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Purpose: With the rapid development of Phase I clinical trials for anticancer drugs in China, addressing ethical concerns is imperative. In order to safeguard the rights, interests, and well-being of research participants, this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs. Methods: This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were submitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023. Based on Chinese and international research regulations and guidelines, these documents, as well as initial and follow-up review resolutions, have been classified and analyzed. Results: Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vulnerability of participants enrolled with advanced cancer status, it is important to review investigator qualifications, preliminary findings, research methods, inclusion and exclusion criteria in the protocol, as well as the validity and readability of informed consent. Additionally, attention should be given to follow-up reviews, particularly regarding safety reports and protocol deviations. Conclusion: To effectively protect the rights, interests and safety of research participants. Relevant stakeholders, including sponsors, researchers, and regulatory bodies, should diligently evaluate potential risks and provision contingency plan to minimize the latent risk. [ABSTRACT FROM AUTHOR]

Copyright of JALT Journal is the property of Japan Association for Language Teaching and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Environmental & Social Management Journal / Revista de Gestão Social e Ambiental is the property of Environmental & Social Management Journal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract Purpose With the rapid development of Phase I clinical trials for anticancer drugs in China, addressing ethical concerns is imperative. In order to safeguard the rights, interests, and well-being of research participants, this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs. Methods This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were submitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023. Based on Chinese and international research regulations and guidelines, these documents, as well as initial and follow-up review resolutions, have been classified and analyzed. Results Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vulnerability of participants enrolled with advanced cancer status, it is important to review investigator qualifications, preliminary findings, research methods, inclusion and exclusion criteria in the protocol, as well as the validity and readability of informed consent. Additionally, attention should be given to follow-up reviews, particularly regarding safety reports and protocol deviations. Conclusion To effectively protect the rights, interests and safety of research participants. Relevant stakeholders, including sponsors, researchers, and regulatory bodies, should diligently evaluate potential risks and provision contingency plan to minimize the latent risk.

Peer review is an essential and integral part of the editorial and academic publication process that contributes to validate manuscripts submitted to biomedical journals. A good review can greatly improve the quality of published manuscripts, thereby improving the journal's reputation, value, and relevance to the reader. This special article includes the main recommendations of the editorial board of Geriatrics, Gerontology and Aging to its current and future reviewers, aiming at a continuous improvement of quality standards in the peer review process used by the journal. In addition, the importance and types of review processes are discussed, as well as the editorial flow and selection of reviewers, and general and specific recommendations are presented for carrying out good reviews.

Abstract Background Nurses’ competence in clinical research is a key element in promoting high quality in the discipline of nursing, and the ethical aspects of research are of paramount importance. Therefore, nurses need to have a comprehensive understanding of the ethics associated with clinical research, which is an integral part of safeguarding the safety of subjects, ensuring the quality of nursing clinical research, and improving the ethical standardization of clinical research. Methods A cross-sectional survey was conducted on 304 nurses in a province of China between April 2023 and September 2023, utilizing convenience sampling. The survey questionnaire comprised two sections: a general information form and a questionnaire focusing on nurses’ knowledge and attitudes towards clinical research ethics. Data analysis encompassed descriptive statistics, t-tests, one-way ANOVA, and multiple linear regression. Results A total of 320 questionnaires were distributed, of which 304 were valid. The ethical attitude of nurses in clinical research was better (91.17 ± 15.96), while the cognitive score was lower (63.08 ± 12.30). The results of multiple linear regression analysis showed that degree, grade of hospital (I, II or III), technical title, number of clinical projects chaired in one year and whether the respondent has ever participated in an ethics training were the five factors influencing the knowledge of clinical research ethics (F = 9.341, P

Ethical review of animal experiments is based on factors such as the necessity of the experiment, its scientific validity, the professional competence of the experimenters, and research conditions, to determine the ethical permissibility of an animal experiment. Attitudes towards laboratory animals and animal experiments vary significantly due to differences in cultural traditions, religious beliefs, personality traits, and roles within the experimentation process. How animal experiment ethics can advance in tandem with the advancements of life sciences, while consistently providing forward-looking guidance and safeguarding fundamental ethics, is a subject that requires continuous exploration, practice, and research. Ensuring the welfare of laboratory animals has now become a widely accepted ethical consensus. However, attitudes and principles towards different types of animal experiments, and the methods to genuinely and effectively ensure the welfare quality of animals during live animal experiments, should be central to animal experiment ethics. Based on the deep integration of biotechnology in the field of laboratory animals, this paper considers the contribution of animal experimentation to the development of scientific ethical concepts. It systematically elucidates the special value of life in laboratory animals and their relationship with biosafety and ecological safety. It also outlines welfare quality assessment methods for different species of laboratory animals, demonstrating that the philosophical ideology of the value of life is the core of animal experiment ethics. The quality and significance of animal experiments determine the ethical level at which the value of life in laboratory animals is realized, and animal welfare technologies provide a robust ethical guarantee for animal experiments. The close integration of ethical theories with life sciences in laboratory animals is an objective requirement for animal experiment ethics. The value of life, animal welfare, and risk prevention collectively form the core elements of ethical review in animal experiments, serving as fundamental factors in improving the quality of ethical reviews and avoiding ethical deviations.

Abstract Public engagement with research (PEwR) has become increasingly integral to research practices. This paper explores the process and outcomes of a collaborative effort to address the ethical implications of PEwR activities and develop tools to navigate them within the context of a University Medical School. The activities this paper reflects on aimed to establish boundaries between research data collection and PEwR activities, support colleagues in identifying the ethical considerations relevant to their planned activities, and build confidence and capacity among staff to conduct PEwR projects. The development process involved the creation of a taxonomy outlining key terms used in PEwR work, a self-assessment tool to evaluate the need for formal ethical review, and a code of conduct for ethical PEwR. These tools were refined through iterative discussions and feedback from stakeholders, resulting in practical guidance for researchers navigating the ethical complexities of PEwR. Additionally, reflective prompts were developed to guide researchers in planning and conducting engagement activities, addressing a crucial aspect often overlooked in formal ethical review processes. The paper reflects on the broader regulatory landscape and the limitations of existing approval and governance processes, and prompts critical reflection on the compatibility of formal approval processes with the ethos of PEwR. Overall, the paper offers insights and practical guidance for researchers and institutions grappling with ethical considerations in PEwR, contributing to the ongoing conversation surrounding responsible research practices.

Background: Nurses' competence in clinical research is a key element in promoting high quality in the discipline of nursing, and the ethical aspects of research are of paramount importance. Therefore, nurses need to have a comprehensive understanding of the ethics associated with clinical research, which is an integral part of safeguarding the safety of subjects, ensuring the quality of nursing clinical research, and improving the ethical standardization of clinical research. Methods: A cross-sectional survey was conducted on 304 nurses in a province of China between April 2023 and September 2023, utilizing convenience sampling. The survey questionnaire comprised two sections: a general information form and a questionnaire focusing on nurses' knowledge and attitudes towards clinical research ethics. Data analysis encompassed descriptive statistics, t-tests, one-way ANOVA, and multiple linear regression. Results: A total of 320 questionnaires were distributed, of which 304 were valid. The ethical attitude of nurses in clinical research was better (91.17 ± 15.96), while the cognitive score was lower (63.08 ± 12.30). The results of multiple linear regression analysis showed that degree, grade of hospital (I, II or III), technical title, number of clinical projects chaired in one year and whether the respondent has ever participated in an ethics training were the five factors influencing the knowledge of clinical research ethics (F = 9.341, P < 0.001, R2 = 18.0%); degree, grade of hospital (I, II or III), technical title, number of clinical research projects chaired in one year, whether the hospital has an ethics committee and whether the respondent has ever participated in an ethics training were the six factors affecting ethical attitudes towards clinical research (F = 8.919, P < 0.001, R2 = 17.3%). Conclusions: Nurses in a Chinese province scored low on the cognitive dimension of clinical research ethics, but their attitudes were at a relative high level, with many influencing factors. Degree, technical title, and grade of hospital, all affect cognitive and attitude scores. It is also worth noting that whether the hospital has an ethics committee affects the attitude scores, but has no effect on the cognitive scores.Nursing administrators and educators should consider providing effective and targeted strategies (e.g., ongoing training, scholarly seminars, and scholarly exchanges) to enhance nurses' knowledge and competence in clinical research ethics to protect subject rights as well as to ensure the quality of clinical research. [ABSTRACT FROM AUTHOR]

There are significant challenges associated with conducting research with a researcher from another institution, in another country or with another culture, and even more challenges when all three factors apply. This paper critically appraises the complexities of a cross-cultural, international and collaborative research project, and identifies the challenges for the researchers and their organisations, and the ways in which these were managed. It evaluates the process of obtaining ethics approval from two organisations in Aotearoa New Zealand and Fiji. This paper presents the perspectives of both the researchers and the organisations providing ethics approval. There is often concern that research conducted by someone from a 'global north' country (here, Aotearoa New Zealand) in a 'global south' country (here, Fiji) will have power asymmetries, and that research will disadvantage the researched community, or not provide any benefit back to them; this project directly addressed these concerns. The research outputs, and research outcomes and impact, need to be considered at the research design stage to ensure they are appropriate for the community in which the research is being conducted. While organisations may be reluctant to approve research conducted in a different culture and country, the risks can be managed and mitigated. [ABSTRACT FROM AUTHOR]

Public engagement with research (PEwR) has become increasingly integral to research practices. This paper explores the process and outcomes of a collaborative effort to address the ethical implications of PEwR activities and develop tools to navigate them within the context of a University Medical School. The activities this paper reflects on aimed to establish boundaries between research data collection and PEwR activities, support colleagues in identifying the ethical considerations relevant to their planned activities, and build confidence and capacity among staff to conduct PEwR projects. The development process involved the creation of a taxonomy outlining key terms used in PEwR work, a self-assessment tool to evaluate the need for formal ethical review, and a code of conduct for ethical PEwR. These tools were refined through iterative discussions and feedback from stakeholders, resulting in practical guidance for researchers navigating the ethical complexities of PEwR. Additionally, reflective prompts were developed to guide researchers in planning and conducting engagement activities, addressing a crucial aspect often overlooked in formal ethical review processes. The paper reflects on the broader regulatory landscape and the limitations of existing approval and governance processes, and prompts critical reflection on the compatibility of formal approval processes with the ethos of PEwR. Overall, the paper offers insights and practical guidance for researchers and institutions grappling with ethical considerations in PEwR, contributing to the ongoing conversation surrounding responsible research practices. Plain English summary: This paper talks about making research fairer for everyone involved. Sometimes, researchers ask members of the public for advice, guidance or insight, or for help to design or do research, this is sometimes known as 'public engagement with research'. But figuring out how to do this in a fair and respectful way can be tricky. In this paper, we discuss how we tried to make some helpful tools. These tools help researchers decide if they need to get formal permission, known as ethical approval, for their work when they are engaging with members of the public or communities. They also give tips on how to do the work in a good and fair way. We produced three main tools. One helps people understand the important words used in this kind of work (known as a taxonomy). Another tool helps researchers decide if they need to ask for special permission (a self-assessment tool). And the last tool gives guidelines on how to do the work in a respectful way (a code of conduct). These tools are meant to help researchers do their work better and treat everyone involved fairly. The paper also talks about how more work is needed in the area, but these tools are a good start to making research fairer and more respectful for everyone. [ABSTRACT FROM AUTHOR]

Ethical review of animal experiments is based on factors such as the necessity of the experiment, its scientific validity, the professional competence of the experimenters, and research conditions, to determine the ethical permissibility of an animal experiment. Attitudes towards laboratory animals and animal experiments vary significantly due to differences in cultural traditions, religious beliefs-personality traits, and roles within the experimentation process. How animal experiment ethics can advance in tandem with the advancements of life sciences, while consistently providing forward-looking guidance and safeguarding fundamental ethics, is a subject that requires continuous exploration, practice, and research. Ensuring the welfare of laboratory animals has now become a widely accepted ethical consensus. However, attitudes and principles towards different types of animal experiments, and the methods to genuinely and effectively ensure the welfare quality of animals during live animal experiments, should be central to animal experiment ethics. Based on the deep integration of biotechnology in the field of laboratory animals, this paper considers the contribution of animal experimentation to the development of scientific ethical concepts. It systematically elucidates the special value of life in laboratory animals and their relationship with biosafety and ecological safety. It also outlines welfare quality assessment methods for different species of laboratory animals, demonstrating that the philosophical ideology of the value of life is the core of animal experiment ethics. The quality and significance of animal experiments determine the ethical level at which the value of life in laboratory animals is realized, and animal welfare technologies provide a robust ethical guarantee for animal experiments. The close integration of ethical theories with life sciences in laboratory animals is an objective requirement for animal experiment ethics. The value of life, animal welfare, and risk prevention collectively form the core elements of ethical review in animal experiments, serving as fundamental factors in improving the quality of ethical reviews and avoiding ethical deviations. [ABSTRACT FROM AUTHOR]

Copyright of Arthroskopie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The lack of formal education in research ethics is a significant issue for the ethical conduct of research in Serbia. We conducted a cross-sectional survey on a sample of researchers and ethics committee members in Serbia to evaluate their self-assessed competence and educational needs in research ethics. Results indicated that previous ethics education had a significant effect on respondents’ perception of their own competence in addressing issues like informed consent, authorship, and publishing. Respondents expressed a high motivation for further research ethics education. Moreover, the study revealed that researchers with different specializations and different research experience have different educational needs. [ABSTRACT FROM AUTHOR]

Brain-computer interface (BCI) technology is rapidly advancing in medical research and application. As an emerging biomedical engineering technology, it has garnered significant attention in the clinical research of brain disease diagnosis and treatment, neurological rehabilitation, and mental health. However, BCI also raises several challenges and ethical concerns in clinical research. In this article, the authors investigate and discuss three aspects of BCI in medicine and healthcare: the state of international ethical governance, multidimensional ethical challenges pertaining to BCI in clinical research, and suggestive concerns for ethical review. Despite the great potential of frontier BCI research and development in the field of medical care, the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI. To ensure "responsible innovation" in BCI research in healthcare and medicine, the creation of an ethical global governance framework and system, along with special guidelines for cutting-edge BCI research in medicine, is suggested. [ABSTRACT FROM AUTHOR]

Copyright of Högre Utbildning is the property of Cappelen Damm Akademisk and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The involvement of animals in research procedures that can harm them and to which they are deemed unable to consent raises fundamental ethical dilemmas. While current ethical review processes emphasize the application of the 3Rs (Replacement, Reduction, and Refinement), grounded in a humancentered utilitarian ethical approach, a comprehensive ethical review also involves a harm-benefit analysis and the consideration of wider ethical issues. Nevertheless, to our knowledge, approaches are still needed to facilitate the integrative assessment and iterative revision of research designs to improve their ethical value or to identify cases in which using animals is irremediably unethical. Additionally, frameworks are lacking that explicitly include an animalcentered perspective into the ethical review process beyond welfare concerns, failing to cover broader ethical considerations (such as consent). In previous work we proposed an Animal-Centered Research framework (ACRf) comprising four animal-centered research principles (relevance, impartiality, welfare and consent) which could help researchers and ethical review bodies apprise research designs from an animal-centered perspective. This paper builds on and further develops our previous work by contextualizing the ACRf within the bigger picture of animal research ethical review and by illustrating how the ACRf could be operationalized within current ethical review processes. We contribute an extended framework that integrates the application of the ACRf principles within the ethical review process. To this end, we present findings from a theoretical case study focusing on the ethical review of a research protocol on the study of stress response in pigs. We discuss how our extended framework could be easily applied to facilitate a holistic approach to the ethical review process, and inform an iterative process of refinement, to support the development of research designs that are both more ethical and scientifically valid. [ABSTRACT FROM AUTHOR]

Oncology clinical trial is an important means for new drug development and treatment evaluation, and ethical review is an important step to protect the rights and safety of subjects. Therefore, establishing a mutual recognition mechanism for the ethical review of clinical trials of tumors has important practical significance, which can improve the approval efficiency, reduce repeated reviews, reduce the ethical risks, and promote international cooperation. This study conducted a comprehensive analysis and summary of the development status of mutual recognition of ethical review of clinical trials of tumors at home and abroad through literature analysis and research. The results showed that the mutual recognition of ethical review of clinical trials of tumors has become an international consensus and has been widely practiced worldwide. However, there are still some problems in the mutual recognition of ethical review of clinical trials of tumors, such as the lack of unified ethical review standards, insufficient training of ethical review personnel, and the lagging construction of an information sharing platform for ethical review. Therefore, the following suggestions are proposed: establish unified ethical review standards, standardize ethical review procedures; strengthen the training of ethical review personnel, improve the level of ethical review; establish an information sharing platform for ethical review to achieve resource sharing and mutual recognition. [ABSTRACT FROM AUTHOR]

Animals are used for scientific purposes across Africa to benefit humans, animals or the environment. Nonetheless, ethical and regulatory oversight remains limited in many parts of the continent. To strengthen this governance framework, the Pan-African Network for Laboratory Animal Science and Ethics brought together experts from 12 African countries to create an Africa-centric practical guide to facilitate the establishment and appropriate functioning of Institutional Animal Ethics Committees across Africa. The Guidelines are based on universal principles for the care and use of sentient animals for scientific purposes, with consideration of the cultural, religious, political and socio-economic diversity in Africa. They focus on 11 key elements, including responsibilities of institutions and of the Institutional Official; composition of the Committee; its responsibilities, functioning and authority; ethical application and review processes; oversight and monitoring of animal care and use and of training and competence; quality assurance; and the roles of other responsible parties. The intent is for African institutions to adopt and adapt the guidelines, aligning with existing national legislation and standards where relevant, thus ensuring incorporation into practice. More broadly, the Guidelines form an essential component of the growing discourse in Africa regarding moral considerations of, and appropriate standards for, the care and use of animals for scientific purposes. The increased establishment of appropriately functioning animal ethics committees and robust ethical review procedures across Africa will enhance research quality and culture, strengthen societal awareness of animals as sentient beings, improve animal well-being, bolster standards of animal care and use, and contribute to sustainable socio-economic development. [ABSTRACT FROM AUTHOR]

Copyright of Revista Colombiana de Bioetica is the property of Universidad El Bosque and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The involvement of animals in research procedures that can harm them and to which they are deemed unable to consent raises fundamental ethical dilemmas. While current ethical review processes emphasize the application of the 3Rs (Replacement, Reduction, and Refinement), grounded in a human-centered utilitarian ethical approach, a comprehensive ethical review also involves a harm-benefit analysis and the consideration of wider ethical issues. Nevertheless, to our knowledge, approaches are still needed to facilitate the integrative assessment and iterative revision of research designs to improve their ethical value or to identify cases in which using animals is irremediably unethical. Additionally, frameworks are lacking that explicitly include an animal-centered perspective into the ethical review process beyond welfare concerns, failing to cover broader ethical considerations (such as consent). In previous work we proposed an Animal-Centered Research framework (ACRf) comprising four animal-centered research principles (relevance, impartiality, welfare and consent) which could help researchers and ethical review bodies apprise research designs from an animal-centered perspective. This paper builds on and further develops our previous work by contextualizing the ACRf within the bigger picture of animal research ethical review and by illustrating how the ACRf could be operationalized within current ethical review processes. We contribute an extended framework that integrates the application of the ACRf principles within the ethical review process. To this end, we present findings from a theoretical case study focusing on the ethical review of a research protocol on the study of stress response in pigs. We discuss how our extended framework could be easily applied to facilitate a holistic approach to the ethical review process, and inform an iterative process of refinement, to support the development of research designs that are both more ethical and scientifically valid.

Abstract Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

Objective In 2019, A Chinese medical research team constructed a transgenic rhesus monkey model of human MCPH1, which is necessary to understand the cognition and behavior tendency of researchers on this new type of ethical issues. Methods The research group developed a questionnaire containing demographic information and ethical situational questions. The respondents were medical researchers who applied for the National Natural Science Foundation of China in 2019. The data obtained are analyzed by descriptive statistics. Results Overall, 70.9% of respondents (n=11 164) believed that there were ethical challenges when use the genetically modified monkeys who carrying human genes for medical research; The most prominent ethical issues were “unacceptable risk-benefit ratio” (49.1%) and “harm to rhesus monkeys” (33.7%); 31.1% of them believed that the study could be carried out when improvement from the ethics committee of their institution was availabl. Conclusions Medical researchers are cautious about such genetically modified monkeys. The 3R principle shouldbe strictly implemented in the medical research of transgenic monkeys, and the study of human-rhesus monkey chimerism should follow ethical norms and be strictly reviewed.

With the rapid development of biomedical science and technology in China, the number of clinical research projects is increasing rapidly, which is accompanied by ethical challenges. In recent years, a number of regional ethics committees have been established in China, and some experience has been gained in regional ethical review, but there is a certain difficulty in implementing it. In response to the difficulties in regional ethical review, the ethical cooperative review mode of medical union with the leading units as the core has been established based on the experience of foreign regional ethical review and the characteristics of the medical consortium structures that have been widely established in the county-level hospitals and prefecture level tertiary hospitals in Jiangsu region. It is expected to give full play to the flexible advantages of regional ethics committees by radiating and promoting the ethical review ability of medical union.

Abstract Background It has been argued that ethics review committees—e.g., Research Ethics Committees, Institutional Review Boards, etc.— have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data. Main body Focusing on the example of medical research databases we highlight here ethical issues around de-identified data sharing which motivate the need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work. Conclusion Data access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise.

Under the background of severe shortage of donor organs and organ donation after citizen's death becoming the main source of donor organs in China, expanded criteria donor (ECD) has been widely applied in clinical practice. However, ECD has the disadvantages of basic diseases, old age, trauma, shock or infection, which will affect the quality of donor organs to varying degrees and become one of critical factors affecting clinical efficacy of organ transplantation. The recipients of ECD organ transplantation will also bear the additional risk and uncertainty of efficacy brought by ECD organs. Hence, it is necessary to pay attention to the protection of the recipients’ rights and interests. In this article, ethical issues faced by ECD organ transplantation in recipient protection and the shortcomings in the ethical review of organ ethics committee were reviewed, and suggestions on the ethical review institution and system construction of the rights and interests of organ transplantation recipients were elucidated, aiming to provide reference for promoting the advancement of ECD organ transplantation. [ABSTRACT FROM AUTHOR]

Human Organ Procurement Organization (OPO) is an indispensable part of organ donation. In recent years, with rapid development of organ donation in China, united OPO has been established based on China's national conditions and establishment of global OPO. This innovative model serves as favorable supplement and exploration for the development of OPO, promoting the development of organ donation to enter a new stage. However, there are still some shortcomings during the process of development. Efforts should be made to catch up with the development of organ donation, aim at long-term goals, and promote development in a targeted manner. In this article, by analyzing the advantages and disadvantages of united OPO in the development of organ donation, the establishment of a long-term operation mechanism of united OPO was analyzed from policy support, talent training, technology upgrading, quality control, ethical review, financial management and full-course supervision, aiming to provide reference for further development of united OPO in China. [ABSTRACT FROM AUTHOR]

Copyright of Studia Socjologiczne is the property of Studia Socjologiczne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Modern biomedical technology is in an era of dramatic development, which brings unprecedented challenges to the work of ethics review and provides a turning point for the construction of ethics review system. The current ethics review committee (ERC) in China is executed with low efficiency and quality, which can hardly meet the current needs of biomedical research involving human beings. This paper summarizes the main connotations and roles of the sign system technique and the discipline mechanism through the idea of Foucault’s Panopticism, and proposes to incorporate the Panopticism into the construction of the ethics review system and establish the sign system and discipline mechanism of ethics review, in order to build an ethics review system and the operation system of the ethics review committee suitable for China’s national conditions.

Objective In 2019, A Chinese medical research team constructed a transgenic rhesus monkey model of human MCPH1, which is necessary to understand the cognition and behavior tendency of researchers on this new type of ethical issues. Methods The research group developed a questionnaire containing demographic information and ethical situational questions. The respondents were medical researchers who applied for the National Natural Science Foundation of China in 2019. The data obtained are analyzed by descriptive statistics. Results Overall, 70.9% of respondents (n=11 164) believed that there were ethical challenges when use the genetically modified monkeys who carrying human genes for medical research; The most prominent ethical issues were “unacceptable risk-benefit ratio” (49.1%) and “harm to rhesus monkeys” (33.7%); 31.1% of them believed that the study could be carried out when improvement from the ethics committee of their institution was available. Conclusions Medical researchers are cautious about such genetically modified monkeys. The 3R principle should be strictly implemented in the medical research of transgenic monkeys, and the study of human-rhesus monkey chimerism should follow ethical norms and be strictly reviewed. [ABSTRACT FROM AUTHOR]

Background: It has been argued that ethics review committees—e.g., Research Ethics Committees, Institutional Review Boards, etc.— have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data. Main body: Focusing on the example of medical research databases we highlight here ethical issues around de-identified data sharing which motivate the need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work. Conclusion: Data access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise. [ABSTRACT FROM AUTHOR]

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution's ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies.

This article is devoted to an ethical review of planned real-world studies. The legal basis of such examinations has also been considered. Most real-world studies are non-interventional, so the ethical review of such studies is similar to that of observational studies.

A large number of investigator-initiated clinical trials (IIT) were conducted in China, some of them should play an important supporting role in new drug development. Due to the large number, small scale and uneven quality of IIT in China, especially a big gap between the IIT and industry-sponsored trials in terms of protocol design, quality management and ethical review, many IIT can’t be used to support the new drug development. Therefore, it is necessary for regulatory authorities, sponsors, research institutions, ethics committees and researchers to improve their understanding of the role of IIT. In order to support the new drug development with high-quality IIT, formulating supervising system, establishing an effective quality management system, enhancing the training of researchers and improving the ability of ethical review should be implemented effectively.

A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards deliberate, with particular attention given to the lack of transparency and opportunities for researcher recourse that characterise ethics review processes. Centered specifically on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how Deliberative communication, Engagement with researchers and the Distribution of responsibility for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas' (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984) articulation of 'communicative action' and Fraser's (Social Text, 25(26), 56–80, 1990) consideration of 'strong publics' to cast consideration of the role that human ethics review boards might play in supporting university research cultures. Deliberative communication, Engagement with researchers and the Distribution of responsibility provide useful conceptual prompts for considering how ethics review boards might undertake their work. [ABSTRACT FROM AUTHOR]

Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and of the Council explicitly recognised the ethics committees' duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The burden of research ethics review falls not just on researchers, but also on those who serve on research ethics committees (RECs). With the advent of automated text analysis and generative artificial intelligence (AI), it has recently become possible to teach AI models to support human judgment, for example, by highlighting relevant parts of a text and suggesting actionable precedents and explanations. It is time to consider how such tools might be used to support ethics review and oversight. This essay argues that with a suitable strategy of engagement, AI can be used in a variety of ways that genuinely support RECs to manage their workload and improve the quality of review. It would be wiser to take an active role in the development of AI tools for ethics review, rather than to adopt ad hoc tools after the fact., (© 2024 The Authors. Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

Tim Schutte,1,2 Fedde Scheele,3,4 Scheltus van Luijk5 1Department of Internal Medicine, Amsterdam UMC, Amsterdam, The Netherlands; 2Department of Internal Medicine, Zaans Medisch Centrum, Zaandam, The Netherlands; 3Athena Institute for Transdisciplinary Research, VU University, Amsterdam, The Netherlands; 4Department of Healthcare Education, OLVG Hospital, Amsterdam, The Netherlands; 5Institute for Post Graduate Education MUMC+, Medical University Hospital, Maastricht, The NetherlandsCorrespondence: Tim Schutte Email t.schutte@amsterdamumc.nlAbstract: Recently, the balance between value and necessity of ethical review of health professions education research has been debated. At present, there are large differences in how ethical review of research proposals for health professions education is organized. We present a framework that describes the organization of ethical review in health professions education research, based on the interpersonal circumplex model, also known as Leary’s Rose. The framework is based on the two main balances in ethical review of health professions education research, being the protectiveness for the subjects and how ethical review is organized and responsibilities are shared. The axis/balance of protectiveness ranges between the extremes “paternalistic protective” to “liberal permissive”. The axis/balance of organization and responsibility ranges between the extremes of “centralized” to “local/decentralized”. This model offers insight in the position of an ethical review board and shows the dynamics of the decisions for ethical approval and the consequences of the different approaches to the organization of ethical review of health professions education research.Keywords: ethical review, health professions education research, ethical approval of health professions education research

Abstract Background Suicide research aims to contribute to a better understanding of suicidal behaviour and its prevention. However, there are many ethical challenges in this research field, for example, regarding consent and potential risks to participants. While studies to-date have focused on the perspective of the researchers, this study aimed to investigate the views and experiences of members of Human Research Ethics Committees (HRECs) in dealing with suicide-related study applications. Methods This qualitative study entailed a thematic analysis using an inductive approach. We conducted semi-structured interviews with a purposive sample (N = 15) of HREC Chairs or their delegates from Australian research-intensive universities. The interview guide included questions regarding the ethical concerns and challenges in suicide-related research raised by HREC members, how they dealt with those challenges and what advice they could give to researchers. Results The analysis identified four main themes: (1) HREC members’ experiences of reviewing suicide-related study applications, (2) HREC members’ perceptions of suicide, suicide research, and study participants, (3) Complexity in HREC members’ decision-making processes, and (4) HREC members’ relationships with researchers. Conclusions Reliance on ethical guidelines and dialogue with researchers are crucial in the assessment of suicide-related study applications. Both researchers and HREC members may benefit from guidance and resources on how to conduct ethically sound suicide-related studies. Developing working relationships will be likely to help HRECs to facilitate high quality, ethical suicide-related research and researchers to conduct such research.

International internet-based studies could be accessible by participants from various countries worldwide. However, the jurisdiction of research ethics committees (RECs) or institutional review boards (IRBs) is bound to geographical state or country borders. How can researchers deal with the geographical boundaries in the jurisdiction of RECs/IRBs versus the worldwide, open character of international internet-based research? Should ethical approval be sought in each country where participants will be recruited? In this paper, we want to share our challenges in setting up the ethical review procedures in an international internet-based mHealth intervention study, to further the discussion on ethical procedures in internet-based research.

Objective: To analyze the fundamentals used by members of Research Ethics Committees in solving ethical and/or moral problems experienced during their activities in these Committees. Methods: Qualitative study, using a self-administered online questionnaire on the Google Forms Platform, which involved 39 effective members of 10 Research Ethics Committees, from Salvador, Bahia, Brazil. Data analyzed from the Triadic, Humanist, Existentialist, Personalist Configuration. Results: Among the foundations used by members of the Research Ethics Committees to solve moral and/or ethical problems experienced are the instructions and normative documents within the scope of research involving human beings, bioethics, principles and values. Conclusion: The members of the Ethics Committees use norms and bioethics principles to solve moral and/or ethical problems experienced in their activities, with a view to developing research in line with the appropriate ethical and scientific aspects. [ABSTRACT FROM AUTHOR]

Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana (UB). We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then assembled Focus Group Discussions (FGDs) to engage the UB community to select the best 2–3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions.

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics., (© 2023 John Wiley & Sons Ltd.)

Ethics committees ensure compliance with ethical principles in medical research. They are oriented towards clinical studies, but also review e. g., qualitative research. Using a semi-structured online survey, we collected data on experiences of qualitative researchers with the review by ethics committees and analysed them via content analysis. In July 2019, 73 researchers took part in the survey. Five main topics were derived from their statements regarding the ethics review of qualitative research: 1. relevance of qualitative research expertise; 2. cooperation between researchers and ethics committees; 3. transparency of review criteria; 4. dealing with formal review requirements; 5. evaluation of the review's significance for qualitative research. The results show the potential of ethics review for reflection on ethical questions in qualitative research. Prerequisites for this are the fit with the characteristics and quality criteria of qualitative research, the presence of qualitative research expertise in ethics committees, the transparency of the ethics review process as well as openness to different professional cultures and a constructive communication culture., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: Qualitative Humanities research is perturbed by ethical review processes that routinely invoke epistemological assumptions skewed towards positivistic or deductive research, giving rise to several concerns, including increased risk aversion by University Research Ethics Committees (URECs) and the evaluation of qualitative research designs according to STEM standards., Methods/materials: This paper presents findings from an AHRC-funded research network built to better understand how research ethics frameworks and processes might be reformed to more appropriately fit ethically challenging qualitative methodologies., Results: There remains dissatisfaction with the current processes for awarding ethical approval and the subsequent management of ethical dimensions of projects. In spite of recent developments, UREC frameworks remain seriously flawed, with a wide divergence in the quality of expertise, procedures, and practices, leading to inconsistency in ethical approval awards., Conclusions: These factors downgrade UK Higher Education research power in the Humanities and undermine our commitments to the researched. We propose a series of recommendations for reform.