Informed consent and coordinating site for EAST and IRB members
Survey | EAST | IRB | P values |
Frequency (%) | Frequency (%) | ||
Do you feel informed consent for prospective observational trials WITHOUT blood/tissue collection is ethically necessary and a reasonable burden to research? | (n=159) | (n=22) | <0.001 |
No | 125 (78.6) | 8 (36.4) | |
Yes | 34 (21.3) | 14 (63.6) | |
Do you feel informed consent for prospective observational trials WITH blood/tissue collection is ethically necessary and a reasonable burden to research? | (n=158) | (n=22) | 0.07 |
No | 19 (12.0) | 0 (0) | |
Yes | 139 (88.0) | 22 (100) | |
Does your IRB currently accept IRB approval from an outside centralized institutional coordinating site to participate in multicenter studies/trials? | (n=157) | (n=22) | <0.001 |
No | 99 (62.7) | 0 (0) | |
Yes | 59 (37.3) | 22 (100) | |
Does your IRB currently allow your institution to serve as a coordinating site IRB holder for multicenter studies/trials? | (n=157) | (n=22) | 0.41 |
No | 36 (22.9) | 3 (13.6) | |
Yes | 121 (77.1) | 19 (86.4) |
EAST, Eastern Association for the Surgery of Trauma; IRB, institutional review board.