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.

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.

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.

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.

研究者发起的中医药临床研究伦理审查要点

中医药的发展源于大量的临床实践,通过临床研究验证中医药的疗效及其作用机制,验证中医药的独特价值,有利于中医药的传承和发展。目前,研究者发起的临床研究(IIT)数量越来越多,涉及中药干预的IIT项目,在基础理论、辨证分型、组方配伍、剂型剂量等方面设计不同,更是对伦理委员会的项目审查提出了挑战。中医药与现代医学临床研究所遵循的基本伦理原则是一致的。中药干预的IIT项目的伦理审查,需要体现中医药自身发展规律,符合中药的特点及新药研发的规律。中医医疗机构需要结合专业特色,对临床经验方进行梳理,引导研究者以患者为中心,以临床价值为导向,有序开展中医药临床研究,验证中药新药的临床价值,提高中药新药成果转化的成功率。

研究者发起的未上市产品临床研究的挑战、对策和伦理审查要点

研究者发起的临床研究是涉及以人为研究参与者的科技活动的重要组成部分,其中高质量的研究者发起的临床研究在条件许可时可用于支持药物、医疗器械等产品上市、注册申请。目前研究者发起的临床研究与企业发起的临床试验有着巨大差距,未上市产品用于研究者发起的临床研究存在法规尚不支持、研究经费支持力度不足、临床研究管理部门能力有待提升、临床研究专业化团队薄弱、伦理审查难以匹配需求等问题。可通过完善法规并小范围先行试行、保障充足的研究经费、加强临床研究管理体系建设、打造临床研究专业化团队、确保伦理审查质量和严格跟踪审查、从伦理审查向研究参与者保护体系转变、加强培训研究者等措施应对挑战。伦理委员会应严格审查风险获益比,知情同意,研究经费,损害的赔偿,研究团队成员资质和设备,利益冲突管理等要点。

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。

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。

医疗公平视角下互联网医疗伦理治理路径初探

经济发展推动内生需求增加,互联网医疗整合区域医疗资源,扩大了群众享受医疗卫生服务机会的公平性,但伴随着技术发展,伦理危机也产生了,需要不断规范和实践。以医疗公平原则为起点,分别从数据公平、成本公平、机会公平、教育公平维度梳理了互联网医疗发展中的主要优势特征,分析出互联网医疗存在的伦理问题包括:伦理审查机制保障不公平、科技主体数据采集不公平、利益与风险分配不公平、互联网医疗资源利用不公平。并提出压实主体责任,健全审查监管;完善共享机制,弥合数字鸿沟;强化风险预防,保障公民权益;加强教育引导,增加基层投入的治理路径。

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。

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。

采供血机构开展医学伦理审查的探索与思考

目前国内越来越多的采供血机构陆续开展涉及人的生命科学与医学研究,这就要求机构设立医学伦理委员会对其进行伦理审查,以确保医学研究试验的设计和实施合乎道德和法律,同时保护受试者的安全、健康、隐私等权益。本研究结合采供血机构的性质与特点,以南京红十字血液中心伦理委员会为例,探索采供血机构医学伦理委员会规范化建设中的经验与不足,并针对采供血机构以献血者血液样本及相关信息开展医学研究和采供血机构医疗器械临床试验的伦理审查提出思考,从而更好地保护受试者权益,促进采供血机构输血医学研究健康平稳发展。

关于伦理委员会是否应作为同情用药审查主体的探讨

在中国相关法规未对同情用药审查主体予以明确的前提下,谁来承担审查和批准的责任存在争议。就同情用药的特点进行总结和阐述,从伦理委员会的职责、专业性和审查的必要性等方面展开讨论,认为伦理委员会应当作为同情用药审查主体,需对医生资质、风险受益比、知情同意书和利益冲突等方面进行重点审查。

医院临床试验伦理审查的时效性分析与探讨

目的分析药物临床试验中伦理审查各环节耗时情况,探讨提高伦理审查效率的措施。方法选取2018年1月1日至2023年11月30日本伦理审查委员会完成初始审查的药物临床试验项目,统计分析各个审查环节所需时间。结果2023年伦理审查平均总耗时4.38周,总耗时中申办方所用时间约占30%,其次是伦理审查耗时,初审快速审查项目中,伦理审查的各个环节时间耗时均比会议审查时间短。结论伦理审查中,申办方与伦理委员会应各司其职,加强沟通,合力提高伦理审查效率。

机构伦理视域下我国医院伦理审查研究的可视化分析

目的探讨机构伦理视域下我国医院伦理审查领域的研究现状、研究热点及发展趋势。方法基于机构伦理视域,以2014年1月1日至2024年10月15日中国知网、万方、维普数据库中发表的我国医院伦理审查相关文献为本研究数据集,利用CiteSpace 6.2.R6软件分析发表年份、作者、研究机构、关键词等信息,绘制相关知识图谱。结果共纳入569篇文献,研究发文量呈上升趋势,已形成高产作者群,但研究作者整体合作网络较少,且研究机构分布存在地域局限,伦理学、医学伦理、知情同意、伦理、临床研究、医院、医学研究、科技伦理、伦理档案、大数据、器官移植等是当前研究的热点主题,受试者、伦理治理、科技伦理、医学、审查效率、隐私保护等是近3年研究的前沿主题。结论当前我国医院伦理审查领域研究发展迅速,但跨机构、跨地区合作较少,未来应加强沟通,共享资源,推动领域内深入合作关系网络的建立。

Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine

Three features of ethics review in Chinese medicine（CM） and integrative medicine（IM） were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

我国伦理委员会网络会议审查现状调查与分析

目的 为伦理委员会网络会议审查的规范、有效开展提供参考。方法 通过调查问卷收集国内医疗机构伦理委员会2020年1月至6月的网络会议审查开展情况,分析网络会议审查模式在临床试验伦理审查中的应用现状及存在的问题,并提出针对性建议与对策。结果 参与调查的64家机构中,有24家机构使用网络会议审查,有59家机构会继续或开始使用网络会议审查。存在网络稳定性、委员的签到和投票形式的规范性、网络会议审查的保密性、委员讨论的充分性等问题。结论 网络会议审查是伦理审查的重要补充形式。应建立完善的伦理网络会议审查相关法规或指引,建立标准操作规程与培训规范。

某三甲综合性医院临床试验项目伦理审查效率分析及策略探讨

目的:通过对伦理委员会临床试验项目伦理审查各环节的耗时情况进行分析,探讨进一步提高医学伦理审查效率的策略。方法:分析某三甲综合性医院医学研究伦理委员会2023年受理的278项初始审查项目和522项修正案审查项目在各环节的耗时情况,包括不同审查类型、不同审查方式的等待耗时、审查耗时及审批耗时等。结果:药物/医疗器械临床试验项目初始审查的等待耗时和审批耗时平均为12天和22天;体外诊断试剂临床试验项目初始审查的等待耗时和审批耗时平均为3天和9.5天;修正案审查方式为快速审查时等待耗时和审批耗时平均为6天和11天,审查方式为会议审查时等待耗时和审批耗时平均为13天和15.5天。结论:建议通过加强形式审查,提高会议审查项目的一次性通过率;优化伦理审查管理及审查流程,提升快审审批效率;加强研究项目申办者与伦理办公室的沟通交流等,进一步提高伦理审查效率。