Table 3.
Hospital-Specific IRB Regulations
| N (%) | Enrollment rate (SD) | P-value | |
|---|---|---|---|
| IRB approach to consent | |||
| Allowed by phone | 0.37 | ||
| Yes | 14 (67%) | 0.67 (0.14) | |
| No | 7 (33%) | 0.61 (0.15) | |
| Allowed remote signatures | 0.33 | ||
| Yes | 18 (86%) | 0.64 (0.14) | |
| No | 3 (14%) | 0.73 (0.17) | |
| Required in-person signatures | 0.31 | ||
| Yes | 9 (43%) | 0.61 (0.16) | |
| No | 12 (57%) | 0.68 (0.13) | |
|
| |||
| How frequently was consent obtained over the phone? | 0.78 | ||
| Never or rarely | 9 (43%) | 0.62 (0.13) | |
| Occasionally | 3 (14%) | 0.80 (0.09) | |
| Frequently or very frequently | 9 (43%) | 0.64 (0.14) | |
|
| |||
| In what languages other than English could consent be obtained? | 0.43 | ||
| Spanish | |||
| Yes | 18 (86%) | 0.66 (0.14) | |
| No | 3 (14%) | 0.59 (0.11) | |
| Other | 0.68 | ||
| Yes | 7 (33%) | 0.67 (0.19) | |
| No | 14 (67%) | 0.64 (0.11) | |
|
| |||
| Who was able to obtain consent (general)? | 0.20 | ||
| Study PI | |||
| Yes | 18 (86%) | 0.67 (0.14) | |
| No | 3 (14%) | 0.55 (0.15) | |
| Any study physician | 0.88 | ||
| Yes | 15 (71%) | 0.65 (0.14) | |
| No | 6 (29%) | 0.66 (0.16) | |
| Research coordinator | 0.91 | ||
| Yes | 13 (62%) | 0.65 (0.14) | |
| No | 8 (38%) | 0.65 (0.15) | |
| Research nurse | 0.07 | ||
| Yes | 6 (29%) | 0.74 (0.09) | |
| No | 15 (71%) | 0.62 (0.14) | |
|
| |||
| Did the IRB require the clinical team to approach the family before the research team could approach? | 0.93 | ||
| Yes | 5 (24%) | 0.66 (0.12) | |
| No | 16 (76%) | 0.65 (0.15) | |
|
| |||
| IRB rules/regulations negatively impacted enrollment. | 0.83 | ||
| Strongly disagree | 10 (48%) | 0.64 (0.13) | |
| All other responses | 11 (52%) | 0.66 (0.15) | |