医学研究伦理学的发展现状与前景

创新技术的开展和转化医学的注重给医学的发展注入了新的活力,但同时,也带来了一系列社会伦理问题和法律问题。生命医学伦理学的兴起和发展催生了医学研究伦理学分支学科形成,目的在于推进解决涉及人体的医学研究的伦理问题。当前,面临的最突出的伦理问题在于,对医学研究合法性、先进性及伦理性的把握,对医学研究伦理审查必要性的认知,对医学研究方案设计与伦理道德的匹配,对医学研究知情同意的告知,对医学研究风险与受益的平衡。逐步与国际接轨,加强伦理委员会制度建设;提高伦理审查能力建设,形成高水平的伦理审查队伍;学术组织和团体共同努力,推进医学研究伦理学的发展,这将助推医学研究伦理学的发展。     

生命伦理学委员会

生命伦理学委员会是从伦理学角度审查人体试验研究,保护受试者权益的决策咨询组织。该委员会一般由来自法学、伦理学、医学、药学等领域的专家学者组成,其审查遵循的重要依据是世界医学会制订的《赫尔基辛宣言》。近年来,伦理委员会快速发展,但各伦理委员会审查质量参差不齐。因此,相关部门尚需加强对伦理委员会成员的培训,并加强对伦理委员会的监管,方能促进我国伦理委员会的良性发展。     

伦理管理在人类辅助生殖技术中的应用与价值

辅助生殖技术（assisted reproduction technique,ART）的飞速发展给社会带来了复杂伦理难题。因此,在ART全过程中加强伦理管理并对其后果进行评价,具有深刻的内涵价值和深远的社会意义。只有发挥生殖医学伦理委员会作为一个工作机构的职能,在医患人群中加强ART技术基本原理及相关伦理原则的宣传教育,强化医学伦理的监督机制,落实充分的知情同意等措施,才能促使医患人群都能够自觉遵守优良的医学伦理道德规范,保证人类辅助生殖技术的健康发展,使ART发挥积极的、革命性的意义。     

我国药物临床试验伦理审查能力建设发展趋势

我国药物临床试验的深入广泛开展,促进了药物临床试验伦理审查水平的提高,伦理审查能力建设也取得了长足进步。但我国药物临床试验伦理审查能力建设面临系统的评估标准及体系、持续性培训和信息化程度缺乏等问题。加强药物临床试验伦理审查能力建设是我国医药领域进一步推进的重要工作,也是继续探索研究的热点内容及医学伦理审查工作者的自身需求。     

从医院等级评审谈医院伦理委员会建设

通过对照医院等级评审标准,阐述了评审标准对医院医学伦理学建设的相关要求,分析了医院伦理委员会建设中存在的问题,提出了推进医学伦理建设的建议。文章强调,推进伦理学教育,加强医德医风建设;严格伦理学督导,提高医疗科研水平;遵循伦理学原则,构建和谐的医患关系。     

药物临床试验伦理审查存在的问题及对策研究

依据GCP药物临床试验管理规范,分析我国药物临床试验伦理审查工作中存在的问题,从如何保障受试者知情同意、加强伦理委员伦理知识培训、全程伦理监督及引入伦理验收、加强监管力度和完善监督体制等4个方面对药物临床试验伦理审查工作提出针对性建议,以逐步完善我国药物临床试验伦理审查工作。     

转化医学研究中生命伦理学辩护的现况分析与前瞻思考

转化医学作为一门新兴学科,运用多学科交叉策略来推动医学发展,从临床实践中发现问题,将其凝练成科学问题进行基础医学研究,再将研究成果应用到疾病诊断、治疗和预防过程中,使其真正发挥作用,是一个从基础医学到临床应用的双向进程。转化医学已逐步融入各个学科,并在干细胞研究、生物标志物、细胞信号转导、药物及器具研发及个体化医学等各个领域发挥重要作用。随着转化医学研究深入,一些临床试验势必对人体存在一定伤害和潜在危险,存在各种伦理问题。虽说科学研究与伦理道德是一对相互冲击的矛盾,但两者在总体上又是一致的,共同决定着社会前进步伐。科研的重大进步必然会对伦理道德提出更高要求,而伦理道德的高标准又规范、引导、促进科学研究朝着正确方向迈进,两者相辅相成。鉴于伦理辩护对于转化医学研究强有力的支撑,建议在转化医学研究中能进一步完善伦理监管体系,发挥机构伦理委员会的功效,持续加大伦理培训的力度,强化研究人员的伦理道德修养,从而为转化医学的发展夯实人文基础。     

干细胞研究伦理

干细胞具有＂分化＂和＂脱分化＂的特点和潜能,干细胞研究有着良好的医学前景,许多人类严重疾病的治疗有了新的希望。伴随着干细胞研究的开展和深入,出现了诸多伦理问题的争论。拟就干细胞研究的希望和现实、伦理争论的主要观点及干细胞研究伦理准则的构建,作一简要介绍,并就加强干细胞管理提出建议。     

中国临终关怀服务现状与伦理探讨

随着社会经济的发展、人口老龄化和疾病谱的改变,临终关怀已成为我国社会所关注的重要民生问题,也成为医学伦理的热点。该文结合中国生命关怀协会对我国城市临终关怀服务利用与需要状况的调研,反映当前我国城市临终关怀服务的基本特征,对临终关怀中涉及医学伦理的部分概念,以及临终关怀服务中的相关权益进行阐述,并建议应当在逐步完善全民医疗保健制度的基础上,健全服务体系,包括临终关怀伦理道德法规体系,才能更好地为临终患者服务,提高患者的生命质量。     

医院伦理委员会建设中的问题及对策

为了解决临床科研中的伦理问题,和谐医患关系,医院伦理委员会应运而生。通过回顾医院伦理委员会的发展历程,介绍其主要功能和职责,探讨和分析其运行中存在的问题,并提出相应的对策,以期对医院伦理委员会的普及和发展提供有益参考。     

Ethical issues and GenomEUtwin.

The post-genomic era is witnessing a proliferation of large-scale and population based genetic and genomic research projects. Many countries have or are establishing research biobanks and, as with GenomEUtwin, there is great interest in building multinational projects that link genotypic and phenotypic information from different centers. Clearly, the conduct of these projects raises multiple ethical issues, and the knowledge generated will continually recast the ethical, legal and social implications (ELSI) of such research. Maximising the scientific profit from this work while minimizing the risks to the participants requires full integration of ethics components into the structure and functioning of these projects. GenomEUtwin is organized around five intellectual cores, including an Ethics Core which operates across the entire project. This paper describes the role of the Ethics Core and presents an overview of the guidelines on which the principles followed in GenomEUtwin are based. We outline the major ethical concerns of our project and highlight complexities arising from diverse national legislations. Finally, the role of empirically based ethics research is discussed for understanding the ethical, legal, social and economic implications of human genetics and genomics research.     

Challenges and practices arising during public health emergencies: A qualitative survey on ethics committees

The particular dynamics of public health emergencies urge scientists and Ethics Committee (EC) members to change and adapt their operating procedures to function effectively. Despite having previous pandemic experiences, ethics committees were unprepared to adapt to COVID-19 pandemic challenges. This survey aims to learn and thoroughly discuss the most salient issues for ECs during the COVID-19 pandemic. The results indicate that the main problems faced by ECs were lack of/insufficient regulations, lack of data/experience/knowledge, sloppy review, poor research design, and poor adaptation to quarantine measures. Coping with factors that threaten the autonomy and independence of ECs, the ethical dilemma regarding maximizing common good versus protecting the rights and well-being of study participants, comprehending the change in the context of vulnerable populations, and redefining the role of ECs to strengthen trust in science and vaccine confidence were outstanding issues.     

Patient-Centred Care: Qualitative Findings on Health Professionals’ Understanding of Ethics in Acute Medicine

In recent years the literature on bioethics has begun to pose the sociological challenge of how to explore organisational processes that facilitate a systemic response to ethical concerns. The present discussion seeks to make a contribution to this important new direction in ethical research by presenting findings from an Australian pilot study. The research was initiated by the Clinical Ethics Committee of Redland Hospital at Bayside Health Service District in Queensland, Australia, and explores health professionals’ understanding of the nature of ethics and their experience with ethical decision-making within an acute medical ward. This study focuses on the actual experience, understanding and attitudes of clinical professionals in a general medical ward. In particular, the discussion explores the specific findings from the study concerned with how a multi-disciplinary team of health professionals define and operationalise the notion of ethics in an acute ward hospital setting. The key issue reported is that health professionals are not only able to clearly articulate notions of ethics, but that the notions expressed by a multi-disciplinary diversity of participants share a common definitional concept of ethics as patient-centred care. The central finding is that all professional groups indicated that there is a guiding principle to address their ethical sense of the ‘good’ or the ‘ought’ and that is to act in a way that furthered the interests of patients and their families. The findings affirm the importance of a sociological perspective as a productive new direction in bioethical research.     

Module one: introduction to research ethics

This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.     

Guidelines for Community-based Ethics Review of Children’s Science Fair Projects

Low-level community based ethics committees staffed by teachers, parents and community representatives can readily review children’s science fair projects subject to the revision of two core assumptions currently governing children’s Science Fairs. The first part of the paper recasts the New Zealand Royal Society guidelines from its primary emphasis on risk to a new assumption, without benefit there can be no risk. Equally, this revision gives more prominence to the participant information sheet, allowing it to act as a quasi application form which provides ethical transparency between student researchers, participants and a community based ethics committee. A second core assumption, more accurately labeled a cult of originality, produces a random, open-ended array of student topics taking ethics review beyond the confidence level of most community based ethics review committees. This paper reins in Science Fair coordinators recommending they make community level ethics review more manageable by providing a list of preapproved topics for those students wanting to conduct research involving human participants. These revised assumptions create a workable division of labour. Teachers’ preapproved topics involving human participants are more likely to be low risk, permitting community level ethics review to focus primarily on two aspects of the minimization of harm: first, for all participants, especially those with diminished autonomy, and second, for the child researchers themselves, as some participants may be unknown to the student. These revised assumptions make science and ethics more accessible to public education thus demonstrating how Science Fairs can lead students and the community into better understanding the role and function that ethics has in all scientific research human participants. Martin Tolich chaired New Zealand’s National Health Ethics committee, the multi-region ethics committee.     

Module five: implementation of ethics review

The objective of this module is to inform you on issues of concern for Research Ethics Committee members and investigators during the review process. The many guidelines on research ethics, including those from the South African Department of Health and the World Health Organisation, will be referred to extensively to educate you on the requirements of Research Ethics Committees. The evolution of the review process in South Africa will be detailed.     

TRAINING NEEDS ASSESSMENT IN RESEARCH ETHICS EVALUATION AMONG RESEARCH ETHICS COMMITTEE MEMBERS IN THREE AFRICAN COUNTRIES: CAMEROON,MALI AND TANZANIA

Background: As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well‐resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally. Objective: To assess training needs for biomedical research ethics evaluation among targeted countries. Methods: Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi‐structured questionnaire in English and in French. Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC. Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need.     

CONTEMPORARY MEDICAL ETHICS: AN OVERVIEW FROM IRAN

The growing potential of biomedical technologies has increasingly been associated with discussions surrounding the ethical aspects of the new technologies in different societies. Advances in genetics, stem cell research and organ transplantation are some of the medical issues that have raised important ethical and social issues. Special attention has been paid towards moral ethics in Islam and medical and religious professions in Iran have voiced the requirement for an emphasis on ethics. In the last decade, great strides have been made in biomedical ethics, especially in the field of education, research and legislation. In this article, contemporary medical ethics in Iran, and the related moral philosophy, have been reviewed in brief and we have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years. These activities have included the establishment of the National and Regional Committees for Medical Research Ethics and the production of national codes of ethics in biomedical research in the 1990s and the introduction of a comprehensive strategic plan for medical ethics at the national level in 2002. This paper will discuss these issues, along with the production, in 2005, of the Specific National Ethical Guidelines for Biomedical Research.     

Addressing ethical issues in H3Africa research – the views of research ethics committee members

In June 2014, the H3Africa Working Group on Ethics organised a workshop with members of over 40 research ethics committees from across Africa to discuss the ethical challenges raised in H3Africa research, and to receive input on the proposed H3Africa governance framework. Prominent amongst a myriad of ethical issues raised by meeting participants were concerns over consent for future use of samples and data, the role of community engagement in large international collaborative projects, and particular features of the governance of sample sharing. This report describes these concerns in detail and will be informative to researchers wishing to conduct genomic research on diseases pertinent to the African research context.