Proportional ethical review and the identification of ethical issues

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted.     

Participation of healthy volunteers in research projects

Research that involves healthy normal volunteers frequently is performed. This article examines ethical guide-lines for the recruitment of healthy volunteers in research projects. Ethical decisions on projects that are based on patient-volunteers or healthy normal volunteers should balance the risk to the volunteer and the collective benefit to the community. For healthy normal volunteers that risk should be minimal or trivial. Investigators should follow recruitment practices that avoid approaches to persons who are dependent upon them in some way, and should carry the day-to-day ethical responsibility even after institutional ethical approval has been granted. Pilot studies and self-experimentation readily can transgress ethical guide-lines. Compensation for mishaps or injuries that occur during research in which there is no question of negligence (for example, an unforeseeable reaction in a phase-1 drug trial) is an unresolved issue which should be addressed by the research community. It is recommended that action be taken to ensure that healthy volunteers who participate in approved research have redress in the rare event of an accident, whether this is a result of negligence, chance or misadventure. Hospitals/institutions or other bodies that sponsor research should extend their insurance to cover specifically such unforeseeable events in which there may be liability, and to have the facility for a payment of beneficence in the case of accidents in which liability cannot be established.     

对人类胚胎干细胞来源的伦理审视

伦理审查的重点之一:胚胎干细胞的来源是否符合了伦理要求,2003年出台的《人胚胎干细胞研究的伦理指导原则》没有提供可操作的审查要求。结合我国国情,审视了人胚胎干细胞来源中若干伦理问题,并提出了四点审查要点:①在目前的情况下,"冷冻的多余的胚胎"可以作为胚胎干细胞研究的主要来源,但研究者不可过度依赖多余的胚胎;②在接受自愿捐献的卵子时,研究者要实现对捐卵者的伤害最低化,不得采取胁迫、引诱的方式获取卵子;③在使用"流产胎儿"时,要获得孕妇或家庭的知情同意,不可为获得一个研究用的流产胎儿,而让一个妇女先怀孕。④为达治疗性克隆研究之目的,研究者可以通过体细胞核移植技术制造胚胎干细胞,但研究中胚胎要在14天内销毁。     

Attitudes to research ethical committees.

A questionnaire on the attitudes towards the functions of research ethical committees was sent to members of selected research ethical committees in Wessex and some controls. Almost all respondents felt there was a need for ethical review of research projects; 42 per cent thought there was a need for some training before joining a committee; 67 per cent thought the system could be improved and 47 per cent thought that monitoring or follow-up procedures should be adopted. Ethical committees were thought to be purely advisory, as opposed to mandatory, by 33 per cent, and 63 per cent thought they should restrict their review to ethical problems as opposed to scientific or design problems. Views about the function of non-medical members ranged from 'none at all' to 'very important'. Of the 10 controls who were asked whether they would become a member of an ethical committee if asked, seven said that on balance they would and the reasons stated varied from the view that it was a 'very important committee' to the feeling that it was 'a necessary but irksome job'.     

生物医药研究伦理审查的风险意识和风险管理

在生物医药研究伦理审查中,应提高风险意识,加强风险管理。要在伦理审查与科学审查统一、科学研究与临床诊治统一、社会效益与经济效益统一、常规管理与危机管理统一上防控风险。提高人体试验伦理审查风险管理水平,要完善制度、落实制度。防控人体试验中的风险,要加强伦理委员会审查能力建设。     

注重审查项目的辨证论治内容——中医药研究伦理审查特点研究（二）

在中医药研究伦理审查中,审查项目的辨证论治内容是检验项目是否符合中医规律和理论,其目的不是检验项目的科学性,而是为了保护受试者的安全.在这其中,要坚持伦理审查与科学审查的统一,更要注重中医药本身发展研究的特点和规律,不能简单的套用审查西医西药的方法.在审查辨证论治内容的实践操作层面,应当注意：对辨证论治内容的审查,要纳入中医药研究伦理审查标准操作规程.在保护患病受试者安全的审查上,要坚持证候标准,要审查既往临床应用证候与研究中患病受试者证候是否一致.对辨证论治的审查,要重视理法方药的内在逻辑关系,要充分发挥熟悉项目研究内容的中医药专家的作用.在强调审查辨证论治内容的同时,要注重审查项目的其他内容,形成伦理审查的合力,防止片面性.     

The ethical use of paradoxical interventions in psychotherapy.

The purpose of this paper is to establish ethical guidelines for the use of paradoxical interventions in psychotherapy. These are defined as interventions which are counterintuitive, coercive, and which require non-observance by the client. Arguments are developed to show that such interventions are associated with a psychology that understands individuals solely in terms of their relationship: a 'strong interactionist' position. Ethical principles consistent with such a position are considered, and from these it is derived that: paradox is an ethical technique with resistive patients; it requires consent; its content should be consistent with general ethical principles, especially those of beneficence and non-maleficence; non-paradoxical techniques should be preferred when possible; and it should not be used as an assessment procedure. It is concluded that research is needed to explore the effect of such ethical guidelines of effectiveness, though preliminary impressions are encouraging.     

Research ethics committees: the role of ethics in a regulatory authority

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.     

Ethical challenges in conducting research in humanitarian crisis situations

Research is vital to accurately describe phenomena in humanitarian emergency situations and to evaluate the effectiveness and appropriateness of interventions. Although the ethical principles of justice, beneficence and respect for autonomy/ respect for persons should be upheld in research, their application in emergency situations may differ from non-emergency situations. Just like in non-emergency situations, research in emergency situations should be conducted in the best interest of the victims or future victims. The research should not unnecessarily expose human subjects and the researcher to careless harm, and should be of adequate scientific rigor. Victims of emergency situations are vulnerable populations that need special protection from exploitation. Technical competency to conduct research in emergency situations should include the ability to conduct a fair risk-benefit assessment in order to come up with a risk management plan, and being culturally sensitive to the needs of the victims of the humanitarian crisis. In emergency situations, the roles of Institutional Review Boards (IRBs) may have to be modified without compromising the ethical standards that health researchers have globally attempted to achieve.     

Ethics of clinical trials in Nigeria

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.     

Disclosure of individual research results in clinico-genomic trials: challenges, classification and criteria for decision-making

While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration. In regard to a concrete research setting--the one of clinico-genomic research--we discuss what kinds of difficulties have to be faced when returning individual research results to trial participants. In a last step, we elaborate on a stepwise model to trigger the individual feedback process. Hence, this paper gives guidance on how to feedback individual research results in a specific research setting and responds at the same time to new challenges in the debate on the duty to return individual research findings.     

What makes clinical research ethical?

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.     

浅析人类生殖细胞基因治疗的伦理学问题及对策

人类生殖细胞基因治疗是一个全新的医学领域,它可以从根本上治疗许多疾病,但是由于技术不完善以及存在众多伦理问题,所以该技术未能广泛应用于临床治疗和研究.人类生殖细胞基因治疗引发的伦理问题有：科学不可预知性的问题;生殖细胞基因治疗的社会风险问题;生殖细胞基因治疗改变人类多样性的问题;生殖细胞基因治疗的人权问题;如何判断基因“好”与“坏”的问题;生殖细胞基因治疗的经济价值问题.避免这些问题的对策有：政府应建立有效的管理和法律制度;生殖细胞治疗基因应符合国际技术规范和伦理规范;科学家和医学工作者应该加强道德修养,掌握应有的伦理学知识;加强教育宣传工作,使公众了解并接受该治疗方法.     

人类基因组多样性研究及其伦理问题

人类基因组多样性研究在人类发生学，人类进化史以及诊断，预防和治疗疾病方面具有重要意义；人类基因组多样性研究和环境基因组，药物基因组研究的结合，呈现出复杂性和伦理价值倾向；在人类基因组多样性研究过程中必须十分重视和贯彻伦理原则。     

医学伦理学论文写作的依据、类型及若干方法

医学伦理学论文的写作就是要运用医学伦理学的理论、观点,用辩证唯物主义和历史唯物主义的方法阐述、解答医学和医疗卫生实践中的医学伦理学问题及医学伦理学学科体系中的发展问题。这类论文有两种类型：研究医学伦理学学科本身问题、应用医学伦理学的问题。医疗临床、护理、管理、改革类文章的写作则应达到伦理的层次。写作的具体方法：1．开门见山选起点;2．重视学科交叉、移植;3．内容提要概而明;4．参考文献新而全。     

干细胞研究与应用的伦理思考

干细胞研究与应用是很有前景的前沿探索,应给予足够支持。同时,也提出了诸多新的伦理问题,尤其是成体干细胞的应用急需规范。支持与规范是有矛盾的,区分临床前研究、临床试验和临床应用有助于支持与规范的平衡;基础研究要宽松,临床试验要规范,医疗准入要严格。     

Duty to disclose what? Querying the putative obligation to return research results to participants

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of "research results," specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action.     

异性医患诊治的伦理探讨

性别伦理研究和教育的缺失、医院对异性医患诊治伦理问题的忽视、部分医务人员异性医患诊治伦理意识的淡漠导致了异性医患诊治伦理问题长期存在。对此提出建议：加强异性医患诊治伦理方面的理论研究;加强医学生和医务人员异性医患诊治伦理的教育和继续教育;医疗机构要重视异性医患诊治伦理的实践;医务人员要重视自身伦理素养的提升。     

Supervision Strategy and Implementation Key Points of Scientific and Technological Ethical Governance in Health and Medical Field

The ethical governance of science and technology is a kind of practical ethics, which develops in the process of continuously solving the ethical problems and ethical conflicts arising from scientific and technological activities. Ethical governance has common requirements and professional standards. Health- related science and technology activities, including the application of life science and artificial intelligence in health and medical field, make the medical ethical governance face common and unique challenges. The supervision and ethical review should consider the speciality of life science and medical research, and bring the existing ethical review system into full play. However, the focus, emphasis and standards of ethical governance have changed with the application of some technologies (ex. the next-generation sequencing, gene editing, and artificial intelligence). Actions should be taken to strengthen the ethical governance and promote ethics in advance with science and technological implementation in health and medical field. Here in this article, the classified, hierarchical supervision and ethical review strategies are discussed; then some potential effective organization and mechanisms for regional ethics committees are introduced. Promoting the medical education and continuing education of ethical governance of science and technology is also recommended. © 2022, Editorial department of Chinese Medical Ethics. All rights reserved.