World Medical Association
世界醫學會

Proposed revision by WMA DoH Workgroup:
WMA DoH 工作組的擬議修訂：

WMA Declaration of Helsinki
赫爾辛基 WMA 宣言

Ethical Principles for Medical Research Involving Human Participants
涉及人類參與者的醫學研究的倫理原則

PREAMBLE
序言

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.
世界醫學協會 （WMA） 制定了《赫爾辛基宣言》，作為涉及人類參與者的醫學研究的道德原則聲明，包括使用可識別的人體材料或數據進行的研究。

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.
本宣言應作為一個整體來閱讀，其每個組成部分的段落都應在考慮所有其他相關段落的情況下適用。

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.
雖然該宣言被醫生採用，但 WMA 認為，所有參與醫學研究的個人、團隊和組織都應維護這些原則，因為這些原則是尊重和保護所有研究參與者（包括患者和健康志願者）的基礎。

GENERAL PRINCIPLES
一般原則

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.”
WMA 日內瓦宣言以「患者的健康和福祉將是我的首要任務」這句話約束醫生，WMA 國際醫學道德準則宣稱「醫生必須致力於將患者的健康和福祉放在首位，並且必須為患者的最佳利益提供護理。

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. [No proposed changes]
醫生有責任促進和保護患者的健康、福祉和權利，包括那些參與醫學研究的人。醫生的知識和良知致力於履行這一職責。[無建議的更改]

Medical progress is based on research that ultimately must include participants.
醫學進步的基礎是研究，而研究最終必須包括參與者。

Even well-proven interventions should be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality
即使是行之有效的干預措施，也應通過研究不斷評估其安全性、有效性、效率、可及性和品質.

Medical research involving human participants is subject to ethical standards that promote and ensure respect for all participants and protect their health and rights.
涉及人類參與者的醫學研究受道德標準的約束，這些標準促進和確保尊重所有參與者，並保護他們的健康和權利。

Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed.
由於醫學研究是在各種結構性不平等的背景下進行的，因此研究人員應仔細考慮收益、風險和負擔是如何分配的。

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.
應在醫學研究之前、期間和之後與潛在和註冊參與者及其社區進行有意義的接觸。研究人員應使潛在和註冊的參與者及其社區能夠分享他們的優先事項和價值觀;參與研究設計、實施和其他相關活動;並參與理解和傳播結果。

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.
涉及人類參與者的醫學研究的主要目的是產生知識以瞭解疾病的原因、發展和影響;改進預防、診斷和治療干預措施;並最終促進個人和公共衛生。

These purposes can never take precedence over the rights and interests of individual research participants.
這些目的絕不能淩駕於個人研究參與者的權益之上。

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.
雖然在公共衛生緊急情況下可能迫切需要新的知識和干預措施，但在此類緊急情況下，維護本宣言中的道德原則仍然至關重要。

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.
參與醫學研究的醫生有責任保護研究參與者的生命、健康、尊嚴、完整性、自主性、隱私和個人資訊的機密性。保護研究參與者的責任必須始終由醫生或其他研究人員承擔，而不是由研究參與者承擔，即使他們已經同意。

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.
醫生和其他研究人員必須考慮在研究起源國和進行研究的國家/地區涉及人類參與者的研究的道德、法律和監管規範和標準，以及適用的國際規範和標準。 任何國家或國際道德、法律或監管要求均不得減少或消除本宣言中規定的對研究參與者的任何保護。

Medical research should be designed and conducted in a manner that avoids or minimizes harm to the environment and strives for environmental sustainability.
醫學研究的設計和實施應避免或盡量減少對環境的危害，並努力實現環境的可持續性。

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.
涉及人類參與者的醫學研究只能由具有適當道德和科學教育、培訓和資格的個人進行。此類研究需要有能力且具有適當資格的醫生或其他研究人員的監督。

Scientific integrity is essential in the conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct.
科學誠信在進行涉及人類參與者的醫學研究中至關重要。涉事個人、團隊和組織絕不能從事研究不端行為。

Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
應為醫學研究中代表性不足的群體提供適當的參與研究的機會。

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.
將醫學研究與醫療保健相結合的醫生應僅在具有潛在預防、診斷或治療價值的範圍內讓患者參與研究，並且醫生有充分的理由相信參與研究不會對作為研究參與者的患者的健康產生不利影響。

Appropriate compensation and treatment for participants who are harmed as a result of participating in research must be ensured.
必須確保對因參與研究而受到傷害的參與者進行適當的賠償和治療。

Risks, Burdens, and Benefits
風險、負擔和益處

In medical practice and in medical research, most interventions involve risks and burdens.
在醫學實踐和醫學研究中，大多數干預措施都涉及風險和負擔。

Medical research involving human participants may only be conducted if the importance of the objective outweighs the risks and burdens to the research participants.
只有當目標的重要性超過研究參與者的風險和負擔時，才能進行涉及人類參與者的醫學研究。

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.
在進行所有涉及人類參與者的醫學研究之前，必須仔細評估參與研究的個人和團體的可預見風險和負擔，以及對他們以及受調查病症影響的其他個人或團體的可預見利益。

Measures to minimize the risks and burdens must be implemented. The risks and burdens must be continuously monitored, assessed, and documented by the researcher.
必須採取措施將風險和負擔降至最低。研究人員必須持續監測、評估和記錄風險和負擔。

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.
醫生和其他研究人員不得參與涉及人類參與者的研究，除非他們確信風險和負擔已經得到充分評估並且可以得到令人滿意的管理。

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.
當發現風險和負擔超過潛在益處時，或者當有確鑿的證據證明明確的結果時，醫生和其他研究人員必須評估是否繼續、修改或立即停止研究。

Individual, Group, and Community Vulnerability
個人、團體和社區漏洞

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 any harms of inclusion. In order to be fairly and responsibly included in research, they should receive specifically considered support and protections.
由於可能是固定的或背景和動態的因素，一些個人、群體和社區作為研究參與者處於更脆弱的境地，因此面臨更大的被冤枉或受到傷害的風險。當這些個人、群體和社區有獨特的健康需求時，他們被排除在醫學研究之外可能會延續或加劇他們的差距。因此，必須考慮排斥的危害，並權衡包容的任何危害。為了公平和負責任地參與研究，他們應該得到特別考慮的支持和保護。

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.
對處於特別脆弱情況下的個人、群體或社區進行的醫學研究 只有在回應他們的健康需求和優先事項並且個人、群體或社區能夠從由此產生的知識、實踐或干預措施中受益時才有理由。研究人員只應在無法在不太脆弱的群體或社區中進行研究，或者當排除他們可能會延續或加劇他們的差距時，才包括那些處於特別脆弱情況下的人。

Scientific Requirements and Research Protocols
科學要求和研究方案

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.
涉及人類參與者的醫學研究必須具有科學合理和嚴格的設計和執行，有可能產生可靠、有效和有價值的知識，並避免研究浪費。研究必須符合公認的科學原則，基於對科學文獻、其他相關信息來源的透徹瞭解以及適當的實驗室和動物實驗。

The welfare of animals used for research must be respected.
必須尊重用於研究的動物的福利。

The design and performance of all medical research involving human participants must be clearly described and justified in a research protocol.
所有涉及人類參與者的醫學研究的設計和實施必須在研究方案中明確描述和證明。

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.
該協定應包含所涉及的道德考慮的聲明，並應說明如何解決本宣言中的原則。該方案應包括有關目標、方法、預期收益和潛在風險和負擔、研究人員的資格、資金來源、任何潛在利益衝突、保護隱私和機密的規定、對參與者的激勵措施、治療和/或補償因參與而受到傷害的參與者的規定，以及研究的任何其他相關方面。

In clinical trials, the protocol must also describe any post-trial provisions.
在臨床試驗中，方案還必須描述任何試驗后規定。

Research Ethics Committees
Research 倫理委員會

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.
在研究開始之前，必須將方案提交給相關研究倫理委員會以供考慮、評論、指導和批准 。該委員會的運作必須透明，並且必須具有獨立性和權威，以抵制來自研究人員、贊助商或其他人的不當影響。委員會必須有足夠的資源來履行其職責，其成員和工作人員必須集體獲得足夠的教育、培訓、資格和多樣性，以有效地評估其審查的每種類型的研究。

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.
該委員會必須對當地情況和背景有充分的了解，並且至少包括一名公眾成員。它必須考慮到進行研究的國家/地區的道德、法律和監管規範和標準以及適用的國際規範和標準，但不得允許這些減少或消除本宣言中規定的對研究參與者的任何保護。

When collaborative research is performed internationally, the research protocol must be approved by research ethics committees in both the sponsoring and host countries.
當在國際上進行合作研究時，研究方案必須得到贊助國和東道國的研究倫理委員會的批准。

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.
委員會必須有權監督、建議更改、撤回批准和暫停正在進行的研究。在需要監測的情況下，研究人員必須向委員會和/或主管數據和安全監測實體提供資訊，尤其是有關任何嚴重不良事件的資訊。未經委員會考慮和批准，不得對議定書進行修改。研究結束后，研究人員必須向委員會提交一份最終報告，其中包含調查結果和結論的摘要。

Privacy and Confidentiality
隱私和保密

Every precaution must be taken to protect the privacy of research participants and the confidentiality of their personal information.
必須採取一切預防措施來保護研究參與者的隱私及其個人資訊的機密性。

Free and Informed Consent
自由和知情同意

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個人自主權的重要組成部分。能夠給予知情同意的個人參與醫學研究必須是自願的。儘管諮詢家庭成員或社區代表可能是適當的，但能夠給予知情同意的個人不得參與研究，除非他們自願同意。

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.
在涉及能夠給予知情同意的人類參與者的醫學研究中，必須以通俗易懂的語言充分告知每個潛在參與者的目標、方法、預期收益和潛在風險和負擔、研究人員的資格、資金來源、任何潛在的利益衝突、保護隱私和機密的規定、對參與者的激勵措施、治療和/或補償因以下原因而受到傷害的參與者的規定參與以及研究的任何其他相關方面。

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.
必須告知潛在參與者有權隨時拒絕參與研究或撤回參與同意，而不會受到報復。應特別注意個別潛在參與者的具體資訊和通信需求以及用於傳遞資訊的方法。

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.
在確保潛在參與者已理解資訊后，醫生或其他合格個人必須尋求潛在參與者的自由知情同意，並以書面或電子形式正式記錄。如果無法以書面或電子方式表達同意，則必須正式見證和記錄非書面同意。

All medical research participants should be given the option of being informed about the general outcome and results of the research.
所有醫學研究參與者都應該可以選擇瞭解研究的一般結果和結果。

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.
在尋求參與研究的知情同意時，如果潛在參與者與他們處於依賴關係或可能在脅迫下同意，醫生或其他研究人員必須特別小心。在這種情況下，必須由獨立於這種關係的具有適當資格的個人尋求知情同意。

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.
在涉及無法給予自由和知情同意的人類參與者的醫學研究中，醫生或其他合格個人必須尋求合法授權代表的知情同意，同時考慮潛在參與者表達的偏好和價值觀。

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.
那些無法給予自由和知情同意的人 處於特別脆弱的境地，有權獲得相應的保障措施。除了獲得對特別弱勢群體的保護外，只有當研究可能使他們個人受益，或者它只帶來最小的風險和最小的負擔時，才必須包括那些無法給予同意的人。

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.
當無法給予自由和知情同意的潛在研究參與者能夠同意有關參與研究的決定時，醫生或其他合格個人必須在合法授權代表的同意之外尋求該同意，同時考慮潛在參與者表達的任何偏好和價值觀。潛在參與者的異議應該得到尊重。

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.
涉及 身體或精神上無能力給予同意的參與者（例如，昏迷患者）的研究只有在阻止給予知情同意的身體或精神狀況是研究小組的必要特徵時才能進行。在這種情況下，醫生或其他合格個人必須尋求合法授權代表的知情同意。如果沒有這樣的代表並且不能延遲研究，研究可以在沒有知情同意的情況下進行，前提是研究方案中說明瞭讓參與者患有使他們無法給予知情同意的情況的具體原因，並且研究已獲得研究倫理委員會的批准。

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.
必須儘快從合法授權代表那裡獲得自由和知情同意才能繼續參與研究 ，或者如果他們恢復了給予同意的能力，則必須從參與者那裡獲得同意。

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.
醫生或其他研究人員必須充分告知潛在參與者他們的護理的哪些方面與研究相關。患者拒絕參與研究或患者退出研究的決定不得對醫患關係或護理標準的提供產生不利影響。

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.
醫生或其他合格個人必須獲得研究參與者的自由和知情同意，才能收集、處理、存儲和可預見的二次使用生物材料和可識別或再識別的數據。任何從研究參與者收集和存儲數據或生物材料以進行多次和無限期使用的行為，都應符合臺北 WMA 宣言中規定的要求，包括個人權利和治理原則。研究倫理委員會必須批准建立並監督此類資料庫和生物樣本庫的持續使用。

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.
在無法或不切實際地獲得同意的情況下，只有在研究倫理委員會考慮和批准后，才能對存儲的數據或生物材料進行二次研究。

Use of Placebo
安慰劑的使用

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:
新干預措施的益處、風險、負擔和有效性必須與最經過驗證的干預措施進行比較，但以下情況除外：

If no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
如果不存在經過驗證的干預措施，則使用安慰劑或不干預是可以接受的;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.
如果出於令人信服且科學合理的方法論原因，需要使用除最佳證明以外的任何干預措施、使用安慰劑或不進行干預來確定干預措施的有效性或安全性;以及接受除最佳證明之外的任何干預、安慰劑或不干預的參與者不會  因未接受最好的經過驗證的干預措施。

Extreme care must be taken to avoid abuse of this option.
必須格外小心，以避免濫用此選項。

Post-Trial Provisions
審後條款

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.
在臨床試驗之前，試驗后規定必須由申辦方和研究人員安排，由他們自己、醫療保健系統或政府為所有仍然需要試驗中確定為有益且合理安全的干預措施的參與者提供。此要求的例外情況必須得到研究倫理委員會的批准。作為知情同意的一部分，必須向參與者披露有關試驗后條款的具體資訊。

Research Registration, Publication, and Dissemination of Results
研究註冊、出版和結果傳播

Medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.
在招募第一位參與者之前，涉及人類參與者的醫學研究必須在可公開訪問的資料庫中註冊。

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.
研究人員、作者、贊助商、編輯和出版商都對研究成果的出版和傳播負有道德義務。研究人員有責任公開他們對人類參與者的研究結果，並對其報告的及時性、完整性和準確性負責。所有各方都應遵守公認的道德報告準則。陰性和不確定以及陽性結果必須公佈或以其他方式公開。必須在出版物中聲明資金來源、機構隸屬關係和利益衝突。不符合本宣言原則的研究報告不應被接受出版。

Unproven Interventions in Clinical Practice
臨床實踐中未經證實的干預措施

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.
當由於批准的選項不充分或無效並且無法參加臨床試驗而使用未經證實的干預措施來試圖恢復個體患者的健康或減輕其痛苦時，應將其隨後作為旨在評估安全性和有效性的研究物件。參與此類干預的醫生必須首先尋求專家建議，權衡可能的風險、負擔和益處，並獲得知情同意。他們還必須在適當的時候記錄和共享數據，並避免影響臨床試驗。絕不能採取這些干預措施來規避本宣言中規定的對研究參與者的保護。

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10.10.2024
10 10.2024