Unethical clinical trials in Thailand: a community response

Loff, Bebe; Jenkins, C. E.; Ditmore, Melissa Hope; Overs, Cheryl; Barbero, Rosanna

doi:10.1016/s0140-6736(05)66502-6

Cited by 19 publications

(11 citation statements)

References 2 publications

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“…In part, this was due to the WNU understanding that researchers were lobbying the Cambodian Ministry of Health and other government officials for reinstatement of the trial. The WNU mobilized accordingly, conducting training sessions for sex workers on their rights in a clinical trial and posting letters to the editor of journals (Loff et al, 2005;WAC, 2005a;WNU, 2005aWNU, , 2005bWNU, , 2005c. Other articles were published in support of the WNU and its concerns (Bourdier, 2005;Hammer and Lundstrom, 2006).…”

Section: Introductionmentioning

confidence: 99%

From subjects to relations: Bioethics and the articulation of postcolonial politics in the Cambodia Pre-Exposure Prophylaxis trial

Grant

2016

Soc Stud Sci

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Controversies about global clinical trials, particularly HIV trials, tend to be framed in terms of ethics. In this article, I explore debates about ethics in the Cambodia Pre-Exposure Prophylaxis trial, which was designed to test the safety and efficacy of tenofovir as a prevention for HIV infection. Bringing together studies of public participation in science with studies of bioethics, I show how activists around the Cambodian Pre-Exposure Prophylaxis trial circulated and provoked debates about standards of research ethics, as opposed to research methodology. This postcolonial bioethics was configured through the circulation of and debate about ethics guidelines, and historically and culturally specific relations of vulnerability and responsibility between foreigners and Cambodians and between Cambodian leaders and Cambodian subjects. I argue that this shift in the object of ethical concern, from the experimental human subject to the relation between subjects and researchers, illustrates how a postcolonial field of articulation reformulates classical bioethics.

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Section: Introductionmentioning

confidence: 99%

From subjects to relations: Bioethics and the articulation of postcolonial politics in the Cambodia Pre-Exposure Prophylaxis trial

Grant

2016

Soc Stud Sci

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“…38 Trust -identified by the investigators as a key component in working with communities -would be an elusive commodity, and deservedly so. 39 Indeed, the record of drug companies in providing reasonable access to drugs, to the populations in which they (the drugs) were tested, is not good: in Brazil, where the human papilloma virus (HPV) vaccine was tested, it is now sold at higher price than in the US. 40 On August 13, 2004 the Cambodian Prime Minister, Hun Sen, put an end to the trial (which had ethics approval in Cambodia, Australia and the US), stating that: 'Cambodian people are not waste, and Cambodia is not a waste bin', and researchers should take their trials elsewhere.…”

Section: The Role Of Community Protest In the Prep Trial Closuresmentioning

confidence: 99%

BECAUSE WE CAN: CLASHES OF PERSPECTIVE OVER RESEARCHER OBLIGATION IN THE FAILED PrEP TRIALS

Haire

2011

Developing World Bioethics

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This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers' entrustment, both to avoid exploitation and to enact reciprocal justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities.

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“…To ensure adequate power within the trial participants, the participants must be at risk of infection [ 21]. Thus, enrolling females at high risk in HIV-endemic regions allows room to make important clinical inferences, but puts these individuals in potentially risky situations [ 22]. …”

Section: Benefits Of Participationmentioning

confidence: 99%

Enrolling Women into HIV Preventive Vaccine Trials: An Ethical Imperative but a Logistical Challenge

Mills¹,

Nixon²,

Singh³

et al. 2006

PLoS Med

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Unethical clinical trials in Thailand: a community response

Cited by 19 publications

References 2 publications

From subjects to relations: Bioethics and the articulation of postcolonial politics in the Cambodia Pre-Exposure Prophylaxis trial

From subjects to relations: Bioethics and the articulation of postcolonial politics in the Cambodia Pre-Exposure Prophylaxis trial

BECAUSE WE CAN: CLASHES OF PERSPECTIVE OVER RESEARCHER OBLIGATION IN THE FAILED PrEP TRIALS

Enrolling Women into HIV Preventive Vaccine Trials: An Ethical Imperative but a Logistical Challenge

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