2024年10月19日，在第 75 屆世界醫學會全(quan)體大(da)會上正式通過了《赫(he)爾(er)辛(xin)基宣言》的最(zui)新修訂版本；《赫(he)爾(er)辛(xin)基宣言》作為人類參與者的醫學研究倫理原則，必(bi)將為全(quan)球醫學研究和臨床實踐(jian)帶(dai)來全(quan)新的指引和規範。以下內容是來翻譯自世界醫學官網的譯文內容及其英文原文：

世界醫學會《赫(he)爾(er)辛(xin)基宣言》——涉及人類參與者的醫學研究倫理原則

1964年6月芬兰赫(he)尔(er)辛(xin)基第18届世界医学会全(quan)体大(da)会通过，经下列全(quan)体大(da)会修订；

1975年10月日本东京第29届世界医学会全(quan)体大(da)会；

1983年10月意大(da)利威尼斯第35届世界医学会全(quan)体大(da)会；

1989年9月中国香港第41届世界医学会全(quan)体大(da)会；

1996年10月南非萨默塞特(te)第48届世界医学会全(quan)体大(da)会；

2000年10月英国苏格兰爱丁(ding)堡(bao)第52届世界医学会全(quan)体大(da)会；

2002年美国华(hua)盛顿哥伦比亚特(te)区第53届世界医学会全(quan)体大(da)会（增(zeng)加澄清说明）；

2004年10月日本东京第55届世界医学会全(quan)体大(da)会（增(zeng)加澄清说明）；

2008年10月韩国首尔(er)第59届世界医学会全(quan)体大(da)会；

2013年10月巴(ba)西福塔莱萨第64届世界医学会全(quan)体大(da)会；

2024年10月芬兰赫(he)尔(er)辛(xin)基第75届世界医学会全(quan)体大(da)会。

序言

1、世界医学会（The World Medical Association, WMA）制定《赫(he)尔(er)辛(xin)基宣言》作为涉及人类参与者（包括(kuo)利用可识别(bie)身份的人体材料或数据）的医学研究伦理原则的一项声明。

《宣言》应整体阅读，其每一个构(gou)成段落在应用时应考虑所有其他有关的段落。

2、虽然《宣言》是由医生采纳的，但(dan)世界医学会确信，所有参与医学研究的个人、团队和机构(gou)都应遵守这些原则，因为这些原则对尊重和保(bao)护所有研究参与者，包括(kuo)患(huan)者和健康志愿(yuan)者是至关重要的。

一般原則

3、世界医学会《日内瓦宣言》用以下誓言约束医生：“我的患(huan)者的健康和福祉是我的首要考虑”，《国际医学伦理准则》主张“ 医生必(bi)须把患(huan)者的健康和福祉放(fang)在第一位，必(bi)须以患(huan)者的最(zui)佳利益为出发点提供(gong)医疗护理。”

4、医生有责任促进和保(bao)护患(huan)者——包括(kuo)那些参与医学研究的患(huan)者——的健康、福祉和权利。医生的知识和良心应致力于履行这一责任。

5、医学进步基于最(zui)终必(bi)须包括(kuo)参与者的研究。

即使是经过充分证明的干预措(cuo)施，也应通过研究不断评估其安全(quan)性、有效性、效率、可及性和质量。

6、涉及人类参与者的医学研究应遵循伦理标准，促进并确保(bao)对所有参与者的尊重，保(bao)护他们的健康和权利。

鉴于医学研究是在各种结构(gou)性不平(ping)等的背景下开展的，研究者应仔细考虑如何(he)分配(pei)获益、风险和负担。

应在医学研究开展之前、期间和结束后，与潜在和已(yi)入组的参与者及其社群进行有意义的互(hu)动。研究者应确保(bao)潜在和已(yi)入组的参与者及其社群能(nen)够分享他们的优先事项和价值观，参与研究的设计、实施和其他相关活(huo)动，并参与理解和传播研究结果。

7、涉及人类参与者的医学研究的首要目的是产出知识，以了解疾病的起(qi)因、发展和影响；改进预防、诊(zhen)断和治疗的干预措(cuo)施；并最(zui)终增(zeng)进个人和公众的健康。

这些目的绝不能(nen)凌驾于研究参与者个人的权利和利益之上。

8、虽然在公共卫(wei)生紧急情况下可能(nen)迫切需要新知识和干预措(cuo)施，但(dan)在这种紧急情况下仍必(bi)须维护本宣言中的伦理原则。

9、参与医学研究的医生有责任保(bao)护研究参与者的生命、健康、尊严、完整性、自主性、隐(yin)私和个人信息的保(bao)密。保(bao)护研究参与者的责任必(bi)须始终由医生或其他研究者承担，绝不能(nen)由研究参与者承担，即使他们已(yi)经同意。

10、医生和其他研究者在开展涉及人类参与者的研究时，必(bi)须考虑研究发起(qi)和实施所在国或多国的伦理、法律与监管规范和标准，以及适用的国际规范和标准。任何(he)国家或国际的伦理、法律或监管要求均不得(de)削(xiao)弱(ruo)或取消本《宣言》所述的对研究参与者的任何(he)保(bao)护。

11、医学研究的设计和进行应避免或最(zui)小(xiao)化对环境(jing)的伤(shang)害，并努力实现环境(jing)的可持(chi)续性。

12、涉及人类参与者的医学研究必(bi)须由受过适当的伦理和科学教育(yu)、培训，且具备资质的人员开展。此类研究要求由一名称职且具有适当资质的医生或其他研究者进行监督。

科学诚信对于开展涉及人类参与者的医学研究至关重要。相关个人、团队和机构(gou)必(bi)须严格杜(du)绝科研不端行为。

13 、应为在医学研究中代表(biao)性不足的群体提供(gong)适当的参与研究的机会。

14、将医学研究与医疗照护相结合的医生，只有在研究具有潜在的预防、诊(zhen)断或治疗价值，并且有充分理由相信，参与研究不会对作为研究参与者的患(huan)者健康产生不利影响时，方可让患(huan)者参与研究。

15、必(bi)须确保(bao)对因参与研究而受到伤(shang)害的参与者进行适当的补偿和治疗。

風險，負擔和收益

16、在医疗实践(jian)和医学研究中，大(da)多数干预措(cuo)施都涉及风险和负担。

只有在研究目的的重要性超(chao)过对研究参与者的风险和负担的情况下，才能(nen)进行涉及人类参与者的医学研究。

17、所有涉及人类参与者的医学研究都必(bi)须先对研究涉及的个人和群体的可预测风险和负担进行仔细评估，并与对他们和其他受研究条(tiao)件影响的个人或群体的可预见利益进行比较(jiao)。

必(bi)须采取措(cuo)施确保(bao)风险和负担最(zui)小(xiao)化。研究者必(bi)须对风险和负担进行持(chi)续监测、评估和记录。

18、只有在确认研究的风险和负担得(de)到了全(quan)面(mian)地评估并能(nen)被妥善地管理时，医生和其他研究者才可以开展涉及人类参与者的研究。

当发现风险和负担超(chao)过潜在的获益，或有确凿证据证明研究已(yi)有了明确的结果时，医生和其他研究者必(bi)须对继续、修正，还是立即停止(zhi)该研究进行评估。 

個人、群體和社群的脆弱(ruo)性

19、作为研究参与者，一些个人、群体和社群可能(nen)由于固定的或情境(jing)的及动态的因素(su)而处于更加脆弱(ruo)的境(jing)地，因而受到不公平(ping)对待或遭受伤(shang)害的风险更大(da)。当这些个人、群体和社群有特(te)殊的健康需求时，将他们排除(chu)在医学研究之外可能(nen)会延续或加剧其不平(ping)等。因此，必(bi)须对排除(chu)他们参与研究的危(wei)害与将他们纳入研究的任何(he)危(wei)害进行考虑和权衡(heng)。为了公平(ping)和负责任地将其纳入研究，应考虑给予他们特(te)别(bie)的支持(chi)和保(bao)护。

20、对于处于特(te)别(bie)脆弱(ruo)境(jing)况的个人、群体或社群，只有在能(nen)够满(man)足他们的健康需求和优先事项，并且这些个人、群体或社群能(nen)够从研究产生的知识、实践(jian)或干预措(cuo)施中获益的情况下，开展医学研究才是可以得(de)到辩护的。只有当研究无法在不那么(me)脆弱(ruo)的群体或社群中进行，或者排除(chu)他们可能(nen)会延续或加剧其不平(ping)等时，研究者才能(nen)仅(jin)纳入那些特(te)别(bie)脆弱(ruo)的人。

科學要求和研究方案

21、涉及人类参与者的医学研究必(bi)须具备科学合理和严谨的设计与实施，从而可能(nen)产生可靠、有效和有价值的知识，并避免研究浪费(fei)。研究必(bi)须符合普遍认可的科学原则，这应基于对科学文献、其他相关信息来源、充分的实验室研究，以及适当的动物实验的全(quan)面(mian)知识。

必(bi)须尊重用于研究的动物的福利。

22、所有涉及人类参与者的医学研究的设计和执(zhi)行必(bi)须在研究方案中得(de)到清晰(xi)描述和合理论证。

方案应包括(kuo)一项相关伦理考虑声明，说明如何(he)贯彻本《宣言》所述原则。方案应包括(kuo)以下信息：目的、方法、预期获益与潜在的风险和负担、研究者资质、资金来源、任何(he)潜在的利益冲突、隐(yin)私保(bao)护和信息保(bao)密规定、对参与者的激(ji)励、参与者因参与研究受到损(sun)害的治疗和/或补偿规定，以及研究的任何(he)其他相关方面(mian)的信息。

对于臨床試驗，方案还必(bi)须描述试验后相关规定。

研究倫理委員會

23.研究开始前，方案必(bi)须提交给相关研究伦理委员会进行审议、意见反馈、指导和批准。该委员会的运行必(bi)须透明，必(bi)须具有独立性和权威以抵制来自研究者、申办者或其他的不当影响。委员会必(bi)须有足够的资源来履行其职责，委员和工作人员必(bi)须共同具备足够的教育(yu)、培训、资质和多样(yang)性，以有效地评审各种类型(xing)的研究。

委员会必(bi)须足够熟悉当地的情况和背景，并至少包括(kuo)一名普通公众委员。委员会必(bi)须考虑研究实施所在国或多国的伦理、法律与监管规范和标准，以及适用的国际规范和标准，但(dan)这些规范和标准均不能(nen)削(xiao)弱(ruo)或取消本《宣言》所述的对研究参与者的任何(he)保(bao)护。

开展国际合作研究时，研究方案必(bi)须得(de)到研究申办国和所在国相关研究伦理委员会的批准。

委员会必(bi)须有权监督、建议修改、撤销批准和暂停正在进行的研究。需要进行监督时，研究者必(bi)须向委员会和/或胜任的数据安全(quan)监查实体提供(gong)信息，特(te)别(bie)是关于任何(he)严重不良事件的信息。未经委员会审议和批准，不得(de)对研究方案进行任何(he)修改。研究结束后，研究者必(bi)须向委员会提交结题(ti)报告，包括(kuo)对研究结果和结论的总结。

隱(yin)私和保(bao)密性

24、必(bi)须采取一切预防措(cuo)施，以保(bao)护研究参与者的隐(yin)私和他们的个人信息的保(bao)密性。

自由和知情同意

25、自由和充分的知情同意是尊重个人自主性的重要组成部分。有能(nen)力做出知情同意的个人参与医学研究必(bi)须是自愿(yuan)的。虽然征求家庭成员或社群代表(biao)的意见可能(nen)是恰当的，但(dan)除(chu)非有知情同意能(nen)力的个人自由地表(biao)示同意，否则不能(nen)入组参与研究。

26、在涉及有能(nen)力做出知情同意的人类参与者的医学研究中，必(bi)须以简明的语(yu)言充分告知每个潜在的参与者：目的、方法、预期获益与潜在的风险和负担、研究者资质、资金来源、任何(he)潜在的利益冲突、隐(yin)私保(bao)护和信息保(bao)密规定、对参与者的激(ji)励、参与者因参与研究受到损(sun)害的治疗和/或补偿规定，以及研究的任何(he)其他相关方面(mian)的信息。

必(bi)须告知潜在参与者，他们有权拒绝参与研究或在任何(he)时候撤回参与同意，而不会遭到报复(fu)。应特(te)别(bie)关注个别(bie)潜在参与者的具体信息和沟通需求，以及用于传递信息的方法。

在确保(bao)潜在参与者理解了相关信息后，医生或其他有资质的个人必(bi)须设法获得(de)潜在参与者自由表(biao)达的知情同意，并以书面(mian)或电子形(xing)式正式记录。如果不能(nen)以书面(mian)或电子方式表(biao)达同意，非书面(mian)的同意必(bi)须有正式的见证和记录。

所有医学研究的参与者都应该有权选择是否被告知研究的总体成果和结果。

27、如果潜在的参与者与医生存在依赖(lai)关系，或有可能(nen)被迫同意，在获取其参与研究的知情同意时，医生或其他研究者必(bi)须特(te)别(bie)谨慎。在这种情况下，知情同意必(bi)须由一个合适的、具有资质的，且独立于这种关系之外的个人获取。

28、在涉及无法做出自由和充分的知情同意的人类参与者的医学研究中，医生或其他有资质的个人必(bi)须征求其法定代理人的知情同意，并考虑到潜在参与者所表(biao)达的偏好和价值观。

那些无法做出自由和充分的知情同意的人处于特(te)别(bie)脆弱(ruo)的境(jing)况，有权得(de)到相应的保(bao)护。除(chu)了为特(te)别(bie)脆弱(ruo)者提供(gong)保(bao)护外，对于那些不能(nen)做出知情同意的人，只有在研究很可能(nen)带(dai)来个人获益或仅(jin)涉及最(zui)小(xiao)风险和最(zui)小(xiao)负担的情况下，才能(nen)将其纳入研究。

29、当一个无法做出自由和充分的知情同意的潜在研究参与者能(nen)够表(biao)达同意参与研究的决定时，医生或其他有资质的个人除(chu)了获取法定代理人的知情同意外，还必(bi)须征求潜在参与者的同意，并考虑其所表(biao)达的任何(he)偏好和价值观。潜在参与者的不同意见应该得(de)到尊重。

30、涉及身体或精神(shen)上无法做出自由和充分的知情同意的参与者（例如，失去意识的患(huan)者）时，只有当妨碍(ai)做出知情同意的身体或精神(shen)状况属于研究目标人群的一个必(bi)要特(te)征，研究才能(nen)开展。这种情况下，医生或其他有资质的个人必(bi)须获取法定代理人的知情同意。如果无法找到此类代理人，且研究不能(nen)被延误(wu)，研究可以在未获得(de)知情同意的情况下开展，前提是研究方案中已(yi)经说明将那些因病情不能(nen)做出知情同意的参与者纳入研究的具体理由，并且该研究已(yi)经获得(de)研究伦理委员会的批准。

必(bi)须尽(jin)快获取法定代理人或参与者本人（如果其恢复(fu)了知情同意能(nen)力），继续参与研究的自由和充分的知情同意。

31、医生或其他研究者必(bi)须充分告知潜在参与者其医疗的哪些部分与研究有关。患(huan)者拒绝参与研究或患(huan)者决定退(tui)出研究，绝不能(nen)对医患(huan)关系或提供(gong)标准治疗产生不良影响。

32、对生物材料和可识别(bie)或可重新识别(bie)的数据进行收集、处理、存储，以及可预见的二次利用时，医生或其他有资质的个人必(bi)须获得(de)研究参与者的自由和充分的知情同意。基于多种目的或不确定性目的，收集和存储研究参与者的任何(he)数据或生物材料，都应遵循《世界医学会台北宣言》提出的要求，包括(kuo)个人权利和治理原则。研究伦理委员会必(bi)须对此类数据库和生物样(yang)本库的建立进行批准，并监督其持(chi)续使用。

在获取同意不可能(nen)或不可行的情况下，只有经过研究伦理委员会的考虑和批准，才能(nen)对存储的数据或生物材料进行二次研究。

安慰劑使用

33、新干预措(cuo)施的好处、风险、负担和有效性必(bi)须与最(zui)佳已(yi)证明干预措(cuo)施的好处、风险、负担和有效性进行测试，除(chu)非在以下情况下：

*如果不存在已(yi)被证明的干预措(cuo)施，使用安慰剂或不进行干预是可以接受的；或者

*如果出于令人信服的且科学合理的方法学原因，对于确定一种干预措(cuo)施的有效性或安全(quan)性，使用已(yi)被证明的最(zui)佳干预措(cuo)施之外的任何(he)干预措(cuo)施、使用安慰剂或不进行干预是必(bi)要的；同时，接受其他干预措(cuo)施、安慰剂或不进行干预的参与者，不会承担因未接受已(yi)被证明的最(zui)佳干预措(cuo)施而遭受严重或不可逆伤(shang)害的额外风险。

必(bi)须格外注意避免滥(lan)用这一选择。

試驗後規定

34、在临床试验开展前，申办者和研究者必(bi)须就试验后规定做出安排，通过他们自己、医疗保(bao)健系统或政府，为所有参与者提供(gong)其仍然需要的，在试验中确定为有益且合理安全(quan)的干预措(cuo)施。此要求的例外情况必(bi)须得(de)到研究伦理委员会的批准。关于试验后规定的具体信息必(bi)须作为知情同意的一部分，向参与者披露。

研究注冊、發表(biao)和結果傳播

35、涉及人类参与者的医学研究在招募第一个参与者之前，必(bi)须在公开可访问的数据库中注册。

36、研究者、作者、申办者、编(bian)辑和出版商在发表(biao)和传播研究结果方面(mian)都负有伦理义务。研究者有责任公开涉及人类参与者的研究结果，并对报告的及时性、完整性和准确性负责。所有各方都应遵守公认的指南进行伦理的报道。阴性的、无定论的和阳性的结果都必(bi)须发表(biao)或通过其他途径(jing)公开。资金来源、机构(gou)隶属关系和利益冲突必(bi)须在出版物中声明。不符合本《宣言》原则的研究报告不应被接收发表(biao)。

臨床實踐(jian)中未經證明的幹預措(cuo)施

37、为了恢复(fu)个体患(huan)者的健康或减轻患(huan)者的痛苦(ku)，由于缺(que)少充足的或被证明有效的干预措(cuo)施，且不可能(nen)入组临床试验，而尝试使用的未经证明的干预措(cuo)施，应在随(sui)后被作为研究对象，对其安全(quan)性和有效性进行评估。开展此类干预措(cuo)施的医生必(bi)须首先征求专家建议，权衡(heng)可能(nen)的风险、负担和获益，并获得(de)知情同意。他们还必(bi)须记录，在适当的时候共享数据，并避免影响临床试验。这些干预措(cuo)施绝不能(nen)规避本《宣言》提出的对研究参与者的保(bao)护。

英文原文：

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants

Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964

and amended by the:

29th WMA General Assembly, Tokyo, Japan, October 1975

35th WMA General Assembly, Venice, Italy, October 1983

41st WMA General Assembly, Hong Kong, September 1989

48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996

52nd WMA General Assembly, Edinburgh, Scotland, October 2000

53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)

55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)

59th WMA General Assembly, Seoul, Republic of Korea, October 2008

64th WMA General Assembly, Fortaleza, Brazil, October 2013

and by the 75th WMA General Assembly, Helsinki, Finland, October 2024

PREAMBLE

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.

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.

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.

GENERAL PRINCIPLES

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.”

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.

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.

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.

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

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.

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.

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

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.

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.

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.

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

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.

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

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

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.

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

Risks, Burdens, and Benefits

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

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

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.

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

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.

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.

Individual, Group, and Community Vulnerability

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.

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.

Scientific Requirements and Research Protocols

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.

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

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

Research Ethics Committees

23.The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the research 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.

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.

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

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.

Privacy and Confidentiality

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

Free and Informed Consent

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Use of Placebo

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:

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

*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.

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

Post-Trial Provisions

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.

Research Registration, Publication, and Dissemination of Results

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

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.

Unproven Interventions in Clinical Practice

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.

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