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。     

知情同意书信息要素完整性研究

目的:研究临床试验知情同意书中要素的完整性,评价撰写质量。方法:对第二军医大学长海医院伦理委员会受理的80项研究的知情同意书要素与标准要点进行对照,统计其吻合度,评价完整性;对要素逐项进行统计,包括缺失情况;调查审查记录,分析伦理审查关注点。结果:知情同意书撰写完整性基本合格,且逐年向好,但如下要素缺失较多:入选/排除标准、研究人员资质、替代治疗方案、指定联系人和联系方式、受试者有充分时间考虑、重新获得知情同意。伦理审查最关注的要素有补偿和赔偿、不良事件的处理、联系人和联系方式等、风险受益告知等。结论:知情同意书既要涵盖必要的要素,又要使每条要素的信息完整,使受试者真正全面理解告知的信息。     

人体药物临床试验受试者知情同意权保护法律问题研究

目的为人体药物临床试验受试者知情同意权利的保护提供完善的对策与建议。方法通过结合现行相关规定与司法实践中的案例,分析实践中存在的问题。结果目前,我国人体药物临床试验受试者知情同意权的保护仍存在诸多问题,如知情同意告知对象的规定与实践操作不统一、受试者对药物试验信息的理解不准确等。结论应尽快修订相关法律法规,切实履行知情同意的告知义务、内容,保障受试者的意思表示真实有效,落实伦理审查等多方面来保护受试者的知情同意权利。     

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...     

成瘾患者生物医学研究的伦理审查现状与思考

伦理审查是医学研究中受试者权益保护的必要措施。成瘾患者作为弱势群体，在相关医学研究中伦理审查和知情同意执行情况如何?作为弱势受试者的权益保障如何?本文简要调查了相关期刊近年发表的涉及人体的临床研究中伦理审查情况，针对存在的问题，提出了相应的建议和意见，供参考。     

我院抗肿瘤药物临床试验知情同意书伦理审查问题分析

目的 提高注册类抗肿瘤药物临床试验知情同意书的规范性和完整性，保障受试者合法权益。方法 汇总我院伦理委员会2020年7月1日-2022年7月1日进行初始审查的注册类抗肿瘤药物临床试验项目的伦理审查决议，根据我院自拟的“知情同意书质量分析表”，对其中存在问题的项目进行统计分析。结果 在进行初始审查的316项注册类抗肿瘤药物临床试验项目中，知情同意书告知内容存在问题的试验项目有257项（占81.3%），以国内多中心试验、Ⅲ期试验为主。主要问题包括试验费用承担者告知模糊（占68.5%）、试验内容告知不全（占59.1%）、权益和风险告知不充分（占58.4%）、个人信息保护告知不足（占56.0%）、知情同意书表述方式不规范（占52.5%）。结论 我院注册类抗肿瘤药物临床试验项目的知情同意书撰写与新版《药物临床试验质量管理规范》（GCP）的要求尚有差距，试验相关各方可采取多项措施以提高知情同意书的规范性和完整性。研究团队应严格按照新版GCP要求进行知情同意书设计，注重试验相关信息的全面告知；伦理委员会则可面向申办者和研究者提供知情同意书模板和撰写要点，不断加强审查能力、提高审查质量，切实保障受试者...     

儿童临床研究项目伦理审查关键点

在开展以儿童为对象的临床研究时,儿童作为弱势群体,严格的伦理审查是保障其受试者权益的重要手段。伦理审查宜注重全面性、持续性,制定额外的保护措施,正确对待知情同意。     

我国药物临床试验中伦理审查存在的问题与对策

目的 促进伦理审查程序规范化.方法 通过对相关文献的总结与归纳,指出目前我国药物临床试验中伦理审查存在的问题,有针对性的提出了一些对策与措施.结果 与欧美等发达国家相比,我国的药物临床试验伦理审查起步较晚,存在一些问题,比如研究方案不够科学、知情同意不够规范、相关培训不充分、对受试者的经济补偿不到位等.结论 应建立和完善药物临床试验机构的管理制度,加强各级伦理委员会的监督和管理;科学设计药物临床试验方案;完善知情同意;制定合理的补偿措施;并开展伦理委员会的专项培训.     

药物临床试验伦理审查质量风险的管理研究

目的:为提高我国药物临床试验伦理审查质量、保障受试者权益提供参考。方法:以风险管理理论为指导,运用文献研究法、专家意见法和层次分析法对药物临床试验伦理审查流程进行梳理,提取并确定影响伦理审查质量的风险因素及其权重,并对我国药物临床试验伦理审查工作提出改进建议。结果与结论:构建的药物临床试验伦理审查风险指标体系包括5个方面共31个影响因素,其中影响药物临床试验伦理审查质量的5个方面的重要性(权重)排序依次为医学伦理委员会的自身建设(0.2635)、审查会议的管理(0.2514)、跟踪审查(0.1945)、审查申请的受理与处理(0.1892)、文件档案的管理(0.1014);权重较高的影响因素包括"讨论投票过程利益冲突人员回避(0.0787)""对方案修改、知情同意修改、严重不良事件等情形及时审查或召开会议讨论(0.0705)""明确伦理审查工作流程及时间并对外公示(0.0598)""统一、规范的审查标准与批准标准(0.0521)"等。建议可通过讨论投票环节利益冲突人员予以回避,对方案修改、知情同意修改、严重不良事件等情形及时审查或召开伦理会议讨论,明确伦理审查工作流程及时间,建立统一、规范的审查标准和批准标准等方式提高药物临床试验伦理审查的质量。     

SFDA日前印发《药物临床试验伦理审查工作指导原则》

本刊讯为了加强对伦理委员会药物临床试验伦理审查工作的指导,规范伦理委员会的药物临床试验伦理审查工作,切实保护受试者的安全和权益,国家食品药品监督管理局（SFDA）日前公布了《药物临床试验伦理审查工作指导原则》（以下简称《指导原则》）,旨在促进国内药物临床试验伦理审查能力的提高,充分发挥伦理委员会在保护受试者安全和权益中的作用,进一步规范药物临床试验的研究行为。     

儿童药物临床试验项目质控中的常见问题与对策

目的:在药物临床试验中,应保障儿童受试者的合法权益和生命安全,确保试验记录和报告数据准确、完整、可信.方法:收集无锡市儿童医院药物临床试验机构、自2018年以来所有项目的质控报告,将报告中记录的问题进行分类汇总,分析问题原因,提出解决方法.结果:儿童药物临床试验在知情同意过程、试验方案执行、试验记录、原始资料收集、检查...     

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

Preparation of an effective informed consent document presents significant problems to those investigators not familiar with federal and institutional requirements. This article examines a detailed format for preparation of an informed consent instrument. Prepared by the authors and supplied to potential clinical investigators by a university institutional review committee, the guidelines incorporate Department of Health, Education, and Welfare regulations. An example consent form is provided.     

Scientific drug safety information for patients' consent

One of the important roles of pharmacists is to continue their contributions to new drug discovery and development. However, it seems to be very difficult to obtain patient satisfaction with new drugs. Because new medicines have both benefit and risk, there should be many systems to maximize the safety and efficacy of the drugs. In clinical trials, the rights, safety and welfare of human subjects under the investigator's care must be protected. Good Clinical Practice is a harmonized ICH-guideline, and the safety information of an investigational product is explained to patients who voluntarily enter the clinical trials. Since safety information about investigational products is still limited, subjects are informed about the results of animal experiments and those of finished clinical trials. The sponsor of clinical trials should be responsible for the on-going safety evaluation of the investigational products. When additional safety information is collected in the clinical trials, the written informed consent form should be appropriately revised. During the review process, quality, safety and efficacy of new drugs are evaluated and judged based on the scientific risk-benefit balance. The safety information collected in clinical trials is reflected in the decision-making process written in the review reports. All-case investigation should be also performed until data from a certain number of patients has been accumulated in order to collect early safety and efficacy data. Important messages written in review reports for drug safety and patient consent are explained. Risk communication will improve the application of patients' consent for new drugs.     

Ethical considerations in human experimentation.

An accepted practice in medical research has been the subordination of individual rights to the benefit of mankind. The Nazi experiments, and other recent abuses, have focused increased attention on the dignity and rights of human research subjects and have led to new regulations to control human experimentation. Central to establishing what constitutes permissible human experimentation are the issues of risk-benefit ratio and informed consent. Evaluating the risk-benefit ratio requires consideration of the nature of the experiment, the likelihood of its success, and the type of subjects to be utilized. Participation in a study requires voluntary "educated" informed consent. Certain categories of subjects, such as children and the mentally handicapped, require special protection in this regard. Finally, formal education in medical ethics and prohibiting publication of unethical studies are likely to prove more effective in curbing unethical experimentation than increasing government regulation.     

Ethical issues in schizophrenia: considerations for treatment and research

Clinicians who treat patients with schizophrenia may encounter a variety of ethical issues related to both psychiatric and medical treatment of patients. While informed consent is a crucial aspect of the care of all patients, it may present special challenges for patients with schizophrenia. Schizophrenia is a severe mental illness that is frequently accompanied by neuropsychological deficits. These impairments, as well as psychotic symptoms and lack of insight, can affect patients' abilities to make fully informed decisions about their own care. Ensuring that consent for treatment is informed, voluntary, and competent can thus become a more difficult endeavor. The ethical principles underlying treatment of these patients, however, are the same as those guiding treatment of all patients. Informed consent, as an embodiment of these ethical principles, represents the expression of individual rights in both clinical and research contexts. Attention to the process of informed consent as an ongoing dialogue strengthens the clinician-patient relationship, improves adherence, and helps the patient clarify options, values, and preferences. In the research setting, psychiatric researchers are increasingly concerned with maximizing the abilities of individuals with severe mental illnesses such as schizophrenia to provide meaningful informed consent for protocols. This review addresses decision-making abilities of people with schizophrenia in both treatment and research contexts.     

临床试验的关键环节节译自WHO《GCP手册:指南的补充》(2005年)

临床试验的关键环节包括：试验方案的制定；标准操作规程的制定；支持系统和工具的制定；试验信息记录文件的制定和批准；试验场所的选择，以及合格的、经过训练的、富有经验的研究者和研究人员的选择；伦理委员会审查和批准方案；行政管理当局的审查和批准；研究受试者的纳入：招募、合格和知情同意；试验药物：质量、管理和清点；试验数据的采集：实施试验；安全性管理和报告；试验的监查；试验数据的管理；试验实施和数据的质量保证；试验报告。     

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.     

Exceptions to Fully Informed Consent in Clinical Research

Abstract

The doctrine of informed consent is fundamental to all medical personnel involved in investigational research. Informed consent arose from the Helsinki declaration that stated, “concern for the interests of the subject must always prevail over the interests of science and society.” (6) As clinical research is a part of medical practice, it is reasonable to assume that exceptions to fully informed consent that are defendable in medical practice can be applied to clinical research as well. The exceptions to fully informed consent are waiver, incompetence, therapeutic priviledge, emergency, or proxy.