RECs' requests for revisions by applicants before and during the intervention. Source: REC meeting minutes and opinion letters
| Baseline (n=110 applications) | Intervention (n=100 applications) | |||
|---|---|---|---|---|
| Number of revisions requested | Number (% of all) applications | Number of revisions requested | Number (% of all) applications | |
| Documentation revisions | ||||
| Consent documentation | 84 | 44 (40) | 74 | 46 (46) |
| Other documentation | 373 | 89 (81) | 310 | 86 (86) |
| Subtotal | 457 | 93 (85) | 384 | 89 (89) |
| Procedural revisions | ||||
| Consent procedures | 8 | 7 (6) | 17 | 17 (17) |
| Data storage procedures | 1 | 1 (1) | 0 | 0 (0) |
| Recruitment procedures | 7 | 6 (5) | 0 | 0 (0) |
| Study design | 6 | 6 (5) | 7 | 7 (7) |
| Study protocol | 15 | 12 (11) | 14 | 12 (12) |
| Subtotal | 37 | 24 (22) | 38 | 29 (29) |
| Further information to be submitted | ||||
| Study design | 69 | 38 (35) | 58 | 28 (28) |
| Further documentation | 19 | 17 (15) | 9 | 8 (8) |
| Ethical practice | 71 | 50 (45) | 63 | 33 (33) |
| Improved application | 7 | 6 (5) | 13 | 9 (9) |
| Protocol and procedures | 1 | 1 (1) | 47 | 33 (33) |
| Researcher credentials | 33 | 27 (25) | 7 | 7 (7) |
| Other | 12 | 12 (11) | 0 | 0 (0) |
| Subtotal | 212 | 77 (70) | 197 | 58 (58) |
| Total | 706 | 97 (88) | 619 | 92 (92) |
REC, research ethics committee.