Q1. What is a cohort study?
A. A cohort study examines lifestyle (smoking, alcohol consumption, dietary habits, etc.), environment, and physical state (e.g., check-up results and laboratory data) over a prolonged period of time. Such studies reveal the association between health status and the development of illness.
*Cohort is a term that originally referred to a unit of soldiers in the Roman army. In medical research, a cohort refers to a group of research subjects that are followed for a certain period of time.
Q2. What is the purpose of the cohort study of local residents?
A. The purpose of the cohort study of local residents by Iwate Tohoku Medical Megabank Project is to assess mental and physical health following the Great East Japan Earthquake and Tsunami of March 2011 by investigating the association between stress brought on by the disaster and onset of lifestyle-related diseases (e.g., stroke and cardiovascular diseases), psychiatric disorders (e.g., depression, anxiety, and posttraumatic stress disorders), cancer, and allergic conditions.
The health assessment facilitates early detection and treatment of disease. The study will be used for the development of preventive and medical care tailored to individuals on the basis of health information, medical records, and biological samples.
Q3. Why is genetic analysis necessary?
A. Lifestyle-related diseases (e.g., stroke and cardiovascular disease), psychiatric disorders, cancer, and allergic conditions occur as a result of both an individual’s lifestyle (factors related to living conditions), as well as genetic factors inherited from parents. Examination of the relationship between genetic factors and lifestyle leads to prevention and treatment of various diseases. This is known as “personalized prevention and medicine.”
Q4. What will we learn from this Project?
A. Those who participate in this Project will be given more detailed health check-up results than usual, which may help modify lifestyles and prevent disease (e.g., stroke and cardiovascular disease), stress, cancer, and allergic conditions.
Typically, medical treatment only begins when a person is sick or showing symptoms. However, some diseases may be prevented (prophylaxis) based on individual susceptibility (presymptomatic diagnosis) and lifestyle. In addition, adverse effects to medication may be predicted based on the genetic analysis.
Q5. What is the overall purpose of the cohort study?
A. Analysis of the relationship between genetic factors and lifestyle will help to develop “personalized prevention and medicine.”
Q6. What can I do?
A. There are two major parts to this Project: the “annual check-up” and “follow-up.” In the annual check-up, you will be asked to provide blood and urine samples, as well as to fill out surveys on your lifestyle and medical history. During follow-ups, your medical record will be checked in association with local hospitals. Your current address or disease status will also be filed.
*With proper and strict protection, the following items are subject to survey:
- Health and medical questionnaires
- Local hospital records
- Bills/invoices for medical care
*In case of a change of address (outside the municipality, prefecture, etc.) or death, your information will be verified by checking basic resident registration records at a local government office or by death certificate. An individual’s death certificate (a public document describing the name of the deceased, date of death, and cause of death) will, with the approval of the Ministry of Health, Labour, and Welfare, be checked by a public health center.
Q7. Can I discontinue participation at any time?
A. Participation in this study is completely voluntary, so you can discontinue participation in the study at any time. Refusal to participate or withdrawal from the study will not result in any penalty or loss of benefit to which the participant is otherwise entitled. If you wish to withdraw from the study, please contact the Iwate Medical Megabank Administration Office at Iwate Medical University.
Q8. Which test results will participants be notified of?
A. In addition to specific health check-up results, all participants will be given more detailed blood test results, calculation of nutrient intake, their risk factor for gastric cancer (via Helicobacter pylori testing), assessment of heart and kidney function, and mental health.
Q9. Will I know the results of my genetic analysis?
A. Currently, genetic analysis alone is not suitable for direct prediction of potential disease risk. Hence, you should be aware that the results of genetic analyses are unlikely to yield practical information for your health or treatment of most diseases. If you still wish to be notified of the results of genetic analyses, the Genomic Information Review Board for Notification will review your request based on the following four criteria:
The genetic information is precise and credible to the assessment of your health.
The genetic information provides important facts relating to your health.
Provision of information will not cause significant obstacles in the conduct of this Project.
Effective treatments can be applicable in accordance with genetic information.
Q10. How is my privacy protected?
A. Information obtained from your biological samples (blood and urine) is anonymized to all those potentially handling samples. In accordance with the Act on Protection of Personal Information, the Ethical Guidelines for Research on the Human Genome and Genes, and the Ethical Guidelines for Epidemiological Research, we will strive to protect your privacy using the best methods currently available.
Q11. What is anonymization?
A. Biological samples (blood and urine) and medical information you provide will be assigned a reference number from which the individual source cannot be identified. The reference number is used for data matching, but the identification number and individual personal information are fully disconnected. All data is under strict management and security.
Only restricted data handling personnel are allowed to access data after sufficient training regarding handling of personal information, including the Personal Information Protection Act and the National Ethics Guidelines for Research. Data-handling personnel are required to sign a nondisclosure agreement. In addition, the study will be overseen and controlled by researchers in each anonymization key.
Q12.What does “external organization” mean?
A. An “external organization” means a firm or institution conducting medical, pharmaceutical, or other research activities, such as universities or private companies. When researchers at external organizations request to use biological samples or medical information for their research, a proposal is reviewed by the Organizational Review for Sample Allocation and Information jointly set up by Iwate Medical University and Tohoku University. The board will assess whether their research is pertinent for the use of your valuable biological samples and data, and whether a system to sufficiently protect personal information has been instituted.
Q13. When consent is withdrawn, what happens to biological samples (blood and urine) that have already been collected?
A. Depending on how consent is withdrawn, sample manipulation will differ from the standard procedure. Consent may be withdrawn in one of the following ways:
- Discontinuation of contact
- Discontinuation of contact and follow-up
- Discontinuation of contact, follow-up, and the use of biological samples and medical information
*If discontinuation by steps 1 or 2 is requested, samples will still be used. If discontinuation by step 3 is requested, samples will be promptly discarded. Notification of sample elimination will be formally provided.
Q14. How are anonymized materials discarded?
A. Although biological samples (blood and urine) are anonymized, the link to individuals is still active, so withdrawn samples can still be selected. However, please be aware that disposal of samples may not be possible if the information has already been made available for Project use or if information has been allocated to outside organizations.
Q15. What are “incidental findings”?
A. Significant life-impacting information that is discovered unintentionally apart from the primary purposes of our research is known as “incidental findings.” These findings will be reviewed by an Organizational Review Board for Sample Allocation and Information.
Q16. What are “conflicts of interest”?
A. A “conflict of interest” occurs when a researcher receives financial benefit (research expenses, honorarium, etc.) from a private company or outside parties that could influence research activity. This may cause proprietary issues, cast suspicion on research quality and outcomes, and may affect their disclosures.
Research activities of the Medical Megabank are conducted with governmental funds. If funding is provided by private companies or outside parties in the future, funding will be checked by the Conflict of Interest Committee and disclosed on Iwate Tohoku Medical Megabank website.