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Boghuma Kabisen Titanji: Ethical riddles in HIV research
Boguma Kabisen Titandži (Boghuma Kabisen Titanji): Etičke zagonetke u HIV istraživanjima
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To je veoma uobičajena priča: posle učestvovanja u HIV kliničkom testiranju, žena u podsaharaskoj Africi je ostavljena bez sredstava da kupi autobusku kartu do svoje zdravstvene klinike, da ne spominjemo antiretroviralne lekove koji život znače. Boguma Kabisen Titandži postavlja važno pitanje: kako da istraživači koji traže lek budu sigurni da ne iskorišćavaju one koji su najviše pogođeni pandemijom? (Snimljeno na TEDxGoodenoughCollege)
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. Full bio
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
Double-click the English transcript below to play the video.
00:17
I'd like to share with you
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Htela bih sa vama da podelim
00:19
the story of one of my patients called Celine.
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priču o jednoj mojoj pacijentkinji
po imenu Selin.
po imenu Selin.
00:23
Celine is a housewife and lives in a rural district
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Selin je domaćica
i živi u ruralnom okrugu
i živi u ruralnom okrugu
00:26
of Cameroon in west Central Africa.
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Kameruna u zapadnom delu
Centralne Afrike.
Centralne Afrike.
00:29
Six years ago, at the time of her HIV diagnosis,
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Pre šest godina, u vreme
kad joj je otkriven HIV
kad joj je otkriven HIV
00:33
she was recruited to participate in the clinical trial
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bila je regrutovana da učestvuje
u kliničkim ispitivanjima
u kliničkim ispitivanjima
00:36
which was running in her health district at the time.
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koja su sprovođena, u to vreme,
u njenom zdrastvenom okrugu.
u njenom zdrastvenom okrugu.
00:39
When I first met Celine, a little over a year ago,
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Kada sam prvi put srela Selinu,
pre malo više od godinu,
pre malo više od godinu,
00:42
she had gone for 18 months
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prošla je 18 meseci
00:44
without any antiretroviral therapy,
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bez ikakve antiretrovirusne terapije
00:46
and she was very ill.
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i bila je veoma bolesna.
00:49
She told me that she stopped coming to the clinic
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Rekla mi je da je prestala
da dolazi u bolnicu
da dolazi u bolnicu
00:52
when the trial ended
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kada se ispitivanje završilo,
00:53
because she had no money for the bus fare
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jer nije imala novca za autobusku kartu
00:56
and was too ill to walk the 35-kilometer distance.
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i bila je previše bolesna da bi pešačila
razdaljinu od 35 kilometara.
razdaljinu od 35 kilometara.
01:00
Now during the clinical trial,
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U toku kliničkog ispitivanja,
01:01
she'd been given all her antiretroviral drugs free of charge,
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dobijala je antiretrovirusne lekove besplatno
01:06
and her transportation costs
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i troškovi prevoza
01:08
had been covered by the research funds.
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su bili pokriveni istraživačkim fondom.
01:10
All of these ended once the trial was completed,
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Sve ovo se završilo
kada je istraživanje završeno,
kada je istraživanje završeno,
01:14
leaving Celine with no alternatives.
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ostavljajući Selin bez alternative.
01:17
She was unable to tell me the names of the drugs
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Nije mogla da mi kaže imena lekova
01:19
she'd received during the trial,
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koje je primala u toku istraživanja
01:21
or even what the trial had been about.
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ili čak u vezi sa čim je istraživanje bilo.
01:24
I didn't bother to ask her what the results of the trial were
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Nisam se trudila da je pitam
koji su bili rezultati istraživanja,
koji su bili rezultati istraživanja,
01:28
because it seemed obvious to me that she would have no clue.
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jer mi je bilo očigledno
da ona to ne bi znala.
da ona to ne bi znala.
01:32
Yet what puzzled me most
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Ipak, ono što me je najviše zbunjivalo
01:34
was Celine had given her informed consent
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bio je njen pristanak
01:37
to be a part of this trial, yet she clearly did not understand
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da bude deo istraživanja,
iako ona očigledno nije razumjela
iako ona očigledno nije razumjela
01:41
the implications of being a participant
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koje su implikacije ako je učesnik
01:44
or what would happen to her once the trial had been completed.
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ili šta će joj se desiti
kada istraživanje bude gotovo.
kada istraživanje bude gotovo.
01:48
Now, I have shared this story with you as an example
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Podelila sam ovu priču sa vama, kao primer
01:52
of what can happen to participants in the clinical trial
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šta se dešava učesnicima
bolničkih istraživanja
bolničkih istraživanja
01:55
when it is poorly conducted.
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kada su loše sprovedena.
01:57
Maybe this particular trial yielded exciting results.
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Možda je ovo konkretno istraživanje iznedrilo
uzbudljive rezultate.
uzbudljive rezultate.
02:01
Maybe it even got published in a high-profile scientific journal.
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Možda je čak i objavljeno u uglednom
naučnom časopisu.
naučnom časopisu.
02:05
Maybe it would inform clinicians around the world
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Možda je informisalo bolnice širom sveta
02:07
on how to improve on the clinical management of HIV patients.
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o tome kako da se poboljša klinički tretman
prema HIV pacijentima.
prema HIV pacijentima.
02:13
But it would have done so at a price
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Ali sve bi to bilo urađeno po ceni
02:16
to hundreds of patients who, like Celine,
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stotina pacijenata koji su, kao Selina,
02:19
were left to their own devices
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bili prepušteni sami sebi,
02:21
once the research had been completed.
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kada je istraživanje završeno.
02:24
I do not stand here today to suggest in any way
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Ja ne stojim ovde da kažem,
na bilo koji način,
na bilo koji način,
02:27
that conducting HIV clinical trials
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da je sprovođenje HIV kliničkih istraživanja
02:29
in developing countries is bad.
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u državama u razvoju loše.
02:32
On the contrary, clinical trials are extremely useful tools,
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Naprotiv, klinička istraživanja
su veoma korisne alatke
su veoma korisne alatke
02:36
and are much needed to address the burden
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i veoma potrebna da se obrati pažnja na teret
02:38
of disease in developing countries.
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bolesti u državama u razvoju.
02:41
However, the inequalities that exist between
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Međutim, nejednakosti koje postoje između
02:43
richer countries and developing countries in terms of funding
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bogatih država i država u razvoju,
u pogledu finansiranja
u pogledu finansiranja
02:47
pose a real risk for exploitation,
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predstavlja stvarnu opasnost za eksploataciju,
02:50
especially in the context of externally-funded research.
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posebno u kontekstu
spoljno-finansiranog istraživanja.
spoljno-finansiranog istraživanja.
02:54
Sadly enough, the fact remains that
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Nažalost, ostaje činjenica
02:57
a lot of the studies that are conducted in developing countries
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da dosta istraživanja koja su sprovođena
u zemljama u razvoju,
u zemljama u razvoju,
03:01
could never be authorized in the richer countries
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nisu mogla da budu odobrena
u bogatijim zemljama
u bogatijim zemljama
03:03
which fund the research.
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koja finansiraju ta istraživanja.
03:06
I'm sure you must be asking yourselves
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Sigurna sam da se pitate,
03:08
what makes developing countries,
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šta čini zemlje u razvoju,
03:10
especially those in sub-Saharan Africa,
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pogotovu one u podsaharaskoj Africi,
03:12
so attractive for these HIV clinical trials?
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toliko privlačnim za HIV istraživanja?
03:16
Well, in order for a clinical trial to generate
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Pa, da bi klinička istraživanja proizvela
03:19
valid and widely applicable results,
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validne i široko primjenjive rezultate,
03:22
they need to be conducted with large numbers of study participants
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ona moraju biti sprovedena sa velikim
brojem učesnika
brojem učesnika
03:26
and preferably on a population
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i poželjno, na populaciji
03:29
with a high incidence of new HIV infections.
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sa velikom incidencijom novih HIV zaraženih.
03:33
Sub-Saharan Africa largely fits this description,
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Podsaharaska Afrika u velikoj meri
odgovara ovom opisu,
odgovara ovom opisu,
03:36
with 22 million people living with HIV,
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sa 22 miliona ljudi koji žive sa HIV-om,
03:39
an estimated 70 percent of the 30 million people
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što je 70 posto od 30 miliona ljudi
03:43
who are infected worldwide.
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koji su zaraženi u svetu.
03:46
Also, research within the continent
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Takođe, istraživanje unutar kontinenta
03:48
is a lot easier to conduct due to widespread poverty,
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je mnogo lakše da se izvede zbog
rasprostranjenog siromaštva,
rasprostranjenog siromaštva,
03:52
endemic diseases and inadequate health care systems.
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endemskih bolesti i neadekvatnog sistema
zdrastvene zaštite.
zdrastvene zaštite.
03:56
A clinical trial that is considered to be
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Bolničko istraživanje koje se smatra
03:59
potentially beneficial to the population
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potencijalno korisnim za populaciju
04:01
is more likely to be authorized,
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je verovatnije da bude odobreno,
04:04
and in the absence of good health care systems,
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a u nedostatku dobrog sistema
zdrastvene zaštite,
zdrastvene zaštite,
04:07
almost any offer of medical assistance
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skoro svaka ponuda medicinske pomoći
04:10
is accepted as better than nothing.
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je prihvatljivija nego nikakva.
04:12
Even more problematic reasons include
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Još problematičniji razlozi uključuju
04:15
lower risk of litigation,
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manji rizik suđenja,
04:17
less rigorous ethical reviews,
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manje rigorozne etičke kritike
04:20
and populations that are willing to participate
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i populacije koje žele da učestvuju
04:22
in almost any study that hints at a cure.
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u bilo kojem istraživanju koje
nagoveštava lek.
nagoveštava lek.
04:27
As funding for HIV research
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Kako se finansiranje HIV istraživanja
04:31
increases in developing countries
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povećava u zemljama u razvoju
04:33
and ethical review in richer countries become more strict,
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i etičke kritike u bogatim zemljama
postaju strožije,
postaju strožije,
04:37
you can see why this context becomes
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možete videti kako ovaj kontekst postaje
04:39
very, very attractive.
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veoma, veoma atraktivan.
04:42
The high prevalence of HIV drives researchers
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Visok porast HIV-a tera istraživače
04:45
to conduct research that is sometimes scientifically acceptable
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da izvode istraživanja koja su
ponekad naučno prihvatljiva,
ponekad naučno prihvatljiva,
04:50
but on many levels ethically questionable.
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ali u mnogo pogleda etički diskutablna.
04:53
How then can we ensure that, in our search for the cure,
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Kako onda možemo osigurati to da
u našim traganjima za lek,
u našim traganjima za lek,
04:56
we do not take an unfair advantage
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ne iskoristimo nepravednu prednost
04:59
of those who are already most affected by the pandemic?
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od onih koji su već najviše
pogođeni pandemijom?
pogođeni pandemijom?
05:02
I invite you to consider four areas I think we can focus on
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Pozivam vas da razmotrite četiri oblasti na koje
mislim da možemo da se fokusiramo
mislim da možemo da se fokusiramo
05:06
in order to improve the way in which things are done.
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u cilju unapređenja načina
na koji se stvari rade.
na koji se stvari rade.
05:10
The first of these is informed consent.
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Prvi od tih je informisani pristanak.
05:13
Now, in order for a clinical trial to be
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Da bi kliničko istraživanje bilo
05:15
considered ethically acceptable,
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razmatrano kao etički prihvatljivo,
05:19
participants must be given the relevant information
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učesnicima moraju biti date važne informacije
05:21
in a way in which they can understand,
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na način na koji oni mogu da razumeju
05:24
and must freely consent to participate in the trial.
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i moraju slobodno pristati da učestvuju
u istraživanju.
u istraživanju.
05:28
This is especially important in developing countries,
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Ovo je posebno bitno u zemljama u razvoju,
05:31
where a lot of participants consent to research
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gdje dosta učesnika prihvati istraživanje
05:34
because they believe it is the only way in which
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jer veruju da je to jedini način na koji
05:36
they can receive medical care or other benefits.
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oni mogu dobiti medicinsku brigu
i druge pogodnosti.
i druge pogodnosti.
05:40
Consent procedures that are used in richer countries
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Procedure saglasnosti koje se koriste
u bogatijm zemljama
u bogatijm zemljama
05:43
are often inappropriate or ineffective
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su često neprikladne ili neefikasne
05:46
in a lot of developing countries.
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u dosta zemalja u razvoju.
05:48
For example, it is counterintuitive to have
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Na primer, nelogično je dati
05:51
an illiterate study participant, like Celine,
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nepismenom učesniku, kao Selin,
05:54
sign a lengthy consent form that they are unable to read,
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da potpiše poduži obrazac za saglasnost,
koji on ne može da pročita,
koji on ne može da pročita,
05:57
let alone understand.
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a kamoli razume.
05:59
Local communities need to be more involved
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Lokalne zajednice
moraju biti više uključene
moraju biti više uključene
06:02
in establishing the criteria for recruiting participants
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u postavljanju kriterijuma
za regrutovanje učesnika
za regrutovanje učesnika
06:06
in clinical trials, as well as the incentives for participation.
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u kliničkim istraživanjima,
kao i kod podsticaja za učestvovanje.
kao i kod podsticaja za učestvovanje.
06:10
The information in these trials
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Informacije o ovim istraživanjima
06:12
needs to be given to the potential participants
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moraju biti date potencijalnim učesnicima
06:15
in linguistically and culturally acceptable formats.
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u jezički i kulturno prihvatljivom formatu.
06:20
The second point I would like for you to consider
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Sledeća stvar koju bih želela da razmotrite
06:22
is the standard of care that is provided
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je standard zaštite koji je obezbeđen
06:25
to participants within any clinical trial.
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učesnicima kliničkih istraživanja.
06:28
Now, this is subject to a lot of debate and controversy.
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Ovo je predmet mnogih debata i kontraverze.
06:32
Should the control group in the clinical trial
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Treba li kontrolnoj grupi
u medicinskim istraživanjima
u medicinskim istraživanjima
06:35
be given the best current treatment which is available
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dati trenutno najbolji tretman koji postoji
06:38
anywhere in the world?
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bilo gde u svetu?
06:40
Or should they be given an alternative standard of care,
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Ili im treba dati alternativni standard brige,
06:43
such as the best current treatment available
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koje je trenutno najbolji tretman,
koji je dostupan
koji je dostupan
06:46
in the country in which the research is being conducted?
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u zemlji u kojoj se istraživanje izvodi?
06:49
Is it fair to evaluate a treatment regimen
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Da li je fer proceniti režim lečenja
06:52
which may not be affordable or accessible
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koji nije novčano moguć ili dostupan
06:55
to the study participants once the research has been completed?
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učesnicima kada je istraživanje završeno?
06:59
Now, in a situation where the best current treatment
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U situaciji gde je trenutno najbolja terapija
07:03
is inexpensive and simple to deliver,
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jeftina i jednostavna za isporuku,
07:06
the answer is straightforward.
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odgovor je jasan.
07:08
However, the best current treatment available
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Međutim, trenutno najbolju dostupnu terapiju
07:11
anywhere in the world is often very difficult
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bilo gde u svetu je često veoma teško
07:14
to provide in developing countries.
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obezbediti u zemljama u razvoju.
07:17
It is important to assess the potential risks and benefits
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Važno je proceniti potencijalne rizike i benefite
07:20
of the standard of care which is to be provided
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standarda brige koja je obezbeđena
07:23
to participants in any clinical trial,
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učesnicima u bilo kom bolničkom istraživanju
07:25
and establish one which is relevant for the context of the study
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i uspostaviti one koje su relevantni
u kontekstu studije
u kontekstu studije
07:31
and most beneficial for the participants within the study.
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i najkorisniji za učesnike u istraživanju.
07:34
That brings us to the third point I want you think about:
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To nas dovodi do treće stvari,
o kojoj želim da razmislite:
o kojoj želim da razmislite:
07:38
the ethical review of research.
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etičke kritike istraživanja.
07:40
An effective system for reviewing the ethical suitability
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Efikasan sistem za razmatranje
etičke ispravnosti
etičke ispravnosti
07:44
of clinical trials is primordial to safeguard participants
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bolničkih istraživanja je primaran
za zaštitu učesnika
za zaštitu učesnika
07:48
within any clinical trial.
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u okviru bilo kog istraživanja.
07:50
Unfortunately, this is often lacking
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Nažalost, ovo često nedostaje
07:53
or inefficient in a lot of developing countries.
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ili je neefikasno u dosta zemalja u razvoju.
07:57
Local governments need to set up effective systems
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Lokalne vlade bi trebalo
da postave efikasne sisteme
da postave efikasne sisteme
08:01
for reviewing the ethical issues around the clinical trials
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za razmatranje etičkih problema
oko kliničkih istraživanja
oko kliničkih istraživanja
08:04
which are authorized in different developing countries,
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koja su ovlašćena u zemljama u razvoju
08:08
and they need to do this by setting up
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i moraju da urade ovo postavljajući
08:10
ethical review committees that are independent
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odbore za razmatranje,
koji su nezavisni
koji su nezavisni
08:13
of the government and research sponsors.
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od vlade i sponzora istraživanja.
08:16
Public accountability needs to be promoted
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Javna odgovornost
mora da bude promovisana
mora da bude promovisana
08:19
through transparency and independent review
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kroz transparentno i nezavisno razmatranje
08:22
by nongovernmental and international organizations
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od strane nevladinih i međunarodnih organizacija
08:25
as appropriate.
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kao što priliči.
08:26
The final point I would like for you to consider tonight
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Poslednja stvar koju želim
da razmotrite večeras
da razmotrite večeras
08:30
is what happens to participants in the clinical trial
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je šta se dešava sa učesnicima
kliničkog ispitivanja
kliničkog ispitivanja
08:33
once the research has been completed.
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kada je ono završeno.
08:36
I think it is absolutely wrong for research to begin
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Mislim da je potpuno pogrešno
da istraživanje počne
da istraživanje počne
08:39
in the first place without a clear plan
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bez jasnog plana
08:42
for what would happen to the participants
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šta će se desiti sa učesnicima
08:44
once the trial has ended.
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onda kada se istraživanje završi.
08:46
Now, researchers need to make every effort to ensure that
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Istraživači bi trebalo da se potrude
da obezbede
da obezbede
08:52
an intervention that has been shown to be beneficial
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da je intervencija
koja se pokazala korisnom
koja se pokazala korisnom
08:55
during a clinical trial
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tokom kliničkog ispitivanja,
08:56
is accessible to the participants of the trial
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dostupna učesnicima istraživanja
09:00
once the trial has been completed.
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onda kada se istraživanje završi.
09:03
In addition, they should be able to consider the possibility
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Pored toga, trebalo bi da budu u stanju
da razmotre mogućnost
da razmotre mogućnost
09:06
of introducing and maintaining effective treatments
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upoznavanja i održavanja efikasnih tretmana
09:10
in the wider community once the trial ends.
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širim zajednicama kada se istražvanje završi.
09:13
If, for any reason, they feel that this might not be possible,
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Ako, iz bilo kog razloga, oni smatraju
da to ne bi bilo moguće,
da to ne bi bilo moguće,
09:17
then I think they should have to ethically justify
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onda mislim da bi trebalo
etički da opravdaju
etički da opravdaju
09:20
why the clinical trial should be conducted in the first place.
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zašto kliničko istraživanje i treba
uopšte da bude sprovedeno.
uopšte da bude sprovedeno.
09:24
Now, fortunately for Celine,
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Sada, srećom za Selin,
09:26
our meeting did not end in my office.
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naš sastanak se nije završio
u mojoj kancelariji.
u mojoj kancelariji.
09:29
I was able to get her enrolled into a free HIV treatment program
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Bila sam u mogućnosti da je upišem
na besplatni HIV tretman
na besplatni HIV tretman
09:33
closer to her home,
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bliže njenoj kući
09:35
and with a support group to help her cope.
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i sa grupom za podršku
da joj pomogne da se izbori.
da joj pomogne da se izbori.
09:38
Her story has a positive ending,
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Njena priča ima pozitivan kraj,
09:41
but there are thousands of others in similar situations
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ali ima na hiljade drugih
u sličnim situacijama
u sličnim situacijama
09:44
who are much less fortunate.
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koji su mnogo manje srećni.
09:47
Although she may not know this,
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Iako možda ona ne zna ovo,
09:49
my encounter with Celine has completely changed the way
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moj susret sa Selin je totalno promenio način
09:53
in which I view HIV clinical trials in developing countries,
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na koji sam posmatrala HIV klinička istraživanja
u zemljama u razvoju
u zemljama u razvoju
09:57
and made me even more determined to be part of the movement
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i učinilo me odlučnijom
da budem deo pokreta
da budem deo pokreta
10:01
to change the way in which things are done.
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koji menja način na koji se stvari rade.
10:04
I believe that every single person
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Verujem da svaka osoba
10:06
listening to me tonight can be part of that change.
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koja me sluša večeras
može biti deo promene.
može biti deo promene.
10:11
If you are a researcher, I hold you
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Ako ste istraživači, pozivam vas
10:13
to a higher standard of moral conscience,
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na veće standarde moralne savesti,
10:16
to remain ethical in your research,
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da zadržite etiku u vašim istraživanjima
10:18
and not compromise human welfare in your search for answers.
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i ne ugrožavate dobrobit ljudi
u potrazi za odgovorom.
u potrazi za odgovorom.
10:22
If you work for a funding agency or pharmaceutical company,
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Ako radite za agencije za finansiranje
ili farmaceutske kompanije,
ili farmaceutske kompanije,
10:25
I challenge you to hold your employers
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izazivam vas da navodite svoje poslodavce
10:28
to fund research that is ethically sound.
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da finansiraju samo istraživanja
koja su etički ispravna.
koja su etički ispravna.
10:32
If you come from a developing country like myself,
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Ako dolazite iz zemlje u razvoju kao ja,
10:35
I urge you to hold your government
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podstičem vas da navodite svoju vladu
10:38
to a more thorough review of the clinical trials
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na detaljnije razmatranje kliničkih istraživanja
10:40
which are authorized in your country.
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koja su odobrena u vašoj zemlji.
10:43
Yes, there is a need for us to find a cure for HIV,
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Da, postoji potreba da nađemo lek za HIV,
10:47
to find an effective vaccine for malaria,
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da se nađe efikasnija vakcina za malariju,
10:50
to find a diagnostic tool that works for T.B.,
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da se nađe dijagnostički instrument
za tuberkulozu,
za tuberkulozu,
10:54
but I believe that we owe it to those who willingly
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ali ja verujem da onima koji voljno
10:57
and selflessly consent to participate in these clinical trials
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i nesebično prihvataju da učestvuju
u tim kliničkim istraživanjima,
u tim kliničkim istraživanjima,
11:01
to do this in a humane way.
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dugujemo da uradimo ovo na human način.
11:03
Thank you.
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Hvala vam.
ABOUT THE SPEAKER
Boghuma Kabisen Titanji - Clinical researcherBoghuma 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.
Boghuma Kabisen Titanji | Speaker | TED.com