"Researchers" here refers to all individuals involved in research, including faculty members, undergraduate students, graduate students, and research students engaged in research activities at the University, as well as joint researchers conducting research activities at the University.
However, for research that a graduate or undergraduate student intends to conduct, the content must be thoroughly reviewed by a faculty member from our university who will be supervising the student and approval must be obtained before an application can be made.
In principle, ethical review must be conducted in advance. Be sure to apply for it before starting the research or making any changes to the plan.
1. About the Ethics Training Seminar
Prior to conducting research, researchers at our university must receive education and training on research ethics and the knowledge and skills necessary to conduct said research (Article 11 of the Research Ethics Regulations).
We will inform you about this training closer to the date. (In principle, it will take about 90 minutes during the day on weekdays.)
2. Ethical guidelines and related university regulations
Our university has established relevant university regulations based on the "Ethical Guidelines for Life Science and Medical Research Involving Human Subjects" (Notice No. 1 of the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labor and Welfare, and the Ministry of Economy, Trade and Industry of 2021) and guidance, and conducts research ethics reviews.
- Ethical Guidelines for Life Science and Medical Research Involving Human Subjects (Main Text)
- Ethical Guidance for Life Science and Medical Research Involving Human Subjects
- Research Ethics Guidelines
- Research Ethics Committee Regulations
- Research Ethics Committee Regulations
- Research Ethics Guidelines
- Ethical Guidelines for Student Research
- Agreement on ethical review for research involving students
3. Research ethics review
Prior to the research, you will be required to submit the specified application documents for ethical review (the attached form and checklist in the Hokkaido Bunkyo University Research Ethics Guidelines).
After submission, we will conduct an examination as follows (1) or (2) depending on the content of the application, and notify the individual of the result at a later date.
The Research Ethics Review Committee will review the application documents and decide whether to conduct a "written review" or an "in-person review."
① "Document Review": A review of documents by several committee members.
There is no deadline for submitting your application; you can submit it at any time.
*The review period will take approximately one month after the application documents are accepted. Depending on the results of the review, the review period may be extended further if documents need to be revised or additional documents need to be submitted.
Criteria for "document review"
- Review of research conducted in collaboration with another research institution, where the entire research has already been reviewed by the ethical review committee of the collaborating research institution and an opinion has been obtained stating that the research is appropriate.
- Review of minor changes to the research plan of a reviewed study
- Review of non-invasive and non-interventional research
- Review of studies involving minor invasion and no intervention
The Research Ethics Committee will consult with the researcher on the fourth Wednesday of each month, and application documents must be submitted by the second Wednesday of the same month in order to be consulted by the committee. After submitting the application documents, you will be required to attend a Research Ethics Committee meeting to give an overview of the application and answer questions from the committee members.
After the in-person review, depending on the review results, you may be required to revise or add documents. Regardless of whether the review method is "document review" or "in-person review," depending on the review results, it may take a considerable amount of time for approval, so please submit your application with sufficient time in advance.
4. About the "Overall flow" and each "Form" of the application
- Overall process from application for research ethics review to the end of research
- Research Ethics Guidelines Form
- Research Ethics Review Application Form (Appendix Form 1) [MS-Word format] (19.5KB)...Necessary when consulting with a new research ethics committee
- Checklist for research ethics review application (submission required) [MS-Word format] (24.0KB)...Necessary when consulting with a new research ethics committee
- Research Completion Report (Information Management Status Report) (Attachment Form 2) [MS-Word format] (18.8KB)
- Report on the provision of samples and information to other research institutions "To the President of our University" (Attachment Form 3) [MS-Word format] (20.0KB)
- Report on the provision of samples and information to other research institutions "To the head of the receiving research institution" (Appendix Form 4) [MS-Word format] (19.2KB)
- Record of provision of samples and information from other research institutes (Appendix Form 5) [MS-Word format] (19.4KB)
- Power of Attorney (Appendix Form 6) [MS-Word format] (18.8KB)
- Appeal form for research ethics review results (Appendix Form 7) [MS-Word format] (18.7KB)