Table 1 Standard elements covered on REB applications
Element | No. (%) of the 16 sites |
|---|---|
Basic Study Information | Â |
Purpose/objectives | 9 (56%) |
Signature of department head or supervisor | 7 (44%) |
Checklist of documents | 7 (44%) |
Study Methods | Â |
Multicentre | 10 (63%) |
Study Design | 9 (56%) |
Location of research | 12 (75%) |
Description of procedures | 9 (56%) |
How outcomes measured | 4 (25%) |
Subjects | Â |
Normal subjects enrolled? | 4 (25%) |
Inclusion/exclusion criteria | 12/11 (75, 69%) |
Risks | 10 (63%) |
Benefits | 10 (63%) |
Time required of subject | 4 (25%) |
Participant contacted by telephone or letter during study? | 4 (25%) |
Privacy/Confidentiality | Â |
General description of privacy/confidentiality measures | 6 (38%) |
Conflict of interest | 6 (38%) |
Research staff credentials | 6 (38%) |
Independent peer review? | 5 (31%) |
Budget | Â |
Fee for Service Payment details with sponsor | 6 (38%) |
Budget Details Requested | 11 (68%) |
Resource implications for hospital | 4 (25%) |