P11.03
Background: Informed consent (IC) is accepted as an essential ethical requirement for clinical trials, including HIV vaccine trials (HVT). Authentic IC requires that potential participants adequately understand various trial concepts and the implications of trial participation before being accepted into trials. While assessment of understanding is usually done using forced choice questionnaires, there are many limitations to this method of assessment. This paper reports on a series of studies done to compare various methods of assessment of understanding, including true/false questionnaires, vignettes and narrative approaches.
Methods: Three studies have been conducted to date. The methodology involved quantitatively comparing the levels of measured understanding on three assessment tools, viz. forced choice questionnaires, trial related vignettes and narratives of trial participation. The comparisons were conducted first on a group of potential HVT trial participants in South Africa. A second study was conducted using a hypothetical HVT trial on samples of potential trial participants in South Africa and Zambia. A subsequent study compared measured understanding on these tools on samples of potential participants in HVT in Uganda and South Africa.
Results: Results of all studies show a significant difference between measured levels of understanding, with the forced choice questionnaire having the highest scores, arguably over-estimating levels of understanding, and open-ended measures the lowest scores.
Conclusions: It is suggested that open-ended methods of assessment provide more realistic and appropriate measures of understanding, which should be incorporated in IC procedures for HVT. Reservations have been expressed about the cost and skill implications of using such methods, however, suggestions are made for how these measures might be cost-effectively incorporated into HVT.
