From: Assessing the quality of informed consent in a resource-limited setting: A cross-sectional 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 |