|
KMID : 1234820190200020173
|
|
Korean Society of Law and Medicine
2019 Volume.20 No. 2 p.173 ~ p.206
|
|
|
The Characteristic of Research Regulation in Recent Japanese Medical World
|
|
Song Young-Min
|
|
|
Abstract
|
|
|
This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as ?dynamic guideline?) and ethics guideline on clinical research(here after, referred to as ?clinical guideline?) to ethics guideline on medical research aimed at human(here after, referred to as ?integrated guideline?), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of ?invasiveness?, a preliminary consideration of evaluation.
?Evaluation issue of risk and profit?, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define ?invasiveness? concept, a preliminary consideration of risk evaluation for human subjects.
This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of ?invasiveness? concept, a preliminary of risk evaluation to protect human subjects.
|
|
|
KEYWORD
|
|
|
Clinical Trial, Act of Clinical Research, Risk, Institutional Review Board (IRB), Invasiveness, Human Subjects
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|