世界医学协会赫尔辛基宣言--涉及人类参与者的医学研究伦理原则

PREAMBLE

序言

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human participants, including research using identifiable human material or data.

世界医学协会（WMA）制定了《赫尔辛基宣言》，作为涉及人类参与者的医学研究 （包括使用可识别的人类材料或数据的研究）的伦理原则声明。

The Declaration is intended to be read as a whole, and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

本《宣言》应作为一个整体来阅读，在应用其每一个组成段落时，都应考虑到所有其他相关段落。

2. While the Declaration is adopted by physicians, the WMA holds that these principles should be upheld by all individuals, teams, and organizations involved in medical research, as these principles are fundamental to respect for and protection of all research participants, including both patients and healthy volunteers.

虽然《宣言》是由医生通过的，但世界医学协会认为，所有参与医学研究的个人、团队和组织都应坚持这些原则，因为这些原则是尊重和保护所有研究参与者（包括患者和健康志愿者）的根本。

 

GENERAL PRINCIPLES

一般原则

3. The WMA Declaration of Geneva binds the physician with the words, “The health and well-being of my patient will be my first consideration," and the WMA International Code of Medical Ethics declares “The physician must commit to the primacy of patient health and well-being and must offer care in the patient's best interest.”

世界医学协会《日内瓦宣言》对医生的约束是：“病人的健康和权益将是我首先考虑的问题。”世界医学协会《国际医学伦理守则》宣布："医生必须承诺将病人的健康和权益放在首位，必须以病人的最大利益为出发点提供医疗服务。

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

医生有责任促进和保障病人（包括参与医学研究的病人）的健康、获益和权利。医生的知识和良知都致力于履行这一职责。

5. Medical progress is based on research that ultimately must include participants.

Even well-proven interventions should be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality.

医学进步建立在研究的基础上，而研究最终必须包括参与者。即使是行之有效的干预措施，也应通过研究不断评估其安全性、有效性、效率、可及性和质量。

6. Medical research involving human participants is subject to ethical standards that promote and ensure respect for all participants and protect their health and rights.

涉及人类参与者的医学研究必须遵守伦理标准，以促进和确保对所有参与者的尊重，并保护他们的健康和权利。

Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed.

由于医学研究是在各种结构性不平等的背景下进行的，研究人员应认真考虑如何分配利益、风险和负担。

Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research. Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results.

在医学研究之前、期间和之后，应与潜在和注册参与者及其社区进行有意义的接触。研究人员应让潜在和注册参与者及其社区分享他们的优先事项和价值观；参与研究设计、实施和其他相关活动；并参与了解和传播研究结果。

7. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions; and ultimately to advance individual and public health.

涉及人类参与者的医学研究的主要目的是产生知识，以了解疾病的原因、发展和影响；改进预防、诊断和治疗干预措施；并最终促进个人和公众健康。

These purposes can never take precedence over the rights and interests of individual research participants.

这些目的决不能凌驾于研究参与者个人的权利和利益之上。

8. While new knowledge and interventions may be urgently needed during public health emergencies, it remains essential to uphold the ethical principles in this Declaration during such emergencies.

虽然在公共卫生紧急状态下可能迫切需要新的知识和干预措施，但在这种紧急状态下坚持本宣言中的伦理原则仍然至关重要。

9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, autonomy, privacy, and confidentiality of personal information of research participants. The responsibility for the protection of research participants must always rest with physicians or other researchers and never with the research participants, even though they have given consent.

参与医学研究的医生有责任保护研究参与者的生命、健康、尊严、完整性、自主性、隐私和个人信息的保密性。保护研究参与者的责任必须始终由医生或其他研究人员承担，而绝不能由研究参与者承担，即使他们已经表示同意。

10. Physicians and other researchers must consider the ethical, legal and regulatory norms and standards for research involving human participants in the country or countries in which the research originated and where it is to be performed, 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 participants set forth in this Declaration.

医生和其他研究人员必须考虑研究发起国和研究实施地所在国涉及人类参与者的研究伦理、法律和监管规范与标准，以及适用的国际规范与标准。任何国家或国际伦理、法律或监管要求都不应减少或取消本宣言中规定的对研究 参与者的任何保护。

11. Medical research should be designed and conducted in a manner that avoids or minimizes harm to the environment and strives for environmental sustainability.

医学研究的设计和开展应避免或尽量减少对环境的危害，并努力实现环境的可持续发展。

12. Medical research involving human participants must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Such research requires the supervision of a competent and appropriately qualified physician or other researcher.

涉及人类参与者的医学研究必须仅由受过适当伦理和科学教育、培训并具备相应资格的个人进行。此类研究必须在有能力和适当资格的医生或其他研究人员的监督下进行。

Scientific integrity is essential in the conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct.

科学诚信对于开展涉及人类参与者的医学研究至关重要。参与研究的个人、团队和组织绝不能有研究不当行为。

13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

应为在医学研究中代表性不足的群体提供参与研究的适当机会。

14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research will not adversely affect the health of the patients who serve as research participants.

将医学研究与医疗服务相结合的医生，只有在研究具有潜在的预防、诊断或治疗价值，且医生有充分理由相信参与研究不会对作为研究参与者的患者的健康造成不利影响的情况下，才应让患者参与研究。

15. Appropriate compensation and treatment for participants who are harmed as a result of participating in research must be ensured.

必须确保对因参与研究而受到伤害的参与者给予适当的补偿和治疗。

Risks, Burdens, and Benefits

风险、负担和获益

 

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

在医疗实践和医学研究中，大多数干预措施都涉及风险和负担。

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

只有在研究目标的重要性大于给研究参与者带来的风险和负担时，才能进行涉及人类参与者的医学研究。

17. All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

在进行所有涉及人类参与者的医学研究之前，必须认真评估参与研究的个人和群体可预见的风险和负担，并与他们以及受研究条件影响的其他个人或群体可预见的利益进行比较。

Measures to minimize the risks and burdens must be implemented. The risks and burdens must be continuously monitored, assessed, and documented by the researcher.

必须采取措施，尽量减少风险和负担。研究人员必须对风险和负担进行持续监测、评估和记录。

18. Physicians and other researchers may not engage in research involving human participants unless they are confident that the risks and burdens have been adequately assessed and can be satisfactorily managed.

除非医生和其他研究人员确信已对风险和负担进行了充分的评估，并能对其进行令人满意的管理，否则不得从事涉及人类参与者的研究。

When the risks and burdens are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians and other researchers must assess whether to continue, modify or immediately stop the research.

当发现风险和负担超过了潜在的益处，或有确凿证据证明存在明确的结果时，医生和其他研究人员必须评估是否继续、修改或立即停止研究。

Individual, Group, and Community Vulnerability

个人、群体和社区的脆弱性

 

19. Some individuals, groups, and communities are in a situation of more vulnerability as research participants due to factors that may be fixed or contextual and dynamic, and thus are at greater risk of being wronged or incurring harm. When such individuals, groups, and communities have distinctive health needs, their exclusion from medical research can potentially perpetuate or exacerbate their disparities. Therefore, the harms of exclusion must be considered and weighed against the harms of inclusion. In order to be fairly and responsibly included in research, they should receive specifically considered support and protections.

一些个人、群体和社区作为研究参与者，由于其因素可能是固定的，也可能是与环境和动态相关的，因此处于更加脆弱的境地，被误解或受到伤害的风险更大。当这些个人、群体和社区有独特的健康需求时，将他们排除在医学研究之外可能会延续或加剧他们的差异。因此，必须考虑排斥的危害，并与包容的危害进行权衡。为了公平、负责任地将他们纳入研究，他们应得到特别考虑的支持和保护。

20. Medical research with individuals, groups, or communities in situations of particular vulnerability is only justified if it is responsive to their health needs and priorities and the individual, group, or community stands to benefit from the resulting knowledge, practices, or interventions. Researchers should only include those in situations of particular vulnerability when the research cannot be carried out in a less vulnerable group or community, or when excluding them would perpetuate or exacerbate their disparities.

对处于特别弱势的个人、群体或社区进行医学研究，只有在符合他们的健康需求和优先事项，且个人、群体或社区能从由此产生的知识、实践或干预措施中受益的情况下，才是合理的。研究人员只有在无法在弱势程度较低的群体或社区开展研究时，或者将他们排除在外会延续或加剧他们的不平等时，才应将处于特别弱势状况的人包括在内。

Scientific Requirements and Research Protocols

科学要求和研究方案

 

21. Medical research involving human participants must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste. The research 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.

涉及人类参与者的医学研究必须有科学合理、严谨的设计和执行，有可能产生可靠、有效和有价值的知识，并避免研究浪费。研究必须符合公认的科学原则，基于对科学文献、其他相关信息来源的充分了解，以及充分的实验室试验和适当的动物试验。

必须尊重用于研究的动物的福利。

22. The design and performance of all medical research involving human participants must be clearly described and justified in a research protocol.

所有涉及人类参与者的医学研究的设计和实施都必须在研究方案中明确说明并证明其合理性。

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 aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

研究方案应包含对所涉及的伦理因素的说明，并应说明如何遵守本宣言中的原则。研究方案应包括以下方面的信息：目的、方法、预期效益、潜在风险和负担、研究人员的资质、资金来源、任何潜在的利益冲突、保护隐私和保密的规定、对参与者的激励措施、对因参与研究而受到伤害的参与者的治疗和/或补偿规定，以及研究的任何其他相关方面。

In clinical trials, the protocol must also describe any post-trial provisions.

在临床试验中，协议还必须说明试验后的任何规定。

Research Ethics Committees

研究伦理委员会

 

23. The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the research begins. This committee must be transparent in its functioning and must have the independence and authority to resist undue influence from the researcher, the sponsor, or others. The committee must have sufficient resources to fulfill its duties, and its members and staff must collectively have adequate education, training, qualifications, and diversity to effectively evaluate each type of research it reviews.

研究开始前，必须将研究方案提交给相关的研究伦理委员会，供其审议、评论、指导和批准。该委员会的运作必须透明，必须具有独立性和权威性，能够抵制研究人员、申办方或其他人的不当影响。委员会必须有足够的资源来履行其职责，其成员和工作人员必须共同接受过足够的教育、培训、资历和多样性，以便有效评估其审查的每一类研究。

The committee must have sufficient familiarity with local circumstances and context, and include at least one member of the general public.  It must take into consideration the ethical, legal, and regulatory norms and standards 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 participants set forth in this Declaration.

委员会必须充分熟悉当地的情况和背景，并至少包括一名公众成员。 委员会必须考虑到研究所在国家的伦理、法律和监管准则与标准以及适用的国际准则与标准，但这些准则与标准不得减少或取消本宣言中规定的对研究参与者的任何保护。

When collaborative research is performed internationally, the research protocol must be approved by research ethics committees in both the sponsoring and host countries.

在国际范围内开展合作研究时，研究方案必须获得发起国和东道国研究伦理委员会的批准。

The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research.  Where monitoring is required, the researcher must provide information to the committee and/or competent data and safety monitoring entity, especially about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusions.

委员会必须有权监督、建议修改、撤销批准或暂停正在进行的研究。 在需要监督的情况下，研究人员必须向委员会和/或主管数据和安全监督实体提供信息，特别是有关任何严重不良事件的信息。未经委员会审议和批准，不得修改研究方案。研究结束后，研究人员必须向委员会提交一份包含研究结果和结论摘要的最终报告。

Privacy and Confidentiality

隐私和保密

 

24. Every precaution must be taken to protect the privacy of research participants and the confidentiality of their personal information.

必须采取一切预防措施，保护研究参与者的隐私及其个人信息的机密性。

Free and Informed Consent

自由和知情同意

 

25. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals capable of giving informed consent in medical research must be voluntary. Although it may be appropriate to consult family members or community representatives, individuals capable of giving informed consent may not be enrolled in research unless they freely agree.

自由和知情同意是尊重个人自主权的重要组成部分。有能力做出知情同意的个人参与医学研究必须是自愿的。尽管征求家庭成员或社区代表的意见可能是适当的，但有能力做出知情同意的个人除非自由同意，否则不得参与研究。

26. In medical research involving human participants capable of giving informed consent, each potential participant must be adequately informed in plain language of the aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

在涉及有能力做出知情同意的人类参与者的医学研究中，必须以通俗易懂的语言向每一位潜在参与者充分告知研究的目的、方法、预期效益、潜在风险和负担、研究人员的资格、资金来源、任何潜在的利益冲突、保护隐私和保密的规定、对参与者的激励措施、对因参与研究而受到伤害的参与者的治疗和/或补偿规定，以及研究的任何其他相关方面。

The potential participant must be informed of the right to refuse to participate in the research or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information and communication needs of individual potential participants as well as to the methods used to deliver the information.

必须告知潜在参与者有权拒绝参与研究或随时撤回参与同意而不会受到报复。应特别注意个别潜在参与者的具体信息和沟通需求，以及传递信息的方法。

After ensuring that the potential participant has understood the information, the physician or another qualified individual must then seek the potential participant's freely given informed consent, formally documented on paper or electronically.  If the consent cannot be expressed on paper or electronically, the non-written consent must be formally witnessed and documented.

在确保潜在参与者理解了相关信息后，医生或其他有资格的人员必须征得潜在参与者的自由知情同意，并以书面或电子形式正式记录在案。 如果无法以书面或电子形式表示同意，非书面同意必须有正式的见证和记录。

All medical research participants should be given the option of being informed about the general outcome and results of the research.

应让所有医学研究参与者选择是否了解研究的一般结果和成果。

27. When seeking informed consent for participation in research the physician or other researcher must be particularly cautious if the potential participant is in a dependent relationship with them or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is independent of this relationship.

在征求参与研究的知情同意时，如果潜在的参与者与医生或其他研究人员存在依赖关系，或可能在胁迫下表示同意，医生或其他研究人员就必须特别谨慎。在这种情况下，必须由独立于这种关系的具有适当资格的个人来征求知情同意。

28. In medical research involving human participants incapable of giving free and informed consent, the physician or other qualified individual must seek informed consent from the legally authorized representative, considering preferences and values expressed by the potential participant.

在涉及无能力作出自由和知情同意的人类参与者的医学研究中，医生或其他有资格的个人必须在考虑潜在参与者所表达的偏好和价值观的情况下，征得合法授权代表的知情同意。

Those persons incapable of giving free and informed consent are in situations of particular vulnerability and are entitled to the corresponding safeguards. In addition to receiving the protections for the particularly vulnerable, those incapable of giving consent must only be included if the research is likely to either personally benefit them or if it entails only minimal risk and minimal burden.

无能力作出自由和知情同意的人处于特别脆弱的境地，有权得到相应的保障。除了接受对特别脆弱者的保护外，只有在研究可能使无能力表示同意者本人受益或只带来极小风险和极小负担的情况下，才可让他们参与研究。

29. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation in research, the physician or other qualified individual must seek that assent in addition to the consent of the legally authorized representative, considering any preferences and values expressed by the potential participant. The potential participant's dissent should be respected.

当无能力作出自由和知情同意的潜在研究参与者能够对参与研究的决定表示同意时，医生或其他有资格的个人必须在征得合法授权代表同意的基础上征求其同意，同时考虑潜在参与者表达的任何偏好和价值观。应尊重潜在参与者的异议。

30. Research involving participants 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 group. In such circumstances the physician or other qualified individual must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the research may proceed without informed consent provided that the specific reasons for involving participants with a condition that renders them unable to give informed consent have been stated in the research protocol and the research has been approved by a research ethics committee.

只有在无法做出知情同意的身体或精神状况是研究群体的一个必要特征的情况下，才可以进行涉及身体或精神上无能力做出同意的参与者（例如，昏迷的病人）的研究。在这种情况下，医生或其他有资格的个人必须征得法律授权代表的知情同意。如果没有这样的代表，而研究又不能推迟，则可以在没有知情同意的情况下进行研究，条件是在研究方案中说明了让患有无法做出知情同意的疾病的参与者参与研究的具体原因，而且研究已获得研究伦理委员会的批准。

Free and informed consent to remain in the research must be obtained as soon as possible from a legally authorized representative or, if they regain capacity to give consent, from the participant.

必须尽快从法律授权的代表那里获得自由和知情的同意，或者，如果参与者恢复了作出同意的能力，则从参与者那里获得自由和知情的同意，以便继续参与研究。

31. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of a patient to participate in research or the patient's decision to withdraw from research must never adversely affect the patient-physician relationship or provision of the standard of care.

医生或其他研究人员必须充分告知潜在参与者其护理的哪些方面与研究有关。患者拒绝参与研究或决定退出研究，绝不能对医患关系或提供标准护理产生不利影响。

32. Physicians or other qualified individuals must obtain free and informed consent from research participants for the collection, processing, storage, and foreseeable secondary use of biological material and identifiable or re-identifiable data. Any collection and storage of data or biological material from research participants for multiple and indefinite uses should be consistent with requirements set forth in the WMA Declaration of Taipei, including the rights of individuals and the principles of governance. A research ethics committee must approve the establishment and monitor ongoing use of such databases and biobanks.

对于生物物质和可识别或可再次识别的数据的收集、处理、储存和可预见的二次使用，医生或其他有资格的个人必须征得研究参与者的自由知情同意。任何收集和储存研究参与者的数据或生物物质以供多次和无限期使用的行为都应符合《世界医学协会台北宣言》中规定的要求，包括个人权利和管理原则。研究伦理委员会必须批准建立此类数据库和生物库，并监督其持续使用情况。

Where consent is impossible or impracticable to obtain, secondary research on stored data or biological material may be done only after consideration and approval of a research ethics committee.

在无法或不可能征得同意的情况下，只有经研究伦理委员会审议和批准后，才能对储存的 数据或生物物质进行二次研究。

Use of Placebo

安慰剂的使用

 

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

新干预措施的益处、风险、负担和有效性必须与已证实的最佳干预措施的益处、风险、负担和有效性进行对比测试，但以下情况除外：

• If no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

       如果没有经过验证的干预措施，使用安慰剂或不采取任何干预措施都是可以接受的；

       或

• If for compelling and scientifically sound methodological reasons the use of any intervention other than the best proven one(s), the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention; and the participants who receive any intervention other than the best proven one(s), placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

      如果出于令人信服和科学合理的方法学原因，有必要使用除已证实的最佳干预措施以外

      的任何干预措施、使用安慰剂或不采取任何干预措施，以确定干预措施的有效性或安全

      性；并且接受除已证实的最佳干预措施、安慰剂或不采取任何干预措施以外的任何干预

      措施的参与者不会因未接受已证实的最佳干预措施而面临遭受严重或不可逆转伤害的额

      外风险。

Extreme care must be taken to avoid abuse of this option.

必须格外注意避免滥用这一方案。

Post-Trial Provisions

试验后规定

 

34. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all participants who still need an intervention identified as beneficial and reasonably safe in the trial. Exceptions to this requirement must be approved by a research ethics committee. Specific information about post-trial provisions must be disclosed to participants as part of informed consent.

在临床试验之前，申办者和研究人员必须安排好试验后的准备工作，由申办者、医疗保健系统或政府为所有仍需要在试验中被确认为有益且合理安全的干预措施的参与者提供。这一要求的例外情况必须得到研究伦理委员会的批准。作为知情同意书的一部分，必须向参与者披露有关试验后规定的具体信息。

Research Registration, Publication, and Dissemination of Results

研究注册、出版和成果推广

 

35. Medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.

涉及人类参与者的医学研究必须在招募第一名参与者之前在可公开访问的数据库中登记。

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

研究人员、作者、申办方、编辑和出版商都有发表和传播研究成果的道德义务。研究人员有义务公开其对人类参与者的研究成果，并对其报告的及时性、完整性和准确性负责。各方都应遵守公认的伦理报告准则。必须公布或以其他方式公开阴性和非结论性以及阳性结果。必须在出版物中声明资金来源、所属机构和利益冲突。不符合本宣言原则的研究报告不应接受发表。

Unproven Interventions in Clinical Practice

临床实践中未经证实的干预措施

 

37. When an unproven intervention is utilized in an attempt to restore health or alleviate suffering for an individual patient because approved options are inadequate or ineffective and enrollment in a clinical trial is not possible, it should subsequently be made the object of research designed to evaluate safety and efficacy. Physicians participating in such interventions must first seek expert advice, weigh possible risks, burdens, and benefits, and obtain informed consent. They must also record and share data when appropriate and avoid compromising clinical trials. These interventions must never be undertaken to circumvent the protections for research participants set forth in this Declaration.

如果由于已获批准的方案不充分或无效，且不可能加入临床试验，而试图使用未经证实的干预措施来恢复患者的健康或减轻其痛苦，则应随后将其作为旨在评估安全性和有效性的研究对象。参与此类干预的医生必须首先征求专家意见，权衡可能的风险、负担和益处，并获得知情同意。他们还必须在适当的时候记录和共享数据，避免影响临床试验。绝不能为了规避本宣言中规定的对研究参与者的保护而采取这些干预措施。

 

Disclaimer: ©2024 World Medical Association. All Rights Reserved. All intellectual property rights in the Declaration of Helsinki are vested in the World Medical Association. The WMA has granted JAMA exclusive rights to publish the English-language version of the Declaration through December 31, 2024.

免责声明：©2024 世界医学协会。保留所有权利。《赫尔辛基宣言》的所有知识产权归世界医学协会所有。世界医学协会已授权《美国医学会杂志》在 2024 年 12 月 31 日之前独家出版该宣言的英文版。