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Ethics of Trials
Consultation on HIV Treatment in the Context of Prevention Trials
On February 28 2003, a diverse group of researchers, clinicians, ethicists and advocates met for a consultation on HIV treatment in the context of prevention trials, co-organised by the Global Campaign for Microbicides and the International AIDS Vaccine Initiative (IAVI), and co-facilitated by Lori Heise, Director of the Global Campaign, and Saul Walker, Policy Advisor for IAVI.
Several factors prompted this meeting. Global access to highly active antiretroviral therapy (ART) for HIV-infected adults and children is increasing, as is provision of antiretrovirals (ARVs) to prevent mother to child transmission of HIV. The costs associated with these medicines are dropping. New funding streams, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) are helping to put ARVs within reach of more countries where sophisticated AIDS treatment has historically been considered unfeasible.
At the same time, microbicides and vaccines are moving from small-scale Phase 1 trials to larger, community-based efficacy and effectiveness trials, which will screen and enrol thousands of volunteers. The majority of these trials will take place in resource-poor settings where provision of ART exists on a pilot basis, if at all.
Against this backdrop, those involved in HIV prevention trials, including studies of vaccines, microbicides and behavioural interventions, have focused increased attention on the type of care offered to trial participants, their families and their communities, particularly HIV-positive individuals within these groups.
Key questions include: What constitutes an acceptable basic package of care to be provided to individuals who become HIV-positive during the course of a prevention trial? Should this care also be made available to participants’ family members and the wider community? Do trial sponsors have an obligation to provide ART to any or all of these groups? If so, does the obligation extend beyond the duration of the trial? Who should be expected to pay for care once a trial is finished?
The meeting was designed as a forum for open discussion of these complex issues. The goal of the meeting was to identify issues and points of agreement and disagreement, not to build consensus or to generate a single standard for all trials. Instead, the meeting sought to facilitate sharing across the major UK and US research networks of the ongoing discussions happening within networks and between communities and research partners in resource poor settings.
For the full meeting report, 
click here.
Mapping the Standard of Care at Microbicide Clinical Trial Sites
In mid 2006, the Global Campaign for Microbicides (GCM) embarked on a project to map the care and prevention services provided to women enrolled in large-scale (Phase 2b and 3) microbicide effectiveness trials. Our goal was four-fold:
- To conduct an independent assessment of the health care and prevention services provided to women in the trials;
- To better understand the factors that inform care-related decisions at the trial sites;
- To explore the microbicide field's progress toward achieving the ethical aspirations laid out in key ethics guidance documents; and
- To make recommendations to strengthen the field's ability to respond to care-related challenges in future trials.
A full report of this effort is currently being developed and will be published in mid-2008. But, in order to share some preliminary findings from this exercise and highlight several recommendations that may help direct future trials at the Microbicides 2008 Conference, GCM released a draft summary for review. The draft summary, Mapping the Standard of Care at Microbicide Clinical Trial Sites, can be downloaded here.
