A transformative solution to build effective, transparent, and resilient "fit-for-purpose" national health research ethics systems.

The current research ethics review systems are composed of isolated institutional Research Ethics Committees (RECs) that develop their own standard operating procedures (SOPs), templates and so on, with low adoption of digital solutions to manage submission and review processes. This poses several challenges, such as delays, higher costs, and hindering multi-site research. We propose an online national research ethics platform that all RECs can use, with common review processes and documentation requirements following national policy. The system will scale up adoption of digital solutions to all RECs. It will reduce administrative burden and harmonize review procedures. It will also obviate the need for separate and isolated interventions such as national REC registries or clinical trial registries, as these can be generated as transactional outputs of the system. The harmonized procedures and possibility of single submission will facilitate multi-site research. Sharing of resources and expertise among RECs on the platform will enhance resilience. An e-EC system developed in India and a Regional Health research portal developed by the WHO South-East Asia office offer proof of concepts to demonstrate the feasibility of developing and using such systems. The proposed solution is ambitious but feasible. Developing the proposed system will be a vital cost-effective investment in national health infrastructure to strengthen the research ecosystem and accelerate delivery of improved healthcare innovations by reducing unnecessary delays in conducting research. To maximize benefits, concurrent efforts are needed to build researchers' capacity and enhance the quality and efficiency of human reviews of the research proposals by REC.

Current status and influencing factors of nurses' knowledge and attitudes towards clinical research ethical in China: a province-wide cross-sectional survey.

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.

The readiness of the Asian research ethics committees in responding to the COVID-19 pandemic: A multi-country survey.

Background: COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs' responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods: The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members.The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results: A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions: Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

Ethical considerations in public engagement: developing tools for assessing the boundaries of research and involvement.

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.

Ethical committee frameworks and processes used to evaluate humanities research require reform: Findings from a UK-wide network consultation.

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.

Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces.

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.

Toward an integrated ethical review process: an animal-centered research framework for the refinement of research procedures.

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.

A Qualitative Research Survey on Cardiologist's Ethical Stance in Cases of Moral Dilemmas in Cardiology Clinics.

This study sought to determine cardiologists' degrees of ethical awareness and preferred courses of action for ethical dilemmas frequently encountered in clinical settings. For this evaluation, an online survey was created and sent to cardiologists affiliated with various academic posts in Ankara, Turkey. The survey included ten cases with various ethical considerations selected from our book, "Clinic Ethics with Cases from Cardiology." Four possible action choices were defined for each case. Participants were asked to choose one or more of these preferences. In addition, a fictional change was made in each case's context without changing the original ethical issue, and participants were asked whether an attitude different from the first chosen one was preferred. The participation ratio was 49/185 (26%), consent ratio 47/185 (25,4%), and completion ratio 44/185 (23,7%). Nine of the ten scenario changes did not change participants' preferred action. For most questions, action preferences were concentrated between the two options. Although legal regulations did not reduce ethical dilemmas, they clarified physicians' action preferences. Similarly, as an obscure moral issue gained prominence, physicians were forced to draw clearer lines in their actions. External factors such as healthcare emergencies can change physicians' ethical dilemma-solving attitudes.

Guidelines for the establishment and functioning of Animal Ethics Commitees (Institutional Animal Care and Use Committees) in Africa.

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.

Critical points in the current construction of ethics committees at medical institutions / 现代医院

Significant advancements have been made in the establishment of ethics committees within medical institu-tions.However,in order to achieve a high-quality development it is imperative to focus on such critical points as distinguishment between biomedical research and the clinical application of medical technologies,steadfast adherence to the fundamental princi-ples of ethical review,establishment of an ethics committee with independent administrative authority,establishing independent ethics review committees in large medical institutions based on specialty,and strengthening of ethical training for medical person-nel and biomedical researchers.

Ethical and Welfare Review in the Modeling Process of Disease Animal Models / 医用生物力学

Disease animal model is an indispensable part of studying the pathogenesis and treatment of diseases.Review of the ethics and welfare is the necessary measure to ensure the quality of scientific research and promote the scientific and rational use of laboratory animals.In the review practice,it is found that most applicants are difficult to accurately understand the items listed in the application form and ethical principles related to items.Therefore,a practical and feasible set of ethical guidelines for animal experiments is necessary.This review focuses on the legal and ethical basis of developing oral disease animal models,and divides the methods of establishing oral disease animal models into physical methods,chemical methods,biological methods,and combined methods.It also elaborates on the ethical and welfare review points of different modeling methods and model evaluation methods.Hopefully,ethical censors and project applicants may get more understanding of ethical review for disease animal models,and ultimately improve the standardization and applicability of animal models.

Interpretation of the Measures for Ethical Review of Life Sciences and Medical Research Involving Humans developing responsible research and innovation / 中国医学伦理学

The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans responded to the new issues faced by ethical review arising from the development of science and technology， society， and ethics， as well as the requirements of laws and regulations for ethical review. It adapted to the continuous increase of investment in scientific and technological innovation research and the development of biotechnology in China， and expanded the applicable institutions and research types of the ethical review system. Facing the ethical review of life sciences and medical research involving humans is one of the practical forms of responsible research and innovation. Therefore， it is necessary to establish and improve the ethical review system， implement the “subject responsibility” of life sciences and medical research involving humans， carry out classified and hierarchical bioethics education， and enhance the consciousness of researchers， research managers， and students in responsible research and innovation.

Requirements for biological samples and challenges to ethical review under the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans / 中国医学伦理学

Regarding biological samples， compared to the Measures of Ethical Review of Biomedical Research Involving Humans， the newly released Measures of Ethical Review of Life Science and Medical Research Involving Humans updated the definitions， clarified the scope， defined the responsibilities of the subject， as well as emphasized the management system， ethical review， and informed consent. By comparing and analyzing the current management status of biological samples at home and abroad， it was found that there were still many problems in the management and ethical review of biological samples in China， such as a chaotic management system of biological samples， unclear responsible entities for management， lack of widely recognized management standards of biological samples in the industry， absence of ethics committee， the non-standard ethical review， the inadequacy or inability to implement informed consent， and the difficulty in providing feedback on research results. Therefore， it is recommended to establish a standardized management system of biological samples， conduct a standardized and effective ethical review， as well as sufficient and necessary informed consent， in order to comply with the requirements of the Measures of Ethical Review of Life Science and Medical Research Involving Humans on biological samples， and enhancing the quality of the management of biological samples in China.

New requirements and key points for review for research related to health information data in the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans / 中国医学伦理学

To further standardize the ethical review of life science and medical research involving humans， the National Health Commission， the Ministry of Education， the Ministry of Science and Technology， and the State Administration of Traditional Chinese Medicine jointly issued the Measures of the Ethical Review of Life Science and Medical Research Involving Humans in 2023. The provisions concerning research related to health information data within it include： emphasizing the protection of personal information and privacy rights， personal information can only be collected， stored， and used under the premise that research participants know and permit， and must not be disclosed to third-party without the authorization of research participants； the ethical committee should focus on reviewing the adequacy of confidentiality measures of personal information； for research that provides information and data or cooperation with external organizations， it is necessary to fully understand the research， conduct a full ethical review， and clarify the use， processing， and disposal after completion of information data through an agreement. The research institutions should improve the information data governance and supervision system in conjunction with the key points of information data management in the new regulations. The initial ethical review should focus on the risk-benefit ratio of the research， the reasonableness of the informed consent procedure， the feasibility of the opt-out procedure， the protection measures for the privacy of the research participants， and the data management capability of the research team. The knowledge training of researchers should be strengthened， policy advisory services should be provided for them， and even a unified information data management platform should be built for them from the overall level of research institutions. The ethical follow-up review emphasizes whether the researchers continue to protect the participant’s right to independent information or personal information， and privacy. It is believed that through a series of governance measures， the health information data of research participants in China will be better protected， thus safeguarding their legitimate rights and interests.

Challenges， countermeasures and key points of ethical review for decentralized clinical trials / 中国医学伦理学

Decentralized clinical trials （DCT） are bringing new changes to clinical trials， the core concept of “patient-centered” must be adhered， and the safety and rights of research participants must be adequately safeguarded. Although DCTs have similarities with traditional clinical trials， they are not suitable for all clinical trials， and are more suitable for oral administration， stable condition of study participants， and longer duration of treatment in clinical trials. DCT， elements must be selected based on the characteristics of clinical trials， and strike a balance between improving the sense of gain， safety， and rights and dignity of research participants， as well as the quality of data collected. Currently， DCT in China face many challenges. To actively promote DCTs in China， regulatory regulations and guiding principles should be improved. Based on patient-centered design principles， the first discussion requires real-time online communication. Researchers should provide more clinical trial services， improve risk control and accessibility of medical assistance， use third-party convenient payments， ensure fair recruitment of research participants， consider compliance， validate digital health technology， remote monitoring and electronic informed consent compliance， ensure the security of data collection， transmission， and analysis， as well as strengthen multi-party training. Ethical review is one of the important means to protect the safety and rights of research participants. Ethics committees should focus on appropriate DCTs elements that are patient-centered， compliance and effectiveness of electronic informed consent， processing and reporting of security information， privacy protection of data collection， compliance of remote monitoring， family health follow-up， management of biological samples and experimental medical products， and training programs. The author believed that the complementarity and combination with traditional clinical trials will make DCTs elements implemented more easily and smoothly. By leveraging the power of scientific and technological advances， DCTs will boost the speed of China’s drug and medical device research and development， enhance international competitiveness， and benefit more patients.

Exploration of the misunderstandings， challenges， and countermeasures of exemption from ethical review from the perspective of medical and health institutions / 中国医学伦理学

In the implementation of exemption from ethical review， medical institutions equate exemption from ethical review with no ethical review or simple review， misunderstand the scope of exemption from ethical review， confuse the concepts of de-identification and anonymization， and equate privacy with personal information. The implementation faced challenges such as the coordination of conditions for exempt review with other regulations， the lack of clear decision-making subjects for exempting from ethical review， the legality and compliance of using general informed consent for biological samples and information data， as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review. Measures such as improving relevant laws and regulations， perfecting the construction and management of information databases and biological sample libraries， strengthening the project management and process supervision of exemption from ethical review， and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.

The importance and updated key point of ethical review in health management research： based on the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans / 中国医学伦理学

The release of the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans has brought new requirements to the field of ethical review in health management research. Based on the background of new regulations and combining the characteristics of the health management discipline， this paper explored the needs and necessity of ethical review in health management research. In the Measures， the ethical governance of health management research was updated， the concept of exemption from the ethical review was put forward， as well as the importance of protecting the rights and interests of research participants and the protection of personal information were emphasized. This paper also explored the ethical review framework for health management research， including the formulation of operational standards for exemption from ethical review， the refinement of standardized ethical review work systems and processes， and the clarification of information data source verification. These explorations aimed to provide an ethical guarantee for health management research， promote its healthy development， and ensure that the rights and interests of research participants are fully respected and protected. Through research， it is hoped that the ethical level of health management research can be further improved， promoting the development of the discipline and social progress.

Ethical reviewof cosmetic efficacy claims evaluation trails / 中国医学伦理学

The supervision of cosmetics started relatively late in China， and corresponding laws and regulations on ethical review are not yet perfect. The Cosmetics Supervision and Administration Regulations， which came into force on January 1， 2021， had stricter requirements for cosmetic efficacy claims， requiring that cosmetic efficacy claims should have a sufficient scientific basis. Cosmetic efficacy claims evaluation trials include human efficacy evaluation trials， consumer use tests， and laboratory trials. Human efficacy evaluation trials and consumer use tests should comply with the requirements of ethical principles， the necessary product safety evaluation should be completed before the tests are carried out， to ensure that there is no harm to the human health of research participants （or consumers） under normal， foreseeable circumstances. The Regulations on the Administration of Registration and Filing Materials for Cosmetics required that product test reports should include microbiological and physical-chemical tests， toxicological trials， human safety trial reports， and human efficacy trial reports. The key points of the ethics committee’s review of cosmetic efficacy claims evaluation trials include the reasonableness of the trial protocol， consumer survey and expert evaluation， selection of detection methods， study population and sample size， safety evaluation of the cosmetics， risk assessment of cosmetic raw materials， protection of privacy， and qualifications of the testing institutions and researchers. High-quality ethical review is conducive to safeguarding the safety and rights of research participants （or consumers）， and will also promote the quality of cosmetic efficacy claims evaluation trails in China.

Research on the necessity and program design of the development of an ethical review information system for organ donation and transplantation / 中国医学伦理学

Currently， the ethical review model for organ donation and transplantation in domestic hospitals is generally characterized by suddenness， unpredictability， tight time， difficulty in convening meetings and training committee members， as well as generally low quality and efficiency of ethical review， which cannot meet clinical needs and cause the waste of some scarce resources. The team of the Clinical Application Center of Human Organ Transplantation and the Ethics Committee of the First People’s Hospital of Kunming combine more than 10 years of review practice experience， as well as continuously explore and optimize the ethical review process and operating procedures for organ donation and transplantation. The special application has been approved and jointly developed with Soochow University and the Medical Ethics Committee of Fujian Province to build a full-process information software system management platform for organ ethical review of donation and transplantation， giving the full play the advantages of the review information system in improving work efficiency and review quality， facilitating full-process information management， and conducting online training and learning for committee members， with a view to providing a specialized practical model for addressing the difficulties and challenges related to ethical review of human organ donation and transplantation.

Exploration and construction of an evaluation indicator framework for clinical research benefits in China / 中国医学伦理学

ObjectiveThe aim is to construct an evaluation framework for clinical research benefits， and provide a reference for the formulate of evaluation standards for clinical research benefits. MethodsThe Delphi method was used to carry out expert consultation， and the mean， score of importance， coefficient of variation and coordination， etc. of evaluation indicators were summarized and calculated， to screen evaluation indicators for clinical research benefits. ResultsTwenty-three experts in this field were selected for correspondence， and their enthusiasm was 100% in both rounds， the authority coefficients were≥0.90， and Kendall’s coefficients of concordance were<0.25 （P<0.001）. By referring to the mean and coefficient of variation of the indicators， as well as combining them with expert suggestions， an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators， 5 secondary indicators， and 8 tertiary indicators. ConclusionThe evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits， as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.