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利益冲突null利益衝突 Conflicts of Interest利益衝突 Conflicts of InterestConflicts of interest 利益衝突Conflicts of interest 利益衝突利益衝突利益衝突利益衝突是「一種複雜的狀況,此時當事人對於主要利益的專業判斷容易受到次要利益的不當影響」。 Conflict of interest is a set of conditions in which professional judgement concerning a primary i...

利益冲突
null利益衝突 Conflicts of Interest利益衝突 Conflicts of InterestConflicts of interest 利益衝突Conflicts of interest 利益衝突利益衝突利益衝突利益衝突是「一種複雜的狀況,此時當事人對於主要利益的專業判斷容易受到次要利益的不當影響」。 Conflict of interest is a set of conditions in which professional judgement concerning a primary interest (such as patients' welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain). Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993; 329: 573-576倫理ETHICS John Williams- Director of Ethics WMA倫理ETHICS John Williams- Director of Ethics WMA倫理反應出一個人的價值觀及面對倫理情境做決定時的行為原則。 Ethics identifies values and principles for decision-making and behaviour and resolves conflicts over ethical issues. 倫理情境:不知到怎樣做才對的情境。 An ethical issue: a situation where it is not clear what is the right thing to do.臨床人員的利益臨床人員的利益Three Primary Interests主要利益 Patient Health and well being Clinical Research Education of future health professionals Secondary Interests 次要利益 Financial gain promotion grants for research publication of research results desire of fame family obligations認識「利益衝突」 Understanding Conflicts of Interest認識「利益衝突」 Understanding Conflicts of Interest任何專業都有主要利益及次要利益 Any professional has a primary as well as a myriad of secondary interests 當次要利益影響到專業判斷時,便有「利益衝突」 。 A conflict of interest occurs when the secondary interests “unduly influence” the persons “professional judgments concerning a primary interest”認識「利益衝突」認識「利益衝突」利益衝突是「一種狀況,不是一個行為。 Conflict of interest is a condition not a behaviour.利益衝突 vs 責任衝突 Conflicts of Interest vs Conflicts of Commitment利益衝突 vs 責任衝突 Conflicts of Interest vs Conflicts of Commitment利益衝突 COI between primary and secondary interests Secondary interests are not part of physician’s duty Secondary interests should not influence on professional judgment 責任衝突 COC arises between primary interests e.g, caring of a patient and educating medical students and completing research study Not very problematic from ethical point of view過度使用檢查的動機對於醫生本身除在醫院診所看病以外,又投資其他如抽血驗尿的檢驗中心、或是影像學中心,而轉介病人到這種地方做進一步的檢驗,各醫療團體也開始重視這種現象,也列入利益衝突。過度使用檢查的動機實證研究 令人驚訝的是,許多醫師認為他們不會受到與企業互動的影響。結論是接受越多禮物的醫師不見得就對企業所提供的資料持比較正面的態度; 這項研究的作者認為醫師其實比我們一般所認為的更謹慎敏銳。然而,作者雖總結醫師開藥的方式不會受到贈禮或其他互動太大的影響,卻沒有實際分析開藥的方式與醫師的行為。實證研究研究中的利益衝突研究中的利益衝突Historical Evidences 历史事件Historical Evidences 历史事件1980- Massachusetts Eye and Ear Infirmary and Harvard Medical School- Opthalmology fellow trial on Vit-A based ointment for dry eye syndrome, he owned half million shares of company Spectra Pharmaceutical Services, his mentor also had stocks. 1980 – 马萨诸塞眼耳医院和哈佛医学院 – Vit-A 油膏治疗干眼症的临床研究,研究者拥有制药公司50 万股份,他的导师也持有股份。 More patients were enrolled than required, Fellow sold stock when he realized the product was ineffective. 许多患者参加了研究。当研究者意识到药物无效时,就抛出了股票。Duke UniversityDuke UniversityIn1999 OHRP shut down Duke University IRB as Grant Officer was in the IRB and should not be a voting member. 1999年美国人体研究保护办公室关闭了Duke大学的伦理委员会,因为基金办公室官员作为伦理委员会委员,而他不应参与投票。 There was inadequate IRB supervision of human subject experiments 人体试验中,伦理委员会的监管不到位。 Fred Hutchunson Cancer Research Center (FHC), SeattleFred Hutchunson Cancer Research Center (FHC), SeattleResearchers were charged with financial conflicts of interest related to a bone marrow transplantation study. 研究者因在一起骨髓移植研究中涉嫌有经济利益冲突而被起诉。 Several key researchers including Nobel Prize winner Donald Thomas had stock shares in Genetic Systems 数位重要研究者,包括诺贝尔奖获得者Donald Thomas ,都持有遗传研究系统的股份。 FHC had financial relationships relating to commercial rights to antibodies produced by its researchers- FHI对由它的研究者研发的疫苗的商业权利存在金融联系。 20 out of 82 patients died as a result of participation in study. 82名参加试验的患者中20名死亡。Jesse GelsingerJesse Gelsinger1999- Death of 18 yr old male with genetic disorder that impairs ammonia metabolism 1999 – 一名18岁年轻男性患有影响氨代谢的遗传疾病死亡案例 Underwent gene therapy at University of Pennsylvania 他在宾西法尼亚大学接受基因治疗 Injected with adenovirus carrying the gene - developed serious problems and died in 4 days 在注射了携带基因的腺病毒后发生了严重问 快递公司问题件快递公司问题件货款处理关于圆的周长面积重点题型关于解方程组的题及答案关于南海问题 ,4天后死亡。 Later it was found that 后来发现 Two Rhesus monkeys had died in tests involving a gene delivery system similar to the one used with Jesse; four other human patients had suffered toxicity to their livers earlier in study 两只恒河猴在与Jesse相似的基因研究中死亡;另外其他4名患者在研究早期出现肝损害。 PI and Head of Instt had 30% shares in Genovo, private company producing the gene-altered adenovirus 主要研究者和机构领导享有生产该基因变异腺病毒公司30%的股权。 Genovo was sponsoring the research for its product. 该公司向研究机构提供一定的研究经费。 Types of COI利益冲突类型Types of COI利益冲突类型Financial Stock Ownership Equities Consultancies Patent - licensing arrangements Research Grants with Pharma, or manufacturers of research products Non-Financial Publications Promotion Peer recognition Grant renewals经济类 持有股票 资产 顾问 专利 – 许可权的安排 制药公司的研究基金,或厂商的研究产物 非经济类 发 关于同志近三年现实表现材料材料类招标技术评分表图表与交易pdf视力表打印pdf用图表说话 pdf 文章 晋升 同行认可 经费重申 Financial COI 经济利益冲突Financial COI 经济利益冲突Are not the only conflicts, but the more dangerous ones 不是唯一的利益冲突,但危险性较大 Money as key motivating factor, the more the better 金钱是非常关键的激发因子,越多越好 Financial ties between researchers and industry in US (by Dr E.Emmanuel, NIH) 研究者和产业之间的经济联系 34% occasional speaking engagements 34%偶然作为 演讲 办公室主任竞聘演讲中层竞聘演讲护士长竞聘演讲演讲比赛活动要求对演讲比赛的点评 者 33% consulting arrangements 33%作为顾问 32% paid position on board of directors 32%受聘为董事会成员 14% equity in company- mean value $100,000 14%有公司资产 – 价值$100,000Reviews and Meta-analysis Reviews and Meta-analysis 研究經費來源和研究結果間也顯示出關聯。由藥商贊助的臨床試驗比較不會做出「傳統治療比新藥好」的結論。 Clinical trials and meta-analyses sponsored by drug companies favored the product produced by the funder Lexchin et al. BMJ, 2003 Conclusions of trials were significantly more likely to recommend the experimental drug as the treatment of choice if the trials were funded by for-profit organisations Nielsen et al. JAMA 2003Evaluating COI 評估利益衝突Evaluating COI 評估利益衝突判斷被扭曲的可能性 Probability that judgment will be distorted. If the secondary interest is small unlikely to corrupt decision making Large financial incentive influence is great 潛在傷害的程度 Potential magnitude of harm If small or transient in nature, concern is less Harm life threatening or disabling or lead to loss of public confidence, concern is heightened 很難決定是否有影響 Difficult to determine when secondary influences have improper influence or notConflict of Interest Policy 管理利益冲突的方针Conflict of Interest Policy 管理利益冲突的方针3 elements 3 个基础原理 Requirement for regular disclosure to Institution of potential conflicts by faculty members with appropriate administrative scrutiny of financial interests 要求学院教职员工定期向学院说明潜在的利益冲突,并对经济利益进行适当的行政方面的详细审查。 Monitoring by a standing or specially appointed oversight committee 由一常设的或特别任命的委员会进行监察 Mechanism of granting exceptions to the policy when they are warranted by extraordinary circumstances 通过特殊外部环境/机制来避免利益冲突影响 Martin JB & Kasper DL, In whose Best Interest? Breaching the Academic-Industrial Wall NEJM 343 (2000): 1646-49Protections for Conflicts of Interest 防范利益冲突Protections for Conflicts of Interest 防范利益冲突Small amounts may be acceptable 数额较少,可考虑接受 Middle amounts need to be disclosed or watched 中等数额,需要上报或监控 Large amounts need to be prohibited 数额巨大,需被禁止 Reducing the magnitude of harm is difficult but requires additional oversight 减少损害的大小是困难的,但需要额外的监察Management Strategies 管理策略Management Strategies 管理策略NEJM has a requirement NEJM 的要求 “Authors to disclose any financial arrangement with the company whose product figures prominently in the submitted manuscript or with the company making a competing product” “作者要申明与文中涉及的产品的制造公司或竞争产品的公司是否存在经济利益关系” “Authors of such articles will not have significant financial interest in a company that makes a product discussed in the article” “此类文章的作者不能与文中涉及的产品的制造公司有明显的经济利益关系” Many Universities in US-美国的许多大学- disclosure policies and Conflicts of Interest Committees 制定有“申明政策”和利益冲突委员会 Conflict of Interest Committee 利益冲突委员会Conflict of Interest Committee 利益冲突委员会Advisory Committee to advise 顾问委员会 > 5 members COI acceptable without further action COI 可以接受,不需要进一步措施 Disclosure to subjects necessary 需要告知受试者 Controls need to be in place 需要对此采取一定的措施 extra monitoring, consent process performed by someone other than conflicted party, or other measures 特别监察,由其他人进行知情同意等 Conflict is unacceptable and must be eliminated for research to proceed 必须消除存在的利益冲突,研究才能进行。 「利益衝突」的現況「利益衝突」的現況不知道或不承認「利益衝突」的存在 Awareness of COI poor or non-existent 認知「利益衝突」的存在便已解決大部份的問題 Half the problem would be solved if presence COI is recognized由醫學倫理看醫療工作之利益衝突當醫療人員面對有可能發生利益衝突時,最好的 方法 快递客服问题件处理详细方法山木方法pdf计算方法pdf华与华方法下载八字理论方法下载 是坦然以對,一切透明化。 一味地合理化(rationalization),就有可能導致嚴重的倫理上的缺失而不自知。 由醫學倫理看醫療工作之利益衝突「醫師與廠商間關係」守則- 95年9月8日公告 Guidelines for relationship between medical doctor and industry. Sep 8, 1996「醫師與廠商間關係」守則- 95年9月8日公告 Guidelines for relationship between medical doctor and industry. Sep 8, 1996
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