Table 2

Characteristics of study participants stratified by clinical trial vs. observational study
Sociodemographic characteristics
Clinical Trial± Observational± P-value
Mean age (mean, SD), yr 38.2 (7.5) 36.7 (7.3) 0.027
No formal education (n, %) 39 (16.6) 81 (30.7) 0.001
Female Gender (n, %) 146 (62.1) 173 (65.8) NS
Informed Consent Process No aOR
First research project for participant* 5.1 % (12/235) 8.3 % (22/264) NS
Felt were given enough information* 3.0 % (7/235) 7.3 % (19/262) 0.3(0.13-0.84)
Signed a consent form* 4.3 % (10/234) 6.6 % (17/258) NS
Felt pressured to participate* 99.1 % (232/234) 95.1 % (251/264) NS
Refusal to participate would affect regular medical care* 48.5 % (113/233) 65.4 % (172/263) 0.5(0.35-0.78)
Anticipated benefits for participation* 1.7 % (4/235) 2.7 % (7/263) NS
Anticipated risks for participation* 68.9 % (162/235) 65.9 % (174/264) NS
Knowledge of voluntary withdrawal* 28.8 % (67/235) 36.4 % (96/264) NS

*The overall numbers in rows do not add up to 600 participants due to missing data.

± Data on clinical trial vs. observational study status were available for 499 out of 600 participants with 235 in clinical trials and 264 in observational studies.

aOR Odds Ratio adjusted for age, gender, educational level and whether participant was involved in an initial or repeat consent process.

Kiguba et al.

Kiguba et al. BMC Medical Ethics 2012 13:21   doi:10.1186/1472-6939-13-21

Open Data