Survey | EAST | IRB | P values |
Frequency (%) | Frequency (%) | ||
Level of IRB review required for retrospective observational trials using patient identifiers | (n=160) | (n=22) | 0.05 |
Exempt | 19 (11.9) | 0 (0) | |
Expedited review | 110 (68.8) | 21 (95.5) | |
Full IRB review | 21 (13.1) | 0 (0) | |
Case-by-case basis | 10 (6.3) | 1 (4.5) | |
Level of informed consent required when using patient identifiers for retrospective studies | (n=160) | (n=22) | 0.46 |
Waiver of informed consent | 121 (75.6) | 19 (86.4) | |
Require informed consent | 13 (8.1) | 0 (0) | |
Case-by-case basis | 26 (16.3) | 3 (13.6) | |
Level of IRB review required for prospective observational trials WITHOUT blood/tissue collection | (n=160) | (n=21) | 0.01 |
Exempt | 4 (2.5) | 1 (4.8) | |
Expedited review | 60 (37.5) | 12 (57.1) | |
Full IRB review | 77 (48.1) | 2 (9.5) | |
Case-by-case basis | 19 (11.9) | 6 (28.6) | |
Level of informed consent required for prospective observational trials WITHOUT blood/tissue collection | (n=159) | (n=22) | <0.001 |
Waiver of informed consent | 49 (30.8) | 1 (4.5) | |
Require informed consent | 58 (36.5) | 2 (9.1) | |
Case-by-case basis | 52 (32.7) | 19 (86.4) | |
Level of IRB review required for prospective observational trials WITH blood/tissue collection | (n=155) | (n=22) | <0.001 |
Exempt | 1 (0.6) | 0 (0) | |
Expedited review | 6 (3.9) | 10 (45.5) | |
Full IRB review | 124 (80.0) | 3 (13.6) | |
Case-by-case basis | 24 (15.5) | 9 (40.9) | |
Level of informed consent required for prospective observational trials WITH blood/tissue collection | (n=156) | (n=22) | 0.34 |
Waiver of informed consent | 3 (1.9) | 0 (0) | |
Require informed consent | 118 (75.6) | 14 (63.6) | |
Case-by-case basis | 35 (21.9) | 8 (36.4) | |
Accepted policy/precedence available for prospective observational trials requiring informed consent | (n=150) | (n=21) | 0.81 |
No | 65 (43.3) | 10 (47.6) | |
Yes | 85 (56.7) | 11 (52.4) |
EAST, Eastern Association for the Surgery of Trauma; IRB, institutional review board.