药物临床试验无障碍知情同意·广东共识(2022年版)

<正>临床试验知情同意的规范实施需要评估受试者的知情同意能力及民事行为能力,处于弱势或存在脆弱性的受试者可能存在知情同意能力受影响的情形。一方面,任何人不应剥夺其参加临床试验的机会,另一方面,应采取无障碍知情同意措施,使其合规地参加药物临床试验。当涉及儿童、残疾人、精神病患者等特殊受试者群体知情同意过程时,研究者应充分评估潜在受试者的知情同意能力,落实临床试验的知情同意要求;当涉及知情同意书签署时,     

我国临床研究受试者知情同意现状及改善措施

目的:了解我国临床研究受试者的知情同意现状,并提出相应的改善措施。方法:通过分析我国临床研究受试者的知情同意现状,指出其不足,并提出相应的改善措施。结果与结论:我国临床研究受试者的知情同意在立法、受试者认知、研究者执行、知情同意书及伦理审查中仍存在问题。具体体现在临床研究的立法较薄弱;受试者对临床研究存在错误认知;研究者对知情同意的认识误区,执行知情同意时出现行为失范和告知不充分的现象;知情同意书暂无统一标准;伦理委员会的审查力度不强等。建议构建完善的法律法规制度,加强对受试者的健康教育,加强研究者的培训教育,规范知情同意书,加强伦理委员会的能力建设,以改善知情同意现状。     

儿童与未成年人临床试验的伦理审查*

由于儿童和未成年人不具有完全民事行为能力，属于弱势群体，邀请他们参加临床试验需要特殊的理由，并必须切实履行保护他们权利和健康的措施。对于涉及儿童和未成年人的临床试验，伦理委员会应该确信：以成人为受试对象，研究不能同样好地进行；研究的目的是获得有关儿童健康需要的知识；每位儿童的父母或法定代理人已同意；已获得每位儿童在其能力范围所给予的赞同；儿童拒绝参加或拒绝继续参加研究的意见将得到尊重。     

对药物临床试验伦理审查中的知情同意的概述

1知情同意的定义所谓知情同意,是指人体试验受试者享有知情同意权,研究者必须取得受试者知情同意才可开展试验,即试验者必须真实充分地向受试者说明有关人体试验的情况,如果受试者本人不能行使知情同意权,则必须取得与受试者没有利益     

从民法角度探讨药物临床试验质量管理规范中伦理委员会的职责

《药物临床试验质量管理规范》规定伦理委员会的职责是保护受试者的权益和安全，应当特别关注弱势受试者。合法有效的知情同意是免除申办者和研究者(研究机构)因药物临床试验药物不良反应对受试者造成人身损害产生侵权责任的前提。合法有效的知情同意应该具备民事法律行为的有效要件，包括未成年人和精神疾病受试者的监护人履行知情同意；受试者(监护人)避免产生重大误解，避免可能外在干预致使意思表示不真实，为失明、聋哑等获取知识能力低下者提供辅助器具等，实现知情同意真实意思表示。欺诈、胁迫、重大误解等不符合民事法律行为有效要件的知情同意，受试者可以请求人民法院予以撤销。民法角度，伦理委员会的职责实质是保障受试者充分知情同意，保障申办者、研究者(研究机构)开展临床试验避免因知情同意缺陷而承担侵权责任。申办者向研究者和临床试验机构提供与临床试验相关的保险是保护临床试验机构权益，知情同意撤回不影响撤回前基于个人同意已进行的个人信息处理活动的效力属于保护申办者权益，受试者或其监护人无阅读能力的公正见证人制度更多保护研究者权益。民法角度，伦理委员会的职责确保受试者知情同意合法有效、保护临床试验参与各方的合法权益相对合理全...     

临床试验的伦理审查:服刑人员、劳教人员

本文所谓的“服刑人员”是指监狱服刑人员,“劳教人员”是指劳动教养管理所的收容人员,简称“服刑劳教人员”.涉及这一特殊群体临床研究的伦理审查要求包括：伦理委员会的组成应该包括具有相应背景和经验的服刑劳教人员代表;研究是针对服刑劳教人员所患的疾病,并且如果不选择服刑劳教人员为受试者,研究不能同样好地进行;最小风险应该参照“健康人群”进行判断;知情同意应充分尊重其自主选择权;试验结束后治疗安排;以及公平招募,保护隐私,合理补偿等.     

医学研究知情同意过程及信息告知的伦理审查要点

提高伦理委员会审查质量与严格执行知情同意是保障受试者权益的主要措施。伦理委员会应依据国际、国内公认的法规,把握充分告知、特殊告知及获取知情同意过程等审查要点,对知情同意的过程及知情同意书告知信息进行审查,达到维护受试者权益和安全的目的。     

新药临床研究中的伦理探讨

新药临床研究的目的是为了减少患者的痛苦,提高人们的健康水平.按照赫尔辛基宣言原则,只有在符合患者利益,使受试者的权益得到充分保障的情况下,新药,临床研究才具有合理性、合法性.目前,大多数国内临床研究的进行已经规范,国家也有保障受试者安全与权益的法规和措施,但在某些方面仍存在一些问题.本文主要对存在于相关法律、法规,伦理委员会职责.临床研究知情同意以及受试者权益保护方面的一些问题及对策进行探讨,力求使临床研究中受试者的安全与权益得到更加有效的保障,以促进我国临床研究更加规范化、科学化、法制化.     

从研究者角度谈Ⅰ期临床试验健康受试者的管理和权益保护

Ⅰ期临床试验是药物临床研究的起始阶段,是整个药物研发链中十分重要的一环。Ⅰ期临床试验通常是以健康受试者为主要研究对象的单中心临床研究,健康受试者不但不能获得疾病治疗的益处,还常常需要承受高剂量试验药物所引起的不良反应。对Ⅰ期临床试验受试者的保护应贯穿在试验的整个过程中,从方案设计、伦理审查和知情同意、保险和研究协议、身份识别和个人信息保护、临床观察及安全性评价等方面进行严格管理。     

仿制药生物等效性研究中健康受试者的分阶段知情同意

生物等效性(BE)临床研究有别于Ⅱ～Ⅳ期临床试验,有其自身特点。健康受试者的知情同意是BE临床试验的一个极其重要的部分。从本院Ⅰ期临床试验中心的实践出发,发现渐进式的分阶段知情同意过程(网络平台和视频的预先教育、集体知情同意和一对一知情同意)有助于帮助受试者了解BE临床试验的具体细节,克服恐惧情绪,且能保护受试者的隐私,提高其参加试验的依从性,使BE临床试验能够获得真实准确的试验数据。     

Inclusion of patients with severe mental illness in clinical trials: issues and recommendations surrounding informed consent

Modern medicine would be unthinkable without the possibility of administering pharmaceuticals and other evidence-based interventions. The development of these interventions requires scientific research, ultimately with human subjects. This venture raises ethical, legal and human rights issues, which are addressed in numerous national and international declarations and regulations. In these documents, special attention is usually directed towards research involving vulnerable groups, such as children, pregnant women, unemployed persons, refugees, patients with psychiatric disorders, dementia or mental retardation, and those who are dying. In relation to patients with psychiatric disorders, two important and mutually connected ethical questions can be posed. Firstly, is research with persons who have severe psychiatric illnesses permissible? And, secondly, how can the mental capacity of prospective research subjects be assessed? We investigate these questions using the Dutch legal system as an example. Regarding the first question, the Dutch Medical-Scientific Research on Human Subjects Act (1998) presents a detailed regulation that is in line with relevant international documents, such as the Convention on Human Rights and Biomedicine (1997). In the Dutch statute, the possibilities for research involving subjects who lack mental capacity are limited, but not completely excluded. Under certain conditions, two types of research are exempted from the general prohibition of research with such subjects that is included in article 4 of the statute. These two types are (i) therapeutic research and (ii) non-therapeutic research that could not take place without the participation of subjects from the category to which the mentally incapacitated person belongs. The conditions pertain to ethical and scientific review, insurance, written proxy consent and respect for resistance by the subject. An extra condition for the permissibility of non-therapeutic research is that the risks for the prospective subject are negligible and the burdens minimal. Although the Dutch regulation obviously does not solve all problems, it is relatively clear when compared with the situation in other European countries, such as Belgium, France, Germany, and England and Wales. Regarding the second question, two basic factors need to be considered when defining 'mental capacity'. These relate to the assumption of competence and to the task-specificity of capacity. The crucial issue in assessing mental capacity is not whether a psychiatric diagnosis is present, but whether the patient has the mental abilities required to make the decision at hand in a meaningful way. In establishing an appropriate standard for capacity assessment, several interests have to be weighed. The ethical demands of protection of subjects and stimulation of scientific research may be balanced by attempting to enhance patients' mental capacity. The procedure of 'experienced consent' seems promising in this regard, although this approach entails its own ethical problems.     

A collaborative model for research on decisional capacity and informed consent in older patients with schizophrenia: Bioethics unit of a geriatric psychiatry intervention research center

Rationale The numbers of older persons with psychiatric disorders are expected to rise rapidly in coming decades, yet most studies of the safety and efficacy of treatments for such disorders have focused on younger adults. A substantial expansion in research involving older patients is needed to meet the treatment needs of this fast growing group. A critical issue in intervention research is ensuring a patient's decision-making capacity. Considerable heterogeneity exists in this regard even within diagnostic groups. Cognitive changes as well as increased complexity of medication regimens in elderly patients may make it particularly difficult for some older persons to fully understand, appreciate, and/or reason about the risks and benefits of participating in any particular study. Objectives Empirical research into assessing and possibly improving decisional capacity is warranted in older people with severe mental illness. Such research may be accomplished through collaborations among specialists from various related disciplines and, importantly, with active involvement of community partners. Methods We present one model of this type of collaboration, the Bioethics Unit of an Intervention Research Center, comprising a multi-disciplinary team along with a Community Advisory Board. Results Preliminary studies in our Center suggest that older individuals with psychotic disorders vary considerably in their decisional capacity, and many subjects appear to be fully capable for consenting to research projects. Furthermore, the patients' level of understanding of the consent material can be improved significantly through repetition and clarification of key elements in the consent form. Conclusions The decisional capacity for a given research protocol is not necessarily an unmodifiable trait, but can be enhanced with improvements in consenting procedures, even in older persons with psychotic disorders.     

Research note: ethics of drug treatment research with court-supervised subjects

The last two decades have seen an acceleration of clinical research on, and treatment advances in, addictive illness. Much important research in this area requires the participation of subjects who themselves suffer from drug dependence and have a strong likelihood of becoming involved in the criminal justice system at some point. However, using court-supervised persons with addictive disorders in drug research raises a number of significant ethical issues. These include, among others, worries about the individual's ability to provide capable, voluntary, informed consent and the obligation of researchers to safeguard sensitive clinical information. A variety of potentially coercive factors can influence court-supervised persons in their decision whether to enter research and can compromise their ability to provide informed consent. In this paper, we explore the ethical issues arising in this research and offer some suggestions for approaches to address these concerns.     

Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders

Rationale Optimizing the abilities of individuals with psychiatric disorders to provide meaningful informed consent for research has become a heightened concern for psychiatric researchers. Objectives We examined a post-consent test of comprehension given to older patients with psychotic disorders to identify problem areas in the understanding of informed consent for research. Methods One hundred and two middle-aged and older outpatients with schizophrenia or related psychotic disorders and twenty normal comparison subjects were administered a 20-item questionnaire to assess their comprehension of consent for a low-risk research protocol after receiving either a routine (paper-based) or an enhanced (computerized, structured slideshow incorporating greater review) consent procedure. Data on individual questions were analyzed. Results Patients had more difficulty than normal comparison subjects on open-ended questions, including those asking about study procedures, time involved, and potential risks and benefits. Among patients, the enhanced procedure was associated with better performance on questions about potential risks and time required than the routine procedure. Conclusions Problem areas in the understanding of informed consent, such as study procedures and potential risks and benefits, should be the focus of attempts to improve the consent process for patient participants with severe mental illness. Research also should be done to clarify how best to assess understanding of consent, since the wording of questions likely affects the responses.     

Legal and ethical issues in clinical pharmacy research--informed consent, Part I

The continued growth of hospital and clinical pharmacy should be paralleled by the development of sound research methods justifying innovative practices. Such research will, on occasion, require experimentation involving human subjects. The principal means of assuring that the welfare of research participants is not compromised is through the procurement of effective informed consent. Pharmacists, like many other health professionals, have had relatively little exposure to methodology involved in the writing of an informed consent instrument. A comprehensive document must not only conform to the requirements of federal regulatory agencies, but must also satisfy various institutional guidelines. Past instances of unethical human experimentation are discussed, and a format for preparation of an informed consent instrument is examined. Circumstances requiring informed consent and identification of the basic elements of consent are also explained.     

临床试验中特殊受试人群选择的国际伦理要求

弱势人群是指那些相对地(或绝对地)没有能力维护自身利益的人，即他们没有足够的权力、智力、教育、财力、力量、或其他必需的属性束保护他们的自身利益。邀请弱势个体作为受试需要特殊的理由，如果选择他们，必须切实履行保护他们权利和健康的措施。本重点论述了涉及儿童、因智力或行为障碍不能给予充分知情同意、妇女、孕妇等弱势群体生物医学研究的国际伦理要求。最后谈到研究是负担和利益并存的，任何群体或个人，包括弱势人群，都不应过多承担研究的负担，但也绝不能被排除在能使其受益的研究之外。     

精神医学临床研究中知情同意书的设计与应用

在精神医学临床研究中,精心设计并合理应用知情同意书能更好地发挥其对受试者的保护作用。本文对精神医学受试者知情同意书的设计进行简要介绍,阐述如何在研究中合理应用知情同意书,以期为我国精神医学临床研究中受试者知情同意书的设计与应用提供参考。