighted the need for special consideration of certain populations in the application of its general principles of respect for persons, beneficence, and justice in research with human participants. Since then, a body of literature has emerged regarding the content, status, and scope, as well as ethical and practical implications of vulnerability in biomedical research. The social history of HIV treatment development has at various points reflected and actively influenced bioethics' debate on vulnerability. In the late 1980s and early 1990s, people with AIDS activist groups drafted landmark patient empowerment manifestos like The Denver Principles, fighting to have greater involvement in the design and oversight of clinical trials related to HIV treatment, and in doing so, pushed against research ethics protocols created with the intention of protecting vulnerable populations. The determination of appropriate benefit/risk profiles in clinical trials was no longer limited to the purview of clinicians and scientists, but began to include the perspectives of people with HIV (PWH) and affected communities. In contemporary HIV cure-related research, where participants often risk health for no personal clinical benefit, the community's voiced motivations and objectives for participation continue to challenge population-based accounts of vulnerability. While the development of a framework for discussion and the establishment of clear regulatory requirements are necessary to support the practical and ethical conduct of research, they risk distraction from the fundamental value of voluntary participation and potentially overlook the unique history and perspectives of PWH in their participation in the quest toward an HIV cure.


Assuntos
Pesquisa Biomédica , Infecções por HIV , Humanos , Infecções por HIV/tratamento farmacológico , Ética em Pesquisa , Populações Vulneráveis , Medição de Risco
18.
Nurs Ethics ; 31(1): 101-113, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37493023

RESUMO

BACKGROUND: Nursing students must graduate prepared to bravely enact the art and science of nursing in environments infiltrated with ethical challenges. Given the necessity and moral obligation of nurses to engage in discourse within nursing ethics, nursing students must be provided a moral supportive learning space for these opportunities. Situating conversations and pedagogy within a brave space may offer a framework to engage in civil discourse while fostering moral courage for learners. RESEARCH OBJECTIVE: The aim of this research is to explore the influence of a structured self-assessment tool called the ESA "Engagement Self-Assessment" on the alignment and creation of a brave space in a nursing ethics course. RESEARCH DESIGN: This study used an exploratory, cross-sectional survey design. PARTICIPANTS AND STUDY SETTING: Data from 39 undergraduate nursing students enrolled in a nursing healthcare ethics & law course using the ESA were recruited. ETHICAL CONSIDERATIONS: Participation was voluntary and informed without coercion. Written consent was obtained prior to participation. Research ethics approval was obtained by the Institutional Research Ethics Board of the recruited participants (Ethics # 2022-23-03). FINDINGS: The ESA provided structured self-reflection on the impact of shared vulnerability within a brave space. However, commitment to a brave space was not strongly influenced by the ESA, but rather by a mutual "commitment to others." CONCLUSION: A teaching tool such as an ESA can be used to facilitate instructor expectations of civil discourse and discussion of difficult topics. Rules of engagement such as those found in brave spaces can help transform fear of vulnerability into authentic growth for learners. A morally supportive learning space can support critical opportunities for ethical development. This study provides insight into how self-assessment and the use of a brave space in nursing ethics education can facilitate a morally supportive learning space.


Assuntos
Coragem , Bacharelado em Enfermagem , Ética em Enfermagem , Estudantes de Enfermagem , Humanos , Estudos Transversais , Ética em Pesquisa
19.
Camb Q Healthc Ethics ; 33(1): 89-101, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37288487

RESUMO

The first "R" from animal research ethics prescribes the replacement of animal experiments with animal-free alternatives. However, the question of when an animal-free method qualifies as an alternative to animal experiments remains unresolved.Drawing lessons from another debate in which the word "alternative" is central, the ethical debate on alternatives to germline genome editing, this paper develops a general account of when something qualifies as an alternative to something. It proposes three ethically significant conditions that technique, method, or approach X must meet to qualify as an alternative to Y: (1) X must address the same problem as Y, under an appropriate description of that problem; (2) X must have a reasonable chance of success, compared to Y, in solving the problem; and (3) X must not be ethically unacceptable as a solution. If X meets all these conditions, its relative advantages and disadvantages determine whether it is preferable, indifferent, or dispreferable as an alternative to Y.This account is then applied to the question of whether animal-free research methods qualify as alternatives to animal research. Doing so breaks down the debate around this question into more focused (ethical and other) issues and illustrates the potential of the account.


Assuntos
Experimentação Animal , Animais , Alternativas aos Testes com Animais , Ética em Pesquisa , Edição de Genes
20.
J Orthop Res ; 42(3): 568-577, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38124294

RESUMO

As scientific advancements continue to reshape the world, it becomes increasingly crucial to uphold ethical standards and minimize the potentially adverse impact of research activities. In this context, the implementation of the 3R principles-Replacement, Reduction, and Refinement-has emerged as a prominent framework for promoting ethical research practices in the use of animals. This article aims to explore recent advances in integrating the 3R principles into fracture healing research, highlighting their potential to enhance animal welfare, scientific validity, and societal trust. The review focuses on in vitro, in silico, ex vivo, and refined in vivo methods, which have the potential to replace, reduce, and refine animal experiments in musculoskeletal, bone, and fracture healing research. Here, we review material that was presented at the workshop "Implementing 3R Principles into Fracture Healing Research" at the 2023 Orthopedic Research Society (ORS) Annual Meeting in Dallas, Texas.


Assuntos
Experimentação Animal , Consolidação da Fratura , Animais , Bem-Estar do Animal , Ética em Pesquisa , Texas
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