2024年10月19日，在第 75 屆世界醫(yī)學(xué)會(huì)全體大會(huì)上正式通過(guò)了《赫爾辛基宣言》的最新修訂版本；《赫爾辛基宣言》作為人類參與者的醫(yī)學(xué)研究倫理原則，必將為全球醫(yī)學(xué)研究和臨床實(shí)踐帶來(lái)全新的指引和規(guī)范。以下內(nèi)容是來(lái)翻譯自世界醫(yī)學(xué)官網(wǎng)的譯文內(nèi)容及其英文原文：

世界醫(yī)學(xué)會(huì)《赫爾辛基宣言》——涉及人類參與者的醫(yī)學(xué)研究倫理原則

1964年6月芬蘭赫爾辛基第18屆世界醫(yī)學(xué)會(huì)全體大會(huì)通過(guò)，經(jīng)下列全體大會(huì)修訂；

1975年10月日本東京第29屆世界醫(yī)學(xué)會(huì)全體大會(huì)；

1983年10月意大利威尼斯第35屆世界醫(yī)學(xué)會(huì)全體大會(huì)；

1989年9月中國(guó)香港第41屆世界醫(yī)學(xué)會(huì)全體大會(huì)；

1996年10月南非薩默塞特第48屆世界醫(yī)學(xué)會(huì)全體大會(huì)；

2000年10月英國(guó)蘇格蘭愛(ài)丁堡第52屆世界醫(yī)學(xué)會(huì)全體大會(huì)；

2002年美國(guó)華盛頓哥倫比亞特區(qū)第53屆世界醫(yī)學(xué)會(huì)全體大會(huì)（增加澄清說(shuō)明）；

2004年10月日本東京第55屆世界醫(yī)學(xué)會(huì)全體大會(huì)（增加澄清說(shuō)明）；

2008年10月韓國(guó)首爾第59屆世界醫(yī)學(xué)會(huì)全體大會(huì)；

2013年10月巴西福塔萊薩第64屆世界醫(yī)學(xué)會(huì)全體大會(huì)；

2024年10月芬蘭赫爾辛基第75屆世界醫(yī)學(xué)會(huì)全體大會(huì)。

序言

1、世界醫(yī)學(xué)會(huì)（The World Medical Association, WMA）制定《赫爾辛基宣言》作為涉及人類參與者（包括利用可識(shí)別身份的人體材料或數(shù)據(jù)）的醫(yī)學(xué)研究倫理原則的一項(xiàng)聲明。

《宣言》應(yīng)整體閱讀，其每一個(gè)構(gòu)成段落在應(yīng)用時(shí)應(yīng)考慮所有其他有關(guān)的段落。

2、雖然《宣言》是由醫(yī)生采納的，但世界醫(yī)學(xué)會(huì)確信，所有參與醫(yī)學(xué)研究的個(gè)人、團(tuán)隊(duì)和機(jī)構(gòu)都應(yīng)遵守這些原則，因?yàn)檫@些原則對(duì)尊重和保護(hù)所有研究參與者，包括患者和健康志愿者是至關(guān)重要的。

一般原則

3、世界醫(yī)學(xué)會(huì)《日內(nèi)瓦宣言》用以下誓言約束醫(yī)生：“我的患者的健康和福祉是我的首要考慮”，《國(guó)際醫(yī)學(xué)倫理準(zhǔn)則》主張“ 醫(yī)生必須把患者的健康和福祉放在第一位，必須以患者的最佳利益為出發(fā)點(diǎn)提供醫(yī)療護(hù)理?！?

4、醫(yī)生有責(zé)任促進(jìn)和保護(hù)患者——包括那些參與醫(yī)學(xué)研究的患者——的健康、福祉和權(quán)利。醫(yī)生的知識(shí)和良心應(yīng)致力于履行這一責(zé)任。

5、醫(yī)學(xué)進(jìn)步基于最終必須包括參與者的研究。

即使是經(jīng)過(guò)充分證明的干預(yù)措施，也應(yīng)通過(guò)研究不斷評(píng)估其安全性、有效性、效率、可及性和質(zhì)量。

6、涉及人類參與者的醫(yī)學(xué)研究應(yīng)遵循倫理標(biāo)準(zhǔn)，促進(jìn)并確保對(duì)所有參與者的尊重，保護(hù)他們的健康和權(quán)利。

鑒于醫(yī)學(xué)研究是在各種結(jié)構(gòu)性不平等的背景下開(kāi)展的，研究者應(yīng)仔細(xì)考慮如何分配獲益、風(fēng)險(xiǎn)和負(fù)擔(dān)。

應(yīng)在醫(yī)學(xué)研究開(kāi)展之前、期間和結(jié)束后，與潛在和已入組的參與者及其社群進(jìn)行有意義的互動(dòng)。研究者應(yīng)確保潛在和已入組的參與者及其社群能夠分享他們的優(yōu)先事項(xiàng)和價(jià)值觀，參與研究的設(shè)計(jì)、實(shí)施和其他相關(guān)活動(dòng)，并參與理解和傳播研究結(jié)果。

7、涉及人類參與者的醫(yī)學(xué)研究的首要目的是產(chǎn)出知識(shí)，以了解疾病的起因、發(fā)展和影響；改進(jìn)預(yù)防、診斷和治療的干預(yù)措施；并最終增進(jìn)個(gè)人和公眾的健康。

這些目的絕不能凌駕于研究參與者個(gè)人的權(quán)利和利益之上。

8、雖然在公共衛(wèi)生緊急情況下可能迫切需要新知識(shí)和干預(yù)措施，但在這種緊急情況下仍必須維護(hù)本宣言中的倫理原則。

9、參與醫(yī)學(xué)研究的醫(yī)生有責(zé)任保護(hù)研究參與者的生命、健康、尊嚴(yán)、完整性、自主性、隱私和個(gè)人信息的保密。保護(hù)研究參與者的責(zé)任必須始終由醫(yī)生或其他研究者承擔(dān)，絕不能由研究參與者承擔(dān)，即使他們已經(jīng)同意。

10、醫(yī)生和其他研究者在開(kāi)展涉及人類參與者的研究時(shí)，必須考慮研究發(fā)起和實(shí)施所在國(guó)或多國(guó)的倫理、法律與監(jiān)管規(guī)范和標(biāo)準(zhǔn)，以及適用的國(guó)際規(guī)范和標(biāo)準(zhǔn)。任何國(guó)家或國(guó)際的倫理、法律或監(jiān)管要求均不得削弱或取消本《宣言》所述的對(duì)研究參與者的任何保護(hù)。

11、醫(yī)學(xué)研究的設(shè)計(jì)和進(jìn)行應(yīng)避免或最小化對(duì)環(huán)境的傷害，并努力實(shí)現(xiàn)環(huán)境的可持續(xù)性。

12、涉及人類參與者的醫(yī)學(xué)研究必須由受過(guò)適當(dāng)?shù)膫惱砗涂茖W(xué)教育、培訓(xùn)，且具備資質(zhì)的人員開(kāi)展。此類研究要求由一名稱職且具有適當(dāng)資質(zhì)的醫(yī)生或其他研究者進(jìn)行監(jiān)督。

科學(xué)誠(chéng)信對(duì)于開(kāi)展涉及人類參與者的醫(yī)學(xué)研究至關(guān)重要。相關(guān)個(gè)人、團(tuán)隊(duì)和機(jī)構(gòu)必須嚴(yán)格杜絕科研不端行為。

13 、應(yīng)為在醫(yī)學(xué)研究中代表性不足的群體提供適當(dāng)?shù)膮⑴c研究的機(jī)會(huì)。

14、將醫(yī)學(xué)研究與醫(yī)療照護(hù)相結(jié)合的醫(yī)生，只有在研究具有潛在的預(yù)防、診斷或治療價(jià)值，并且有充分理由相信，參與研究不會(huì)對(duì)作為研究參與者的患者健康產(chǎn)生不利影響時(shí)，方可讓患者參與研究。

15、必須確保對(duì)因參與研究而受到傷害的參與者進(jìn)行適當(dāng)?shù)难a(bǔ)償和治療。

風(fēng)險(xiǎn)，負(fù)擔(dān)和收益

16、在醫(yī)療實(shí)踐和醫(yī)學(xué)研究中，大多數(shù)干預(yù)措施都涉及風(fēng)險(xiǎn)和負(fù)擔(dān)。

只有在研究目的的重要性超過(guò)對(duì)研究參與者的風(fēng)險(xiǎn)和負(fù)擔(dān)的情況下，才能進(jìn)行涉及人類參與者的醫(yī)學(xué)研究。

17、所有涉及人類參與者的醫(yī)學(xué)研究都必須先對(duì)研究涉及的個(gè)人和群體的可預(yù)測(cè)風(fēng)險(xiǎn)和負(fù)擔(dān)進(jìn)行仔細(xì)評(píng)估，并與對(duì)他們和其他受研究條件影響的個(gè)人或群體的可預(yù)見(jiàn)利益進(jìn)行比較。

必須采取措施確保風(fēng)險(xiǎn)和負(fù)擔(dān)最小化。研究者必須對(duì)風(fēng)險(xiǎn)和負(fù)擔(dān)進(jìn)行持續(xù)監(jiān)測(cè)、評(píng)估和記錄。

18、只有在確認(rèn)研究的風(fēng)險(xiǎn)和負(fù)擔(dān)得到了全面地評(píng)估并能被妥善地管理時(shí)，醫(yī)生和其他研究者才可以開(kāi)展涉及人類參與者的研究。

當(dāng)發(fā)現(xiàn)風(fēng)險(xiǎn)和負(fù)擔(dān)超過(guò)潛在的獲益，或有確鑿證據(jù)證明研究已有了明確的結(jié)果時(shí)，醫(yī)生和其他研究者必須對(duì)繼續(xù)、修正，還是立即停止該研究進(jìn)行評(píng)估。 

個(gè)人、群體和社群的脆弱性

19、作為研究參與者，一些個(gè)人、群體和社群可能由于固定的或情境的及動(dòng)態(tài)的因素而處于更加脆弱的境地，因而受到不公平對(duì)待或遭受傷害的風(fēng)險(xiǎn)更大。當(dāng)這些個(gè)人、群體和社群有特殊的健康需求時(shí)，將他們排除在醫(yī)學(xué)研究之外可能會(huì)延續(xù)或加劇其不平等。因此，必須對(duì)排除他們參與研究的危害與將他們納入研究的任何危害進(jìn)行考慮和權(quán)衡。為了公平和負(fù)責(zé)任地將其納入研究，應(yīng)考慮給予他們特別的支持和保護(hù)。

20、對(duì)于處于特別脆弱境況的個(gè)人、群體或社群，只有在能夠滿足他們的健康需求和優(yōu)先事項(xiàng)，并且這些個(gè)人、群體或社群能夠從研究產(chǎn)生的知識(shí)、實(shí)踐或干預(yù)措施中獲益的情況下，開(kāi)展醫(yī)學(xué)研究才是可以得到辯護(hù)的。只有當(dāng)研究無(wú)法在不那么脆弱的群體或社群中進(jìn)行，或者排除他們可能會(huì)延續(xù)或加劇其不平等時(shí)，研究者才能僅納入那些特別脆弱的人。

科學(xué)要求和研究方案

21、涉及人類參與者的醫(yī)學(xué)研究必須具備科學(xué)合理和嚴(yán)謹(jǐn)?shù)脑O(shè)計(jì)與實(shí)施，從而可能產(chǎn)生可靠、有效和有價(jià)值的知識(shí)，并避免研究浪費(fèi)。研究必須符合普遍認(rèn)可的科學(xué)原則，這應(yīng)基于對(duì)科學(xué)文獻(xiàn)、其他相關(guān)信息來(lái)源、充分的實(shí)驗(yàn)室研究，以及適當(dāng)?shù)膭?dòng)物實(shí)驗(yàn)的全面知識(shí)。

必須尊重用于研究的動(dòng)物的福利。

22、所有涉及人類參與者的醫(yī)學(xué)研究的設(shè)計(jì)和執(zhí)行必須在研究方案中得到清晰描述和合理論證。

方案應(yīng)包括一項(xiàng)相關(guān)倫理考慮聲明，說(shuō)明如何貫徹本《宣言》所述原則。方案應(yīng)包括以下信息：目的、方法、預(yù)期獲益與潛在的風(fēng)險(xiǎn)和負(fù)擔(dān)、研究者資質(zhì)、資金來(lái)源、任何潛在的利益沖突、隱私保護(hù)和信息保密規(guī)定、對(duì)參與者的激勵(lì)、參與者因參與研究受到損害的治療和/或補(bǔ)償規(guī)定，以及研究的任何其他相關(guān)方面的信息。

對(duì)于臨床試驗(yàn)，方案還必須描述試驗(yàn)后相關(guān)規(guī)定。

研究倫理委員會(huì)

23.研究開(kāi)始前，方案必須提交給相關(guān)研究倫理委員會(huì)進(jìn)行審議、意見(jiàn)反饋、指導(dǎo)和批準(zhǔn)。該委員會(huì)的運(yùn)行必須透明，必須具有獨(dú)立性和權(quán)威以抵制來(lái)自研究者、申辦者或其他的不當(dāng)影響。委員會(huì)必須有足夠的資源來(lái)履行其職責(zé)，委員和工作人員必須共同具備足夠的教育、培訓(xùn)、資質(zhì)和多樣性，以有效地評(píng)審各種類型的研究。

委員會(huì)必須足夠熟悉當(dāng)?shù)氐那闆r和背景，并至少包括一名普通公眾委員。委員會(huì)必須考慮研究實(shí)施所在國(guó)或多國(guó)的倫理、法律與監(jiān)管規(guī)范和標(biāo)準(zhǔn)，以及適用的國(guó)際規(guī)范和標(biāo)準(zhǔn)，但這些規(guī)范和標(biāo)準(zhǔn)均不能削弱或取消本《宣言》所述的對(duì)研究參與者的任何保護(hù)。

開(kāi)展國(guó)際合作研究時(shí)，研究方案必須得到研究申辦國(guó)和所在國(guó)相關(guān)研究倫理委員會(huì)的批準(zhǔn)。

委員會(huì)必須有權(quán)監(jiān)督、建議修改、撤銷批準(zhǔn)和暫停正在進(jìn)行的研究。需要進(jìn)行監(jiān)督時(shí)，研究者必須向委員會(huì)和/或勝任的數(shù)據(jù)安全監(jiān)查實(shí)體提供信息，特別是關(guān)于任何嚴(yán)重不良事件的信息。未經(jīng)委員會(huì)審議和批準(zhǔn)，不得對(duì)研究方案進(jìn)行任何修改。研究結(jié)束后，研究者必須向委員會(huì)提交結(jié)題報(bào)告，包括對(duì)研究結(jié)果和結(jié)論的總結(jié)。

隱私和保密性

24、必須采取一切預(yù)防措施，以保護(hù)研究參與者的隱私和他們的個(gè)人信息的保密性。

自由和知情同意

25、自由和充分的知情同意是尊重個(gè)人自主性的重要組成部分。有能力做出知情同意的個(gè)人參與醫(yī)學(xué)研究必須是自愿的。雖然征求家庭成員或社群代表的意見(jiàn)可能是恰當(dāng)?shù)?，但除非有知情同意能力的個(gè)人自由地表示同意，否則不能入組參與研究。

26、在涉及有能力做出知情同意的人類參與者的醫(yī)學(xué)研究中，必須以簡(jiǎn)明的語(yǔ)言充分告知每個(gè)潛在的參與者：目的、方法、預(yù)期獲益與潛在的風(fēng)險(xiǎn)和負(fù)擔(dān)、研究者資質(zhì)、資金來(lái)源、任何潛在的利益沖突、隱私保護(hù)和信息保密規(guī)定、對(duì)參與者的激勵(lì)、參與者因參與研究受到損害的治療和/或補(bǔ)償規(guī)定，以及研究的任何其他相關(guān)方面的信息。

必須告知潛在參與者，他們有權(quán)拒絕參與研究或在任何時(shí)候撤回參與同意，而不會(huì)遭到報(bào)復(fù)。應(yīng)特別關(guān)注個(gè)別潛在參與者的具體信息和溝通需求，以及用于傳遞信息的方法。

在確保潛在參與者理解了相關(guān)信息后，醫(yī)生或其他有資質(zhì)的個(gè)人必須設(shè)法獲得潛在參與者自由表達(dá)的知情同意，并以書(shū)面或電子形式正式記錄。如果不能以書(shū)面或電子方式表達(dá)同意，非書(shū)面的同意必須有正式的見(jiàn)證和記錄。

所有醫(yī)學(xué)研究的參與者都應(yīng)該有權(quán)選擇是否被告知研究的總體成果和結(jié)果。

27、如果潛在的參與者與醫(yī)生存在依賴關(guān)系，或有可能被迫同意，在獲取其參與研究的知情同意時(shí)，醫(yī)生或其他研究者必須特別謹(jǐn)慎。在這種情況下，知情同意必須由一個(gè)合適的、具有資質(zhì)的，且獨(dú)立于這種關(guān)系之外的個(gè)人獲取。

28、在涉及無(wú)法做出自由和充分的知情同意的人類參與者的醫(yī)學(xué)研究中，醫(yī)生或其他有資質(zhì)的個(gè)人必須征求其法定代理人的知情同意，并考慮到潛在參與者所表達(dá)的偏好和價(jià)值觀。

那些無(wú)法做出自由和充分的知情同意的人處于特別脆弱的境況，有權(quán)得到相應(yīng)的保護(hù)。除了為特別脆弱者提供保護(hù)外，對(duì)于那些不能做出知情同意的人，只有在研究很可能帶來(lái)個(gè)人獲益或僅涉及最小風(fēng)險(xiǎn)和最小負(fù)擔(dān)的情況下，才能將其納入研究。

29、當(dāng)一個(gè)無(wú)法做出自由和充分的知情同意的潛在研究參與者能夠表達(dá)同意參與研究的決定時(shí)，醫(yī)生或其他有資質(zhì)的個(gè)人除了獲取法定代理人的知情同意外，還必須征求潛在參與者的同意，并考慮其所表達(dá)的任何偏好和價(jià)值觀。潛在參與者的不同意見(jiàn)應(yīng)該得到尊重。

30、涉及身體或精神上無(wú)法做出自由和充分的知情同意的參與者（例如，失去意識(shí)的患者）時(shí)，只有當(dāng)妨礙做出知情同意的身體或精神狀況屬于研究目標(biāo)人群的一個(gè)必要特征，研究才能開(kāi)展。這種情況下，醫(yī)生或其他有資質(zhì)的個(gè)人必須獲取法定代理人的知情同意。如果無(wú)法找到此類代理人，且研究不能被延誤，研究可以在未獲得知情同意的情況下開(kāi)展，前提是研究方案中已經(jīng)說(shuō)明將那些因病情不能做出知情同意的參與者納入研究的具體理由，并且該研究已經(jīng)獲得研究倫理委員會(huì)的批準(zhǔn)。

必須盡快獲取法定代理人或參與者本人（如果其恢復(fù)了知情同意能力），繼續(xù)參與研究的自由和充分的知情同意。

31、醫(yī)生或其他研究者必須充分告知潛在參與者其醫(yī)療的哪些部分與研究有關(guān)?；颊呔芙^參與研究或患者決定退出研究，絕不能對(duì)醫(yī)患關(guān)系或提供標(biāo)準(zhǔn)治療產(chǎn)生不良影響。

32、對(duì)生物材料和可識(shí)別或可重新識(shí)別的數(shù)據(jù)進(jìn)行收集、處理、存儲(chǔ)，以及可預(yù)見(jiàn)的二次利用時(shí)，醫(yī)生或其他有資質(zhì)的個(gè)人必須獲得研究參與者的自由和充分的知情同意?；诙喾N目的或不確定性目的，收集和存儲(chǔ)研究參與者的任何數(shù)據(jù)或生物材料，都應(yīng)遵循《世界醫(yī)學(xué)會(huì)臺(tái)北宣言》提出的要求，包括個(gè)人權(quán)利和治理原則。研究倫理委員會(huì)必須對(duì)此類數(shù)據(jù)庫(kù)和生物樣本庫(kù)的建立進(jìn)行批準(zhǔn)，并監(jiān)督其持續(xù)使用。

在獲取同意不可能或不可行的情況下，只有經(jīng)過(guò)研究倫理委員會(huì)的考慮和批準(zhǔn)，才能對(duì)存儲(chǔ)的數(shù)據(jù)或生物材料進(jìn)行二次研究。

安慰劑使用

33、新干預(yù)措施的好處、風(fēng)險(xiǎn)、負(fù)擔(dān)和有效性必須與最佳已證明干預(yù)措施的好處、風(fēng)險(xiǎn)、負(fù)擔(dān)和有效性進(jìn)行測(cè)試，除非在以下情況下：

*如果不存在已被證明的干預(yù)措施，使用安慰劑或不進(jìn)行干預(yù)是可以接受的；或者

*如果出于令人信服的且科學(xué)合理的方法學(xué)原因，對(duì)于確定一種干預(yù)措施的有效性或安全性，使用已被證明的最佳干預(yù)措施之外的任何干預(yù)措施、使用安慰劑或不進(jìn)行干預(yù)是必要的；同時(shí)，接受其他干預(yù)措施、安慰劑或不進(jìn)行干預(yù)的參與者，不會(huì)承擔(dān)因未接受已被證明的最佳干預(yù)措施而遭受嚴(yán)重或不可逆?zhèn)Φ念~外風(fēng)險(xiǎn)。

必須格外注意避免濫用這一選擇。

試驗(yàn)后規(guī)定

34、在臨床試驗(yàn)開(kāi)展前，申辦者和研究者必須就試驗(yàn)后規(guī)定做出安排，通過(guò)他們自己、醫(yī)療保健系統(tǒng)或政府，為所有參與者提供其仍然需要的，在試驗(yàn)中確定為有益且合理安全的干預(yù)措施。此要求的例外情況必須得到研究倫理委員會(huì)的批準(zhǔn)。關(guān)于試驗(yàn)后規(guī)定的具體信息必須作為知情同意的一部分，向參與者披露。

研究注冊(cè)、發(fā)表和結(jié)果傳播

35、涉及人類參與者的醫(yī)學(xué)研究在招募第一個(gè)參與者之前，必須在公開(kāi)可訪問(wèn)的數(shù)據(jù)庫(kù)中注冊(cè)。

36、研究者、作者、申辦者、編輯和出版商在發(fā)表和傳播研究結(jié)果方面都負(fù)有倫理義務(wù)。研究者有責(zé)任公開(kāi)涉及人類參與者的研究結(jié)果，并對(duì)報(bào)告的及時(shí)性、完整性和準(zhǔn)確性負(fù)責(zé)。所有各方都應(yīng)遵守公認(rèn)的指南進(jìn)行倫理的報(bào)道。陰性的、無(wú)定論的和陽(yáng)性的結(jié)果都必須發(fā)表或通過(guò)其他途徑公開(kāi)。資金來(lái)源、機(jī)構(gòu)隸屬關(guān)系和利益沖突必須在出版物中聲明。不符合本《宣言》原則的研究報(bào)告不應(yīng)被接收發(fā)表。

臨床實(shí)踐中未經(jīng)證明的干預(yù)措施

37、為了恢復(fù)個(gè)體患者的健康或減輕患者的痛苦，由于缺少充足的或被證明有效的干預(yù)措施，且不可能入組臨床試驗(yàn)，而嘗試使用的未經(jīng)證明的干預(yù)措施，應(yīng)在隨后被作為研究對(duì)象，對(duì)其安全性和有效性進(jìn)行評(píng)估。開(kāi)展此類干預(yù)措施的醫(yī)生必須首先征求專家建議，權(quán)衡可能的風(fēng)險(xiǎn)、負(fù)擔(dān)和獲益，并獲得知情同意。他們還必須記錄，在適當(dāng)?shù)臅r(shí)候共享數(shù)據(jù)，并避免影響臨床試驗(yàn)。這些干預(yù)措施絕不能規(guī)避本《宣言》提出的對(duì)研究參與者的保護(hù)。

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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