Application / Report to Teikyo University Medical Research Ethics Committee

Please submit the following documents to the Ethics Committee Secretariat (Itabashi Campus Office). Please also attach any other documents as necessary.
Please read the requirements carefully before preparing the documents.
If the documents are not filled out in accordance with the requirements, your application may not be accepted.
Information session materials on how to fill out the Ethics Committee application form
The video of the briefing session can be viewed below. (Only accessible to LMS registrants)
Teikyo University LMS site

Application to Teikyo University Medical Research Ethics Committee

Please refer to the FAQ along with the guidelines when creating your plan.

• * Please submit all documents electronically to the Ethics Committee Secretariat (turb-office@teikyo-u.ac.jp). Printed copies are not required.
• * 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 use this checklist for your own reference only. Submission is not required.
• * For external organizations wishing to undergo a comprehensive review including external institutions, or a review conducted by the university, please refer to "Comprehensive Review at the University (including review requests from external institutions)".

Request for examination to an external organization

• * For the time being, prior procedures are not required when requesting a review by an external ethics review committee. Please contact the secretariat only if you are submitting or declaring the results of the conflict of interest review.
• * We also accept consultations regarding how to fill out the required documents.
• *Once the ethical review by an external organization is complete, you will need to go through the implementation permit procedure, so please be sure to contact the secretariat. Please also refer to item (6) in "Notes on Application" below.

When applying to other accredited Clinical Research Review Boards (CRBs), the internal procedures are also required. Please refer to School of Medicine Clinical Research Review Board page for the required documents.
Teikyo University School of Medicine Clinical Research Review Committee

(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 Completion Certificate (Basic Knowledge of Clinical Research Course) ... All students within the university
   If our university is the primary research institution, please also include information on co-researchers at institutions that do not have an ethics committee.
2. APRIN e-Learning Program Completion Certificate (Teikyo University Medical Researcher Recommended Course (within validity period)) ... All members of the university
   If you have a certificate of completion from another course, you may be required to take additional courses. Please contact us for details. If our university is your primary research institution, please also attach information about co-researchers at institutions without 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 preliminary check, please request a review via the COI Web Declaration System following instructions from the secretariat.
If you have not yet registered as a user, please contact the Research Compliance Office (anpo@teikyo-u.ac.jp).
For details on how to log in to the system, please see below (accessible 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 Teikyo University, students are required to take the necessary courses at each campus.
If you have a certificate of completion from another institution or organization in the past, please contact us.
If this is your first time taking the course, please contact the administrative office to register.
External collaborators who are unable to attend the course at their affiliated institution should contact the administrative office.

(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 May
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

• Requests for review by external ethics review committees require internal procedures both beforehand (if a conflict of interest review result is needed) and afterward. Please consult with the Ethics Committee Secretariat.
• The procedure at the University Ethics Committee is as follows.

[Before external review]
Prior procedures will only be carried out if it is necessary to submit or declare the results of a conflict of interest review.
Please submit the university's declaration form, along with the necessary documents, to the Ethics Committee Secretariat. For a list of required documents, please refer to the "Attachments" section at the end of the Ethics Review Application Form. For the Ethics Review Application Form format, please refer to the section "Request for Review of Required Documents (University Form) by External Organizations."
Flowchart (before review)

[After approval by external organization]
Once the requested institution has completed its review and approved the application, please submit the review results report along with the necessary documents to the Ethics Committee Secretariat.
For the format of the review result report, please refer to the section "Documents required for reporting (University form)."
After submitting the report, the research can begin only after the procedure to obtain permission from the Dean of School of Medicine has been completed.
Flow diagram (after review)

(8) Frequently asked questions

For inquiries regarding the Ethics Committee, please see the link below.
FAQ

Please attach materials as necessary.

Standard Operating Procedures for Record-Keeping in Clinical Research (Updated July 4, 2024)
Standard Operating Procedures for Record Retention in Clinical Research (Application for Retention of Materials After Research Ends) (Updated June 24, 2021)
Procedures for the storage of specimens obtained from the human body (Updated June 24, 2021)
Standard Operating Procedures for Reporting Serious Adverse Events in Research (Updated December 10, 2022)

• * 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.