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.

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.

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.

Preparing ethical review systems for emergencies: next steps.

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.

Artificial intelligence and medical research databases: ethical review by data access committees.

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.

Development of Two Korean IACUC Guidance Documents to Foster Implementation of the Three Rs.

In Korea, Institutional Animal Care and Use Committees (IACUCs) have been legally required to apply the Three Rs principles (i.e. replacement, reduction and refinement) and undertake the ethical review of animal study protocols, since 2008. According to Korean law, each IACUC is required to appoint at least one lay member recommended by a non-governmental animal protection organisation, who participates in the ethical review process as part of this role. Despite the importance of the Three Rs and the ethical review process, limited information and practical resources are available for IACUC members in the Korean language, particularly for lay members who are inexperienced in animal experimentation. In January 2020, the Animal and Plant Quarantine Agency announced the funding for a six-month research project to develop guidance to assist IACUC members in carrying out effective and efficient protocol reviews in line with Korean legislative requirements. This funding was awarded for the production of two IACUC guidance documents - 'Guide for Animal Study Protocols' and 'Guide for the IACUC Lay Member' - which were published in December 2020. These guidance documents aim to foster the implementation of the Three Rs and provide practical resources for IACUC members, researchers and other relevant personnel. This paper describes the framework for animal use in Korea and the overall production of these two IACUC Guidance Documents.

Is UK Animal Research Governance Facing a 'New Normal'? Considering the Risks and Benefits of 'Going Online'.

Since a return to in-office working after the extensive disruption caused by the COVID-19 pandemic and associated challenges, many conversations are still being had with regard to what the 'new normal' might look like in professional spaces and networks, and what lessons can be learnt from long periods of remote working. The regulation of animal research practice in the UK is no exception here and, like many other systems, it has been transformed by the increasingly recognised value of streamlining procedures through the use of virtual online spaces. In early October 2022, the author attended an AWERB-UK meeting in Birmingham (convened by the RSPCA, LAVA, LASA and IAT), which focused on the induction, training and Continuing Professional Development (CPD) opportunities for Animal Welfare and Ethical Review Body (AWERB) members. This comment article reflects on this meeting and raises some interesting questions surrounding animal research governance in an evolving online era, specifically the associated ethical and welfare dimensions.

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New drug clinical trials have been considered as a positive way for treating cancer by cancer patients and doctors, and the extended dosing is a special way for patients' withdrawal from antitumor clinical trials to obtain investigational new drugs. However, neither the regulations of expanded dosing nor the detail documents for expanded dosing have been officially published in China. At present, expanded dosing of investigational drugs is still at the exploratory stage in various medical institutions, and a complete management system has not been established to meet patients' urgent needs for drug use. Based on the practical experience of extended dosing in Hunan Cancer Hospital, this paper preliminarily explored the application procedures and ethical review requirements of extended dosing for subjects in antitumor clinical trials. It is necessary to clarify the responsibilities of all patients in the procedure and establish a patient-medical institution-sponsor joint application system. In the process of ethical review, it is recommended that all parties fully consider the risks and benefits of extended dosing for patients, and then the ethics committee makes a comprehensive assessment to decide whether to approve extended dosing.

Establishing the doctor of nursing practice project ethical review process to improve standardization, efficiency, and timeliness.

BACKGROUND: DNP Scholarly projects require review for scientific merit and human subject protection. Rapid growth of DNP programs and projects has increased Institutional Review Board (IRB) burden and increased the length of project approval time when most DNP scholarly projects are quality improvement (QI) projects and not deemed Human Subjects Research (HSR). PURPOSE: Develop a process and describe the rationale for creating and implementing a Project Ethical Review Committee (PERC) in the School of Nursing and to evaluate the experience of the first cohort of submissions. PROCESS: Committee was formed using expert consensus approach, in collaboration with IRB. Standards of Procedures and training materials created. OUTCOME MEASURE: 100 projects submitted to committee; 95 deemed QI (95%) and 5 projects considered HSR (5%). First 94 projects were reviewed, and approval letters sent within 8 weeks. DISCUSSION: This paper discusses how PERC ensures rigorous and ethical review process for standardization, timeliness, and efficiency.

Ethical concerns in suicide research: thematic analysis of the views of human research ethics committees in Australia.

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.

Identifying and Classifying Tools for Health Policy Ethics Review: A Systematic Search and Review.

Ethical review and analysis of health policy may help to ensure policies address the needs of society and align with relevant values and principles. Indeed, researchers and bioethicists have recognized the need for ethical frameworks specifically for public health applications. The objective of this research was to compile structured tools for ethical review of (drafted or existing) health policy and to analyze these tools for their scope and philosophical underpinnings. A systematic search and review of academic and grey literature was conducted to compile existing tools designed for health policy ethics review. The search yielded 13 health policy ethical review tools. Qualitative content analysis revealed that all of the tools were influenced by multiple ethical values and that a majority were influenced by more than one ethical theory. The most common values were non-maleficence and beneficence (92.3%). The most common influencing ethical theory was the Principles Approach (92.3%). The structure of the tools demonstrates a heterogeneity of methodology designs to approach policy ethics review. This research offers a unique contribution to the bioethics field that provides a useful resource and understanding of the current ethical review tools for health policy.

Development proposals of Human Research Protection Program.

BACKGROUND: China's ethics committees alone are unable to meet the growing need for human participant protection. Several scandals in recent years indicate weaknesses in the protection of human participants in China. OBJECTIVES: The aim of the study is to summarize the status and problems of human research protection program in China and to explore its establishment proposals at national and hospital levels. RESEARCH DESIGN: To conduct literature retrieval, Chinese National Knowledge Infrastructure, Chinese Biomedical Document Database, and English databases Web of Science and PubMed were searched; laws, guidelines, and regulations were also searched on web by Google and Chinese search engine Baidu. ETHICAL CONSIDERATIONS: No data were collected from human participants, and ethical review was not required. FINDINGS: There are problems for China's Human Research Protection Program, such as weak relevant legal systems, insufficient administrative supervision, and incompetent ethics committee capacities. To fully protect human participants, China should promote the development of Human Research Protection Program, which can formulate ethics-related laws, improve regulations for the protection of the safety and rights of human participants, strengthen supervision, and enforce compensation for human participants. Owing to the frequency with which human participants are recruited in hospitals in China, hospitals can utilize existing ethics committees and establish data and safety monitoring committees, quality control, fund and contract management, and conflict of interest management offices. DISCUSSION: As a growing program, it remains necessary to learn from the experience of developed countries with high ethics standards and reformulate them to fit China's conditions to explore potential future development. The program will also be an experience for other developing countries. CONCLUSION: Human Research Protection Program can strengthen communication and coordination among various hospital departments to effectively protect the rights and welfare of human participants.

Bystanders and ethical review of research: Proceed with caution.

Scientists seeking to conduct research with human subjects must first submit their proposals to research ethics committees (Institutional Review Boards [IRBs], in the United States). Some of these studies pose risks to "bystanders," i.e., people who may be affected by the research but who are not enrolled as study subjects. Should IRBs expand their scope to include oversight over possible harms to bystanders as well as research subjects? This paper presents arguments against this step. Prior review of research with human subjects, despite its evident burden on the research enterprise, is a necessary caution, because the tension between the objectives of humane treatment of research subjects and sound scientific design and procedure has in the past led to serious abuses. This rationale is inapplicable in the case of bystanders. Moreover, in view of the many and varied effects of both research practices and scientific advances on the broader public over time, those who may be considered to be "bystanders" may potentially expand without limit; requiring IRBs to anticipate these distant and long-term effects as part of prior ethical review could greatly increase its burden and its deterrent effect on research. While conducting research without concern for serious potential harm to bystanders may be irresponsible and unethical, expanding the scope of prior review by IRBs to include risks to bystanders is not required by the principles governing human subjects research, and the costs and burdens of this expansion may outweigh any expected gains.

[Ethical review of clinical study on intervention with traditional Chinese medicine in new public health emergencies].

High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.

Stepped-wedge trials should be classified as research for the purpose of ethical review.

BACKGROUND: All studies classified as research involving human participants require research ethics review. Most regulation and guidance on ethical oversight of research involving human participants was written for pharmacotherapy interventions. Interpretation of such guidance for cluster-randomized trials and stepped-wedge trials, which commonly evaluate complex non-therapeutic interventions such as knowledge translation, public health, or health service delivery interventions, can pose challenges to researchers and regulators. CURRENT GUIDANCE: The Ottawa Statement on the Ethical Design and Conduct of Cluster-Randomized Trials provides guidance on the ethical oversight and consent procedures for cluster-randomized trials, and while not explicit, this includes stepped-wedge trials. Yet, stepped-wedge trials have unique characteristics that differentiate them from standard cluster-randomized trials. In particular, they can be used to evaluate knowledge translation interventions within the context of a routine health system rollout; they may have a non-randomized design; and the decision to implement the intervention is not always made by the researcher. Many stepped-wedge trials do not undergo ethical review and do not report trial registration. This suggests that those undertaking these studies and research ethics committees perceive them as non-research activities. RECOMMENDATIONS: Through an ethical analysis of two case studies, we argue that stepped-wedge trials, like parallel arm cluster trials, are systematic investigations designed to produce generalizable knowledge. We contend that stepped-wedge trials usually include human research participants, which may be patients, health care providers, or both. Stepped-wedge trials are therefore research involving human participants for the purpose of ethical review. Nevertheless, the use of a waiver or alteration of consent may be appropriate in many stepped-wedge trials due to the infeasibility of obtaining informed consent and the low-risk nature of the interventions. To ensure that traditional ethical principles such as respect for persons are upheld, these studies must undergo research ethics review.

The ethical oversight of learning health care activities in Switzerland: a qualitative study.

OBJECTIVE: This study aims to identify the key issues regarding the ethical oversight of health care improvement activities in Switzerland. DESIGN: Individual semi-structured qualitative interviews, analysed using conventional content analysis. SETTING: Interviews were conducted in Switzerland between July 2017 and February 2018. PARTICIPANTS: A purposive sample of 38 key stakeholders from four different groups: health care improvement researchers and practitioners (n = 19), representatives of clinical trial units (n = 3), clinical ethicists (n = 5), quality heads of university hospitals (n = 5), and cantonal ethics committee members (n = 6). RESULTS: There appears to be widespread uncertainty regarding when certain learning health care activities require ethical review by a research ethics committee in Switzerland. This situation is exacerbated by legislative ambiguity and limited guidance. It was reported that the lack of other oversight mechanisms for activities outside of the Human Research Act is also leading many investigators to submit projects to research ethics committees to avoid barriers to publication. CONCLUSIONS: The continuous, integrated, and dynamic nature of learning health care poses significant challenges to the current regulatory framework. It will be important that more clarification and guidance is provided regarding which activities require ethical review, and that it is considered how the ethical oversight of activities falling outside human research legislation can be strengthened. However, the traditional model of ethical oversight is poorly suited to learning health care and may need to be replaced with new systemic oversight approaches.

Response to Correspondence from Kolstoe and colleagues concerning our paper entitled, Research approvals iceberg: How a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

In their letter to the Editor in this issue, Kolstoe and Carpenter challenge a core aspect of our recently published case study of research approvals [BMC Medical Ethics 20:7] by arguing that we conflate research ethics with governance and funding processes. Amongst the key concerns of the authors are: 1) that our paper exemplifies a typical conflation of concepts such as governance, integrity and ethics, with significant consequences for claims around the responsibility and accountability of the organisations involved; 2) that, as a consequence of this conflation, we misrepresent the ethics review process, including in fundamental aspects such as the ethics approval-opinion distinction; 3) that it is difficult to see scope for greater integration of processes such as applying for funding, research approvals, Patient and Public Involvement, etc., as suggested by us. Here we present an alternative point of view towards the concerns raised.

Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

BACKGROUND: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change. MAIN TEXT: We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. CONCLUSION: Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.

[Scientific and ethical evaluation of projects in data-driven medicine]. / Wissenschaftliche und ethische Bewertung von Projekten in der datengetriebenen Medizin.

The generation and usage of extensive data from medical care aims at answering crucial medical research questions. Buzzwords in this area are learning health system, data-driven medicine and big data. In addition to classical biostatistical methods, machine learning approaches are frequently applied for analysis.In the evaluation of projects from data-driven medicine by research ethics committees, the question arises of how to assess the benefit-risk ratio and the scientific and social value. Which knowledge is required for that purpose? How can research ethics committees prepare for these challenges? Scientific approaches from the area of observational studies and the consideration of agreed-upon ethical aspects (consent, validity, justice, benefit-risk ratio and transparency) can help to answer the above-mentioned questions. One has to bear in mind that data-driven medicine is no paradigm shift that in principle challenges the established scientific and ethical evaluation procedures. Nevertheless, the evaluation of projects from data-driven medicine requires enhanced specialisation and comprehensive methodical expertise from the areas of machine learning and observational studies.Empirical research of the progression and governance of data-driven medicine will support the development and continual adaptation of effective strategies for evaluation by research ethics committees. Training and networking of experts will enable us to meet the challenges of data-driven medicine.