Number and type of issues identified by ethics officers when they pre-reviewed applications. Source: ethics officer review forms
| Number of issues (number of applications affected*) | ||||
|---|---|---|---|---|
| Favourable opinion (n=26) | Provisional opinion (n=63) | Unfavourable opinion (n=11) | All opinions (n=100) | |
| Document issues | ||||
| Consent documents, including patient information sheets | 7 (4) | 34 (20) | 3 (3) | 44 (27) |
| Other documentation (eg, protocols, intervention descriptions) | 21 (10) | 93 (44) | 26 (11) | 140 (65) |
| REC application | 12 (8) | 32 (23) | 7 (6) | 51 (37) |
| Subtotal | 40 (12) | 159 (52) | 36 (11) | 235 (75) |
| Ethical issues | ||||
| Participant care | 13 (6) | 31 (24) | 8 (5) | 52 (35) |
| Confidentiality | 11 (7) | 46 (27) | 8 (5) | 65 (39) |
| Informed consent | 3 (2) | 16 (16) | 5 (5) | 24 (23) |
| Community issues | 5 (3) | 7 (7) | 1 (1) | 13 (12) |
| Subtotal | 32 (13) | 100 (43) | 22 (8) | 154 (64) |
| Study issues | ||||
| Design and conduct | 8 (7) | 33 (25) | 13 (7) | 54 (39) |
| Recruitment | 4 (4) | 20 (14) | 5 (3) | 29 (21) |
| Subtotal | 12 (10) | 53 (32) | 18 (8) | 83 (50) |
| Total number of issues (number of applications affected) | 84 (18) | 312 (58) | 76 (11) | 472 (87) |
| Mean issues per opinion category | 3.2 | 5.0 | 6.9 | 4.7 |
*One application can generate more than one issue.