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. 2016 Aug 31;6(8):e011973. doi: 10.1136/bmjopen-2016-011973

Table 8.

Issues with applications identified by RECs before and during the ethics officer intervention. Source: REC meeting minutes and opinion letters

Baseline (n=110 applications)
Intervention period (n=100 applications)
Type of issue Number of issues Number (% of all) applications with an issue Mean number of issues per application Number of issues Number (% of all) applications Mean number of issues per application
Document issues
 Consent documents 45 27 (25) 0.4 46 32 (32) 0.5
 Other documentation 298 85 (77) 2.7 268 85 (85) 2.7
 REC application 121 57 (52) 1.1 81 43 (43) 0.8
 Subtotal 464 93 (85) 4.2 395 88 (88) 3.9
Ethical issues
 Participant care 249 89 (81) 2.3 207 75 (75) 0.7
 Confidentiality 147 68 (62) 1.3 132 57 (57) 0.6
 Informed consent 30 23 (21) 0.3 31 24 (24) 0.2
 Community issues 10 10 (9) 0.1 20 18 (18) 0.2
 Subtotal 436 101 (92) 4.0 390 84 (84) 0.8
Study issues
 Design and conduct 299 93 (85) 2.7 225 78 (78) 0.8
 Recruitment 179 82 (75) 1.6 131 65 (65) 0.6
 Subtotal 478 104 (95) 4.3 356 88 (88) 0.9
 Total issues 1378 108 (98) 12.5 1141 96 (96) 11.4

REC, research ethics committee.