Table 3

Prevalence of characteristics of consent processes stratified by whether obtaining of individual consent was reported

Trials that report obtaining individual consent
Total N=51Report obtaining ethical approval N=45Did not report obtaining ethical approval N=6Published 1992–2004 N=22Published 2005–2010 N=29
Reporting using proxy for consent37 (72%)34 (76%)3 (50%)13 (59%)24 (83%)
Type of proxy
 Next of kin or other relative19 (37%)19 (42%)0 (0%)8 (36%)11 (38%)
 Family members or guardians6 (12%)4 (9%)2 (33%)3 (14%)3 (10%)
 Legal or designated guardian11 (22%)10 (22%)1 (17%)2 (9%)9 (31%)
 Member of staff or relative1 (3%)1 (2%)0 (0%)0 (0%)1 (3%)
Reported process to assess capacity8 (16%)7 (16%)1 (16%)2 (9%)6 (21%)
Quality of consent process:
 Insufficient details reported22 (43%)18 (40%)4 (67%)12 (59%)10 (31%)
 Poor15 (29%)15 (34%)0 (0%)5 (23%)10 (34%)
 Fair8 (16%)7 (16%)1 (17%)3 (14%)5 (17%)
 High6 (12%)5 (11%)1 (17%)2 (9%)4 (14%)
Trials that did not report obtaining individual consent
Total N=22N=14N=8N=7N=15
No consent needed because of nature of intervention and data collection*148 (57%)6 (75%)5 (72%)9 (60%)
Consent needed because of data collection procedures64 (29%)2 (25%)1 (14%)5 (33%)
Consent needed because of type of intervention22 (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.