Application / Report to Teikyo University Medical Research Ethics Committee

Please submit the following documents to the Institutional Review Board Secretariat (Itabashi Campus Secretariat). Also, please attach materials as necessary.
Please read the guidelines carefully before creating the documents.
Applications may not be accepted for documents that do not meet the requirements.
Information session materials on how to fill out the application form of the Ethics Committee
The briefing session video can be viewed from the following. (Accessable only on campus)
Teikyo University Itabashi Campus Office General Affairs Division Site

Application to Teikyo University Medical Research Ethics Committee

• * Please submit a formal application form after the prior confirmation is completed. The official application file will be sent by e-mail from the secretariat to the person in charge of the application after the preliminary confirmation is completed.
• * Please submit the change request in the latest format. In that case, please refer to the latest description requirements.
• * Please submit Word files and printouts for various documents.
• * Please submit the checklist as an Excel file.
• * Please submit Word and Excel files to the Institutional Review Board Secretariat (turb-office@teikyo-u.ac.jp) by email.
• * For those who wish to have a batch screening including off-campus institutions and a screening at our university, please see "Batch screening at our university (including screening requests from external institutions)".

Request for examination to an external organization

• ※外部機関の倫理審査委員会での審査を希望される場合は、まず事務局にご一報ください。
  学内の事前手続きについてご説明いたします。
• * For required documents other than the tax return, please refer to the attached document column at the end of the tax return.
• ※学内での事前手続きおよび審査終了後の学内実施許可手続きについては、下部「申請時の注意事項」の項目（6）を参照してください。

On-campus procedures are also required when applying to other Accredited Clinical Research Review Boards (CRBs). Please refer to the page of the Clinical Research Review Board of the Faculty of School of Medicine for the required documents.
Teikyo University School of Medicine Clinical Research Review Board

(1) About application for ethical review in the form of holding

Studies that fall under the following are subject to institutional review by the Institutional Review Board. The attendance of the applicant or a research organization member who understands the research content is required.

1. Research by the university alone or multi-institutional research centered on the university with intervention or invasion (research not subject to accelerated examination)
2. What the chairman (or vice chairman) deems necessary

Please refer to the following for the dates and deadlines.
Scheduled date of the event / Scheduled deadline for submitting documents
Please refer to the following for the details of the examination. In the case of an institutional review board review, please attach the review application form.
About the institutional review of the ethics committee
Examination application form

(2) Documents to be submitted other than application documents

Please attach the following required documents to all researchers belonging to the University listed in the research plan "5. Research Organization".

1. ICRweb Certificate of Completion (Basic Knowledge Course for Clinical Research (formerly Beginner's Course for Clinical Research))
   If the university is the main research institution, please also attach the collaborators of institutions that do not have an ethics committee.
2. APRIN e-learning program (medical researcher recommended course: former medical researcher standard course) or CITI Japan (medical researcher standard course)
   If you have a certificate of completion of another course, you may need to take additional courses. Please contact us for more information. If the university is the main research institution, please also attach the collaborators of institutions that do not have an ethics committee.

(3) Declaration and examination of conflicts of interest

Members of the research organization on campus are required to examine conflicts of interest.

• At the time of new application ... Required
• At the time of application for change ... New organization participants and organizational members who have changed their interests are required.
  Other organizational members are at the discretion of the Conflict of Interest Management Committee

After completing the prior confirmation, please request the examination using the conflict of interest Web filing system after the guidance from the secretariat.
If you have not registered as a user, please contact the Research Compliance Office (anpo@teikyo-u.ac.jp).
Please refer to the following for how to log in to the system. (Accessable only on campus).
Teikyo University Itabashi Campus Conflict of Interest Management Committee Page

If the university is the main research institution, it is necessary to confirm conflicts of interest even for collaborators of institutions that do not have an ethics committee. Please contact the secretariat (outside the university will not be examined).

(4) E-learning program that requires attendance

ICRweb
Please check the site for ICRweb. Introduction to ICR Clinical Research
I have a facility contract. Please contact the secretariat before taking the course.
If you took the course before January 17, 2013 (old course), please take the basic knowledge course of clinical research of the current course again.

APRIN e-learning program
At Itabashi Campus (including Mizoguchi Hospital and Chiba General Medical Center), attendance is compulsory from 2015.
Please contact us if you have a certificate of completion of the CITI Program in the United States or a certificate of completion that you have taken at another institution in the past.
If you are taking this course for the first time, please contact us as we will register at the secretariat.
If you are a collaborative researcher outside the university and cannot take the course at your institution, please contact the secretariat.

(5) Precautions when multiple hospitals / clinics attached to the university participate in the same research

In the case of multi-institutional joint research in which a member of the university is the principal investigator, the ethics committee of the university will conduct a batch review, so the principal investigator should apply collectively.
If you apply to the Institutional Review Board of the University for multi-institutional joint research with major research organizations other than the University, the Institutional Review Board of the University will conduct a batch review. Please apply by collecting the names.

• * For affiliated hospitals and clinics other than this hospital, please check the procedures in the hospital / clinic in advance.

(6) Precautions for general application

For joint research with a major institution other than the University, please attach a copy of the plan and approval of the main institution.
When creating a research plan, be sure to refer to the written guidelines and various procedure manuals of the university.
To download the procedure manual, refer to the item "Various procedure manuals" at the bottom.
Please refer to the following for statistical consultation. It is not resident, so a reservation is required.
About statistical consultation in June
Submit the report to the Institutional Review Board at the time stated in the research plan.
Please download the form from the item "Documents required for reporting (University form)" at the bottom.

(7) Request for examination to the ethics examination committee of an external organization

• For institutional review requests to the ethics review committee of an external organization, it is necessary to carry out procedures on campus before and after the examination, so please consult with the ethics committee secretariat.
• The procedure at the University Ethics Committee is as follows.

[Before examination by an external organization]
Please submit the University Declaration Form with the necessary documents to the Institutional Review Board Secretariat. For the documents that need to be submitted, please refer to the attached documents column at the end of the ethical review application report. For the format of the ethics examination application report, please refer to the item "Request for examination of documents (university format) required at the time of application to an external organization".
Flow chart (before examination)

[After approval by an external organization]
When the examination at the request destination is completed and approved, please submit the examination result report together with the necessary documents to the Institutional Review Board Secretariat.
For the format of the examination result report, please refer to the item "Documents required for reporting (University format)".
After submitting the report, the research can be started after the procedure for obtaining the approval of the director of the Faculty of School of Medicine is completed.
Flow chart (after examination)

Please attach materials as necessary.

臨床研究における記録保管に関する標準業務手順書（2022年6月28日更新）
臨床研究における記録保管に関する標準業務手順書別紙（研究終了後資料保管申請書）（2021年6月24日更新）
人体から取得された試料の保管に関する手順書（2021年6月24日更新）
研究における重篤な有害事象報告に関する標準業務手順書（2022年12月10日更新）

• * For required documents other than the tax return, please refer to the attached document column at the end of the tax return.
• * Please refer to the [Application Procedure] below for the procedure.
• * Please refer to the following for the commissioned examination fee.
  Contract examination fee

If you are a researcher (institution) who wishes to be examined by the Teikyo University Medical Research Ethics Committee, please check the following notes and contact the committee secretariat in advance.

[Contract requirements]
Please make sure that you meet the requirements of our university. (Teikyo University Medical Research Ethics Committee Regulations Operation Detailed Regulations Article 7)
Teikyo University Medical Research Ethics Committee Regulations Operation Detailed Regulations
We will accept the examination request only if all of the following conditions are met.

1. Matters deemed necessary by the University Ethics Committee regarding the ethics of life science and medical research.
2. The research-related rules within the research institution include rules that allow researchers belonging to the institution to request research examinations outside their own institution. Or, if the research institution does not have an ethics review committee, etc., and the review cannot be conducted within the institution.
3. It can be confirmed that the research institution has the necessary implementation system for conducting the research.

[Application procedure]

1. The principal investigator (in the case of a single institution, the principal investigator) should confirm that the above requirements are met before contacting the Secretariat of the Institutional Review Board of the University.
2. Please apply with the ethics review request form and the plan prescribed by the university. For the format, refer to the item "Documents required at the time of application (University format)".
3. Please submit the research implementation system confirmation and attached documents (examination results regarding conflicts of interest, education / training attendance certificate).
4. When applying from an off-campus principal investigator (in the case of a single institution, the principal investigator), a consignment contract will be concluded.