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

Abstract

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.

Improving Ethical and Participatory Practice for Marginalized Populations in Biomedical HIV Prevention Trials: Lessons from Thailand

“…While such a provision is indicated internationally as a needed and socially just component of a standard of prevention in a biomedical HIV prevention trial, in certain contexts in Thailand, such as when Thailand-based research may be U.S. funded, the provision of injecting equipment may not be possible. It was explained that this was due to U.S. policy perspectives concerning certain forms of harm reduction such as the provision of clean injecting equipment [1]. This could result in a disjuncture between what the community believed should and could be provided within a trial context under local laws, and what researchers and trial sponsors were willing to offer based on their interpretations of these local laws and policies, combined with any pressures applied by international donors.…”

“…These trials sought to test the efficacy of Tenofovir (Viread) as pre-exposure prophylaxis (PrEP) for HIV prevention in locations as diverse as Thailand, Cambodia, Malawi, Nigeria, Ghana and Cameroon [1]. The closure of these trials acted to prevent or in some cases slow the development of other biomedical HIV prevention trials in marginalized populations across these regions.…”

“…The closure of these trials acted to prevent or in some cases slow the development of other biomedical HIV prevention trials in marginalized populations across these regions. The reasons for these closures have been documented at length [1]–[5]. The role of ethical and participatory practice in these trial stoppages has received substantial attention also [6]–[10].…”

Community Inclusion in PrEP Demonstration Projects: Lessons for Scaling Up

“…A number of randomized control trials have demonstrated clinical efficacy of PrEP [4][5][6][7][8][9][10][11] . However, early oral tenofovir trials among marginalized communities, including in Cambodia, Cameroon, Nigeria, and Malawi among female sex workers (FSWs) and in Thailand among people who inject drugs, drew international attention with concerns over ethical violations in research practices [12][13][14] . Organized community action led to a halt of the trials in Cambodia and Cameroon due to concerns about the standard of prevention and care 12 .…”

Legal and Ethical Values in the Resolution of Research-Related Disputes: How Can IRBs Respond to Participant Complaints?

“…Approximately ten years ago, international protests contributed to the early closure of two of the first placebo-controlled trials of antiretroviral pre-exposure prophylaxis (PrEP) – oral pills for preventing HIV infection in uninfected people (Editorial, 2004; Global Campaign for Microbicides, 2009; Grant et al, 2005; Haire, 2011; McGrory, Irvin, & Heise, 2009; Mills et al, 2005; Singh & Mills, 2005). One of these trials took place in Cameroon; the design was to enroll healthy adult women with multiple sex partners, including female sex workers, and to randomize these women to receive either placebos or antiretroviral pills intended to reduce the risk of acquiring HIV.…”