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.

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 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.

Contributions and new achievements of medical ethics to ethical governance of science and technology / 中国医学伦理学

The release of Guidelines to Strengthen the Governance over Ethics in Science and Technology marked that China's ethical governance system of science and technology has entered a new stage.The research and practice on ethics in science and technology in China are carried out along two approaches.One approach is to derive the rules of specific science and practice from the principles of general ethics.The other is to gradually form ethical governance principles and consensus for a specific type of phenomenon or problem in the process of science and technology,starting from scientific research problems and scientific and technological events and cases.Medical ethics research has also formed the tradition of medical ethics and modern bioethics in this way.In the practice of ethical governance,medical ethics is at the forefront of scientific and technological ethics,forming a"pilot area"for the research and development of scientific and technological ethics,an"explorer"for the institutionalization of ethical review,and a"demonstration area"for scientific and technological ethical governance.The release of ethical governance opinions is not the end of research on medical ethics governance,and medical ethics needs to have new achievements.Firstly,rethinking the theoretical basis and methodology of medical ethics and adhering to the guidance of Marxist theory.Secondly,a rethinking of the two research paths and how they can balance development and support each other.Thirdly,rethinking the relationship between ethics and the rule of law,and continuously improving the level of legalization of ethical governance.

Preliminary exploration on the ethical governance path of internet medicine from the perspective of medical equity / 中国医学伦理学

Economic development drives the increase of endogenous demand,and Internet medicine integrates regional medical resources,expanding the fairness of the public's access to medical and health services.However,it is also accompanied an ethical crisis with the development of technology,which requires continuous standardization and practice.Starting from the principle of medical fairness,this paper sorted out the main advantaged characteristics of the development of Internet medicine from the aspects of data fairness,cost equity,opportunity equity,and educational equity.The existing ethical problems of Internet medicine were explored including unfair protection of ethical review mechanisms,unfair data collection of scientific and technological subjects,unfair distribution of benefits and risks,and unfair utilization of Internet medical resources.It also proposed the governance paths of compacting the subject responsibility,perfecting review and supervision,improving the sharing mechanism,bridging the digital divide,strengthening risk prevention,protecting the citizens'rights and interests,strengthening education and guidance,and increasing grassroots investment.

Double investigation of gene therapy / 中国医学伦理学

From the biological point of view,genes are the key to being human.With the continuous advancement of human gene technology,gene therapy has become a frontier topic with great vitality and controversy in the field of life science:it has brought more hope for the cure of diseases to human beings,but it has also triggered many ethical debates.This paper sorts out the ethical questions faced by gene therapy,extracts the challenges faced by individual rights,social justice,natural order and so on,and responds one by one,which shows that the development of gene therapy does not violate these ethical values in principle.However,the occurrence of gene editing events has sounded the alarm for us:where should the implementation boundary of gene therapy be?Through the comparative analysis of the gene editing incident and the Berlin patient case,the article points out that the study of technical safety is the key to safe application of gene therapy in clinical applications.

The ethical review and reflection on in-utero pediatrics / 中国医学伦理学

In-utero pediatrics is a fetal general medicine for perinatal medicine redevelopment,with the main purpose of preventing and treating fetal diseases,which studies the early prevention,screening,diagnosis,and treatment of diseases from gametes,fertilized eggs,and embryos sequential to children,adolescents,adolescence,and even the entire life cycle.Medical ethics provides strong support for the normative development of this discipline.This paper summarized the formation and development of in-utero pediatrics,analyzed the vulnerability of service subjects within in-utero pediatrics,and sorted out their ethical issues in the prevention and control of birth defects,fetal intrauterine diagnosis and treatment,as well as multidisciplinary collaborative diagnosis and treatment.It was proposed that in-utero pediatrics should follow the medical principle of maternal and fetal interests first,the principle of respect,and the principle of no harm.Finally,suggestions for ethical review of clinical and research projects on in-utero pediatrics were proposed,including strengthening the advisory service role of the ethics committee in clinical practice,timely launching the guidelines of ethical review for clinical research,and enhancing the ethical awareness of medical staff.

Reflections on ethical review and management of medical artificial intelligence social experiment projects / 中国医学伦理学

The medical artificial intelligence(AI)social experiment aims to more comprehensively understand the comprehensive impact of medical AI technologies and products on society,with the characteristics of wide application scenarios,complex research types and methods,multi-dimensional evaluation indicators,cross-disciplinary,and diverse subjects.To ensure the quality of ethical review in medical AI social experiment,it is urgent for relevant parties such as government authorities,research initiators,medical and health institutions,universities,scientific research institutions,enterprises,and research teams to shoulder their respective responsibilities,establish a technology product access mechanism for medical AI social experiments,improve the ethical review ability of the ethical review committee,and construct a whole cycle regulatory system.

Discussion on whether ethics committee should serve as the review subject of compassionate drug use / 中国医学伦理学

Under the premise that the relevant laws and regulations in China do not specify the review subject of compassionate drug use,it is controversial who should bear the responsibility for the review and approval.This paper summarized and elaborated on the characteristics of compassionate drug use,and discussed the responsibilities,professionalism,and necessity of review of the ethics committee.It is believed that the ethics committee should serve as the review subject of compassionate drug use,and focus on doctor qualifications,risk-benefit ratio,informed consent forms,and conflicts of interest.

Construction and practice of an informatization management system for institutional ethical review / 中国医学伦理学

With the progress of society,the global development of scientific and technical research activities,and the increasing number of medical Institutional Review Board(IRB)review projects,the construction and management of electronic informatization have become extremely important.In the process of electronic information construction in institutional ethics review,it is necessary to take into account the new policy of ethical governance of science and technology,consider the system and standard operating procedures of IRB,and develop reasonable processes based on practical work,simplify manual operation,improve the accuracy of project management,achieve refined management,and facilitate communication among researchers,ethics committee secretaries,and members.

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.