2013年10月29日倫理培訓(xùn)與討論.ppt-無錫市人民醫(yī)院

1、“知情同意書審查”和“倫理學(xué)新觀點(diǎn)”,無錫市人民醫(yī)院倫理委員會(huì) 時(shí)間： 2013年10月29日16:00,要點(diǎn),一、知情同意書審查 J Karbwang SIDCER 協(xié)調(diào)員二、 涉及人的研究的倫理學(xué)新觀點(diǎn)Daniel Wikler, Ph.D.哈佛公共衛(wèi)生學(xué)院教授,一、知情同意書審查,J Karbwang SIDCER 協(xié)調(diào)員,如何審查知情同意書,1.

2、Step1: 審查知情同意過程：誰？何時(shí)？哪里？怎么做？2.Step2: 審查內(nèi)容是否符合指南要求？3. Step3：審查語言的可理解性4. Step4：評(píng)判知情同意是否有效,Step1:知情同意過程,誰？ 合適的人選，例如沒有不正當(dāng)?shù)挠绊憽⒚{迫什么時(shí)候? 在篩選/入組前 再次知情同意，如：急診病人，無意識(shí)病人，知情同意修改等什么地點(diǎn)？ 醫(yī)院：急診室、門診、病房 社區(qū)：學(xué)校、家庭、村莊等,知情同

3、意過程：怎樣進(jìn)行？,足夠的時(shí)間寬敞的環(huán)境ICF和招募廣告中簡單充分的信息法定代理人、弱勢(shì)群體贊同，弱勢(shì)群體需要口頭同意文盲受試者需要見證人,Step2 內(nèi)容：指南要求的審查內(nèi)容,總體：研究/試驗(yàn)背景；資料保密；誰能接觸受試者的信息；受試者責(zé)任；聯(lián)系人科學(xué)性：試驗(yàn)?zāi)康暮褪茉囌呷脒x條件；研究期限；樣本量；隨機(jī)分組情況；研究過程；備選方案及過程自愿參加：可以拒絕參加；有退出權(quán)利；及時(shí)獲取新信息權(quán)利，這些新信息決定受試者是否繼續(xù)參與

4、研究,Step3:知情同意書的語言,非專業(yè)性用語：通俗易懂簡潔：以簡潔的語言恰到好處抓到重點(diǎn)考慮當(dāng)時(shí)的環(huán)境,Step4:評(píng)判知情同意書的有效性,自愿受試者的權(quán)利相關(guān)信息,知情同意書常見問題,沒有告知受試者為什么適合該研究太長，信息超負(fù)荷備選治療及過程信息不充分風(fēng)險(xiǎn)信息不充分（尤其是與受試者相關(guān)的風(fēng)險(xiǎn)）研究過程過于復(fù)雜，太多專業(yè)術(shù)語不恰當(dāng)?shù)脑囼?yàn)后獲益過度保證的語言補(bǔ)償和賠償不清晰,影響自主選擇的因素,研究結(jié)束后支付補(bǔ)

5、償補(bǔ)償金額：過高、過低家庭困難，慢性病（無備選治療）迫于壓力不當(dāng)影響（主治醫(yī)師）,改進(jìn)理解,建立一個(gè)普遍的名詞解釋制作一個(gè)本地的知情同意模板使用海報(bào)、流程圖解釋研究過程知情同意過程中使用影像資料預(yù)測(cè)知情同意工具與受試者群體進(jìn)行問答,改進(jìn)理解,病人參觀研究機(jī)構(gòu)，熟悉研究過程對(duì)病人進(jìn)行研究過程的教育培訓(xùn)研究者和工作人員如何使用知情同意書培訓(xùn)倫理委員會(huì)改進(jìn)審查知情同意書質(zhì)量咨詢社區(qū)人員改進(jìn)知情同意過程,A New P

6、erspective on the Ethics of Research with Human Subjects涉及人的研究的倫理學(xué)新觀點(diǎn),Daniel Wikler, Ph.D.,注意：PPT中的觀點(diǎn)僅代表作者自己的觀點(diǎn)，不代表哈佛公共衛(wèi)生學(xué)院的觀點(diǎn),1.The Conventional View is based on a series of fictions傳統(tǒng)觀點(diǎn)是基于一系列的杜撰,Does research ethics r

7、equire us to give the highest priority to the individual research subject? 研究倫理是否要求我們將研究受試者個(gè)體至于首位？We owe research subjects our best effort to provide the care they need, consistent with the goal of conducting research.

8、我們應(yīng)盡最大的努力向受試者提供他們需要的醫(yī)護(hù)，這與開展研究的目標(biāo)相一致。But research often requires that the interest of patients be balanced against the requirements of scientific method.但研究常要求患者的利益應(yīng)平衡與科學(xué)方法的要求。Example: the last patient enrolled in a dou

9、ble-blinded randomized clinical trial 例：隨機(jī)雙盲研究中最后一名納入的受試者,Research as an unavoidable social obligation研究是不可避免的社會(huì)責(zé)任,We all want health care that is safe and effective 我們都希望衛(wèi)生保健是安全有效的Safe and effective health care require

10、s research that in some cases may involve discomfort or moderate risk 安全有效的衛(wèi)生保健需要研究，某種情況下會(huì)有不適或中度的風(fēng)險(xiǎn)It is unfair to ask others to accept the risk so that you may benefit 要求他人承擔(dān)風(fēng)險(xiǎn)而你獲益是不公平的Analogy: the medical student’s f

11、irst spinal tap 類推：醫(yī)學(xué)生的第一次腰穿,Justice, Groups, and Individuals (1)公平，群體，個(gè)人（1）,Research ethics should require: 研究倫理應(yīng)該要求Protection from unnecessary risk 保護(hù)，以免不必要的風(fēng)險(xiǎn)Informed, voluntary consent to any necessary risk 告知必要的風(fēng)

12、險(xiǎn)，自愿同意Subjects endorse the goal of obtaining knowledge 受試者對(duì)獲得知識(shí)這個(gè)目標(biāo)表示贊同All risk to subjects must be justified by potential gains to future patients 受試者的所有風(fēng)險(xiǎn)相對(duì)于將來患者的潛在獲益是合理的Concern for subjects; humane standards; no br

13、utality 對(duì)受試者的關(guān)心，人道標(biāo)準(zhǔn)，沒有暴行,Justice, Groups, and Individuals (2): Some Principles公平，群體，個(gè)人（2）：一些原則,No one is “expendable” or less important 沒有人是“可犧牲”或不那么重要的Everyone should bear a fair share of the risks of research, and sh

14、ould receive a fair share of the benefits對(duì)每個(gè)人應(yīng)該公平分配研究風(fēng)險(xiǎn)和研究獲益Patients may be asked to endure some discomfort or moderate risk if: 患者應(yīng)該被征求承受一些不適或適度的風(fēng)險(xiǎn)，如果The research is needed to relieve significant suffering 研究是為了減輕嚴(yán)重的苦

15、痛The risk or discomfort is at most moderate 風(fēng)險(xiǎn)和不適至多是中度的All unnecessary risk has been avoided 所有不必要的風(fēng)險(xiǎn)已被避免Patients are fully informed and free to refuse 患者被充分告知并可自由地拒絕,2.Risk-Benefit Ratio 風(fēng)險(xiǎn)-獲益比,Must all risks to part

16、icipants be smaller than expected benefits to participants? 是否受試者所有的風(fēng)險(xiǎn)都應(yīng)小于受試者預(yù)期的獲益?Estimating Risk and Benefit 估算風(fēng)險(xiǎn)和獲益Determining the ethically acceptable ratio 確定倫理可接受的比例Distinguishing between: 區(qū)別在于Research that may

17、 yield benefits to future patients 研究可能對(duì)將來的患者帶來獲益Poorly designed research 設(shè)計(jì)不充分的研究Research performed chiefly for commercial purposes 研究主要是出于商業(yè)目的,Ethics Committees should:倫理委員會(huì)應(yīng)該,Protect human subjects from unnecessar

18、y, inhumane, or unreasonable risk 保護(hù)受試者免受不必要，不人道，或是不合理的風(fēng)險(xiǎn)Ensure that any risk is justified by potential benefits to future patients (note: this is an ethical judgment) 確保任何風(fēng)險(xiǎn)相對(duì)于將來患者的潛在獲益是合理的Ensure that any patients ask

19、ed to endure risk understand fully what is being asked of them and that they are free to say “no” and to withdraw at any time 確保任何一個(gè)被要求承受風(fēng)險(xiǎn)的受試者對(duì)風(fēng)險(xiǎn)充分理解并能自由地說“不”，能夠隨時(shí)退出。,Ethics committees should not…倫理委員會(huì)不應(yīng)該…,Insist that

20、in all cases, all net expected benefits to individual human subjects always outweigh expected risks. 在任何情況下堅(jiān)持對(duì)受試者個(gè)體的凈獲益必須大于預(yù)期的風(fēng)險(xiǎn)Fail to estimate potential benefits of research for future patients as well as risks to par

21、ticipants, and make an ethical judgment on whether the risk-benefit ratio is justified. 未能評(píng)估研究對(duì)未來患者可能帶來的獲益以及對(duì)受試者的風(fēng)險(xiǎn)，沒有針對(duì)該風(fēng)險(xiǎn)-獲益比進(jìn)行倫理判斷,Ethics committees should not…倫理委員會(huì)不應(yīng)該…,Judge all research the same way regardless of

22、scientific and humanitarian merit 采取同樣的方法評(píng)判所有的研究，忽視科學(xué)和人道價(jià)值Research performed for commercial purposes with little social value does not justify risks to subjects 出于商業(yè)目的的研究，且沒有什么社會(huì)價(jià)值，對(duì)受試者的風(fēng)險(xiǎn)是不正當(dāng)?shù)腁ct primarily to protect

23、their institutions from bad publicity or financial or legal difficulty. 采取行動(dòng)，首先為了保護(hù)所在機(jī)構(gòu)免受負(fù)面宣傳或財(cái)務(wù)/法律困境。,3.Declaration of Helsinki, #29:赫爾辛基宣言：#29,“ The benefits, risks, burdens and effectiveness of a new method should be

24、 tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic m

25、ethod exists.”獲益，風(fēng)險(xiǎn)，負(fù)擔(dān)和一個(gè)新方法的有效性必須與那些當(dāng)今最好的預(yù)防，診斷，治療方法進(jìn)行對(duì)照測(cè)試。這并不排除一些研究，當(dāng)沒有已被證明的預(yù)防，診斷和治療方法時(shí)，使用安慰劑或空白治療。,Three Standards of Care三種標(biāo)準(zhǔn)療法,Helsinki: All receive best current care 所有人都獲得現(xiàn)今最好的治療Helsinki alternative: 赫爾辛基替代選擇A

26、ll are offered care that is no worse than what they would have received had the study not been done 提供給所有人的治療將不差于不參加研究所獲得的治療New proposal: 新的建議All are offered care that is no worse than what they should have received h

27、ad the study not been done提供給所有人的治療應(yīng)不差于不參加研究所獲得的治療,4.Standards of Care and Potential Benefits of Research標(biāo)準(zhǔn)治療和潛在的研究獲益,The international principle on standard of care specifies what everyone should get: a right or entitl

28、ement. 國際有關(guān)標(biāo)準(zhǔn)治療的原則指出每個(gè)人應(yīng)該獲得：一種權(quán)利Research that targets diseases of the host population and that requires the “floor” standard can be permitted. 針對(duì)東道國目標(biāo)疾病的研究，可以允許“底層”標(biāo)準(zhǔn)的需求Research that benefits mainly the sponsors can be