Table 2

IRB review and informed consent for EAST and IRB members

SurveyEASTIRBP values
Frequency (%)Frequency (%)
Level of IRB review required for retrospective observational trials using patient identifiers(n=160)(n=22)0.05
 Exempt19 (11.9)0 (0)
 Expedited review110 (68.8)21 (95.5)
 Full IRB review21 (13.1)0 (0)
 Case-by-case basis10 (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 consent121 (75.6)19 (86.4)
 Require informed consent13 (8.1)0 (0)
 Case-by-case basis26 (16.3)3 (13.6)
Level of IRB review required for prospective observational trials WITHOUT blood/tissue collection(n=160)(n=21)0.01
 Exempt4 (2.5)1 (4.8)
 Expedited review60 (37.5)12 (57.1)
 Full IRB review77 (48.1)2 (9.5)
 Case-by-case basis19 (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 consent49 (30.8)1 (4.5)
 Require informed consent58 (36.5)2 (9.1)
 Case-by-case basis52 (32.7)19 (86.4)
Level of IRB review required for prospective observational trials WITH blood/tissue collection(n=155)(n=22)<0.001
 Exempt1 (0.6)0 (0)
 Expedited review6 (3.9)10 (45.5)
 Full IRB review124 (80.0)3 (13.6)
 Case-by-case basis24 (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 consent3 (1.9)0 (0)
 Require informed consent118 (75.6)14 (63.6)
 Case-by-case basis35 (21.9)8 (36.4)
Accepted policy/precedence available for prospective observational trials requiring informed consent(n=150)(n=21)0.81
 No65 (43.3)10 (47.6)
 Yes85 (56.7)11 (52.4)

  • EAST, Eastern Association for the Surgery of Trauma; IRB, institutional review board.