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 research80(76.2%)78(74.3%)1.026(0.878–1.198)0.749
 2. Subjects’ responsibility85(81.0%)84(80.0%)1.012(0.886–1.156)0.862
 3. Confidentiality of records74(70.5%)64(61.0%)1.156(0.950–1.408)0.146
 4. Who can access the data82(78.1%)68(64.8%)1.206(1.014–1.435)0.032
 5. Research contact persons98(93.3%)96(91.4%)1.021(0.944–1.103)0.603
Patient’s rights
 6. Right to refuse76(72.4%)87(82.9%)0.874(0.754–1.012)0.069
 7. Right to withdraw95(90.5%)87(82.9%)1.092(0.981–1.215)0.104
 8. Consequences of withdrawal96(91.4%)87(82.9%)1.103(0.994–1.225)0.064
 9. Right to receive new information91(86.7%)78(74.3%)1.167(1.019–1.336)0.024
Scientific aspects
 10. Eligibility of the subject81(77.1%)72(68.6%)1.125(0.953–1.328)0.163
 11. Number of subjects required87(82.9%)43(41.0%)2.023(1.583–2.587)<0.001
 12. Purpose of the study80(76.2%)75(71.4%)1.067(0.908–1.254)0.433
 13. Trial treatment and random assignment38(36.2%)28(26.7%)1.357(0.904–2.038)0.137
 14. Trial procedures65(61.9%)52(49.5%)1.250(0.979–1.596)0.071
 15. Identification of experimental procedures80(76.2%)66(62.9%)1.212(1.011–1.454)0.036
 16. Duration of the subject’s participation88(83.8%)79(75.2%)1.114(0.970–1.279)0.124
 17. Storage and reuse of human materials60(57.1%)57(54.3%)1.053(0.827–1.340)0.677
Ethics aspects
 18. Alternative course of treatment94(89.5%)82(78.1%)1.146(1.016–1.293)0.025
 19. Foreseeable risks70(66.7%)61(58.1%)1.148(0.929–1.418)0.200
 20. Expected direct/indirect benefits52(49.5%)42(40.0%)1.238(0.914–1.677)0.165
 21. Post-trial benefits82(78.1%)72(68.6%)1.139(0.966–1.342)0.119
 22. Prorated payment for participation91(86.7%)84(80.0%)1.083(0.959–1.223)0.195
 23. Anticipated expenses60(57.1%)53(50.5%)1.132(0.880–1.456)0.333
 24. Compensation for injury92(87.6%)83(79.0%)1.108(0.981–1.252)0.096
  • Data represent the number (percentage) of parents. 2 test.