IRB Guidelines Tokyo Metropolitan University, Arakawa campus(Updated April 1, 2019)

Ⅰ. Basic rationale on research ethics
Ⅱ. Subjects of research ethics review
Ⅲ. Research ethics training
Ⅳ. Documents required when applying for research ethics review
Ⅴ. Full board review application procedures
Ⅵ. Full board meetings and departmental review meetings
Ⅶ. Review outcomes
Ⅷ. Response to the review result
Ⅸ. Changes to the research protocol, etc.
Ⅹ. Research period
Ⅺ. Storage of research data
Ⅻ. Submission of report
Annex
・Research protocol form for research ethics review
・Consent form for joint (or contributing) researchers

Ⅰ. Basic rationale on research ethics
While it is self-explanatory that “research involving human subjects” must be
conducted in compliance with law, such research must also be undertaken withappropriate ethical consideration for research subjects based on the Declaration of
Helsinki and the Declaration of Lisbon, as well as other benchmarks such as “Ethical
Guidelines for Medical and Health Research Involving Human Subjects” and “Ethical
Guidelines for Nursing Research.” Accordingly, faculty members, graduate students,
research students, etc. affiliated with the Arakawa Campus must, before conducting
research involving human subjects, apply for and undergo review by the IRB at Tokyo
Metropolitan University, Arakawa Campus(hereinafter, the committee) and receive
approval from the committee. This will help to guarantee the safety of and ethicalconsideration for research subjects, while also protecting the position of the researchers
themselves.
Ⅱ. Subjects of research ethics review
The committee shall conduct reviews of research involving human subjects applied byfaculty members and students (research students) affiliated with the Tokyo
Metropolitan University Arakawa Campus. Should an individual wish to conduct
research to which any of the following apply, they must receive the approval of thecommittee.
・Research when this university is the implementing entity
・Research undertaken by students of this university (research students)
・ Research undertaken with a budget, expenses or research costs from thisuniversity
・Research undertaken by a full-time member of this university’s teaching staff as theresearch representative
・Research undertaken as part of a degree course at this university
・Research implemented by another entity but undertaken on the Arakawa Campus
Besides the above, applicants should consult a chairperson of departmental review
committee(DRC) covering their own research department when unsure whether review
is required or not, or when there is any uncertainty about an application.

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Ⅲ. Research ethics training
1.

PurposeIn response to the stipulation in “Ethical Guidelines for Medical and Health Research
Involving Human Subjects” (December 22, 2014, MEXT and MHLW) that training inresearch ethics must be provided, training will be implemented using the APRIN
e-learning program “Research Involving Human Subjects: Fundamentals (HSR), Stage
1.” This will ensure that researchers who wish to conduct research involving humansubjects and apply for research ethics review by the Arakawa Campus of Tokyo
Metropolitan University will learn about ethics related to the research and theknowledge and technology required when conducting such research.
2.

Course recipients
Researchers (including applicants, principal investigators, Co-Investigators andsupervisors) who apply for research ethics review by the Arakawa Campus of Tokyo
Metropolitan University.

Note: However, applicants other than staff, graduate students and research
students at Tokyo Metropolitan University Arakawa Campus should read
“Ethical Guidelines for Medical and Health Research Involving Human
Subjects” instead of the e-learning mentioned above, and must then receive
guidance on ethics concerning research involving human subjects from anapplicant, research representative or joint researcher enrolled at this
University.
Note: Applicants affiliated to Tokyo Metropolitan University Arakawa Campus
must still attend the training even if they have already received e-learning fromanother institution or attended the “Responsible Research Conduct Digest” course
offered by this University.
3.

Method of course attendance
・Course recipients log in to the APRIN Home Page (http://edu.aprin.or.jp/) using
the login Username (ID) and password provided by the Arakawa Campus
Research ethics Secretariat (hereinafter, “the Secretariat”), then attend thecourse “Research Involving Human Subjects: Fundamentals (HSR), Stage 1.”・After studying the research ethics course materials, course recipients take acomprehension test (quiz) to confirm understanding of the course content. A testscore of at least 80% (four out of five questions answered correctly) signals course2completion, and a course completion certificate will be issued.
Note: The procedures for operating the system are as described in the proceduresfor taking the APRIN ON-Screen e-learning course “Digest on Research Involving
Human Subjects.”
4.

Research ethics review
At the time of the deadline for the submission of application documents to

Secretariat, the Secretariat will confirm that individuals who have applied for review
with the Committee have taken and completed the training program. The research
protocols of applicants who have been confirmed to have taken and completed“Research Involving Human Subjects: Fundamentals (HSR), Stage 1” shall be
accepted as matters for review by the committee.
5.

Period of completion
In order to confirm completion of the training course as described in “4. Research

ethics review” above, the applicant and any other researchers, etc. (research
representative, joint researcher, supervisor) must have completed the training course
before the submitting their application documents to the Secretariat.
6.

Course frequency
The course must be re-taken every academic year.

Ⅳ. Documents required when applying for research ethics review
When applying for a review by the DRC and the committee applicants must submit
the documents 1-12 listed below.
1.

Application for research ethics review (separate form No.1)*

2.

Research protocol for research ethics review (annexed prescribed form)

3.

Research cooperation request form (for partnering institutes/facilities, freeform, template available)

4.

Explanation to research subjects (free form, template available)

5.

Consent form for research subjects or legal representatives (free form, template
available)

6.

Form for record of provision of specimens and information (template available)

7.

Form for notice of provision of existing specimens and information (template
available)

8.

Questionnaire and other documents for distribution (if distributed to research3subjects)
9.

Literature, documents and others related to the research

10. Copy of approval certification issued by another institution’s ethics review
committee
11. Consent form for joint (or contributing) researchers (form specified in annex)*
12. (If re-applying based on

assessment giving conditional

approval

or

recommending changes) Assessment Notice*
13. Certificate of completion of the training on research ethics
14. Japanese manual of research ethics review*Copies are acceptable when submitting documents 1, 11, and 12 to the DRC.
However, the original documents must be used when submitting to the Secretariat.
Notes・Application documents must be compiled in the above order, with documents 1 to 11
marked with their respective numbers in the bottom right corner.
・Documents 3 to 9 must be marked with a document number in the top right corner.
・When applying for review by the committee (submission to the Secretariat), theoriginal copy of document 11 personally signed by joint (or contributing)researchers must be submitted.
・Regarding research requiring the approval of the ethics review committees of otherinstitutes such as partnering and other research institutes, the documents thatmust be submitted to the committee will depend on whether the central instituteinvolved in the research is TMU or another institute. In particular, in the eventthat the research topics and applicants (research representative) submitted to TMU
differ from those listed on the approval certification from the ethics review
committee of the other institute, make sure to include an explanation in the“Remarks”

sectionoftheapplication

form

that

clarifies

theresearch

implementation system (how the research will be implemented).
・When the central entity conducting the research is TMU, such as research conductedin order to acquire a TMU degree (full board review), in addition to the documents
listed above, make sure to attach documents showing consent has been received
regarding both the provision of specimens and information acquired at otherinstitutes to TMU and the publication of the results of the research in question.
・When the central entity conducting the research is another institute (expedited
review is allowed in this case), make sure to attach copies of the application
documents submitted to the ethics review committee of the other institute, as well4

as of the approval certification.
・If the research is implemented by another entity that has no research ethics review
committee, a request for ethics review from that institution (free format) and, if
necessary, documents or similar (free format) clarifying the location of
responsibility for implementing the research (research body, etc.) must be
submitted in addition to the above documents.
V. Full board review application procedures
1.

DRC review
1） Applicants are asked to submit copies of a full set of the application documents
listed in “Ⅳ. Documents required for receiving a research ethics review”(printed on both sides and stapled once on the top left corner) to the laboratory
postboxes of all the members of the DRC of the department with which they areaffiliated and also email digital copies of the documents to the members.
2） If an application cannot be accepted (for example, if documents are missing, if
the application clearly cannot be approved based on ethics principles, or if theapplication does not need to be considered by the committee), the DRC will
return it to the applicant. If the application can be accepted, the DRC will
notify the applicant of the review result as soon as possible after the review has
been made.
Application deadline
・In principle, the deadline for submitting application documents to the DRC is
5 p.m. on the 4th Tuesday of every month. See the website of the Graduate
School of Human Health Sciences for specific schedules.
・If an applicant is unavoidably prevented from submitting the application
documents in person by the deadline above, they must be submitted by asupervisor on the applicant’s behalf.

2.

Committee review
1） The applicant, or his or her agent, must submit a full set of application
documents revised based on the DRC review to the Secretariat (submission by
post is accepted) and When submitting to the Secretariat, original documents
must be submitted. And the applicant email data of” Application for research
ethics review (separate form No.1)*”and” Research protocol for research ethics
review (annexed prescribed form)”.
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Application acceptance times
Weekdays, 9 a.m. to 5:45 p.m. (excluding 12:30 p.m. – 1:30 p.m.)2） The Secretariat will stamp the submitted “Application for Research ethics
Review” and “Research Protocol for Research ethics Review” with anacceptance stamp and attach an acceptance number and return copies to theapplicant.
Numbers attached to documents
・Serialized acceptance numbers are attached to the “Application for Research
ethics Review” and “Research Protocol for Research ethics Review” in orderof acceptance.
(Example) 19001-19999 (No. 1 in AY2019-No. 999 in AY2019)
・The acceptance number will be re-used as an approval number after anAssessment Notice has been issued.
・Applications for expedited review, when reapplying within the same academic
year with research protocols that have already received an assessment ofconditional approval, will be accepted using the same acceptance number as
the original application.
Application deadline
・ In principle, the deadline for submitting application documents to theSecretariat is 5:45 p.m. on the 2nd Tuesday of every month. See the website of
the individual research department for specific schedules.
・There are the following three application methods:
1) An applicant himself/herself, or his/her research collaborator, submits
application documents to the Secretariat by the deadline.
2) If an applicant is a graduate student, his/her supervisor submits application
documents on his/her behalf.
3) An applicant submits one set of application documents to the Secretariat bypost.
When submitting by post, an applicant must submit to the mailing address
listed below via trackable mailing services (e.g., registered post) a full set of
application documents with a return-mail envelop with a sufficient amountof stamps affixed for receiving the full set of application documents withacceptance stamps.
[Mailing address]
6TokyoMetropolitan

University

Arakawa

CampusResearch Ethics Committee Secretariat
7-2-10Higashi-Ogu,

Arakawa

City,

Tokyo,

Japan

116-8551

3.

Animal experiments, gene recombination experiments
Reviews of animal experiments and gene recombination experiments are carriedout by the Research Ethics Committee of the Minami-Osawa Campus. As such,applicants need not submit an application to the DRC and should instead confirm
with the Secretariat regarding the submission deadline.
Ⅵ. Full board meetings and departmental review meetings
DRC meetings shall be held in each department and committee meetings shall in
principle be held once a month.
Ⅶ. Review outcomes
1.

Types of assessment
1） Approved2） Conditionally approved
3） Changes recommended
Note: In principle, this committee only reviews research protocols in connection
with ethics matters. However, an assessment of “Changes recommended” issometimes made when the research method or other aspects are in conflictwith other provisions, or when the research is deemed clearly inappropriate,
for example because it would compromise the safety of research subjects, and it
is judged that this part impacts the whole of the research protocol, which
therefore cannot be implemented.
4） Not approved5） Not applicable2.

Notification of assessment
An Assessment Notice drafted by a committee member from the applicant’s

research department and finalized via the committee is issued by the dean of thegraduate school. The review result is sent from the Secretariat to the email address of
the applicant named in the Application Form for Research ethics Review.
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Notifications are sent about 2-3 weeks after the date of the committee meeting.
3.

Return of review documents
Application documents submitted to the DRC and the committee may be returnedto the applicant if so desired, with the exception of the “Application for Research
ethics Review” and “Research Protocol for Research ethics Review.” However, of
documents submitted to the committee, copies of documents to be returned andelectronic data are stored in the Secretariat.
4.

Receipt of Assessment Notices
In principle, applicants shall receive Assessment Notices by going to the Secretariat

in person on weekdays (in principle 9 a.m. to 5:45 p.m.). If the applicant is unable toattend in person during these hours, notices may be received by post if so desired.
Applicants who wish to receive Assessment Notices must send to the Secretariat areturn-addressed Letter Pack (a flat-rate package delivery service of Japan Post).

Ⅷ. Response to the review result
1.

If “Approved”
As soon as possible after receiving notification of the assessment, the applicant

should use Microsoft Word or some other document creation tool to create a set of
application documents with amendments marked in red in accordance with the issues
flagged in the Assessment Notice, then send them as email attachments to the email
address of the Secretariat (i.e. the source of the assessment result notification). In
addition, the original of the “Application for Research ethics Review” (separate form
No.1), marked with an outline of amendments in response to the issues flagged in theAssessment Notice, should be submitted to the Secretariat (students should submit to
the Academic Affairs Section).
2.

If “Conditionally approved”
The applicant should re-apply in accordance with the method given in “Ⅴ. Fullboard review application procedures,” using the “Application for Research ethics
Review” (separate form No.1) marked with an outline of amendments in response to
the issues flagged in the Assessment Notice, and a set of application documents with
amendments marked in red (specific details should be confirmed under “ Ⅳ .
Documents required when applying for research ethics review”).
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3.

If “Changes recommended”
Within one month starting from the day after the notification was received (i.e.

after the date marked in the top right corner of the Assessment Notice), a set of
application documents amended in line with the content of the Assessment Notice, a“Re-application for research ethics review” (separate form No. 5), and a copy of the“Changes recommended” Assessment Notice shall be submitted to the DRC members
for DRC review. After the review, one set of originals of the above application
documents shall be submitted by the applicant in person to the Secretariat in order to
re-apply to the committee.
4.

Objections to the assessment result

If an applicant has an objection to the committee’s assessment (including the content
of flagged issues), the applicant may request a second review. Second reviews must be
requested by submitting a “Request for second review of research safety ethics”(separate form No. 3) in person to the Secretariat.
A request for a second review must be made within two weeks starting from the day
after notification was received (i.e. after the date marked in the top right corner of theAssessment Notice), and may only be made once per research protocol (one acceptancenumber).
Ⅸ. Changes to the research protocol, etc.
Should any change arise in the content of the research protocol after the assessment“Approved” has been received, the applicant must first confirm whether the content of
the change falls under any of 1), 2) or 3) below. If the change falls under none of these, it
shall be taken as a “minor change.”

1.

1)

Protection of the research subjects’ human rights

2)

Method of obtaining the understanding and consent of research subjects

3)

Disadvantage to research subjects and risks borne by them
When a change does not constitute a “minor change”

The applicant should consult with a chairperson of departmental review committee
in their research department, and if necessary, apply for full board review. When
doing so, the applicant should enter details of the change in the “5. Outline ofamendments or changes” section of the “Application for Research ethics Review”(separate form No.1), as well as submitting the normal set of documents.
2.

When a change constitutes a “minor change”
9Electronic data of the set of documents, with changes marked in red, should be
emailed together with a “Notification of Changes to Research Protocol” (separate form
No.6) to the Secretariat.
3.

When a research representative’s status (e.g. graduate course) changes during
the research period
A new application for ethics review must be made to the committee. When changes

are due to occur, the research completion date must be set to fall on or before the dateof the scheduled change, and a new application must be made to the committee after
the change.
Ⅹ. Research period
Although no time limit is set on the validity of ethics review approvals, the committee
chairperson must be consulted in cases of long-term research (lasting 5 years or so).
Moreover, when the research is likely to continue beyond the period specified in the“Research Protocol for Research ethics Review,” an application to change the research
period must be made to the Secretariat by 30 days before the end of the period, following
the procedure in paragraph 2. of “Ⅸ. Changes to the research protocol, etc.”
However, in situations such as when a degree thesis is due to be submitted, the needto submit the “Research Safety Ethics Report” (separate form No.4) as specified in “Ⅻ.
Submission of report” while enrolled at the university should be taken into accountwhen setting the research period.
Ⅺ. Storage of research data
The research representative must take responsibility for ensuring that data and otherdetails concerning research approved by the Committee are stored for as long as
possible. As a minimum requirement, the “Research Safety Ethics Report” (separate
form No.4) related to the research in question must be appropriately stored using themethod and in the location specified below for each research department, for five years
from the date of submission or for three years from the date on which theannouncement of the research results was finally reported, whichever is later.
Department of Nursing Sciences
・While enrolled: In principle, stored by research representative in the graduate
student common room or research lab (however, may also be stored in a lockabledesk in his/her private residence, as there are not enough desks or lockers forstorage in the graduate student common room).
10・After completion: Stored in a new storage location specified by the research
representative in the “Research Safety Ethics Report” (separate form No.4).
Department of Physical Therapy
・While enrolled: Stored on a lockable shelf in the research lab if the research isinternal to the university (in the case of students, stored in the supervisor’s room infuture).
・After completion: Same as while enrolled
Department of Occupational Therapy
・While enrolled: In principle, stored in the graduate student common room・After completion: Stored in supervisor’s research lab
Department of Radiological Sciences
・While enrolled: In principle, stored in the respective research lab
・After completion: Stored by research representative
Department of Frontier Health Sciences
・Stored as instructed by the supervisor
Ⅻ. Submission of report
When halting the research or after completion, the research representative mustcompile a “Research Safety Ethics Report” (separate form No.4) and email it as a PDF to
the Secretariat within 60 days after completion of the research and while enrolled at
this university. If leaving the university early, the report should be submitted
provisionally even if the research is not yet complete.
Approved by Faculty Meeting, [insert date], 201911