Assessing voluntariness of consent to research in South African HIV prevention and treatment trials.

Consent to research participation is only valid if voluntarily given. Voluntariness in research generally implies that a person is able to act of their own free will, free from coercive influences and undue pressure, when deciding whether or not to participate in research. The high rates of HIV/AIDS in South Africa make HIV prevention and treatment research essential in this country. Studies on the voluntariness of consent conducted in South Africa suggest that participants may believe they are not free to make decisions to participate or to withdraw from research. However, voluntariness and its impairments have been poorly conceptualised and studied to date (Appelbaum, Lidz & Klitzman, 2009a).This study aims to develop a method to assess voluntariness of consent and to provide empirical data to contribute to this debate and inform future studies of voluntariness in the context of HIV prevention and treatment research. This will be achieved by identifying, reviewing and comparing appro aches to the assessment of voluntariness; developing a method to assess voluntariness; and piloting the method to assess voluntariness of consent to research to explore the degree of voluntariness exercised by research participants in their decision to enrol in HIV prevention and treatment trials.