Patient Information Sheet on the Storage of Specimens and Utilization in Future Research

Ver. 20151028

Explanation Document

In this document, we request your consent to donate specimens (specifically blood, urine, and parts of organs or tissues removed during surgery) and to allow us to store these specimens for use in various future medical research and education to achieve new medical advances. Once we have prepared the research protocol specifying the objectives of the research and education, and the methods for handling the stored specimens, it will be strictlyreviewed by the Ethical Review Committee and, only if it is approved, will we utilize your specimens.

Why we need to store and utilize your specimens

-Significant advances in medical analytical techniques have enabled more precise and detailed analysis of various components in specimens. While we already know about the factors that are shared by patients with the same disease, this analysis has shown that there are also many factors that differ among individual patients.

-Under these circumstances, research using new analytical techniques and identifying new disease factors is essential to realize future advances in various medical research and education so that previous advances do not go unheeded. However, once a research plan is formulated, a great deal of time and money is required to gather the required number of patient specimens. As a result, implementing the research itself can be a difficult task to achieve.

-Therefore, by collecting and storing specimens that have been donated in advance by a large and varied group of patients and healthy volunteers, we can immediately provide the necessary type and quantity of specimens when the research is planned. This approach would likely allow us to fast-track the application of our research results to practical health care settings.

-The storage of specimens at a dedicated facility (known as a biobank or repository) for this purpose is indispensable in today's global medical research, and systems have been developed to enable this storage. Given that many disease factors are unique to people of Japanese ethnicity, there is a need for such a system in Japan.

The specimens that we would like you to donate for future research and education are indicated by the checkedboxes below.

We will ask you to donate specimens in the following situations:

□1. Unused specimens that you have already donated for the purpose of medical care (tests and therapy) or other research

□2. Additional specimens of the same type that you have already provided in a biopsy or blood sampling for the purpose of medical care (tests and therapy)

Where applicable:

□Specimens to be donated and utilized for purposes other than medical care or specific research objectives

Type and quantity of specimens to be donated

The type and quantity of specimens that we will ask you to donate are described below.

□Organs and tissues (specific names: )

(In terms of quantity, we will ask you to donate part of any tissues collected during surgery, and 2 to 4 additional 1–2 mm segments of tissue for biopsy)

□Blood (in the event of additional blood sampling, we will ask you to provide approximately 10 ml when needed for routine medical care every 1 to 3 months during the treatment period to carefully prevent the occurrence of anemia, etc.)

□Urine (we will utilize 20–100 ml of each urine sample that you provide)

□Other ( )

Storage of specimens and protection of personal information

-Specimen storage will be conducted under appropriate conditions (e.g., protected from light at a suitable temperature and properly managed). While no time limit has been set for the storage of specimens, we will be storing them semi-permanently until all remaining specimens have been utilized or until they are no longer suitable for use due to deterioration caused by aging. In the latter case, the specimens will be disposed of in accordance with procedures and methods stipulated by Kyoto University Hospital.

-The specimens that you donate will be labeled with a code/number (specimen number) to facilitate their management. The donors and specimen numbers will be linked and managed using an anonymizing table. The anonymizing table will be strictlymanaged by the Personal Information Officer in accordance with the personal information protection policy stipulated by Kyoto University Hospital. No persons other than the specimen bank personnel will be permitted to access the anonymizing table, and the table itself will be not removed from Kyoto University.

-Moreover, the anonymizing table will only contain the specimen codes and numbers. Even in the event that the anonymizing table is disclosed, persons without authority to access Kyoto University Hospital's electronic medical records system are not able to access individual information (names and addresses or medical treatment and test histories and data, etc.).

-In research involving the use of specimens, we may require information on the specimens including the name of the disease, the date that the specimen was collected, and the donor's age, sex and treatment details. This information will be provided to researchers via the Personal Information Officer. In this case, any information (names and addresses) that could identify the donor will be anonymized before it is provided to the researchers.

Method of utilizing the specimens

-Before donated specimens can be utilized, the specific research or education methods must be determined and submitted in a research protocol to be approved by the Ethical Review Committee. The Ethical Review Committee includes members who do not belong to the organization to which the committee organizer belongs. It reviews the research protocol to determine its scientific and ethicalvalidity and whether its content adheres to ethical guidelines on medical research.

-Furthermore, specimens in the biological specimen bank and information related to these specimens cannot be utilized outside the scope of approval granted by the Ethical Review Committee.

-If more detailed information on the specimens (such as new or more detailed medical records) becomes necessary to conduct the research, this additional information will be provided to the researchers by the Personal Information Officer only when the approval is given via prescribed procedures.

-The specimens may also be utilized in collaborative research with Kyoto University in the form of analytical research conducted by external research organizations including private companies in Japan and overseas under the strict management of Kyoto University. This is because we often need to cooperate with external research organizations on current and future medical research.

-In these instances also, the utilization of specimens will be subject to the approval of the research protocol by the Ethical Review Committee. Moreover, the purpose of the research will be limited to the development of medical therapies and new drugs and basic medical research.

-Any specimens and information to be analyzed by external organizations will be anonymized so that the individual donors cannot be identified. Your personal information will not be provided to any parties outside the research institution.

-Future research in which the specimens may be utilized includes research to analyze human genome information (i.e., information on the structure and function of genes contained in the specimens), research to analyze proteins in the specimens, and research investigating the link between this information and clinical information (disease symptoms and test data, etc.).

-Analytical data obtained from research utilizing the specimens will be integrated into a single database so it may be further utilized in various research projects. However, as stated above, since this information will not be registered in a format that would enable individual donors to be identified, and only authorized personnel have an access to the database, donors’ privacy will be fully protected.

Informed Consent and Withdrawal of Consent

-The decision on whether or not to provide informed consent for the donation and utilization of specimens is voluntary. You can also withdraw your consent for the donation and utilization of specimens at any time. If you wish to withdraw your consent, please fill out the "Withdrawal of Consent Form" available on the website listed below and contact the help desk.

-Once you withdraw your consent, we will promptly process the withdrawal according to the following three options on the "Withdrawal of Consent Form". Please note, however, that data that have already been analyzed and study results that have already been reported cannot be canceled.

□ 1. I allow the future use of all specimens and information that have already been collected.

□ 2. I request the disposal of all specimens that have already been collected. However, I will allow the continued use of information that has already been collected.

□ 3. I request the disposal of all specimens that have already been collected, and I will not allow any future use of information that has been collected.Even if you do not provide informed consent for the donation of specimens or if you withdraw your consent, you will not be disadvantaged in any way in terms of your medical care.

Legally Acceptable Representative

-Minors and adults who are objectively considered unable to provide informed consent must have a legally acceptable representative such asa person with parental authoritywho provides consent on their behalf. However, individuals who are 16 years or older and who are considered to have sufficient judgment concerning the research to be conducted on donated specimens must make their own decision on whether to provide informed consent in addition to the consent of a legally acceptable representative.

Disclosure of Analytical Results

-Specimen analysis will be conducted as part of the research, so the significance and accuracy of the analyses will not be assured as in clinical tests. Therefore, as a general rule, the researchers will not disclose the data and results obtained from analysis of individual specimens to the donors.

-For a similar reason, any requests from donors for the disclosure of analytical data and results from their donated specimens will not in principle be granted.

Disclosure of Information

-Disclosure of information regarding the utilization of specimens will be provided via the Kyoto University Hospital website (

-When commencing the use of donated specimens for specific research and education, a summary of the research (theme, research period, name and affiliation of the principal investigator, etc.) will be promptly published on the website.

-Disclosure of information will also include who to contact with queries, the withdrawal of consent form, and a summary of any changes to the management of specimens, such as outsourcing to a specimen bank outside the University.

-Disclosure of information will be made via the website listed above, but any changes to this location will be published on the Ethical Review Committee's website.

-The results of research obtained from the utilization of donated specimens may be reported at academic conferences and in academic journals, but the format and method of this reporting will ensure that the identity of individual donors is concealed.

Possibility of Changes to Specimen Management

-We are planning to store the donated specimens on a semi-permanent basis, so there is a possibility of major changes to the storage location and the management policy and format, etc. in the future (i.e., transfer to an external organization or integration with an external research project, etc.). If this occurs, any changes to specimen management and operation, etc. will be subject to the review and approval bythe Ethical Review Committee before the relevant information is disclosed on the website. Even in this situation, you will still be able to withdraw your consent at any time.

Other Matters

-Donors will not receive any financial compensation or gratuity for donating specimens.

-Furthermore, donors will not have any ownership of patents or other intellectual property that may occur as a result of research using the specimens and information associated therewith.

Department Help Desk:

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Kyoto University Hospital Patient Information Sheet and Informed Consent Form

Storage of Specimens and Utilization in Future Research

Approved by the Medical Faculty Council on 9 April 2015 and the Kyoto University Graduate School and Faculty of Medicine, Ethics Committee on 28October 2015

Ver. 20151028

Consent Form (Patient’s Copy)

Consent Form for the Storage of Specimens and Utilization in Future Research

Director of Kyoto University Hospital

I have received and understood the explanation from the person listed below based on the "Patient Information Sheet on the Storage of Specimens and Utilization in Future Research", and I hereby voluntarily provide my informed consent for the following matters.

-That I will participate in medical research/education through the storage of my specimens and their utilization in future research

-That my specimens and the basic information associated therewith will be stored after being anonymized so that I cannot be identified as the donor

-That personal information and anonymization numbers in the Anonymizing Table will be strictlymanaged by the Personal Information Officer at Kyoto University

-That my specimens may also be utilized in collaborative research with Kyoto University in the form of analytical research conducted by external research organizations including private companies in Japan and overseas (and that if my specimens and information are utilized for analysis by an external organization, they will be anonymized and any information that could be used to identify me will not be provided to any parties outside Kyoto University)

-That the Anonymizing Table will not be removed from Kyoto University

-That the research will only be conducted once the specific research methods have been determined and subsequently approved by the Ethical Review Committee

-That the term "future research" may include genome/gene analysis research and protein research

-That the decision on whether to provide or withdraw informed consent is voluntary

-That regardless of my decision on whether to provide or withdraw informed consent, I will not be disadvantaged in any way in terms of my medical care

-That my individual analytical results will not be disclosed

-That the research results will be reported in a manner that prevents me from being identified

-That the disclosure of information on the specimen storage conditions and research will be provided via the Kyoto University Hospitalwebsite

-That I will not receive any compensation for the specimen donation

-That I will not own any intellectual property rights that may occuras a result of the research

Specimens to be donated (only checked items are applicable)

I will donate specimens in the following circumstances:

□1. Unused specimens that I have already donated for the purpose of medical care (tests and therapy) or other research

□2. Additional specimens of the same type that Ihave already provided in a biopsy or blood sampling for the purpose of medical care (tests and therapy)

Where applicable:

□Specimens to be donated and utilized for purposes other than medical care or specific research objectives

Type and quantity of specimens to be donated

□Organs and tissues (specific names: )

(In terms of quantity, part of any tissues collected during surgery, and 2 to 4 additional 1–2 mm segments of tissue for biopsy)

□Blood (in the event of additional blood sampling, approximately 10 ml will be collected when required for routine medical care every 1 to 3 months during the treatment period to carefully prevent the occurrence of anemia, etc.)

□Urine (20–100 ml of each provided urine sample)

□Other ( )

Date of informed consent (dd/mm/yyyy): / /

Patient's name (to be handwritten by patient):

If the consenting party is a legally acceptable representative: Name of patient:

Name of Legally Acceptable Representative (to be handwritten by representative):

Relationship to patient:

I explained the storage of specimens and their utilization in future research to the patient based on the Patient Information Sheet.

Date of explanation (dd/mm/yyyy):

Name and affiliation (handwritten) of person who provided the explanation:

* Please safely keep this copy of the Consent Form along with the Explanation Document.

Kyoto University Hospital Patient Information Sheet and Informed Consent Form

Storage of Specimens and Utilization in Future Research

Approved by the Medical Faculty Council on 9 April 2015 and the Kyoto University Graduate School and Faculty of Medicine, Ethics Committee on 28October 2015

Ver. 20151028

Consent Form (Medical Institution’s Copy)

Consent Form for the Storage of Specimens and Utilization in Future Research

Director of Kyoto University Hospital

-That I will participate in medical research/education through the storage of my specimens and their utilization in future research

-That my specimens and the basic information associated therewith will be stored after being anonymized so that I cannot be identified as the donor

-That personal information and anonymization numbers in the Anonymizing Table will be strictly managed by the Personal Information Officer at Kyoto University

-That the Anonymizing Table will not be removed from Kyoto University

-That the research will only be conducted once the specific research methods have been determined and subsequently approved by the Ethical Review Committee

-That the term "future research" may include genome/gene analysis research and protein research