Regulations and Rules for Research

*Headings indicate the publication date.

Keio University Conflict of Interest Management Policy

Keio University Conflict of Interest Management Regulations

Keio University University School of Medicine Conflict of Interest Management Regulations

Keio University University School of Medicine and Hospital Regulations on Special Provisions for Conflict of Interest Management in Clinical Research and Related Activities

Regulations on the Management of Conflicts of Interest in AMED Research Activities

Regulations on the Management of Conflicts of Interest in AMED Research Activities Q&A

Guidelines on the Management of Conflict of Interest (COI) in Health, Labour, and Welfare Sciences Research

Q&A on the “Guidelines on the Management of Conflict of Interest (COI) in Health, Labour, and Welfare Sciences Research”

Guidelines on the Management of Conflict of Interest in Children and Families Science Research

Q&A on the “Guidelines on the Management of Conflict of Interest (COI) in Children and Families Science Research”

Guidelines on Procedures for Holding Concurrent Positions as Executives and Other Roles in Companies Utilizing Research Outcomes

Request for Submission of the Conflict of Interest Self-Disclosure Form

FY2024 Conflict of Interest Web Declaration System Instruction Manual

Animal Experiment, Genetic Recombination, and Pathogen Review Application System

Applications for the review of genetic recombination experiments can now be submitted through the web system.

https://keio2.bvits.com/agv/

*For explanatory materials, user guides, and various manuals, please refer to "Announcements" in the main menu.

*Authentication with keio.jp is required.

The official English name for Keio University University School of Medicine Genetic Modification Safety Committee is as follows:

Genetic Modification Safety Committee, Keio University School of Medicine

FY2025 Genetic Recombination Experiment Safety Training [For General Participants]

Individuals newly engaging in genetic recombination experiments must attend (or view) the training session held by the Keio University University School of Medicine Genetic Modification Safety Committee before starting their experiments.

For details, please see the link in the right-hand column.

Additionally, videos of past training sessions for general participants and principal investigators are being sequentially posted on the School of Medicine website's "Lecture Archive," starting from the "For Researchers: FY2019 Training Sessions" page.

If you require materials, please contact the Biosafety-related Administrative Office at med-biosafety@adst.keio.ac.jp.

Lecture Archive: https://archive.med.keio.ac.jp/

*Authentication with keio.jp is required.

FY2025 Genetic Recombination Experiments Training Course for general participants

Genetic Recombination Experiments Training Course for General Participants

・Completion of a Training Course once a year is MANDATORY for those who engage in genetic recombination experiments.

・If you have completed the Japanese version of the Genetic Recombination Experiments Training Course, you don't need to retake this English version.

*keio.jp authentication is required.

FY2025 Genetic Recombination Experiment Safety Training Course [For Principal Investigators]

Principal Investigators should take the [For Principal Investigators] course, while those who are not Principal Investigators (i.e., those not certified as Principal Investigators) should take the [For General Participants] course.

Those who are not Principal Investigators but plan to take the Principal Investigator certification exam in the future may take the [For Principal Investigators] course in addition to the [For General Participants] course. However, please note that taking only the [For Principal Investigators] course does not grant Principal Investigator certification.

For details, please see the link in the right column.

The FY2026 Principal Investigator certification exam is scheduled to be held around June 2026.

*keio.jp authentication is required.

[Videos for Beginners] (Japanese, English, and Chinese versions)

We have released educational videos on the safe use of genetically modified organisms.

These videos focus on basic and fundamental content. Watching these videos alone does not qualify you to conduct experiments, but they serve as instructional material for beginners who are about to start genetic recombination experiments.

English and Chinese versions are also available, so we encourage foreign researchers and international students who have difficulty understanding Japanese to watch them.

Please access the Google Drive folder from the link in the right column.

*keio.jp authentication is required.

[Training Session for Beginners] <Held on August 19, 2019> This training session focused on basic content. Attending this session alone does not qualify you to conduct experiments, but we encourage everyone, not just beginners, to watch it to deepen their understanding of genetic recombination experiments.

Training Session for Beginners: Lecture Video [Dr. Yoichiro Abe] (Lecture Archive)

Click the link in the right column to watch.

*Requires keio.jp authentication.

Training Session for Beginners: Training Materials [Dr. Yoichiro Abe]

About the Office Hours System

We have launched an office hours system to provide an opportunity for direct consultation with the Biosafety Officer for Recombinant DNA Experiments regarding the preparation and submission of Recombinant DNA Experiment Plans, including how to fill them out and any questions you may have. Resolving questions in advance can help streamline the process from review to approval. We also welcome questions and consultations on matters such as laboratory equipment, precautions for conducting experiments, and containment measures. Please apply using the application form below.

<Note> Added on May 20, 2022: For Those with Questions or Inquiries

Since the implementation of the Principal Investigator system, Recombinant DNA Experiment Plans must be submitted after being reviewed by the Principal Investigator. For questions regarding how to write the plan, please first consult the materials on the web system or speak with your Principal Investigator.

If questions remain, the Principal Investigator should apply for the consultation.

While we will endeavor to respond to inquiries by email, if you request an in-person consultation during office hours, the Principal Investigator must be present with the applicant.

Office Hours Application Form

Please apply using the link in the right column.

(Previous application documents have been removed due to the transition to a web-based system. Required forms will be posted as they become available.)

Manual for the Type 2 Use of Genetically Modified Organisms at the Research and Development Stage (Ministry of Education, Culture, Sports, Science and Technology)

Export Form - 12

Information Provision Form

Sample Information Provision Form

P2 Level Sign

[Regulation] School of Medicine Safety Management Regulations for Gene Recombination Experiments

Initiatives for Bioethics and Safety (Ministry of Education, Culture, Sports, Science and Technology)

[Legal Explanation] Overview of Gene Recombination Experiments

[Legal Explanation] About the Cartagena Protocol (Ministry of Foreign Affairs)

[Checklist] Checklist for Containment Measures (Ministry of Education, Culture, Sports, Science and Technology)

[Emergency Response to Needlestick Injuries, etc.] Response to Needlestick Injuries and Animal Bites (Pathogen Safety Committee)

[Health Checkups]

Individuals affiliated with designated laboratories are required to undergo health checkups twice a year, while those not affiliated with designated laboratories are required to undergo a health checkup once a year. For details, please see the University Health Service Center website.

(Health Service Center)

Review Application System for Animal Experiments, Genetically Modified Organisms, and Pathogens

The web-based system for review applications for the handling of pathogens and other materials is now available.

https://keio2.bvits.com/agv/

*For explanatory materials, operation guides, and various manuals, please refer to "Announcements" in the main menu.

*keio.jp authentication is required.

The English name for the Keio University University School of Medicine Pathogen Safety Committee is as follows:

Pathogen Safety Committee, Keio University School of Medicine

2025 Safety Training by the Pathogen Safety Management Committee. All personnel who handle pathogens must complete the training course designated by the Keio University University School of Medicine Pathogen Safety Management Committee (an e-learning program by eAPRIN consisting of nine modules) once every four fiscal years before beginning experiments. (*Authentication with your keio.jp ID is required.)

Available Courses: Keio University Researcher Course (School of Medicine "Safety in Research") 2025 / Keio Researchers Course (School of Medicine, BIO Course) 2025

Please refer to the following link and, after completing all nine modules, register your completion number on the Course Completion Report Form. Please note that individuals without a keio.jp account (i.e., those from external institutions) who wish to take the course must contact the Biosafety Office (med-biosafety@adst.keio.ac.jp) in advance.

Notification Form for Handling Pathogens (Levels 1 and 2) → Moved to the web system (link)

Notification Form for Handling Pathogens (Level 3)

Notification Form for the Transfer of Pathogens (Levels 1 and 2) → Moved to the web system (link)

Notification Form for the Transfer of Pathogens (Level 3)

Notification Form for Laboratory and Manager (Notification for Laboratory and Manager)

Notification Form for Continuation of Experiments with Pathogens, etc. (Continuation Notification)

This has been migrated to the web system (link).

Termination Notification Form for Laboratory and Manager (Termination Notification for Laboratory and Manager)

Incident Report Form (Incident Report)

Biohazard Sign

[Regulations] School of Medicine Regulations for Safety Management of Pathogens, etc.

BSL Classification for Pathogens, etc.

Emergency Response Procedures for Pathogens, etc. (Designated Laboratories)

Emergency Response Procedures for Pathogens, etc. (BSL-2 Laboratories Handling Specified Pathogens)

Emergency Response Procedures for Pathogens and Other Materials (General BSL-2 Laboratories)

[Regulations] School of MedicineBiosafety Steering Committee Regulations

[Regulations] School of MedicinePathogen Safety Management Committee Regulations

[Transport of Pathogens] Transport Methods

[Transport of Pathogens] Hazard Labels (Actual Size)

[Health Checkup] Members of designated laboratories are required to undergo a health checkup twice a year, while all other members are required to undergo one once a year. For details, please refer to the University Health Center website (link).

This is an instructional video from the Specimen and Information Utilization Review Committee. Please watch this if you are conducting:

1) research using hospital medical records, or

2) research using specimens and information from the PIRMS Biobank.

The Keio Biobank website can be found here.

Request Form for Registration as a Data Use Manager for the Research DWH

Research DWH Training Video

This video is mandatory for anyone who wishes to register as a Research DWH Data Usage Manager.