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1、1,社区咨询： COMMUNITY CONSULTATION: 以社区为基础的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,2,在过去的70年中,生物医学研究的伦理学领域已经成为社会关注的中心 The realms of biomedical research ethics have been a central
2、 societal concern during the past 70 years. 两个主要的历史事件：2 main historical events: 1. 纳粹医学试验 Nazi Medial Experimentation 2. Tuskegee 梅毒研究 Tuskegee Syphilis Study,3,研究的历史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的问题 AIDS research began slowly in the 1980s and the delay produced much con
3、cern 同性恋社区的活动分子带头挑战研究的优先权和研究进度 Activists from the Gay community lead in challenging research priorities and the pace of research 活动组织有争议的活动导致在HIV/AIDS研究京进行社区咨询 Activist organizations controversial efforts resulted in including community consultation in HIV/AIDS research. 近些年，很多研究课题都使用社会顾问 In recent
4、years community advisors have been included in a wide range of research projects.,4,社区与科学家结合计划（ LinCS) Linking Communities and Scientists LinCS项目旨在了解与科学家和社区相联系的社会和伦理学问题 Project LinCS was launched to investigate the social and ethical issues in linking scientists and communities. 由CDC和NIAID共同资助 Funde
5、d 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,5,目标1：Goal 1: 了解社区怎样认识生物医学研究，做什么可以提高社区对科学、科研机构及科技工作者的信任度 To understand how communities perceive biomedical research and what can be done to improve community trust in science, scientific institutions and sci
6、entists.,6,目标2：Goal 2: 找出能够促进生物医学研究组织及其寻求合作社区之间合作的因素 To identify factors that facilitate collaboration between biomedical research establishments and the communities they seek to work with.,7,焦点：Focus: 社区怎样能够真正参与HIV疫苗临床试验中？ How Communities Can be Meaningfully Involved in HIV Clinical Efficacy Trials
7、,8,CAB是什么？ What is a CAB?,“社区顾问委员会” Community Advisory Board 社区成员Community members 研究中可能参与者的代表 Representing potential participants in research 有研究课题方面的知识Educated about the project 社区成员中的倡导者Advocates for community members 研究和合作者Research collaborators,9,社区的参与：Community Involvement: 社区顾问委员会(CAB)作为伙伴进行以
8、社区为基础的研究设计 Community-based research design in partnership with Community Advisory Boards (CAB) 明确地将研究对象纳入研究的设计实施中 Explicitly incorporate subjects of research into the design and conduct of the research.,10,较大的疑问：Larger Questions: 怎样建立大学和社区之间的合作关系？How do you construct university-community partnership
9、s? 怎样界定社区？How do you define community? 社区的代言人是谁？Who speaks for the community? CABs 社区的作用是什么？What is the role of CABs? 谁控制研究？方法学？结果？Who controls the research? The methodology? The results? 怎样建立信任？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 res
10、earch?,11,进行过程中提出的主要问题：Major questions were raised in the process: 1. 生物医学研究始终是有益的吗？Is biomedical research always positive? 2. 研究中不理想的结果如何处理？How should poor outcomes of research be managed? 3. 生物医学研究应该受到控制吗？怎样控制？行为准则是什么？Should biomedical research be controlled? How? Codes of conduct? 4. 怎样真正达到知情同意？H
11、ow can truly informed consent be achieved? 5. 科学家伦理选择的价值标准是什么？环境？法规？宗教？What values guide the ethical choices of scientists? Situational? Principles? Religious? 6. 科学家利用和尊重社区的意见吗？Do scientists utilize and respect community input?,12,经验总结：Lessons Learned : 使社区参与到研究中来 Getting the Community Involved in
12、Research.,13,社区最重要 Community Comes First,1. 在研究开始之前，研究人员必须与社区沟通并建立信任 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社区咨询 Scientists should think about community consultation before writing their grant.,14,3. 调查者有利益冲突时，应向社区和伦理审查委员会说明和提供相
13、应依据. Conflicts of interest for investigators should be declared and made evident to the community and review boards 4. 健康和其他危险因素教育必须贯穿所有研究的始终 Health and other risk factor education must be part of all HIV-related research 5. 调查人员必须注意，参与者没有因为参加研究而进行更危险的行为 Investigators must be careful that participan
14、ts 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”,15,担心：Concerns: 临床试验中安慰剂的理解 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 sensi
15、tive to cultural values, having time to think 3. 边缘化的和被剥夺权利的社区 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/ CAB的作用 Control of the research/ role of the CAB,16,HIV 特有问题：HIV Specific Issues: 羞耻和恐惧 Stigma and fear 研究过程中的HIV
16、传播 HIV transmission during research HIV测试- 隐私 HIV testing Privacy,17,社区顾问能够：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 findi
17、ngs 7. 发布结果 disseminate results,18,社区顾问问题：Community Advisor Issues: 1. 自治和权威 autonomy and authority 2. 他们只是为“展示”吗？ Are they just “for show”? 3. 资源/时间 resources/time 4. 领导阶层 leadership 5. 机构 organization 6. 报酬和鼓励 payment and incentives,19,社区顾问的目的 CommunityAdvisor Goals: 1. 说明医生/病人与调查者/调查对象之间的相似与不同Cla
18、rify the similarity and difference between Doctor/Patient relationships and Investigator/Subject relationships. 2. 保证在研究过程中感染HIV的人得到治疗 Assure treatment for people who become HIV+ during the research. 3.确定未来研究产出的使用以及研究结束后社区可以使用这些产出 Determine future use of research products and community access to pro
19、ducts after the research concludes. 4. 使参与者了解全部的情况 Promise full-disclosure to participants,20,社区顾问目标 (续） Community Advisor Goals (continued) 5. 澄清利益/资助冲突-公司，政府，大学 Clarify conflicts of interest/funding corporate, government, university 6. 改善地方关怀和医疗卫生机构水平 Improve the local standard of care and health
20、care infrastructure. 7. 接受随机临床试验的教育-包括早期效果、资料安全管理、试验的完成 Become educated about randomized clinical trials Early efficacy, Data safety management, Trial completion,21,LINCS 计划 CAB 发展： PROJECT LINCS CAB Developed: 有关研究应该问什么？ WHAT QUESTIONS SHOULD YOU ASK ABOUT RESEARCH STUDIES? 你可以询问以下任一个你或你的家人或研究社区要问的
21、问题 You could ask the following questions of anyone who wants you or members of your family or community to be part of a research study,22,“该研究的目的是什么？ ” “What is the study about? 1. 为什么要做这项研究？ Why are you doing this study? 2. 为什么要研究我或像我一样的人？谁还会被研究？Why do you want to study me or people like me? Who el
22、se is being studied? 3. 从此项研究中想得到什么？结果做什么用？ What do you want to get out of this study? What will you do with the results? 4. 之前你做过其它或此类研究吗？围绕这一领域？你学会什么？Have you or others done this type of study ever before? Around here? What did you learn?,23,“谁执行该研究？”“Who put this study together?” 1. 谁管理或对研究负责？ Wh
23、o is running or in charge of this study? 2. 该研究是谁的意见？Whose idea was this study? 3. 像我这样的人如何共同参与？How were people like me part of putting it together? 4. 谁是研究人员？是医生或科学家吗？他们的单位性质？Who are the researchers? Are they doctors or scientists? Who do they work for? 5. 他们以前做过这类研究吗？Have they done studies like th
24、is before? 6. 政府参与该研究吗？谁还参与了此项研究？ Is the government part of this study? Who else is a part of this study? 7. 谁资助该研究？Who is paying for this study? 8. 谁会从研究结果中得到经济利益？Who will make money from the results of this study?,24,“在研究中像我这样的人怎样相互交流思想？” “How can people like me share their ideas as you do this st
25、udy?” 怎样在我的社区进行研究说明？ How will the study be explained in my community? 2. 在研究开始前，我们找谁？ Who of people like me will look at this study before it starts? 3. 在研究中，我们与谁谈话？Who of people like me are you talking to as you do this study? A Community Advisory Board? 4. 在研究中我们向谁表达意见，提问或抱怨？Who from the study can
26、 I go to with ideas, questions or complaints? 5. 我们如何知道研究的进展？ How will people like me find out about how the study is going?,25,“谁参加研究” “Who is going to be in this study?” 1. 需要怎样的人？为什么？What kinds of people are you looking for? Why? 2. 研究中是否需要少数民族？Are you trying to get minorities in this study? 3. 需
27、要18岁以下的人吗？Are you including people less than 18 years old? 4. 怎样为研究找人？How are you finding people for this study? 5. 研究中是否给提供交通和/或日常关怀？ Is transportation and/or daycare provided for people in this study? 6. 参与是否需要签字？Do I need to sign to participate? 7. 在我签署知情同意书之前能回答我全部问题吗？Will you answer all of my q
28、uestions before I sign the consent form? 8. 在签署知情同意书后我是否可以退出研究？如果退出研究，我会怎样？Can I quit the study after signing the consent form? If I quit the study, will anything happen to me?,26,“从此研究中我会得到什么？”“What will I get out of this study?” 1. 利益是什么？What are the benefits? 2. 包括报酬吗？怎样得到报酬？ Is payment involved?
29、 How will I be paid? 3. 如果参与会得到免费的健康检查或其他服务吗？多久？Will I get free health care or other services if I participate? For how long? 4. 如果我参与会得到常规的健康和/或心理关怀吗？多久？Will I get general health care and/or psychological care if I participate? For how long?,27,“我怎样在伤害中受到保护？”“How will I be protected from harm?” 1.
30、在研究中我受伤害的可能多大？将来会怎样？How do I stand a chance of being harmed in this study? In the future? 2. 该研究会使我免受各种伤害吗？ Does the study protect me from all types of harm? 3. 如果我受到伤害，谁会照顾我？谁负责？ If I get harmed, who will take care of me? Who is responsible? 4. 如果我在任何情况下受到伤害都会得到需要的待遇吗？谁来支付费用？If I get harmed in any
31、way will I get all needed treatment? Who pays for treatment?,28,“我的隐私会受到怎样保护”“How will my privacy be protected?” 1. 谁会看我的资料？ Who is going to see the information I give? 2. 我的名字会在资料中使用吗？Will my name be used with the information? 3. 如果我退出研究我的资料怎么办？ What happens to the information I gave if I quit the
32、study? 4. 有隐私保密的书面保证吗？ Is there a written guarantee of privacy?,29,“在该研究中我必须做什么？” “What do I have to do in this study?” 1. 何时开始这项研究？持续多久？ When did you start this study? How long will it last? 2. 该研究的经费已解决多少？ How much of this study have you already done? 3. 到目前为止还有问题吗？ Have there been any problems so
33、 far? 4. 我会得到与其他人同样的对待吗？ Will I get treated the same as everyone else? 5. 在该研究中有什么与众不同要求？这是真和假的治疗吗？What kinds of different treatments are offered in this study? Is there a real and a fake treatment?,30,“研究结束后会有什么遗留下来” “What will be left behind after the study is over?” 1. 得到信息的人员会怎样？怎样保持？What will h
34、appen to the information people give? How will it be kept? 2.研究结果将做什么？What are you going to do with the results of the study? 3. 公众如何了解结果？结果会放在公众可以看到的地方吗？How will the public learn about the results? Will results be in places where the public can see them? 4. 你们会寄给我们结果的副件吗？什么时候？Are you going to send me a copy of the results? When? 5. 在这里还要进行什么研究？What other studies are you planning to do here?,31,提 问 Questions,