Table 8.
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.