BBJ Sample and Data Utilization Guidelines
Established on September 14,
2018
Revised on April 1, 2019
Revised on December 23, 2020

Contents
I Introduction···························································································1
II Operational Principles············································································· 2
III Definition of Terms················································································2
IV Scope of Application·············································································· 3
V Utilization of the BBJ Samples and the BBJ Data·············································3
VI Sample Storage at BBJ (BBJ Storage Entrustment Application)···························7
VII Procedures of Revision of These Guidelines················································· 9
VIII Others····························································································· 9

I Introduction
Under the “Tailor-made Medical Treatment Program (1st and 2nd),” which was started as aprogram entrusted by the Ministry of Education, Culture, Sports, Science and Technology in fiscal
2003, and a new phase of the “Tailor-made Medical Treatment Program,” the Institute of Medical
Science, The University of Tokyo, which served as the central body of the program, established“BioBank Japan (BBJ)” within its organization and installed storage facilities with fully automaticconveying systems, one of which can store about 2,000,000 tubes at 4°C and another of which canstore about 480,000 tubes at -150°C, and a manual-type storage facility that can store about
3,300,000 at -150°C. With the cooperation of 12 domestic medical institutions and Riken, BBJ
collected clinical information and biological samples (DNA and serum) for 51 diseases of about
266,000 patients (about 420,000 cases) and conducted genomic analyses utilizing these samples.
BBJ stored and managed the samples and information and provided them to domestic researchers.
In April 2018, the former project was succeeded by the “Operation and Management of Japan’s
Disease BioBank Intended for Utilization” of the Biobank Japan Project for Genomic and ClinicalResearch funded by the medical research and development promotion grants of the Japan Agency
for Medical Research and Development, and BBJ’s samples and information continue to be stored
and provided.

As operational rules to promote BBJ itself and the utilization of samples and information ofresearch participants that are stored at BBJ while respecting protection of personal informationand complying with the “Ethical Guidelines for Human Genome/Gene Analysis Research,” BBJ
has established these guidelines.

II Operational Principles
The provision of samples and data collected at BBJ shall be conducted based on the following
principles.
Principle 1: The results of research utilizing samples and data provided by BBJ are to contributeto various medical research and the realization of genomic medicine.
Principle 2: Samples and clinical information collected with support of public funds and data
produced by utilizing such samples are to be shared widely.
Principle 3: The data is to be managed and provided appropriately in consideration of protectionof personal information.
III Definition of Terms
The definition of terms used in these guidelines shall be as follows.
(1) BioBank Japan
A biobank established within the Institute of Medical Science, The University of Tokyo, under
the Tailor-made Medical Treatment Program (abbr.: BBJ)
(2) BBJ Sample/Data Users
The Principal Researcher who utilizes samples/data stored at BBJ, and co-researchers who wereregistered at the time of application for data utilization by the Principal Researcher(3) BBJ Storage Entrustors
The Principal Researcher and co-researchers of an organization that entrusts storage of samplesof human origin to BBJ(4) Principal Researcher
A researcher who is responsible for specific research (a researcher who applied for an ethics
review of their research project by the ethics review committee of their organization and has
obtained its approval, or a co-researcher who was listed in the ethics review application form)(5) BBJ Samples
Human biological samples stored at BBJ (DNA, serum, tissue, etc.)(6) BBJ Data
Data (the BBJ Clinical Information Data and the BBJ Prognosis Information Data) of research
participants that are collected at 12 cooperating medical institutions and stored at BioBank
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Japan under the “Tailor-made Medical Treatment Program (1st and 2nd)” and a new phase of
the “Tailor-made Medical Treatment Program,” the NBDC Registered Data Correspondence
Table, data of cooperating medical institutions (the BBJ Regional Information Data) andgenomic data obtained by utilizing DNA of research participant origin(7) BBJ Clinical Information Data
Clinical information data associated with the BBJ Samples. Items of clinical informationcollected at 12 cooperating medical institutions under the “Tailor-made Medical Treatment
Program (1st and 2nd)” and a new phase of the “Tailor-made Medical Treatment Program” (listof clinical information items) are made public on the official website of BioBank Japan.
(8) BBJ Prognosis Information Data
Data of survival/death information and cause-of-death information obtained as results ofsurvival surveys (surveys on hospital visits, resident records, and causes of death) conducted at
12 cooperating medical institutions under the “Tailor-made Medical Treatment Program (1stand 2nd)” and a new phase of the “Tailor-made Medical Treatment Program.” Sincecause-of-death information utilizes data of vital statistics provided by the Ministry of Health,Labour and Welfare, there are limits on utilization of the information.
(9) BBJ Regional Information Data
Data of ID numbers of hospitals belonging to 12 cooperating medical institutions under the“Tailor-made Medical Treatment Program (1st and 2nd)” and a new phase of the “Tailor-madeMedical Treatment Program” and information on locations of the hospitals that is produced
based on the hospital ID numbers (including location categories, such as region, prefecture, andcity/town/village)(10) BBJ Genomic Data
Genotype data and sequence data that are produced by utilizing the BBJ Samples stored at BBJ(11) BBJ Sample Derived Data
Data obtained by the BBJ Sample/Data Users by analyzing the BBJ Samples, and all data
produced derivatively by them by processing the data. Data produced by collating the BBJ
Sample Derived Data with the BBJ Data and individual data produced by processing thecollated data are included in Secondary Data.
(12) Secondary Data
All individual data produced derivatively by processing the BBJ Data provided by BBJ.
Deliverables and aggregate results are not included in Secondary Data.
(13) NBDC Registered Data Correspondence Table
A correspondence table of IDs for collating genomic data obtained by analyzing the BBJ
Samples registered at the National Bioscience Database Center (NBDC) (NBDC RegisteredData) with the BBJ Samples/BBJ Data3

(14) BBJ Sample and Data Utilization Review Committee
A review committee established within BioBank Japan in order to conduct neutral and fairreviews with the aim of having the BBJ Samples and the BBJ Data utilized appropriately andeffectively in accordance with the purpose of the program(15) Storage Entrustment
Action of receiving and keeping samples from another organization for a certain period of time.
Clinical information linked to the samples is not to be brought in to the Institute of Medical
Science, The University of Tokyo, and storage space will only be provided for the information.

IV Scope of Application
All BBJ Sample/Data Users shall comply with these guidelines. Persons who have been BBJ
Sample/Data Users since before the establishment of these guidelines are also subject to theseguidelines.

V Utilization of the BBJ Samples and the BBJ Data
1. Qualification for Utilization
Persons who can apply for utilization as the Principal Researcher and co-researchers arelimited to domestic researchers who have engaged in a relevant research (who belong to auniversity, public research institute, private company or any other similar organization and haveresearch experience in a relevant research). Upon making an application, the applicants shallsubmit their past papers concerning research related to samples and data intended for utilization,and e-mail addresses issued by their organization.
Persons who can apply for utilization of cause-of-death information are limited to those whohave made an application for utilization of survey data of vital statistics to the Ministry of Health,Labour and Welfare and obtained its approval in advance.
2. Rights of the Users(1) Users of samples and data may publish research achievements utilizing the BBJ Samples andthe BBJ Data freely as long as they fulfill the responsibilities of the users.
(2) The users may acquire intellectual property rights based on research achievements utilizing
the BBJ Samples and the BBJ Data freely as long as they fulfill the responsibilities of theusers.
3. Responsibilities of the Users4

(1) The users shall utilize the BBJ Samples and the BBJ Data at their own responsibility andjudgment on the quality, content, and scientific validity of the samples and the data.
(2) When utilizing the BBJ Samples and the BBJ Data, the users shall comply with the “Ethical
Guidelines for Human Genome/Gene Analysis Research,” “Ethical Guidelines for Medicaland Health Research Involving Human Subjects” and other relevant guidelines, laws andregulations. That is to say, the users shall obtain review and approval of the ethics review
committee of their organizations for utilization of the BBJ Samples and the BBJ Data. In an
ethical review application form (research project plan), a description equivalent to thefollowing item shall be specified.
<Example of a description in an ethical review application form (research project plan)>◆Item to be included in an ethical review application form
Samples and data (XXX) of BioBank Japan are to be utilized for analysis of this research.
(3) The users shall comply with the following matters.
Basic matters to be complied with in utilization of the BBJ Samples and the BBJ Data
- Limit the users (only to the Principal Researcher and co-researchers for whom theapplication was made)- Specify the purposes of utilization- Do not use the BBJ Samples and the BBJ Data for any purpose other than the
purposes for which the application was made- Utilize the BBJ Samples and the BBJ Data only for research- Do not identify any individual- Do not provide the BBJ Samples and the BBJ Data to any person or organization
other than the users for whom the application was made- Do not sell the BBJ Samples and the BBJ Data
(4) The BBJ Sample/Data Users shall handle data safely by complying with the “BBJ Data
Handling Security Guidelines (for Users)” in Appendix. Note that the required security level*
may differ depending on the data. The BBJ Sample/Data Users shall also cooperate with anaudit on the implementation status of security measures which audit is to be conducted by athird party at the request of the BBJ Sample and Data Utilization Review Committee or BBJ.
* [Security level]
Standard level [Type I] security is required in principle, but high level [Type II] security
may be required through discussion with the BBJ Sample and Data Utilization Review
Committee. For details of [Type I] and [Type II], refer to the “BBJ Data Handling
Security Guidelines (for Users).”
When utilizing cause-of-death information of the BBJ Prognosis Information Data, theBBJ Sample/Data Users shall comply with, in addition to the “BBJ Data Handling Security
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Guidelines (for Users),” the purposes of utilization, the place of utilization, and the measures
for appropriate management specified in a written request (Form No.1) that is submitted to
the Ministry of Health, Labour and Welfare.
(5) The BBJ Sample/Data Users shall establish a security control system in accordance with arequired security level (Type I, Type II, etc.) and submit “BBJ Data Handling Security
Guideline Checklist” to the Office of BioBank Japan for confirmation of compliance with thestandards prescribed by BBJ.
(6) If data leakage or any other security accident occurs, the BBJ Sample/Data Users shalldisconnect the device in question from the network and report to BBJ immediately. For
subsequent handling of the accident, the BBJ Sample/Data Users shall promptly takemeasures in accordance with the instructions of BBJ.
(7) Upon completion of the utilization of the BBJ Samples and the BBJ Data, the BBJ
Sample/Data Users shall cease utilization of or dispose of all samples obtained from BBJ andcease utilization of or delete all data obtained from BBJ (or in the case where all or part ofthe data is stored, all of the stored data) and shall report cease of utilization (and disposal) of
the BBJ Samples and the BBJ Data by using a “BBJ Sample and Data Utilization Cease (andDisposal) Report.” For continuation of storage of the BBJ Samples, the BBJ Data, and theSecondary Data, as well as genomic data in the BBJ Sample Derived Data obtained bygenomic analysis, refer to the separate item (V-4-(9)).
(8) When publishing analysis results containing samples and data provided by BBJ in a paper or
any other publication, the BBJ Sample/Data Users shall specify that the samples and data
were provided by BBJ, by listing papers specifying the overview of samples and informationof BBJ as references or by any other similar means. For examples of references anddescriptions, refer to the following sentences:[Papers that should be listed as references for methods, etc.](1) Nagai A, Hirata M, Kamatani Y, Muto K, Matsuda K, Kiyohara Y, et al. Overview of
the BioBank Japan Project: Study design and profile. Journal of Epidemiology 2017
MAR;27(3):S2-S8.
(2) Hirata M, Kamatani Y, Nagai A, Kiyohara Y, Ninomiya T, Tamakoshi A, et al.
Cross-sectional analysis of BioBank Japan clinical data: A large cohort of 200,000
patients with 47 common diseases. Journal of Epidemiology 2017 MAR;27(3):S9-S21.
[Examples of citations]“本研究に使用した試料及びデータ（の一部）は、ゲノム研究バイオバンク事業「利活用を目的とした日本疾患バイオバンクの運営・管理」の支援を受けているバイオバンク・ジャパンから提供を受けたものです。”“The sample and data used for this research were provided from the BioBank Japan
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Project that was supported by AMED.”(9) The BBJ Sample/Data Users shall acknowledge that BBJ may publish individual information
or statistical information when disclosing the utilization status of its samples and data
(examples of individual information to be disclosed: name of utilized samples and data, dateof application, user’s name and organization, and starting date of utilization).
(10) The BBJ Sample/Data Users shall acknowledge that BBJ may retain information on
utilization of samples and data, such as user’s information from the time of application to thetime of report of utilization completion and information on accident occurrence, in order toutilize the information for disclosure of the utilization status of its samples and data.
(11) In the case where registration of individual genomic data/clinical information data in a
public database is required upon publication of a paper, the BBJ Sample/Data Users shalldiscuss with BBJ in advance about items to be disclosed so that participants will not suffer adisadvantage.
(12) In the case of utilizing the BBJ Regional Information Data or any other case of conducting
analysis for a specific region, the BBJ Sample/Data Users shall discuss with BBJ in advanceabout a conference presentation or paper submission so that participants or the region will not
suffer a disadvantage.
(13) In the case of making a conference presentation or submitting a paper about achievements
utilizing cause-of-death information of the BBJ Prognosis Information Data, the BBJ
Sample/Data Users shall notify BBJ and obtain its approval in advance.
If a breach of any of the above provisions has been found, the utilization permission may be
rescinded, and the breach may be disclosed on the website or by any other means. The above
provisions apply not only to the Principal Researcher but also to co-researchers. The Principal
Researcher is responsible for ensuring that co-researchers comply with these guidelines and the“BBJ Data Handling Security Guidelines (for Users).”
4. Procedures of Utilization(1) The BBJ Sample/Data Users shall apply for utilization in accordance with the procedures ofutilization application. In the case where several researchers belonging to different
organizations intend to conduct joint research, information on each organization shall be
included in the utilization application. Incidentally, each of such researchers may apply forsample and data utilization separately. In the case where the BBJ Sample/Data Users intend
the BBJ Samples and the BBJ Data to be provided in a way that can be linked to the NBDCRegistered Data (intend to use the NBDC Registered Data Correspondence Table), an
application to that effect shall be made at the time of utilization application to BBJ. With
respect to utilization of the NBDC Registered Data, the BBJ Sample/Data Users shall make a7utilization application to the NBDC.
(2) In any of the following cases, the BBJ Sample/Data Users shall develop a research project inwhich The University of Tokyo is listed as a joint research institute, through discussion withthe person in charge in BBJ.
- In the case of intending to utilize the BBJ Regional Information Data
- In the case where users who utilize only the BBJ Data (those who do not receive the BBJ
Samples) intend to utilize six items or more of clinical information data (excluding age,sex, and morbidity information for one disease) The number of items of clinicalinformation data is calculated based on the list of clinical information items.
- In the case of intending to utilize cause-of-death information of the BBJ Prognosis
Information Data
(3) For utilization of the BBJ Samples and the BBJ Data, the BBJ Sample/Data Users shallobtain review and approval of the ethics review committee of their organization and shallsubmit a copy of a written notification of permission from the head of their organization, at
the time of making a utilization application; provided, however, that in the case where theethics review committee has determined that the utilization is excluded from review, the BBJ
Sample/Data Users shall submit a document or any other evidence to that effect.
(4) In making a utilization application, the BBJ Sample/Data Users shall submit “BBJ Data
Handling Security Guideline Checklist” and other information and documents required by
the BBJ Sample and Data Utilization Review Committee.
(5) The BBJ Sample and Data Utilization Review Committee shall judge whether utilization ofsamples and data is permitted or not.
(6) Information necessary for access to data will be provided after the BBJ Sample and Data
Utilization Review Committee approves an application for utilization of the BBJ Samples
and the BBJ Data. The users of the BBJ Data shall access the data by using the information at
the place specified in “Appendix A to BioBank Japan Application Form for Sample/Data
Utilization” as a place for utilization of provided samples/information. Information on
categories of city/town/village, etc. in the BBJ Regional Information Data shall be utilized
only within the Institute of Medical Science, The University of Tokyo, after approval of the
medical institute providing the information.
(7) The BBJ Sample/Data Users shall report the status of utilization of the BBJ Samples/BBJ
Data every August by using a “BBJ Sample and Data Utilization Cease (and Disposal)
Report.” At the same time, the BBJ Sample/Data Users shall also re-submit “BBJ Data
Handling Security Guidelines Checklist”; provided, however, that in the case where the last
day of August comes within six months from the starting day of utilization, the submission
for August at that occasion is not required.
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(8) In the case of intending to use samples and data in excess of the initial utilization period forthe samples and data, the BBJ Sample/Data Users may continue utilizing the samples anddata by, at least one month prior to the expiration of the initial utilization period, making anapplication for utilization continuation to the Office of BioBank Japan with a written
notification of approval of ethical review from their organization (document indicating theapproved research period) being attached and obtaining the approval of the Sample and Data
Utilization Review Committee.
(9) Upon completion of the utilization of the BBJ Samples and the BBJ Data, or if the utilization
has been terminated by the BBJ Sample and Data Utilization Review Committee on the
ground of falling under “V-6. Actions Taken on the Ground of Misconduct (Including
Suspicion),” the BBJ Sample/Data Users shall promptly cease utilization of or dispose of theBBJ Samples and cease utilization of or delete the BBJ Data and the Secondary Data andshall report cease of utilization (and disposal) of the BBJ Samples, and the BBJ Data and theSecondary Data to the BBJ Sample and Data Utilization Review Committee by using a “BBJ
Sample and Data Utilization Cease (and Disposal) Report.” In the case of intending tocontinue to store the BBJ Samples, and the BBJ Data and the Secondary Data based on data
storage guidelines or other similar rules of their organization, the BBJ Sample/Data Users
may do so by making a storage application to the Office of BioBank Japan by using a “BBJ
Sample and Data Storage Continuation Application Form” and obtaining the approval of theBBJ Sample and Data Utilization Review Committee.
5. Expenses for Utilization
Actual expenses incurred in utilization of the BBJ Samples and the BBJ Data (such as
expenses for materials needed for provision/sending of samples and expenses for media needed
for transmission of data) shall be borne by the users.
6. Actions Taken on the Ground of Misconduct (Including Suspicion)In the event of a suspected breach by the BBJ Sample/Data Users of any of the items in “V-3.
Responsibilities of the Users” or the Security Guidelines, BBJ shall conduct an investigation into
the alleged misconduct, and the BBJ Sample and Data Utilization Committee shall judge whether
or not the alleged misconduct occurred based on the results of such investigation. If the BBJ
Sample and Data Utilization Committee judges that misconduct occurred, or depending on thesituation, even at the stage of suspicion of misconduct, any or all of the following actions shallbe taken.
(1) The BBJ Sample/Data Users are to be ordered to cease their utilization of the BBJ Samples
and the BBJ Data, and the permission to utilize the BBJ Samples that are being used and the9permission to access the BBJ Sample Derived Data, and the BBJ Data and the Secondary
Data are to be rescinded.
(2) No new utilization application from a researcher who committed the misconduct will be
accepted for a certain period of time. The period of time is to be determined by the BBJ
Sample and Data Utilization Review Committee.
(3) A report is to be made to the head of the BBJ Sample/Data Users’ organization as necessary.
Upon notice of utilization termination, the BBJ Sample/Data Users shall immediately ceaseutilization of, or delete, all of the BBJ Samples and the BBJ Data that have already been obtained,
as well as the BBJ Sample Derived Data and the Secondary Data. The BBJ Sample/Data Users
shall also report the status of utilization cease or disposal of data to the Office of BioBank Japan
promptly by using a “BBJ Sample and Data Utilization Cease (and Disposal) Report.”

VI Sample Storage at BBJ (BBJ Storage Entrustment Application)
1. Qualification for Utilization
Persons who can apply for Storage Entrustment of human samples are limited to domestic
researchers who have engaged in a relevant research (who belong to a university, public research
institute, private company or any other similar organization and have research experience in therelevant research). Upon making an application, the applicants shall submit information on thesamples to be stored, relevant papers, and e-mail addresses issued by their organization. For
utilization of Storage Entrustment, the Sample and Data Utilization Review Committee shalldeliberate whether the facility of BBJ will be utilized appropriately and effectively in accordancewith the purpose of the program.
2. Rights of the BBJ Storage Entrustors
The BBJ Storage Entrustors hold the ownership of stored samples. At the request of the BBJ
Storage Entrustors, BBJ shall accept, store, and provide samples. In principle, expenses for
acceptance, storage, and provision of samples shall be borne by the BBJ Storage Entrustors.
Acceptance of samples the ownership of which is to be transferred to BBJ shall be discussed
separately between the BBJ Storage Entrustors and BBJ.
3. Responsibilities of the BBJ Storage Entrustors
For entrustment of storage of specific samples at BBJ, the BBJ Storage Entrustors shall obtainreview and approval of the ethics review committee of their organization and then obtain
permission from the head of their organization. When providing samples to BBJ, the BBJ
Storage Entrustors shall use the container designated by BBJ. The samples shall be in accordance
10with the samples specified in the BBJ utilization application form. For storage at BBJ, the BBJ
Storage Entrustors shall anonymize the samples.
4. Procedures of Storage Entrustment(1) The BBJ Storage Entrustors shall confirm that they fulfill the responsibilities stipulated in“VI-3. Responsibilities of the BBJ Storage Entrustors.”(2) The BBJ Storage Entrustors shall arrange the timing of acceptance of samples and othersettings with the Office of BioBank Japan.
(3) The BBJ Storage Entrustors shall apply for utilization in accordance with the procedures ofthe sample storage entrustment application. A copy of the research project plan (ethicalreview application), a copy of the written notification of approval, and forms of consent
document and explanation document shall be attached to the application.
(4) The BBJ Sample and Data Utilization Review Committee shall judge whether acceptance ofsamples is permitted or not.
(5) The BBJ Storage Entrustors shall prepare samples to be stored and accompanying
information.
(6) The BBJ Storage Entrustors shall send anonymized samples and necessary accompanying
information in the way instructed by BBJ.
5. Provision of Stored Samples to a Third-party Organization
In the case where part or all of the ownership of samples that have been entrusted by the BBJ
Storage Entrustors to BBJ and stored by BBJ is transferred to BBJ, and the samples are to beprovided to another organization by BBJ, the provision of the samples shall be conducted inaccordance with the procedures stipulated in “V Utilization of the BBJ Samples and the BBJ
Data.”VII Procedures of Revision of These Guidelines
1. Procedures of Revision
Revision of these guidelines shall be conducted by the Office of BioBank Japan. The Office of
BioBank Japan shall refer to an opinion of the Sample and Data Utilization Review Committee asnecessary.
2. Proposal of Revision
The BBJ Sample/Data Users, the BBJ Storage Entrustors, persons providing samples, or
persons thinking about utilizing samples and data may make a proposal of revision of these11

guidelines to the Office of BioBank Japan if they consider that the revision will make provisionand utilization of samples and data smoother. In doing so, they shall make a specific proposal orpoint out a specific part in question.
3. Examination of Revision Proposal
When receiving the above proposal, the BBJ Sample and Data Utilization Review Committee
shall examine it promptly and provide an opinion on whether or not to accept or amend the
proposal to the Office of BioBank Japan, and the Office of BioBank Japan shall conduct revision
based on the opinion.
4. Publication and Application of Revision
When the content of revision is determined, the revised version of these guidelines shall be
published on the official website promptly and shall apply after a certain period of time
stipulated by the Office of BioBank Japan. The revised version of these guidelines apply also topersons who have made an application for data provision or data utilization and obtained
permission prior to the start of its application unless the persons request otherwise.

VIII Others
1. Disclosure of Information on Data Provision Applications and Information on Data
Utilization Applications
Among information on an individual application for utilization and provision of the BBJ
Samples and the BBJ Data, information for which the applicant has given consent (refer toV-3-(9)) will be disclosed on the official website of BioBank Japan. With respect to otherinformation that is not to be disclosed on the website, the BBJ Sample and Data Utilization
Review Committee and staff of the Office of BioBank Japan shall not disclose the information to
any third party.
2. Notification of Inaccurate Data, etc.
The Office of BioBank Japan shall accept and respond to notification from data users of
inaccurate data in the BBJ Data. The same applies to notification from consenters and othersimilar persons about insufficiency of the method for obtaining consent, the possibility offabricated consent or any other similar problem.

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