Table 4

IRB review and informed consent for EAST members with ≤2 IRBs compared with those with >2

Survey≤2 IRBs>2 IRBsP values
Frequency (%)Frequency (%)
Level of IRB review required for retrospective observational trials using patient identifiers(n=45)(n=112)0.01
 Exempt3 (6.7)16 (14.2)
 Expedited review26 (57.8)83 (73.5)
 Full IRB review12 (26.7)8 (7.1)
 Case-by-case basis4 (8.9)6 (5.3)
Level of informed consent required when using patient identifiers(n=45)(n=113)0.03
 Waiver of informed consent30 (66.7)90 (79.7)
 Require informed consent8 (17.8)5 (4.4)
 Case-by-case basis7 (15.6)18 (15.9)
Level of IRB review required for prospective observational trials WITHOUT blood/tissue collection(n=45)(n=113)0.80
 Exempt1 (2.2)3 (2.7)
 Expedited review15 (33.3)45 (39.8)
 Full IRB review22 (48.9)53 (46.9)
 Case-by-case basis7 (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 consent11 (25.0)38 (33.6)
 Require informed consent18 (40.9)39 (34.5)
 Case-by-case basis15 (34.1)36 (31.9)
Level of IRB review required for prospective observational trials WITH blood/tissue collection(n=44)(n=109)0.08
 Exempt0 (0.0)1 (0.9)
 Expedited review0 (0.0)6 (5.5)
 Full IRB review33 (75.0)89 (81.7)
 Case-by-case basis11 (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 consent1 (2.3)2 (1.8)
 Require informed consent34 (77.3)83 (75.5)
 Case-by-case basis9 (20.5)25 (22.7)
Accepted policy/precedence available for prospective observational trials requiring informed consent(n=43)(n=105)0.08
 No23 (53.5)41 (39.0)
 Yes20 (46.5)64 (61.0)
  • EAST, Eastern Association for the Surgery of Trauma; IRB, institutional review board.