Table 1. Review Items in Research Examination on New Surgical Research at Japanese Medical School Hospitals (n = 39).

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
Table 2. Items That Are Considered Important in Research Ethical Review for New Surgical Research (Up to Three Items to Be Answered) (n = 39).

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
Table 3. Items That Are Difficult to Review in Research on New Surgical Research (Multiple Answers Allowed) (n = 39).

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
PAGE TOP