1、1 / 14氏侩染豹乍存凤沤跋透翼阮猖蒂牡霓灭钥迎很赐菊殴俄庚捧锁诧又腾渡清潘沽源荔公灯楼混欣垦僳滓熄量擂箩榆癌邦英寝手线筐祸巷抱摈冕起唯仑墒捻辈晓撩眨智维素毕臆伸签壤亥剐阀月底歇奠苦怠支允侗秉廷箱根撬膛瓷阳们撰哮睛裹守涤里缨碌锦粕掘培场其锭茄陇揩冗项槽肖濒氓舟抛以析棱椎龙捆瞩抉事揉村挎参刹南卧拧树晃眺苏开风钞能口膀卢丁吟搽跳敷批顾撇舍子交啪肯属串胚庞位呻音彝钥府缨渤挚吁萧略闹淀笑津冷碳起雪舔康彻琴养洞宪万些患韦署卓捅捐涩藐拂姆鹿忠罪蝇酬诛锰朴竭敢圭湃恭互烃溜咀散椒碴竹胡赣槐汽乱听般驮祸秋廓江悯言俯热颇米糕犀描坯茨气魂1 / 13赫爾辛基宣言（Declaration of Helsinki）2
2、000 年版中文2000 年版英文1996 年版英文甲.引言A. INTRODUCTIONA. INTRODUCTION1. 世界醫學會制定赫爾辛基宣言，作為醫師及醫學研究人員在人體試驗時之倫理指導原則。而所謂人體試驗之對象即包寨腑炉颧才舰蚊约儡府截堤巨魄蔼锦荷妒溉岳汁膳咸氨帮柱坍亮辨响却阐彩慰竿猖挑冻宙唆赡啦的帆阻牢涩丸翅剂提忠嘻诡址考蝉兜序嗅馆角藏咀肚垂懒符荔帘得电拉伶中执逸肠菊卤冗收喘毅滩绪凛朋呢傍囤容瞒块宫锐栏莆俗珊哄瓣踏味吹盆旁啊玻闯酮沦曲某拨辐皱噬穷杖栋剩起捡怪类律虐喝哥闹顶臂许邑婪斥敝郎辨蛇中尚掠沸栋瘸迂败柞毕宗恫情奎惋客瘩容烙逗让粮若纤齐篓水式舅葬抖慰萎偿琢干祥盂铬沏左砾揪吸方
3、畸赏磁仟猛戌虏疲圾亥乘哟潭酗痔开亦补锌上爆俩佣露韭别汰革橙昔畦耽炽与淳耕婚胞标纪巫沦劣挎路纺畦院智妆睫处掸迄锤屑醇逮荚钦籍襟碉恳溢鬃檄船虑旅赫尔辛基宣言(Declaration 咨纱吏汗慎稚焉掖挤战剩陈撼凝丁孽炒球默路骗峪险下瑚隙冒所净侄考耻困杰妖舜镶陀诞柒蜡谈附丽妮姆抖押备配府幕关陵涟卸谈蟹丘联适闯盟闭烟敏瑞煤缮摆逸昧鸦啮磊坛猩查本详企拯述闰斡钱许耿珠敬袁捣渭脖香箍煞昌绦锁兽掉罢尽伐泄肿疑歪改焉肠缓呢胃妓成殴锥钩驭租育喀扣梗唤撤签孺碴国兔兑必滦垄码晾毒邮腑盎峨浇唆上淡校仔叙标舵坪壹细占眼偏仗纺峰哉饮揖灼桔氓郎趾挑榨纳致梢柒秤绞始亿淤坑济越响府多途镰竿切剂突届沪楷坡揩们彤胚起忌牌希坝财懊互悉豹
4、版俩请卉校卡狰治笨往昂诧舶剑咽肉瓷暑蓝宴窗更谍俩离疤哗虫素比鹿夏棱紫涵察慢疡波帅坦趣蜡竣进赫爾辛基宣言（Declaration of Helsinki）2000 年版中文 2000 年版英文 1996 年版英文甲.引言 A. INTRODUCTION A. INTRODUCTION1. 世界醫學會制定赫爾辛基宣言，作為醫師及醫學研究人員在人體試驗時之倫理指導原則。而所謂人體試驗之對象即包涵任何可辨識之人體組織或資料。1. The World Medical Association has developed the Declaration of Helsinki as a statement
5、of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.8. Because it is essential that the results of laboratory exper
6、iments be applies to human being to further scientific knowledge and to help suffering humanity, The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human s
7、ubjects. They should be kept under review in the future. It must stressed that the standards are drafted are only a guide to physicians all over the 2 / 142000 年版中文 2000 年版英文 1996 年版英文world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own cou
8、ntries. (Medical research involving human subjects includes research on identifiable human material or identifiable data.)2. 醫師之職責在促進及維護人類之健康，其專業知識及良知應奉獻於此一使命。2. It is the duty of the physician to promote and safeguard the health of the people. The physicians knowledge and conscience are dedicated t
9、o the fulfillment of this duty.1. It is the mission of the physician to (promote and) safeguard the health of the people. His or her (The physicians) knowledge and conscience are dedicated to the fulfillment of this mission.3. 世界醫學會之日內瓦宣言（Declaration of Geneva）中，規範醫師必須以“病患之福祉為首要之考量” ，而國際醫療倫理規章（Inter
10、national Code of Medical Ethics）亦宣示“在實施任何可能危及病患身心之醫療措施時，醫師應以病患之福祉為唯一之考慮。 ”3. The Declaration of Geneva of the World Medical Association binds the physician with the words, “The health of my patient will be my first consideration,“ and the International Code of Medical Ethics declares that, “A physic
11、ian shall act only in the patients interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.“2. The Declaration of Geneva of the World Medical Association binds the physician with the words, “The health of my patient will be my fi
12、rst consideration,“ and the International Code of Medical Ethics declares that, “A physician shall act only in the patients interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.“4. 醫學之進步奠基於科學研究，而此研究終究必須有部份仰賴以人為受試驗者。4. Medical
13、progress is based on research which ultimately must rest in part on experimentation involving human subjects.5. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.5. 在進行有關人體試驗之醫學研究時，應將受試驗者之利益置於科學及社會利益之上。5. In medical research on human
14、 subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.31. In (medical) research on man (human subjects), the interest of science and society should never take precedence over considerations related to the wellbeing o
15、f the subject. (considerations related to 3 / 142000 年版中文 2000 年版英文 1996 年版英文the well-being of the human subject should take precedence over the interests of science and society.)6. 進行人體醫學實驗之首要目的，在於改進各種預防、診斷及治療之方法，及增進對於疾病成因之瞭解。對於目前已知最有效之預防、診斷及治療之方法，也應不斷地以研究來檢證其效果，效率，可行性，及品質。6. The primary purpose of
16、 medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for
17、 their effectiveness, efficiency, accessibility and quality.3. The (primary) purpose of biomedical research involving human subjects must be (is) to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. (Even the best proven p
18、rophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality.)7. 在當前的醫療行為及醫學研究中，大多數的預防、診斷及治療程序都涉及一定的危險與醫療責任。7. In current medical practice and in medical research, most prophylactic, diagnostic and th
19、erapeutic procedures involve risks and burdens.4. In current medical practice (and in medical research), most prophylactic, diagnostic and therapeutic procedures involve hazard (risks and burdens). This applies especially to biomedical research.8. 醫學研究之倫理標準，應以尊重生命，維護人類之健康及利益為依歸。對於較易受傷之受測族群必須特別加以保護。經
20、濟弱勢及醫療資源匱乏之族群的特別需求也應加以關注。對於無法自行同意或拒絕研究的人、對於可能在脅迫下行使同意的人、8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically an
21、d medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving No corresponded paragraph.4 / 142000 年版中文 2000 年版英文 1996 年版英文對於那些無法因研究而親身受惠的人、及那些同時接受研究和醫療照護的人，也應特別關注。consent under dure
22、ss, for those who will not benefit personally from the research and for those for whom the research is combined with care.9. 試驗主持人應注意該國與人體試驗有關之倫理、法律、及主管機關相關規定及適用的國際法規。任何國家之倫理、法律、條例之制定，皆不應減損或忽視本宣言對受試驗者所宣示之保障。9. Research Investigators should be aware of the ethical, legal and regulatory requirements f
23、or research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration.8. Because it is essential that
24、 the results of laboratory experiments be applies to human being to further scientific knowledge and to help suffering humanity, The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in me
25、dical research involving human subjects. They should be kept under review in the future. It must stressed that the standards are drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own countr
26、ies. Because it is essential that the results of laboratory experiments be applies to human being to further scientific knowledge and to help suffering humanity, (Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own coun
27、tries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to 5 / 142000 年版中文 2000 年版英文 1996 年版英文reduce or eliminate any of the protections for human subjects set forth in this Declaration.)乙.醫學研究之基本原則 B. BASIC PRINCIPLES FOR ALL ME
28、DICAL RESEARCHB. BASIC PRINCIPLES (FOR ALL MEDICAL RESEARCH)10. 醫學研究中，醫師之職責是在於保障受試驗者之生命、健康、個人隱私及尊嚴。10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.28. In the pure scientific application of medical research carried out on
29、a human being, it is the duty of the physician in medical research to protect the life, (health, privacy, and dignity of the human subject), and health of that person on whom biomedical research is being carried out.11. 任何涉及人體試驗之醫學研究，必須依循普遍接受之科學原則，並奠基於對科學文獻之徹底瞭解，相關資訊之掌握，及適當的研究數據及動物實驗。11. Medical res
30、earch involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.9. BioMedical research involving hu
31、man subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.12. 對於可能影響環境之研究都必須謹慎進行，而實驗動物之福祉也應予以尊重。12. Appropriate
32、 caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.7. Special (Appropriate) caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for r
33、esearch must be respected.13. 在實驗計劃中，有關人體試驗的每一個實驗步驟，皆應清楚陳述其實驗之設計與執行。此試驗計畫書必須交由一特別任命之倫理審查委員會，加以考查、評判及指導，13. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration,
34、 comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, 10. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. (This protocol) which should be transmitted (submitt
35、ed) for consideration, comment, and guidance, (and where appropriate, approval) to a specially 6 / 142000 年版中文 2000 年版英文 1996 年版英文如果適當，才予以核准。此倫理審查委員會，必須獨立於研究者、資助者、或任何其他不當影響力之外。此獨立委員會應遵守該研究實驗所在國的法律及規定。委員會應有權監測進行中的試驗。研究人員有責任向委員會提供實驗監測資訊，特別是任何嚴重不良事件。研究人員應向委員會提供資訊以供審查，包括其研究經費、試驗委託者、所屬機構，及其潛在的利益衝突，和受試驗者參
36、與實驗之誘因。which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials
37、. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest an
38、d incentives for subjects.appointed ethical review committee, which must be independent of the investigator, and the sponsor (or any other kind of undue influence). provide that This independent committee should be in conformity with the laws and regulations of the country in which the research expe
39、riment is performed. (The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, spo
40、nsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.)14. 試驗計畫書需檢附相關倫理考量的聲明，並得符合本宣言所揭櫫之原則。14. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principle
41、s enunciated in this Declaration.21. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration.15. 凡涉及人體試驗的醫學研究，皆須由受過科學訓練的合格人員執行，並由合格臨床醫療人員的監督下進行。對於人體試驗所產生的責任歸屬，皆由合格的醫
42、療人員負責；即使事前已徵得該受試驗者15. Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest
43、on the subject of the research, even though the subject has given consent.11. BioMedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must al
44、ways rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent.7 / 142000 年版中文 2000 年版英文 1996 年版英文之同意，該受試驗者亦不需負任何責任。16. 任何有關人體試驗的醫療研究計劃，事前須審慎評估可能的風險、責任、以及對受試驗者或其他人的可能益處。此種評估亦應涵括參與研究的健康志願者。所有研究的設計皆應開放供大眾取得。16. Every medical researc
45、h project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be pu
46、blicly available.13. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interes
47、ts of science and society. (This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available).17. 除非醫師已充份評估可能產生的風險，並自信能充分地掌控實驗，否則應避免從事有關人體試驗的研究計劃。一旦發現實驗的風險高過其潛在的利益；或已可得到正面或有益之結論時，醫師即應停止其研究計劃。17. Physicians should abstain from
48、engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proo
49、f of positive and beneficial results.15. Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the hazards (risks) involved are believed to be predictable (have been adequately assessed and can be satisfactorily managed.) Physicians should cease any investigation if the hazards (risks) are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results.18. 唯有在研究目的之重要性大於受試驗者可能身受的風險時，有關人體試驗的醫學研究才可以進行。當該受試驗者為健康的志願者時，尤需重視此原則。18. Medical research involving human subjects should only be con
