From: Current Status and Issues of Ethical Review for Surgical Research in Japanese University Hospitals
Review Items | Yes | No | Fisher’s exact test | |||
---|---|---|---|---|---|---|
n | (%) | n | (%) | p | ||
Before review | The necessity of review | 33 | (84.6) | 6 | (15.4) | 0.025 |
Review for studies | Review on ethics | 39 | (100.0) | 0 | (0) | reference |
Review for the efficiency | 38 | (97.4) | 1 | (2.6) | ns | |
Review on technical aspects | 30 | (76.9) | 9 | (23.1) | 0.002 | |
Review on safety | 39 | (100.0) | 0 | (0) | ns | |
Review on research team systems | 39 | (100.0) | 0 | (0) | ns | |
Review on informed consent | 39 | (100.0) | 0 | (0) | ns | |
Progress and Results | Report on the progress and results | 35 | (89.7) | 4 | (10.3) | 0.115 |
Evaluation of the progress and results | 22 | (56.4) | 17 | (43.6) | <0.001 |
From: Current Status and Issues of Ethical Review for Surgical Research in Japanese University Hospitals
Review Items | Yes | No | Chi-square test or Fisher’s exact test | ||||||
---|---|---|---|---|---|---|---|---|---|
n | (%) | n | (%) | OR | 95% CI | P-value | |||
Ethical review | Review | Definition of novelty | 12 | (30.8) | 27 | (69.2) | 0.28 | 0.11-0.71 | 0.012 |
Implementation conditions | 13 | (33.3) | 26 | (66.7) | 0.31 | 0.12-0.79 | 0.023 | ||
Technical aspects and ethical review | 24 | (61.5) | 15 | (38.5) | - | - | reference | ||
Informed consent | 12 | (30.8) | 27 | (69.2) | 0.28 | 0.11-0.71 | 0.012 | ||
Research expenses and compensation | 10 | (25.6) | 29 | (74.4) | 0.22 | 0.08-0.57 | 0.002 | ||
Release | Study registration and disclosure | 1 | (2.6) | 38 | (97.4) | 0.02 | 0.0004-0.12 | <0.001 | |
Results | Evaluation of results | 4 | (10.3) | 35 | (89.7) | 0.07 | 0.02-0.27 | <0.001 | |
Management and oversight | Effective | Lack of monitoring range, effectiveness, and enforcement | 7 | (17.9) | 32 | (82.1) | 0.14 | 0.05-0.39 | <0.001 |
Burden | Operational effort (research site) | 5 | (12.8) | 34 | (87.2) | 0.10 | 0.02-0.32 | <0.001 | |
Operational burden (review committee) | 2 | (5.1) | 37 | (94.9) | 0.04 | 0.003-0.17 | <0.001 | ||
Discretion | Restrictions of discretion | 4 | (10.3) | 35 | (89.7) | 0.07 | 0.02-0.27 | <0.001 | |
Division | Relationship between research and treatment | 8 | (20.5) | 31 | (79.5) | 0.16 | 0.06-0.44 | <0.001 |
From: Current Status and Issues of Ethical Review for Surgical Research in Japanese University Hospitals
Review Items | Yes | No | Chi-square test | ||||||
---|---|---|---|---|---|---|---|---|---|
n | (%) | n | (%) | OR | 95% CI | P-value | |||
Ethical review | Review | Definition of novelty | 20 | (51.3) | 19 | (48.7) | 0.53 | 0.21-1.31 | 0.250 |
Implementation conditions | 18 | (46.2) | 21 | (53.8) | 0.43 | 0.17-1.07 | 0.110 | ||
Technical aspects and ethical review | 26 | (66.7) | 13 | (33.3) | - | - | reference | ||
Informed consent | 10 | (25.6) | 29 | (74.4) | 0.17 | 0.06-0.46 | <0.001 | ||
Research expenses and compensation | 21 | (53.8) | 18 | (46.2) | 0.58 | 0.23-1.46 | 0.355 | ||
Release | Study registration and disclosure | 9 | (23.1) | 30 | (76.9) | 0.15 | 0.06-0.41 | <0.001 | |
Results | Evaluation of results | 12 | (30.8) | 27 | (69.2) | 0.22 | 0.09-0.58 | 0.003 | |
Management and oversight | Effective | Lack of monitoring range, effectiveness, and enforcement |
19 | (48.7) | 20 | (51.3) | 0.48 | 0.19-1.19 | 0.169 |
Burden | Operational effort (research site) | 18 | (46.2) | 21 | (53.8) | 0.43 | 0.17-1.07 | 0.110 | |
Operational burden (review committee) | 14 | (35.9) | 25 | (64.1) | 0.28 | 0.11-0.71 | 0.013 | ||
Discretion | Restrictions of discretion | 19 | (48.7) | 20 | (51.3) | 0.48 | 0.19-1.19 | 0.169 | |
Division | Relationship between research and treatment | 14 | (35.9) | 25 | (64.1) | 0.28 | 0.11-0.71 | 0.013 |