Boghuma Kabisen Titanji: Ethical riddles in HIV research

49,509 views ・ 2013-01-10

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Translator: Joseph Geni Reviewer: Morton Bast
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I'd like to share with you
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the story of one of my patients called Celine.
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Celine is a housewife and lives in a rural district
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of Cameroon in west Central Africa.
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Six years ago, at the time of her HIV diagnosis,
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she was recruited to participate in the clinical trial
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which was running in her health district at the time.
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When I first met Celine, a little over a year ago,
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she had gone for 18 months
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without any antiretroviral therapy,
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and she was very ill.
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She told me that she stopped coming to the clinic
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when the trial ended
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because she had no money for the bus fare
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and was too ill to walk the 35-kilometer distance.
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Now during the clinical trial,
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she'd been given all her antiretroviral drugs free of charge,
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and her transportation costs
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had been covered by the research funds.
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All of these ended once the trial was completed,
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leaving Celine with no alternatives.
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She was unable to tell me the names of the drugs
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she'd received during the trial,
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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.
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Yet what puzzled me most
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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.
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Maybe this particular trial yielded exciting results.
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Maybe it even got published in a high-profile scientific journal.
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Maybe it would inform clinicians around the world
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on how to improve on the clinical management of HIV patients.
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But it would have done so at a price
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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.
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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
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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,
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especially in the context of externally-funded research.
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Sadly enough, the fact remains that
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a lot of the studies that are conducted in developing countries
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could never be authorized in the richer countries
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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,
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so attractive for these HIV clinical trials?
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Well, in order for a clinical trial to generate
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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
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who are infected worldwide.
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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
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potentially beneficial to the population
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is more likely to be authorized,
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and in the absence of good health care systems,
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almost any offer of medical assistance
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is accepted as better than nothing.
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Even more problematic reasons include
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lower risk of litigation,
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less rigorous ethical reviews,
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and populations that are willing to participate
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in almost any study that hints at a cure.
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As funding for HIV research
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increases in developing countries
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and ethical review in richer countries become more strict,
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you can see why this context becomes
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very, very attractive.
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The high prevalence of HIV drives researchers
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to conduct research that is sometimes scientifically acceptable
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but on many levels ethically questionable.
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How then can we ensure that, in our search for the cure,
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we do not take an unfair advantage
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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
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in a lot of developing countries.
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For example, it is counterintuitive to have
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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.
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Local communities need to be more involved
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in establishing the criteria for recruiting participants
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in clinical trials, as well as the incentives for participation.
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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
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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
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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
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in the country in which the research is being conducted?
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Is it fair to evaluate a treatment regimen
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which may not be affordable or accessible
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to the study participants once the research has been completed?
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Now, in a situation where the best current treatment
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is inexpensive and simple to deliver,
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the answer is straightforward.
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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
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of the standard of care which is to be provided
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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
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or inefficient in a lot of developing countries.
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Local governments need to set up effective systems
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for reviewing the ethical issues around the clinical trials
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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
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for what would happen to the participants
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once the trial has ended.
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Now, researchers need to make every effort to ensure that
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an intervention that has been shown to be beneficial
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during a clinical trial
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is accessible to the participants of the trial
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once the trial has been completed.
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In addition, they should be able to consider the possibility
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of introducing and maintaining effective treatments
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in the wider community once the trial ends.
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If, for any reason, they feel that this might not be possible,
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then I think they should have to ethically justify
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why the clinical trial should be conducted in the first place.
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Now, fortunately for Celine,
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our meeting did not end in my office.
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I was able to get her enrolled into a free HIV treatment program
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closer to her home,
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and with a support group to help her cope.
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Her story has a positive ending,
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but there are thousands of others in similar situations
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who are much less fortunate.
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Although she may not know this,
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my encounter with Celine has completely changed the way
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in which I view HIV clinical trials in developing countries,
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and made me even more determined to be part of the movement
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to change the way in which things are done.
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I believe that every single person
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listening to me tonight can be part of that change.
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If you are a researcher, I hold you
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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.
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If you work for a funding agency or pharmaceutical company,
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I challenge you to hold your employers
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to fund research that is ethically sound.
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If you come from a developing country like myself,
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I urge you to hold your government
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to a more thorough review of the clinical trials
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which are authorized in your country.
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Yes, there is a need for us to find a cure for HIV,
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to find an effective vaccine for malaria,
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to find a diagnostic tool that works for T.B.,
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but I believe that we owe it to those who willingly
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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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