Ethical riddles in HIV research
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0:02 - 0:04I'd like to share with you
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0:04 - 0:07the story of one of my patients called Celine.
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0:07 - 0:11Celine is a housewife and lives in a rural district
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0:11 - 0:14of Cameroon in west Central Africa.
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0:14 - 0:17Six years ago, at the time of her HIV diagnosis,
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0:17 - 0:20she was recruited to participate in the clinical trial
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0:20 - 0:23which was running in her health district at the time.
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0:23 - 0:27When I first met Celine, a little over a year ago,
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0:27 - 0:29she had gone for 18 months
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0:29 - 0:31without any antiretroviral therapy,
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0:31 - 0:34and she was very ill.
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0:34 - 0:36She told me that she stopped coming to the clinic
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0:36 - 0:38when the trial ended
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0:38 - 0:40because she had no money for the bus fare
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0:40 - 0:44and was too ill to walk the 35-kilometer distance.
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0:44 - 0:46Now during the clinical trial,
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0:46 - 0:50she'd been given all her antiretroviral drugs free of charge,
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0:50 - 0:52and her transportation costs
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0:52 - 0:55had been covered by the research funds.
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0:55 - 0:58All of these ended once the trial was completed,
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0:58 - 1:01leaving Celine with no alternatives.
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1:01 - 1:04She was unable to tell me the names of the drugs
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1:04 - 1:06she'd received during the trial,
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1:06 - 1:09or even what the trial had been about.
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1:09 - 1:12I didn't bother to ask her what the results of the trial were
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1:12 - 1:17because it seemed obvious to me that she would have no clue.
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1:17 - 1:19Yet what puzzled me most
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1:19 - 1:22was Celine had given her informed consent
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1:22 - 1:26to be a part of this trial, yet she clearly did not understand
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1:26 - 1:28the implications of being a participant
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1:28 - 1:33or what would happen to her once the trial had been completed.
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1:33 - 1:36Now, I have shared this story with you as an example
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1:36 - 1:39of what can happen to participants in the clinical trial
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1:39 - 1:42when it is poorly conducted.
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1:42 - 1:45Maybe this particular trial yielded exciting results.
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1:45 - 1:49Maybe it even got published in a high-profile scientific journal.
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1:49 - 1:52Maybe it would inform clinicians around the world
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1:52 - 1:57on how to improve on the clinical management of HIV patients.
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1:57 - 2:00But it would have done so at a price
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2:00 - 2:03to hundreds of patients who, like Celine,
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2:03 - 2:05were left to their own devices
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2:05 - 2:09once the research had been completed.
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2:09 - 2:12I do not stand here today to suggest in any way
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2:12 - 2:14that conducting HIV clinical trials
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2:14 - 2:16in developing countries is bad.
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2:16 - 2:20On the contrary, clinical trials are extremely useful tools,
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2:20 - 2:23and are much needed to address the burden
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2:23 - 2:25of disease in developing countries.
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2:25 - 2:28However, the inequalities that exist between
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2:28 - 2:32richer countries and developing countries in terms of funding
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2:32 - 2:35pose a real risk for exploitation,
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2:35 - 2:39especially in the context of externally-funded research.
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2:39 - 2:41Sadly enough, the fact remains that
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2:41 - 2:45a lot of the studies that are conducted in developing countries
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2:45 - 2:48could never be authorized in the richer countries
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2:48 - 2:50which fund the research.
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2:50 - 2:53I'm sure you must be asking yourselves
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2:53 - 2:54what makes developing countries,
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2:54 - 2:57especially those in sub-Saharan Africa,
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2:57 - 3:01so attractive for these HIV clinical trials?
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3:01 - 3:04Well, in order for a clinical trial to generate
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3:04 - 3:07valid and widely applicable results,
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3:07 - 3:11they need to be conducted with large numbers of study participants
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3:11 - 3:14and preferably on a population
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3:14 - 3:17with a high incidence of new HIV infections.
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3:17 - 3:21Sub-Saharan Africa largely fits this description,
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3:21 - 3:24with 22 million people living with HIV,
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3:24 - 3:28an estimated 70 percent of the 30 million people
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3:28 - 3:30who are infected worldwide.
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3:30 - 3:33Also, research within the continent
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3:33 - 3:37is a lot easier to conduct due to widespread poverty,
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3:37 - 3:41endemic diseases and inadequate health care systems.
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3:41 - 3:43A clinical trial that is considered to be
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3:43 - 3:46potentially beneficial to the population
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3:46 - 3:48is more likely to be authorized,
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3:48 - 3:51and in the absence of good health care systems,
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3:51 - 3:54almost any offer of medical assistance
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3:54 - 3:57is accepted as better than nothing.
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3:57 - 4:00Even more problematic reasons include
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4:00 - 4:02lower risk of litigation,
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4:02 - 4:04less rigorous ethical reviews,
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4:04 - 4:07and populations that are willing to participate
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4:07 - 4:12in almost any study that hints at a cure.
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4:12 - 4:15As funding for HIV research
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4:15 - 4:17increases in developing countries
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4:17 - 4:21and ethical review in richer countries become more strict,
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4:21 - 4:24you can see why this context becomes
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4:24 - 4:26very, very attractive.
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4:26 - 4:30The high prevalence of HIV drives researchers
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4:30 - 4:34to conduct research that is sometimes scientifically acceptable
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4:34 - 4:38but on many levels ethically questionable.
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4:38 - 4:41How then can we ensure that, in our search for the cure,
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4:41 - 4:43we do not take an unfair advantage
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4:43 - 4:47of those who are already most affected by the pandemic?
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4:47 - 4:51I invite you to consider four areas I think we can focus on
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4:51 - 4:54in order to improve the way in which things are done.
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4:54 - 4:57The first of these is informed consent.
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4:57 - 4:59Now, in order for a clinical trial to be
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4:59 - 5:03considered ethically acceptable,
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5:03 - 5:06participants must be given the relevant information
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5:06 - 5:08in a way in which they can understand,
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5:08 - 5:13and must freely consent to participate in the trial.
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5:13 - 5:15This is especially important in developing countries,
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5:15 - 5:18where a lot of participants consent to research
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5:18 - 5:21because they believe it is the only way in which
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5:21 - 5:24they can receive medical care or other benefits.
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5:24 - 5:27Consent procedures that are used in richer countries
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5:27 - 5:30are often inappropriate or ineffective
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5:30 - 5:33in a lot of developing countries.
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5:33 - 5:36For example, it is counterintuitive to have
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5:36 - 5:39an illiterate study participant, like Celine,
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5:39 - 5:42sign a lengthy consent form that they are unable to read,
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5:42 - 5:44let alone understand.
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5:44 - 5:47Local communities need to be more involved
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5:47 - 5:50in establishing the criteria for recruiting participants
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5:50 - 5:55in clinical trials, as well as the incentives for participation.
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5:55 - 5:57The information in these trials
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5:57 - 6:00needs to be given to the potential participants
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6:00 - 6:04in linguistically and culturally acceptable formats.
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6:04 - 6:07The second point I would like for you to consider
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6:07 - 6:10is the standard of care that is provided
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6:10 - 6:12to participants within any clinical trial.
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6:12 - 6:16Now, this is subject to a lot of debate and controversy.
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6:16 - 6:19Should the control group in the clinical trial
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6:19 - 6:22be given the best current treatment which is available
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6:22 - 6:24anywhere in the world?
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6:24 - 6:27Or should they be given an alternative standard of care,
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6:27 - 6:30such as the best current treatment available
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6:30 - 6:34in the country in which the research is being conducted?
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6:34 - 6:37Is it fair to evaluate a treatment regimen
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6:37 - 6:40which may not be affordable or accessible
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6:40 - 6:44to the study participants once the research has been completed?
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6:44 - 6:48Now, in a situation where the best current treatment
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6:48 - 6:50is inexpensive and simple to deliver,
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6:50 - 6:52the answer is straightforward.
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6:52 - 6:56However, the best current treatment available
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6:56 - 6:58anywhere in the world is often very difficult
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6:58 - 7:01to provide in developing countries.
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7:01 - 7:05It is important to assess the potential risks and benefits
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7:05 - 7:07of the standard of care which is to be provided
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7:07 - 7:10to participants in any clinical trial,
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7:10 - 7:15and establish one which is relevant for the context of the study
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7:15 - 7:19and most beneficial for the participants within the study.
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7:19 - 7:22That brings us to the third point I want you think about:
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7:22 - 7:25the ethical review of research.
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7:25 - 7:29An effective system for reviewing the ethical suitability
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7:29 - 7:33of clinical trials is primordial to safeguard participants
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7:33 - 7:35within any clinical trial.
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7:35 - 7:38Unfortunately, this is often lacking
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7:38 - 7:42or inefficient in a lot of developing countries.
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7:42 - 7:46Local governments need to set up effective systems
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7:46 - 7:49for reviewing the ethical issues around the clinical trials
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7:49 - 7:53which are authorized in different developing countries,
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7:53 - 7:55and they need to do this by setting up
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7:55 - 7:57ethical review committees that are independent
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7:57 - 8:01of the government and research sponsors.
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8:01 - 8:03Public accountability needs to be promoted
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8:03 - 8:06through transparency and independent review
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8:06 - 8:10by nongovernmental and international organizations
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8:10 - 8:11as appropriate.
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8:11 - 8:15The final point I would like for you to consider tonight
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8:15 - 8:18is what happens to participants in the clinical trial
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8:18 - 8:21once the research has been completed.
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8:21 - 8:24I think it is absolutely wrong for research to begin
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8:24 - 8:27in the first place without a clear plan
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8:27 - 8:29for what would happen to the participants
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8:29 - 8:31once the trial has ended.
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8:31 - 8:36Now, researchers need to make every effort to ensure that
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8:36 - 8:39an intervention that has been shown to be beneficial
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8:39 - 8:41during a clinical trial
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8:41 - 8:45is accessible to the participants of the trial
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8:45 - 8:47once the trial has been completed.
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8:47 - 8:51In addition, they should be able to consider the possibility
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8:51 - 8:54of introducing and maintaining effective treatments
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8:54 - 8:58in the wider community once the trial ends.
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8:58 - 9:01If, for any reason, they feel that this might not be possible,
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9:01 - 9:04then I think they should have to ethically justify
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9:04 - 9:08why the clinical trial should be conducted in the first place.
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9:08 - 9:11Now, fortunately for Celine,
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9:11 - 9:13our meeting did not end in my office.
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9:13 - 9:18I was able to get her enrolled into a free HIV treatment program
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9:18 - 9:19closer to her home,
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9:19 - 9:23and with a support group to help her cope.
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9:23 - 9:25Her story has a positive ending,
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9:25 - 9:29but there are thousands of others in similar situations
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9:29 - 9:31who are much less fortunate.
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9:31 - 9:34Although she may not know this,
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9:34 - 9:38my encounter with Celine has completely changed the way
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9:38 - 9:42in which I view HIV clinical trials in developing countries,
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9:42 - 9:46and made me even more determined to be part of the movement
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9:46 - 9:48to change the way in which things are done.
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9:48 - 9:51I believe that every single person
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9:51 - 9:55listening to me tonight can be part of that change.
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9:55 - 9:58If you are a researcher, I hold you
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9:58 - 10:00to a higher standard of moral conscience,
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10:00 - 10:03to remain ethical in your research,
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10:03 - 10:06and not compromise human welfare in your search for answers.
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10:06 - 10:10If you work for a funding agency or pharmaceutical company,
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10:10 - 10:13I challenge you to hold your employers
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10:13 - 10:16to fund research that is ethically sound.
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10:16 - 10:19If you come from a developing country like myself,
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10:19 - 10:22I urge you to hold your government
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10:22 - 10:25to a more thorough review of the clinical trials
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10:25 - 10:28which are authorized in your country.
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10:28 - 10:32Yes, there is a need for us to find a cure for HIV,
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10:32 - 10:34to find an effective vaccine for malaria,
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10:34 - 10:38to find a diagnostic tool that works for T.B.,
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10:38 - 10:42but I believe that we owe it to those who willingly
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10:42 - 10:46and selflessly consent to participate in these clinical trials
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10:46 - 10:48to do this in a humane way.
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10:48 - 10:50Thank you.
- Title:
- Ethical riddles in HIV research
- Speaker:
- Boghuma Kabisen Titanji
- Description:
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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.)
- Video Language:
- English
- Team:
- closed TED
- Project:
- TEDTalks
- Duration:
- 11:10
Thu-Huong Ha edited English subtitles for Ethical riddles in HIV research | ||
Thu-Huong Ha approved English subtitles for Ethical riddles in HIV research | ||
Thu-Huong Ha edited English subtitles for Ethical riddles in HIV research | ||
Morton Bast accepted English subtitles for Ethical riddles in HIV research | ||
Morton Bast edited English subtitles for Ethical riddles in HIV research | ||
Joseph Geni added a translation |