Boghuma Kabisen Titanji: Ethical riddles in HIV research

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。