Guidelines for survey researchers at the Graduate School of Medicine of the
University of Tokyo
Approved by the Senior Faculty Senate on January 26, 2011
Revised: March 2014
Revised: April 2014
This document is intended as a guide to proper conduct by survey researchersaffiliated with the Graduate School of Medicine at the University of Tokyo. It has
guidelines related to planning survey research, conducting it, and reporting its findings.
The increasing sophistication and diversity of research in medicine has beenaccompanied by rapid growth in the complexity of the process of doing research. Some
ethical, procedural, and organizational concerns are common to all survey researchstudies, and the present Guidelines emphasize some that should be particularly
important to scientists who are just beginning their research careers. Nonetheless,please note that survey research studies are multifarious, so not all of the points in these
Guidelines will apply to all such studies. These Guidelines are also intended to further
improve the quality of the scientific research done at the University of Tokyo, and toensure the propriety of activities done under the University’s auspices.
Section 1. Planning survey research
What researchers should do before they begin their work (including applications for
permissions, etc.)
Carefully read the University’s Code of Conduct for Scientific ResearchFirst, before beginning your research, you should carefully read the “Code of Conduct
for Scientific Research.” The Code of Conduct sets forth the basic rules and thefundamental attitudes expected of all researchers who are affiliated with the Universityof Tokyo. Versions in Japanese and in English can be found via <http://www.utokyo.ac.jp/ja/administration/codeofconduct/pdf/leaflet.pdf>.
Research involving humans
Everyone who expects to do research that involves human participants (whether thoseparticipants are studied as individuals or as groups, including studies that use clinicalrecords), or research that involves samples (including genetic material) taken fromhumans (whether the humans are patients or healthy people) must first attend the
University of Tokyo’s prescribed training in human-research ethics and must obtain acertificate of completion of that training. Before starting their research work, researchers
must also understand the various guidelines, etc. on this topic that are available via theInternet, which are introduced during the research-ethics training. Depending on thenature of the research, the researcher may need to first submit to the Research Liaison
Officer (kenkyuu-kyouryoku-gakari) 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. Further information
about the research-ethics training and about submission of the appropriate applications
can be found at the website of the Research Ethics Committee and the Human Genome,
Gene Analysis Research Ethics Committee. Information in Japanese can be found at<http://www.m.u-tokyo.ac.jp/research/rinri.html>
and at<http://www.m.u-tokyo.ac.jp/ethics/ethcom/index.html>.
Some information in English can be found at<http://www.m.u-tokyo.ac.jp/english/research/rinri.html>.
All research involving humans must strictly adhere to the applicable guidelines
from the Japanese government, which may include ethics guidelines for
epidemiological research, ethics guidelines for clinical research, and ethics guidelines
for research in genetics. These guidelines are currently under discussion and will berevised in near future. For research involving biomarkers, determining which
guidelines should be followed depends on knowing whether the study involves genetic
information or not, but in either case examination by the Research Ethics Committee isrequired, as are the informed consent of all participants and careful planning for
appropriate management of information. Even if you use only pre-existing data, there
are still rules that must be followed: for example, you still must protect confidentiality,
etc. Some research may be exempt from the requirement for examination by the
Research Ethics Committee. Such studies can include those using no information about
individuals (for example, studies that use only data at the level of a town or city) or
those using only information that is already publicly available (for example, studies oftrends in the size of the workforce). Research using only data that are completely
anonymous and that can no longer be linked to individuals is also regarded in ethics
guidelines for epidemiological research and ethics guidelines for clinical research as
exempt from the examination requirements. Nonetheless, before starting any research
you must examine your study in the context of all appropriate guidelines on research
ethics, and also in the light of your own sense of ethics. Graduate students should
discuss these issues in detail with their advisors.
In the aforementioned ethics guidelines for epidemiological research and ethics
guidelines for clinical research one can find statements that seem to define conditions
under which research plans need not be examined and approved by a research ethics
committee before the research begins. (For example, they refer to studies that a person
previously designated by the ethics committee approved as research involving only
statistical analyses of data from records of patients treated at the medical facility withwhich the researcher is affiliated, etc.) However, researchers should remember that theymust not make such decisions themselves.
For research that involves human participants and interventions, you will be
required to use appropriate methods when you recruit the participants and when you
seek their consent to participate. You will also be required to obtain approval from the
Research Ethics Committee before you start. After that approval has been given, you
may begin explaining the study to potential participants and seeking their consent toparticipate. Invasive interventional studies done at the University of Tokyo Hospital:
Before an invasive interventional study is done at the University of Tokyo Hospital, theHospital’s institutional review board (IRB) must be informed of the study’s details, andpermission to do the study must be obtained from the IRB. The IRB is part of the
Hospital’s
ClinicalResearch
SupportCenter<http://www.cresc.h.utokyo.ac.jp/en/index.html>. If circumstances require that the information in theapplication to the Research Ethics Committee be changed before the study ends, theappropriate change-notification form must be submitted and approved.
Important point #1: Begin survey research only after permission to do so has been
granted by the Research Ethics Committee.
The application procedures described in these Guidelines may take time, but
you may not start your survey research work 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 without permission to do so.
Section 2. Doing survey researchA) Appropriate use of intellectual property (if applicable)
Some psychological tests, quality-of-life scales, etc., are protected by copyright.
Before using anything to which a claim of intellectual property rights exists, you should
first contact the person or organization that holds those rights and make the necessary
arrangements for contracting, registration, etc. Keep in mind that a scale’s properties
can change in important ways if you use only a part of the original scale, and if youchange the wording of a question item, the number of response choices, the order of theitems, etc. After any such alteration you may need to measure the altered scale’s
reliability, validity, etc. If your research requires that you use an altered scale, you
would be well-advised to first obtain the permission of (or at least consult with) the
author of the original version. As a minimum, in any report of your research you
should cite the original version of the scale and you should clearly describe how you
altered it.
B) Points to consider when collecting data (if applicable)
If you obtain permission to collect data from an organization, institution, etc.,
then you can prevent problems by obtaining it in writing from a person who has theright to grant that permission (for example, the head of the organization or institution).
For research that involves sampling of biomarkers or any other fieldwork that could be
dangerous, all necessary safety precautions should be taken to protect both theresearcher and the study’s participants. If you are a graduate student you should
discuss this as needed with your advisor, and follow your advisor’s instructions.
C) Handling data (if applicable)
C-1 Handling personal information in survey data
C-1a Storing data safely•
Anonymize data as soon as possible. If the data are to be anonymized
reversibly (that is, in a way such that individuals could still be identified if
necessary), such as via a “mapping” code or a Table of Correspondence, thenthat code or Table and the reversibly-anonymized data should be stored inseparate places. Information that could be used to identify an individual (names,
medical-record numbers, and other commonly used personal identifiers) should
be stored in a locked place, and access to the key should be strictly limited.
•
If you use electronic files to store information that could be used to
identify an individual (including the kinds of codes or Tables mentioned above),then those files should be encrypted and password-protected.
•
Reversibly-anonymized data (as described above) should also be
encrypted.
•
If you store data on a portable device (portable USB memory, etc.), thenthe files or the entire device should be password-protected. Whenever possible,
such devices should also have software, etc. that allows them to resist viruses
and other malware.
•Your plans regarding the length of time that data will be stored and themethod of data destruction should be documented in the application that you
submit to the Research Ethics Committee, and you should implement the plansapproved by the Committee.
C-1b Managing computers used to analyze data that have not been irreversibly
anonymized•
Access to such computers should be limited by user ID and password,and guest accounts should be deleted. Use an appropriate “firewall.”•Install anti-malware software on all such computers. You should checkfor virus-definition updates and operating-system updates at least once each
week, and install those updates when they are available.
•
Do not allow Winny or other file-sharing software to be installed onsuch computers.
•
Prevent theft of such computers by physically locking them in placewith a security wire, etc.
C-2 Analyzing secondary data•
Before you start, obtain from the data provider all necessarypermissions to report findings. Be aware that some providers may denypermission for certain results to be reported.
•
If you analyze secondary data, you are responsible for knowing andunderstanding those data, and the processes by which they were collected, as
well as you would if you had collected them yourself.
D) Other important points regarding data handling in survey research (if applicable)• If any part of your research requires the employment of an external serviceprovider, do not begin that work until after an appropriate non-disclosureagreement has been concluded. Be especially careful if the external serviceprovider has access to any data containing personal information.
• If your research requires the development of new software, you can prevent
problems by first concluding a written statement that clearly identifies the holderof the intellectual property rights to that software.
E) Appropriate use of research funds
Misuse of research funds is absolutely prohibited.
If you use KAKENHI refer to the KAKENHI handbook. A new edition is released eachyear, and a version in English can be downloaded via the link at the bottom of<http://www.jsps.go.jp/j-fellow/j-fellow_14/19_shorei_download.html> or directlyfrom <http://www.jsps.go.jp/j-fellow/j-fellow_14/data/syorei/10.pdf>. Use researchfunds in a well-planned manner and with care, and only after detailed deliberations
with the Principal Investigator and with the administrator in charge.
Important point #2: Prevent and be prepared for unexpected problems in data
management.
Pay close attention to all aspects of the management of personal data, and bearin mind that incidents caused by improper handling of data can bring research into
disrepute. It is important to prevent unforeseen problems from occurring by thinking
ahead with the intention of making things fail-safe and taking preventive action.
Section 3. Writing reports of your research and submitting them for publication
Authorship and co-authorship• Choosing co-authors: Before submitting a manuscript for publication, it isessential to decide who, of all the people who had some connection with yourresearch, should be included as co-authors. This will depend on how much they
contributed to your work. You will also need to obtain their consent to coauthorship and to the order in which their names will be listed. Do not ask forthat consent until after they have seen the manuscript.
• Graduate students may submit a Master’s or Doctoral thesis that incorporates
research done with collaborators or includes content from a manuscript with coauthors, but only after they have obtained written permission to do so from all of

the collaborators or co-authors.
References, text, and Figures• Handle citations carefully. Ensure that your references to previous research are
fair, and that your citations are correct. Do not cite only those previous reportsthat support your opinion or position. Instead, your decisions about citation
should be dispassionate and neutral, and you should refer to opposing views.
• Verbatim copying from previously published or presented materials without
proper citations, even verbatim copying of only a small part, is strictly prohibited.
Even verbatim copying of as little as one sentence can be considered plagiarism.
Exceptions to this rule can be made only if both of the following conditions are
met: the copied text is marked as a quotation by enclosure in quotation marks(“”), and the source of the quotation is clearly indicated in, as noted above, aproper citation.
• Rather than showing long lists of numbers in large Tables, it is better to use
graphs, diagrams, etc. that clearly illustrate only the points you want to make.
Take care to give neither too much nor too little information.
Other points to remember• The corresponding author has the greatest responsibility for the manuscript,
including all the points mentioned above.
• Be sure that you are prepared to respond to requests arising from publication ofyour report (requests for copies of questionnaires used in your study, etc.).
• Before you name someone in the Acknowledgements (for example, someone
who provided data, or was in charge of your fieldwork, or is affiliated with afunding organization), be sure to obtain that person’s permission.
A useful reference•
For further information about preparing reports of your work, refer tothe statement on STrengthening the Reporting of OBservational studies in
Epidemiology (the STROBE statement).
•
The English-language version is available via the link near the top of<http://www.strobe-statement.org/>.
•
Versions in Chinese, Spanish, German, Italian, Japanese, Persian, andPortuguese are available via the links on <http://www.strobestatement.org/index.php?id=strobe-translations>.
Important point #3: Avoid duplicate submission.
Submitting reports of the same findings (i.e. duplicate submission) to more than one
journal is prohibited. Presenting the same results (including Tables, Figures, etc.) in
more than one original article is also prohibited. However, if, for example, the samedata are analyzed for different purposes or with different methods, then the findings
might be publishable separately; in such a case, you should notify the Editor of thejournal of the situation and of any relevant publications, and abide by the Editor’s
decision.
Important point #4: All co-authors must agree on a manuscript before it is submitted
for publication.
Before a manuscript is submitted for publication, each co-author must receive a copy ofthe manuscript and must agree to be included as a co-author. Some journals require allco-authors to sign statements declaring conflict(s) of interest, agreeing to transfer of
copyright, etc. To avoid trouble, ensure beforehand that you adhere strictly to therequirements of the journal to which you submit your manuscript. Remember thatbeing 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 readthe paper before it is submitted for publication and to promptly inform the author
inviting you to become a co-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 eventthat any problems should arise.
Important point #5: Handling potential conflicts of interest.
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 writing a manuscript andpreparing 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 theirwork 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 thesource of their funding. When writing in Japanese, include an acknowledgement suchas 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 is an endowed department, supported with an unrestricted grantfrom YYY.”
If funding for the research being reported has been received from more than one
company, then, to ensure transparency, the acknowledgment should list the name ofevery company from which funding was no less than a certain sum (e.g., every
company that contributed 2 million yen or more).
Section 4. Applying for Patents (if applicable)
Applications for patents based on findings of your research should be filed asearly as possible before the findings are presented at conferences or published in any
form. Patent applications related to non-hospital-based, basic-science, and public-healthresearch are handled via the Faculty of Medicine’s Research Support Section (kenkyuushien-gakari), and those related to clinical research are handled via the University ofTokyo Hospital’s Public Relations Center (paburikku-rireeshon-sentaa).
Bear fully in mind that once your research findings are made public throughpresentation 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 theapplication is based are presented at a meeting (within 6 months after distribution of an
abstract) or published.
Further information (in Japanese) on the relevant patent law can be found at< http://www.jpo.go.jp/index/tokkyo.html >.
Section 5. Other things you should do when your findings are disclosed to the public
Feedback to your research collaborators and participants
When a report of your research has been accepted and your results are madepublic, you should also report the results to people who collaborated with you or
participated in your research. If some of those collaborators or participants are patients,
members of the general public, or other non-specialists, then you should also reportyour results in a way that they will understand easily, and you should make that reportreadily available via, for example, the Internet or one of the University’s publications.
For research that requires agreement to participate in a survey, you shouldmake clear beforehand how you expect the results to be made public and whether you
plan to report the results to the participants.
Section 6. Doing better research
The points listed below are not requirements, but they should be kept in mindby anyone who is dedicated to doing research well.
Planning your research
Before starting your research, you should have clear ideas of the purpose of the study,of what you are trying to elucidate, and of what you will be able to say on the basis ofyour results. In accord with those ideas, you collect and analyze data. You should
prepare by collecting and reading reviews of the literature and the most recent reportsof all relevant previous research related to your topic, to ensure that your work will be
novel, creative, and meaningful. The mere fact that a study was never done before does
not make it meaningful.
You should state your study’s purpose and your hypothesis in writing as
clearly as possible. They will directly and closely relate to your study’s methods. You
should also keep the study’s purpose always in mind as you collect data. It is also agood idea to decide on your analytic methods before you begin collecting data.
Remember this: using analytic methods to compensate for limitations in data after they
have been collected is extremely difficult. [Don’t let yourself get stuck doing an afterthe-fact patch-up job!] Even if the data have already been collected, that is, even if you
plan to analyze secondary data, it is best to establish a hypothesis-based plan foranalysis before you begin.
Before starting, you should subject your questionnaires and other survey tools
to scrutiny by others, and if possible you should pilot-test them with a group of people
similar to those whom you intend to study. If your study involves an intervention, thenyou should also consider collecting data to verify its "penetration", that is, the extent towhich the intervention is implemented as intended. As much as possible, all of thesepoints should be addressed in the written study protocol. To make the relationships
among the variables that you plan to analyze understandable, whenever possible
illustrate those relationships graphically.
Points to keep in mind in the course of research• Quality-control for data entry: To minimize errors, when paper-based data areentered into a computer, the data should be entered separately by two people,
whose work should then be compared.
• Appropriate statistical analyses and interpretations: You should perform
appropriate statistical analyses, and your interpretations of their results should
be objective and based not only on the presence or absence of differences that are
statistically significant, but also on the sizes of the effects (the effect size).
• You must understand the premises and assumptions of all statistical tests thatyou use, and you must show that those premises are met by your data.
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