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  • Translator: Joseph Geni Reviewer: Morton Bast

    譯者: Shin-Yuan Tzou 審譯者: Maria Liu

  • I'd like to share with you

    我想與你們分享

  • the story of one of my patients called Celine.

    我的病人之一,席琳的故事

  • Celine is a housewife and lives in a rural district

    席琳是一個生活在農村地區的家庭主婦

  • of Cameroon in west Central Africa.

    中非西部的喀麥隆

  • Six years ago, at the time of her HIV diagnosis,

    六年前,當時她被診斷出患有愛滋病毒

  • she was recruited to participate in the clinical trial

    她就被吸收參加當時的健康區域

  • which was running in her health district at the time.

    進行的臨床試驗

  • When I first met Celine, a little over a year ago,

    一年多以前,當我第一次見到席琳

  • she had gone for 18 months

    她已經過了 18 個月

  • without any antiretroviral therapy,

    沒有任何的抗逆轉錄病毒治療的日子

  • and she was very ill.

    而且她病得很厲害

  • She told me that she stopped coming to the clinic

    她告訴我她已經不去診所了

  • when the trial ended

    當試驗結束的時候

  • because she had no money for the bus fare

    因為她沒有錢買車票

  • and was too ill to walk the 35-kilometer distance.

    而且太虛弱走不完 35 公里的路

  • Now during the clinical trial,

    因為在臨床試驗中

  • she'd been given all her antiretroviral drugs free of charge,

    她可以免費得到抗逆轉錄病毒藥物

  • and her transportation costs

    和交通費

  • had been covered by the research funds.

    這些都由研究經費支出

  • All of these ended once the trial was completed,

    但是只要這個試驗完成結束

  • leaving Celine with no alternatives.

    席琳就別無選擇只好離開

  • She was unable to tell me the names of the drugs

    她無法告訴我在治療期間

  • she'd received during the trial,

    藥物的名稱

  • or even what the trial had been about.

    甚至這個試驗的相關資訊

  • I didn't bother to ask her what the results of the trial were

    我根本毋需刻意去問她試驗的結果

  • because it seemed obvious to me that she would have no clue.

    很明顯地,她也沒有任何線索

  • Yet what puzzled me most

    但我最困惑的

  • was Celine had given her informed consent

    是席琳簽署了一份知情同意書

  • to be a part of this trial, yet she clearly did not understand

    作為試驗的一部分,但她顯然不明白

  • the implications of being a participant

    作為一個參與者的含義

  • or what would happen to her once the trial had been completed.

    或一旦試驗完成會產生什麼樣的結果

  • Now, I have shared this story with you as an example

    現在,我分享這個故事給你們做個例子

  • of what can happen to participants in the clinical trial

    有關在臨床試驗中進行得不順利的參與者

  • when it is poorly conducted.

    會發生什麼事

  • Maybe this particular trial yielded exciting results.

    也許這個特別的試驗產生了令人振奮的成果

  • Maybe it even got published in a high-profile scientific journal.

    也許可以在高知名度的科學雜誌上發表

  • Maybe it would inform clinicians around the world

    也許它告知了全世界的臨床醫生

  • on how to improve on the clinical management of HIV patients.

    如何提升對愛滋病毒患者的臨床管理

  • But it would have done so at a price

    但這樣做的代價

  • to hundreds of patients who, like Celine,

    是數百名像席琳的患者,

  • were left to their own devices

    讓他們自生自滅

  • once the research had been completed.

    一旦研究已經完成

  • I do not stand here today to suggest in any way

    我今天站在這裡,不是指出在

  • that conducting HIV clinical trials

    在發展中國家進行愛滋

  • in developing countries is bad.

    臨床試驗是壞事

  • On the contrary, clinical trials are extremely useful tools,

    相反地,臨床試驗在發展中國家

  • and are much needed to address the burden

    對於公諸大眾這疾病所造成的負擔,是有急迫需要

  • of disease in developing countries.

    並且是極其有用的工具

  • However, the inequalities that exist between

    但是,不平等的現象還是

  • richer countries and developing countries in terms of funding

    存在於富裕國家和發展中國家,就資金而言

  • pose a real risk for exploitation,

    構成實際的開發風險

  • especially in the context of externally-funded research.

    尤其是在外部資金研究的情況下

  • Sadly enough, the fact remains that

    令人遺憾的是,事實上仍然存在於

  • a lot of the studies that are conducted in developing countries

    在發展中國家進行的很多研究

  • could never be authorized in the richer countries

    永遠不可能在較富裕的國家中得到批准

  • which fund the research.

    因為他們提供了研究的資金

  • I'm sure you must be asking yourselves

    我肯定你必須問自己

  • what makes developing countries,

    什麼使得發展中國家

  • especially those in sub-Saharan Africa,

    特別是在撒哈拉以南的非洲地區

  • so attractive for these HIV clinical trials?

    對於這些愛滋病毒臨床試驗有如此大的吸引力?

  • Well, in order for a clinical trial to generate

    嗯,在臨床試驗中,為了產生

  • valid and widely applicable results,

    有效和廣泛適用的結果

  • they need to be conducted with large numbers of study participants

    他們需要大量的參與者來進行研究

  • and preferably on a population

    最好是在新愛滋病毒

  • with a high incidence of new HIV infections.

    感染發生率高的人口地區

  • Sub-Saharan Africa largely fits this description,

    撒哈拉以南的非洲最符合這種條件

  • with 22 million people living with HIV,

    有 2千2百萬人感染了愛滋病毒

  • an estimated 70 percent of the 30 million people

    估計是全世界3千萬愛滋病感染者

  • who are infected worldwide.

    的百分之七十

  • Also, research within the continent

    另外,在非洲大陸內

  • is a lot easier to conduct due to widespread poverty,

    很容易在普遍貧窮、地方疾病

  • endemic diseases and inadequate health care systems.

    與衛生保健系統不足的地區進行研究

  • A clinical trial that is considered to be

    一項被認為

  • potentially beneficial to the population

    對居民可能有利的臨床試驗

  • is more likely to be authorized,

    更容易在沒有良好

  • and in the absence of good health care systems,

    衛生保健系統下獲得認可

  • almost any offer of medical assistance

    幾乎任何醫療援助提供都會

  • is accepted as better than nothing.

    被接受,因為總比沒有好

  • Even more problematic reasons include

    即使當中有更多的問題,像是

  • lower risk of litigation,

    為了降低訴訟風險

  • less rigorous ethical reviews,

    不嚴格的倫理道德審查

  • and populations that are willing to participate

    和願意參加的人員

  • in almost any study that hints at a cure.

    幾乎在任何暗示得以治癒的研究中

  • As funding for HIV research

    當愛滋病毒的研究經費

  • increases in developing countries

    在發展中國家不斷增加

  • and ethical review in richer countries become more strict,

    富有國家倫理審查變得更嚴格

  • you can see why this context becomes

    您可以看到為什麼這事情變得

  • very, very attractive.

    非常、非常有吸引力

  • The high prevalence of HIV drives researchers

    愛滋病的高患病率趨使研究者

  • to conduct research that is sometimes scientifically acceptable

    進行有時候是科學上可接受的研究

  • but on many levels ethically questionable.

    但其道德在多數層面上值得質疑

  • How then can we ensure that, in our search for the cure,

    我們又如何確保,在我們尋求治癒的同時

  • we do not take an unfair advantage

    我們沒有不當受益於那些

  • of those who are already most affected by the pandemic?

    來自於已深受感染的病患

  • I invite you to consider four areas I think we can focus on

    為了改善這些事情完成的方式

  • in order to improve the way in which things are done.

    請你們考慮專心注意的四個領域

  • The first of these is informed consent.

    第一是知情同意書

  • Now, in order for a clinical trial to be

    現在,為了臨床試驗可以

  • considered ethically acceptable,

    在道德上被接受

  • participants must be given the relevant information

    參與者必須被告知他們可以

  • in a way in which they can understand,

    理解的相關資訊

  • and must freely consent to participate in the trial.

    和必須自由同意參加試驗。

  • This is especially important in developing countries,

    這在發展中國家尤其重要

  • where a lot of participants consent to research

    很多參與研究者同意做研究

  • because they believe it is the only way in which

    因為他們認為這是可以得到

  • they can receive medical care or other benefits.

    醫療或其他福利的唯一途徑

  • Consent procedures that are used in richer countries

    富有國家中使用的同意流程

  • are often inappropriate or ineffective

    常常不適用於很多的發展中國家

  • in a lot of developing countries.

    或起不了作用

  • For example, it is counterintuitive to have

    例如,這是違反常理的

  • an illiterate study participant, like Celine,

    研究參與者是文盲,像席琳

  • sign a lengthy consent form that they are unable to read,

    簽署冗長的知情同意書,而他們卻都無法閱讀

  • let alone understand.

    更不用說瞭解

  • Local communities need to be more involved

    當地社區需要多人參與來

  • in establishing the criteria for recruiting participants

    建立吸收臨床試驗參與者的標準

  • in clinical trials, as well as the incentives for participation.

    以及參與者的動機

  • The information in these trials

    這些試驗中的資訊

  • needs to be given to the potential participants

    需要在口頭上告知且以文化上可接受的方式來通知

  • in linguistically and culturally acceptable formats.

    可能的參與者

  • The second point I would like for you to consider

    第二點,我想請你們考慮

  • is the standard of care that is provided

    的是提供給任何臨床試驗參與者

  • to participants within any clinical trial.

    的治療標準

  • Now, this is subject to a lot of debate and controversy.

    現在,這很容易引起辯論和爭議

  • Should the control group in the clinical trial

    臨床試驗中的對照組

  • be given the best current treatment which is available

    是否應該給予

  • anywhere in the world?

    全世界最好的治療?

  • Or should they be given an alternative standard of care,

    或者是,他們應當被給予一個替代標準的治療?

  • such as the best current treatment available

    如正在進行研究中的國家可行的

  • in the country in which the research is being conducted?

    當前最佳治療?

  • Is it fair to evaluate a treatment regimen

    一旦研究完成

  • which may not be affordable or accessible

    參與者可能不是都有機會得到治療

  • to the study participants once the research has been completed?

    而來評估治療方案,這公平嗎?

  • Now, in a situation where the best current treatment

    現在,有一種當前最佳的治療

  • is inexpensive and simple to deliver,

    廉價而且容易提供

  • the answer is straightforward.

    答案就很明確了

  • However, the best current treatment available

    但是,這種全世界都有的

  • anywhere in the world is often very difficult

    當前最佳治療,但就是

  • to provide in developing countries.

    很難在發展中國家中提供

  • It is important to assess the potential risks and benefits

    評估照顧標準的潛在風險和利益,

  • of the standard of care which is to be provided

    以提供給任何參加臨床試驗的參與者

  • to participants in any clinical trial,

    並且建立一個與研究範圍內有關

  • and establish one which is relevant for the context of the study

    並對在研究範圍內對參與者最有利的醫療照顧

  • and most beneficial for the participants within the study.

    是很重要的

  • That brings us to the third point I want you think about:

    接下來我要提出第三點

  • the ethical review of research.

    就是研究的倫理審查

  • An effective system for reviewing the ethical suitability

    臨床試驗的審查道德適用性的有效制度

  • of clinical trials is primordial to safeguard participants

    對保障任何臨床試驗參與者而言

  • within any clinical trial.

    是最根本的

  • Unfortunately, this is often lacking

    不幸的,這通常在發展中國家

  • or inefficient in a lot of developing countries.

    非常欠缺或是效率很低

  • Local governments need to set up effective systems

    地方政府需要建立有效的系統

  • for reviewing the ethical issues around the clinical trials

    以審查臨床試驗的倫理議題

  • which are authorized in different developing countries,

    系統在不同的發展中國家授權

  • and they need to do this by setting up

    而且他們需要建立一個非政府

  • ethical review committees that are independent

    與研究贊助者的

  • of the government and research sponsors.

    道德審查委員會

  • Public accountability needs to be promoted

    公共受托責任需要經由透明

  • through transparency and independent review

    和獨立的審查

  • by nongovernmental and international organizations

    的非政府和國際組織來推動

  • as appropriate.

    較為適當

  • The final point I would like for you to consider tonight

    最後一點,我想請你們今晚考慮一下的就是

  • is what happens to participants in the clinical trial

    一旦研究已經完成

  • once the research has been completed.

    臨床試驗中的參加者會發生什麼情況

  • I think it is absolutely wrong for research to begin

    我認為一開始就沒有明確的計畫

  • in the first place without a clear plan

    這個研究是絕對錯誤的

  • for what would happen to the participants

    因為也不知道一旦臨床試驗結束

  • once the trial has ended.

    參與試驗者會發生什麼事

  • Now, researchers need to make every effort to ensure that

    現在,研究人員需要盡一切努力來確保

  • an intervention that has been shown to be beneficial

    已被證明在臨床試驗期間

  • during a clinical trial

    的介入是有益的

  • is accessible to the participants of the trial

    就是一旦試驗完成

  • once the trial has been completed.

    參與者的狀況是可以被追蹤的到。

  • In addition, they should be able to consider the possibility

    此外,他們應能夠考慮

  • of introducing and maintaining effective treatments

    引進和維護有效治療方法的可能性

  • in the wider community once the trial ends.

    在更廣泛的社會中,一旦試驗結束。

  • If, for any reason, they feel that this might not be possible,

    如果出於任何原因,他們覺得這是不可能的

  • then I think they should have to ethically justify

    那麼,我認為他們應該在道德上證明

  • why the clinical trial should be conducted in the first place.

    臨床試驗的進行為什麼應該被放在第一位是正當的。

  • Now, fortunately for Celine,

    現在,幸運的是對於席琳,

  • our meeting did not end in my office.

    我們的見面並未在我的辦公室結束。

  • I was able to get her enrolled into a free HIV treatment program

    我能讓她登記免費的愛滋病毒治療方案

  • closer to her home,

    離她家很近

  • and with a support group to help her cope.

    還有支援小組來幫她應付。

  • Her story has a positive ending,

    她的故事有一個正面的結局,

  • but there are thousands of others in similar situations

    但還有數以千計的人在類似情況下

  • who are much less fortunate.

    沒這麼幸運。

  • Although she may not know this,

    雖然她可能不知道這一點,

  • my encounter with Celine has completely changed the way

    我和席琳的相遇完全改變了

  • in which I view HIV clinical trials in developing countries,

    我對發展中國家愛滋病毒臨床試驗的看法

  • and made me even more determined to be part of the movement

    並讓我更確定成為活動的一份子

  • to change the way in which things are done.

    去改變目前既定的事實與作法。

  • I believe that every single person

    我相信,每一個人

  • listening to me tonight can be part of that change.

    今晚聽過我的談話就可以成為這種改變的一份子。

  • If you are a researcher, I hold you

    如果你是一位研究人員,我會對你

  • to a higher standard of moral conscience,

    寄望更高的道德良知標準,

  • to remain ethical in your research,

    在你的研究中保持著倫理

  • and not compromise human welfare in your search for answers.

    而非在你尋求的答案中與人類福利妥協。

  • If you work for a funding agency or pharmaceutical company,

    如果你為資助機構或製藥公司工作,

  • I challenge you to hold your employers

    我對你會認為你的雇主

  • to fund research that is ethically sound.

    資助研究是合乎倫理道德的感到質疑。

  • If you come from a developing country like myself,

    如果你像我一樣,來自發展中國家

  • I urge you to hold your government

    我力勸您要求您的政府

  • to a more thorough review of the clinical trials

    對臨床試驗進行更徹底的審查

  • which are authorized in your country.

    這在你的國家是允許的

  • Yes, there is a need for us to find a cure for HIV,

    是的,我們需要找到治療愛滋病毒的方法

  • to find an effective vaccine for malaria,

    和治療瘧疾的有效疫苗

  • to find a diagnostic tool that works for T.B.,

    為結核病尋找診斷工具

  • but I believe that we owe it to those who willingly

    但我相信我們應把它歸功於那些心甘情願地

  • and selflessly consent to participate in these clinical trials

    和無私地同意參加這些臨床試驗的人

  • to do this in a humane way.

    以人道的方式來進行

  • Thank you.

    謝謝。

Translator: Joseph Geni Reviewer: Morton Bast

譯者: Shin-Yuan Tzou 審譯者: Maria Liu

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B1 中級 中文 美國腔 TED 試驗 席琳 研究 參與 治療

【TED】Boghuma Kabisen Titanji:HIV研究中的倫理之謎(Boghuma Kabisen Titanji:HIV研究中的倫理之謎)。 (【TED】Boghuma Kabisen Titanji: Ethical riddles in HIV research (Boghuma Kabisen Titanji: Ethical riddles in HIV research))

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    Zenn 發佈於 2021 年 01 月 14 日
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