Table 8

Issues with applications identified by RECs before and during the ethics officer intervention. Source: REC meeting minutes and opinion letters

Baseline (n=110 applications)Intervention period (n=100 applications)
Type of issueNumber of issuesNumber (% of all) applications with an issueMean number of issues per applicationNumber of issuesNumber (% of all) applicationsMean number of issues per application
Document issues
 Consent documents4527 (25)0.44632 (32)0.5
 Other documentation29885 (77)2.726885 (85)2.7
 REC application12157 (52)1.18143 (43)0.8
 Subtotal46493 (85)4.239588 (88)3.9
Ethical issues
 Participant care24989 (81)2.320775 (75)0.7
 Confidentiality14768 (62)1.313257 (57)0.6
 Informed consent3023 (21)0.33124 (24)0.2
 Community issues1010 (9)0.12018 (18)0.2
 Subtotal436101 (92)4.039084 (84)0.8
Study issues
 Design and conduct29993 (85)2.722578 (78)0.8
 Recruitment17982 (75)1.613165 (65)0.6
 Subtotal478104 (95)4.335688 (88)0.9
 Total issues1378108 (98)12.5114196 (96)11.4

  • REC, research ethics committee.