Informed consent and participant perceptions of influenza vaccine trials in South Africa.
OBJECTIVE
There are few insights from sub-Saharan Africa on research participants' experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa.


METHODS
Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration.


RESULTS
A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication.


CONCLUSIONS
Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.
Moodley
K
K
Bioethics Unit-Tygerberg Division, PO Box 19063, Tygerberg 7505, South Africa. km@sun.ac.za
Pather
M
M
Myer
L
L
D000281:Administration, Intranasal; D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage*; D007251:Influenza, Human / Q000517:prevention & control; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000523:psychology*; D010919:Placebos; D011581:Psychological Tests; D011610:Psychosocial Deprivation; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000523:psychology*; D013019:South Africa
D007252:Influenza Vaccines; D010919:Placebos