Boghuma Kabisen Titanji: Ethical riddles in HIV research

49,662 views ใƒป 2013-01-10

TED


ืื ื ืœื—ืฅ ืคืขืžื™ื™ื ืขืœ ื”ื›ืชื•ื‘ื™ื•ืช ื‘ืื ื’ืœื™ืช ืœืžื˜ื” ื›ื“ื™ ืœื”ืคืขื™ืœ ืืช ื”ืกืจื˜ื•ืŸ.

00:00
Translator: Joseph Geni Reviewer: Morton Bast
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ืžืชืจื’ื: Shlomo Adam ืžื‘ืงืจ: Ido Dekkers
00:16
I'd like to share with you
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ื‘ืจืฆื•ื ื™ ืœืฉืชืฃ ืืชื›ื
00:18
the story of one of my patients called Celine.
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ื‘ืกื™ืคื•ืจื” ืฉืœ ืื—ืช ื”ื—ื•ืœื•ืช ืฉืœื™, ืฉืฉืžื” ืกืœื™ืŸ.
00:22
Celine is a housewife and lives in a rural district
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ืกืœื™ืŸ ื”ื™ื ืขืงืจืช-ื‘ื™ืช ืฉื—ื™ื” ื‘ืื–ื•ืจ ื›ืคืจื™
00:25
of Cameroon in west Central Africa.
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ืฉืœ ืงืžืจื•ืŸ ืฉื‘ืžืจื›ื– ืืคืจื™ืงื” ื”ืžืขืจื‘ื™ืช.
00:28
Six years ago, at the time of her HIV diagnosis,
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ืœืคื ื™ 6 ืฉื ื™ื, ื›ืฉืื•ื‘ื—ื ื” ื›ื—ื•ืœืช ืื™ื™ื“ืก,
00:32
she was recruited to participate in the clinical trial
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ื”ื™ื ื’ื•ื™ื™ืกื” ืœื”ืฉืชืชืฃ ื‘ื ื™ืกื•ื™ ื”ืงืœื™ื ื™
00:35
which was running in her health district at the time.
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ืฉื ืขืจืš ืื– ื‘ืžื—ื•ื– ื”ื‘ืจื™ืื•ืชื™ ืฉืœื”.
00:38
When I first met Celine, a little over a year ago,
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ื›ืฉืคื’ืฉืชื™ ืœืจืืฉื•ื ื” ืืช ืกืœื™ืŸ, ืœืคื ื™ ืงืฆืช ื™ื•ืชืจ ืžืฉื ื”,
00:42
she had gone for 18 months
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ืขื‘ืจื• ืขืœื™ื” ื›ื‘ืจ 18 ื—ื•ื“ืฉื™ื
00:44
without any antiretroviral therapy,
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ืœืœื ื›ืœ ื˜ื™ืคื•ืœ ืื ื˜ื™-ื ื’ื™ืคื™,
00:46
and she was very ill.
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ื•ื”ื™ืชื” ื—ื•ืœื” ืžืื“.
00:49
She told me that she stopped coming to the clinic
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ื”ื™ื ืกื™ืคืจื” ืœื™ ืฉื”ืคืกื™ืงื” ืœื”ื’ื™ืข ืœืžืจืคืื”
00:51
when the trial ended
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ื›ืฉื”ื ื™ืกื•ื™ ื”ืกืชื™ื™ื
00:53
because she had no money for the bus fare
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ื›ื™ ืœื ื”ื™ื” ืœื” ื›ืกืฃ ืขื‘ื•ืจ ื”ืื•ื˜ื•ื‘ื•ืก
00:55
and was too ill to walk the 35-kilometer distance.
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ื•ื”ื™ื ื”ื™ืชื” ื—ื•ืœื” ืžื›ื“ื™ ืœืœื›ืช ืžืจื—ืง ืฉืœ 35 ืงื™ืœื•ืžื˜ืจื™ื.
00:59
Now during the clinical trial,
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ื‘ื–ืžืŸ ื”ื ื™ืกื•ื™ ื”ืงืœื™ื ื™
01:01
she'd been given all her antiretroviral drugs free of charge,
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ื”ื™ื ืงื™ื‘ืœื” ื›ืœ ืžื™ื ื™ ืชืจื•ืคื•ืช ืื ื˜ื™-ื ื’ื™ืคื™ื•ืช ื‘ื—ื™ื ื,
01:05
and her transportation costs
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ื•ื’ื ื“ืžื™ ื”ื ืกื™ืขื”
01:07
had been covered by the research funds.
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ื›ื•ืกื• ืข"ื™ ืงืจืŸ ื”ืžื—ืงืจ.
01:10
All of these ended once the trial was completed,
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ื›ืœ ื–ื” ื ื’ืžืจ ื‘ืจื’ืข ืฉื”ื ื™ืกื•ื™ ื”ื•ืฉืœื,
01:13
leaving Celine with no alternatives.
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ื•ืกืœื™ืŸ ื ื•ืชืจื” ืœืœื ืฉื•ื ื—ืœื•ืคื•ืช.
01:16
She was unable to tell me the names of the drugs
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ื”ื™ื ืœื ื™ื›ืœื” ืœื•ืžืจ ืœื™ ืืช ืฉืžื•ืช ื”ืชืจื•ืคื•ืช
01:19
she'd received during the trial,
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ืฉืงื™ื‘ืœื” ื‘ืžื”ืœืš ื”ื ื™ืกื•ื™,
01:21
or even what the trial had been about.
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ืื• ืขืœ ืžื” ื‘ื›ืœืœ ื”ื™ื” ื”ื ื™ืกื•ื™.
01:24
I didn't bother to ask her what the results of the trial were
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ืœื ื˜ืจื—ืชื™ ืœืฉืื•ืœ ืื•ืชื” ืžื” ื”ื™ื• ืชื•ืฆืื•ืช ื”ื ื™ืกื•ื™
01:27
because it seemed obvious to me that she would have no clue.
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ื›ื™ ื”ื™ื” ื‘ืจื•ืจ ืœื™ ืฉืื™ืŸ ืœื” ืฉืžืฅ ืฉืœ ืžื•ืฉื’.
01:31
Yet what puzzled me most
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ืืš ืžื” ืฉื”ื›ื™ ื”ืคืœื™ื ืื•ืชื™
01:34
was Celine had given her informed consent
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ื”ื•ื ืฉืกืœื™ืŸ ื ืชื ื” ื”ืกื›ืžื” ืžื“ืขืช
01:37
to be a part of this trial, yet she clearly did not understand
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ืœืงื—ืช ื—ืœืง ื‘ื ื™ืกื•ื™ ื”ื–ื”, ืื‘ืœ ื‘ืจื•ืจ ืฉืœื ื”ื‘ื™ื ื”
01:41
the implications of being a participant
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ืืช ื”ื”ืฉืœื›ื•ืช ืฉืœ ื”ื”ืฉืชืชืคื•ืช
01:43
or what would happen to her once the trial had been completed.
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ืื• ืžื” ื™ืงืจื” ืœื” ื›ืฉื”ื ื™ืกื•ื™ ื™ื™ื’ืžืจ.
01:48
Now, I have shared this story with you as an example
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ืฉื™ืชืคืชื™ ืืชื›ื ื‘ืกื™ืคื•ืจ ื”ื–ื” ื›ื“ื•ื’ืžื”
01:51
of what can happen to participants in the clinical trial
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ืœืžื” ืฉืขืœื•ืœ ืœืงืจื•ืช ืœืžืฉืชืชืคื™ ื ื™ืกื•ื™ ืงืœื™ื ื™
01:54
when it is poorly conducted.
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ืฉืžื ื•ื”ืœ ื‘ืฆื•ืจื” ื’ืจื•ืขื”.
01:56
Maybe this particular trial yielded exciting results.
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ืื•ืœื™ ื”ื ื™ืกื•ื™ ื”ืžืกื•ื™ื ื”ื–ื” ื”ืคื™ืง ืชื•ืฆืื•ืช ืžืœื”ื™ื‘ื•ืช,
02:00
Maybe it even got published in a high-profile scientific journal.
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ืื•ืœื™ ื”ื•ื ืืคื™ืœื• ื”ืชืคืจืกื ื‘ืื™ื–ื” ื›ืชื‘-ืขืช ืžื“ืขื™ ื™ื“ื•ืข.
02:04
Maybe it would inform clinicians around the world
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ืื•ืœื™ ื”ื•ื ื™ืœืžื“ ืจื•ืคืื™ื ื‘ืจื—ื‘ื™ ื”ืขื•ืœื
02:07
on how to improve on the clinical management of HIV patients.
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ืื™ืš ืœืฉืคืจ ืืช ื”ื ื™ื”ื•ืœ ื”ืจืคื•ืื™ ืฉืœ ื—ื•ืœื™ ื”ืื™ื™ื“ืก,
02:12
But it would have done so at a price
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ืื‘ืœ ื”ืžื—ื™ืจ ืฉืœ ื›ืœ ื–ื” ื™ื”ื™ื”
02:15
to hundreds of patients who, like Celine,
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ืžืื•ืช ื—ื•ืœื™ื, ืฉื›ืžื• ืกืœื™ืŸ,
02:18
were left to their own devices
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ื ืขื–ื‘ื• ืœื ืคืฉื
02:20
once the research had been completed.
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ื‘ืจื’ืข ืฉื”ืžื—ืงืจ ื”ืกืชื™ื™ื.
02:23
I do not stand here today to suggest in any way
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ืœื ื‘ืืชื™ ืœื›ืืŸ ื”ื™ื•ื ื›ื“ื™ ืœื˜ืขื•ืŸ ื‘ืฉื•ื ืื•ืคืŸ
02:27
that conducting HIV clinical trials
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ืฉื ื™ื”ื•ืœ ื ื™ืกื•ื™ื™ื ืจืคื•ืื™ื™ื ื‘ืชื—ื•ื ื”ืื™ื™ื“ืก
02:29
in developing countries is bad.
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ื‘ืืจืฆื•ืช ืžืชืคืชื—ื•ืช ื”ื•ื ื“ื‘ืจ ืจืข.
02:31
On the contrary, clinical trials are extremely useful tools,
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ืœื”ื™ืคืš. ื ื™ืกื•ื™ื™ื ืงืœื™ื ื™ื™ื ื”ื ื›ืœื™ื ืžื•ืขื™ืœื™ื ื‘ื™ื•ืชืจ,
02:35
and are much needed to address the burden
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ื•ื ื—ื•ืฆื™ื ืžืื“ ื›ื“ื™ ืœื”ืชื™ื™ื—ืก
02:38
of disease in developing countries.
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ืœืขื•ืžืก ื”ืžื—ืœื•ืช ื‘ืืจืฆื•ืช ื”ืžืชืคืชื—ื•ืช.
02:40
However, the inequalities that exist between
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ืื‘ืœ ื‘ืื™-ื”ืฉื•ื•ื™ื•ืŸ ืฉืงื™ื™ื
02:43
richer countries and developing countries in terms of funding
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ื‘ื™ืŸ ื”ืืจืฆื•ืช ื”ืขืฉื™ืจื•ืช ื•ื”ืžืชืคืชื—ื•ืช ื‘ื›ืœ ื”ื ื•ื’ืข ืœืžื™ืžื•ืŸ
02:47
pose a real risk for exploitation,
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ื˜ืžื•ื ื” ืกื›ื ื” ืืžื™ืชื™ืช ืฉืœ ื ื™ืฆื•ืœ ืœืจืขื”,
02:50
especially in the context of externally-funded research.
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ื‘ืžื™ื•ื—ื“ ื‘ื”ืงืฉืจ ืฉืœ ืžื™ืžื•ืŸ ืฉื‘ื ืžื‘ื—ื•ืฅ.
02:54
Sadly enough, the fact remains that
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ืœืžืจื‘ื” ื”ืฆืขืจ, ื ื•ืชืจื” ื‘ืขื™ื ื” ื”ืขื•ื‘ื“ื”
02:56
a lot of the studies that are conducted in developing countries
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ืฉืจื‘ื™ื ืžื”ืžื—ืงืจื™ื ื”ืžื ื•ื”ืœื™ื ื‘ืืจืฆื•ืช ื”ืžืชืคืชื—ื•ืช
03:00
could never be authorized in the richer countries
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ืœืขื•ืœื ืœื ื™ืื•ืฉืจื• ืœื‘ื™ืฆื•ืข ื‘ืืจืฆื•ืช ื”ืขืฉื™ืจื•ืช
03:03
which fund the research.
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ืฉืžืžื ื•ืช ืืช ื”ืžื—ืงืจ.
03:05
I'm sure you must be asking yourselves
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ืื ื™ ื‘ื˜ื•ื—ื” ืฉืืชื ื•ื“ืื™ ืฉื•ืืœื™ื ืืช ืขืฆืžื›ื
03:07
what makes developing countries,
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ืžื” ื”ื•ืคืš ืืช ื”ืืจืฆื•ืช ื”ืžืชืคืชื—ื•ืช
03:09
especially those in sub-Saharan Africa,
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ื‘ืžื™ื•ื—ื“ ืืœื” ืฉื‘ืชืช-ื”ืกื”ืจื” ืฉืœ ืืคืจื™ืงื”,
03:12
so attractive for these HIV clinical trials?
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ื›ื” ืื˜ืจืงื˜ื™ื‘ื™ื•ืช ืขื‘ื•ืจ ืื•ืชื ื ื™ืกื•ื™ื™ ืื™ื™ื“ืก?
03:15
Well, in order for a clinical trial to generate
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ื•ื‘ื›ืŸ, ื›ื“ื™ ืฉื ื™ืกื•ื™ ืื™ื™ื“ืก ื™ืคื™ืง
03:19
valid and widely applicable results,
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ืชื•ืฆืื•ืช ืชืงืคื•ืช ื•ื™ืฉื™ืžื•ืช ื‘ืจื‘ื™ื,
03:22
they need to be conducted with large numbers of study participants
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ืขืœื™ื• ืœื”ื™ื•ืช ืžื ื•ื”ืœ ืขื ืžืกืคืจื™ื ื’ื“ื•ืœื™ื ืฉืœ ืžืฉืชืชืคื™-ืžื—ืงืจ
03:26
and preferably on a population
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ื•ืขื“ื™ืฃ, ื‘ืื•ื›ืœื•ืกื™ื”
03:28
with a high incidence of new HIV infections.
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ืฉื™ืฉ ื‘ื” ืฉื›ื™ื—ื•ืช ื’ื‘ื•ื”ื” ืฉืœ ื–ื™ื”ื•ืžื™ ืื™ื™ื“ืก ื—ื“ืฉื™ื.
03:32
Sub-Saharan Africa largely fits this description,
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ืชืช-ื”ืกื”ืจื” ื”ืืคืจื™ืงืื™ืช ืžืชืื™ืžื” ืžืื“ ืœืชื™ืื•ืจ ื–ื”,
03:36
with 22 million people living with HIV,
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ื™ืฉ ื‘ื” 22 ืžื™ืœื™ื•ืŸ ื‘ื ื™-ืื“ื ืฉื—ื™ื™ื ืขื ืื™ื™ื“ืก,
03:39
an estimated 70 percent of the 30 million people
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ืฉื”ื ื›-70 ืื—ื•ื– ืžื›ืœืœ 30 ืžื™ืœื™ื•ืŸ ื”ืื ืฉื™ื
03:42
who are infected worldwide.
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ืฉื ื“ื‘ืงื• ื‘ืžื—ืœื” ื‘ื›ืœ ื”ืขื•ืœื.
03:45
Also, research within the continent
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ื›ืžื• ื›ืŸ, ื”ืžื—ืงืจ ื‘ื™ื‘ืฉืช ื”ื–ื•
03:47
is a lot easier to conduct due to widespread poverty,
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ืงืœ ื”ืจื‘ื” ื™ื•ืชืจ ืœื‘ื™ืฆื•ืข ื‘ื’ืœืœ ื”ืขื•ื ื™ ื”ืจื‘,
03:51
endemic diseases and inadequate health care systems.
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ื”ืžื—ืœื•ืช ื”ืžืงื•ืžื™ื•ืช ื•ืžืขืจื›ื•ืช ื”ื‘ืจื™ืื•ืช ื”ืœืงื•ื™ื•ืช.
03:55
A clinical trial that is considered to be
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ื ื™ืกื•ื™ ืงืœื™ื ื™ ืฉื ื—ืฉื‘
03:58
potentially beneficial to the population
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ื‘ืขืœ ืคื•ื˜ื ืฆื™ืืœ ืœื”ื•ืขื™ืœ ืœืื•ื›ืœื•ืกื™ื”
04:01
is more likely to be authorized,
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ื™ื–ื›ื” ื‘ื™ืชืจ ืงืœื•ืช ื‘ืื™ืฉื•ืจ,
04:03
and in the absence of good health care systems,
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ื•ื‘ื”ืขื“ืจ ืžืขืจื›ื•ืช ื‘ืจื™ืื•ืช ื˜ื•ื‘ื•ืช,
04:06
almost any offer of medical assistance
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ื›ืžืขื˜ ื›ืœ ื”ืฆืขื” ืœืกื™ื•ืข ืจืคื•ืื™
04:09
is accepted as better than nothing.
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ืชืชืงื‘ืœ, ื›ื™ ื–ื” ื™ื•ืชืจ ื˜ื•ื‘ ืžื›ืœื•ื.
04:12
Even more problematic reasons include
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ื™ืฉ ื’ื ืกื™ื‘ื•ืช ื‘ืขื™ื™ืชื™ื•ืช ื™ื•ืชืจ:
04:14
lower risk of litigation,
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ืกื™ื›ื•ืŸ ื ืžื•ืš ื™ื•ืชืจ ืœืชื‘ื™ืขื” ืžืฉืคื˜ื™ืช,
04:17
less rigorous ethical reviews,
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ื‘ื“ื™ืงื•ืช ืืชื™ืงื” ื ื•ืงืฉื•ืช ืคื—ื•ืช,
04:19
and populations that are willing to participate
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ื•ืื•ื›ืœื•ืกื™ื” ืฉืžื•ื›ื ื” ืœื”ืฉืชืชืฃ
04:22
in almost any study that hints at a cure.
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ื›ืžืขื˜ ื‘ื›ืœ ืžื—ืงืจ ืฉื™ืฉ ื‘ื• ืจืžื– ืœืจื™ืคื•ื™.
04:26
As funding for HIV research
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ื›ื›ืœ ืฉื”ืžื™ืžื•ืŸ ืœื—ืงืจ ื”ืื™ื™ื“ืก
04:30
increases in developing countries
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ื’ื“ืœ ื‘ืืจืฆื•ืช ื”ืžืชืคืชื—ื•ืช
04:32
and ethical review in richer countries become more strict,
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ื•ื›ื›ืœ ืฉื‘ื“ื™ืงื•ืช ื”ืืชื™ืงื” ื‘ืืจืฆื•ืช ื”ืขืฉื™ืจื•ืช ื ืขืฉื•ืช ื ื•ืงืฉื•ืช ื™ื•ืชืจ,
04:36
you can see why this context becomes
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ืืคืฉืจ ืœื”ื‘ื™ืŸ ืžื“ื•ืข ื”ืงืฉืจ ื–ื” ื”ื•ืคืš ืœื”ื™ื•ืช
04:38
very, very attractive.
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ืžืื“ ืžืื“ ืื˜ืจืงื˜ื™ื‘ื™.
04:41
The high prevalence of HIV drives researchers
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ื”ืฉื›ื™ื—ื•ืช ื”ื’ื‘ื•ื”ื” ืฉืœ ื”ืื™ื™ื“ืก ืžื ื™ืขื” ืืช ื”ื—ื•ืงืจื™ื
04:45
to conduct research that is sometimes scientifically acceptable
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ืœื ื”ืœ ืžื—ืงืจ ืฉื”ื•ื ืœืคืขืžื™ื ืงื‘ื™ืœ ืžื‘ื—ื™ื ื” ืžื“ืขื™ืช
04:49
but on many levels ethically questionable.
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ืื‘ืœ ืžืคื•ืงืคืง ืžื”ืจื‘ื” ื‘ื—ื™ื ื•ืช ืืชื™ื•ืช.
04:52
How then can we ensure that, in our search for the cure,
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ืื ื›ืŸ, ืื™ืš ื ื•ื›ืœ ืœื”ื‘ื˜ื™ื—, ืฉื‘ืžื—ืงืจ ืฉืœื ื• ืœืžืฆื™ืืช ืชืจื•ืคื”,
04:56
we do not take an unfair advantage
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ืœื ื ื ืฆืœ ื‘ืื•ืคืŸ ืœื-ื”ื•ื’ืŸ
04:58
of those who are already most affected by the pandemic?
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ืืช ืืœื• ืฉื›ื‘ืจ ื ืคื’ืขื• ื‘ืžื’ืคื” ื–ื• ื™ื•ืชืจ ืžื›ืœ?
05:02
I invite you to consider four areas I think we can focus on
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ืื ื™ ืžื–ืžื™ื ื” ืืชื›ื ืœืฉืงื•ืœ 4 ืชื—ื•ืžื™ื ืฉื‘ื”ื ื ื•ื›ืœ ืœื“ืขืชื™ ืœื”ืชืžืงื“
05:05
in order to improve the way in which things are done.
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ื›ื“ื™ ืœืฉืคืจ ืืช ืคื ื™ ื”ื“ื‘ืจื™ื.
05:09
The first of these is informed consent.
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ื”ืจืืฉื•ืŸ ื”ื•ื ื”ื”ืกื›ืžื” ืžื“ืขืช.
05:12
Now, in order for a clinical trial to be
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ื›ื“ื™ ืฉื ื™ืกื•ื™ ืงืœื™ื ื™ ื™ื™ื—ืฉื‘
05:14
considered ethically acceptable,
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ืœืงื‘ื™ืœ ืžื‘ื—ื™ื ื” ืืชื™ืช,
05:18
participants must be given the relevant information
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ืขืœ ื”ืžืฉืชืชืคื™ื ืœืงื‘ืœ ืืช ื”ืžื™ื“ืข ื”ืจืœื•ื•ื ื˜ื™
05:21
in a way in which they can understand,
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ื‘ืื•ืคืŸ ืฉืื•ืชื• ื™ื•ื›ืœื• ืœื”ื‘ื™ืŸ,
05:23
and must freely consent to participate in the trial.
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ื•ืœื”ืกื›ื™ื ืžืจืฆื•ื ื ื”ื—ื•ืคืฉื™ ืœื”ืฉืชืชืฃ ื‘ื ื™ืกื•ื™.
05:27
This is especially important in developing countries,
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ื™ืฉ ืœื›ืš ื—ืฉื™ื‘ื•ืช ืžื™ื•ื—ื“ืช ื‘ืืจืฆื•ืช ืžืชืคืชื—ื•ืช,
05:30
where a lot of participants consent to research
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ืฉื‘ื”ืŸ ืžืฉืชืชืคื™ื ืจื‘ื™ื ืžืกื›ื™ืžื™ื ืœื‘ื™ืฆื•ืข ื”ืžื—ืงืจ
05:33
because they believe it is the only way in which
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ื›ื™ ื”ื ืžืืžื™ื ื™ื ืฉื–ื• ื”ื“ืจืš ื”ื™ื—ื™ื“ื”
05:36
they can receive medical care or other benefits.
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ื‘ื” ื™ื•ื›ืœื• ืœื–ื›ื•ืช ื‘ื˜ื™ืคื•ืœ ืจืคื•ืื™ ืื• ื‘ืขื–ืจื” ื ื•ืกืคืช.
05:39
Consent procedures that are used in richer countries
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ื ื”ืœื™ ืงื‘ืœืช ื”ื”ืกื›ืžื” ื”ื ื”ื•ื’ื™ื ื‘ืืจืฆื•ืช ื”ืขืฉื™ืจื•ืช
05:42
are often inappropriate or ineffective
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ืœืขืชื™ื ืงืจื•ื‘ื•ืช ืื™ื ืŸ ืžืชืื™ืžื™ื ืื• ื‘ืœืชื™-ื™ืขื™ืœื™ื
05:45
in a lot of developing countries.
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ื‘ืจื‘ื•ืช ืžื”ืืจืฆื•ืช ื”ืžืชืคืชื—ื•ืช.
05:47
For example, it is counterintuitive to have
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ืœื“ื•ื’ืžื”, ื‘ืœืชื™-ื”ื’ื™ื•ื ื™ ืœื’ื™ื™ืก
05:50
an illiterate study participant, like Celine,
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ืžืฉืชืชืฃ-ื ื™ืกื•ื™ ืื ืืœืคืื‘ื™ืชื™, ื›ืžื• ืกืœื™ืŸ,
05:53
sign a lengthy consent form that they are unable to read,
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ืข"ื™ ื—ืชื™ืžื” ืขืœ ื˜ื•ืคืก ื”ืกื›ืžื” ืืจื•ืš ืฉืื•ืชื• ืื™ืŸ ื”ื•ื ืžืกื•ื’ืœ ืœืงืจื•ื,
05:57
let alone understand.
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ื•ื•ื“ืื™ ืฉืœื ืœื”ื‘ื™ืŸ.
05:59
Local communities need to be more involved
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ื”ืงื”ื™ืœื•ืช ื”ืžืงื•ืžื™ื•ืช ืฆืจื™ื›ื•ืช ืœื”ื™ื•ืช ืžืขื•ืจื‘ื•ืช ื™ื•ืชืจ
06:02
in establishing the criteria for recruiting participants
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ื‘ืงื‘ื™ืขืช ืืžื•ืช ื”ืžื™ื“ื” ืœื’ื™ื•ืก ืžืฉืชืชืคื™ื
06:05
in clinical trials, as well as the incentives for participation.
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ื‘ื ื™ืกื•ื™ื™ื ืงืœื™ื ื™ื™ื, ื•ื’ื ื‘ืชืžืจื™ืฆื™ื ืœื”ืฉืชืชืคื•ืช.
06:10
The information in these trials
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ื”ืžื™ื“ืข ื”ื›ืœื•ืœ ื‘ื ื™ืกื•ื™ื™ื ื”ืืœื”
06:12
needs to be given to the potential participants
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ืฆืจื™ืš ืœื”ื™ืžืกืจ ืœืžืฉืชืชืคื™ื-ื‘ื›ื•ื—
06:15
in linguistically and culturally acceptable formats.
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ื‘ื ื•ืกื—ื™ื ืงื‘ื™ืœื™ื ืžื‘ื—ื™ื ื” ืœืฉื•ื ื™ืช ื•ืชืจื‘ื•ืชื™ืช.
06:19
The second point I would like for you to consider
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ื”ื ืงื•ื“ื” ื”ืฉื ื™ื” ืฉืื ื™ ืžื‘ืงืฉืช ืฉืชืฉืงืœื•
06:22
is the standard of care that is provided
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ื”ื™ื ืจืžืช ื”ื˜ื™ืคื•ืœ ื”ื ื™ืชืŸ
06:24
to participants within any clinical trial.
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ืœืžืฉืชืชืคื™ื ื‘ืžืกื’ืจืช ื›ืœ ื ื™ืกื•ื™ ืงืœื™ื ื™ ืฉื”ื•ื.
06:27
Now, this is subject to a lot of debate and controversy.
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ื•ื–ื” ื ื•ืฉื ืœื•ื™ื›ื•ื—ื™ื ื•ืžื—ืœื•ืงื•ืช ืจื‘ื™ื.
06:31
Should the control group in the clinical trial
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ื”ืื ืงื‘ื•ืฆืช ื”ื‘ื™ืงื•ืจืช ื‘ื ื™ืกื•ื™ ื”ืงืœื™ื ื™
06:34
be given the best current treatment which is available
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ืฆืจื™ื›ื” ืœืงื‘ืœ ืืช ืžื™ื˜ื‘ ื”ื˜ื™ืคื•ืœ ื”ืจืคื•ืื™ ื”ื–ืžื™ืŸ
06:37
anywhere in the world?
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ื‘ื›ืœ ืžืงื•ื ื‘ืขื•ืœื?
06:39
Or should they be given an alternative standard of care,
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ืื• ืฉืžื ืขืœื™ื”ื ืœืงื‘ืœ ืื™ื–ื” ืชืงืŸ ื˜ื™ืคื•ืœื™ ื—ืœื•ืคื™,
06:42
such as the best current treatment available
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ืœืžืฉืœ, ืžื™ื˜ื‘ ื”ื˜ื™ืคื•ืœ ื”ื ื•ื›ื—ื™ ื”ื–ืžื™ืŸ
06:45
in the country in which the research is being conducted?
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ื‘ืืจืฅ ื‘ื” ื ืขืจืš ื”ืžื—ืงืจ?
06:48
Is it fair to evaluate a treatment regimen
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ื”ืื ื”ื•ื’ืŸ ืœื”ืขืจื™ืš ืžืฉื˜ืจ ื˜ื™ืคื•ืœื™ ื›ืœืฉื”ื•
06:52
which may not be affordable or accessible
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ืฉืื•ืœื™ ืขืชื™ื“ ืœื”ื™ื•ืช ื™ืงืจ ืื• ืžืจื•ื—ืง ืžื“ื™
06:55
to the study participants once the research has been completed?
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ืขื‘ื•ืจ ืžืฉืชืชืคื™ ื”ื ื™ืกื•ื™, ืœืื—ืจ ื”ืฉืœืžืช ื”ืžื—ืงืจ?
06:59
Now, in a situation where the best current treatment
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ื›ืฉืžื™ื˜ื‘ ื”ื˜ื™ืคื•ืœ ื”ืงื™ื™ื
07:03
is inexpensive and simple to deliver,
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ื”ื•ื ื–ื•ืœ ื•ืงืœ ืœื™ื™ืฉื•ื,
07:05
the answer is straightforward.
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ื”ืชืฉื•ื‘ื” ืคืฉื•ื˜ื”.
07:07
However, the best current treatment available
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ืื‘ืœ ืืช ื”ื˜ื™ืคื•ืœ ื”ื˜ื•ื‘ ื‘ื™ื•ืชืจ, ืฉื–ืžื™ืŸ ื›ื™ื•ื
07:10
anywhere in the world is often very difficult
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ื‘ื›ืœ ืžืงื•ื ื‘ืขื•ืœื, ืœืขืชื™ื ืงืจื•ื‘ื•ืช ืงืฉื” ืžืื“
07:13
to provide in developing countries.
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ืœืกืคืง ื‘ืืจืฆื•ืช ื”ืžืชืคืชื—ื•ืช.
07:16
It is important to assess the potential risks and benefits
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ื—ืฉื•ื‘ ืœื”ืขืจื™ืš ืืช ื”ืกื™ื›ื•ื ื™ื ื•ื”ืชื•ืขืœืช ื”ืืคืฉืจื™ื™ื
07:19
of the standard of care which is to be provided
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ืฉืœ ืจืžืช ื”ื˜ื™ืคื•ืœ ืฉื™ื™ื ืชืŸ
07:22
to participants in any clinical trial,
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ืœืžืฉืชืชืคื™ื ื‘ื ื™ืกื•ื™ ืงืœื™ื ื™ ื›ืœืฉื”ื•,
07:25
and establish one which is relevant for the context of the study
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ื•ืœืงื‘ื•ืข ื˜ื™ืคื•ืœ ืฉื™ื”ื™ื” ืจืœื•ื•ื ื˜ื™ ืœื”ืงืฉืจ ื”ืžื—ืงืจ
07:30
and most beneficial for the participants within the study.
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ื•ื”ื›ื™ ืžื•ืขื™ืœ ืœืžืฉืชืชืคื™ ื”ืžื—ืงืจ.
07:34
That brings us to the third point I want you think about:
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ื–ื” ืžื‘ื™ื ืื•ืชื ื• ืœื ืงื•ื“ื” ื”ืฉืœื™ืฉื™ืช ืฉื‘ืจืฆื•ื ื™ ืฉืชื—ืฉื‘ื• ืขืœื™ื”:
07:37
the ethical review of research.
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ื”ื‘ื“ื™ืงื” ื”ืืชื™ืช ืฉืœ ื”ืžื—ืงืจ.
07:40
An effective system for reviewing the ethical suitability
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ืžืขืจื›ืช ื™ืขื™ืœื” ืœื‘ื“ื™ืงืช ื”ืชืื™ืžื•ืช ื”ืืชื™ืช
07:44
of clinical trials is primordial to safeguard participants
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ืฉืœ ื ื™ืกื•ื™ื™ื ืงืœื™ื ื™ื™ื ื ื•ืขื“ื” ื‘ืžืงื•ืจ ืœืฉืžื•ืจ ืขืœ ื‘ื˜ื—ื•ืŸ ื”ืžืฉืชืชืคื™ื
07:48
within any clinical trial.
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ื‘ื›ืœ ื ื™ืกื•ื™ ืงืœื™ื ื™.
07:50
Unfortunately, this is often lacking
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ืœืžืจื‘ื” ื”ืฆืขืจ, ืœืขืชื™ื ืงืจื•ื‘ื•ืช ื”ื™ื ืœื•ืงื” ื‘ื—ืกืจ
07:53
or inefficient in a lot of developing countries.
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ืื• ื‘ืœืชื™-ื™ืขื™ืœื” ื‘ื”ืจื‘ื” ืืจืฆื•ืช ืžืชืคืชื—ื•ืช.
07:56
Local governments need to set up effective systems
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ืขืœ ื”ืžืžืฉืœื™ื ื”ืžืงื•ืžื™ื™ื ืœื”ืงื™ื ืžืขืจื›ื•ืช ื™ืขื™ืœื•ืช
08:01
for reviewing the ethical issues around the clinical trials
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ืœื‘ื“ื™ืงืช ื”ืกื•ื’ื™ื•ืช ื”ืืชื™ื•ืช ื”ื ื•ื’ืขื•ืช ืœื ื™ืกื•ื™ื™ื ื”ืงืœื™ื ื™ื™ื
08:04
which are authorized in different developing countries,
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ื”ืžืื•ืฉืจื™ื ืœื‘ื™ืฆื•ืข ื‘ืืจืฆื•ืช ืžืชืคืชื—ื•ืช ืฉื•ื ื•ืช,
08:07
and they need to do this by setting up
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ื•ืขืœื™ื”ื ืœืขืฉื•ืช ื–ืืช ืข"ื™ ื›ื™ื ื•ืŸ
08:10
ethical review committees that are independent
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ื•ืขื“ื•ืช ืืชื™ืงื” ืฉืื™ื ืŸ ืชืœื•ื™ื•ืช
08:12
of the government and research sponsors.
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ื‘ืžืžืฉืœ ื•ื‘ืžืžืžื ื™ ื”ืžื—ืงืจ.
08:16
Public accountability needs to be promoted
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ื™ืฉ ืœืฉืคืจ ืืช ื”ืื—ืจื™ื•ืช ื”ืฆื™ื‘ื•ืจื™ืช
08:18
through transparency and independent review
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ื‘ืืžืฆืขื•ืช ืฉืงื™ืคื•ืช ื•ื‘ื“ื™ืงื•ืช ืขืฆืžืื™ื•ืช
08:21
by nongovernmental and international organizations
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ืฉืœ ืืจื’ื•ื ื™ื ืœื-ืžืžืฉืœืชื™ื™ื ื•ื‘ื™ื ืœืื•ืžื™ื™ื
08:24
as appropriate.
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ืœืคื™ ื”ืฆื•ืจืš.
08:26
The final point I would like for you to consider tonight
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ื”ื ืงื•ื“ื” ื”ืื—ืจื•ื ื” ืฉื‘ืจืฆื•ื ื™ ืฉืชืฉืงืœื• ื”ืขืจื‘
08:29
is what happens to participants in the clinical trial
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ื”ื™ื ืžื” ืงื•ืจื” ืœืžืฉืชืชืคื™ ื”ื ื™ืกื•ื™ ื”ืงืœื™ื ื™
08:33
once the research has been completed.
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ืžืขืช ืฉื”ืžื—ืงืจ ื”ื•ืฉืœื.
08:35
I think it is absolutely wrong for research to begin
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ืœื“ืขืชื™ ื–ื”ื• ืขื•ื•ืœ ืžื•ื—ืœื˜ ืœื”ืชื—ื™ืœ ื‘ืžื—ืงืจ
08:39
in the first place without a clear plan
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ื›ืฉืžืœื›ืชื—ื™ืœื” ืื™ืŸ ืชื›ื ื™ืช ื‘ืจื•ืจื”
08:41
for what would happen to the participants
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ืžื” ื™ื”ื™ื” ื’ื•ืจืœ ื”ืžืฉืชืชืคื™ื
08:43
once the trial has ended.
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ืขื ืชื•ื ื”ืžื—ืงืจ.
08:46
Now, researchers need to make every effort to ensure that
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ืขืœ ื”ื—ื•ืงืจื™ื ืœืขืฉื•ืช ื›ืœ ืžืืžืฅ ื›ื“ื™ ืœื”ื‘ื˜ื™ื—
08:51
an intervention that has been shown to be beneficial
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ืฉื”ืชืขืจื‘ื•ืช ืจืคื•ืื™ืช ืฉื”ื•ื›ื—ื” ื›ื™ืขื™ืœื”
08:54
during a clinical trial
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ื‘ืžื”ืœื›ื• ืฉืœ ื ื™ืกื•ื™ ืงืœื™ื ื™
08:56
is accessible to the participants of the trial
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ืชื”ื™ื” ื ื’ื™ืฉื” ืœืžืฉืชืชืคื™ ื”ื ื™ืกื•ื™
08:59
once the trial has been completed.
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ืœืื—ืจ ืชื•ื ื”ื ื™ืกื•ื™.
09:02
In addition, they should be able to consider the possibility
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ื‘ื ื•ืกืฃ, ืขืœื™ื”ื ืœืฉืงื•ืœ ืืช ื”ืืคืฉืจื•ืช
09:05
of introducing and maintaining effective treatments
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ืœื”ื›ื ื™ืก ื•ืœืงื™ื™ื ื˜ื™ืคื•ืœื™ื ื™ืขื™ืœื™ื
09:09
in the wider community once the trial ends.
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ื‘ืงื”ื™ืœื” ื”ืจื—ื‘ื” ื™ื•ืชืจ ืœืื—ืจ ื”ืฉืœืžืช ื”ื ื™ืกื•ื™.
09:13
If, for any reason, they feel that this might not be possible,
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ืื ืžืกื™ื‘ื” ื›ืœืฉื”ื™ ื ืจืื” ืœื”ื ืฉื–ื” ืœื ื™ืชืืคืฉืจ,
09:16
then I think they should have to ethically justify
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ื‘ืžืงืจื” ื–ื”, ืœื“ืขืชื™, ืขืœื™ื”ื ืœื”ืฆื“ื™ืง ืžื‘ื—ื™ื ื” ืืชื™ืช
09:19
why the clinical trial should be conducted in the first place.
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ืžื“ื•ืข ื‘ื›ืœืœ ืฆืจื™ืš ืœื ื”ืœ ืืช ื”ื ื™ืกื•ื™ ื”ืงืœื™ื ื™.
09:23
Now, fortunately for Celine,
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ืœืžื–ืœื” ืฉืœ ืกืœื™ืŸ,
09:26
our meeting did not end in my office.
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ื”ืคื’ื™ืฉื” ืฉืœื ื• ืœื ื”ืกืชื™ื™ืžื” ื‘ืžืฉืจื“ื™.
09:28
I was able to get her enrolled into a free HIV treatment program
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ื”ืฆืœื—ืชื™ ืœืจืฉื•ื ืื•ืชื” ืœืชื›ื ื™ืช ื˜ื™ืคื•ืœ ื—ื™ื ื ื‘ืื™ื™ื“ืก
09:33
closer to her home,
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ืงืจื•ื‘ ืœื‘ื™ืชื”,
09:34
and with a support group to help her cope.
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ื•ืœื”ื›ื ื™ืก ืื•ืชื” ืœืงื‘ื•ืฆืช ืชืžื™ื›ื” ืฉืชืกื™ื™ืข ืœื” ืœื”ืชืžื•ื“ื“ ืขื ืžืฆื‘ื”.
09:38
Her story has a positive ending,
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ืœืกื™ืคื•ืจ ืฉืœื” ื™ืฉ ืกื•ืฃ ื˜ื•ื‘,
09:40
but there are thousands of others in similar situations
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ืืš ื™ืฉื ื ืืœืคื™ ืื—ืจื™ื ืฉื ืžืฆืื™ื ื‘ืžืฆื‘ื™ื ื“ื•ืžื™ื
09:44
who are much less fortunate.
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ื•ืฉืื™ื ื ื›ื” ื‘ืจื™-ืžื–ืœ.
09:46
Although she may not know this,
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ืื•ืœื™ ื”ื™ื ืœื ื™ื•ื“ืขืช ื–ืืช,
09:49
my encounter with Celine has completely changed the way
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ืืš ืžืคื’ืฉื™ ืขื ืกืœื™ืŸ ืฉื™ื ื” ืœื—ืœื•ื˜ื™ืŸ ืืช ื”ืื•ืคืŸ
09:52
in which I view HIV clinical trials in developing countries,
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ื‘ื• ืื ื™ ืจื•ืื” ื ื™ืกื•ื™ื™ ืื™ื™ื“ืก ืงืœื™ื ื™ื™ื ื‘ืืจืฆื•ืช ืžืชืคืชื—ื•ืช,
09:57
and made me even more determined to be part of the movement
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ื•ื”ื’ื‘ื™ืจ ืืช ื”ื ื—ื™ืฉื•ืช ืฉืœื™ ืœื”ื™ื•ืช ื—ืœืง ืžื”ืชื ื•ืขื”
10:00
to change the way in which things are done.
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ืœืžืขืŸ ืฉื™ื ื•ื™ ื”ื“ืจืš ื‘ื” ื ืขืฉื™ื ื”ื“ื‘ืจื™ื.
10:03
I believe that every single person
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ืื ื™ ืžืืžื™ื ื” ืฉื›ืœ ืื“ื ื•ืื“ื
10:06
listening to me tonight can be part of that change.
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ืฉืžืงืฉื™ื‘ ืœื™ ื”ืขืจื‘ ื™ื›ื•ืœ ืœืงื—ืช ื—ืœืง ื‘ืฉื™ื ื•ื™ ื”ื–ื”.
10:10
If you are a researcher, I hold you
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ืื ืืชื ื—ื•ืงืจื™ื, ืื ื™ ืžืฆืคื” ืžื›ื
10:13
to a higher standard of moral conscience,
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ืœืจืžื” ื’ื‘ื•ื”ื” ื™ื•ืชืจ ืฉืœ ืžื•ื“ืขื•ืช ืžื•ืกืจื™ืช,
10:15
to remain ethical in your research,
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ืœื”ื™ืฉืืจ ืืชื™ื™ื ื‘ืžื—ืงืจ ืฉืœื›ื,
10:18
and not compromise human welfare in your search for answers.
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ื•ืœื ืœืคื’ื•ืข ื‘ืจื•ื•ื—ืช ื‘ื ื™-ืื“ื ืื’ื‘ ื—ื™ืคื•ืฉื›ื ืื—ืจ ืชืฉื•ื‘ื•ืช.
10:21
If you work for a funding agency or pharmaceutical company,
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ืื ืืชื ืขื•ื‘ื“ื™ื ืขื‘ื•ืจ ืกื•ื›ื ื•ืช ืžื™ืžื•ืŸ ืื• ื—ื‘ืจืช ืชืจื•ืคื•ืช,
10:25
I challenge you to hold your employers
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ืื ื™ ืงื•ืจืืช ืœื›ื ืœื—ื™ื™ื‘ ืืช ืขื•ื‘ื“ื™ื›ื
10:28
to fund research that is ethically sound.
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ืœืžืžืŸ ืžื—ืงืจื™ื ื‘ืขืœื™ ื‘ืกื™ืก ืืชื™ ืื™ืชืŸ.
10:31
If you come from a developing country like myself,
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ืื ืืชื ื‘ืื™ื ืžืืจืฆื•ืช ืžืชืคืชื—ื•ืช, ื›ืžื•ื ื™,
10:34
I urge you to hold your government
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ืื ื™ ื“ื•ื—ืงืช ื‘ื›ื ืœื“ืจื•ืฉ ืžื”ืžืžืฉืœื” ืฉืœื›ื
10:37
to a more thorough review of the clinical trials
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ืœื‘ืฆืข ื”ืขืจื›ื” ื™ืกื•ื“ื™ืช ื™ื•ืชืจ ืฉืœ ื”ื ื™ืกื•ื™ื™ื ื”ืงืœื™ื ื™ื™ื
10:40
which are authorized in your country.
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ืฉืžืื•ืฉืจื™ื ืœื‘ื™ืฆื•ืข ื‘ืืจืฆื›ื.
10:43
Yes, there is a need for us to find a cure for HIV,
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ื ื›ื•ืŸ, ื™ืฉ ืœื ื• ืฆื•ืจืš ืœืžืฆื•ื ืชืจื•ืคื” ืœืื™ื™ื“ืก,
10:46
to find an effective vaccine for malaria,
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ืœืžืฆื•ื ื—ื™ืกื•ืŸ ื™ืขื™ืœ ื ื’ื“ ื”ืžืœืจื™ื”,
10:49
to find a diagnostic tool that works for T.B.,
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ืœืžืฆื•ื ื›ืœื™ ืื™ื‘ื—ื•ื ื™ ืขื‘ื•ืจ ื”ืฉื—ืคืช,
10:53
but I believe that we owe it to those who willingly
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ืืš ืœื“ืขืชื™ ืื ื• ืžื—ื•ื™ื™ื‘ื™ื ืœืื•ืชื ืฉืžื•ื›ื ื™ื
10:56
and selflessly consent to participate in these clinical trials
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ื‘ื—ื•ืกืจ-ืื ื•ื›ื™ื•ืช ืœื”ืฉืชืชืฃ ื‘ื ื™ืกื•ื™ื™ื ืงืœื™ื ื™ื™ื ืืœื”
11:01
to do this in a humane way.
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ืœืขืฉื•ืช ื–ืืช ื‘ื“ืจืš ืื ื•ืฉื™ืช.
11:03
Thank you.
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ืชื•ื“ื” ืœื›ื.
ืขืœ ืืชืจ ื–ื”

ืืชืจ ื–ื” ื™ืฆื™ื’ ื‘ืคื ื™ื›ื ืกืจื˜ื•ื ื™ YouTube ื”ืžื•ืขื™ืœื™ื ืœืœื™ืžื•ื“ ืื ื’ืœื™ืช. ืชื•ื›ืœื• ืœืจืื•ืช ืฉื™ืขื•ืจื™ ืื ื’ืœื™ืช ื”ืžื•ืขื‘ืจื™ื ืขืœ ื™ื“ื™ ืžื•ืจื™ื ืžื”ืฉื•ืจื” ื”ืจืืฉื•ื ื” ืžืจื—ื‘ื™ ื”ืขื•ืœื. ืœื—ืฅ ืคืขืžื™ื™ื ืขืœ ื”ื›ืชื•ื‘ื™ื•ืช ื‘ืื ื’ืœื™ืช ื”ืžื•ืฆื’ื•ืช ื‘ื›ืœ ื“ืฃ ื•ื™ื“ืื• ื›ื“ื™ ืœื”ืคืขื™ืœ ืืช ื”ืกืจื˜ื•ืŸ ืžืฉื. ื”ื›ืชื•ื‘ื™ื•ืช ื’ื•ืœืœื•ืช ื‘ืกื ื›ืจื•ืŸ ืขื ื”ืคืขืœืช ื”ื•ื•ื™ื“ืื•. ืื ื™ืฉ ืœืš ื”ืขืจื•ืช ืื• ื‘ืงืฉื•ืช, ืื ื ืฆื•ืจ ืื™ืชื ื• ืงืฉืจ ื‘ืืžืฆืขื•ืช ื˜ื•ืคืก ื™ืฆื™ืจืช ืงืฉืจ ื–ื”.

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