Publish and perish: New issues in publication ethics.

The expression "Publish or perish," first appeared in 1942. It signified the rising importance of publication as a means to obtain research funds and establish a secure academic career. The expression is still highly relevant, but increasingly problematic. Perhaps it should be revised to read "Publish and Perish". We have reached a point where researchers, especially in non-English speaking countries, are no longer able to afford to publish their research. There seems little point in undertaking research if we can no longer disseminate or, indeed, apply the wisdom gained from it.

Nippon Medical School's Ethical Review Processes for Studies Involving Human Subjects.

All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS's current ethical review processes for research involving human subjects.

A scoping review of ethics review processes during public health emergencies in Africa.

BACKGROUND: The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). METHODS: We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. RESULTS: Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. CONCLUSIONS: There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

Cross-border data sharing through the lens of research ethics committee members in sub-Saharan Africa.

BACKGROUND: Several factors thwart successful data sharing-ambiguous or fragmented regulatory landscapes, conflicting institutional/researcher interests and varying levels of data science-related expertise are among these. Traditional ethics oversight mechanisms and practices may not be well placed to guarantee adequate research oversight given the unique challenges presented by digital technologies and artificial intelligence (AI). Data-intensive research has raised new, contextual ethics and legal challenges that are particularly relevant in an African research setting. Yet, no empirical research has been conducted to explore these challenges. MATERIALS AND METHODS: We explored REC members' views and experiences on data sharing by conducting 20 semi-structured interviews online between June 2022 and February 2023. Using purposive sampling and snowballing, we recruited representatives across sub-Saharan Africa (SSA). We transcribed verbatim and thematically analysed the data with Atlas.ti V22. RESULTS: Three dominant themes were identified: (i) experiences in reviewing data sharing protocols, (ii) perceptions of data transfer tools and (iii) ethical, legal and social challenges of data sharing. Several sub-themes emerged as: (i.a) frequency of and approaches used in reviewing data sharing protocols, (i.b) practical/technical challenges, (i.c) training, (ii.a) ideal structure of data transfer tools, (ii.b) key elements of data transfer tools, (ii.c) implementation level, (ii.d) key stakeholders in developing and reviewing a data transfer agreement (DTA), (iii.a) confidentiality and anonymity, (iii.b) consent, (iii.c) regulatory frameworks, and (iii.d) stigmatisation and discrimination. CONCLUSIONS: Our results indicated variability in REC members' perceptions, suboptimal awareness of the existence of data protection laws and a unanimously expressed need for REC member training. To promote efficient data sharing within and across SSA, guidelines that incorporate ethical, legal and social elements need to be developed in consultation with relevant stakeholders and field experts, along with the training accreditation of REC members in the review of data-intensive protocols.

Ethical guidance for conducting health research with online communities: A scoping review of existing guidance.

Online research methods have grown in popularity due in part to the globalised and far-reaching nature of the internet but also linked to the Covid-19 pandemic whereby restrictions to travel and face to face contact necessitated a shift in methods of research recruitment and data collection. Ethical guidance exists to support researchers in conducting online research, however this is lacking within health fields. This scoping review aims to synthesise formal ethical guidance for applying online methods within health research as well as provide examples of where guidance has been used. A systematic search of literature was conducted, restricted to English language records between 2013 and 2022. Eligibility focused on whether the records were providing ethical guidance or recommendations, were situated or relevant to health disciplines, and involved the use or discussion of online research methods. Following exclusion of ineligible records and duplicate removal, three organisational ethical guidance and 24 research papers were charted and thematically analysed. Four key themes were identified within the guidance documents, 1) consent, 2) confidentiality and privacy, 3) protecting participants from harm and 4) protecting researchers from harm with the research papers describing additional context and understanding around these issues. The review identified that there are currently no specific guidelines aimed at health researchers, with the most cited guidance coming from broader methodological perspectives and disciplines or auxiliary fields. All guidance discussed each of the four key themes within the wider context of sensitive topics and vulnerable populations, areas and issues which are often prominent within health research thus highlighting the need for unifying guidance specific for health researchers. Further research should aim to understand better how online health studies apply ethical principles, to support in informing gaps across both research and guidance.

Should Children Be Included in Human Challenge Studies?

Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three arguments for exclusion, but suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea.

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.

Research ethics review during the COVID-19 pandemic: An international study.

Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic. We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for descriptive responses to open-ended questions. Two hundred and three participants [130 from high-income countries (HICs) and 73 from low- and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols. ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research.

BACKGROUND: The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. METHODS: The GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was "Ethics of AI in Global Health Research". The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. RESULTS: We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. CONCLUSIONS: The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Corrigendum Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas / Corrigendum La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas / Corrigendum à Priorização da pesquisa é um exercício ético: lições do Fórum Global de Bioética em Pesquisa para a Região das Américas

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.

Corrigendum La priorización de la investigación es un ejercicio ético: lecciones del Foro Global de Bioética en la Investigación para la Región de las Américas / Corrigendum Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas / Corrigendum à Priorização da pesquisa é um exercício ético: lições do Fórum Global de Bioética em Pesquisa para a Região das Américas

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

Bioética y democracia en la sociedad digital / Bioètica i democràcia a la societat digital / Bioethics and democracy in digital society

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)

Research integrity and academic medicine: the pressure to publish and research misconduct.

CONTEXT: This narrative review article explores research integrity and the implications of scholarly work in medical education. The paper describes how the current landscape of medical education emphasizes research and scholarly activity for medical students, resident physicians, and faculty physician educators. There is a gap in the existing literature that fully explores research integrity, the challenges surrounding the significant pressure to perform scholarly activity, and the potential for ethical lapses by those involved in medical education. OBJECTIVES: The objectives of this review article are to provide a background on authorship and publication safeguards, outline common types of research misconduct, describe the implications of publication in medical education, discuss the consequences of ethical breaches, and outline possible solutions to promote research integrity in academic medicine. METHODS: To complete this narrative review, the authors explored the current literature utilizing multiple databases beginning in June of 2021, and they completed the literature review in January of 2023. To capture the wide scope of the review, numerous searches were performed. A number of Medical Subject Headings (MeSH) terms were utilized to identify relevant articles. The MeSH terms included "scientific misconduct," "research misconduct," "authorship," "plagiarism," "biomedical research/ethics," "faculty, medical," "fellowships and scholarships," and "internship and residency." Additional references were accessed to include medical school and residency accreditation standards, residency match statistics, regulatory guidelines, and standard definitions. RESULTS: Within the realm of academic medicine, research misconduct and misrepresentation continue to occur without clear solutions. There is a wide range of severity in breaches of research integrity, ranging from minor infractions to fraud. Throughout the medical education system in the United States, there is pressure to publish research and scholarly work. Higher rates of publications are associated with a successful residency match for students and academic promotion for faculty physicians. For those who participate in research misconduct, there is a multitude of potential adverse consequences. Potential solutions to ensure research integrity exist but are not without barriers to implementation. CONCLUSIONS: Pressure in the world of academic medicine to publish contributes to the potential for research misconduct and authorship misrepresentation. Lapses in research integrity can result in a wide range of potentially adverse consequences for the offender, their institution, the scientific community, and the public. If adopted, universal research integrity policies and procedures could make major strides in eliminating research misconduct in the realm of academic medicine.

Ethical Research and the Institutional Review Board: An Introduction.

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.