Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

Background

Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste.

Aims

To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia.

Methods

In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines.

Results

Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days).

Conclusion

We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.     

涉及病历记录及生物标本研究的伦理审查问题

介绍了针对涉及病历记录及生物标本研究的伦理审查的不同方式,并对相关定义进行了说明,对是否属于涉及人的研究进行了分析.在此基础上提出,为了合理地保护受试者的权益,同时又不给研究者和伦理委员会自身增加不必要的负担,根据国际上的相关做法,可以基于研究的风险大小,对涉及病历记录或生物标本的研究,采取免除伦理审查与快速审查不同的伦理审查与管理方式.     

医学科研活动的伦理审查问题

以医学伦理审查为指导,以医学科研活动过程——科研项目立项、实施、结题为线索,对医学科研活动中的伦理审查问题进行了探讨,并提出了在医学科学研究活动中应注意的医学科研选题立项、医学科研项目实施、医学科研结题等过程中的伦理审查问题。     

干细胞伦理问题的治理

干细胞技术具有广阔的医学前景,但它同时也带来了让人无法忽视的伦理问题。应对这些问题需要我们采取新思路,即用水平治理取代传统的垂直管理。基于新的治理进路,提出四点建议,以缓解干细胞技术所带来的伦理冲击,希望有助于推动细胞技术走上健康发展的道路。     

Discrimination of the Governance Principles of Science and Technology Ethics and Dissemination of Ideas

Ethical governance is inherent in responsible research and innovation. The Opinions on Strengthening Ethical Governance of Science and Technology puts forward five ethical principles:promoting human well-being, respecting the right to life, adhering to fairness and justice, reasonably controlling risks and maintaining openness and transparency. This paper interpreted the ideas, key points and difficulties of these five ethical principles. Three suggestions were put forward to strengthen the ethics education of science and technology:first, optimize the curriculum of science and technology ethics for related majors in colleges and universities, and help young students understand ethical principles and establish the correct ethics view of science and technology; second, colleges and universities should carry out education and training for teachers, researchers, managers and members of ethics committees, and actively explore scientific research ethics training and effect evaluation; third, the professional courses offered by college teachers should be organically integrated with the ideological and political content of the courses to play a warning role. © 2022, Editorial department of Chinese Medical Ethics. All rights reserved.     

Research and Reflection on Strengthening the Construction of Life Science and Medical Research Ethics Training System in Colleges and Universities

The construction of the scientific and technological ethics management system is crucial to ensure the healthy development of scientific research, and is also the premise and foundation for the scientific and technological innovation and “double first-class” construction of colleges and universities. This paper through the investigation of college life science and medical research ethics committees’ relevant situation, concentrated on the comparative analysis of the construction of ethics training system to identify problems and shortcomings, combined with the work example of Peking University and the current development trend of life science and medical research, some suggestions, including take advantage of the combination of medical services, teaching and research at universities, were ut forward to provide possible reference for further updating of the science and technology ethics management in colleges and universities. © 2022, Editorial department of Chinese Medical Ethics. All rights reserved.     

生命科学技术的伦理难题及其生态超越

当代生命科学技术的生物工程特点使之无论在理论研究还是技术实践中无不面临着一系列异质而基本的“善与善”之间的价值冲突，如高新技术对传统伦理观念的可能拓展与价值颠覆、科学技术的”可行”与伦理的”应该”、生命神圣与生命价值、生命质量之间的矛盾等。这些伦理难题必须以科学家及其共同体的道德责任感为依托，同时诉诸于伦理委员会的监督评判作用的充分发挥以及生命科学技术与生命伦理的大力普及与教育等才能得以超越。     

论医学研究知情同意的伦理审查

伦理委员会与知情同意书是保障受试者权益的主要措施。因此,伦理审查工作需要加大对知情同意的审查力度,注重研究受益和风险的平衡,维护受试者权益和安全。知情同意是人体生物医学研究的主要伦理要求之一。知情同意的伦理审查一般要考虑以下要点：信息的完整、充分性;知情同意书签署过程;用语的规范性;知情同意书风险处置等。     

有关机构伦理审查委员会的若干伦理和管理问题

首先,讨论了黄金大米试验带来的两个教训：亟需加强伦理审查的能力,亟需加强对涉及人的研究和伦理审查委员会的监督管理。其次,讨论了伦理审查的研究伦理基础,即有益原则、尊重原则、公正原则。最后就机构伦理委员会的若干伦理和管理问题发表了意见,并提出请有权威性的多学科专家成立相应机构对机构伦理委员会进行考评活动的建议。     

乙型肝炎临床科研中的伦理问题及措施

为了更好地保护乙型肝炎临床科研中的受试者,通过探讨受试者为弱势人群的伦理问题、研究人员和伦理审查人员资质的伦理问题、受试者招募的伦理问题、对照选择的伦理问题和风险与受益比的伦理问题等,提出伦理委员会加强伦理过程管理的相关措施:完善知情同意的过程,提高受试者的理解度;提高跟踪审查频率,尤其加强SAE的风险管理;加强不良反应的处理;结合开展医院“伦理查房”,推进现场检查.     

医院知情同意权行使主体的伦理现状调查

目的了解医院医务人员、患者及其家属对医院知情同意权行使主体的伦理认知现状并进行分析。方法对医生、患者、家属采用自行设计的问卷进行调查,其中对126位医生进行问卷调查方式;对150名患者、148名家属采用问卷访谈形式进行访谈。结果在法律认知上,仅56%的医务人员,20%的患者,8.8%的患者家属完全同意知情同意权行使主体是其本人;在伦理认知上,以患者本人为知情同意权的行使主体,86.5%的医务人员,54%的患者,45.3%的患者家属认为能尊重患者;55.5%的医务人员,82.7%的患者,48%的患者家属认为能对患者有利;84.9%的医务人员,34.7%的患者,14.9%的患者家属认为要贯彻患者的自主选择权。结论在中国传统文化背景下,知情同意权行使主体的法律规定与伦理认知存在巨大差异,为医院医疗纠纷留下隐患;医务人员作为知情同意的告知者,要在有关法规指导下,掌握好告知权限,以适用当前伦理认知现状。     

简论医德医风信访工作的医学伦理支撑

医德医风信访工作是医院的一个重要窗口,其工作人员是医院与患者之间的桥梁和纽带,他们对外是接待员,对内是监督员。以医学伦理为灵魂的良好的医德,既是医学发展的内在动力,也是医院管理的根本依据。作为承担着医德建设重要的特殊使命的医德医风信访工作人员,只有具备良好的医学伦理素养,才能胜任自己的工作,才能对构建和谐的医患关系、创建社会主义和谐医院起到积极的推动作用。     

The Ethical Principles of Science and Technology Need Concrete Research to Guide

On March 20, 2022, the General Office of the CPC Central Committee and the General Office of the State Council issued The Opinions on Strengthening Ethical Governance of Science and Technology, which put forward five ethical principles of science and technology:promoting human well-being, respecting the right to life, adhering to fairness and justice, reasonably controlling risks and maintaining openness and transparency. Ethical principles require to be studied and interpreted concretely by ethical scholars, that is, first, they need to be refined in order to be truly guided; second, the principle of balance is needed to truly guide; third, it is necessary to study ethical theory in order to truly guide; fourth, it is significant to explore Chinese civilization in order to truly guide. In this way, the ethical principles of science and technology can be practically applied and guide the concrete practice of science and technology. © 2022, Editorial department of Chinese Medical Ethics. All rights reserved.     

现代医学创新性研究的自由与伦理制约

生命科学的发展突飞猛进,对伦理形成巨大的冲击,伦理学也给医学的创新性研究自由造成了一定程度的限制。从医学研究的本质与其服务性特征,人文和医学伦理是社会文明的准则,伦理评定标准的社会性以及伦理与医学创新性研究的关系,探讨伦理在医学研究中的作用,祈盼现代医学伦理准则能引导我国医学创新性研究的更好发展。     

医科院校科研管理中的伦理因素分析

在新的形势下探索医学科研管理的新模式，发挥伦理因素的作用，不仅符合现代管理理念的基本要求，也是医科院校加强内部科研管理和促进科技进步的重要手段。文章从医学科研管理和伦理间的关系以及伦理对科研功能实现的影响角度进行了分析，并提出在医科院校科研管理中运用伦理管理的途径和建议。     

论世纪之交我国医学伦理学的若干新发展

世纪之交，中国医学伦理学的发展是多方面的，作者就其中几个方面作了论述：１．研究领域扩大化，伦理技术、人与自然的关系将成为研究的热点之一２；．学科体系系统化，基础医学伦理学、医师职业道德、护理职业道德这三个部分构成了医学伦理学的基本体系；３．医德实践考核化、法规化。     

关于干细胞研究及其临床应用伦理管治的回顾与展望

讨论了干细胞科学技术发展的社会环境,干细胞研究与中国文化,保护病人和受试者权利和利益的意识,管理空白和新的挑战,最后论证必须制订专门有关干细胞研究及其临床应用的条例,以期在发展千细胞研究科学技术的同时,切实保护病人、受试者和公众的权利和利益。     

生命科学技术带来的伦理道德问题思考

器官移植、安乐死、基因计划和辅助生殖技术等生命科学技术的飞速发展给人类带来了福祉,同时也带来了诸多伦理难题。进行制度建设是解决这些问题的一个重要途径,但在这个过程中离不开伦理学的价值导向,而合理的程序又是对伦理导向的重要保障。另外,在伦理问题上也要研究科学家的社会责任。总之,从终极视野来看,解决生命科学技术负面效应的根本还在于社会的进步和协调发展。     

如何评价和改善伦理审查委员会的审查工作

伦理审查委员会在审查工作中存在一些问题,主要有：伦理审查时机的问题,是在项目申报之前进行伦理审查,还是在项目批准后进行伦理审查？关于受益和风险的评估问题,人们普遍感到受益和风险的评估并不那么容易;伦理审查的独立性问题。针对这些问题,应该积极主动地改进伦理审查委员会的工作,加强对受试者的保护;同时,建立SOP（标准操作程序）,以期改进工作质量;还应重视教育和培训的作用。伦理审查委员会的工作还需要高水平的智慧和政治上的独立性。     

论省级医学伦理学会的运行经验及对福建省医学伦理学会建设的启示

通过对全国各省级医学伦理学会的主要工作与经验进行总结,概括为培训教育、学术研究、交流合作、规范管理、咨询鉴定、宣传普及与服务会员七个方面,并结合福建省医学伦理学发展现状,提出学会在职能发挥中对民众医学伦理观引导与互动上应有所加强,同时论述了这些经验对构建福建省医学伦理学会的启示.