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TEDxGoodenoughCollege

Boghuma Kabisen Titanji: Ethical riddles in HIV research

Filmed:

It’s an all too common story: after participating in an HIV clinical trial, a woman in sub-Saharan Africa is left without the resources to buy a bus ticket to her health clinic, let alone to afford life-saving antiretrovirals. Boghuma Kabisen Titanji asks an important question: how can researchers looking for a cure make sure they’re not taking advantage of those most affected by the pandemic? (Filmed at TEDxGoodenoughCollege.)

- Clinical researcher
Boghuma Kabisen Titanji set out to research HIV drug resistant viruses. In the process, Titanji met a woman who changed the way she thinks about research subjects. Full bio

I'd like to share with you
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the story of one of my patients called Celine.
00:19
Celine is a housewife and lives in a rural district
00:23
of Cameroon in west Central Africa.
00:26
Six years ago, at the time of her HIV diagnosis,
00:29
she was recruited to participate in the clinical trial
00:33
which was running in her health district at the time.
00:36
When I first met Celine, a little over a year ago,
00:39
she had gone for 18 months
00:42
without any antiretroviral therapy,
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and she was very ill.
00:46
She told me that she stopped coming to the clinic
00:49
when the trial ended
00:52
because she had no money for the bus fare
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and was too ill to walk the 35-kilometer distance.
00:56
Now during the clinical trial,
01:00
she'd been given all her antiretroviral drugs free of charge,
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and her transportation costs
01:06
had been covered by the research funds.
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All of these ended once the trial was completed,
01:10
leaving Celine with no alternatives.
01:14
She was unable to tell me the names of the drugs
01:17
she'd received during the trial,
01:19
or even what the trial had been about.
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I didn't bother to ask her what the results of the trial were
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because it seemed obvious to me that she would have no clue.
01:28
Yet what puzzled me most
01:32
was Celine had given her informed consent
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to be a part of this trial, yet she clearly did not understand
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the implications of being a participant
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or what would happen to her once the trial had been completed.
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Now, I have shared this story with you as an example
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of what can happen to participants in the clinical trial
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when it is poorly conducted.
01:55
Maybe this particular trial yielded exciting results.
01:57
Maybe it even got published in a high-profile scientific journal.
02:01
Maybe it would inform clinicians around the world
02:05
on how to improve on the clinical management of HIV patients.
02:07
But it would have done so at a price
02:13
to hundreds of patients who, like Celine,
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were left to their own devices
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once the research had been completed.
02:21
I do not stand here today to suggest in any way
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that conducting HIV clinical trials
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in developing countries is bad.
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On the contrary, clinical trials are extremely useful tools,
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and are much needed to address the burden
02:36
of disease in developing countries.
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However, the inequalities that exist between
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richer countries and developing countries in terms of funding
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pose a real risk for exploitation,
02:47
especially in the context of externally-funded research.
02:50
Sadly enough, the fact remains that
02:54
a lot of the studies that are conducted in developing countries
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could never be authorized in the richer countries
03:01
which fund the research.
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I'm sure you must be asking yourselves
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what makes developing countries,
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especially those in sub-Saharan Africa,
03:10
so attractive for these HIV clinical trials?
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Well, in order for a clinical trial to generate
03:16
valid and widely applicable results,
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they need to be conducted with large numbers of study participants
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and preferably on a population
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with a high incidence of new HIV infections.
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Sub-Saharan Africa largely fits this description,
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with 22 million people living with HIV,
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an estimated 70 percent of the 30 million people
03:39
who are infected worldwide.
03:43
Also, research within the continent
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is a lot easier to conduct due to widespread poverty,
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endemic diseases and inadequate health care systems.
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A clinical trial that is considered to be
03:56
potentially beneficial to the population
03:59
is more likely to be authorized,
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and in the absence of good health care systems,
04:04
almost any offer of medical assistance
04:07
is accepted as better than nothing.
04:10
Even more problematic reasons include
04:12
lower risk of litigation,
04:15
less rigorous ethical reviews,
04:17
and populations that are willing to participate
04:20
in almost any study that hints at a cure.
04:22
As funding for HIV research
04:27
increases in developing countries
04:31
and ethical review in richer countries become more strict,
04:33
you can see why this context becomes
04:37
very, very attractive.
04:39
The high prevalence of HIV drives researchers
04:42
to conduct research that is sometimes scientifically acceptable
04:45
but on many levels ethically questionable.
04:50
How then can we ensure that, in our search for the cure,
04:53
we do not take an unfair advantage
04:56
of those who are already most affected by the pandemic?
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I invite you to consider four areas I think we can focus on
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in order to improve the way in which things are done.
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The first of these is informed consent.
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Now, in order for a clinical trial to be
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considered ethically acceptable,
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participants must be given the relevant information
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in a way in which they can understand,
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and must freely consent to participate in the trial.
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This is especially important in developing countries,
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where a lot of participants consent to research
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because they believe it is the only way in which
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they can receive medical care or other benefits.
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Consent procedures that are used in richer countries
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are often inappropriate or ineffective
05:43
in a lot of developing countries.
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For example, it is counterintuitive to have
05:48
an illiterate study participant, like Celine,
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sign a lengthy consent form that they are unable to read,
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let alone understand.
05:57
Local communities need to be more involved
05:59
in establishing the criteria for recruiting participants
06:02
in clinical trials, as well as the incentives for participation.
06:06
The information in these trials
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needs to be given to the potential participants
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in linguistically and culturally acceptable formats.
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The second point I would like for you to consider
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is the standard of care that is provided
06:22
to participants within any clinical trial.
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Now, this is subject to a lot of debate and controversy.
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Should the control group in the clinical trial
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be given the best current treatment which is available
06:35
anywhere in the world?
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Or should they be given an alternative standard of care,
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such as the best current treatment available
06:43
in the country in which the research is being conducted?
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Is it fair to evaluate a treatment regimen
06:49
which may not be affordable or accessible
06:52
to the study participants once the research has been completed?
06:55
Now, in a situation where the best current treatment
06:59
is inexpensive and simple to deliver,
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the answer is straightforward.
07:06
However, the best current treatment available
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anywhere in the world is often very difficult
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to provide in developing countries.
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It is important to assess the potential risks and benefits
07:17
of the standard of care which is to be provided
07:20
to participants in any clinical trial,
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and establish one which is relevant for the context of the study
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and most beneficial for the participants within the study.
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That brings us to the third point I want you think about:
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the ethical review of research.
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An effective system for reviewing the ethical suitability
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of clinical trials is primordial to safeguard participants
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within any clinical trial.
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Unfortunately, this is often lacking
07:50
or inefficient in a lot of developing countries.
07:53
Local governments need to set up effective systems
07:57
for reviewing the ethical issues around the clinical trials
08:01
which are authorized in different developing countries,
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and they need to do this by setting up
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ethical review committees that are independent
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of the government and research sponsors.
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Public accountability needs to be promoted
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through transparency and independent review
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by nongovernmental and international organizations
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as appropriate.
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The final point I would like for you to consider tonight
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is what happens to participants in the clinical trial
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once the research has been completed.
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I think it is absolutely wrong for research to begin
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in the first place without a clear plan
08:39
for what would happen to the participants
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once the trial has ended.
08:44
Now, researchers need to make every effort to ensure that
08:46
an intervention that has been shown to be beneficial
08:52
during a clinical trial
08:55
is accessible to the participants of the trial
08:56
once the trial has been completed.
09:00
In addition, they should be able to consider the possibility
09:03
of introducing and maintaining effective treatments
09:06
in the wider community once the trial ends.
09:10
If, for any reason, they feel that this might not be possible,
09:13
then I think they should have to ethically justify
09:17
why the clinical trial should be conducted in the first place.
09:20
Now, fortunately for Celine,
09:24
our meeting did not end in my office.
09:26
I was able to get her enrolled into a free HIV treatment program
09:29
closer to her home,
09:33
and with a support group to help her cope.
09:35
Her story has a positive ending,
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but there are thousands of others in similar situations
09:41
who are much less fortunate.
09:44
Although she may not know this,
09:47
my encounter with Celine has completely changed the way
09:49
in which I view HIV clinical trials in developing countries,
09:53
and made me even more determined to be part of the movement
09:57
to change the way in which things are done.
10:01
I believe that every single person
10:04
listening to me tonight can be part of that change.
10:06
If you are a researcher, I hold you
10:11
to a higher standard of moral conscience,
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to remain ethical in your research,
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and not compromise human welfare in your search for answers.
10:18
If you work for a funding agency or pharmaceutical company,
10:22
I challenge you to hold your employers
10:25
to fund research that is ethically sound.
10:28
If you come from a developing country like myself,
10:32
I urge you to hold your government
10:35
to a more thorough review of the clinical trials
10:38
which are authorized in your country.
10:40
Yes, there is a need for us to find a cure for HIV,
10:43
to find an effective vaccine for malaria,
10:47
to find a diagnostic tool that works for T.B.,
10:50
but I believe that we owe it to those who willingly
10:54
and selflessly consent to participate in these clinical trials
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to do this in a humane way.
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Thank you.
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Translated by Joseph Geni
Reviewed by Morton Bast

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About the Speaker:

Boghuma Kabisen Titanji - Clinical researcher
Boghuma Kabisen Titanji set out to research HIV drug resistant viruses. In the process, Titanji met a woman who changed the way she thinks about research subjects.

Why you should listen

Born in Cameroon, Boghuma Kabisen Titanji is a medical doctor and MPhil/PhD candidate at University College London. Her research into HIV drug resistant viruses seeks to better understand the mechanisms of drug resistance and to identify new ways of targeting resistant viruses.

During the course of her research, Titanji met a woman named Celine who forever changed the way she thinks about the people who sign informed consent agreements to be research subjects. Ever since, Titanji has been a vocal advocate for ethical medical research, calling for researchers to find less exploitative ways to study diseases in developing countries.

More profile about the speaker
Boghuma Kabisen Titanji | Speaker | TED.com