Incorporating a quiz into informed consent processes: qualitative study of participants' reactions.
BACKGROUND
Formal checks of participant understanding are now widely recommended to improve informed consent processes. However, the views of the participants these assessments are designed to protect are rarely considered. In this paper the findings of a qualitative study aimed at documenting community reactions to a semi-structured questionnaire ('quiz') are reported. The quiz was administered to 189 mothers after consenting for their children to participate in a malaria vaccine trial on the Kenyan Coast.


METHODS
Once the malaria vaccine trial was underway, focus group discussions were held with some of these mothers (nine groups; 103 mothers), and with community-based field staff attached to the malaria vaccine trial (two groups of five workers). Individual interviews with other trial staff were also held.


RESULTS
The quiz prompted community members to voice concerns about blood sampling and vaccine side-effects, thereby encouraging additional discussions and interactions between the research team and potential study participants. However, it also caused significant upset and concern. Some of the quiz questions, or the way in which they were asked, appeared to fuel misconceptions and fears, with potentially negative consequences for both the study and community members.


CONCLUSIONS
Formal approaches to checking study understanding should be employed with sensitivity and caution. They are influenced by and impact upon complex social relationships between and among researchers and community members. Adequate consideration of these contexts in assessments of understanding, and in responding to the issues raised, requires strong social science capacity.
Molyneux
Sassy
S
Senior Research Fellow, Kenya Medical Research Institute Centre for Geographic Medicine Research Coast (KEMRI CGMRC) Wellcome Trust Research Programme, Kilifi, Kenya, P.O. Box 230. SMolyneux@kilifi.kemri-wellcome.org
Gikonyo
Caroline
C
Marsh
Vicki
V
Bejon
Philip
P
D002648:Child; D005260:Female; D006302:Health Services Research; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D007630:Kenya; D017780:Malaria Vaccines / Q000627:therapeutic use; D009035:Mothers; D011795:Surveys and Questionnaires
D017780:Malaria Vaccines