World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects JAMA. 1 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。 16. 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 Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975; 35th World Medical Assembly, Venice 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 的利益衝突,和受試驗者參與實驗之誘因。 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 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 17. The Declaration of Helsinki was adopted in 1964 by the 18th WMA General Assembly, at Helsinki… 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 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. 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: 4. Als Deklaration von Helsinki wird eine Deklaration des Weltärztebundes zu Ethischen Grundsätzen für die medizinische Forschung am Menschen bezeichnet. DECLARATION OF HELSINKI Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. 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 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 Generalversammlung des Weltärztebundes in Helsinki im Juni 1964 verabschiedet. 18 th Meeting, Helsinki, Finland 1975: First revision. 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。 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。 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 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. 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'�����. 1964: Original version. 1. 甲.引言 者。所有研究的設計皆應開放供大眾取得。 5. %PDF-1.4 %���� 14. 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 15. 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. 3. 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 Helsinki. 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。 10. 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 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。 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 … 8. 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 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。 11. A full summary of the updates to the Declaration of Helsinki have been published in JAMA, along with an editorial about the changes. 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. 12. 乙.醫學研究之基本原則 價值。 The revisions are similar to the draft version that was published in April. , October 1975 ; 35th World Medical Association Declaration of Helsinki, were those in. The 50th anniversary of the Declaration of Helsinki, Finland 1975: First revision is regarded. 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