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.     

临床试验的伦理审查:医疗器械

国家对医疗器械实行分类管理,第一类医疗器械无需临床试验,第二类、第三类医疗器械生产注册之前应当通过临床试验(临床试用或临床验证)。医疗器械临床试验的伦理审查要点主要包括试验的科学设计;试验的风险和受益评估,区分重大风险临床试验和非重大风险临床试验;知情同意;受试人群的选择;受试者的医疗和保护等。医疗器械临床试验的批准标准和医疗器械紧急使用都应该符合相应的标准。     

临床试验的伦理审查:精神障碍

精神障碍可能影响患者理解知情告知信息的能力,并可能影响他们做出参加临床研究理性决定的能力.对于涉及因精神障碍而不能给予充分知情同意受试者的临床研究,伦理委员会应该确保：在给予充分知情同意能力没有受损的人身上能同样好地进行研究,这类人就不能成为受试者;研究的目的是为获得有关精神障碍者特有的健康需要的知识;已获得与每位受试者能力程度相应的同意,可能的受试对象拒绝参加研究应始终受到尊重,除非在特殊情况下,没有合理的医疗替代方法,并且当地法律允许不考虑拒绝;如果可能的受试对象没有能力同意,应获得其法定代理人的许可.     

以科学和诚信的态度对待受试者 --兼论知情同意书中存在的问题

在人体临床研究中，受试者是整个研究过程中最重要的组成部分，如何对待受试者，尤其是受试患者，如何才能够真正保护他们的利益不受损伤．是研究者必须高度重视的问题。近年来，随着人们的法律意识和人权意识不断加强，整个社会对受试者的利益及处境都给予了相当多的关注；新闻媒体也经常披露一些药物临床试验不能公正地对待受试患者，有的甚至存在伦理道德问题。     

儿科人群临床试验中对受试者疼痛管理的伦理考虑

作为“临床试验中对受试者疼痛管理的伦理考虑”系列标准之一，主要论述《儿科人群临床试验中对受试者疼痛管理的伦理考虑》的起草背景、制定依据和适用范围，以及儿科人群临床试验中受试者疼痛等负担的来源和识别、在儿科人群临床试验方案设计和临床试验执行过程时使受试者疼痛最小化的措施，以期从伦理角度对儿科人群临床试验中受试者疼痛管理提出指导意见。其适用于伦理审查中对于儿科人群临床试验中受试者疼痛管理的伦理考虑，以及研究者制定临床试验方案和试验流程对儿科人群疼痛管理的关注。对临床试验中儿科人群疼痛予以更多关注，是保护儿科受试者权益的措施之一，有助于保障儿科临床试验顺利开展。     

新型冠状病毒影响下对药物Ⅰ期临床试验受试者管理的思考

2019年末至今新型冠状病毒肺炎疫情在全球蔓延,造成严重的经济冲击和社会影响,对药物临床试验的开展也带来诸多困难与挑战。基于药物I期临床试验受试人群和流程的特殊性,引发了对在新型冠状病毒肺炎疫情影响下药物I期临床试验受试者管理的一些思考。提出从受试者招募、筛选、入住的不同阶段,到受试者宣教、饮食管理及不良事件观察等多方面的应对策略,旨在探讨如何在疫情防控常态化情况下,更好地保护受试者安全与权益,加强临床试验的风险控制,确保试验的顺利完成。     

关于加强临床试验招募广告伦理审查的探讨

招募受试者的广告须经伦理委员会审查和批准之后方可使用。其形式和招募的途径多样化。国内的招募广告伦理审查主要存在以下问题：相应的伦理审查法律法规不完善;临床试验相关人员重视度不够;招募广告自身的缺陷等。审查招募广告的要点包括发放媒介及其主要内容。针对招募广告伦理审查存在的问题,建议通过完善法律和各项规章制度、提高审查招募广告的意识和加强监督管理,以提高招募广告伦理审查水平,更好地保障受试者安全和权益。     

中医药临床试验受试者招募过程中的策略制定

受试者招募在一项临床试验中属于研究实施阶段的前期工作,如果招募工作没有完成或者招募质量没有保证将影响整个临床试验的进度和质量。本文从受试者招募流程、招募方式和影响受试者招募因素等几方面介绍受试者招募过程中的策略和方法,以期对进行临床试验尤其是中医药临床试验的研究者提供借鉴。     

我国药物Ⅰ期临床试验受试者招募及管理存在的问题

受试者招募是影响Ⅰ期临床试验质量的一个重要环节。本文针对我国Ⅰ期临床试验受试者招募与管理存在的问题,探讨相应的对策,以期保护受试者的权益和安全,提高我国药物I期临床试验的水平和质量。     

我国药物临床试验法规与相关国际法规的对比研究

文中通过比较我国药物临床试验法规与相关国际法规的差异,对两者之间存在的临床试验批准、临床试验机构选择、伦理委员会的设置、受试者损害补偿机制、不良事件监控体系和受试者招募广告6个方面的差异进行了分析,并针对上述差异提出了相关的建议,从而使我国的临床试验研究政策与国际接轨,提高我国药物临床研究的水平。     

Spreading it around: money for researcher and research participants

There is a consensus that inducements for participants in research studies are ethically permitted as long as they are not "undue." The subject of inducements for investigators has not been ethically analyzed. This essay outlines the three models for compensation suggested by Dickert and Grady--market model, reimbursement model and wage-payment model--and argues that this analysis can be fruitfully applied to remuneration for investigators. Currently, investigators are compensated according to the market model, resulting in undue inducement. Investigators should be compensated according to the wage-payment model, as skilled workers, at the rate an internist earns per hour. The wage-payment model avoids undue inducement, but compensates investigators, particularly non-academic investigators who are not salaried, for their time and effort. However, additional safeguards must be erected: investigators must demonstrate research competency for the studies they are to manage; they must understand research ethics; all investigators must be routinely audited; and subjects must be informed of all remuneration that investigators receive.     

The recruitment of normal healthy volunteers: a review of the literature on the use of financial incentives

Unresolved issues of ethical, methodological, and legal concerns in the use of normal healthy volunteers persist. Financial incentives in their recruitment offer a unique ethical dilemma because of questions surrounding payment. A review of literature was conducted to obtain research systematically examining volunteer motivation and the role offinancial incentives. The primary selection criterion was motivation and payment to volunteers; seven studies met the criterion for review. Studies that have systematically investigated volunteer motivation have found financial rewards to be an important motivator among normal healthy volunteers in their decision to participate in clinical trials. Also evident is that differences based on demographic characteristics exist in the motivation and rates of volunteerism. Ethical issues surrounding the use of normal healthy volunteers are discussed, with attention to the issue offinancial incentives (e.g., economically vulnerable volunteers, undue inducements). Regulations, guidelines, and recommendations are discussed with regard to volunteers and financial incentives.     

Selection of subjects for human milk surveillance and research studies

Subject selection for studies investigating environmental chemicals in human milk requires thoughtful consideration of multiple factors. Studies often need to produce generalizable and representative data that can be compared to other similar studies. Goals of the study determine the selection of subjects. Exposure is only one factor that influences the levels of environmental chemicals in human milk. Many maternal and infant characteristics should be considered in subject selection. Collection procedures of human milk samples also affect subject selection, as subject burden may be enough to reduce compliance with the collection protocols. Decisions must be made about pooling of samples both within subjects and within populations. Guidelines for subject selection are provided by the World Health Organization for human milk monitoring, but distinct differences in the lactational practices, geography, and ethnic and racial diversity of the U.S. population require somewhat different approaches.     

SELECTION OF SUBJECTS FOR HUMAN MILK SURVEILLANCE AND RESEARCH STUDIES

Subject selection for studies investigating environmental chemicals in human milk requires thoughtful consideration of multiple factors. Studies often need to produce generalizable and representative data that can be compared to other similar studies. Goals of the study determine the selection of subjects. Exposure is only one factor that influences the levels of environmental chemicals in human milk. Many maternal and infant characteristics should be considered in subject selection. Collection procedures of human milk samples also affect subject selection, as subject burden may be enough to reduce compliance with the collection protocols. Decisions must be made about pooling of samples both within subjects and within populations. Guidelines for subject selection are provided by the World Health Organization for human milk monitoring, but distinct differences in the lactational practices, geography, and ethnic and racial diversity of the U.S. population require somewhat different approaches.     

Use of Small Incentives for Increasing Participation and Reducing Dropout in a Family Drug-Use Prevention Program in a Spanish Sample

Poor participation rates represent one of the most serious problems facing family-based drug-use prevention programs. Strategies involving incentives have been used to increase recruitment and retention of the target population of such interventions, but in Spain, such strategies for modifying behavior are unusual. The goal of the research was to study the use of small financial incentives (€10 voucher) as a strategy to increase attendance and reduce dropout in a family drug-prevention program applied in the school context. Participants were 211 pupils (aged 12–13) and their parents. The results show that small financial incentives can be useful to increase the attendance of families in prevention programs and to reduce dropout.     

临床试验的伦理审查:妇女和孕妇

孕妇以及育龄期妇女参加临床试验,涉及她们本人、妊娠、胎儿和由胎儿长成的人、以及她们生育力的风险和受益,伦理委员会审查时需要有一些特殊的考虑.涉及妇女临床研究的特殊伦理审查问题主要包括：研究期间有怀孕的可能,其本身不能作为排除或限制育龄期妇女参加生物医学研究的理由;详尽讨论研究对孕妇和胎儿的风险,是妇女做出参加临床研究理性决定的先决条件;涉及孕妇临床研究的特殊伦理审查问题主要包括：风险和受益的判断应同时考虑研究对孕妇及胎儿两方面的风险与受益,并结合研究的类别进行考虑;只有当研究是针对孕妇或胎儿特有的健康需要,或针对孕妇总体的健康需要,并且如果合适,有来自动物实验、尤其是关于致畸和致突变风险的可靠证据予以支持,才能在孕妇群体中实施研究.     

浅谈I期临床试验受试者管理体会

探讨I期临床试验过程中受试者招募和受试者依从性的管理。分析招募的难点和提高招募效率的措施。在试验全过程中,研究人员扎实的医学知识技能和诚挚的关心、尊重、友善是提高受试者依从性的关键所在。