Survey | ≤2 IRBs | >2 IRBs | P values |
Frequency (%) | Frequency (%) | ||
Level of IRB review required for retrospective observational trials using patient identifiers | (n=45) | (n=112) | 0.01 |
Exempt | 3 (6.7) | 16 (14.2) | |
Expedited review | 26 (57.8) | 83 (73.5) | |
Full IRB review | 12 (26.7) | 8 (7.1) | |
Case-by-case basis | 4 (8.9) | 6 (5.3) | |
Level of informed consent required when using patient identifiers | (n=45) | (n=113) | 0.03 |
Waiver of informed consent | 30 (66.7) | 90 (79.7) | |
Require informed consent | 8 (17.8) | 5 (4.4) | |
Case-by-case basis | 7 (15.6) | 18 (15.9) | |
Level of IRB review required for prospective observational trials WITHOUT blood/tissue collection | (n=45) | (n=113) | 0.80 |
Exempt | 1 (2.2) | 3 (2.7) | |
Expedited review | 15 (33.3) | 45 (39.8) | |
Full IRB review | 22 (48.9) | 53 (46.9) | |
Case-by-case basis | 7 (15.6) | 12 (10.6) | |
Level of informed consent required for prospective observational trials WITHOUT blood/tissue collection | (n=44) | (n=113) | 0.57 |
Waiver of informed consent | 11 (25.0) | 38 (33.6) | |
Require informed consent | 18 (40.9) | 39 (34.5) | |
Case-by-case basis | 15 (34.1) | 36 (31.9) | |
Level of IRB review required for prospective observational trials WITH blood/tissue collection | (n=44) | (n=109) | 0.08 |
Exempt | 0 (0.0) | 1 (0.9) | |
Expedited review | 0 (0.0) | 6 (5.5) | |
Full IRB review | 33 (75.0) | 89 (81.7) | |
Case-by-case basis | 11 (25.0) | 13 (11.9) | |
Level of informed consent required for prospective observational trials WITH blood/tissue collection | (n=44) | (n=110) | 0.93 |
Waiver of informed consent | 1 (2.3) | 2 (1.8) | |
Require informed consent | 34 (77.3) | 83 (75.5) | |
Case-by-case basis | 9 (20.5) | 25 (22.7) | |
Accepted policy/precedence available for prospective observational trials requiring informed consent | (n=43) | (n=105) | 0.08 |
No | 23 (53.5) | 41 (39.0) | |
Yes | 20 (46.5) | 64 (61.0) |
EAST, Eastern Association for the Surgery of Trauma; IRB, institutional review board.