The Databank project covers all the patients who are examined at Osaka University Hospital.

All patients who are examined at Osaka University Hospital will be given an explanation and a consent form, and their cooperation will be requested either at outpatient visits or upon hospitalization so that patient medical information can be used in a wide range of medical research as well as the development and commercialization of pharmaceuticals, medical devices, and other products. Patients should read the explanation and consent form carefully and decide on their own whether or not to consent.

Medical information subject to be used in the Databank

This includes all medical information that was collected from the patient in the past and will be collected in the future. Specifically, this includes examination histories, contents of electronic medical charts (including medical records that were input in audio form by the medical practitioner), tests, image diagnosis, prescriptions, information about payments for medical services (receipt information and diagnosis procedure combination (DPC) information).

How data in the Databank will be accessed

Proposals for R&D related to collected medical information will be accepted from both within and outside of Osaka University Hospital. In such cases, based on applicable regulatory guidelines, access for data will be permitted following the required procedures including examinations by the Data Access Review Committee or the Ethics Review Committee. When providing information to other universities, corporations, or other outside entities, we will check the systems and other matters at the receiving entity, conclude an agreement, and take other suitable steps to construct an Osaka University Hospital control system and protect patient information. Medical information shall be used under these strong controls of information, ethics, technical evaluations, and other matters. Regarding the current conditions of use and related matters, refer to the following pages: Application Review Results, Records for data access, Current Status of Research Presentations,

Steps to protect patients information when data is provided

When providing data access to an external entity, maximum consideration shall be given to prevent individuals from being identified. Because the research will be conducted with strict protection of privacy, the possibility that the patient would suffer disadvantage due to leakage of personal information is extremely small. In case that occur, we promise to respond with all sincerity.

Observing the Act on the Protection of Personal Information Held by Incorporated Administrative Agencies and other laws

Patient medical information that is collected, managed, and used based on the Osaka University Hospital Databank Project shall be handled appropriately in accordance with the Act on the Protection of Personal Information Held by Incorporated Administrative Agencies, etc., as well as with Ethical Guidelines for Medical and Health Research Involving Human Subjects, and other regulations. Even if the patient does not consent to this project, the patient’s medical information may still be used in accordance with laws and regulations.

Brochures and consent forms

The explanation and consent form will be delivered to patients at the time of outpatient visits or upon hospitalization. Patients should read this form carefully, and if they consent should enter the name and date on the back of the explanation and consent form and hand it to the person in charge (outpatient: medical staff, hospitalization: attending physician, nurse, etc.).

We have also prepared explanation and assent (understanding and consent) forms appropriate for the age and level of understanding of pediatric patients.

When pediatric patients reach 16 years of age, their consent will be reconfirmed using the adult explanation and consent form. If a pediatric patient is not examined at this hospital after reaching the age of 16 and consent cannot be confirmed, the collected medical information from before the age of 16 will be used based on past assent.

For underage patients and patients where confirming consent is difficult, the legal representative or guardian* will be asked to sign the forms.

* Legal representative or guardian refers to the patient’s spouse, parent, sibling, child or grandchild, grandparent, or cohabiting relative or person considered equivalent to a close relative (excluding minors), or the patient’s legal representative (including a voluntarily appointed guardian who is granted proxy authority), or other person considered able to represent the intentions and interests of the patient.

If the person suffers vision impairment or hand disability, or is unable to sign for other reason, the family or caregiver shall sign on his or her behalf after first confirming the individual’s intentions.

Procedure when withdrawing consent for this research

Once given, consent for this research may be withdrawn at any time.

Complete this withdrawal form and submit it upon visiting the hospital. Persons who do not have plans to visit the hospital can be accommodated by telephone (+81-70‐2904‐2150) or email (databank@hp-aim.med.osaka-u.ac.jp). Even if consent is withdrawn, past results and presented materials which utilized this information cannot be erased, however the patient’s medical information will not be used after consent is withdrawn.