Table 3

Difficulty and changes required for gaining approvals for most recent research project

VariableN (%)
Whether difficulties were experienced gaining approval (n=56)
 R&D (n=55)24 (44)
 SSA (n=46)12 (26)
 Coordination of approval systems (n=56)12 (21)
 REC (n=56)8 (14)
 CAG (n=5)1 (20)
 Review within institution (n=40)1 (3)
 Other (n=12)1 (8)
Most difficult approval process (for those experiencing difficulties) (n=32)
 R&D15 (47)
 SSA7 (22)
 Coordination of approval systems4 (13)
 REC1 (3)
 CAG1 (3)
 Review within institution0 (0)
 Other4 (13)
Whether changes were required as a result of review process (n=56)
 R&D (n=55)15 (27)
 SSA (n=46)5 (11)
 REC (n=56)35 (63)
 CAG (n=5)2 (40)
 Review within institution (n=40)7 (18)
 Other (n=12)3 (25)
Area where the biggest change was requested (n=40)
 Information sheet19 (48)
 Consent/assent9 (23)
 Data collection methods4 (10)
 Sample size2 (5)
 Data storage1 (3)
 Other5 (13)
  • R&D, Research and Development; SSA, Site Specific Approval; REC, Research Ethics Committee; CAG, Confidentiality Advisory Group.