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醫學倫理委員會

 

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一.台灣醫師誓言--黃勝雄 〈摘自天使的眼睛一書〉

1.准許我進入醫業時,我謹以赤誠宣誓,我將以我的生命奉獻為人類的健康服務。
2.我將對我的師長及我的父母表達最大的尊敬和感恩。
3.我願以良知和對生命的尊重行醫,不論是未出生的或將死去的生命,都一樣尊重。
4.我必視病如親,因此?不收紅包。
5.我必注重自己的禮儀品德,?不在金錢或性方面佔病人的便宜。
6.我必尊敬並保護病人的隱私,不違背病人的信託,不洩漏病人之祕密 。
7.我不因宗教、國籍、種族、政見或社會地位的不同,而影響我對病人應盡的責任。
8.我必不浪費公共醫療資源,也不因醫療給付制度的不合理,而偏待我的病人。
9.我必全心全意,毫無保留來教導向我學習的學生。
10.我必敬重我的同業如弟兄。

二.醫師誓言--資料來源 中華民國醫師公會全國聯合會

1.我願意貢獻我的一生為救人濟世而努力。
2.我願意尊敬和感謝我老師。
3.我願意盡我一切的力量尊重生命,妥善加以維護,並以獨立自由良知與尊嚴之態度執行我的救人聖職。
4.我願意時常追求醫學知進步與社會常識之素養而努力,使我的學識不陷入偏僻之弊。
5.我願意最先考慮病人之利益,不允許任何對病人不利的事情干預我的職務。
6.我願意不違背病人之信託,不洩漏病人之祕密。
7.我願意不接受任何在醫療上不當之報酬,不接受任何以營利為目的之職務。
8.我願意不做不能勝任之醫療行為,不爭奪病人就醫,不避忌共同會診,使病人有選擇醫師之自由權。
9.我願意對同仁有禮貌,互敬互信,協力維護醫師之社會地位。

三、赫爾辛基宣言(Declaration of Helsinki)--指導醫生進行人體生物醫學研究的建議赫爾辛基宣言(Declaration of Helsinki)2000年中文版---資料來源 JIRB

甲.引言
1.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。
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。
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(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.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。
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。
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。
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。
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、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。
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。

乙.醫學研究之基本原則 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。
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。
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。
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,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,和受試驗者參與實驗之誘因。
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。
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。
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。
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。
19. 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價值。
20. 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。
21. 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,並將此研究對其身心健全及人格造成之傷害降到最低。
22. 在任何人體試驗中,每一個可能的受試驗者,必須被告知該研究的目的、方法、經費來源、任何可能的利益衝突、研究人員所屬機構、該研究可預見的益處,及可能伴隨的危險與不適。受試驗者也應被告知其擁有的權利,包括可拒絕參與研究,或可隨時撤回同意而不受報復。在確知受試驗者已充分瞭解以上訊息後,醫師應取得受試驗者於自由意志下簽署之受試同意書,此受試同意書以書面行之為佳。若受試同意書無法以書面方式行之,則非書面之同意必須經過正式地紀錄與見證。
23. 醫師在取得受試同意書時,應特別注意受試驗者是否對醫師有依賴關係,或受試驗者 是否在脅迫下行使同意。在此情況下,此受試同意書應由一位充分瞭解全盤研究,但沒有參與研究,並完全與彼無關係的醫師取得。
24. 若受試驗者無法律上之行為能力,或生理或心智上無同意能力,或無法律上行為能力 之未成年者,研究人員必須取得符合適用法令之法定代理人受試同意書。除非研究本身有其促進上述族群健康之必要性,而研究又無法於法律上具行為能力之人員上施行,否則此研究不應包涵此類族群。
25. 當一個被視為無法律行為能力之受試驗者,例如未成年之孩童,對參與研究的決定有 表達同意之能力時,研究人員除了應取得該受試驗者之同意外,亦必須取得其法定代理人之同意。
26. 當無法從個人取得同意,包括代理人同意或預先同意時,此項對於個人之研究不應進 行;除非阻止其簽署受試同意書的個人特殊身心狀況,正是此受試驗者族群的必然特徵。對於此種在無法簽署受試同意書之受試驗者上的研究,研究人員應於試驗計畫書中,陳述其研究之具體原因,以供審查委員會之考量而核准。試驗計畫書中應表明,會儘速從本人,或合法授權之代理人處,取得繼續參與此研究之同意。
27. 作者及出版者皆負道德責任。研究人員在發表研究成果時,即有責任保持其結果的正 確性。正面與負面的研究結果都應發表,或可公開取得。研究人員之經費來源,其所屬組織,或研究中任何可能之利益爭議皆應公佈於出版之中。凡不合乎此宣言之原則的實驗報告,皆不該被接受發表。

丙.兼顧醫療照護的醫學研究之附加原則
28. 醫師可以結合醫學研究與醫療照護,但此情況僅止於此研究有潛在的預防、診斷或治 療的價值。當醫學研究結合醫療照護時,另有額外的準則來保護這些同為病患和研究對象的人。
29. 一個新醫療方法的益處、危險性、責任、及其效果,應與目前已知最佳的預防、診斷 與治療方法對照檢驗。而對於尚無有效預防、診斷與治療方式之研究,不排除使用安慰劑或不予治療來檢驗其療效。
30. 研究結束後,每一個參與研究的病患,都應得到保證其可以接受經此研究證實為最佳的預防、診斷和治療的方法。
31. 醫師應全盤告知病患,那些方面的醫療照護與研究有關。病患的拒絕參與研究,絕對不應影響醫病關係。
32. 在治療病患的過程中,若無有效的預防,診斷和治療的方法,醫師在取得病患之受試
同意書後,得以自由採用其判斷下有希望挽救生命,重建健康或減輕痛苦的任何未經證實或新的預防,診斷及治療方法。這些方法,在可能的情況下,應被當作研究的目標,來評估其安全性及有效性。在各種情況下,應將新的消息資訊紀錄,適當時並發表,並應遵守此份宣言的其他相關準則。

四、里斯本宣言(Declaration of Lisbon on the Rights of the Patient 1981): 病人權利,人權利宣言(病人應有選擇醫師,不接受治療,及保留秘密等權利) World Medical Association PRINCIPLES

1.Right to medical care of good quality
A.Every person is entitled without discrimination to appropriate medical care.
B.Every patient has the right to be cared for by a physician whom he/she knows to be free to make clinical and ethical judgments without any outside interference.
C.The patient shall always be treated in accordance with his/her best interests. The treatment applied shall be in accordance with generally approved medical principles.
D.Quality assurance always should be a part of health care. Physicians,in particular, should accept responsibility for being guardians of the quality of medical services.
E.In circumstances where a choice must be made between potential patients for a particular treatment, which is in limited supply, all such patients are entitled to a fair selection procedure for that treatment. That choice must be based on medical criteria and made without discrimination.
F.The patient has the right of continuity of health care. The physician has an obligation to cooperate in the coordination of medically indicated care with other health care providers treating the patient. The physician may not discontinue treatment of a patient as long as further treatment is medically indicated, without giving the patient reasonable assistance and sufficient opportunity to make alternative arrangements for care.

2.Right to freedom of choice
A. The patient has the right to choose freely and change his/her physician and hospital or health service institution, regardless of whether they are based in the private or public sector.
B. The patient has the right to ask for the opinion of another physician at any stage.

3.Right to self-determination
A. The patient has the right to self-determination, to make free decisions regarding himself/herself. The physician will inform the patient of the consequences of his/her decisions.
B. A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions. The patient should understand clearly what is the purpose of any test or treatment, what the results would imply, and what would be the implications of withholding consent.
C. The patient has the right to refuse to participate in research or the teaching of medicine.

4.The unconscious patient
A. If the patient is unconscious or otherwise unable to express his/her will, informed consent must be obtained whenever possible, from a legally entitled representative where legally relevant.
B. If a legally entitled representative is not available, but a medical intervention is urgently needed, consent of the patient may be presumed, unless it is obvious and beyond any doubt on the basis of the patient's previous firm expression or conviction that he/she would refuse consent to the intervention in that situation.
C. However, physicians should always try to save the life of a patient unconscious due to a suicide attempt.

5.The legally incompetent patient
A. If a patient is a minor or otherwise legally incompetent the consent of a legally entitled representative, where legally relevant, is required. Nevertheless the patient must be involved in the decision making to the fullest extent allowed by his/her capacity.
B. If the legally incompetent patient can make rational decisions, his/her decisions must be respected, and he/she has the right to forbid the disclosure of information to his/her legally entitled representative.
C. If the patient's legally entitled representative, or a person authorized by the patient, forbids treatment which is, in the opinion of the physician, in the patient's best interest, the physician should challenge this decision in the relevant legal or other institution. In case of emergency, the physician will act in the patient's best interest.

6.Procedures against the patient's will
Diagnostic procedures or treatment against the patient's will can be carried out only in exceptional cases, if specifically permitted by law and conforming to the principles of medical ethics

7.Right to information
A. The patient has the right to receive information about himself/herself
recorded in any of his/her medical records, and to be fully informed about his/her health status including the medical facts about his/her condition. However, confidential information in the patient's records about a third party should not be given to the patient without the consent of that third party.
B. Exceptionally, information may be withheld from the patient when there is good reason to believe that this information would create a serious hazard to his/her life or health.
C. Information must be given in a way appropriate to the local culture and in such a way that the patient can understand.
D. The patient has the right not to be informed on his/her explicit request, unless required for the protection of another person's life.
E. The patient has the right to choose who, if anyone, should be informed on his/her behalf.

8. Right to confidentiality
A. All identifiable information about a patient's health status, medical condition, diagnosis, prognosis and treatment and all other information of a personal kind, must be kept confidential, even after death. Exceptionally, descendants may have a right of access to information that would inform them of their health risks.
B. Confidential information can only be disclosed if the patient gives explicit consent or if expressly provided for in the law. Information can be disclosed to other health care providers only on a strictly "need to know" basis unless the patient has given explicit consent.
C. All identifiable patient data must be protected. The protection of the data must be appropriate to the manner of its storage. Human substances from which identifiable data can be derived must be likewise protected.

9.Right to Health Education
Every person has the right to health education that will assist him/her in making informed choices about personal health and about the available health services. The education should include information about healthy lifestyles and about methods of prevention and early detection of illnesses. The personal responsibility of everybody for his/her own health should be stressed. Physicians have an obligation to participate actively in educational efforts.

10. Right to dignity
A. The patient's dignity and right to privacy shall be respected at all times in medical care and teaching, as shall his/her culture and values.
B. The patient is entitled to relief of his/her suffering according to the current state of knowledge.
C. The patient is entitled to humane terminal care and to be provided with all available assistance in making dying as dignified and comfortable as possible.

11.Right to religious assistance
The patient has the right to receive or to decline spiritual and moral comfort including the help of a minister of his/her chosen religion.

五、日內瓦宣言 (Declaration of Geneva) --世界醫學協會一九四八年日內瓦大會

准許我進入醫業時:
我鄭重地保證自己要奉獻一切為人類服務。
我將要給我的師長應有的崇敬及感戴;
我將要憑我的良心和尊嚴從事醫業;
病人的健康應為我的首要的顧念:
我將要尊重所寄託給我的秘密;
我將要盡我的力量維護醫業的榮譽和高尚的傳統;
我的同業應視為我的手足;
我將不容許有任何宗教,國籍,種族,政見或地位的考慮介於我的職責和病人間;
我將要盡可能地維護人的生命,自從受胎時起;
即使在威脅之下,我將不運用我的醫學知識去違反人道。
我鄭重地,自主地並且以我的人格宣誓以上的約定。

The World Medical Association Declaration of Geneva (1948) Physician's Oath
At the time of being admitted as a member of the medical profession:
I solemnly pledge myself to consecrate my life to the service of humanity;
I will give to my teachers the respect and gratitude which is their due;
I will practice my profession with conscience and dignity; the health of my patient will be my first consideration;
I will maintain by all the means in my power, the honor and the noble traditions of the medical profession; my colleagues will be my brothers;
I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient;
I will maintain the utmost respect for human life from the time of conception, even under threat, I will not use my medical knowledge contrary to the laws of humanity;
I make these promises solemnly, freely and upon my honor.
Citation: Declaration of Geneva (1948). Adopted by the General Assembly of World Medical Association at Geneva Switzerland, September 1948.

六、希波克拉提斯--醫師誓言--西元前五世紀:

准許我進入醫業時:
我鄭重地保證自己要奉獻一切為人類服務;
我將我的師長應有的崇敬與感戴;
我將我的良心和尊嚴從事醫業;
病人的健康應為我的首要顧念;
我將尊重所寄託予我的秘密;
我將盡我的力量維護醫業的榮譽和高尚的傳統;
我的同業應視為我的同袍;
我將不容許有任何宗教、國籍、種族、政治或地位的考慮介入我的職責和病人間;
我對人類的生命,自受胎時起,始終寄予最高的尊敬;
即使在威脅之下,我將不運用我的醫學知識去違反人道。
我鄭重地、自主地以我的人格宣誓以上的誓言。

參考資料:黃勝雄 〈摘自天使的眼睛一書〉、中華民國醫師公會全國聯合會、聯合人體試驗委員會(JIRB)、高雄醫學大學倫理委員會網站

 



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