Table 3.
Comparisons of the parental understanding of each element of the ICF content between the two groups
| SIDCER ICF (n=105) |
Conventional ICF (n=105) | Relative risk (95% CI) | P value* | ||||
| General items | |||||||
| 1. Recognition that this is research | 80 | (76.2%) | 78 | (74.3%) | 1.026 | (0.878–1.198) | 0.749 |
| 2. Subjects’ responsibility | 85 | (81.0%) | 84 | (80.0%) | 1.012 | (0.886–1.156) | 0.862 |
| 3. Confidentiality of records | 74 | (70.5%) | 64 | (61.0%) | 1.156 | (0.950–1.408) | 0.146 |
| 4. Who can access the data | 82 | (78.1%) | 68 | (64.8%) | 1.206 | (1.014–1.435) | 0.032 |
| 5. Research contact persons | 98 | (93.3%) | 96 | (91.4%) | 1.021 | (0.944–1.103) | 0.603 |
| Patient’s rights | |||||||
| 6. Right to refuse | 76 | (72.4%) | 87 | (82.9%) | 0.874 | (0.754–1.012) | 0.069 |
| 7. Right to withdraw | 95 | (90.5%) | 87 | (82.9%) | 1.092 | (0.981–1.215) | 0.104 |
| 8. Consequences of withdrawal | 96 | (91.4%) | 87 | (82.9%) | 1.103 | (0.994–1.225) | 0.064 |
| 9. Right to receive new information | 91 | (86.7%) | 78 | (74.3%) | 1.167 | (1.019–1.336) | 0.024 |
| Scientific aspects | |||||||
| 10. Eligibility of the subject | 81 | (77.1%) | 72 | (68.6%) | 1.125 | (0.953–1.328) | 0.163 |
| 11. Number of subjects required | 87 | (82.9%) | 43 | (41.0%) | 2.023 | (1.583–2.587) | <0.001 |
| 12. Purpose of the study | 80 | (76.2%) | 75 | (71.4%) | 1.067 | (0.908–1.254) | 0.433 |
| 13. Trial treatment and random assignment | 38 | (36.2%) | 28 | (26.7%) | 1.357 | (0.904–2.038) | 0.137 |
| 14. Trial procedures | 65 | (61.9%) | 52 | (49.5%) | 1.250 | (0.979–1.596) | 0.071 |
| 15. Identification of experimental procedures | 80 | (76.2%) | 66 | (62.9%) | 1.212 | (1.011–1.454) | 0.036 |
| 16. Duration of the subject’s participation | 88 | (83.8%) | 79 | (75.2%) | 1.114 | (0.970–1.279) | 0.124 |
| 17. Storage and reuse of human materials | 60 | (57.1%) | 57 | (54.3%) | 1.053 | (0.827–1.340) | 0.677 |
| Ethics aspects | |||||||
| 18. Alternative course of treatment | 94 | (89.5%) | 82 | (78.1%) | 1.146 | (1.016–1.293) | 0.025 |
| 19. Foreseeable risks | 70 | (66.7%) | 61 | (58.1%) | 1.148 | (0.929–1.418) | 0.200 |
| 20. Expected direct/indirect benefits | 52 | (49.5%) | 42 | (40.0%) | 1.238 | (0.914–1.677) | 0.165 |
| 21. Post-trial benefits | 82 | (78.1%) | 72 | (68.6%) | 1.139 | (0.966–1.342) | 0.119 |
| 22. Prorated payment for participation | 91 | (86.7%) | 84 | (80.0%) | 1.083 | (0.959–1.223) | 0.195 |
| 23. Anticipated expenses | 60 | (57.1%) | 53 | (50.5%) | 1.132 | (0.880–1.456) | 0.333 |
| 24. Compensation for injury | 92 | (87.6%) | 83 | (79.0%) | 1.108 | (0.981–1.252) | 0.096 |
Data represent the number (percentage) of parents. *χ2 test.