A1
Non-researchable case reports summarizing 9 or fewer cases.
A2
Maintenance and promotion of human health through understanding the causes and pathology of injury and disease, improving methods of prevention, diagnosis, and treatment of injury and disease, and verifying the
effectiveness and safety of such methods, and reports, etc. not intended to acquire knowledge that contributes to recovery from injury or illness or improves the quality of life*.
*Examples: (1) Only the introduction of treatment methods, education and training methods; (2) Introduction about the institution's medical system and efforts to improve medical examination rates.
A3
Research using only articles, published databases, and guidelines.
A4
Research using samples and information that have already proven academic value, are widely utilized for research purposes and are accessible to the general public.
A5
Research using samples/information that has already been anonymized (processed in such a way that a specific individual cannot be identified and for which no correspondence table exists anywhere, regardless of whether the individual is self-identified or not).
However, the analysis of somatic cell-derived genomic data is excluded.
A6
Research using anonymized processed information or anonymously processed information that has already been created.
A7
Research based on laws and regulations (excluding the Clinical Trials Act and the Act on Ensuring Regenerative Medicine, Safety, etc.).
A8
Research that only analyzes microorganisms such as bacteria, molds, and viruses isolated from the human body and that does not involve research on events related to human health.
A9
Basic research using animal experiments and generally available cells (including iPS cells and tissue stem cells).
A10
Research conducted overseas (excluding those in which the specimens/information subject to the research were obtained in Japan). However, it is necessary to comply with the regulations of the country where the research was conducted.
B1
-Observational studies using existing samples and information.
The use of information from routine medical care or surplus biological specimens collected during medical care is acceptable, regardless of whether it is prospective or retrospective provided it does not affect the routine medical practice (judgment) in any way.
-Observational research that obtains new information only for research purposes and does not involve invasive procedures.
This includes ECG, body surface US tests, and noncardiac invasive questionnaires.
B2
-Observational studies that involve invasive or minimally invasive procedures in obtaining new information for research purposes.
Research that does not affect normal medical practice (judgment) in any way but in which radiography, CT, etc., are performed for research purposes.
-Observational research in which samples are obtained in addition to new information for research purposes.
Some of them are invasive or slightly invasive, such as CT, blood sampling (may include others on top of the usual medical care), tissue collection, etc., for research purposes, while others are non-invasive, such as collection of excretions.
C
Interventional research to which the "Clinical Research Act" does not apply.
This includes interventional studies using in vitro diagnostics and studies evaluating medical procedures and surgical methods.
D1
Clinical research other than specific clinical research (research subject to the obligation to make efforts to comply with the "Clinical Research Act").
Interventional research that evaluates the efficacy and safety of approved drugs and medical devices without funding from related companies.
D2
Specified clinical research (research obliged to comply with the "Clinical Research Act").
Research using unapproved or off-label drugs, medical devices, or interventional research funded by companies falls under this category.
E
Research that meets the following criteria.
-Research that falls under the Act on Ensuring Regenerative Medicine Safety, etc. -Research on Human Gene Therapy.
