Ethical riddles in HIV research

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.)

I'd like to share with you

the story of one of my patients called Celine.

Celine is a housewife and lives in a rural district

of Cameroon in west Central Africa.

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

she was recruited to participate in the clinical trial

which was running in her health district at the time.

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

she had gone for 18 months

without any antiretroviral therapy,

and she was very ill.

She told me that she stopped coming to the clinic

when the trial ended

because she had no money for the bus fare

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

Now during the clinical trial,

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

and her transportation costs

had been covered by the research funds.

All of these ended once the trial was completed,

leaving Celine with no alternatives.

She was unable to tell me the names of the drugs

she'd received during the trial,

or even what the trial had been about.

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

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

Yet what puzzled me most

was Celine had given her informed consent

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

the implications of being a participant

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

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

of what can happen to participants in the clinical trial

when it is poorly conducted.

Maybe this particular trial yielded exciting results.

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

Maybe it would inform clinicians around the world

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

But it would have done so at a price

to hundreds of patients who, like Celine,

were left to their own devices

once the research had been completed.

I do not stand here today to suggest in any way

that conducting HIV clinical trials

in developing countries is bad.

On the contrary, clinical trials are extremely useful tools,

and are much needed to address the burden

of disease in developing countries.

However, the inequalities that exist between

richer countries and developing countries in terms of funding

pose a real risk for exploitation,

especially in the context of externally-funded research.

Sadly enough, the fact remains that

a lot of the studies that are conducted in developing countries

could never be authorized in the richer countries

which fund the research.

I'm sure you must be asking yourselves

what makes developing countries,

especially those in sub-Saharan Africa,

so attractive for these HIV clinical trials?

Well, in order for a clinical trial to generate

valid and widely applicable results,

they need to be conducted with large numbers of study participants

and preferably on a population

with a high incidence of new HIV infections.

Sub-Saharan Africa largely fits this description,

with 22 million people living with HIV,

an estimated 70 percent of the 30 million people

who are infected worldwide.

Also, research within the continent

is a lot easier to conduct due to widespread poverty,

endemic diseases and inadequate health care systems.

A clinical trial that is considered to be

potentially beneficial to the population

is more likely to be authorized,

and in the absence of good health care systems,

almost any offer of medical assistance

is accepted as better than nothing.

Even more problematic reasons include

lower risk of litigation,

less rigorous ethical reviews,

and populations that are willing to participate

in almost any study that hints at a cure.

As funding for HIV research

increases in developing countries

and ethical review in richer countries become more strict,

you can see why this context becomes

very, very attractive.

The high prevalence of HIV drives researchers

to conduct research that is sometimes scientifically acceptable

but on many levels ethically questionable.

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

we do not take an unfair advantage

of those who are already most affected by the pandemic?

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

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

The first of these is informed consent.

Now, in order for a clinical trial to be

considered ethically acceptable,

participants must be given the relevant information

in a way in which they can understand,

and must freely consent to participate in the trial.

This is especially important in developing countries,

where a lot of participants consent to research

because they believe it is the only way in which

they can receive medical care or other benefits.

Consent procedures that are used in richer countries

are often inappropriate or ineffective

in a lot of developing countries.

For example, it is counterintuitive to have

an illiterate study participant, like Celine,

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

let alone understand.

Local communities need to be more involved

in establishing the criteria for recruiting participants

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

The information in these trials

needs to be given to the potential participants

in linguistically and culturally acceptable formats.

The second point I would like for you to consider

is the standard of care that is provided

to participants within any clinical trial.

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

Should the control group in the clinical trial

be given the best current treatment which is available

anywhere in the world?

Or should they be given an alternative standard of care,

such as the best current treatment available

in the country in which the research is being conducted?

Is it fair to evaluate a treatment regimen

which may not be affordable or accessible

to the study participants once the research has been completed?

Now, in a situation where the best current treatment

is inexpensive and simple to deliver,

the answer is straightforward.

However, the best current treatment available

anywhere in the world is often very difficult

to provide in developing countries.

It is important to assess the potential risks and benefits

of the standard of care which is to be provided

to participants in any clinical trial,

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

and most beneficial for the participants within the study.

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

the ethical review of research.

An effective system for reviewing the ethical suitability

of clinical trials is primordial to safeguard participants

within any clinical trial.

Unfortunately, this is often lacking

or inefficient in a lot of developing countries.

Local governments need to set up effective systems

for reviewing the ethical issues around the clinical trials

which are authorized in different developing countries,

and they need to do this by setting up

ethical review committees that are independent

of the government and research sponsors.

Public accountability needs to be promoted

through transparency and independent review

by nongovernmental and international organizations

as appropriate.

The final point I would like for you to consider tonight

is what happens to participants in the clinical trial

once the research has been completed.

I think it is absolutely wrong for research to begin

in the first place without a clear plan

for what would happen to the participants

once the trial has ended.

Now, researchers need to make every effort to ensure that

an intervention that has been shown to be beneficial

during a clinical trial

is accessible to the participants of the trial

once the trial has been completed.

In addition, they should be able to consider the possibility

of introducing and maintaining effective treatments

in the wider community once the trial ends.

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

then I think they should have to ethically justify

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

Now, fortunately for Celine,

our meeting did not end in my office.

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

closer to her home,

and with a support group to help her cope.

Her story has a positive ending,

but there are thousands of others in similar situations

who are much less fortunate.

Although she may not know this,

my encounter with Celine has completely changed the way

in which I view HIV clinical trials in developing countries,

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

to change the way in which things are done.

I believe that every single person

listening to me tonight can be part of that change.

If you are a researcher, I hold you

to a higher standard of moral conscience,

to remain ethical in your research,

and not compromise human welfare in your search for answers.

If you work for a funding agency or pharmaceutical company,

I challenge you to hold your employers

to fund research that is ethically sound.

If you come from a developing country like myself,

I urge you to hold your government

to a more thorough review of the clinical trials

which are authorized in your country.

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

to find an effective vaccine for malaria,

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

but I believe that we owe it to those who willingly

and selflessly consent to participate in these clinical trials

to do this in a humane way.

Thank you.