project_outline

Project Outline

FSR is composed of 2 types of stroke registry:

1. Retrospective database for clinical and epidemiologic study

Medical records of acute stroke patients which were stored in each medical facility are processed into unlinkable anonymized information database. Under the supervision of personal information manager in each health care institution, personal information is completely removed by the personal information staff to develop an unlinkable, anonymized medical database. They do not include investigation of prognosis, collection of samples and genomic examination and are managed as an integrated joint database which is used for retrospective study alone. The integrated electronic files are utilized as an unlinkable, anonymized database in clinical research.

2. Prospective registry of cases with informed consent

Only information on consenting patients will be collected as linkable anonymized cases by the personal information staff under the supervision of each health care institution’s personal information administrator. Linkable anonymized medical records, prognostic information, plasma and DNA samples of stroke patients within 7 days of onset are organized into the prospective database. This linkable anonymized stroke registry is used for prospective research and it is strictly controlled in accordance with the “Guidelines for the Safe Management of Medical Information Systems”.

On a priority basis, plasma is taken from the rest of blood sample required for a medical examination during hospitalization, only from patients whose informed consent has been obtained. If there is no surplus blood sample, we will ask for patients’ cooperation to contribute minimal blood samples necessary for study.

DNA collection can only be done upon obtaining informed consent from the patient. To relief invasiveness, the blood samples are taken during blood collection in a medical examination. All blood samples are made into linkable anonymized information by the personal information staff under the supervision of personal information administrator in each medical institution. Then, as necessary, the plasma samples will be transferred into multiple tubes by the researchers, and kept frozen. These samples are stored in the deep freezer for future use in genomic and proteomic research. They are kept in a locked room which can not be accessible without PIN at the Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University.

For patients who have granted informed consent in prognostic survey, they will receive telephone calls and letters on a regular basis from the Secretariat to confirm their health conditions. In case of adverse events, we will obtain detailed clinical information from the doctor in charge when possible. This information will be integrated into the stroke database and will be utilized for clinical research.

Clinical Research Coordinator (CRC)

When consent is obtained from patients, clinical research coordinator (CRC) will support the research. CRC are research staff of Hisayama Research Institute for Lifestyle Diseases (HisayamaLIFE) who are bound to confidentiality agreements with each medical facility and are fully aware of the personal information protection.

Anonymity

Some or all personally identifiable information are removed from personal information and substituted with codes or numbers unrelated to the person instead.

Informed consent

In epidemiological studies,

The person who was asked to become a research subject, upon receiving a full explanation on the epidemiological research from the researcher beforehand, understands the significance of epidemiological studies, objectives, methods, and the anticipated results or disadvantage, grants consent based on free will to become a research subject and matters related to material handling etc., in the research.

In clinical studies,

The person who was asked to become a research subject, upon receiving a full explanation on clinical research from the researcher beforehand, understands the significance of the clinical studies, objectives, and methods, grants consent based on free will to become a clinical-trial subject and matters related to sample handling etc., in the research.

In human genome research and genetic analysis,

The person who was asked to donate research samples, upon receiving a full explanation on the genome research and genetic analysis from the research director beforehand, understands the significance of the studies, objectives, methods, and the anticipated results or disadvantage, grants consent based on free will to become a clinical-trial subject and matters related to sample handling etc., in the research. Consent shall be obtained after handing the related guide book and giving a full explanation to the patient.

FSR offers a full explanation in the “Fukuoka Stroke Registry Research Cooperation Request Book”. Those who agree to participate on voluntary basis shall sign the “Consent Form for Fukuoka Stroke Registry Research” document.