资源描述
,单击此处编辑母版标题样式,*,*,*,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,小区征询：,COMMUNITY CONSULTATION:,以小区为基础,HIV,研究经验总结：,适合中国吗？,LESSONS LEARNED IN HIV COMMUNITY-BASED RESEARCH:RELEVANCE FOR CHINA?,Ronald P.Strauss,D.M.D.,Ph.D.,University of North Carolina at Chapel Hill,1,第1页,第1页,在过去70年中,生物医学研究伦理学领域已经成为社会关注中心,The realms of biomedical research ethics have been a central societal concern during the past 70 years.,两个主要历史事件：2,main historical events:,1.,纳粹医学试验,Nazi Medial Experimentation,2.Tuskegee,梅毒研究,Tuskegee Syphilis Study,2,第2页,第2页,研究历史,History of Research Activism,艾滋病研究在20世纪80年代开始，这种耽搁产生许多社会所关注问题,AIDS research began slowly in the 1980s and the delay produced much concern,同性恋小区活动分子带头挑战研究优先权和研究进度,Activists from the Gay community lead in challenging research priorities and the pace of research,活动组织有争议活动造成在,HIV/AIDS,研究京进行小区征询,Activist organizations controversial efforts resulted in including community consultation in HIV/AIDS research,.,近些年，诸多研究课题都使用社会顾问,In recent years community advisors have been included in a wide range of research projects.,3,第3页,第3页,小区与科学家结累计划（,LinCS),Lin,king,C,ommunities and,S,cientists,LinCS,项目旨在理解与科学家和小区相联系社会和伦理学问题,Project LinCS was launched to investigate the social and ethical issues in linking scientists and communities.,由,CDC,和,NIAID,共同资助,Funded jointly by CDC and NIAID,三所大学,：,3,Universities:,北卡大学,UNC-Chapel Hill,宾州大学,U of Penn,旧金山加州大学,USF,4,第4页,第4页,目的1：,Goal 1,:,理解小区如何结识生物医学研究，做什么能够提升小区对科学、科研机构及科技工作者信任度,To understand how communities perceive biomedical research and what can be done to improve community trust in science,scientific institutions and scientists.,5,第5页,第5页,目的2,：,Goal 2,:,找出能够增进生物医学研究组织及其寻求合作小区之间合作原因,To identify factors that facilitate collaboration between biomedical research establishments and the communities they seek to work with.,6,第6页,第6页,焦点：,Focus,:,小区如何能够真正参与,HIV,疫苗临床试验中？,How Communities Can be,Meaningfully Involved in,HIV Clinical Efficacy,Trials,7,第7页,第7页,CAB,是什么？,What is a CAB?,“小区顾问委员会,”,Community Advisory Board,小区组员,Community members,研究中也许参与者代表,Representing potential participants in research,有研究课题方面知识,Educated about the project,小区组员中提倡者,Advocates for community members,研究和合作者,Research collaborators,8,第8页,第8页,小区参与：,Community Involvement:,小区顾问委员会,(CAB),作为伙伴进行以小区为基础研究设计,Community-based research design in partnership with Community Advisory Boards(CAB,),明确地将研究对象纳入研究设计实行中,Explicitly incorporate subjects of research into the design and,conduct of the,research,.,9,第9页,第9页,较大疑问：,Larger Questions,:,如何建立大学和小区之间合作关系？,How do you construct university-community partnerships?,如何界定小区？,How do you define community?,小区代言人是谁？,Who speaks for the community?,CABs,小区作用是什么？,What is the role of CABs?,谁控制研究？办法学？结果？,Who controls the research?The methodology?The results?,如何建立信任？,How do you build trust?,为确保伦理、敏感性研究需要做什么承诺？,What promises need to be made to assure ethical,sensitive research?,10,第10页,第10页,进行过程中提出主要问题：,Major questions were raised in the process:,1.,生物医学研究始终是有益吗？,Is biomedical research always positive?,2.,研究中不抱负结果如何处理？,How should poor outcomes of research be managed?,3.,生物医学研究应当受到控制吗？如何控制？行为准则是什么？,Should biomedical research be controlled?How?Codes of conduct?,4.,如何真正达到知情同意？,How can truly informed consent be achieved?,5.,科学家伦理选择价值原则是什么？环境？法规？宗教？,What values guide the ethical choices of scientists?Situational?Principles?Religious?,6.,科学家利用和尊重小区意见吗？,Do scientists utilize and respect community input?,11,第11页,第11页,经验总结：,Lessons Learned,:,使小区参与到研究中来,Getting the Community Involved in Research,.,12,第12页,第12页,小区最主要,Community Comes First,1.在研究开始之前，研究人员必须与小区沟通并建立信任,Before the research begins,researchers must build trust and communication with the community.,2.,科学家在申请资金前应想到向小区征询,Scientists should think about community consultation before writing their grant.,13,第13页,第13页,3.,调查者有利益冲突时，应向小区和伦理审查委员会阐明和提供相应依据.,Con,flicts of interest for investigators should be declared and made evident to the community and review boards,4.,健康和其它危险原因教育必须贯穿所有研究始终,Health and other risk factor education must be part of all HIV-related research,5.,调查人员必须注意，参与者没有由于参与研究而进行更危险行为,Investigators must be careful that participants dont engage in more risky behavior because of being in a study,6.,并且他们必须小心,“,治疗误解,”,And they must be careful about the“therapeutic,misconception”,14,第14页,第14页,紧张：,Concerns:,临床试验中抚慰剂理解,Perceptions of placebos in clinical trials,2.,知情同意，读写能力，理解力，文化敏感性，考虑时间,Informed consent,literacy,understanding,being sensitive to cultural values,having time to think,3.,边沿化和被剥夺权利小区,Marginalized and disenfranchised communities,4.,不信任政府和公共卫生研究人员,Distrust of government and public health researchers,5.,研究控制/,C,AB,作用,Control of the research/role of the CAB,15,第15页,第15页,HIV,特有问题：,HIV Specific Issues:,羞耻和恐惊,Stigma and fear,研究过程中,HIV,传播,HIV transmission during research,HIV,测试-隐私,HIV testing Privacy,16,第16页,第16页,小区顾问能够：,Community Advisors Can:,1.,有助于知情同意,facilitate informed consent,2.,对研究人员提出忠告,advise researchers,3.,调查表格和问卷预试,pretest forms/questionnaires,4.,指导招募,guide recruitment,5.,监督开展研究,monitor conduct of research,6.,分析研究结果,analyze findings
展开阅读全文