也论药品临床试验的伦理要求

本文拟在业已公认的人体实验伦理原则基础上,结合现行GCP中的有关内容,提出了药品临床试验的伦理要求,指出了受试者的具体权益以及保护受试者权益的具体措施,特别强调,为确保临床试验中受试者的权益并为之提供公众保证,应成立临床试验的伦理委员会,伦理委员会的组成和工作应是独立的,不受任何参与试验者的影响,文中就伦理委员会的工作目的、组织形式以及对临床试验的审查要点等亦进行了介绍,相信这对管理者从伦理角度管理好药品临床试验将会有所帮助。     

药品临床试验中对受试者的保护——知情同意

保护临床试验受试者的安全与权益是GCP的宗旨和核心内容之一。在药品临床试验的过程中,在确保试验的科学性和可靠性的同时必须对受试者的安全和权益给予充分的保障.伦理委员会(Ethic Committee)与知情同意(Informed Consent)是保障受试者权益的两项主要措施。在上期中已介绍了伦理委员会,在本文中介绍知情同意。 知情同意顾名思义包括“知情”和“同意”两个方面,即:让受试者知晓和明了和临床试验有关的必要信息(知情)后,受试者自愿确认其同意参加该项临床试验的过程(同意)。各国GCP均明确规定:研究者准备入选为临床试验的受试者的所有病人或健康自愿者,在开始试验程序之前,必须得到本人的同意。也就是说不允许受试者对实验不明了,或者强制性地参加试验。为此任何受试者在参加临床试验前必须获得一份已经伦理委员会审核的知情同意书,经仔细阅读及经研究者或其授权执行     

日本机构伦理委员会关于研究规程的审议要点

随着临床试验国际化进程的加快,在中国进行的国际合作临床试验逐渐增多。保证临床试验的科学性和维护受试者的权益,需要伦理委员会的审查和监督管理。介绍日本伦理委员会审查研究规程的视点,旨在使我国广大临床工作者了解国外的伦理审查工作,以期对提高国内的临床试验水平和质量控制提供参考。     

明晰医学临床试验研究中的申办者、研究者及医学伦理委员会的职责

现代医学临床试验研究的宗旨是：在充分保障受试者权益和利益的前提下,进行符合人类自身发展需要的科学技术研究.显然,保障受试者权益和利益是科学研究的第一要素.现阶段,探索在医学临床试验研究中申办者以契约（保险）的形式保障受试者权益和利益的方法,同时,从根本上解决伦理委员会保障受试者权益和利益的指标-申办者为受试者购买相关保险,二者显得尤为重要,将在临床试验研究受试者权益的保护方面发挥重要作用.     

药物临床试验中受试者权益保护存在的问题及对策

从我国临床试验行政许可、伦理委员会建设和研究者应承担的责任等角度出发,分析临床试验中受试者保护措施现状及在受试者权益保护方面存在的主要问题:不胜任的机构仍在开展临床试验,伦理审查委员会的独立性和能力建设存在问题,知情同意流于形式或在知情同意过程中研究者行为失范。针对这些问题提出了一些建议和改善措施:完善不良反应处理机制和受试者补偿机制,加强伦理审查委员会的能力建设,加强GCP的伦理培训,规范临床试验机构资格认定与复核管理,建立健全行政监督机制。     

药物临床试验中的伦理审查实践

文中介绍了药物临床试验机构伦理委员会的组成和伦理审查的工作程序,并对目前药物临床试验伦理审查中存在的问题进行了探讨,提出了一些建议。为了保障受试者的权益、保证临床试验的质量,临床试验机构伦理审查委员会的伦理审查工作还需要加强。     

再论明晰医学临床试验研究与医学临床治疗之间界限的意义

明晰医学临床试验研究与医学临床治疗之间界限意义的一个重要目的就是明晰医学临床试验研究中的意外事故与医学临床治疗中的意外事故之间的本质区别,循此线索,探索“保护医学临床试验研究中意外事故的受试者（伤害者）的权益和利益的方法”。同时,寻求达成“医学临床试验研究意外事故鉴定委员会对受试者（伤害者）进行鉴定”这一概念和行为的共识,从而达到从制度建设的层面上保障医学临床试验研究中受试者权益和利益的目的。     

发挥医学伦理委员会的作用 保障受试者权益

在药品临床试验过程中,受试者的作用是极其重要的,他们为我国医药科学事业的发展作出了很大贡献.但是药品临床试验属于人体实验的范畴,由于多种因素的影响,受试者们可能会承担一定程度的风险.因此,作为医学科学领域的研究工作者,严格执行国家有关药品临床试验的法规和法律,自觉遵守《赫尔辛基宣言》,保护受试者的个人安全和权益是义不容辞的责任,药品临床试验在我国尚处于不规范管理时期,存在较多缺陷,如参加临床试验的研究人员医疗行为缺乏伦理原则指导,受试者的知情同意权得不到应有的保障、试验中受试者受到非正常损害时补偿机制不健全等,不同程度地影响了受试者的权益.     

关于结核病临床研究论文的医学伦理学分析

目的：对我国近年来结核领域发表的临床研究论文进行分析,了解我国生物医学期刊在医学伦理方面的审查情况。方法选取了在结核领域较为著名的两本杂志自2010年以来发表的与结核临床试验相关的文献进行分析。结果在纳入的33篇文献中,对知情同意描述的数量相对较高,对伦理审查的描述较少。12％的文献对知情同意的描述不规范,9％的文献没有提到伦理委员会的名称。结论我国部分期刊和科研人员对伦理学审查的重视程度有待提高,要重视医学伦理学的宣传教育,提高编辑人员和科研人员对伦理学问题的认识水平,保证受试者的权益,提高科学研究质量。     

病毒性肝炎药物临床试验的护理

我院为济南市首家国家药监局批准的临床药理试验机构，主要进行病毒性肝炎药物的临床试验。为确保药物临床试验的科学、准确以及受试者的权益保障，护士在试验工作中的护理十分重要。     

伦理共同体与卫生大部制

从共同体、伦理共同体的核心出发,认为近年来的医疗体制改革中,十几个部委一起设计中国的医改方案让人看到希望,但同时,每个部门都有自己的利益,分割的部门利益会促使他们通过改革扩权,并尽力维护本部门在其中的利益,指出"大卫生部"是一项关乎体制性的根本解决措施,阐明了卫生大部制的伦理意蕴。     

Trust based obligations of the state and physician-researchers to patient-subjects

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust‐based obligations of the state and the physician‐researcher respectively to the patient‐subject. The state relies on the voluntarism of patient‐subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent‐neutral interests of patient‐subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit‐harm evaluation by research ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent‐neutral welfare interests of the patient‐subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician‐researcher to protect the agent‐relative welfare interests of the patient‐subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician‐researcher to exercise judgment in the interests of the patient‐subject taking into account evidence on treatments and the patient‐subject‘s circumstances.With increasing demand for contemporary medicine to be placed on a firmer scientific foundation, clinical research is enjoying unprecedented expansion. Accordingly, doctors in increasing numbers are participating in clinical trials, as are greater numbers of patients. Hence, it is surprising that the central moral dilemma of the randomised controlled trial (RCT) remains so vexing: when may physicians, consistent with their duty of care to patients, offer the them enrolment in an RCT?¹ If reasonable public trust in the ethical integrity of clinical research is to be maintained, a convincing answer to this question must be given. Presently, we explore the dilemma, examine solutions that have failed to galvanise support, and offer a new one.The dilemma arises because offering patients enrolment in RCTs imperils the doctors'' duty to act in their interests. This is because, in seeming contrast to clinical practice, an activity structured to protect and advance the medical interests of the patient, clinical research necessarily calls for the pursuit of other interests, including the public interest in the production of generalisable knowledge, and the variable private interests of industry, institutions and researchers. The pursuit of these interests inevitably influences the conduct of clinical research materially. To ensure scientifically valid results, treatment in a clinical trial is restricted by design features of the study protocol (eg, randomisation to treatment, blinding of treatment allocation and fixed schedules for treatment provision). Further, patient‐subjects typically undergo non‐therapeutic procedures to answer the scientific question. In these ways, the demands of science place the conduct of clinical trials in tension with the doctor‐researcher''s positive duty of care (hereinafter referred to as duty of care) to the patient‐subject.Hellman and Hellman² have argued that an unmanageable conflict exists between the interests of the patient‐subject and those of others in clinical research. Conducting RCTs, in their view, necessarily violates the rights of patient‐subjects to have their interests protected. They view the rights violation as being of such magnitude that RCTs on patients must be abandoned and replaced by non‐randomised forms of clinical research. We believe that their position is untenable. RCTs have a pivotal role in the generation and scrutiny of the evidentiary foundation of clinical practice. The results of clinical research are not merely of private and academic interest; they further the public good of high quality medical care. Without clinical research, much of the practice of medicine would remain untested, and medical progress would be stymied. Furthermore, we question whether the tension between the demands of science and the rights of patients results in an insoluble conflict of interest, requiring an either/or solution.A recent proposal from the US purports to solve the dilemma by denying its existence. Miller and colleagues deny that doctor‐researchers operate under a duty of care to patient‐subjects. They argue as follows. Clinical practice and clinical research have differing goals. The goal of clinical practice is to provide the patient with optimal care. The goal of research is to produce generalisable knowledge that may benefit future patients and society. They assert that because the goals of clinical practice and clinical research differ, the norms governing each must not overlap.³ Implicit is the suggestion that the physician‐researcher ceases to be a physician when conducting research by virtue of the nature of research as an activity. They explicitly deny that the physician‐researcher has a positive obligation to act in the interests of the patient‐subject when conducting research.^4,5 The only duties of the physician‐researcher to the patient‐subject are to obtain informed consent and avoid exploitation.The solution given by Miller and colleagues is unsatisfactory. It has already been noted that an implausible form of moral dissociation is required, whereby doctors engaging in research must wilfully ignore the professional obligations they have as doctors.⁶ Further, the assertion that activities themselves generate norms is counterintuitive and requires argument. Finally, the additional assertion that the norms governing activities with differing ends are non‐overlapping is obviously false. Norms prohibiting fraud and murder are universal and thus apply across diverse activities. Worse still, Miller et al''s view is internally inconsistent on this very point. They recognise a duty to obtain informed consent applicable to clinical practice and clinical research. Thus, at least one norm in their schema is overlapping, refuting a central premise of their argument.Given this, we think physician‐researchers will rightly continue to wonder about the implications of their duty of care to patient‐subjects when conducting clinical research. When, consistent with this obligation, can a doctor offer a patient enrolment in an RCT? Is approval by the research ethics committee (REC) sufficient? Is there a role for clinical judgement when doctors act as physician‐researchers? To consider these questions and the broader dilemma satisfactorily, in our view, requires recognition and elucidation of the independent obligations of the state and the doctor‐researcher to protect the interests of patient‐subjects. These obligations are understood to be derived from the trust‐based relationship between the patient‐subject and the state and the doctor‐researcher, respectively.     

我国民事上诉审制度的缺陷及改革

民事上诉审制度是诉讼制度的重要组成部分。民事诉讼的这一程序性设置，目的在于形成法院内部的纵向监督机制，使下级法院作出的错误裁判，能够及时地通过上诉审程序得到纠正．但由于我国现行的二审终审的上诉审制度在体制上存在着不少缺陷，直接威胁到司法公正目标的实现，因此有必要遵循上诉审的基本原理，建立三审终审制。但同时也必须严格限定进入第三审案件的范围，明确规定第三审的审判方式，以更好的提高诉讼的效率。     

澳大利亚的临床服务质量指标体系

介绍了澳大利亚的临床服务质量指标体系（CI）。与国内目前使用的医疗质量指标相比较,分析了CI的关注机构服务质量和临床技术质量两个方面的质量评价丁作;注重医疗服务结果和患者利益,指标体系将对具体的临床问题起到筛查、标识和警示的作用;非常重视临床技术指标的分析、结果的沟通和在质量管理中的决策支持作用,利用数据和信息来促进医疗技术质量的改进;指标的选择标准较为严谨,强蒯指标的可比性,关注负性事件的影响等4个主要特点。     

从2013年版《赫尔辛基宣言》的变化生命伦理学研究的新进展

通过对2013年版《赫尔辛基宣言》和旧版本进行比较,分析生命伦理学发展的新进展：一是对受试者的保护工作进一步加强,表现在从研究设计的源头管控保障受试者利益和从知情同意的过程管控维护受试者权利两方面.二是对研究医生的管理进一步规范,涉及研究医生的定义问题、资质问题、职责问题.三是对伦理委员会的定位进一步明确.此外,新版宣言更加重视对生态环境的保护.     

创新医学院校独立学院学生工作初探

简要分析医学院校独立学院学生的特征，以及医学教育的宗旨和目的，并提出做好独立学院学生工作的相应措施。     

无主病人院前救治转送原则及伦理学探讨

无主病人作为病人,享有最基本的医疗权。急救中心作为对无主病人进行首诊的医疗机构,在对其实施院前急救转送过程中应当遵守及时、准确、有效、择优和自主等伦理学原则,做到知情同意、有利无伤、最大限度地维护患者的权益。这是建立健全社会主义保障体系,构建和谐社会的基本要求之一。     

How children can be respected as 'ends' yet still be used as subjects in non-therapeutic research.

The question of whether or not children may be used as subjects in non-therapeutic research projects has generated a great deal of debate and received answers varying from 'no, never' to 'yes, if societal interests are served'. It has been claimed that a Kantian, deontological ethics would necessarily rule out such research, since valid consent would be impossible. The present paper gives a deontological argument for allowing children to be subjects in certain types of research.