Table 3 Ethics-related issues reporting
Year | 2004 (n = 13) | 2009 (n = 28) | 2014 (n = 39) | p | All studies (n = 80) |
|---|---|---|---|---|---|
Ethic committee study approval | 9 (69.2) | 23 (82.1) | 33 (84.6) | .470b | 65 (81.2) |
Details about ethic committee | 6 (46.2) | 13 (46.4) | 22 (56.4) | .667c | 41 (51.2) |
Consent | 11 (84.6) | 26 (92.9) | 37 (94.9) | .443b | 74 (92.5) |
Details about the consent process | 4 (30.8) | 16 (57.1) | 22 (56.4) | .245b | 42 (52.5) |
Assessment of reduced cognitive competence | 3 (23.1) | 18 (64.3) | 20 (51.3) | .049b | 41 (51.2) |
Incentives or compensation, and details | 0 (0.0) | 0 (0.0) | 3 (7.7) | .278b | 3 (3.8) |
Funders and details | 10 (76.9) | 20 (71.4) | 26 (66.7) | .848b | 56 (70.0) |
Potential conflicts of interest | 3 (23.1) | 8 (28.6) | 30 (76.9) | <.001b | 41 (51.2) |
Statement about sample size estimates | 5 (38.5) | 8 (28.6) | 17 (43.6) | .455c | 30 (37.5) |
Performing of power calculations | 5 (38.5) | 7 (25.0) | 15 (38.5) | .478c | 27 (33.8) |
Appropriateness of comparators | 10 (76.9) | 24 (85.7) | 34 (87.2) | .638b | 68 (85.0) |
Matching of comparators | 11 (84.6) | 19 (67.9) | 30 (76.9) | .509b | 60 (75.0) |
Potential harm for participants | 1 (7.7) | 6 (21.4) | 10 (25.6) | .470b | 17 (21.2) |
Reporting presence/absence of adverse events | 4 (30.8) | 7 (25.0) | 20 (51.3) | .081b | 31 (38.8) |
Accordance with the Helsinki declaration. | 0 (0.0) | 3 (10.7) | 6 (15.4) | .403b | 9 (11.2) |
Number of ethics-related issues reporteda | 7.5 (1.6) | 8.5 (2.3) | 9.9 (2.9) | .009d | 9.0 (2.6) |