Table 4.
Duration of ethics review among all eligible protocols submitted by time period (net time protocol is with investigator)
| Review type | Days (median, 95% CI) |
Hazard ratio** | 95% CI | p-value | |
|---|---|---|---|---|---|
| Baseline | Intervention | ||||
| Overall (IRB and SRC, if applicable) | n = 415 * | n = 411 * | |||
| 27 | 37 | <22 days: 1.12 | 0.90, 1.41 | 0.3 | |
| (25, 30) | (32, 42) | ≥22 days: 0.62 | 0.50, 0.78 | <0.0001 | |
| IRB only | n = 414 * | n = 399 * | |||
| All protocols | 24 | 30 | |||
| (21, 27) | (23, 25) | ||||
| Protocols with SRC review | 5 | 21 | |||
| (4, 6) | (14, 32) | ||||
| Protocols without SRC review | 35 | 36 | |||
| (31, 41) | (29, 42) | ||||
| SRC only | n = 126 * | n = 226 * | |||
| 8 | 9 | ||||
| (6, 9) | (8, 11) | ||||
CI = confidence interval.
*
Protocols censored because not yet approved: overall review: baseline = 64, intervention = 109; Institutional Review Board (IRB) review: baseline = 63, intervention = 72; Scientific Review Committee (SRC) review: baseline = 1, intervention = 44.
**
Result adjusted for site as fixed effect.