Table 2.
Critical Element of Consent (CEC) | Median years of experience of investigators who discussed CEC during ICC? | Median years of experience of investigators who did not discuss CEC during ICC? | P-value |
---|---|---|---|
Study Purpose | 14 | 20 | 0.48 |
Risk Side effects | 15 | 16 | 0.27 |
Voluntariness | 14 | 16 | 0.24 |
Withdrawal rights | 14.5 | 16.5 | 0.10 |
Confidentiality | 13.5 | 17 | 0.09 |
Dosing Cohorts | 13 | 16 | 0.07 |
Dose escalation | 14 | 16 | 0.96 |
Dose limiting Toxicity | 9 | 16 | 0.006 |