Table 3 Topics of research ethics consultations of compatibility with Japanese government guidelines and other guidance and regulations
From: Research ethics consultation: an attempt and 5-year experience in a Japanese University Hospital
Topics | 2012 | 2013 | 2014 | 2015 | 2016 | Total (%) |
|---|---|---|---|---|---|---|
Ethical handling of human biological specimens | 2 | 2 | 1 | 5 | 3 | 13 (15.5%) |
Ethical handling of information utilized in research | 6 | 2 | 3 | 6 | 0 | 17 (20.1%) |
Necessity and way of informed consent | 2 | 0 | 5 | 1 | 0 | 8 (9.5%) |
Categorization of invasiveness | 0 | 0 | 0 | 1 | 1 | 2 (2.4%) |
Categorization of intervention | 6 | 0 | 3 | 1 | 3 | 13 (15.5%) |
Application of ethical guidelines | 4 | 3 | 2 | 0 | 5 | 14 (16.7%) |
Examination of functions of food and supplements | 3 | 0 | 0 | 1 | 2 | 6 (7.1%) |
Advanced medicine | 0 | 2 | 1 | 1 | 0 | 4 (4.8%) |
Trials for governmental approval (registration trials) | 0 | 1 | 2 | 0 | 0 | 3 (3.6%) |
Gene therapy | 0 | 1 | 0 | 0 | 0 | 1 (1.2%) |
Regenerative medicine | 0 | 0 | 1 | 0 | 0 | 1 (1.2%) |
Good clinical practice | 0 | 0 | 1 | 0 | 0 | 1 (1.2%) |
Insurance in clinical trials | 0 | 0 | 1 | 0 | 0 | 1 (1.2%) |
Total | 23 | 11 | 20 | 16 | 14 | 84 |