Ethical Aspects

Ethical Aspects

The management of personal information in each medical institution strictly complies with the related personal information protection laws and guidelines for safe management of medical information systems.

Epidemiological research and clinical research are developed in accordance with the ethical guidelines for epidemiological studies and clinical studies respectively, in which research content has received approval by the Ethical Review Board of each medical institution.

As for genetic research, the procedure of obtaining informed consent, consideration for the contributor, handling of samples, protection of personal information and consideration for each patient are carried out in accordance with human genome and genetic analysis ethical guidelines, and has been examined and received approval from the Ethical Review Board of each medical institution.

The environment where correlation analysis of genetic information and clinical information is being carried out is limited to the main research institution (Kyushu University). Therefore, further stringent safety control measures in protecting information are provided.

FSR protects personal information by making it anonymous. In case there is any personally identifiable information in prospective study, FSR will provide strict control in order to protect it.

Information security

Security measures for stroke database information system: Academic Section, Research Institute for Information Technology of Kyushu University in collaboration with NTT Data Corporation has completed the database system and it is being monitored to ensure the highest level of information security in network communications and data storage facilities.
The consenting samples are stored under strict control. When a consenting donor requests us for the contributed samples to be destroyed, the samples will be disposed according to the sample disposal regulations.

Personal information protection

In prospective study, all information about consenting patients such as medical records, prognostic investigation and blood samples (plasma, DNA etc.,) are made into linkable anonymous information. In this study, name, address and contact number are deleted from the samples and each sample will be given a code so that it is unrecognizable by anyone but the personal information administrator, and the information and samples are made into database under stringent control. The reference tables that link the codes to the patients are strictly controlled by personal information administrator of Department of Medical Informatics, Kyushu University Hospital.

By this way, even the researcher in charge will not be able to recognize the DNA owner in a genetic analysis. However, if there is a need to explain the analysis results to the patient (DNA owner), whenever it is necessary, personal information administrator of Department of Medical Informatics, Kyushu University Hospital will return the code to the original information (such as name etc.,) to allow related patients to be tracked and informed of the results.

In addition, due to postings or audits of clinical data, the medical records may be viewed by a third party, such as Clinical Research Coordinator (CRC) who supports the research. In this case, the third party is bound to the confidentiality agreement to protect patients’ personal information. On prognosis survey to check on the patients’ health condition after discharge, the researcher in charge in the medical institution where the patient was admitted may use the patient’s name, address and telephone number to contact the patient by telephone or mail or may send the informed consent form to the family doctor to get detailed clinical information.

In this study, the management of data analysis, blood tests, DNA extracts from blood and its analysis, and other related items, may be outsourced to external parties. However, the information has already been changed to anonymized information at the point of job assignment and provisions are made to secure the contract with the consignees so that patients do not have to worry about personal information leakages to a third party.

We seek for your consent and cooperation upon hearing our full explanation on this matter.