以社區(qū)為基礎(chǔ)hiv研究經(jīng)驗(yàn)總結(jié)適合

1、1,社區(qū)咨詢：COMMUNITY CONSULTATION:以社區(qū)為基礎(chǔ)的HIV研究經(jīng)驗(yàn)總結(jié)：適合中國嗎？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,在過去的70年中,生物醫(yī)學(xué)

2、研究的倫理學(xué)領(lǐng)域已經(jīng)成為社會關(guān)注的中心The realms of biomedical research ethics have been a central societal concern during the past 70 years. 兩個主要的歷史事件：2 main historical events: 1. 納粹醫(yī)學(xué)試驗(yàn) Nazi Medial Experimentation

3、0;2. Tuskegee 梅毒研究 Tuskegee Syphilis Study,研究的歷史History of Research Activism,艾滋病研究在20世紀(jì)80年代開始，這種耽擱產(chǎn)生許多社會所關(guān)注的問題 AIDS research began slowly in the 1980’s and the delay produced much concern同性戀社區(qū)的活動分子帶頭挑戰(zhàn)研究的優(yōu)

4、先權(quán)和研究進(jìn)度 Activists from the Gay community lead in challenging research priorities and the pace of research活動組織有爭議的活動導(dǎo)致在HIV/AIDS研究京進(jìn)行社區(qū)咨詢 Activist organization’s controversial efforts resulted in including community

5、consultation in HIV/AIDS research.近些年，很多研究課題都使用社會顧問 In recent years community advisors have been included in a wide range of research projects.,3,4,社區(qū)與科學(xué)家結(jié)合計(jì)劃（ LinCS) Linking Communities and Scientists LinCS項(xiàng)目旨在了解與科

6、學(xué)家和社區(qū)相聯(lián)系的社會和倫理學(xué)問題 Project LinCS was launched to investigate the social and ethical issues in linking scientists and communities.由CDC和NIAID共同資助 Funded jointly by CDC and NIAID三所大學(xué)：3 Universities:,北卡大學(xué)UNC-Chapel Hill,

7、賓州大學(xué)U of Penn,舊金山加州大學(xué)USF,,,,,,,,,5,目標(biāo)1：Goal 1: 了解社區(qū)怎樣認(rèn)識生物醫(yī)學(xué)研究，做什么可以提高社區(qū)對科學(xué)、科研機(jī)構(gòu)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

8、 institutions and scientists.,6,目標(biāo)2：Goal 2: 找出能夠促進(jìn)生物醫(yī)學(xué)研究組織及其尋求合作社區(qū)之間合作的因素To identify factors that facilitate collaboration between biomedical research establishments and the communities they seek to work with.,7,焦點(diǎn)：Foc

9、us: 社區(qū)怎樣能夠真正參與HIV疫苗臨床試驗(yàn)中？ How Communities Can beMeaningfully Involved inHIV Clinical Efficacy Trials,CAB是什么？ What is a CAB?,“社區(qū)顧問委員會” Community Advisory Board社區(qū)成員Community members研究中可能參與者的代表 Representing potential

10、 participants in research有研究課題方面的知識Educated about the project社區(qū)成員中的倡導(dǎo)者Advocates for community members研究和合作者Research collaborators,8,9,社區(qū)的參與：Community Involvement:· 社區(qū)顧問委員會(CAB)作為伙伴進(jìn)行以社區(qū)為基礎(chǔ)的研究設(shè)計(jì) Community-ba

11、sed research design in partnership with Community Advisory Boards (CAB)· 明確地將研究對象納入研究的設(shè)計(jì)實(shí)施中 Explicitly incorporate subjects of research into the design and conduct of the research.,10,較大的疑問：Larger Questions

12、:· 怎樣建立大學(xué)和社區(qū)之間的合作關(guān)系？How do you construct university-community partnerships?· 怎樣界定社區(qū)？How do you define community?· 社區(qū)的代言人是誰？Who speaks for the community?·  CABs 社區(qū)的作用

13、是什么？What is the role of CABs?· 誰控制研究？方法學(xué)？結(jié)果？Who controls the research? The methodology? The results?· 怎樣建立信任？How do you build trust?· 為確保倫理、敏感性研究需要做什

14、么承諾？What promises need to be made to assure ethical, sensitive research?,11,進(jìn)行過程中提出的主要問題：Major questions were raised in the process:1. 生物醫(yī)學(xué)研究始終是有益的嗎？Is biomedical research always positive? 2. 研究中不理想的結(jié)果如何處理？Ho

15、w should poor outcomes of research be managed?3. 生物醫(yī)學(xué)研究應(yīng)該受到控制嗎？怎樣控制？行為準(zhǔn)則是什么？Should biomedical research be controlled? How? Codes of conduct?4. 怎樣真正達(dá)到知情同意？How can truly informed consent be achieved?5. 科學(xué)

16、家倫理選擇的價值標(biāo)準(zhǔn)是什么？環(huán)境？法規(guī)？宗教？What values guide the ethical choices of scientists? Situational? Principles? Religious? 6. 科學(xué)家利用和尊重社區(qū)的意見嗎？Do scientists utilize and respect community input?,12,經(jīng)驗(yàn)總結(jié)：Lessons Learned : 使社區(qū)參與

17、到研究中來Getting the Community Involved in Research.,社區(qū)最重要 Community Comes First,1. 在研究開始之前，研究人員必須與社區(qū)溝通并建立信任 Before the research begins, researchers must build trust and communication with the community.2. 科學(xué)家在申請資金前應(yīng)想到

18、向社區(qū)咨詢 Scientists should think about community consultation before writing their grant.,13,14,3. 調(diào)查者有利益沖突時，應(yīng)向社區(qū)和倫理審查委員會說明和提供相應(yīng)依據(jù).Conflicts of interest for investigators should be declared and made evident to the communi

19、ty and review boards4. 健康和其他危險(xiǎn)因素教育必須貫穿所有研究的始終 Health and other risk factor education must be part of all HIV-related research5. 調(diào)查人員必須注意，參與者沒有因?yàn)閰⒓友芯慷M(jìn)行更危險(xiǎn)的行為 Investigators must be careful that participants don’t engage

20、 in more risky behavior because of being in a study6. 并且他們必須小心“治療誤解”And they must be careful about the “therapeutic misconception”,15,,擔(dān)心：Concerns:臨床試驗(yàn)中安慰劑的理解 Perceptions of placebos in clinical trials2. 知

21、情同意，讀寫能力，理解力，文化敏感性，考慮時間 Informed consent, literacy, understanding, being sensitive to cultural values, having time to think3. 邊緣化的和被剝奪權(quán)利的社區(qū) Marginalized and disenfranchised communities4. 不信任政府和公共衛(wèi)生研究人員 Distrust of gove

22、rnment and public health researchers5. 研究控制/ CAB的作用 Control of the research/ role of the CAB,16,HIV 特有問題：HIV Specific Issues:· 羞恥和恐懼 Stigma and fear 研究過程中的HIV傳播   HIV transmission during research&#

23、183;  HIV測試- 隱私 HIV testing – Privacy,17,社區(qū)顧問能夠：Community Advisors Can:1. 有助于知情同意 facilitate informed consent2. 對研究人員提出忠告 advise researchers3. 調(diào)查表格和問卷預(yù)試 pretest forms/questionnaires4. 指導(dǎo)招募 guide recruitment

24、5. 監(jiān)督開展研究 monitor conduct of research6. 分析研究結(jié)果 analyze findings7. 發(fā)布結(jié)果 disseminate results,18,社區(qū)顧問問題：Community Advisor Issues:1. 自治和權(quán)威 autonomy and authority2. 他們只是為“展示”嗎？ Are they just “for show”?3. 資源/時間 reso

25、urces/time4. 領(lǐng)導(dǎo)階層 leadership5. 機(jī)構(gòu) organization6. 報(bào)酬和鼓勵 payment and incentives,19,社區(qū)顧問的目的 CommunityAdvisor Goals:1. 說明醫(yī)生/病人與調(diào)查者/調(diào)查對象之間的相似與不同Clarify the similarity and difference between Doctor/Patient relationships an

26、d Investigator/Subject relationships.2. 保證在研究過程中感染HIV的人得到治療 Assure treatment for people who become HIV+ during the research.3.確定未來研究產(chǎn)出的使用以及研究結(jié)束后社區(qū)可以使用這些產(chǎn)出 Determine future use of research products and community access

27、to products after the research concludes.4. 使參與者了解全部的情況 Promise full-disclosure to participants,20,社區(qū)顧問目標(biāo) (續(xù)） Community Advisor Goals (continued) 5. 澄清利益/資助沖突-公司，政府，大學(xué) Clarify confl

28、icts of interest/funding – corporate, government, university 6. 改善地方關(guān)懷和醫(yī)療衛(wèi)生機(jī)構(gòu)水平 Improve the local standard of care and health care infrastructure.7. 接受隨機(jī)臨床試驗(yàn)的教育-包括早期效果、資料安全管理、試驗(yàn)的完成 Become educated about randomized cl

29、inical trials – Early efficacy, Data safety management, Trial completion,21,LINCS 計(jì)劃 CAB 發(fā)展： PROJECT LINCS CAB Developed: 有關(guān)研究應(yīng)該問什么？WHAT QUESTIONS SHOULD YOU ASK ABOUT RESEARCH STUDIES?

30、你可以詢問以下任一個你或你的家人或研究社區(qū)要問的問題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,“該研究的目的是什么？ ” “What is the study about?1.   為什

31、么要做這項(xiàng)研究？Why are you doing this study? 2.   為什么要研究我或像我一樣的人？誰還會被研究？Why do you want to study me or people like me? Who else is being studied?3.   從此項(xiàng)研究中想得到什么？結(jié)果做什么用？ What do you want to get out of thi

32、s study? What will you do with the results?4.   之前你做過其它或此類研究嗎？圍繞這一領(lǐng)域？你學(xué)會什么？Have you or others done this type of study ever before? Around here? What did you learn?,23,“誰執(zhí)行該研究？”“Who put this study together?”

33、1.   誰管理或?qū)ρ芯控?fù)責(zé)？ Who is running or in charge of this study?2.   該研究是誰的意見？Whose idea was this study?3.   像我這樣的人如何共同參與？How were people like me part of putting it together? 4.   誰是研

34、究人員？是醫(yī)生或科學(xué)家嗎？他們的單位性質(zhì)？Who are the researchers? Are they doctors or scientists? Who do they work for?5.   他們以前做過這類研究嗎？Have they done studies like this before?6.   政府參與該研究嗎？誰還參與了此項(xiàng)研究？ Is the govern

35、ment part of this study? Who else is a part of this study?7.   誰資助該研究？Who is paying for this study?8.   誰會從研究結(jié)果中得到經(jīng)濟(jì)利益？Who will make money from the results of this study?,24,“在研究中像我這樣的人怎樣相互交流思想？”“H

36、ow can people like me share their ideas as you do this study?”怎樣在我的社區(qū)進(jìn)行研究說明？ How will the study be explained in my community?2. 在研究開始前，我們找誰？ Who of people like me will look a

37、t this study before it starts? 3. 在研究中，我們與誰談話？Who of people like me are you talking to as you do this study? A Community Advisory Board?4. 在研究中我們向誰表達(dá)意見，提問或抱怨？Who from the study can I go to with ideas, questio

38、ns or complaints? 5. 我們?nèi)绾沃姥芯康倪M(jìn)展？ How will people like me find out about how the study is going?,25,“誰參加研究” “Who is going to be in this study?”1.   需要怎樣的人？為什么？What kinds of people are you looking for

39、? Why?2.   研究中是否需要少數(shù)民族？Are you trying to get minorities in this study?3.   需要18歲以下的人嗎？Are you including people less than 18 years old? 4.   怎樣為研究找人？How are you finding people for this stu

40、dy?5.   研究中是否給提供交通和/或日常關(guān)懷？ Is transportation and/or daycare provided for people in this study?6.   參與是否需要簽字？Do I need to sign to participate?7.   在我簽署知情同意書之前能回答我全部問題嗎？Will you answer all

41、 of my questions before I sign the consent form?8.   在簽署知情同意書后我是否可以退出研究？如果退出研究，我會怎樣？Can I quit the study after signing the consent form? If I quit the study, will anything happen to me?,26,“從此研究中我會得到什么？”“What

42、will I get out of this study?”1.   利益是什么？What are the benefits?2.  包括報(bào)酬嗎？怎樣得到報(bào)酬？ Is payment involved? How will I be paid?3.   如果參與會得到免費(fèi)的健康檢查或其他服務(wù)嗎？

43、多久？Will I get free health care or other services if I participate? For how long?4.   如果我參與會得到常規(guī)的健康和/或心理關(guān)懷嗎？多久？Will I get general health care and/or psychological care if I participate? For how long?,27,“我怎樣在

44、傷害中受到保護(hù)？”“How will I be protected from harm?”1. 在研究中我受傷害的可能多大？將來會怎樣？How do I stand a chance of being harmed in this study? In the future? 2. 該研究會使我免受各種傷害嗎？ Does the study protect me from all types of harm? 3.

45、 如果我受到傷害，誰會照顧我？誰負(fù)責(zé)？ If I get harmed, who will take care of me? Who is responsible?4. 如果我在任何情況下受到傷害都會得到需要的待遇嗎？誰來支付費(fèi)用？If I get harmed in any way will I get all needed treatment? Who pays for treatment?,28,“我

46、的隱私會受到怎樣保護(hù)”“How will my privacy be protected?”1. 誰會看我的資料？ Who is going to see the information I give?2. 我的名字會在資料中使用嗎？Will my name be used with the information?3. 如果我退出研究我的資料怎么辦？ What happens to

47、the information I gave if I quit the study?4. 有隱私保密的書面保證嗎？ Is there a written guarantee of privacy?,29,“在該研究中我必須做什么？”“What do I have to do in this study?”1. 何時開始這項(xiàng)研究？持續(xù)多久？ When did y

48、ou start this study? How long will it last?2. 該研究的經(jīng)費(fèi)已解決多少？ How much of this study have you already done?3. 到目前為止還有問題嗎？Have there been any problems so far?4. 我會得到與其他人同

49、樣的對待嗎？ Will I get treated the same as everyone else?5. 在該研究中有什么與眾不同要求？這是真和假的治療嗎？What kinds of different treatments are offered in this study? Is there a real and a fake treatment?,30

50、,“研究結(jié)束后會有什么遺留下來”“What will be left behind after the study is over?”1. 得到信息的人員會怎樣？怎樣保持？What will happen to the information people give? How will it be kept?2.研究結(jié)果將做什么？What are you going to do with the results of the st

51、udy? 3. 公眾如何了解結(jié)果？結(jié)果會放在公眾可以看到的地方嗎？How will the public learn about the results? Will results be in places where the public can see them?4. 你們會寄給我們結(jié)果的副件嗎？什么時候？Are you going to send me a copy of the results? When?5.&