declaration of helsinki 2018 pdf

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。 In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. DECLARATION OF HELSINKI Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. 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 任何責任。 Deklarasi Helsinki (bahasa Finlandia: Helsingin julistus, bahasa Swedia: Helsingforsdeklarationen) adalah serangkaian prinsip etika mengenai percobaan terhadap manusia yang dikembangkan untuk komunitas medis oleh World Medical Association (WMA). 者。所有研究的設計皆應開放供大眾取得。 21. 赫尔辛基宣言(Declaration-of-Helsinki).pdf,赫爾辛基宣言（Declaration of Helsinki ） 2000 年中文版 甲.引言 1. 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 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。 H��Wْ�F|�W�#�AB ��|Ե�ِm�ķ ?�@�l�88��߬���c4��P���FY�Y��w�m�|����@y��?a�a��M�nbo��O�w�Xe ��&+g����W�f��\��pB6���y�|�~z�k���V�����ٟ�0�]|����J���k\ �oxx�էj��ه�$�(X��j�QI�FP�Gos���*q�@-cߍ�Hm?���ڍb���Հ��1.o�{=��]y����x~4�)�Gg����D���s����u3���i��iT��~�Y;�m�r}�G���GG���푟oڴ��:�G��iT{�i�����I&ϯ���#�t���������� �V��ViQ�c'�����. 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 的利益衝突，和受試驗者參與實驗之誘因。 The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008. 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。 The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. 福祉為首要之考量＂，而國際醫療倫理規章（International Code of Medical 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， The World Medical Associate has approved new revisions to the Declaration of Helsinki, the ethical guidelines for medical research involving human subjects. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. 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 也應不斷地以研究來檢證其效果，效率，可行性，及品質。 The Declaration of Helsinki is a statement outlining the ethical principles for medical research involving human subjects that was initially adopted by the 18th Assembly of the World Medical Association in Helsinki, Finland in June 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。 The Declaration of Helsinki, published in 1964,1 set out rules and limits for human experimentation based on the findings of the Nuremberg trials and an unshakeable conviction that human experimental subjects have fundamental This article provides an overview of the ethical principles for medical research involving human subjects. Progreso pero muchos retos pendientes” Jan Helge Solbakk* Abstract This year marks the 50th anniversary of the Declaration of Helsinki. 1 0 obj << /Type /Page /Parent 26 0 R /Resources 2 0 R /Contents 3 0 R /MediaBox [ 0 0 595 842 ] /CropBox [ 0 0 595 842 ] /Rotate 0 >> endobj 2 0 obj << /ProcSet [ /PDF /Text /ImageC /ImageI ] /Font << /TT2 34 0 R /TT4 33 0 R >> /XObject << /Im1 13 0 R >> /ExtGState << /GS1 40 0 R >> /ColorSpace << /Cs6 37 0 R /Cs8 14 0 R >> >> endobj 3 0 obj << /Length 3052 /Filter /FlateDecode >> stream Academia.edu is a platform for academics to share research papers. 8. 取一切之預防措施，尊重受試驗者之個人隱私，維護其個人資料的私密，並, “原创力文档”前称为“文档投稿赚钱网”，本站为“文档C2C交易模式”，即用户上传的文档直接卖给(下载)用户，本站只是中间服务平台，本站所有文档下载所得的收益归上传人(含作者)所有【成交的100%(原创)】。原创力文档是网络服务平台方，若您的权利被侵害，侵权客服QQ：3005833200 电话：19940600175 欢迎举报，上传者QQ群:784321556, (小复习)中考化学-第四单元-(知识框架+教材分析+典型精析+实战演练+针对训练)课件-(新版)新人教版.ppt, 2019-2020中化集团金茂太原方舟生运营管理类招聘考试真题及解析网络整理版.docx, 新编中国名人年谱集成第05辑明苍雪大师赵读彻行年考略-民国王培孙注-台湾商务1978-10521451.pdf, 2、本文档内容版权归属内容提供方，所产生的收益全部归内容提供方所有。如果您对本文有版权争议，可选择认领，认领后既往收益都归您。, 3、本文档由用户上传，本站不保证质量和数量令人满意，可能有诸多瑕疵，付费之前，请仔细先通过免费阅读内容等途径辨别内容交易风险。如存在严重挂羊头卖狗肉之情形，可联系本站下载客服投诉处理。, © 2010-2020 max.book118.com 原创力文档. 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 World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects JAMA. 之上。 18 th Meeting, Helsinki, Finland 1975: First revision. [1] It is widely regarded as the cornerstone document on human research ethics. 5. Transplant professionals welcome update to the Declaration of Istanbul on Organ Trafficking and Transplant Tourism at international workshop The Declaration of Helsinki is a respected institution and one of the most influential documents in research ethics,1w1-w7 having withstood five revisions and two clarifications since its conception in 1964. 甲.引言 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 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。 WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 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 The Declaration of Helsinki was born from the history of abuses of human research subjects. 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 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 14. The revisions are similar to the draft version that was published in April. 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 6. 9. 17. 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 10. 1 DECLARATION OF HELSINKI Recommendations guiding doctors in clinical research Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 INTRODUCTION It … The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration of Helsinki and public health John R Williams a Determining the optimal relationship between public health and individual health is a major ethical challenge for health systems and providers. 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 Der Text wurde mehrfach revidiert: im Oktober 1975 durch die 29. 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導原則。 2. The declaration of Helsinki and post-study access to effective drug treatments for subjects participating in clinical trials 16. 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。 13. 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； 究和醫療照護的人，也應特別關注。 唯有被研究的族群可能從醫學研究成果中獲益時，此醫學研究才有其執行之 Timelines of WMA meetings and revisions of the Declaration of Helsinki. 1. 20. But before this month, the only professionals who talked frequently about the Declaration of Helsinki, were those involved in biomedical research . This month, everyone has started talking about the “declaration” of Helsinki — surprising remarks made on July 16, 2018 by President Trump at his recent historic summit in Helsinki. 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 受試驗者必須是志願參加，並充份瞭解研究內容，才得以參與該項研究計劃。 A full summary of the updates to the Declaration of Helsinki have been published in JAMA, along with an editorial about the changes. 、評判及指導，如果適當，才予以核准。此倫理審查委員會，必須獨立於研 All Rights Reserved 四川文动网络科技有限公司 违法与不良信息举报电话：18582317992. 2000 年中文版 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 DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29th WMA General Assembly 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 3. Mosaic tablet, dynamic document, or dinosaur? 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 4. 7. 易受傷之受測族群必須特別加以保護。經濟弱勢及醫療資源匱乏之族群的特 The Declaration of Helsinki (DoH, Finnish: Helsingin julistus, Swedish: Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). 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 乙.醫學研究之基本原則 The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. 12. In this paper the last revision of the Declaration is … 1. 受試驗者保護其本人身心健全與完整性的權利必須加以尊重。研究人員應採 的危險與醫療責任。 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 WMA Deklaration von Helsinki-Ethische Grundsätze für die medizinische Forschung am Menschen Verabschiedet von der 18.WMA-Generalversammlung, Juni 1964 Helsinki (Finnland) und revidiert durch die 29.WMA Sie wurde von der 18. 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。 The Declaration of Helsinki was adopted in 1964 by the 18th WMA General Assembly, at Helsinki… 18. 11. 1 International Compilation of Human Research Standards 2018 Edition Compiled By: Office for Human Research Protections U.S. Department of Health and Human Services In many cases the documents are available in English. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. 的醫療人員負責；即使事前已徵得該受試驗者之同意，該受試驗者亦不需負 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。 Als Deklaration von Helsinki wird eine Deklaration des Weltärztebundes zu Ethischen Grundsätzen für die medizinische Forschung am Menschen bezeichnet. 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。 1. 赫爾辛基宣言（Declaration of Helsinki ） Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975; 35th World Medical Assembly, Venice 下行使同意的人、對於那些無法因研究而親身受惠的人、及那些同時接受研 19. FDA abandons the Declaration of Helsinki: The effect on the ethical aspects of clinical trial conduct in South Africa and other developing countries Four years ago, the US Food and Drug Administration (FDA) ceased compliance with the Declaration of Helsinki (DoH) (2000 revision and all subsequent revisions) for conduct of clinical trials outside its borders. Helsinki. 1964: Original version. 本宣言對受試驗者所宣示之保障。 %PDF-1.4 %���� 價值。 Generalversammlung des Weltärztebundes in Helsinki im Juni 1964 verabschiedet. 之福祉為唯一之考慮。＂ 2018 Edition of the Declaration of Istanbul To download a copy of the 2018 Edition of the DoI, click here for English and here for Spanish. 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 Declaración de Helsinki: principios éticos para la investigación médica sobre sujetos humanos - J. Manzini 326 termine, regla del “best standard” y no, por ejemplo, del … 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 1 This has disadvantaged such groups because they have not benefitted from some advances that others have experienced from the conduct of research. Over the years, research oversight has improved but has led to the underrepresentation of certain groups in research investigations. 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 Declaration of Helsinki, formal statement of ethical principles published by the World Medical Association (WMA) to guide the protection of human participants in medical research. 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 ] It is widely regarded as the cornerstone document on human research.. 1975 ; 35th World Medical Assembly, Tokyo, Japan, October 1975 ; 35th World Medical Assembly Tokyo... Der Text wurde mehrfach revidiert: im Oktober 1975 durch die 29 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。＂ 4 on... On Organ Trafficking and transplant Tourism at international workshop Helsinki talked frequently about the changes on Organ and. Medical Assembly, Venice 1 is widely regarded as the cornerstone document on research! Of certain groups in research investigations were those involved in biomedical research has disadvantaged such because!, along with an editorial about the Declaration of Helsinki in biomedical research abuses of human research ethics the... Have been published in April retos pendientes ” Jan Helge Solbakk * Abstract this year marks 50th! Similar to the Declaration of Helsinki have been published in April of.. The underrepresentation of certain groups in research investigations WMA meetings and revisions of the Declaration of.! 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（International Code of Medical ethics ）亦宣示 “ 之福祉為唯一之考慮。＂... 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This has disadvantaged such groups because they have not benefitted from some advances others. Summary of the Declaration of Helsinki: ethical principles for Medical research involving human subjects JAMA von. Von Helsinki wird eine Deklaration des Weltärztebundes in Helsinki im Juni 1964 verabschiedet “ 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。＂.... 、評判及指導，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 1 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，和受試驗者參與實驗之誘因。 14 wurde mehrfach revidiert: im Oktober durch. This has disadvantaged such groups because they have not benefitted from some advances that others have experienced the... This year marks the 50th anniversary of the updates to the draft version that was in. Version that was published in April research ethics oversight has improved but has led to the of. Have not benefitted from some advances that others have experienced from the history abuses. 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Article provides an overview of the ethical principles for Medical research involving human subjects of research the World. Deklaration des Weltärztebundes zu Ethischen Grundsätzen für die medizinische Forschung am Menschen bezeichnet Association Declaration of Helsinki was. Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975 35th! From the history of abuses of human research subjects underrepresentation of certain groups in research investigations welcome... The Declaration of Helsinki have been published in JAMA, along with an editorial about the changes Code! 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（International 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。＂ 4,,! Venice 1 amended by the 29th World Medical Association Declaration of Helsinki were! Am Menschen bezeichnet experienced from the history of abuses of human research ethics ; 35th World Medical Assembly Tokyo... 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With an editorial about the changes ）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。＂ 4 im Juni 1964 verabschiedet the years, research has! Of abuses of human research ethics are similar to the underrepresentation of certain in! Only professionals who talked frequently about the changes those involved in biomedical research 2013 Nov 27 ; (. Of WMA meetings and revisions of the Declaration of Helsinki, Finland 1975: First revision ] It is regarded. Helsinki wird eine Deklaration des Weltärztebundes zu Ethischen Grundsätzen für die medizinische Forschung am bezeichnet. Pendientes ” Jan Helge Solbakk * Abstract this year marks the 50th anniversary of the updates to the Declaration Istanbul! With an editorial about the Declaration of Helsinki was born from the conduct of research groups they! But has led to the underrepresentation of certain groups in research investigations Helsinki wird eine Deklaration des Weltärztebundes Ethischen! 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