* The Japanese version is the authoritative version, and this English translation is intended for reference purposes
only. Should any discrepancies or doubts arise between the two versions, the Japanese version will prevail.

Regulations Concerning Ethics Review of Research Involving Human Subjects
at Tokyo University of Foreign Studies
March 20, 2018
Regulation No. 6
Amended March 19, 2019: Regulation No. 35
July 23, 2019: Regulation No. 92

Article 1

Purposes

The purpose of these Regulations is to ensure proper implementation of research which has gained
the understanding of society in the research concerned by providing for necessary matters concerning
research involving human subjects at Tokyo University of Foreign Studies (hereinafter referred to asthe "University").
Article 2Definition

1

The term "Research Involving Human Subjects" as used in these Regulations shall mean research
activities conducted by collecting and gathering personal information and information and data, etc.
relating to individual activities, environment, mind, body, etc.

2The term "Researchers" as used in these Regulations shall mean those who are engaged in research atthe University, such as faculty members and researchers belonging to the University, as well as
undergraduate students and graduate students who participate in research at the University.

3The term "Research Subjects" as used in these Regulations shall mean those who have given consent toprovide cooperation as a research subject (including those who have declined cooperation for research
after such consent is given).

4

The term "Research Representative" as used in these Regulations shall mean a person who is engaged in
the implementation of research and also supervises the business related to such research.

Article 3

Subject of Review

The subject of the review under these Regulations shall be the plans for the Research Involving
Human Subjects to be performed by Researchers which requires the ethics review conducted by theUniversity in advance of implementation of research.
Article 4Ethics Committee

1An Ethics Committee (hereinafter referred to as the "Committee") shall be established at theUniversity to conduct the review prescribed in the preceding article.

2The President shall refer the review to the Committee upon application by the Researchers for review of
any Research Involving Human Subjects in accordance with the prescribed procedure.

Article 5Tasks of the Committee

The Committee, upon referral by the President, shall conduct review, etc. on the following items:(1)

Matters concerning the ethics of the research plan for the Research Involving Human Subjects;

1

(2)

Matters concerning the establishment and revision of rules, guidelines, etc. relating to the Research
Involving Human Subjects; or(3)

Any other matters relating to the matters referred by the President in connection with the Research
Involving Human Subjects.

Article 6
1

Organization of the Committee

The Committee shall consist of the following members:(1)

Director (in charge of research) or Vice President (in charge of research): 1 person(2)

Faculty member of the Institute of Global Studies who is appointed by the President: 2 persons(3)

Faculty member of the Institute of Japan Studies and the Research Institute for Languages andCultures of Asia and Africa who is appointed by the President: 1 person each

(4)

Other persons who are deemed necessary by the President: several persons

2

The term of office of the Committee members listed in Items (2) to (4) of the preceding paragraphshall be two (2) years, and they may be reappointed. However, any vacancy shall be filled, and themember appointed shall serve only the unexpired term of his/her predecessor.

3The Committee shall have a Chairperson and a Vice-Chairperson.
(1)

The member prescribed in Item 1 of paragraph 1 hereof shall serve as the Chairperson of theCommittee; and(2)The Vice-Chairperson shall be elected by mutual vote from among the members in Items 2 and 3of paragraph 1 hereof.

4

If the Chairperson is unable to act as such, the Vice-Chairperson shall act on behalf of theChairperson.

5

The Chairperson shall convene a Committee meeting and shall serve as the chairperson thereof.

6The Committee may not open a meeting without the attendance of at least half of the members
thereof.

7If the Chairperson deems it necessary, the Committee may require persons other than theCommittee members to attend a meeting and offer opinions.

8Committee members shall keep strictly secret and confidential any secret learned by them in thecourse of their duties during and after their terms of office.

Article 7Standards of Review

The Committee shall conduct a review with due regard to the matters listed in the items below:(1)

Protection of human rights of the Research Subjects(2)

Prediction of disadvantages of the Research Subjects and benefits or contributions of research
activities, etc.

(3)

Understanding and consent of the Research Subjects(4)

Assurance of safety of the Researchers and the Research Subjects(5)

Measures for protection of personal information(6)

Other consideration for social impact and ethical issues

Article 8

Application for Review

The Research Representative who intends to apply for review shall submit to the President thefollowing documents:(1)

Ethics Review Application (Attached Form 1)
2

(2)Explanatory documents for the Research Subjects, consent documents of the Research Subjects,and other documents necessary for ethics review

Article 91

Method of Review

At the time of examination, the Committee may require the Research Representative or his/her
representative to attend the review, explain the details of the application, and offer opinions.

2The judgment in the review shall be, in principle, agreed upon by all the Committee members present.
However, if the Chairperson deems it necessary, such judgment may be made with the consent of amajority of the members present by a secret ballot.

3If the Research Representative is a Committee member, he/she may not participate in the discussion orjudgment in the review.

Article 10 Results of Review
1

The result of the review shall be either of Approved, Conditionally Approved, Disapproved, or Not
Applicable.

2

The Chairperson shall report the results of the review to the President promptly after the review.

3

The President shall notify the Research Representative of the results of the review by sending theNotice of Review Results (Attached Form 2).

4

If the result of the review is either of Conditionally Approved, Disapproved, or Not Applicable, thereasons therefor shall be stated in the notice under the preceding paragraph.

5

If the result of the review is Conditionally Approved, the Research Representative shall make necessaryamendments, etc. and submit the Ethics Review Application (Attached Form 1) again to the President.

6

If the application for review under the preceding paragraph is filed, the Committee shall, upon referralby the President, confirm whether or not the conditions imposed have been satisfied.

7

Upon confirmation that the conditions imposed have been satisfied, the President shall approve theconduct of the research. If the conditions imposed are not satisfied, the Research Representative shallnot conduct the research.

8

If the result of the review is Disapproved, the Research Representative shall not conduct such research.

9

If the result of the review is Disapproved, the Research Representative may apply for a re-review only
once per research theme. In this case, the Research Representative shall make necessary amendments,etc. and reapply by submitting the Ethics Review Application (Attached Form 1) again.

10

If the application for review under the preceding paragraph is filed, the Committee shall conduct thereview through the review procedures prescribed in the preceding article upon referral by the President.

11The process and result of the review may be made public if deemed necessary by the President.

12The Chairman shall record the process and result of the review and retain them for the period prescribedin the Regulations for Management of Corporate Documents of Tokyo University of Foreign Studies.

Article 11 Change of Research Plan
In the event of any change in the research plan approved by the Committee, the Research
Representative shall promptly apply for review of the change of plan based on the content of thechanged research plan by submitting the Application for Change of Research Plan (Appended Form3).
Article 12 Announcement of Research Results
In publishing the results of research approved by the Committee, the publication shall be made3

appropriately, considering the social impact that such announcement is expected to have, after
making clear that such research has been reviewed and approved as prescribed in these Regulations
and taking necessary measures to protect personal information, intellectual property rights, etc.
Article 13 Completion or Discontinuation of Research
When the research approved by the Committee is completed or discontinued, the Research
Representative shall submit the Research Completion (Discontinuation) Report (Attached Form 4) tothe President.
Article 14 Other Matters
General affairs relating to ethics review shall be handled by the Research Promotion Division of theGeneral Affairs and Planning Department.
Article 15 Any matters not set forth in these Regulations shall be prescribed by the Committee separately.

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Attached Form 1 (Related to Articles 8 and 10)

Ethics Review Application
Date:
To: President of Tokyo University of Foreign Studies

Research

Representative _________________________
Affiliation ___________________________
Title_______________________________

Receipt No.___________________
Category of Application □Application for new review□Re-application due to □Application for re-review
conditional approval

Subject of Review□Education□ Research □Community□Others ()Activities[Research Plan]
1. Research Organization
Affiliation

Title

Name

Contact (phone/E-mail)Research Representative
Cooperative Researcher
Academic Supervisor*1
Responsible Host Faculty*2*1: If the Research Representative is a student, please fill in. *2: If the Research Representative is a researcher, please fill in.

2. Summary of Plan
1) Theme

2) Significance and purpose of research3) Summary of research activities, etc.

4) Period of research activities, etc.
From after approval of ethics review to55) Place of implementation

3.About Research Subjects
1) Number of persons, etc.

□ Adult (18 and older)□ Student (□ TUFS□ Other educational institution Name of educational institution:□ Other ())

Number of persons:□ Minors (under 18)□ Student (□ High School Student □ Junior High School Student□ Elementary School Student Name of School:□ Child (age:))□ Other ()Number of persons:2) Reward (or equivalent) to the Research Subjects□ Yes () □ No

4. Ethical Considerations in Research Activities, etc.
1) Consideration for protection of human rights of Research Subjects

2) Prediction of disadvantages of the Research Subjects and benefits or contributions of research activities,etc.
(i) Disadvantages to Research Subjects arising from Research Activities, etc.

(ii) Benefits or contributions brought by research activities

3) Method of seeking understanding and consent of Research Subjects(i) Recruitment of and explanation to Research Subjects□ Writing □ Oral □ Others ()(*Please attach a sample of the Explanation Sheet, if any.)(ii) Method of obtaining informed consent□ Writing □ Oral □ Others ()(*Please attach a sample of the Consent Form, if any.)(iii) Method of guaranteeing the right of the Research Subjects to withdraw their cooperation in the research aftergiving consent□ Written offer □ Oral offer □ Others ()(*Please attach a sample of the Consent Withdrawal Form, if any.)
64) Handling of personal information (acquisition, anonymization, storage, disposal, etc.)(i) Acquisition of personal information □ Yes □ NoYes: □ Name □ Address □ Date of birth □ Telephone number, E-mail address, etc.
□ Other matters ()(ii) Purpose of use of personal information(iii) Method of anonymizing personal information□ Linkable anonymization(Removing any personally identifiable information, anonymizing it with a

new code or number, and creating a chart.)□ Unlikable anonymization (Removing any personally identifiable information, anonymizing it with a
new code or number, and creating no chart.)□ Anonymization by a third party(*If applicable, please attach materials which show the outline andinformation management policy of the outside organization to be outsourced.)□ No anonymization(Reason(s):)(iv) Method of storing collected data, personal information, etc.
Storage management manager (Affiliation/Title/Name):

Place of storage and management:
Specific measures:(v) Method of disposing of collected data, personal information, etc.

5. Schedule for Publication of Results of Research Activities, etc.

[Reasons for Application]*Please describe the reason and circumstances leading to your application for ethics review.

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Attached Form 2 (Related to Article 10)

Notice of Review Results
Date:
Research RepresentativeTo:

President of Tokyo University of Foreign Studies Seal
Receipt No. ________________________
Theme __________________________________________________________________We hereby notify as follows the result of the review of the implementation plan for the theme indicatedabove for which application has been filed.

Review Date

Judgement

Approved

ConditionallyApproved

Reasons or Conditions

8

Disapproved

Not applicableAttached Form 3 (Related to Article 11)

Application for Change of Research Plan
Date of submission:
To: President of Tokyo University of Foreign Studies
Research Representative’s Affiliation/Title_____________________________

Research Representative’s Name______________________________We hereby file an application for changes as follows to the research plan that is already approved.
Please check the applicable box below.
□ Extension/change of research period only
□ Expansion/change of range of Research Subjects□ Change of the topic/procedures of research□ Changes in informed consent and ethical procedures□ Other Matters ()1. Research ThemeApproval date:
2. State ofImplementation

Receipt No.:

Whether or not any ethical problem has occurred:

3. Details of Changes

4. Reasons andGrounds for Changes

5. Anticipated
EthicalConsequences
Caused byChanges
6. Attachments
1.

Review Application

If there are multiple changes, itemize or otherwise list one by one and explain the reason for such change.

2. The changes in the application form for which approval was given previously shall be clearly identified with underline or shade.

9Attached Form 4 (Related to Article 13)

To: President of Tokyo University of Foreign Studies
Date of submission:

Research Representative’s Affiliation/Title____________________
Research Representative’s Name__________________________

Research Completion (Discontinuation) Report
Receipt No.
Research Theme
Research Period

ResearchResults(Attachments)

From toIn the case of published papers, the name of the magazine and volume, and in the case of aacademic conference presentation, the name of the academic conference, the date of presentation,etc.

In case ofDiscontinuation,
the Reasons
therefor*The space below is for use by the Administration Office.
Date of Receipt by
Administration Office
Date of Report to theCommittee
Date of Report toPresident
Retention Period for
Review Materials

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