守护受试者的权益——对“药物研究与应用的伦理监督”

如何保障和守护临床试验研究中受试者的权益?这既是医生、患者(受试者)、工业界与公众注目的问题,也是医院伦理委员会工作面临并要解决的基本而至关重要的问题。从华西医院伦理委员会工作角度出发,分析了临床试验研究中的权益冲突和对受试者权益的科学、伦理与政策守护的要素,论述了如何保障受试者权益问题。     

临床研究中的受试者权益保障面临的挑战

伦理委员会是保障受试者权益的监督、管理者,研究者是保障受试者权益的直接实施者.面对日益增多的国际多中心临床研究,中国的伦理委员会和研究者面临很大的挑战.只有提高伦理委员会和研究者的能力并切实改进临床研究中存在的常见问题,才能更好地保障受试者权益.     

临床研究中的受试者权益保障面临的挑战

伦理委员会是保障受试者权益的监督、管理者,研究者是保障受试者权益的直接实施者。面对日益增多的国际多中心临床研究,中国的伦理委员会和研究者面临很大的挑战。只有提高伦理委员会和研究者的能力并切实改进临床研究中存在的常见问题,才能更好地保障受试者权益。     

涉及人的科研项目伦理审查现状及对策初探

涉及人的科研项目在伦理审查过程中存在诸多问题。从实际工作出发,分别从伦理审查时机选择、伦理委员会管理、委员利益冲突、研究者资质、受试者是否实际获益、政府监管等角度进行了深入分析探讨并探索解决之道。提出只有规范科研项目的伦理审查,提高审查质量,才能切实保障受试者的安全和权益,进而提高研究质量,促进医学科学发展。     

试论临床试验受试者的权利保护机制——以程序规则为视角

临床试验受试者,作为公益的施行人,对其权利进行保护已迫在眉睫.但依据现行的规定,保障受试者权益主要措施--伦理委员会与签署知情同意书,在操作层面上均遭遇程序壁垒.从现行法律规定的弊端入手,健全知情同意权和伦理委员会构成程序性制度及规则,弥补立法缺陷.     

上海市公立医院研究项目负责人对研究伦理的感知

通过问卷调查,分析了上海市13所公立医院研究项目负责人对研究伦理方面的认知.研究显示,医院部分研究项目负责人在研究中缺乏承担起维护患者和受试者权益职责的意识,医院伦理委员会应真正成为维护患者和受试者权益的重要防线,我国应加强各层次生命伦理的培训.     

关于建立医学伦理审查监管体制的探究

医学伦理审查监管体制的框架包括:卫生行政部门对医学伦理委员会的认证和视察;伦理委员会对研究方案的审查;伦理委员会对试验安全性和科学性的监管;伦理委员会对受试者权益的保护及对利益冲突问题的管理;伦理委员会对自身的监管以及爱试者对医学伦理审查的监管;卫生行政部门和伦理委员会对投诉接待的管理.     

试论临床试验受试者的权利保护机制——以程序规则为视角

临床试验受试者,作为公益的施行人,对其权利进行保护已迫在眉睫。但依据现行的规定,保障受试者权益主要措施——伦理委员会与签署知情同意书,在操作层面上均遭遇程序壁垒。从现行法律规定的弊端入手,健全知情同意权和伦理委员会构成程序性制度及规则,弥补立法缺陷。     

药物临床试验伦理审查的跟踪审查研究

伦理委员会对药物临床试验的跟踪审查是保障药物临床试验质量,保护受试者权益的核心手段。通过对伦理审查中跟踪审查的含义、类别、内容和形式的阐述,以及对跟踪审查意义的探讨和研究,结合我国近年来伦理委员会跟踪审查的难点进行分析。在建立伦理委员会的监管机制,完善跟踪审查操作规程,加强对伦理委员会委员及研究者的继续教育和培训,完善伦理审查信息管理几方面提出切实可行的建议。     

国内多中心临床试验的中心伦理审查模式初探

随着现代生物医学的快速发展,多中心合作开展临床试验已成为国际主流趋势。由于我国相关法规欠缺,伦理委员会注册管理制度缺位,监督管理力度薄弱,多中心临床试验的伦理审查面临诸多问题:审查效率低下,审查质量无法评估,各临床试验机构受试者的安全及权益保护工作未能得到有力保障。多中心临床试验的伦理审查,需要机构伦理委员会之间加强沟通与配合,可在选择一家中心伦理委员会的基础上,建立协作审查模式,中心伦理委员会负责审查该多中心临床试验方案的科学性及伦理合理性,参加单位伦理委员会利用地缘优势审查该临床试验方案在本中心的可行性。     

Extremes of self-esteem and narcissism and the experience and expression of anger and aggression

This study examined the level of self-esteem and narcissism as personality variables involved in the disposition to experience and express anger. Three hundred thirty-eight subjects were sampled across two higher education centres and one student teaching programme in the United Kingdom. It was reasoned that individuals with both high self-esteem and narcissism would report especially high tendencies to experience and express anger and aggression and that those with high self-esteem and low narcissism would report the lowest. These predictions were influenced by theories that emphasise the role of threats to high self-esteem in the production of aggression and violence. Results indicate that groups defined by their extreme scores on self-esteem and narcissism scales produced levels of anger expression in the predicted direction. The importance of considering extreme levels of self-esteem and narcissism (in conjunction with other factors) in an analysis of anger is discussed with reference to currently influential theories in the field. Aggr. Behav. 24:421–438, 1998. © 1998 Wiley-Liss, Inc.     

Social and Personal Determinants of Adolescent Use and Abuse of Alcohol and Marijuana

This article summarizes research on social and personal determinants of adolescent use and abuse of alcohol and marijuana to aid practitioners when designing interventions.     

Cognitive and Personality Characteristics of Masculinity and Femininity Predict Wayfinding Competence and Strategies of Men and Women

Bem (1974) reconceptualized masculinity and femininity as independent and orthogonal constructs that both men and women possess to varying degrees. This perspective was used as a starting point to investigate whether the contributions of gender-typed characteristics can help to account for commonly observed gender differences in wayfinding (the ability to identify one’s current location and successfully navigate to an unseen location in the environment) favoring men. We further divided gender-typed characteristics into cognitive and personality characteristics to assess their separate influence on wayfinding and explored whether gender-typed characteristics predicted self-reported use of masculine wayfinding strategies (i.e., orientation strategies) and self-reported wayfinding competence. Participants were 452 college women and men in a southern U.S. public university. They completed the Gender-Stereotypic Characteristics questionnaire (Diekman and Eagly 2000), a social comparison questionnaire (created by the authors), a wayfinding strategy questionnaire (Lawton 1994), and a wayfinding competence questionnaire (Hegarty et al. 2002). For both men and women, higher masculine cognitive characteristics significantly correlated with greater use of orientation wayfinding strategies typical of men. For men, both higher masculine and feminine cognitive characteristics predicted better overall wayfinding competence whereas for women, only higher masculine cognitive characteristics predicted better overall wayfinding competence. For both men and women, higher feminine personality characteristics predicted poorer wayfinding competence. These results demonstrated the importance of considering cognitive and personality characteristics of masculinity and femininity in explaining individual differences in wayfinding.     

Self-ratings of positive and negative affect and retrieval of positive and negative affect memories

Abstract

Based on analysis of self-ratings of mood, positive affect (PA) and negative affect (NA) have been proposed as basic, orthogonal mood dimensions (Watson & Tellegen, 1985). The present study asked subjects (N = 61) to not only provide self-ratings of PA and NA terms but also to retrieve personal memories associated with those terms. Self-rated PA was associated with latency to retrieve PA- but not NA-related memories; self-rated NA was associated with latency to retrieve NA- but not PA-related memories. Self-ratings of PA and NA were not significantly correlated, nor were retrieval latencies for PA and NA memories. Individual item correlations also revealed a strong direct relationship between self-ratings and retrieval latency. The dissociations involving a non-self report measure strengthen the distinction between PA and NA, and the individual item correlations are interpreted as showing that self-ratings of affect are based upon the ease of retrieval of personal memories.