PROGRAM
Microbicides

Ethics and Informed Consent

Obtaining truly informed consent from individuals participating in human clinical trials has been a cornerstone of the Population Council's microbicide research for many years.

It is essential that potential participants fully understand the trial and the product being tested to ensure that their consent to take part is truly voluntary and fully informed.

Thus, as the Council's biomedical scientists work to develop effective and safe microbicides to prevent HIV infection, its public health and social scientists collaborate closely with women’s health advocates and local community members to ensure that the ethical and practical challenges of testing and introducing microbicides are addressed. This is especially important as such trials must take place among women who are at substantial risk of infection from HIV, many of whom may be particularly vulnerable due to poverty and other factors.

In 1997 and 2005, the Population Council and colleagues convened international symposia on the ethical and practical challenges involved in microbicide clinical testing and on improving the informed consent process in HIV prevention trials. (more on these symposia)

Projects

• Evaluating Services for Women Who Test HIV-positive During the Phase 3 Trial

• Evaluation of the Informed Consent Process in the Phase 3 Study of the Microbicide Carraguard®

• Improving the Informed Consent Process in Clinical Trials

• Involving Communities in Clinical Trials

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See Also

• "Ethics in clinical trials: Population Council's microbicides program," fact sheet (2007) (PDF)

• "Testing Carraguard: What you need to know," booklet (2004) (PDF)

• "Informed consent: From good intentions to sound practices" (2002) (PDF)

• 
  "Clinical testing of Carraguard"

• 
  "Informed consent in clinical trials of Carraguard"

• Slide show of trial activities

Offsite Link

• Global Campaign for Microbicides: Ethics & Community

Contact: microbicide@popcouncil.org

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