COI Policy and Disclosure Slides

Disclosure of Conflict of Interest (COI)

The Japanese Society of Kawasaki Disease requires disclosure of any conflict of interest (COI) related to the research presented in an academic conference.
Disclosure is required in the following cases:

  1. If the total amount received for industry–academia collaboration activities is 2 million yen or more per company per year (before deducting indirect costs received by your institution).
  2. If personal income from consulting, advising, lectures, writing, or salary is 1 million yen or more per company per year (before deducting taxes or withholding tax).
  3. If personal income related to industry–academia collaboration (whether public or private, such as acquiring, holding, or selling shares/stock in that company, receiving stock options, director's fees, patent royalties, etc.) , is 1 million yen or more per company per year.
     (Excluding cases where funds are managed through investment trusts or diversified funds that are not controlled by the individual.)
  4. If a first-degree relative is currently employed by a company that meets any of the above conditions (1–3).
  • For personal income, the disclosure period is from January 1 to December 31 of the previous year.
    However, for research funded by donations or commissioned by companies, the period April 1 of the previous year to March 31 of the current year may also be used.
  • If the first author or a co-author of the research meets any of the above conditions (1–4), please select "There is a conflict of interest" when registering the abstract.　
    Please note that we may contact you regarding this matter later.
  • For questions regarding COI, please contact the Secretariat of the Japanese Society of Kawasaki Disease.

Rules and regulations

Ethical Guidelines for Abstract Presentation

Research in the fields of life sciences and medicine presented at the General Assembly and Academic Conference of the Japanese Society for Kawasaki Disease (the Society) must follow the Declaration of Helsinki, the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects, the Guidelines for Clinical Research on Gene Therapy, and other relevant ethical guidelines, as well as applicable laws such as the Act on the Safety of Regenerative Medicine and the Clinical Trials Act.

  1. Guidelines on Protection of Personal Information
  1. Do not include names, initials, or patient IDs that can identify individual patients.
  2. Do not include patient addresses. However, if location is relevant to the clinical condition, you may describe it as a region (such as prefecture or city).
  3. Dates in medical history should be limited to the year and month when necessary. Whenever possible, use expressions such as “day XX of illness.”
  4. Do not include department names if they could lead to patient identification.
  5. When referring to other institutions where the patient received care, the name and location of the institution should generally not be disclosed. If necessary for the presentation, ensure that patient identity is protected and obtain permission from the institution.
  6. When showing facial photographs, the eyes must be masked. If ocular findings are necessary for presenting the disease, use a close-up photograph showing only the area around the eyes so the entire face is not recognizable, or obtain the consent of the patient (or a legal representative). For details, refer to the "Guidelines for Handling Facial Photographs of Patients in Papers, Academic Meetings, and Study Groups: J Pediatr J 107:168-171, 2003.
  7. When presenting images or specimens (e.g., autopsy or biopsy), remove any personal information, including hospital ID number.
  8. If there is a possibility that the individual could be identified even after the above considerations, you must obtain consent for the presentation from the patient (or a legal representative) or obtain approval from the institutional ethics committee.

2. Guidelines for Research

  1. Case reports must ensure confidentiality and fully protect the dignity and human rights of the individuals involved. While decisions should be made in accordance with each institution’s rules, ethical review is required in the following cases:
    ① When there is a high possibility of identifying an individual
    ② When interventions or invasive procedures are conducted for research purposes
  2. Research involving clinical cases or specimens taken from the human body requires approval from the ethics committee at each institution. Furthermore, informed consent must be obtained from participants (or their representatives), unless it meets criteria for “simplified informed consent procedures” as defined in Japan’s administrative ethical guidelines.
    For pediatric participants, you must also make efforts to properly obtain informed assent. However, the details of decisions are left to the judgment of each institution’s ethics committee.

Additionally, all basic research (e.g., epidemiological studies, human cell research, and animal experiments) must comply with applicable laws, guidelines, and rules of each institution.

Supplementary Provisions

• These ethical guidelines came into effect on November 23, 2022.
• Partially revised on March 4, 2024.

References

  1. Japan Medical Association: Declaration of Helsinki
  2. Personal Information Protection Commission: Act on the Protection of Personal Information
  3. Ministry of Health, Labour and Welfare: Ethical guidelines for research
  4. Ministry of Health, Labour and Welfare: Regenerative medicine
  5. Ministry of Health, Labour and Welfare: Clinical Trials Act
  6. Ministry of Education, Culture, Sports, Science and Technology: Bioethics in life sciences
  7. Ministry of Education, Culture, Sports, Science and Technology: Safety in life sciences
  8. Ministry of Health, Labour and Welfare: Advanced and unapproved medical technologies
  9. Ministry of Health, Labour and Welfare: Guidelines on handling personal information
  10. Japanese Pediatric Society: Guidelines on the use of patient photographs in publications, academic meetings, and study groups: Journal of the Japan Pediatric Society, 2003, Vol. 107, pp. 168-171
  11. Japan Medical Association Ethics Committee: Ethical procedures for abstract submission to Academic Meetings, March 30, 2023