Ethical riddles in HIV research Boghuma Kabisen Titanji

I’d like to share with you the story of

one of my patients called Selene Selene

is a housewife and leaves 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 kilometers now during the

clinical trial she’d been given all her

antiretroviral drugs free of charge and

her transportation cost had been covered

by the research funds all of these ended

once the trial was completed leading

Celine with no alternatives she was

unable to tell me the names of the drugs

should receive during the trial or even

what the trial had been about I didn’t

bother to ask her what the results of

the trial we’re 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 HIV of the 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 a much

needed to address the burden of disease

in developing countries however the

inequalities that exists between richer

countries and developing countries in

terms of funding pose a real risk for

exploitation especially in a 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 am 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% 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 an 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 phase is informed

consent now in order for a clinical

trial to be ethically 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 well 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 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 on these trials need 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 altar

relative 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 risk 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 study but for the

context of the study and most beneficial

for the participants within the study

that brings us to the third point I

wanted to 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 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 an

independent review by non-governmental

and international organizations as

appropriate the final point I’d 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 as accessible

to the participant of the child 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 Saline 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 saline 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

your 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 from a suitable company I

challenge you to hold your employer’s 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 the reason need for

us to find a cure for HIV to find an

effective vaccine for malaria to find a

diagnostic tool that works for TB 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

you