Trials that report obtaining individual consent | |||||
---|---|---|---|---|---|
Total N=51 | Report obtaining ethical approval N=45 | Did not report obtaining ethical approval N=6 | Published 1992–2004 N=22 | Published 2005–2010 N=29 | |
Reporting using proxy for consent | 37 (72%) | 34 (76%) | 3 (50%) | 13 (59%) | 24 (83%) |
Type of proxy | |||||
Next of kin or other relative | 19 (37%) | 19 (42%) | 0 (0%) | 8 (36%) | 11 (38%) |
Family members or guardians | 6 (12%) | 4 (9%) | 2 (33%) | 3 (14%) | 3 (10%) |
Legal or designated guardian | 11 (22%) | 10 (22%) | 1 (17%) | 2 (9%) | 9 (31%) |
Member of staff or relative | 1 (3%) | 1 (2%) | 0 (0%) | 0 (0%) | 1 (3%) |
Reported process to assess capacity | 8 (16%) | 7 (16%) | 1 (16%) | 2 (9%) | 6 (21%) |
Quality of consent process: | |||||
Insufficient details reported | 22 (43%) | 18 (40%) | 4 (67%) | 12 (59%) | 10 (31%) |
Poor | 15 (29%) | 15 (34%) | 0 (0%) | 5 (23%) | 10 (34%) |
Fair | 8 (16%) | 7 (16%) | 1 (17%) | 3 (14%) | 5 (17%) |
High | 6 (12%) | 5 (11%) | 1 (17%) | 2 (9%) | 4 (14%) |
Trials that did not report obtaining individual consent | |||||
Total N=22 | N=14 | N=8 | N=7 | N=15 | |
No consent needed because of nature of intervention and data collection* | 14 | 8 (57%) | 6 (75%) | 5 (72%) | 9 (60%) |
Consent needed because of data collection procedures | 6 | 4 (29%) | 2 (25%) | 1 (14%) | 5 (33%) |
Consent needed because of type of intervention | 2 | 2 (14%) | 0 (0%) | 1 (14%) | 1 (7%) |
*The intervention was aimed directly at the cluster or cluster staff, and there was no direct data collection from the home residents; there might have been identifiable private information obtained from other sources, but this was unclear and, if there were, we judged that a waiver could have been appropriate.