PROGRAM
Microbicides

Ethics and Informed Consent (continued)

Symposia
In April 1997 the Population Council and the Women’s Health Advocates on Microbicides convened an international symposium of 55 scientists, health advocates, policymakers, donors, industry representatives, and experts in the field of microbicide development from 15 countries. Participants explored ways to address a number of the practical and ethical challenges involved in microbicide clinical testing. Many of the points of consensus reached during this meeting have become standard elements in the design of microbicide clinical trials, and a widely distributed report—"Practical and ethical dilemmas in the clinical testing of microbicides"—resulted from the conference.

Community involvement and informed consent of participants were major issues highlighted at the symposium and have subsequently received a great deal of attention in the design of the Council’s trials of Carraguard^®, its lead candidate microbicide.

For example, to protect the health and rights of the women who volunteer to participate in its microbicides studies, the Council and local investigators consult with community members including representatives from governmental organizations, activists, and health authorities. In addition, the ethics committees at each of the Council's partner research institutions in South Africa have reviewed and approved all Carraguard studies to ensure that participants are treated ethically and properly.

In May 2005 the Population Council, in collaboration with Family Health International, convened an important international meeting focused on improving the informed consent process in HIV prevention trials. This workshop was the first to focus entirely on the practical aspects of implementing informed consent in the context of trials of HIV prevention technologies. It was therefore pivotal in helping to advance critical thinking, collaboration, and practical work on improving informed consent processes.

The high level of interest and participation by a wide range of organizations involved in HIV prevention efforts globally signified the importance of this forum to the HIV prevention and research fields. The international participants represented over 40 institutions from 11 countries with varied backgrounds, including international research institutions, key donors, and researchers currently involved in clinical trials of HIV prevention technologies.

The workshop was collaborative and interactive, providing an excellent opportunity for researchers to share their concerns and experiences in a range of current clinical trials and to discuss strategies to improve the informed consent process. Participants viewed materials from studies—informed consent forms, study booklets, flip-charts, videos—and identified difficult terminology and concepts—such as “placebo” and “randomization”—to explore how to improve communication and comprehension of complex concepts.

To continue the work prompted by this cutting-edge workshop, participants suggested regional meetings and further research on informed consent, especially on assessing comprehension. The workshop report and an associated booklet of highlights are available online, and a satellite symposium at Microbicides 2006 was held as a follow-on to the workshop.

(return to Ethics and Informed Consent, page 1)

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