Policy Concerning Protection of Personal Information
Researchers and research support staff members pursuing the research and investigation activities of the study set forth in any of the following 3 study protocols (hereinafter collectively referred to as the “Study”) hereby formulate the following policy concerning the handling of Study subjects’ personal information applied to the Study and will put forth every effort to protect such information. Personal information refers to personal information as defined in the Protection of Personal Information Law (Law No. 57 of May 30, 2003).
- Study Protocol “CIDP Registry (Neuroimmunological Disease Registry [RADDAR‑J[79]])”
- Study Protocol “Neuromyelitis Optica Spectrum Disorder (NMOSD) Registry (Neuroimmunological Disease Registry [RADDAR‑J[79]])”
- Study Protocol “Clinical Study on Efgartigimod Treatment of CIDP Study subjects enrolled in the Neuroimmunological Disease Registry [RADDAR‑J[79‑1‑2]]”
1. Characteristics‑based maintenance of Personal Information
Clinical information, biological samples, test results derived therefrom, and genomic information provided by Study subjects will be maintained separately according to the characteristics of personal information.
(1) Clinical Information, Biological Samples, and Genomic Information
Clinical information, biological samples, and genomic information will not include personally identifiable information such as names or telephone numbers. Upon storage of data, a newly assigned code (hereinafter referred to as the “Study subject ID”) will be used instead. Any items of information provided by Study subjects, excluding directly identifiable information, can be linked through this ID as having been provided by one and the same individual; however, even if a Study subject ID were to be disclosed to the third party, it would be impossible to identify the individual from the information alone.
(2) Personal Information
Personally identifiable information such as names and telephone numbers will be encrypted upon storage and further distributed across multiple storage locations. Therefore, even in the unlikely event that storage device is stolen or any unauthorized access to servers occurs, the information which enables identifying individual cannot be extracted.
In addition, as part of the process to verify whether a Study subject has already been enrolled, those items of information such as names will be consolidated and matched within the personal information management system of the Rare Disease Platform. However, this process will not result in the disclosure of Study subjects’ names or other personal information to outside parties.
2. Purposes of Use of Clinical Information, Biological Samples, and Genomic Information
Researchers and research support staff members engaged in the research and investigation activities of the study will use the acquired clinical information, biological samples, and genomic information for the following purposes or within the scope necessary to achieve such purposes. If any change in the purpose of use becomes necessary, Study subjects will be notified or the change will be published.
(1) Advancement and Acceleration of Research into Rare Disease
By collecting and sharing clinical information and genomic information from a greater number of Study subjects with the same or similar symptoms among healthcare professionals and researchers, understanding of disease causes and symptoms that were previously unknown may improve, potentially leading to the development of new treatments and medications and to the projection of future symptoms.
Furthermore, research using new analytical methods or aimed at identifying new factors may very well require the collection of biological samples. By collecting and storing biological samples in advance from a large and diverse group of Study subjects, research can be initiated immediately once it is planned.
(2) Provision of Medical Care Suitable for the Japanese Population
A nationwide system for collecting Japanese Study subject data is necessary to clarify factors unique to Japanese individuals related to neuroimmunological diseases. Through the research and investigation activities of the study, a broad range of Japanese data will be collected and shared among healthcare professionals and researchers. Comparisons with overseas data may contribute to the provision of medical care better suited to Japanese Study subjects.
(3) Increased Opportunities to Participate in Clinical Trials
Research into treatments tailored to neuroimmunological diseases and individual constitutions is progressing worldwide. By enrolling in the research and investigation activities of the Study, Study subjects will have increased opportunities to participate in the development of treatments suited to them.
(4) Access to the Latest Disease Information
The research and investigation activities of the study are conducted by experts in neuroimmunological diseases. As the latest information concerning neuroimmunological diseases is gathered from both domestic and international sources, enrollment and participation in the research and investigation activities of the Study will make it easier for Study subjects to gain state-of-art information from medical institutions and other sources. Study subjects will also have increased opportunities to connect with other Study subjects.
(5) Health Management Through More Detailed Follow-Up
Once a year, attending physicians or staff members of the registry’s administrative hub may inquire about Study subjects’ health conditions, and Study subjects may be asked to visit medical organizations for blood collection and examinations. This will contribute to more detailed follow-up observation and management of Study subjects’ health conditions.
3. Provision to Third Parties, Outsourcing, and Joint Use of Acquired Clinical Information, Biological Samples, and Genomic Information
(1) Use for Research Purposes
(i) Sharing with Other Research Institutions
Study subjects’ clinical information may be shared with other research institutions, including those overseas (such as university research institutions and companies engaging in commercial use; hereinafter referred to as “Secondary Use Institutions”). Biological samples managed by Study subject ID may also be provided to Secondary Use Institutions.
When sharing Study subjects’ clinical information, biological samples, or genomic information with Secondary Use Institutions, the Registry Review Committee (note: a committee established within the Japanese Society for Neuroimmunology; to prescribe the registry under the supervision of the Society and engage in long-term longitudinal collection of data, with a view to improve the long term prognosis of patients by accelerating the development of most suitable therapy and innovative medication; the committee assumes the role of the registry’s operating committee set forth in the Study Protocols; the members of the committee are posted on the website of the Society) and disease-specific working groups (note: medical experts specializing in each disease field comprise the members of each working group; as part of its activities the working group reviews into whether the proposed study plans are ethically, medically and scientifically appropriate; as of June, 2026, CIDP Registry Working Group and NMO Registry Working Group have been put in place and are operational; the members of each Working Group are posted on the website of the Society) review into the study plans proposed by Secondary Use Institutions to see whether the study plans are scientifically and ethically appropriate, do not disadvantage Study subjects, and comply with ethical guidelines for medical study involving human subjects. Only those Secondary Use Institutions which are approved through this review process will be permitted to use Study subjects’ clinical information, biological samples, and genomic information, either free of charge or for charge. Secondary Use Institutions are prohibited from using such information or samples beyond the approved scope.
(ii) Sharing with the Rare Disease Platform
The Rare Disease Platform is one of the research initiatives of the Japan Agency for Medical Research and Development (AMED), aimed at promoting rare disease studies conducted in Japan by consolidating information derived from clinical information, biological samples, and genomic information collected through various rare disease studies.
The research and investigation activities of the Study are linked with the Rare Disease Platform, and the information derived from Study subjects’ clinical information, biological samples, and genomic information maintained along Study subject ID will ultimately be shared with the Rare Disease Platform together with the information from study subjects participating in other rare disease registry studies.
Furthermore, the information derived from Study subjects’ clinical information and biological samples shared with the Rare Disease Platform may also be provided to research institutions other than the Rare Disease Platform. In such cases where the information is provided to Secondary Use Institutions, the Registry Review Committee, the disease-specific Working Groups will review into, and the Steering Committee of the Rare Disease Platform will further review into whether the proposed research plans of the Secondary Use Institutions are scientifically and ethically appropriate, do not disadvantage Study subjects, and comply with ethical guidelines for medical research involving human subjects. Only those approved Secondary Use Institutions will be permitted to use such information, either free of charge or for charge, and they are prohibited from using the information beyond the approved scope.
In relation to items (i) and (ii) above, if more detailed Study subject information becomes necessary for study purposes, Study subjects may be contacted through the registry’s administration hub. However, Secondary Use Institutions will neither contact Study subjects directly nor obtain information capable of identifying Study subjects.
(2) Possible Registration with Open and Public Databases
In the future, information completely anonymized so that it cannot be identified as referring to any Study subject may very well be registered with open and public databases. This is because sharing and comparing as much study subjects’ data as possible domestically and internationally is expected to progress rare disease studies.
An open and public database is a repository that aggregates study subjects’ clinical and genomic information for sharing among many researchers. None of the individuals who are Study subjects can be identified from such databases.
(3) Academic Publications
Results obtained through the research and investigation activities of the Study may be published in domestic and international academic symposia, journals, databases, and other media. Such publications will be made in the manner that prevents identification of Study subjects.
(4) Outsourcing
Researchers and research support staff members engaged in the research and investigation activities of the Study may outsource all or part of the handling of personal information to outside contractors within the scope necessary to achieve the purposes of use. In such cases, the fitness of the contractors will be thoroughly examined into, and contract provisions regarding confidentiality and related matters will be set forth to ensure there be ways of properly managing the information.
4. Disclosure, Correction, and Suspension of Use of Personal Information
- If a Study subject requests disclosure of its own personal information pursuant to the Protection of Personal Information Law, researchers and research support staff members engaged in the research and investigation activities of the Study will, after confirming that the request is made by the genuine Study subject, disclose the requested personal information without delay, but only where such disclosure is required under the Law.
Certain fees for disclosure may be charged in accordance with procedures separately prescribed in connection with the research and investigation activities of the Study. - If a Study subject requests correction of personal information on the grounds that the information is inaccurate, or requests suspension of use on the grounds that the information has been handled beyond the scope of the publicly announced purposes of use or obtained through fraudulent or otherwise improper means, researchers and research support staff members will, after confirming that the request is made by the genuine Study subject, conduct the necessary investigation without delay and, based on the results yielded, correct the content or suspend the use of the personal information and notify the Study subject accordingly.
- If a Study subject requests deletion of its personal information, researchers and research support staff members will, after confirming that the request is made by the genuine Study subject and determining that compliance with the request is necessary, delete the personal information without delay and notify the Study subject accordingly.
- When making requests under items (1) through (3) above, Study subjects are requested to submit the following information and other information and materials prescribed in connection with the research and investigation activities of the Study:
- Name, address, telephone number, and email address
- Details of the request, background, and supporting materials
- Identity verification documents
- Requests made pursuant to items (1) and (2) above may not necessarily be accommodated in the requests fall under any of the following. In such event, the Study subject will be notified accordingly and provided with the reasons.
- Where there is a risk of harm to the life, body, property, or other rights and interests of the Study subject or a third party
- Where there is a risk of significant interference with the proper conduct of this entity’s operations
- Where compliance would violate the applicable laws or regulations
- Where it cannot be confirmed that the request was made by the genuine Study subject
5. Contact Information
To pose opinions, questions, other inquiries regarding this Policy or to raise any other matters involving the handling of personal information, and to bring up requests pursuant to Clause 4 above, please contact the following:
Contact for Personal Information Inquiries
Office Space 302, Chiba University Inohana Innovation Plaza
Chiba University Inohana Campus
1–8–15 Inohana, Chuo-ku, Chiba-shi, Chiba 260–0856, JAPAN
kizuna, a general incorporated association
Person responsible fo personal nformation protection matters: Yukihisa Hotta
dataprivacy@kizunaai.org
6. Revisions
If this Policy is revised, the date and details of the revision will be promptly posted on the website of the research and investigation activities of the Study.
