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e-Learning Course on Research Ethics

[eL CoRE]

Understanding Research Ethics


Through Case Examples
-The Attitude of the Conscientious Scientist

Point Confirmation Lists

Japan Society for the Promotion of Science


Understanding Research Ethics Through Case Examples
The Attitude of the Conscientious Scientist

Responsible Research Activity: Why Now?


Chapter 1
Introduction

Introduction

Scientific research is an activity motivated by intellectual curiosity and a


desire for exploration.
Today, scientific results are indispensable to people’s lives, with science
making extremely significant impacts on society, particularly over recent
years.

Science is built upon a foundation of trust. But, unfortunately, there


have been incidents of research misconduct such as data fabrication and
falsification and also improper use of research funds. Some of these
cases have received large coverage in the news media.

Can we just dismiss these incidents as “rare cases of scientists who’ve


gone astray”?

This eLearning course, titled "Understanding Research Ethics Through


Case Examples—The Attitude of the Conscientious Scientist," is
designed to help those engaged in research to reexamine important
points pertinent to the proper execution of research activities.

In our daily research activities, there are various situations that may
arise which can spawn improper conduct. Needless to say, no one with
a passion for research and high ethical standards would intentionally
engage in misconduct.

Nevertheless, a simple misunderstanding or error in judgment can


cause an unexpected and serious problem.

We hope this eLearning course will help to renew scientists’ awareness


of the proper attitude they should maintain while conducting research.

No doubt, those of you who are in a position of fostering young


scientists already have a good understanding of most of the information
covered in this eLearning course. We hope, however, that taking the
course will remind you of the kinds of problems that can easily occur
when doing research, and that you will utilize this information in
training the next generation of scientists.

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Copyright © 2016 JSPS All Rights Reserved.
Case studies to be explored in this course

Chapter 2 Examples Related to Research


Lesson 1 Research Misconduct
Lesson 2 Improper Authorship
Lesson 3 Improper Presentation Methods
Lesson 4 Usage of Written Works

Chapter 3 Examples of Improper Use of Research Funds


Lesson 1 Appropriate Use of Research Funds
- Misconduct through Fictitious Orders (deposits)
- Misconduct through Fictitious Labor Costs
- Misconduct through Fictitious Travel and Transportation Expenses

Chapter 4 Examples that Cannot be Ignored


for the Healthy Development of Science
Lesson 1 Questionable Research Practices (QRP)
Lesson 2 Safety Consideration in the Research Environment
Lesson 3 Necessity of Informed Consent
Lesson 4 Role and Responsibilities of the Reviewer

Chapter 5 Examples that Cannot be Ignored


for Gaining the Trust of Society
1
Lesson 1 Definition and Proper Handling of Conflicts of Interest
Lesson 2 Appropriate Handling of Personal Information
Lesson 3 Dialogue between Scientists and Society

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Copyright © 2016 JSPS All Rights Reserved.
Understanding Research Ethics Through Case Examples
The Attitude of the Conscientious Scientist

Examples Related to Research


Chapter 2
Conclusion

Lesson 1 Research Misconduct

Overview of Examples
Professor A, who is studying the effectiveness of various country's
economic policies, drafted a paper that included a unique analysis method
that had previously been reported in the Lab’s seminar by Doctoral
Student B, who studied under him.
Student B claimed that Professor A’s use of the analysis method was
plagiarism on his part. Professor A denied the accusation, stating that the
analytical method was his own original idea that he had previously
formulated and that Student B could not have devised without his help.
Not agreeing with the professor, Student B consulted with others
including Professor C of the department’s student consultation section,
who determined that it was not a case of plagiarism. Student B
understood her decision. Later, Professor C discussed the matter with
Professor A, and they agreed that if the student’s doctoral dissertation
were published in its current state, it may cause the reader a
misunderstanding, who could think that the idea originated with Student
B. Therefore, they agreed to give the relevant chapter of the dissertation
co-authorship. As a result, Professor A’s originality was preserved.

Research Misconduct [Green Book: Section III, Paragraph 5.1]

(a) Fabrication
Making up data or research results, etc.
(b) Falsification
Manipulating research materials, equipment, or processes to change data or
results obtained from research activities.
(c) Plagiarism
Appropriating the ideas, analyses, analytical methods, data, research results,
research paper(s), or words of other researchers without obtaining their
permission or giving them appropriate credit.
The above three types of misconduct are together abbreviated “FFP.”

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In the "Guidelines for Responding to Misconduct in Research" (August 26, 2014,
issued by the Ministry of Education, Culture, Sports, Science and Technology
(MEXT), FFP related to published research is defined as "Specific Research
Misconduct," and measures for addressing it are stipulated. Internationally, not
only is FFP considered to be research misconduct, but there is a trend to define
various other devious acts as also being problematic.

Examples of Fabrication and Falsification


[Green Book: Section III, Paragraph 5.2]
The “Diovan” incident (2012)
Multiple university hospitals participated in clinical research on “Diovan,” a drug
for treating high-blood pressure.
It was alleged that, when each hospital conducted its own research, numerical
data such as the subjects’ blood pressure and statistics were manipulated by
some in such a way that the conclusion would be advantageous to a certain
pharmaceutical company.
After this misconduct was exposed and made public, those research papers were
retracted. However, a former hospital employee involved in the data fabrication
and falsification and an employee of the pharmaceutical company, which used
that invalid papers to advertise the medicine, were prosecuted for deceptive
advertisement prohibited by the Pharmaceutical Affairs Law.

Plagiarism [Green Book: Section III, Paragraph 5.3]

An obvious example of plagiarism is the use of large parts of someone else’s


paper without proper citation, writing as if those parts were the result of one’s
own work. But, there are also other forms of plagiarism such as a university
professor taking ideas from his student’s unpublished paper and using them in a
preprint as his own ideas. This also constitutes plagiarism.
In experimental research, a different type of problem exists: not citing the
sources of published papers when describing the materials and methods used in
one’s own experiments.
Not only should the sources be cited when using someone else’s original
descriptions but they also need to be cited when making changes or
modifications to the original descriptions.

Citing Sources [Green Book: Section III, Paragraph 5.4]

When using someone else’s research results, one must cite the source so that
the reader can reference it. Using someone else’s results without citing the
source constitutes plagiarism.
When citing sources, a scientist must clearly specify which parts are his/her own
and which parts belong to other scientists.
Plagiarism is not limited to taking ideas from published papers. When one uses
an idea or technique obtained through reviewing a paper or a grant application,
as with insider trading, such an act constitutes plagiarism.
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Even when attending a public lecture, if one later uses an idea presented by a
speaker without his/her proper permission, it may constitute plagiarism. In such
a case, it is wise to clearly credit the speaker as the source of the idea or obtain
the speaker’s permission in advance. When using a theory or an idea originated
in a discussion at a research workshop or conference, a similar step should be
taken from the standpoint of science ethics.

Lesson 2 Improper Authorship

Overview of Examples
Professor A is recognized as a leading scientist in a basic research field.
He receives a call from a former student Lecturer B, who currently
belongs to a national university in another prefecture. Lecturer B had
listed Professor A as a co-author of his paper. He asked Professor A for his
approval to do so after the paper had been submitted. Professor A
acquiesced.
Knowing that Professor A is a leading scientist in the field, Lecturer B
thought that including his name would draw greater attention to the
paper, resulting in a higher evaluation of his work and of himself.
After the paper was published, a claim of fabrication was made on the
Internet regarding Lecturer B's paper. The investigation committee at his
university held a hearing that included Professor A, as he was listed as a
co-author, and found that he had not contributed to the actual research.

Authorship [Green Book: Section IV, Paragraph 2]

Being listed as a writer of a paper is what is referred to as authorship.


Authorship indicates not only who made the research achievements, but
also who is responsible for their content.

Examples of authorship standards in the research community:


(1) Substantial contributions to the concept or design of the work; or the
acquisition, analysis, or interpretation of data used in the work
(2) Drafting the paper or making critical revisions to its important specialized
content
(3) Final approval of the version to be published
(4) Agreement to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are
appropriately investigated and resolved.

Reference:
International Committee of Medical Journal Editors (ICMJE), “Recommendations for the
Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals”,
Updated December 2013.

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List of Authors [Green Book: Section IV, Paragraph 2.5]

Many papers list multiple names as their authors.


In such cases, if a particular author only contributed to or is accountable for a
specific part of the research, this fact must be disclosed.
Unless such disclosure is made, it will be perceived that each author is fully
responsible for the contents of the entire paper and can be held responsible for
any research misconduct related to the paper, even if the misconduct is in a part
of the research in which that author did not actually participate.

Gift authorship [Green Book: Section IV, Paragraph 3.1]

Gift authorship is a term referring to a practice in which the actual author, out
of kindness or favor, gives authorship to someone not deserving it.
Because the authors are persons held accountable for the research, it is not
permissible to list someone as an author who did not actually contribute
to the research. Such persons can be acknowledged for their cooperation, but
should not be listed as authors.

Ghost Authorship [Green Book: Section IV, Paragraph 3.2]

The opposite of gift authorship is the practice of ghost authorship, in which a


truly deserving author is not given credit as an author.

Credit [Green Book: Section IV, Paragraph 2.2]

Recognition of a scientist’s contribution to research is called “credit.” This


includes authorship, indicating who has written the paper. Other ways of giving
credit are “citing” the research of other authors and listing the scientists who
contribute to a study in the paper’s “Acknowledgements.”
The authors of an original paper (the first published with the subject results) in
an academic journal receive credit as the original inventors or discoverers.
Receiving such credit implies that the scientists have made a contribution to
advancing the subject research.

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Acknowledgements [Green Book: Section IV, Paragraph 4.4]

When presenting a research paper, it is necessary to acknowledge those who


cooperated with the author(s) and to recognize the research funding providers.

More specifically, this includes persons who secured funding for the research,
laboratory supervisors, principal investigators, persons who provided advice and
who helped the author in composing a draft or writing a paper in English or
other foreign language (persons who are not eligible to be included as authors).
If the research was funded by a research grant, that fact needs to be
acknowledged. This is to exercise accountability to the research-funding
organization. When the funding is provided by a private corporation, a statement
of the funding source is also necessary from a conflict-of-interest standpoint.

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Lesson 3 Improper Presentation Methods

Overview of Examples
Associate Professor A is planning to apply for a government grant. On
the application form, there is a box for "research achievements," in which
past achievements related to the proposed theme are entered. Up till now,
Associate Professor A had been doing this research below the surface, so
he had published few if any papers regarding it. Wondering what to do,
he decided to repost some papers he had previously published by just
changing their titles so as to enhance his record of research achievements.
Thus, he completed the grant application and submitted it.
In the grant selection meeting, it was found that Associate Professor A
had padded his achievements. As a result, he was not approved for the
grant.

Duplicate Posting, Duplicate Publication


[Green Book: Section IV, Paragraph 4.1]

Duplicate posting and duplicate publication constitute a practice of submitting


(posting) and publishing identical information. They are not acts of submitting
information already made public. "Duplicate posting" can include submitting the
same paper to multiple academic journals at the same time.
When submitting a research paper, if an important part of the paper has already
been published elsewhere, that fact must be clearly stated.
This is a problem because duplication is a form of achievement padding. It
causes unnecessary review work that wastes the time and resources of other
scientists. Moreover, an inflated number of papers with the same results can
mislead policy decision-makers.

Salami Publishing (Bologna Publishing)


[Green Book: Section IV, Paragraph 4.2]

The act of publishing one research study as multiple smaller studies (sliced out
of the main study) is referred to as “salami publishing” or “bologna publishing.”
Please remember that one excellent research paper abounding in originality
has greater impact than many unnecessarily divided papers, and can
better contribute to scientific advancement.
Salami publishing is also a problem because it’s a form of achievement padding.
Slicing up a paper makes it difficult to grasp the overall significance of the
research, while making other scientists spend unnecessary time and energy in
trying to evaluating it.

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Lesson 4 Usage of Written Works

Overview of Examples
After years of research, Lecturer A finally published a paper in an
academic journal. She wanted as many people as possible to read about
her work. After obtaining permission from the publisher, she scanned the
page of the journal and posted it on her blog.
After a while, she found that on the Internet there was a growing
suspicion that she had violated the copyright law. This was because she
failed to mention that she had received permission. She had to post an
apology on her blog for not having initially provided information about her
copyright usage.

Copyright [Green Book: Section IV, Paragraph 5.1]

A copyright is granted automatically, without any required procedures


such as application or registration, to a person who creates a work, such as a
novel, musical score, art work, film, or computer program. It covers the
paragraphs, figures, charts, diagrams, photographs, and illustrations contained
in lectures given by, and articles in newspapers, magazines, books and journals
written by scientists.

Transfer of Copyrights [Green Book: Section IV, Paragraph 5.2]

Regarding the copyright of papers and articles posted in journals, those that
have the signature of the scientist or poster are considered to belong to the
author. If the author enters into an agreement to transfer the copyright to the
publisher, it will belong to that publishing company. In this case, when there is a
desire to use either in whole or part such papers or articles posted in a journal,
permission must, as a rule, be obtained from the publisher, even by the author.

When Using Someone Else’s Copyrighted Material


[Green Book: Section IV, Paragraph 5.2]

When preparing a secondary work that copies or modifies someone else’s work,
generally one must first obtain permission from the copyright holder before
using the material.

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Secondary Use When No Permission of the Copyright Owner Is
Necessary [Green Book: Section IV, Paragraph 5.3]

・Quotations

The practice whereby an author refers in his/her own work to a portion of


someone else’s work is referred to as “quotation.”

It is permissible to quote from a work “already made public” provided that it is


“compatible with fair practice” and “to the extent justified by the purpose of the
quotation such as news reporting or research critiquing.”

If the following requirements are satisfied, permission from the copyright holder
is not necessary.
(1) the work being quoted has already been made public
(2) the quotation is necessary
(3) the portion being quoted is expressly indicated
(4) the work being quoted is not modified without permission
(5) the author’s work is primary while the quoted portion is secondary
(6) the source is clearly cited.

Any use of another’s work without meeting these requirements


constitutes a violation of the Copyright Act and could be considered
plagiarism, hence research misconduct.

・Secondary Use of a Work for Educational or Examination Purposes

In schools and other educational institutions (excluding for-profit organizations


such as private tutorial schools), the use of reproduced material does not to the
extent it’s deemed necessary for lessons constitute a copyright violation as long
as the source is cited.

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Understanding Research Ethics Through Case Examples
The Attitude of the Conscientious Scientist

Examples of Improper Use of Research Funds


Chapter 3
Conclusion

Lesson 1 Appropriate Use of Research Funds

Appropriate Use of Research Funds


[Green Book: Section VI, Paragraph 1]

In conducting scientific research, “research funding” is indispensable, and


scientists are expected to use it in appropriate ways.
There are rules pertaining to the use of research funds; they apply not only to
public research grants but also to subsidies from private foundations, donations,
and research contracts from private companies—virtually all funds used for
research purposes.

Understanding Rules Concerning the Use of Public Research Funds


[Green Book: Section VI, Paragraph 2.1]

When public funds are used in research, usage rules are in place, along with
required paperwork, management methods and other aspects to ensure that the
funds are appropriately used to accomplish the objectives of the subject research.
Funding organizations and research institutions hold briefings, publish pamphlets
and conduct other activities so that when scientists carry out research they will
at least have the minimum required knowledge of funding usage rules. It is
important for scientists to take advantage of these opportunities so as to acquire
a firm grasp of the rules governing the proper use of research funds.
Some of these rules are revised every year. Therefore, scientists need to attend
briefing sessions on a regular basis and read the most recently issued pamphlets,
even if they had learned the rules a few years earlier.
If there is anything that scientists do not understand concerning the
interpretation or implementation of a rule, they should contact an administrative
official at their research institution.

Return of Public Research Funds Connected to Improper Use


[Green Book: Section VI, Paragraph 4.1]

When research funding is improperly used by a scientist at a research institution,


the funding organization may request that the amount of money used
improperly be returned. Such a request is made based on a final project report
submitted by the research institution and on laws governing the proper
execution of budgets related to grants and other funding and/or contract
documents.

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Even in cases when the entire amount of the improperly used money was not
spent by the researcher—for instance, by a student in the laboratory—ultimately
the principal investigator in charge of the publicly funded project is held
responsible for returning the money.
A refund may be ordered when a violation of the research-fund accounting rules
occurs, even if no problem is found with the purpose for which the money was
actually used.

Limitations on Eligibility to Apply for Competitive Funding


[Green Book: Section VI, Paragraph 4.2]

Scientists who misuse the competitive funding system will be restricted from
applying for competitive funds for a set period of time (from 1 to 10 years). This
measure is based on the “Guidelines for Proper Execution of Competitive Funds”
(September 9, 2005), applied by government ministries and agencies
administering competitive funding systems.
When the funds improperly used are MEXT’s Kakenhi Grants-in-Aid, culpable
scientists can be banned from applying for any funds/grants in all of Japan’s
competitive funding systems, including those of other ministries and agencies.
If an assistant, for example, working in a support role under such a scientist is
found to have used funding improperly, while the scientist him/herself is not
guilty of any improper use, s/he is still subject to this measure—that is, the
scientist could become ineligible to apply for a grant from a competitive funding
system.

Disciplinary Actions within Research Institutions


[Green Book: Section VI, Paragraph 4.3]

When a scientist uses research funds improperly, the research institution to


which s/he is affiliated can also take disciplinary action against the scientist
based on its rules and standards. When the misconduct is particularly malicious,
the research institution can even press criminal charges against the offending
scientist, resulting in the court imposing criminal penalties.
For example, if an honorarium or salary is received for work not actually
performed and it is determined to be a malicious act, such as perpetrated by
deceiving the research institution, charges of fraud may be levied.
Applying their respective rules, some research institutions disclose the names of
and other information on scientists involved in misconduct.
It should be borne in mind that any improper use of research funds can result in
not only penalties, such as an order to return the funds and loss of application
eligibility, but also in disciplinary actions taken by the research institution.

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Summary of Research Expenses
[Green Book: Section VI, Paragraph 5]

Just as with research misconduct, misuse of research funds can damage public
trust and aspiration in scientific research, potentially leading to reductions in
scientific research budgets. Whether due to actions of a handful of scientists or
just carelessness, misconduct of any kind can have a detrimental impact on the
entire Japanese scientific research community. It is, therefore, imperative to
exercise constant care in the proper use of research funds.
Rules are not there to constrain research. There are reasons and background for
them. It is not necessary to memorize all the rules related to research funding
and usage. When, however, you have a question, ask someone in your
university’s administrative office or the research-funding agency. An accurate
understanding of related rules will allow your research to proceed smoothly.
To carry out research activities most efficiently and effectively, it is important to
engage in dialogue with your institution’s administrative staff. And, when it is felt
that rule enhancements are needed, to request a review of those rules by the
funding agency.
This too is a responsibility of scientists.

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Misconduct through Fictitious Orders (deposits)

Overview of Examples
Professor A felt that the procedure for purchasing goods was too
cumbersome. He accepted a suggestion from Mr. B, a supplier of
laboratory instruments, to make a bogus purchase and pool the research
funds provided by the university in a deposit account with the supplier so
that he could use the funds for other purposes.
This manipulation was discovered in an audit by the regional tax bureau.
For this misconduct, penalties were imposed on Professor A by the
investigative committee of his university.

The practice of depositing money with a supplier for a fictitious order as an


example of improper use.

Analysis of misconduct factors


・ Researchers want to use their research funds freely regardless of the fiscal
year they were allocated for (motive).
・ The system allows researchers to control all steps of ordering from invoice to
delivery and billing (opportunity)/
・ Researchers lack awareness of the rules they must obey and of the fact that
their funds are public money (justification).

Measures taken
・ Researchers are ordered to return the funds.
・They are banned from applying for and participating in research with
competitive funding.
・ The supplier involved is suspended from any transaction for a certain period of
time.
・ Some personnel measures are taken within the research institution, such as
disciplinary actions.

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Misconduct through Fictitious Labor Costs

Overview of Examples
Professor A asked Student B to record more working hours than she
actually put in so that the lab could collect the extra amount of honoraria
to cover her travel expenses to attend an academic meeting. This scheme
was discovered when Student B, who felt a bit uneasy about the situation,
consulted the university's administration office.
It was Professor A’s claim that, since the money was not for personal use,
but for student, his action was not tantamount to misconduct. As,
however, his reasoning was not accepted, he received severe disciplinary
action.

The practice of logging more hours than collaborators actually worked and using
the excess for improper purposes.

Factors leading to this misconduct:


・ Researchers want to use their funds freely irrespective of the specified purpose.
(motive)
・ Worker attendance is managed solely by the research laboratory, and the
administrative office doesn’t have a good grasp of the situation. (opportunity)
・ Researchers lack proper awareness of the grant usage rules and of the fact
that their funds are public money. (justification)

Penalties enforced:
・ The researchers are ordered to return the funds.
・ They are banned from applying for or participating in research supported with
competitive funding.
・ Other disciplinary action is taken by the research institution.

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Misconduct through Fictitious Travel and Transportation Expenses
Overview of Examples
Associate Professor A submitted an application for an overnight business
trip. At the last minute, the event he was to attend on the second day
was cancelled. However, he did not change his trip schedule. Later, when
an internal audit was conducted, it was discovered that the travel
expenses he received did not match his actual trip itinerary.
The audit office considered the matter to be serious and reported it to
the comptroller along with a suggestion that the faculty be more
thoroughly informed of the need to submit proper evidence of trip
expenses. The comptroller asked the university president to develop
countermeasures, which initiated a discussion involving all the
departments on ways to improve compliance.

The practice of claiming research funds in an amount exceeding cost, and using
the extra money for improper purposes.

Factors leading to this misconduct:


・ Researchers want to use their funds freely irrespective of the specified purpose.
(motive)
・ There is no system in place to check whether a research-related trip actually
took place as reported. (opportunity)
・ Researchers lack proper awareness of the grant usage rules and of the fact
that their funds are public money. (justification)

Penalties enforced:
・ The researchers are ordered to return their funds.
・ They are banned from applying for or participation in research supported with
competitive funding.
・ Other disciplinary action are taken by the research institution.
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Understanding Research Ethics Through Case Examples
The Attitude of the Conscientious Scientist

Examples that Cannot be Ignored


Chapter 4 for the Healthy Development of Science
Conclusion

Lesson 1 Questionable Research Practices (QRP)

Overview of Examples
Dr. A is a scientist who participated in a clinical study to develop a new
drug. After the drug’s release, an issue was raised concerning its side
effects. Dr. A was asked to disclose some data from the clinical tests, but
she had mistakenly discarded them when moving her laboratory.
Even though she explained that it was not done intentionally, she was
still suspected of disposing of the data on purpose in order to hide
problems related to the drug’s side effects prior to its release.

Avoiding Questionable Research Practices


[Green Book: Section III, Paragraph 6]

Fabrication, falsification and plagiarism are not the only forms of intentional
misconduct in research, though they definitely impede scientific advancement
and societal development. Situated between research integrity and research
misconduct are so-called “questionable research practices” (QRPs), which can
also threaten research credibility.

The National Academy of Sciences in the US states the following about “QRPs.”
“A questionable research practice is a practice that violates the traditional values
of research activities, potentially resulting in harmful impacts on the research
process. These practices could damage trust in the honesty of the research
process, threaten a variety of traditional customs of science, affect research
results, waste time and resources, and weaken the education of young
scientists.”
Source:
National Academy of Sciences, Responsible Science: Ensuring the Integrity of the Research
Process, Vol. 1. Washington, D.C., National Academy Press p.28 (1992)

Example of Questionable Research Practices


• Not keeping critical research data for a certain period of time
• Inappropriate management of research records
• Problems in the way paper authors are described
• Refusal to provide research materials and/or data
• Insufficient research training, exploitation of students
• Dishonest presentation of research results (especially to the media)
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Data and Their Importance [Green Book: Section III, Paragraph 4.1]

Data comprise “all types of information based on facts used for rational
deduction.” The importance of data in research is obvious; without data, there
could be no research.
With the exception of few special circumstances, the quality of all scientific
research is determined upon the assumption that the “data” were obtained using
the utmost care and rigor available at the time. Accordingly, scientists must
handle “data” with integrity in every phase of their research activities.
As shown in the "Example of a Questionable Research Practice," after research is
completed, important research data must be retained for a prescribed period of
time.

Reference:
Science Council of Japan (answer) "Improvements to the Soundness of Scientific
Research" March 6, 2015, "2 Consideration of Each Item for which Examination was
Requested," "(2) Basic Duties of Scientists, and Storage Periods and Methods for
Experiment Data, etc."

Lesson 2 Safety Consideration in the Research Environment

Overview of Examples
Following directions from Professor A, Assistant Professor B took an
inventory of the poison reagents managed by the laboratory. She
prepared an inventory report based on the poison-substances
management ledger recorded by the lab members. Later, inconsistencies
in the record were found by the university’s environmental committee.
The cause was determined to be mistakes in the numbers entered in the
ledger.
As a result of corrective action taken, the inventory status of the
reagents was reconfirmed and the management of poison substances
strengthened.

What Is to Be Protected [Green Book: Section II, Paragraph 3.1]

One should never forget that freedom in research is to be guaranteed only so far
as the research fulfills its responsibility of protecting those things that are to be
protected.
Science is expected to make contributions to the health and welfare of
humankind, safety and security within society, and the sustainability of the
global environment. When conducting research, therefore, these values are
expected to be protected. In other words, planning to do research that may
jeopardize the safety of society is not permitted

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The Kakenhi Grants-in-Aid application form stipulates the following as measures
that must be taken by researchers.
• Protection of human rights
• Informed consent
• Confidentiality of personal information
• Compliance with laws and regulations related to human life ethics
• Compliance with laws and regulations related to safety
• Approval of an ethics review committee

Safety Consideration in the Research Environment


[Green Book: Section II, Paragraph 3.3]

When preparing a research plan, one must pay attention to the safety of not
only oneself but also of the co-investigators and research collaborators including
students. Safety-related subjects and contents vary from field to field.
There are many safety risks involved in conducting research. Scientists may
handle materials or equipment with which they are not fully familiar, particularly
in carrying out interdisciplinary joint research projects.
It is, therefore, necessary at the research planning stage to discuss all potential
safety risks with members experienced in handling the subject
materials/equipment, including technical staffs, and to take appropriate
measures to mitigate risks and accidents.

・Research in which Chemicals are Handled


To use chemical substances safely, one needs to fully understand the dangers
associated with them and have knowledge of related laws.
Among the various chemical substances of particular importance is the handling
of radioactive materials, which requires special knowledge and high level of
caution. Not only does one need to have a fundamental knowledge of radiation,
but also an understanding of its effects on the human body, critical exposure
amounts, and other relevant factors. If not, one needs to acquire them before
handling radiation and radioactive isotopes.

・Life science research


When handling organisms that are toxic to humans and/or the environment, not
only the people who use them in the laboratory but also people in nearby
laboratories and university staff need to be knowledgeable about the risks.

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Lesson 3 Necessity of Informed Consent

Overview of Examples
Associate Professor A is conducting research in the field of psychology.
His project was selected for a Kakenhi grant. Having difficulty in
coordinating his schedule with that of his co-investigator Professor Y, he
asked students in the Psychology Department who were under his
influence to participate in a preliminary experiment in order to secure the
needed 150 subjects.
In addition to biasing the subjects, many of students said that they had
not received a sufficient explanation of their role. These points were taken
up as issues in an ethics review.
As a result, Associate Professor A was forced to make major changes to
his research plan just prior to project’s scheduled start. That left Professor
Y with no choice but to temporarily suspend his research.

Concept and Necessity of Informed Consent


[Green Book: Section III, Paragraph 2.1]

The "Ethical Guidelines for Medical and Health Research Involving Human
Subjects" established by the Ministry of Education, Culture, Sports, Science and
Technology, and the Ministry of Health, Labour and Welfare state that informed
consent means "the consent to be given voluntarily by research subjects or their
legally acceptable representative, etc. to investigators, etc. or individuals
providing existing specimens or information, with respect to whether the
research shall be commenced or continued (including how specimens or
information shall be handled), having enough understanding after receiving
adequate prior information with regard to the purpose and significance of the
research, burdens on the research subjects and predicted results of the research
(including both risks and benefits), etc."

Components and Procedures of Informed Consent


[Green Book: Section III, Paragraph 2.2]

Informed consent has three essential components: Being “fully informed,”


participating at one’s “own discretion,” and giving “consent.” These correspond
with the three components of informed consent described in the Belmont
Report: information, comprehension, and voluntariness.
Source: The Belmont Report,
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

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Information [Green Book: Section III, Paragraph 2.2.1]

Information necessary to being fully informed must be disclosed to participants


so that they can make an informed decision.

Such information includes but is not limited to “a paragraph containing the


processes and methods used in the research, its objectives, expected risks and
benefits, possibilities for other methods being used (if medical treatment
accompanies the research), and the fact that the subject may, at any time, ask
questions or terminate his/her participation.” It is also to include information on
the method used in selecting the subjects and information on the principal
investigator of the research project.

Comprehension [Green Book: Section III, Paragraph 2.2.2]

Even if sufficient information is provided, a subject candidate would not be able


to comprehend the information or rationally exercise his/her free will if the way
in which it is presented is complicated or confusing or if the items are listed in
rapid succession.
Ways should be devised to explain the information in an easy-to-understand
manner, taking into consideration the candidate’s knowledge level and age. If the
candidate is a foreign national, his/her cultural background and language should
also be taken into account. It is furthermore important to be aware of the fact
that the language scientists use in their daily research is often very specialized
and, therefore, difficult for the average person to understand. Even when these
considerations are taken, quite often the candidate may still not fully
comprehend the explanation. Thus, close attention must be paid to verifying
whether the candidate has understood all of the explanation. Testing his/her
comprehension may be appropriate.

Voluntariness [Green Book: Section III, Paragraph 2.2.3]

Informed consent is established only when the subject voluntarily agrees to


participate in the research. Scientists affiliated with a university or other
educational institution should avoid using their own students, upon whom they
have strong influence. They should rather try to find other subjects. Should that
not be possible, the scientist may approach his/her students but only when a
reliable method is used to confirm that they would participate at their own free
will. Offering them a big honorarium or giving them other forms of compensation
would undermine the principle of “voluntariness.” Obviously, even hinting at
giving them higher grades or a promotion would clearly be unethical.

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Other [Green Book: Section III, Paragraph 2.2.4]

In research involving human subjects, it is necessary to ask for the cooperation


of those who will serve as the subjects. In the case of psychological research,
disclosing certain information in advance to the participants may bias the
research. In some cases, therefore, careful and detailed discussion on the ethics
involved is required, particularly when asking for participant’s cooperation in
research that necessitates not giving the subject certain information or even
employing deception (giving the subjects false information).
Other considerations and procedures may be required in certain cases, such as
when informed consent is not required, e.g. in observational studies.
Even after informed consent has been obtained, if the research situation changes
it will need to be obtained again by providing the subjects a proper explanations
of the changes.

Lesson 4 Role and Responsibilities of the Reviewer

Overview of Examples
Professor A is an expert on energy technology. She received a request to
peer-review a paper authored by Processor C. After looking over the
paper, she realized that its contents were in competition with a paper she
is writing. So, she decided to withhold her review report until after her
own paper is published.
Some days later, Professor A's paper was published in an international
journal. Two months after that, the peer-reviewed paper authored by
Professor C was published in the journal of the academic society.
As both papers had similar conclusions, Professor A was suspected of
plagiarism. Though she claimed to be innocent, the investigation
committee of the society determined that she violated peer review ethics
because she had failed to declare a conflict of interest when accepting the
review request and because she had withheld her review report. As a
result, the society decided to suspend her from the list of peer reviewers
for a certain period of time.

Role and Responsibilities of the Reviewer


[Green Book: Section VII, Paragraph 1.3]
Peer reviewers have extremely important responsibilities. The Council of Science
Editors lists the following points as guidelines for peer review.

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Confidentiality Contents of a paper to be peer-reviewed shall not be disclosed
to a third party. The reviewer shall not keep the submitted paper after the peer
review is completed, nor use the information obtained in the peer-review
process for purposes other than the peer review.
Constructive critique The reviewer shall laud the good points of a paper
subject to peer review while pointing out problems from a constructive
standpoint and suggest ways to improve the paper.
Competence The reviewer shall accept a peer-review assignment only if s/he
has sufficient expertise in the field to appropriately evaluate the paper.
Impartiality and integrity The reviewer shall exclude any bias or preconceived
notions, and review the paper from an objective and impartial standpoint. The
reviewer shall evaluate the paper solely on such grounds as its scientific
significance, originality, organization, and the fields covered by the academic
journal.
Disclosure of conflict of interest If any conflict of interest exists that could
impact the objectivity of the review, the reviewer shall disclose that fact to the
editor when the review is requested and, if necessary, decline to review the
paper.

Timeliness and responsiveness The reviewer shall promptly respond to the


peer-review request and submit the peer-review report by the deadline. If the
reviewer cannot adhere to the deadline, s/he shall decline to review the paper or
contact the editor in advance.

Source: CSE's White Paper on Promoting Integrity in Scientific Journal Publications,2012


Update,2012.

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Understanding Research Ethics Through Case Examples
The Attitude of the Conscientious Scientist

Examples that Cannot be Ignored


Chapter 5 for Gaining the Trust of Society
Conclusion

Lesson 1 Definition and Proper Handling of Conflicts of Interest

Overview of Examples
Professor A is an expert in the field of neuroscience and is also working
as a consultant for a game machine company. He joined a research group
to compare the performance of game machines of different companies,
including the one he was working for.
Being very significant, the group’s research is attracting much attention.
So, Professor A went ahead and joined the research group without
disclosing the fact that he is working for one of the surveyed companies—
which was improper. As a result, the "objectivity" of the group’s research
paper was place in doubt.

Conflicts of Interest [Green Book: Section II, Paragraph 4]

Conflict of interest
as an individual
Conflict of interest
(in a narrow sense)
Conflict of an interest
Conflict of interest as a university (institution)
(in a broad sense)

Conflict of responsibilities

There are two types of conflicts of interest: “Conflict of interest” in a narrow


sense and “conflict of responsibilities.” While conflict of interest in a narrow
sense involves economic profits or losses, conflict of responsibilities refers to
situations “where a person is involved in various activities with responsibilities to
carry out multiple duties, results in a loss of judgment in executing his/her main
duty or in properly attending to his/her main duty, including cases where a third
person perceives such to be happening.”
One example of this would be a university professor who takes on multiple jobs
outside the university, and gets so busy with them that s/he slacks off in his/her
main duty of teaching students and supervising their research.

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There are many schools of thought regarding conflicts of interest, among them
guidelines issued by the Ministry of Health, Labour and Welfare state the
following:
A conflict of interest specifically refers to a situation wherein, due to a financially
profitable relationship with an outside entity (for example), fair and appropriate
judgment, which is necessary in doing public research, is compromised or
appears to be possibly compromised to a third person.
When fair and appropriate judgment is obstructed, data can be falsified, certain
corporations can get special treatment, research can continue despite reasons
to suspend it, and/or other results could follow.
Source: Ministry of Health, Labour and Welfare. Guidelines on the Management of COI in
Health and Labour Sciences Research

Measures to Avoid Conflicts of Interest


[Green Book: Section II, Paragraph 4]

When planning a research project, one must ensure that there are no conflicts
of interest. Should a conflict of interest exist, appropriate action must be taken
to disclose that information in accordance with the rules and guidelines of one’s
affiliated institution. This is to give sufficient information to those who will read
his/her research paper to decide for themselves its value.

Conflicts of interest not related to financial advantages


[Green Book: Section II, Paragraph 4]

If a paper assigned to you for review is very close to your own research or in a
competitive relation with it, it is proper to refrain from reviewing it. Even if you
were to evaluate it fairly, you must think of how others may view the situation.
If you are asked to review or evaluate a research application of a person in a
project in which you are participating as a collaborator or co-investigator, you
should decline the request due to the clear-cut conflict of interest it would
involve.
"Conflicts of interest such as these are inherently bad, though some of them
may be impossible to prevent as science advances. For example, a particular
research field may have very few scientists who are qualified to conduct peer
reviews. In such a case, if a qualified scientist declines, the chance to conduct
the peer review, which is a process critical to scientific advancement, may be
lost. In situations like this, it is necessary to disclose the conflict of interest and
related problems to the journal editor or the research funding agency, and leave
the decision up to them."

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Lesson 2 Appropriate Handling of Personal Information
Overview of Examples
Associate Professor A participated in a large-scale survey related to
political thinking. He asked a student to help with the data collection and
tabulation. To process the large volume of data, the student input the
collected data into his own computer and worked on it at home.
Later, it was discovered that the data from the survey had leaked. The
source of the leakage was determined to be the student's computer,
which had been infected with a virus. Luckily, however, individual
respondents couldn’t be identified because their data had been
anonymized.

Definition of “Personal Information”


[Green Book: Section III, Paragraph 3.1]

"Personal information" means that information relating to a living individual


which falls under any of each following item:
(i) those containing a name, date of birth, or other descriptions etc. (meaning
any and all matters (excluding an individual identification code) stated,
recorded or otherwise expressed using voice, movement or other methods
in a document, drawing or electromagnetic record (meaning a record kept
in an electromagnetic form (meaning an electronic, magnetic or other
forms that cannot be recognized through the human senses))) whereby a
specific individual can be identified (including those which can be readily
collated with other information and thereby identify a specific individual)
(ii) those containing an individual identification code

Source: Article 2, Paragraph 1 of the Act on the Protection of Personal Information

"Personal information" is not limited to identifying information such as a person's


name, address, gender, date of birth, or facial image. The term also includes any
information revealing facts, judgments, or evaluations concerning an individual’s
physical body, assets, occupation, position, or other attributes. In addition,
"personal information" applies to information already made public through
evaluation information or publications (etc.), and information contained in
images and audio, regardless of whether said information has been made secret
via encryption or other means.
In cases where information related to a non-living individual is also related to a
living individual, such as a surviving relative, said information becomes
information about the living individual.

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As corporations and other organizations do not apply to a specific "individual,"
information related to corporations and other organizations is not considered
"personal information." (However, information related to executives and
employees is considered "personal information.") The term "individual" applies to
both Japanese citizens and foreigners.

Source: Guidelines on the Act on the Protection of Personal Information (General Rules)
(published by the Personal Information Protection Commission, November 2016), (2)
Definitions, (2-1) Personal information (pertaining to Article 2, Paragraph 1 of the Act on
the Protection of Personal Information)

An "individual identification code" means those prescribed by cabinet order


which are any character, letter, number, symbol or other codes falling under any
of each following item:
(i) those able to identify a specific individual that are a character, letter,
number, symbol or other codes into which a bodily partial feature of the
specific individual has been converted in order to be provided for use by
computers
(ii) those character, letter, number, symbol or other codes which are assigned
in regard to the use of services provided to an individual or to the purchase
of goods sold to an individual, or which are stated or electromagnetically
recorded in a card or other document issued to an individual so as to be
able to identify a specific user or purchaser, or recipient of issuance by
having made the said codes differently assigned or, stated or recoded for
the said user or purchaser, or recipient of issuance

Source: Article 2, Paragraph 2 of the Act on the Protection of Personal Information

Anonymizing

In general, research involving human subjects includes a process of


"anonymizing," which the Ethical Guidelines for Medical and Health Research
Involving Human Subjects defines as follows.
Removal from information of all or part of descriptions (including individual
identification codes), which enable identification of a specific individual (including
a specific deceased individual; the same applies hereinafter). Anonymizing also
includes the replacement of all or part of the said descriptions with other
descriptions irrelevant to the said specific individual.

Source: Ethical Guidelines for Medical and Health Research Involving Human Subjects
(published by the Ministry of Education, Culture, Sports, Science and Technology and the
Ministry of Health, Labour and Welfare, December 22, 2014), Chapter 1, Part 2:
Definitions, (24) Anonymizing

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Lesson 3 Dialogue between Scientists and Society

Overview of Examples
Lecturer A is engaged in research on genetically modified plants. Having
successfully developed an innovative variety, he was interviewed about it
on a live TV program.
When asked by the media what he thought about arguments against
genetically modified foods, Lecturer A answered without hesitation, "I will
continue to develop more and more new varieties. That could solve the
world's food problems. No one will argue against genetic modification
when that happens." His remarks caused a controversy, which was
magnified over the Internet. Many people called the university to complain,
which interfered with its administrative work.

Dialogue between Scientists and Society


[Green Book: Section VIII, Paragraph 2]

Disseminating information to society by scientists and advancing dialogue


(communication) between scientists and the public is essential to realizing the
principle of “science in society, science for society.” In the Code of Conduct for
Scientists, revised by the Science Council of Japan after the Great East Japan
Earthquake, a new chapter “III. Science in Society” was added.

It states the following:

Scientists shall participate actively in dialogue and exchange with citizens so as


to achieve better mutual understanding between society and the scientific
community. In order to resolve various issues and realize welfare in society,
they shall also work to provide scientific advice effective for policymaking to
persons involved in the planning and formulation of policies. On such occasions,
advice shall be given based on consensus among scientists, and, when
differences of opinion exist, scientists shall offer explanations that are easy to
understand.
Source:
Science Council of Japan. Statement: Code of Conduct for Scientists -Revised Version-
(January 25, 2013)

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In other words, scientists need to communicate, not just within the scientific
community, but also with people in society at large. In the past, these roles
and responsibilities were not strongly emphasized, so insufficient consideration
was given to them when nurturing scientists. In the present age, however,
when science exerts significant impact on society in a variety of ways,
scientists are expected to enhance their posture relative to their role in society.

Meanwhile, as science and technology become larger in scale and complexity, it


is less easy to give readily understood explanations on the uncertainties that
exist within scientific knowledge and on the benefits and risks inherent in
science and technology.
Scientists need to adopt a posture of mutual learning between the scientific
community and society. After all, scientists are themselves members of society.

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