Voluntariness of consent to HIV clinical research : a conceptual and empirical study.
While obtaining voluntary informed consent for research participation is an ethical imperative, there appears to be little consensus regarding what constitutes a voluntary consent decision. As a result, considerable controversy exists in the research ethics literature, with researchers and ethicists advancing numerous concerns about the voluntariness of consent to research. For example, concerns about the voluntariness of consent to research are frequently raised when financial compensation or care and treatment are offered in return for research participation, when participants are recruited by their health care providers, when risks are more than minimal, and when research is conducted in developing countries by developed country researchers. However, without a valid conceptualisation of voluntariness and an appropriate means of assessing it is impossible to determine whether commonly expressed concerns about voluntariness are well founded. As such, a comprehensive conceptual and empirical review of voluntary consent was conducted. The conceptual and empirical review revealed that voluntary consent to research consists of a legal imperative that consent be free from controlling influences of other people and a moral imperative that consent be perceived as voluntary by the person providing consent. On the basis of this conceptualisation the Voluntariness Assessment Instrument was developed. The Voluntariness Assessment Instrument was piloted on 100 women enrolled in two South African HIV clinical trials. The study found high levels of perceived voluntariness. A desire to please the researchers, feelings of having no alternative to research participation as well as a need for money were significantly associated with lower perceived voluntariness. An absence of controlling influences from others was also observed for the overwhelming majority of research participants. Overall the data suggests that it is possible to obtain voluntary and valid consent from research participants in ethically complex HIV clinical trials in developing country contexts.