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赫爾辛基宣言(2000年版)
Declaration of Helsinki

A、引言
A、INTRODUCTION

         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有關以人類為受試者
            之醫學試驗時的倫理指導原則。而有關人類受試者之醫學試驗係包括任何可辨
            識之人體組織或資料。
             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 subjects. Medical research involving human
             subjects includes research on identifiable human material or identifiable data.

         2.醫師之使命在促進及維護人類之健康,其專業知識與良知應奉獻於此一使命。
             It is the duty of the physician to promote and safeguard the health of the people. The
              physician's knowledge and conscience are dedicated to the fulfillment of this duty.

         3.在世界醫學會之日內瓦宣言(Declaration of Geneva)中以下列文字規範醫師:
            「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考慮。」
            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 physician shall act only in the
             patient's 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類為受試者。
            Medical progress is based on research which ultimately must rest in part on
             experimentation involving human subjects.

         5.在進行以人類為受試者的醫學研究時,應將受試者利益置於科學及社會利益之
            上。
             In medical research on human subjects, considerations related to the well-being of the
             human subject should take precedence over the interests of science and society.
             

         6.以人類為受試者之醫學試驗的首要目的,在於增進各種預防、診斷與治療之方
            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、診斷與治療之
            方法,也應不斷地以研究來檢證其效果、效率、可行性與品質。
            The primary purpose of 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 their
            effectiveness, efficiency, accessibility and quality.

         7.在目前的醫療行為及醫學研究中,大多數的預防、診斷與治療程序都涉及一定
            的風險與醫療責任。
            In current medical practice and in medical research, most prophylactic, diagnostic and
            therapeutic procedures involve risks and burdens.

         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。對於易
            受傷害之受試群體必須特別加以保護。經濟弱勢及醫療資源匱乏之群體的特別
            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。
            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 and 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
            consent under duress, 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
            宣言對受試者所宣示之保障。
            Research Investigators should be aware of the ethical, legal and regulatory for 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 eliminateany of the protections for human subjects set forth in this
            Declaration.

B、醫學研究之基本原則
B、BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH

       10.醫學研究中,醫師之職責是在於保障受試者之生命、健康、個人隱私及尊
            嚴。
            It is the duty of the physician in medical research to protect the life, health, privacy,
            and dignity of the human subject.

       11.任何以人類為受試者的醫學研究,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。
            Medical research 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.

       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。
            Appropriate 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.

       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(註:本院稱為
            人體試驗審查委員會),加以考查、評論與指導,如果適當,才會予以核准。
            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,和受試者參與實驗之誘因。
            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, comment, guidance, and where appropriate, approval to a
            specially appointed ethical review committee, 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. 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 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。
            The research protocol should always contain a statement of the ethical considerations
            involved and should indicate that there is compliance with the principles nunciated in
            this Declaration.

       15.以人類為受試者的醫學研究皆須由受過科學訓練的合格人員執行,並在合格臨
            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者之同意,該受試者亦不需負任何責任。
            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 on the subject of the research, even though the subject has given
            consent.

       16.任何以人類為受試者的醫學研究計劃,事前須審慎評估可能的風險、責任、以
            及對受試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。
            Every medical 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. 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。
            Physicians should abstain from 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 proof of positive and
            beneficial results.

       18.唯有在研究目的之重要性大於受試者可能身受的風險時,以人類為受試者的醫
            學研究才可以進行。當該受試者為健康的自願者時,尤需重視此原則。
            Medical research involving human subjects should only be conducted if the
            importance of the objective outweighs the inherent risks and burdens to the subject.
            This is especially important when the human subjects are healthy volunteers.

       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。
            Medical research is only justified if there is a reasonable likelihood that the populations
            in which the research is carried out stand to benefit from the results of the research.

       20.受試者必須是自願參加且充份瞭解研究內容,才得以參與該項研究計劃。
            The subjects must be volunteers and informed participants in the research project.
            

       21.受試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。
            The right of research subjects to safeguard their integrity must always be respected.
            Every precaution should be taken to respect the privacy of the subject, the
            confidentiality of the patient's information and to minimize the impact of the study on
            the subject's physical and mental integrity and on the personality of the subject.

       22.在任何人體試驗中,每一個可能的受試者,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。在確知受試者已充分瞭解以上訊息後,
            醫師應取得受試者自願給予之知情同意,並以書面方式為佳。若知情同意無法
            以書面方式取得,則非書面之同意必須經過正式地紀錄與見證。
            In any research on human beings, each potential subject must be adequately informed
             of the aims, methods, sources of funding, any possible conflicts of interest,
            institutional affiliations of the researcher, the anticipated benefits and potential risks of
            the study and the discomfort it may entail. The subject should be informed of the right
            to abstain from participation in the study or to withdraw consent to participate at any
            time without reprisal. After ensuring that the subject has understood the information,
            the physician should then obtain the subject's freely-given informed consent,
            preferably in writing. If the consent cannot be obtained in writing, the non-written
            consent must be formally documented and witnessed.

       23.醫師在取得知情同意時,應特別注意受試者是否對醫師有依賴關係,或受試者
            是否在脅迫下行使同意。在此情況下,此知情同意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。
            When obtaining informed consent for the research project the physician should be
             particularly cautious if the subject is in a dependent relationship with the physician or
            may consent under duress. In that case the informed consent should be obtained by a
            well-informed physician who is not engaged in the investigation and who is completely
            independent of this relationship.

       24.若受試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,否則此研究不應包含此類族群。
            For a research subject who is legally incompetent, physically or mentally incapable of
            giving consent or is a legally incompetent minor, the investigator must obtain informed
            consent from the legally authorized representative in accordance with applicable law.
            These groups should not be included in research unless the research is necessary to
            promote the health of the population represented and this research cannot instead be
            performed on legally competent persons.

       25.當一個被視為無法律行為能力之受試者,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者之同意外,亦必須取得
            其法定代理人之同意。
            When a subject deemed legally incompetent, such as a minor child, is able to give
            assent to decisions about participation in research, the investigator must obtain that
            assent in addition to the consent of the legally authorized 6 representative.

       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。
            Research on individuals from whom it is not possible to obtain consent, including
            proxy or advance consent, should be done only if the physical/mental condition that
            prevents obtaining informed consent is a necessary characteristic of the research
            population. The specific reasons for involving research subjects with a condition that
            renders them unable to give informed consent should be stated in the experimental
            protocol for consideration and approval of the review committee. The protocol should
            state that consent to remain in the research should be obtained as soon as possible from
            the individual or a legally authorized surrogate.

       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衝突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。
            Both authors and publishers have ethical obligations. In publication of the results of
            research, the investigators are obliged to preserve the accuracy of the results. Negative
            as well as positive results should be published or otherwise publicly available. Sources
            of funding, institutional affiliations and any possible conflicts of interest should be
            declared in the publication. Reports of experimentation not in accordance with the
            principles laid down in this Declaration should not be accepted for publication.

C、兼顧醫療照護的醫學研究之附加原則
C、ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE

       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。
            The physician may combine medical research with medical care, only to the extent
            that the research is justified by its potential prophylactic, diagnostic or therapeutic
            value. When medical research is combined with medical care, additional standards
            apply to protect the patients who are research subjects.

       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。但對於尚無有效預防、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。
            The benefits, risks, burdens and effectiveness of a new method should be tested against
            those of the best current prophylactic, diagnostic, and therapeutic methods. This does
            not exclude the use of placebo, or no treatment, in studies where no proven
            prophylactic, diagnostic or therapeutic method exists.

       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。
            The benefits, risks, burdens and effectiveness of a new method should be tested against
            tAt the conclusion of the study, every patient entered into the study should be assured
            of access to the best proven prophylactic, diagnostic and therapeutic methods
            identified by the study.

       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。
            The physician should fully inform the patient which aspects of the care are related to
            the research. The refusal of a patient to participate in a study must never interfere with
            the patient-physician relationship.

       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。
            In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic
            methods do not exist or have been ineffective, the physician, with informed consent
            from the patient, must be free to use unproven or new prophylactic, diagnostic and
            therapeutic measures, if in the physician's judgement it offers hope of saving life, re-
            establishing health or alleviating suffering. Where possible, these measures should be
            made the object of research, designed to evaluate their safety and efficacy. In all cases,
            new information should be recorded and, where appropriate, published. The other
            relevant guidelines of this Declaration should be followed.

 


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