A. INTRODUCTION

A．前言

1. 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 is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs.

1．世界醫(yī)學會（WMA）制定了《赫爾辛基宣言》，是作為對涉及人體受試者的醫(yī)學研究的倫理原則的一項聲明，此研究還包括對可識別身份的人體材料和數(shù)據(jù)進行的研究。

《宣言》應整體閱讀，其中任一段落的運用都應同時考慮到其他所有相關段落的內容。

2. Although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles.

2．盡管《宣言》主要針對醫(yī)生，世界醫(yī)學會鼓勵參與涉及人體受試者的研究的其他相關人員采納這些原則。

3. It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.

3．促進和維護患者的健康，包括那些參加醫(yī)學研究的患者，是醫(yī)生的職責。醫(yī)生以知識和良知致力于完成該職責。

4. The Declaration of Geneva of the WMA 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 in the patient's best interest when providing medical care.”

4．世界醫(yī)學會的《日內瓦宣言》用下列詞語約束醫(yī)生“患者的健康是我首先需要考慮的”。《國際醫(yī)學倫理守則》宣告，“醫(yī)生在提供醫(yī)護時應從患者的最佳利益出發(fā)。”

5. Medical progress is based on research that ultimately must include studies involving human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research.

5．醫(yī)學進步以科學研究為基礎，而研究最終必須涉及人體受試者。應使那些在醫(yī)學研究中缺乏代表性的人群有機會參加研究。

6. In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.

6．在涉及人體受試者的研究中，個體研究受試者的福祉必須高于所有其他利益。

7. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

7．涉及人類受試者的醫(yī)學研究的首要目的，是了解疾病的起因、發(fā)展和影響，并改進預防、診斷和治療干預措施（方法、操作程序和治療）。即使是當前最佳干預措施，也必須不斷通過對其安全性、有效性、效率、可及性和質量進行研究，予以評估。

8. In medical practice and in medical research, most interventions involve risks and burdens.

8．在醫(yī)學實踐和醫(yī)學研究中，大多干預措施具有風險，會造成負擔。

9. Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence.

9． 醫(yī)學研究要遵循那些促進尊重人體受試者、保護他們的健康和權利的倫理標準。一些研究涉及的人群特別易受傷害，需要特別保護。這包括那些無能力自主決定同意或拒絕的人群、和可能受到強迫或不正當影響的人群。

10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

10．醫(yī)生不僅要考慮本國的、有關涉及人體受試者的研究的倫理、法律和法規(guī)條例標準，也要考慮適用的國際規(guī)范和標準。任何國家或國際的倫理、法律或法規(guī)要求不應減少或刪除本宣言提出的對研究受試者的任一保護措施。

B. PRINCIPLES FOR ALL MEDICAL RESEARCH

B. 適用于所有醫(yī)學研究的原則

11. It is the duty of physicians who participate in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.

11． 參與醫(yī)學研究的醫(yī)生有責任保護研究受試者的生命、健康、尊嚴、完整性、自我決定權、隱私和個人信息的保密。

12. 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 adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

12． 涉及人體受試者的研究必須符合公認的科學原則，并以對科學文獻、其他相關資料、充分的實驗室研究、適當?shù)膭游飳嶒灥某浞至私鉃榛A。實驗動物的福利必須得到尊重。

13. Appropriate caution must be exercised in the conduct of medical research that may harm the environment.

13．開展有可能破壞環(huán)境的醫(yī)學研究應予以適當?shù)闹斏鳌?/p>

14. The design and performance of each research study involving human subjects must be clearly described in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits.

14． 任何涉及人體受試者的研究，其設計和操作，必須在研究方案中明確描述。方案應陳述該研究涉及的倫理問題，簡要說明如何體現(xiàn)《宣言》中的原則。研究方案應包括有關資金來源、資助者、機構隸屬關系、其他潛在的利益沖突、對受試者的激勵措施，以及對研究造成的傷害如何治療和/或予以補償?shù)男畔ⅰＱ芯糠桨笐f明研究結束后，有關受試者獲得經(jīng)研究確定為有益的干預措施的安排，或得到其他適當?shù)恼兆o或益處。

15. The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee.

15． 研究開始前，研究方案必須遞交至研究倫理委員會，供其考慮、評論、指導和批準。該委員會必須獨立于研究者、資助者和其他任何不當影響之外。委員會必須考慮本國和研究項目開展國的法律和法規(guī)、以及適用的國際規(guī)范和標準，但這些絕不允許減少或刪除本宣言提出的對研究受試者的保護措施。委員會必須有權監(jiān)督正在進行中的研究。研究人員必須向該委員會提供監(jiān)督的信息，特別是關于嚴重不良事件的信息。未經(jīng)該委員會的考慮和批準，不得修改研究方案。

16. Medical research involving human subjects must be conducted only by individuals with the appropriate scientific training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional. The responsibility for the protection of research subjects must always rest with the physician or other health care professional and never the research subjects, even though they have given consent.

16．唯有受過適當科學培訓和具備資格的人員方可開展涉及人體受試者的研究。針對患者或健康受試者的研究需要由一位勝任、并有資質的醫(yī)生或其他衛(wèi)生保健專業(yè)人員負責監(jiān)督。保護研究受試者的責任必須始終在于醫(yī)生和衛(wèi)生保健專業(yè)人員，而不是研究受試者本身，即使先前他們已經(jīng)給出同意。

17. Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research.

17．涉及處于不利地位或弱勢人群的醫(yī)學研究，唯有這項研究是針對該人群的健康需要且是此人群或社區(qū)優(yōu)先關注的問題，并且有理由認為該人群可能從研究結果中獲益時，方能認為這項研究是正當?shù)摹?/p>

18. Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation.

18．每項涉及人體受試者的研究在實施前，必須對參加研究的受試個體和群體，就可預見的研究風險和負擔，與帶給他們及其他受到研究疾病狀況影響的個體或群體的可見的益處對比，進行謹慎評估。

19. Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.

19．每項臨床試驗必須在招募第一個受試者前，在公眾可及的數(shù)據(jù)庫上注冊登記。

20. Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefits or when there is conclusive proof of positive and beneficial results

20．除非醫(yī)生相信已對研究相關的風險進行了充分評估，并能滿意地控制風險，否則不可以參與該涉及人體受試者的研究。一旦發(fā)現(xiàn)研究的風險大于潛在獲益，或已獲得了肯定和有益的研究結論時，醫(yī)生必須立即停止該研究。

21. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects.

21．唯有研究目的之重要性超出受試者承擔的研究內在的風險和負擔時，涉及人體受試者的研究方可開展。

22. Participation by competent individuals as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no competent individual may be enrolled in a research study unless he or she freely agrees.

22．有行為能力的個體作為受試者參加醫(yī)學研究必須是自愿的。盡管同其家人或社區(qū)負責人進行商議可能是合適的，除非他或她自由表達同意，否則不得將有行為能力的個體納入研究中。

23. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity.

23．必須采取一切措施保護研究受試者的隱私和個人信息機密性，并使研究對他們的身體、精神和社會完整性造成的影響降低到最小。

24. In medical research involving competent human subjects, 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, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

24.涉及有行為能力受試者的醫(yī)學研究，每位潛在受試者必須被充分告知：研究目的、方法、資金來源、任何可能的利益沖突、研究人員的機構隸屬關系、研究預期的獲益和潛在的風險、研究可能造成的不適，以及任何其他相關方面的信息。潛在受試者必須被告知有拒絕參加研究或隨時撤回同意退出研究而不會因此受到報復的權利。應特別關注個體潛在受試者對于特定信息的需求、以及傳遞信息的方式。在確保潛在研究受試者理解了告知信息后，醫(yī)生或其他 適當?shù)挠匈Y格的人員必須尋求其自主的知情同意，最好是書面形式。如果不能以書面形式表達同意，非書面同意必須被正式記錄并有見證。

25. For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse. There may be situations where consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research. In such situations the research may be done only after consideration and approval of a research ethics committee.

25. 對于使用可識別身份的人體材料或數(shù)據(jù)的醫(yī)學研究，通常情況下，醫(yī)生必須尋求受試者對采集、分析、存放和/或再次使用人體材料或數(shù)據(jù)的同意意見。可能存在這樣的情況，對某些研究而言，獲得受試者同意已不可能或不現(xiàn)實，或尋求同意會對研究的有效性造成威脅，在這樣的情況下，唯有經(jīng)研究倫理委員會考慮并批準后，研究方可進行。

26. When seeking informed consent for participation in a research study the physician should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship.

26．在尋求參與研究項目的知情同意時，如果潛在受試者與醫(yī)生有依賴關系，或可能會被迫表示同意，醫(yī)生應特別謹慎。在這些情況下，應該由一個適當?shù)挠匈Y格且完全獨立于這種關系之外的人來尋求知情同意。

27. For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, and the research entails only minimal risk and minimal burden.

27．對無行為能力的潛在受試者，醫(yī)生必須尋求法定代理人的知情同意。上述潛在受試者絕不能被納入到一個不可能帶給他們益處的研究中，除非研究旨在促進該潛在受試者所代表的人群的健康，且研究不能以有行為能力的受試者代替進行，同時研究僅造成最小風險和負擔。

28. When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject's dissent should be respected.

28．當一個被認為無行為能力的潛在受試者是能夠做出同意參加研究的決定時，醫(yī)生除了尋求法定代理人的同意之外，還必須尋求該受試者的同意。該潛在受試者做出的不同意意見應予以尊重。

29. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative.

29．研究涉及因身體或精神狀況而不能做出同意意見的受試者時，如喪失意識的患者，唯有在阻礙給出知情同意的身體或精神狀況是該研究人群的一個必要特征時，研究方可開展。這種情況下，醫(yī)生應尋求法定代理人的知情同意。如果無法聯(lián)系到法定代理人，而且研究不能延誤時，研究可以在沒有獲得知情同意的情況下進行 -- 前提是，研究方案中陳述了需要納入處于不能做出同意意見情況下的受試者的特殊理由，且該研究已得到了倫理委員會的批準。研究者應盡早地從受試者或法定代理人處獲得繼續(xù)參與研究的同意意見。

30. Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

30．對研究結果的出版，作者、編輯和出版方均負有倫理義務。作者有責任公開涉及人體受試者的研究的成果，并對其報告的完整性和準確性負責。他們應遵守關于符合倫理的報告的被認可的指南。陰性的或未得出結論的研究結果應同陽性結果一樣發(fā)表或公開，或通過其他途徑使公眾可以得到。在發(fā)表物上應聲明資金來源、機構隸屬以及利益沖突等。未能遵守本《宣言》原則的研究的報告，不應被接受發(fā)表。

C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE

C．有關與醫(yī)療照護相結合的醫(yī)學研究的補充原則

31. The physician may combine medical research with medical care only to the extent that the research is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

31．只有當研究潛在的預防、診斷或治療價值被證明正當，而且醫(yī)生有良好的理由相信患者作為受試者參加研究對其健康不會造成不良影響時，醫(yī)生才可以將醫(yī)學研究與醫(yī)療照護相結合。

32. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

· -The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

-Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.  

32．一種新的干預措施的益處、風險、負擔和有效性，必須與當前被證明的最佳干預措施進行對照試驗，但下述情況除外：

- 在當前不存在被證明有效的干預措施的情況下，使用安慰劑或不予治療是可以被接受的；或

- 出于令人信服的以及科學合理的方法學上的理由，使用安慰劑是確定一種干預措施的有效性或安全性所必須的，而且使用安慰劑或不予治療不會使患者遭受任何嚴重的風險或不可逆的傷害。為避免此種選擇被濫用，須極其謹慎。

33. At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.

33．研究結束時，參加研究的患者有權得知研究的結果并分享由此產(chǎn)生的任何益處，例如，有權獲得研究證實的有益的干預措施或其他適當?shù)恼兆o或益處。

34. The physician must fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never interfere with the patient-physician relationship.

34．醫(yī)生必須完全告知患者治療的哪些方面與研究有關。絕不能因患者拒絕參加研究或決定退出研究而妨礙醫(yī)患關系。

35. In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.

35．在患者治療過程中，若尚沒有被證明有效的干預措施，或干預措施已經(jīng)無效，醫(yī)生在尋求專家意見后，并得到患者或法定代理人的知情同意后，如果根據(jù)自己的判斷，該干預措施有望挽救生命、重獲健康或減少痛苦，那么醫(yī)生可以采用未被證實的干預措施。只要可能，該干預措施應作為一個研究目的，并進行研究設計來評估其安全性和有效性。無論何種情況，新信息都應被記錄下來，適當情況下，將其公開。