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.

Biobanks and biomarkers:Their current and future role in biomedical research

The importance and utility of biobanks has increased exponentially since their inception and creation.Initially used as part of translational research,they now contribute over 40%of data for all cancer research papers in the United States of America and play a crucial role in all aspects of healthcare.Multiple classification systems exist but a simplified approach is to either classify as population-based or disease-oriented entities.Whilst historically publicly funded institutions,there has been a significant increase in industry funded entities across the world which has changed the dynamic of biobanks offering new possibilities but also new challenges.Biobanks face legal questions over data sharing and intellectual property as well as ethical and sustainability questions particularly as the world attempts to move to a low-carbon economy.International collaboration is required to address some of these challenges but this in itself is fraught with complexity and difficulty.This review will examine the current utility of biobanks in the modern healthcare setting as well as the current and future challenges these vital institutions face.

Chinese Ethics Review System and Chinese Medicine Ethical Review:Past,Present,and Future

The Chinese medical ethics committee and the ethical review system have made the following achievements： （1） enabled the institutionalization of medical ethics, （2） carried out the ethics review of Chinese medicine （CM） and integrative medicine extensively, （3） trained a large number of ethical professionals, （4） supported and protected the interests of patients and subjects, and （5） ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways： （1） to refine the relevant rules of ethical review, （2） to develop the relevant standards of the CM and integrative medicine ethical review, （3） to enhance the independence and authority of ethics committee, （4） to emphasize innovation and to discover and solve new problems, and （5） to increase international exchanges and improve relevant research.

Meru University of Science and Technology Research Ethics Review System: A SWOT Analysis

The objectives of this article are as follows: 1) to propose a university research ethics system framework, 2) to provide a brief anatomy of the Meru University of Science and Technology (MUST) Institutional Research Ethics Review Committee (MIRERC), 3) to perform a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis of MIRERC, and 4) to make recommendations for improving its performance. The 13-member multi-disciplinary MIRERC was established in April 2017 to provide effective ethical oversight of research undertaken by the University’s scholarly community. Strengths of the MUST research ethics review system include a functional MIRERC, a pertinent national law and ethical guidelines, an Innovation and Enterprise Centre that could house a dedicated MIRERC Secretariat, and a supportive University Management Board. The weaknesses include lack of graduate schools to assure scientific rigor of proposals before submission to the MIRERC, lack of research ethics training in most school’s curricula, absence of a dedicated MIRERC Secretariat, undergraduate research proposals being not ethically reviewed, dearth of faculty trained in research ethics, and lack of an operating budget for MIRERC work. The opportunities include existence of about 22 accredited Institutional Research Ethics Review Committees (IRERC) in Kenya, existence of international standards and operational guidance for ethics review, availability of guidelines and codes of best ethical practices in research, existence of a free automated platform called Research for Health Innovation Organizer (RHInnO) Ethics for managing the ethics review process, and availability of external resources for strengthening IRERCs. In order to improve the performance and sustainability of the MUST research ethics system, there is need to include research ethics training in all undergraduate and post-graduate curricula, create a dynamic database of potential research ethics reviewers, allocate a percentage of the annual MUST research budget for MIRERC operations, charge a graduated fee for proposal ethics review, require all students’ and faculties’ internal and external research proposals be cleared by the MIRERC, and use the RHInnO Ethics platform to manage the ethics review process.

Purpose, Composition and Function of the Research Ethical Committee in the Sarah Rehabilitation’s Hospital

Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant and its relevant social participation.

Practice on Capability Accreditation Program(CAP)of Ethics Review System for Chinese Medicine Research

Capability Accreditation Program(CAP) of Ethics Review System for Chinese Medicine Research of World Federation of Chinese Medicine Societies(WFCMS) is the first certification project in the field of Chinese medicine research on ethics review. Based on the Requirements for Ethical Review of Biomedical Research Involving Human, ethical review system for Chinese medicine research was established and standardized from 4 aspects, such as organization, ethics committee, office of the ethics committee, and researchers. The period of CAP certification is three years, which include certification application and acceptance, initial certification(document review, on-site audit), certification decision, and supervision audit. The implementation of the CAP certification is of great importance for upgrading the research on ethics review system of Chinese medicine, which promotes the development of the research on ethics review system in China and the continuous improvement of the ability of the Chinese medicine research on ethics review.

Applications and advancements in animal models for antiviral research on mosquito-borne arboviruses

Vector-borne diseases caused by arthropod-borne viruses(arboviruses) are a considerable challenge to public health globally. Mosquito-borne arboviruses, such as Chikungunya, Dengue, and Zika viruses, cause a range of human illnesses and may be fatal. Currently, efforts to control these diseases still face challenges due to growing vector resistance towards insecticides, urbanization, and limited effective antiviral treatments and vaccines. Animal models are crucial in antiviral research on mosquito-borne arboviruses, playing a role in understanding disease mechanisms,vaccine development, and toxicity testing, but the application of animal models still faces the challenges of ethical considerations and animal-to-human translational success. Genetically engineered mouse models, hamster models and non-human primate(NHP) are currently used in arbovirus research, but new models such as tree shrews and novel humanized mice are emerging. In the context of Malaysian research, the use of long-tailed macaques as potential NHP models for arbovirus research is possible;however, it faces the ethical dilemma of using an endangered species for scientific purposes. Overall, animal models play a crucial role in advancing infectious disease research, but a balance between medical research and species conservation must be upheld.

Institutional Review Board Compliance with National Regulatory Body: A Successful Experience from Saudi Arabia

Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent ethical matters.

医疗机构伦理委员会实地访查实践与思考

实地访查是伦理委员会对临床研究实施情况的监督检查方式之一。作者从实地访查的具体实施要点和流程、有因访查和无因访查等访查类型、实地访查开展过程中各方人员的具体职责和访查内容、访查发现问题的讨论及反馈等方面,分享了伦理委员会通过实地访查及时发现研究过程中存在的问题,形成切实可行改进措施,达到保护研究参与者的目的。伦理委员会通过开展实地访查,可以协助临床专业科室及研究团队在临床研究项目准备或实施过程中遵守伦理原则,对医疗机构开展的临床研究进行实时质量控制,及时反馈项目存在的问题并落实整改。伦理委员会通过实地访查,了解临床研究开展的真实情况和实施过程中遇到的具体问题,及时解决,切实保护研究参与者的安全和权益。

研究参与者补偿权保障探析

涉及人的生命科学和医学研究离不开研究参与者的支持,研究参与者的安全、健康和权益是临床研究中首要考虑因素,研究参与者的权益包含补偿权、隐私权、健康权等。保护研究参与者补偿权是研究相关部门和人员的主要职责。在法规规范和文献研读的基础上,结合实践经验对补偿权深入探讨,提出了补偿类别(常规补偿、研究相关损害补偿)、补偿原则(必要性、及时性、适当性、公平性)、补偿要素(补偿方式、补偿额度、补偿计划、补偿同意、补偿告知、补偿参照)、特殊情况下的补偿(无民事行为能力或者限制民事行为能力的研究参与者的补偿、中途退出研究参与者的补偿)、补偿权保障措施(申办者/合同研究组织、研究机构、研究管理部门、〈主要〉研究者及研究团队、伦理〈审查〉委员会等单位的保障措施),落实补偿权,保护研究参与者。

加强医学伦理审查体系建设的医学人道主义反思

好的伦理治理需要好的伦理审查、好的伦理组织和好的伦理委员。伦理审查是对涉及人的研究的科学性与伦理性进行审查,其中存在技术话语与伦理话语两套体系,分别代表着医学人道主义的两个方面。其中后者居于主导地位,二者应当统一于伦理话语。伦理审查的认知基础、价值观念、问题分析、问题处理和评价反思均应体现人道主义的要求。风险和受益的计算同样如此。伦理审查活动是人道主义的实践过程,需要体现科技发展与维护人的尊严融合的伦理治理理念;形成科技创新与人文关怀融合的伦理审查机制;建立科学精神与人文精神融合的伦理教育体系。

医院伦理委员会审查权的程序规制

医院伦理委员会的审查权是基于共同体自治而产生的社会公权力,由此产生的伦理审查决定具有区别于一般民事行为或行政决定的特殊性。审查权的行使不可因医学自治“庇佑”而脱离法制轨道,成为“法治真空”。检视现行相关规定,在不干预伦理审查独立性的同时,需要通过重构程序要件为其提质增效:应该明确会议审查、简易和免除伦理审查的界限和适用条件,确立专家复核程序的方式及多元评价体系;扩大利益冲突回避主体范围、丰富利益冲突回避内涵、完善回避程序;强化事前信息披露、事中听证等程序保障申请人和研究参与者的合法利益;确立区域伦理委员会评价职能的救济渠道。审查权的程序规制,以期使医院伦理委员会审查权行使更符合程序正义和法治要求。

研究型医院临床研究全流程质量控制的构建与运行

研究型医院开展的临床研究项目越来越多。通过对研究型医院开展的临床研究进行包括立项前、实施中、结题后等多角度、全流程的质量控制,可以及时识别临床研究中存在的风险或潜在风险因素,实时评估并解决质量问题,避免发生重大临床研究问题的可能性。研究型医院通过全流程质控过程中及时主动发现问题,确立协调机制、优化沟通流程,减少研究项目质量问题的发生,持续完善临床研究的质量管理体系,保证研究合规、数据完整准确,提升研究结论的可靠性。

某肿瘤专科医院伦理委员会初审能力现状分析及提升策略研究

目的:通过伦理委员会初审能力现状分析,提出改善伦理审查能力的策略。方法:收集临床试验项目初审受理、会审、批件日期及重审项目审查意见,利用审查等待耗时、批准耗时及受理到批件耗时反映审查效率,通过主审会审意见一致率及既往批件与重审意见一致率反映审查能力一致性。结果:2020年—2022年临床试验项目数及Ⅰ,Ⅱ期项目占比逐年增多,复审率逐年下降(χ^(2)=12.74,P<0.001);受理到批件、审查等待及审查批准耗时呈逐年缩短趋势。三年间主审会审意见一致率及重审一致率比较,差异无统计学意义(P>0.05)。结论:山西省肿瘤医院伦理委员会审查能力逐年提高,但仍有诸多不足之处,增加会审频数、实现电子信息化管理、加强培训、增加专职工作人员、实现伦理互认等措施势在必行。

伦理视角下对肿瘤患者作为临床研究参与者的权益保护

随着临床医学研究的发展,肿瘤患者作为临床研究参与者在医学研究中具有重要地位。然而,由于特殊的身体状况和医疗需求,肿瘤患者需要额外的保护措施以保障其权益得到充分尊重和保障。文章将探讨肿瘤患者作为临床研究参与者的权益保护问题,参与者的权益包括生命健康权、知情同意权、隐私保护权、获得补偿和赔偿权以及公平权。文章讨论了申办方、研究者、伦理委员会三方在研究参与者权益保护中存在的问题以及受试者抱怨。提出通过加快伦理委员会建设、加强研究者教育、开展科普宣传以及加强对临床研究的监督和管理的措施,保障研究参与者的权益不受损害。

涉及脑机接口临床研究的多学科伦理审查专家共识

作为一项新兴的生物医学工程技术,脑机接口为脑疾病诊疗、神经康复、精神障碍与心理健康等医疗健康领域提供了突破性技术。脑机接口临床研究发展迅速,涉及脑科学、工程学、计算科学、人工智能等学科,面临诸多伦理挑战,亟待规范。伦理审查是有效应对风险,促进各类科研主体实现负责任创新的重要保障,基于目前已有脑机接口临床研究的伦理审查实践,北京大学第六医院与北京医学伦理学会合作,广泛征求专家意见,包括伦理学、神经病学、精神医学、康复医学、工程学、计算科学及信息科学等多学科专家,经过多轮专家研讨形成初稿,应用德尔菲专家咨询法修订完成,制定了“涉及脑机接口临床研究的多学科伦理审查专家共识”:在《脑机接口研究伦理指引》的指导下,对重大伦理风险防控等方面提出建议,厘清各方责任,从多维度为涉及脑机接口临床研究伦理审查的实质内容及程序提供参考。

伦理协作审查与互认模式的实践

随着越来越多的多中心、跨领域合作医学研究开展,建立高质量、高效率的伦理协作审查与互认制度是多机构研究的必然需求,也是落实国家相关政策的必然之举。基于深圳市伦理协作审查与互认工作实践,通过分析国内伦理协作审查与互认工作的现实挑战,提出保证审查同质性与高效性,需要政府部门牵头,建立伦理审查联盟,明确职责权利,并从实际需求出发、制度先行、有效沟通,共同推进伦理协作审查与结果互认,旨在为我国同行推动跨机构研究的伦理协作审查与互认工作提供借鉴与参考。

新时期医疗机构伦理委员会建设需厘清的一些问题

当前,医疗机构伦理委员会建设已取得了明显进步,但为取得高质量发展,尚需要厘清一些关键性问题:甄别生物医学研究和医疗技术临床应用、始终坚持伦理审查的基本原则、建立具备独立行政建制的伦理委员会办公室、根据专业不同大型医疗机构应设立多个相互独立的伦理审查委员会以及加强对机构内部医务群体和科学研究人员的伦理培训。

国际科技伦理审查制度研究热点与展望——以生物医学为例

伦理审查作为科技伦理治理中的关键一环,对于强化科技伦理风险防控,促进负责任创新具有重要保障作用。借助科学计量学方法系统梳理了国际生物医学伦理审查研究发展概况、知识基础、研究热点等,结果发现:①科技伦理审查主题研究发文量呈加速增长趋势,核心期刊主题较为多样,需要更多作者持续深耕;②生物伦理学、医事法学、公共管理学从指导原则、流程优化、强化伦理分析等多个维度提供知识基础;③伦理审查存在严重地域不平衡性;组织运行机制完善和效能建设成为研究热点主题。未来中国科技伦理审查可以从加强审查委员会主体能力建设、优化审查程序、加强审查外部监管、加快审查信息化建设、推动建立经常性对话机制等方面进一步完善。

2022版《医疗器械临床试验质量管理规范》对伦理审查的新要求及思考

2022年3月国家药品监督管理局发布了新版《医疗器械临床试验质量管理规范》,删除了伦理委员会组成和运行上的具体要求,简化了临床试验中递交初始审查文件、报告严重不良事件等流程。首先,梳理和分析了对伦理委员会的新要求,包括职责、组成、委员和秘书的资格和培训,以及档案的管理。其次,阐述对伦理初始审查的新要求,包括递交资料,审查内容,审查方式,审查结论,以及药械组合医疗器械和医疗器械使用学习曲线的风险管理,强调知情同意的合规性和有效性,严格限制免除知情同意的条件,并重新限定查阅试验资料的组织和个人。最后,阐述对跟踪审查的严重不良事件,器械缺陷,结题后临床试验资料的补正的新要求。新版《医疗器械临床试验质量管理规范》操作性更强,对伦理委员会的审查质量和效率提出了更高要求,伦理委员会应当在确保审查质量的前提下提高审查效率,以切实保障受试者的安全和权益。