Guidelines for laboratory researchers at the Graduate School of Medicine of the
University of Tokyo
January 2011
Revised: March 2014
Revised: April 2014
This document is intended as a guide to proper conduct by laboratory
researchers affiliated with the Graduate School of Medicine at the University ofTokyo. It has guidelines in three main sections: planning laboratory research,
conducting it, and reporting its findings. The increasing sophistication anddiversity of research in medicine and life sciences has been accompanied by
rapid growth in the complexity of the process of doing research. Many ethical,
procedural, and organizational concerns are common to all the laboratory
sciences, and the present Guidelines emphasize some that should beparticularly important to scientists who are just beginning their research careers.
In doing so, the present Guidelines are also intended to further improve thequality of the scientific research done at the University of Tokyo, to enhance thealready-high regard in which the University is held, and to protect the
University’s rights to its research-based intellectual property.
SECTION 1: Planning laboratory research
What researchers should do before they begin their work (including
applications for permissions, etc.):
Carefully read the “Code of Conduct for Scientific Research,” which wasdeveloped by the Committee on Standards of Conduct in Scientific Research of
The University of Tokyo. That document can be found at<http://www.u-tokyo.ac.jp/public/pdf/180310_02.pdf>
andat<http://www.u-tokyo.ac.jp/ja/administration/codeofconduct/pdf/leaflet.pdf>. That Code of Conduct applies to all researchers who are affiliated with the
University of Tokyo. To prevent and respond to violations of the Code of
Conduct, a committee promotes compliance with the Code and prescribes
actions to be taken if the Code is violated.
Appropriate use of research funds: It should go without saying that researchers
must be careful to use research funds only in appropriate ways. This of course
includes KAKENHI and other research funds obtained through competitions.
Misuse of research funds is absolutely prohibited. For more information on this,carefully read the most recent edition of the KAKENHI handbook. A newedition is released each year, and a version in English can be downloaded via
the
link
at
the
bottomof<http://www.jsps.go.jp/j-fellow/j-fellow_14/19_shorei_download.html>
ordirectlyfrom<http://www.jsps.go.jp/j-fellow/j-fellow_14/data/syorei/10.pdf>.
Research involving humans: Everyone who expects to do research that involves
human subjects (whether patients or healthy people) or samples taken fromhumans (including genetic material) must first attend the University of Tokyo’sprescribed training in human-research ethics and must obtain a certificate ofcompletion of that training. Before starting their research work, researchers
must also understand the various Guidelines, etc. on this topic that areavailable via the Internet, which are introduced during the research-ethics
training. Depending on the nature of the research, the researcher may need tofirstsubmittotheFaculty’s
committee
onresearch
ethics(http://www.m.u-tokyo.ac.jp/ethics/ethcom/index.html) the appropriate
application for an examination of the proposed research from the standpoint of
ethics, or for a research-ethics examination specific to studies involving human
genetics. The Faculty’s committee on research ethics must also give its approval
before the research can start. After approval is obtained, if written informed
consent of the people to be studied (the participants in the research) is needed,that consent must be obtained before the study begins. If circumstances requirethat the information in the application be changed before the study ends, theappropriate change-notification form must be submitted and approved.
Research involving (non-human) animals: Everyone who expects to do researchthat involves animals must first attend the designated training in animal
experimentation and must obtain a certificate of completion of that training.
Before starting any experiments on animals, the researcher must first prepare a
written protocol, and must submit it to the Faculty’s animal experimentationcommittee (researchers affiliated with the Center for Disease Biology andIntegrative Medicine should submit protocols to the office of the Section ofAnimal Research within that Center). An experiment can begin only after it isapproved by the department’s animal experimentation committee and by thehead of the department. Before planning animal experimentation, theresearcher must carefully read the University of Tokyo’s rules regarding animal
experimentation and the University’s animal-experimentation manual (refer to<http://www.adm.u-tokyo.ac.jp/gakunai/res/res1/kenkyoweb/bioscience/doubutuHOME.html>). The written protocol must clearly indicate that the
researcher has fully taken into account the “three R’s” of animal

experimentation: replacement (considering whether a substitution by anothermethod is possible), reduction (using no more animals than necessary), andrefinement (minimizing each animal’s pain and suffering). If a change in theinformation provided in the application occurs before the study ends, theappropriate change-notification form must be submitted and reviewed.
Research involving recombinant DNA: All researchers who perform
recombinant DNA experiments must do so with full knowledge of and inaccord with both Japanese law (the Act on the Conservation and Sustainable
Use of Biological Diversity through Regulations on the Use of Living Modified
Organisms) and the relevant University of Tokyo rules and regulations. Before
starting any such experiments, the researcher must prepare the designatedapplication form (application for approval of measures for containment) andmust submit it to the Faculty’s office in charge of bioscience research assistance,
for consideration by the committee on genetically modified organisms. An
experiment can begin only after it is approved by the Faculty’s committee on
genetically modified organisms and by the head of the Faculty of Medicine.
Depending of the nature of the experiment, cabinet-level approval may also be
required. Researchers must ensure that their facilities conform to standards. If achange in the information provided in the application occurs before the study
ends, a change-notification form must be submitted. Researchers must attend
all the necessary training sessions organized by the Faculty of Medicine and by
the University, and must have full knowledge of the rules and regulations.
Research using ionizing radiation: As conditions for doing research involving
ionizing radiation, researchers affiliated with the University of Tokyo’s Facultyof Medicine and Graduate School of Medicine must register with the Faculty of
Medicine’s Office in charge of Radioisotope Control (R.I.-kanrishitsu), and mustmeet the following three requirements.
1. Twice each year they must undergo radioisotope handling training andpractice (graduates of the University of Tokyo’s Faculty of Medicine are
exempt), and they must undergo the specified health examination.
2. Once each year they must attend the Faculty of Medicine’s radioisotope
lecture.
3. They must be included on the list of people who are planning to use
radioisotopes, which is submitted once every three months by each laboratory’s
person in charge of radioisotopes to the office in charge of radioisotope control.
Short-term users (i.e. users from the hospital or from other universities who will
work in a laboratory for only a short time) must, every three months, submit aform requesting permission for short-term use of radioisotopes.

If you register for radioisotope use in a different Faculty or University and lose
your eligibility to register for radioisotope use via your Faculty, you willautomatically also lose your eligibility to use radioisotopes throughout theFaculty of Medicine, so be sure to attend the necessary Faculty’s training
sessions and to undergo the required health examinations. In addition, you will
be required to attend the Faculty of Medicine’s initial lecture and its additional
radioisotope lecture once each year. For safe handling and use of radioisotopes,
follow the three “C’s”: contain, confine, and control.
Contain: Keep radioactive materials in small spaces. Do not let them spread.
Confine: Use only the smallest amount of radioactivity necessary.
Control: Be precise and accurate when obtaining, using, and disposing ofradioactive materials.
To avoid injury from exposure to gamma rays, X rays, and beta rays, follow
these three guidelines: minimize the duration of exposure, stay as far away as
possible from the radiation source, and interpose radiation-absorbing material
between yourself and the source.
Invasive interventional studies done at the University of Tokyo Hospital: Before
an invasive interventional study is done at the University of Tokyo Hospital,
the Hospital’s institutional review board (IRB) must be informed of the study’s
details, and permission to do the study must be obtained from the IRB. The IRB
is part of the Hospital’s Clinical Research Support Center <http://www.cresc.h.u-tokyo.ac.jp/en/index.html>.
Environmental safety in research: The Faculty of Medicine and Graduate Schoolof Medicine has an office in charge of environmental safety(kankyou-anzen-kanri-shitsu) to ensure that appropriate and reliable safetymeasures are implemented. All faculty and staff involved in education andresearch must behave in ways that ensure not only their own safety but also thesafety of others and of their surroundings, and they may be required toundergo safety-related training when they first become affiliated with the
University. Also, before starting research you must be well-informed of the
University’s environmental-safety systems and all relevant national laws andregulations and University rules as indicated below.
1. Handling of chemicals and generation of waste from experiments:
To comply with the Industrial Safety and Health Act, the Basic Environment
Act, and the law regarding the Pollutant Release and Transfer Register system,
before starting research you must attend the environmental-safety lecturesorganizedbytheEnvironmental
SafetyResearchCenter(kankyou-anzen-kenkyuu-sentaa), and you must have received a certificate ofcompletion.
2. Storage of chemicals and waste management, safe handling of high-pressuregases and of laboratory equipment:
To comply with the Industrial Safety and Health Act, the University of Tokyo’s
rules regarding the handling of chemicals, the Narcotics and Psychotropics
Control Act, the Pharmaceutical Affairs Act, the Fire Services Act, the High
Pressure Gas Safety Act, the University’s rules regarding the handling of
high-pressure gases, and the University’s own standards for handlinghigh-pressure gases, you must attend the relevant lectures organized by the
University’s central Office of Environmental Safety (kankyou-anzen-honbu).
These lectures cover the proper handling of chemicals, the proper handling of
high-pressure gases, and the use of the University of Tokyo Chemical
Registration Information System (UTCRIS), as well as the proper use,
inspection, and maintenance of laboratory equipment (lasers, centrifuges,
autoclaves, draft chambers). Because correct and thorough entries in the
UTCRIS(fordetails,refer
to<https://utcris.adm.u-tokyo.ac.jp/CRIS_v1_0/index.aspx>) are essential forthe proper University-wide management of chemicals and high-pressure gases,
even researchers who have completed the required formal training are strongly
urged to receive instruction and guidance from their own laboratory’s person
in charge and manager of health and safety.
3. Ensuring safe working conditions:Occupational-health physicians regularly inspect workplaces to prevent
accidents, fires, environmental pollution, etc. in compliance with the Industrial
Safety and Health Act and the Fire Services Act. Those employed at the sites ofsuch inspections should cooperate with the inspectors’ work and seek tocomply with their instructions for improvement. The laboratory’s health andsafety manager is present during repeat inspection(s) and cooperates with theinspector(s) to ensure compliance with their instructions.
In the event of a fire, explosion, or other such accident or emergency, consider
how urgent the situation is, and take appropriate action. As soon as possible,
notify the proper authorities: the police or fire department, University Security,
the Faculty of Medicine’s Emergency Response Center (bousai-sentaa), theFaculty of Medicine’s General Affairs Office (shomu-gakari), or the Faculty of
Medicine’s Office of Environmental Safety. Reports on accidents andemergencies are submitted online via the University of Tokyo’s Safety
Management&
Information
System(UTSMIS,<http://utsmis.adm.u-tokyo.ac.jp/UT_Anei_User/Report/Accident/>)
andapproved by the Office of Environmental Safety.
Participation in consortia and other large-scale projects:
You should explain the present Guidelines to your collaborators and research
partners and discuss them beforehand to ensure the credibility of the researchfindings and assign respective rights appropriately.
Important point #1: Begin experiments only after permission to do so has been
granted.
The application procedures described in these Guidelines may take time, but
you may not start experiments until after the applications have been approved.
Even if an application seems to be simple or a mere formality, do not assume
that permission will be granted, and never start an experiment without
permission to do so.
SECTION 2: Conducting laboratory research
What researchers should do while their work is in progress (including
Guidelines regarding laboratory notebooks, etc.)
Confirmation of your research’s originality and creativity: You should
be constantly collecting information that attests to the originality andcreativity of your research work.
Experimental validity: New discoveries generally require confirmation
via at least two different methods (for example, obtaining consistent
results in biochemical, physiological, and histological experiments).
Reproducibility: You should be able to obtain non-contradictory datafrom multiple experiments done separately.
Appropriate controls: Any experiments done without the necessarycontrols will have to be done over.
Appropriate statistical analyses: Use appropriate statistical analyses.
Evaluate objectively the statistical significance of your findings.
Points to keep in mind regarding records of experiments (laboratory notebooks,etc.): Laboratory notebooks should include as much detail as possible. They
should include enough information to permit a researcher who reads them to
do follow-on studies. One can even go so far as to say that new discoveries
depend on both deep insights and careful records.

What must be recorded?
Laboratory notebooks (written accounts of each experiment’s purpose,
methods, results, and conclusions)Raw data (those that cannot be attached to a laboratory notebook,including long base sequences, image data, etc.)
Information obtained from outside providers of materials or services(including records regarding the breeding and rearing of experimental
animals, reports on the conditions under which purchased antibodies
were manufactured, etc.)
Points to remember when writing in laboratory notebooks
Use A4 paper for everything. Whatever format you choose, you willfind it convenient to number all the pages and to begin with a Table ofContents. Each laboratory notebook should also have a serial number.
In principle, laboratory notebooks should be bound (i.e., in book form).
For simple day-to-day memoranda regarding experiments, a loose-leafbinder is appropriate.
Entries in laboratory notebooks should be made in indelible ink. Do
not use pencil.
Your penmanship need not be attractive, but your writing must be
legible. Undecipherable entries are meaningless.
For each entry, be sure to include the date (years should be writtenAD) and, if it is not already printed on the page, the page number.
Do not leave large blank spaces. To prevent blank spaces from being
filled in at a later date, draw lines through them or write something such
as “End of this note.” or “No further notes on this page.”If you need to correct a mistaken entry, draw two lines through thesection to be corrected (ensuring that the original entry can still be read)
and write the correction above, below, or to the right-hand side of it. Do
not use correction fluid or correction paper.
When you begin an experiment, write its title and purpose in thelaboratory notebook: What are you trying to understand or clarify? Whatquestion are you trying to answer? How would you interpret the various
results that you might obtain?
If you need to attach any materials or documents, use paste or glue.
Be sure also to record your interpretations. It is particularly importantfor you to record any ideas or other relevant thoughts you have while
doing the experiment, even if they are not directly related to that study.

These written records of your ideas could prove to be very useful forplanning future research and in obtaining patents.
Record the brand name and the lot number of any reagents used. Thisis particularly important for reagents not commonly used in thatlaboratory. Once the reagent’s container is empty, you may remove thelabel and attach it to a page in the laboratory notebook.
If you receive any samples from someone else (whether that person isin the same laboratory or not), you must record what you received, howmuch of it you received, when you received it, and from whom you
received it. If you received it together with a letter or other document, besure to include that in the laboratory notebook.
Other important points regarding laboratory records
You must have a written protocol before you start any experiments. At
the start of any new experiments, you should write a protocol that
includes the following: the purpose of the study, the methods andprocedures, the reagents and equipment required, and the approximate
budget needed. Then you should fully discuss the protocol with therelevant staff members or directly with your advisor. That protocol mustbe attached to the laboratory notebook.
As much as possible, data that can be stored in electronic form should
also be printed and stored on paper. This includes base sequences, datafrom fluorescence-activated cell sorting, data obtained by microscopy,
etc. If the paper records of such data are too large to be attached to thelaboratory notebook, they should be bound in files and the location of
those raw data files should be recorded in the laboratory notebook. The
name of the person in charge of the experiment should be written on
those paper records. If the date on which the data were printed is notalready on those records, that date must be written in by hand.
The date on which the data were collected, the name of the person
doing the experiment, and any other information that might be needed
to analyze the data or interpret the results must be included together
with all raw data. Ideally, that information and the raw data should be
included in or attached to the laboratory notebook. If that is not possible,
then it can be stored by some other method: in a loose-leaf binder, boundin clear folders, etc. When stored separately from the laboratory
notebook, a smaller-size (photocopier-reduced) copy of the raw data andother information should be attached to the laboratory notebook and thelocation (file number, etc.) of the full-size paper copy should be written
in the laboratory notebook.
If the experiment involves x-ray films, copies of them should be
attached to the laboratory notebook and the originals should be stored in
special-purpose clear files or other appropriate containers. Don’t forget
to record their storage location in the laboratory notebook. The date on
which the film was exposed (including the year in AD) and the name ofthe person doing the experiment should be recorded on the film.
Of course it is also extremely important to preserve many files otherthan the laboratory notebooks described above. On the front cover of
each file, be sure to record the name of the user, the topic or contents ofthe file, and the date (including the year in AD) on which the file wasmade.
Records kept in electronic form are particularly susceptible to loss
(erasure), and thus require special efforts to prevent falsification throughoverwriting, etc. Some kinds of data (examples include image data andvery long base sequences) would be qualitatively different if stored on
paper, or would require extremely large amounts of paper. Because suchdata would be very inconvenient to store on paper, they may be stored
in electronic form.
Important point #2: Remember that laboratory notebooks belong to thelaboratory where they were produced.
All researchers should understand clearly that laboratory notebooks are not theproperty of any individual researcher; they are the property of the laboratory
where they were produced. In principle, when a researcher moves from one
laboratory to another, laboratory notebooks written by or used by that
researcher must remain in the original laboratory.
SECTION 3: Reporting laboratory research findings: writing and submitting
manuscripts
Author information: Be sure to enter every item of required
information, including each author’s affiliation with related research
projects, etc.
Selection of co-authors: Decisions about co-authorship must take into
account the degree to which the potential co-author contributed to theresearch. Consent to co-authorship should also be obtained (including
agreement on the order in which co-authors are listed). Do not invite
anyone to be a co-author until after that person has read the manuscript.

Handle citations carefully. Ensure that your citations from previous
research are fair and note the source explicitly.
Be care when writing your Acknowledgements. Thank people who
made your work possible (for example, anyone who provided you withsamples), as well as any organizations that provided funding, but not
co-authors. Before you include anyone in the Acknowledgements, obtain
their permission for you to do so. If your research was supported by
KAKENHI, be sure that your acknowledgement of that funding follows
the example in the KAKENHI handbook. In the 2010 edition’s Japaneseversion, the example is on page 21. In the 2010 edition’s English version,
this is covered in section 14, on pages 34 and 35 (slides 37 and 38 in some
PDF viewers).
Depending on the type of experiment you have done, you may need toinclude an explicit statement that your research was approved by the
University of Tokyo’s committee on research ethics or by the
University’s committee for evaluating the ethics of human-genome
research. If your experiment involved (non-human) animals, you should
include the statement “This research was done in accordance with the
University of Tokyo’s guidelines regarding animal research.”
Materials received from outside: When reporting results ofexperiments done using materials obtained from outside the Universityof Tokyo, be sure to adhere to the provisions (such as prior approval) of
the relevant contract or material transfer agreement (MTA), and be sure
to mention the source of the materials in the Materials section of thereport.
Obtaining consent to report results: Before reporting results ofexperiments done using materials obtained from a pharmaceuticalcompany or similar organization, be sure to obtain the consent of thatcompany or organization.
The corresponding author takes full responsibility for matters related
to a submitted paper, including the points mentioned above.
Upon request, you may provide biological materials, recombinant
genes, antibodies, reagents, etc. related to experiments and findings thathave been made public. Keep in mind, however, that Japanese law may
prohibit you from allowing certain samples to leave the laboratory or the
University.
Important point #3: Handle data from experiments appropriately.
Reporting the same findings (which includes Figures, Tables, etc.) in more than
one original research article (i.e. dual publication) is prohibited. Occasionallyone finds that a Figure showing control results has been used in more than one
paper, but in an original article that is unacceptable. Be sure to avoid
excessively retouching, altering, or manipulating Figures. Occasionally one
finds that Photoshop® or other such software has been used to unnecessarily
alter a Figure. For example, when SDS-PAGE is used a non-specific band may
appear, but you are not allowed to erase that band. Some journals check forsuch alterations before a paper is published. If excessive alteration is detected,
the journal may refuse to publish the paper in question and the journal may
temporarily refuse to consider other papers by that author.
Important point #4: Keep in mind and disclose all conflicts of interest (COI).
Do your research in accord with the COI-related guidelines of the Japan
Association of Medical Sciences and of all other relevant groups. When writinga manuscript and preparing it for publication, bear in mind and carefully
consider any COI, and comply with the requirements for disclosure.
When researchers affiliated with an endowed department report the results of
their work they should include the complete, formal name of the institution
with which they are affiliated and they should clearly acknowledge, by name,the company that is the source of their funding. When writing in Japanese,
include an acknowledgement such as this: “謝辞：ＸＸＸ寄附講座は、ＹＹＹ製
薬 の 寄 附金に て支援 されている。” When writing in English, include an
acknowledgement such as this: “Acknowledgement: The department of XXX isan endowed department, supported with an unrestricted grant from YYY.”
If funding for the research being reported has been received from more than
one company, then, to ensure transparency, the acknowledgment should list thename of every company from which funding was no less than a certain sum(e.g., every company that contributed 2 million yen or more).
What should be done when a report is submitted for publication: Long-term
storage of laboratory notebooks and raw data (copies, etc.)
All of the following should be copied and kept on file in eachlaboratory: the findings used to make all Tables and Figures in all papers
published or submitted for publication (including numerical findings in
the text of the paper and data referred to as “data not shown”), allprimary and secondary data, the experimental protocol(s) used at thetime those data were collected, all records of materials used in theexperiments, notes on the experiments, etc. Decisions regarding what is
to be copied and kept should be made by the person in charge of theexperiment in consultation with the principal investigator.

Preserving samples (for example, samples to be provided on request):
When a report is submitted for publication, the principal investigatorand the people in charge of the experiments should together decide
which of the materials used in that study are important to preserve (e.g.,
genes, expression plasmids, antibodies, proteins). These materials
become the responsibility of the principal investigator.
· Applying for patents: Applications for patents based on findings ofyour research should be filed as early as possible. If possible, they should
be filed before the findings are presented at conferences or published inany form. Applications for patents should be reported to the Department
of Intellectual Property (chiteki-zaisan-shitsu). For basic-science research,that is done via the Faculty of Medicine’s Research Support Section(kenkyuu-shien-gakari). For clinical research, it is done via the Universityof Tokyo Hospital’s Public Relations Center (paburikku-rireshon-sentaa).
· Bear fully in mind that once your research findings are made publicthrough presentation or publication, they may lose patentability. In
Japan, however, application for a patent can be made up to 6 months
after research findings on which the application is based are presented ata meeting (within 6 months after distribution of an abstract) or
published.
Further information (in Japanese) on the relevant patent law can befound at <http://www.jpo.go.jp/index/tokkyo.html>.
Important point #5: All co-authors must agree on a manuscript before it issubmitted for publication.
Before a manuscript is submitted for publication, each co-author must receive a
copy of the manuscript and must agree to be included as a co-author. Somejournals require all co-authors to sign statements declaring conflict(s) of interest,
agreeing to transfer of copyright, etc. To avoid trouble, ensure beforehand thatyou adhere strictly to the requirements of the journal to which you submit yourmanuscript. Remember that being included as a co-author is not necessarily
desirable; some researchers may prefer not to be co-authors of your paper. If
you are asked to be a co-author, be sure to read the paper before it is submitted
for publication and to promptly inform the author inviting you to become aco-author whether you do or do not agree to be included among the co-authors.
Bear in mind that co-authors share responsibility in the event that any problems
should arise.