Kyushu University Hospital and Medical Institutions Ethical Review Boards

• Certified Institutional Review Board for Clinical Trials *Japanese
• Institutional Review Board for Clinical Research *Japanese
• Institutional Review Board for Clinical Trials (Intervention Studies)
• Institutional Review Board for Clinical Trials for Approval of Drugs/Equipment *Japanese
• Certified Special Committee for Regenerative Medicine *Japanese
• Institutional Review Board for Human Embryonic Stem Cells Derivation and Utilization Research *Japanese
• Institutional Review Boards for Clinical Research / Clinical Trials based for Former Guidelines *Japanese
• Hospital Ethics Committee (Fukuoka) *Japanese
• Hospital Ethics Committee (Beppu) *Japanese

Application Forms - Clinical Trials (Intervention Studies) -

On June 30, 2021, the "Ethical Guidelines for Person-Centered Medical Research" and "Ethical Guidelines for Human Genome and Gene Analysis Research" were integrated to create the "Ethical Guidelines for Person-Centered Life Sciences and Medical Research."
For more information go →here.

[New Application Submission Documents]
Go →here to batch download the New Application Submission Documents

	Forms	Conducted by Kyushu University only	Multi-institutional joint research
			Kyushu University is main	Other institution is main Separately reviewed by Kyushu University	Other institution is main Comprehensive review by other institution
1	Request for Ethical Review	○	○	○
2	List of Participating Organizations	(○)	○	○
3	Research Plan *In cases where Kyushu University shares responsibility with other organizations as part of multi-institutional joint research, please submit the research plan of the main research organization	○	○
4	Explanatory Document	○	○	○
5	Consent Form	○	○	○
6	Conflict of Interest Update Form	○	○	○
7	Self-Check Sheet	○	○	○
8	Homepage Display Materials (Opt-Out)	(○)	(○)	(○)
9	Other documents requested by the Board ・Clinical Research Insurance Estimate ・Research Subject Recruitment Materials ・etc.	(○)	(○)	(○)
10	Implementation Authorization Request (to the Research Director)	○	○	○	○
11	Documents related to the main research organization ・Ethical Review Results Notification ・Research Plan; Consent Explanation Form ・etc.			○	○
12	Documents to be submitted by other organizations wanting comprehensive review at Kyushu University ・Research Institution Requirements Confirmation ・Conflict of Interest Update Form		(○)

◆Documents marked with (○) are to be submitted as needed.
◆In cases where Kyushu University is the main research institution for multi-institutional joint research and comprehensive review by Kyushu University is sought, each institution should prepare and submit Form #12 (Research Institution Requirements Confirmation and Conflict of Interest Update Form).
Each institution that will be part of the comprehensive review must, after receiving the Review Results Notification, obtain permission to conduct the research in question from its head.

[Revised Application Submission Documents (including central review/comprehensive review)]

	Forms	Conducted by Kyushu University only	Multi-institutional joint research
			Kyushu University is main	Other institution is main Separately reviewed by Kyushu University	Other institution is main Comprehensive review by other institution
1	Table of Revisions *Please make sure to provide the reason for the revision	○	○	○
2	Request for Ethical Review	○	○	○
3	List of Participating Organizations	(○)	○	○
4	Research Plan *In cases where Kyushu University shares responsibility with other organizations as part of multi-institutional joint research, please submit the research plan of the main research organization.	○	○
5	Explanatory Document	○	○	○
6	Consent Form	○	○	○
7	Conflict of Interest Update Form	(○)	(○)	(○)
8	Homepage Display Materials (Opt-Out)	(○)	(○)	(○)
9	Implementation Authorization Request (to the Research Director)	○	○	○	○
10	Documents related to the main research organization ・Ethical Review Results Notification ・Research Plan ・Consent Explanation Form ・etc.			○	○

◆Documents marked with (○) are to be submitted as needed.
◆Revisions judged to be minor revisions by the chairperson may receive expedited review.

[Revised Application Submission Documents]
*These documents should be submitted for research currently underway which was approved according to the former guidelines in place before the enactment of the new guidelines on June 30, 2021.

	Forms
1	Application
2	List of Revisions *Please make sure to provide the reason for the revision
3	Research Plan *In cases where Kyushu University shares responsibility with other organizations as part of multi-institutional joint research, please submit the research plan of the main research organization.
4	Explanatory Document
5	Consent Form
6	A copy of the review board notification of approval for the main research institution (when Kyushu University shares responsibility with other organizations as part of multi-institutional joint research)

[Reports]

	Forms
1	Periodical Report *Must be submitted once a year.
2	Research Conclusion Report
3	Severe Adverse Event Report *Required regardless of whether the cause is connected with the research conducted.  ・"Medicinal Drugs"  ・"Medical Instruments"
4	Unforeseeable Severe Adverse Event Report >Report for the Minister of Health, Labour and Welfare< *When an unforeseeable severe adverse event occurs, and when the research in question cannot be ruled out as a direct cause, a report must be promptly provided to the authorities.

Submissions and inquiries:
University Hospital Administration Department, Research Support Division, Section of IRB & Ethics Committee Administration (West Wing Bldg. 6FL, 610)
TEL: 092-642-5082 (ext.: 3982)
E-mail: byskenkyu@jimu.kyushu-u.ac.jp