Responsible Conduct of Research

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MEXT Project
CITI Japan Project
Introduction
Responsible Conduct of Research includes roughly (1) responsibility to correctly conduct the
scientific research itself, (2) responsibility to correctly deal with research subjects such as human
research subjects and laboratory animals, and (3) accountability to society that supports research.
Although this section mainly deals with (1), we will also introduce laws and guidelines on (2).
There is no universal method of responsible research conduct that applies to all scientific
investigations. Specific practices that can be considered as exactly the responsible conduct of
research vary from discipline to discipline and even from laboratory to laboratory. There are,
however, some important shared values that bind all researchers together when seeking for the
responsible conduct of research for the actual situation, in terms of:
Honesty: conveying information truthfully and honoring commitments.
Accuracy: reporting findings precisely and taking care to avoid errors.
Efficiency: using resources wisely and avoiding waste.
Objectivity: letting the facts speak for themselves and avoiding improper bias.

At the very least, the essence of responsible research is a commitment to these important values
that define what is meant by integrity in research. So what exactly does it mean to conduct
research in a responsible way? The following sections will discuss generally accepted standards
in the academic domain, ranging from formal regulations to common practices such as
regulations based on statutes and instruments thereof, administrative guidelines or other rules
based on informal guidelines set out by academic societies.
The Rules of the Road for Research

The public and those involved in research expect “researchers to follow many rules and
commonly accepted practices as they go about their work advancing knowledge and putting
knowledge to work”. Responsible conduct in research is conduct that meets this expectation
from society.

However, society’s expectations for the responsible conduct of research are complex and not
always well defined. Becoming a responsible researcher is not same as becoming a responsible
driver. Responsible driving is clearly defined through laws and written down in drivers’
manuals. Individuals are tested on both their knowledge of the road rules and their driving skills
before they are allowed to drive. Then licensed drivers are constantly reminded of their
responsibilities by signs, traffic signals, and road markings. They also know that their behavior
as a driver is monitored and there are specific penalties for improper driving.

Guidance for the responsible conduct of research is not well organized as this. Some responsible
practices are defined by laws and institutional policies that must be followed. Others are set out
in non-binding codes and guidelines that should be followed. Although other responsible
practices are commonly accepted by most researchers, it hasn’t been written down. Instead, these
are transmitted informally through mentoring based on the understandings and values of each
mentor. This situation is further complicated by the fact that researchers are not routinely tested
on their knowledge of responsible practices or licensed. Moreover, their behavior as researchers
are inconsistently monitored and the penalties for irresponsible behavior vary considerably.
Researchers care deeply about responsible behavior in research and pay a great deal of attention
to the best research practices. However, the fact remains that is able to take some effort to find
out what these practices are and how to act when behavior is conflicting with some of the
complex rules for responsible practice. To this end, learning opportunities must be provided to
the researchers.

This module describes four categories of rules that can be used as sources for the responsible
conduct of research:

 Code of conduct set out by professional groups.

 Government regulations.
 Institutional policies.
 Personal convictions.

Case Study: Publication of Research Results

Publishing research results are an important activity for researchers. Science Council of Japan
(SCJ) states in its “Statement: Code of Conduct for Scientists” as follows:[1]
“Scientists shall strive to disclose and actively explain the roles and significance of their own
research, evaluate the possible effects of their research on people, society and the environment as
well as the changes that their research might engender, neutrally and objectively disclose the
results of this evaluation, and build a constructive dialog with society.” (Accountability and
Disclosure)

Also, in 2014, the Ministry of Education, Culture, Sports, Science and Technology (MEXT)
published “Guidelines for Responding to Misconduct in Research” that includes the following
comments on ethical considerations pertaining to the methods by which research results are
published:[2]
“Publication of research results is the act of making public the results obtained from research,
while presenting data and materials that can be objectively verified, so that the scientific
community can examine and judge those results.” (from Section1-2 of the guidelines)
“Research misconduct --------- hinders the normal process of communication in the scientific
community.” (from Section1-3 of the guidelines)

Published research results are a common asset of an academic community. Other researchers are
to perform next-step research based on the published results. They may conduct a replication
study to confirm that the same results can be obtained as necessary. Since unintended mistakes
are sometimes found in the validation process, it is important that data and materials are
verifiably presented in order for research to progress step by step with cooperation of
researchers. The following case study presents an ethical issue relating to this process. Please
read this case study and use it to consider ethical issues in the publication of research.

Ms. A is a graduate student in Dr. K’s laboratory and her manuscript has just been accepted for
publication in a prestigious research journal on condition of a few important changes. Most
importantly, the editor has requested her to shorten significantly the methods section to save on
space. If she makes the changes that the editor requested, other researchers might not be able to
replicate her work. Ms. A consulted about the situation with Dr. K, and he recommends Ms. A to
go ahead with the changes. After all, if other researchers want more information, they can
always get-in-touch. She remains concerned that an inadequate explanation of her methods could
lead other researchers to waste time and valuable research money attempting to replicate her
work.

 Should Ms. A shorten the descriptions as requested by the editor of the journal?
 Is Ms. A’s concern adequate about providing inadequate information to colleagues?
 Is reducing detail in the methods sections a reasonable way to save valuable space in a
journal?
 How should Ms. A respond to a variety of ethical issues properly from a standpoint of
the responsible conduct of research?

Professional Self-regulation

Prior to World War II in Europe and the U.S., society provided little public support for research
and did not expect much from researchers in return. Researchers were more or less left alone to
run their own affairs except when they assumed other roles as teachers, physicians, or engineers.

Research is the process of critically examining existing scientific knowledge and developing this
knowledge through methods such as experimentation. The usual process of validating newly
discovered knowledge was traditionally believed to be enough to ensure that research was done
with integrity. It appears that research activities were basically self-regulating and there was no
necessity to create rules by which researchers could regulate themselves.

However, research has now begun to communicate more with society and research progress
impacts on society significantly. News of Dr. Shinya Yamanaka, Drs. Isamu Akasaki, Hiroshi
Amano and Shuji Nakamura had won the Nobel Prize for successfully establishing iPS cells or
blue light-emitting diode and respectively caught public attention. Now research is highly
expected by society and the expectation has become bigger for modern science and research.

On the other hand, it appears that the “3.11 Great East Japan Earthquake” and the subsequent
“Fukushima nuclear power plant accident” decreased confidence in scientists among the general
public in Japan which was relatively high prior to the above. Presently some people doubt about
credibility of researchers and even doubts the adequacy of laying the future of science and
technology in the hands of Japanese scientists, although they are the experts in this field.
Today, researchers are required to behave autonomously as individuals and as part of the
scientific community. Historically speaking, rules for self-regulation by researchers such as the
guidelines on recombinant DNA experiment have been developed since the 1970’s.

Also in recent years, regarding specific research areas such as human genome analysis, academic
societies and business communities have voluntarily started formulating ethical guidelines that
their members should comply with. It seems to be that because the progress of studies and
practical use relating to human genome, societies consisting of specialists have become matured
enough to autonomously formulate their internal guidelines. It is expected in the near future that
not only researchers in the human genome area but also those in more extended areas such as
those studying the relationship between scientific technologies and the society, those in arts and
social sciences and even their patients etc. will get together to formulate and implement
autonomous rules based on the public trust without depending on the government-led ethical
guidelines.

Many guidelines and ethical guidelines only apply to a particular field. This is because research
practices, culture and conditions differ depending on the field. Some code of ethical conduct
have presented a standard of behavior for all researchers regardless of their field, however, these
have mostly contained abstract discussions of ideals and concepts and not provided the kind of
concrete guidance that would be of use in the complicated situations arising in the actual course
of research.

In response to the mounting sense of crisis surrounding research ethics, some materials have
recently started to appear which provide researchers with concrete and practical guidance and in
addition to presenting ideals of scientific conduct. These include reports and publications from
academic societies, guidelines issued by academic journals and some code of ethical conduct.
These materials are a good place to start learning about responsible research conduct and the
Japanese research community is expected referring to the materials as standards of practice.

In the following, we will overview the general sections of a report published by the National
Academy of Sciences in the U.S. (1995) and a statement of the Science Council of Japan (SCJ)
(2013).

National Academy of Sciences, On Being a Scientist (1995)

The booklet published by the National Academy of Sciences is for graduate students and young
scientists to develop better understanding of research ethics. A Japanese translation has also been
published.[3]

The scientific research enterprise, like other human activities, is built on a foundation of trust.
Scientists trust that the results reported by others are valid. Society trusts that the results of
research reflect an honest attempt by scientists to describe the world accurately and without bias.
The level of trust that has characterized science and its relationship with society has contributed
to a period of unparalleled scientific productivity. But this trust will endure only if the scientific
community devotes itself to exemplifying and transmitting the values associated with ethical,
responsible scientific conduct.

Science Council of Japan (SCJ): the Statement: Code of Conduct for Scientists (2013)

SCJ is gravely concerned about the media coverage of frequent occurrences of misconduct such
as data fabrication by scientists who undertake leading research in Japan and is keenly aware of
its responsibility to prevent undermining the public trust toward science and sciences. SCJ as the
representative of scientists gathered opinions from the public and has revised the “Science
Council of Japan: The Statement on the Code of Conduct for Scientists” of October 2006 and
has announced the statement regarding code of conduct for scientists in 2013 as follows:
“Science is a system of knowledge based on the principles of reason and empirical proof that is
assiduously built up over time, and constitutes an irreplaceable common asset of all humanity.
Scientific research is an act that creates new knowledge by boldly pursuing the challenges of
unknown fields.

Science and scientific research exist both with and for society. Therefore, research activities
based on scientific freedom and the subjective judgments of scientists only gain social
recognition once they are premised upon public trust and the mandate of the people. Here, the
word “scientists” refers to researchers and specialists engaged in activities that create new
knowledge, or in the use and application of scientific knowledge, in all academic fields ranging
from humanities and social sciences to natural sciences, regardless of which institution they
belong to.

While scientists engaged in such intellectual activities enjoy the prerogative to pursue truth
under academic freedom based on their own expert judgments, independent of the interests of
specific authorities or organizations, as experts they also bear a grave responsibility to respond
to the mandate given to them by society at large. Especially in the modern world, where
scientific activities and their results exert a vast and profound influence on all humanity, society
demands that scientists always make ethical judgments and engage in ethical actions. There are
also societal demands for the role that should be played by science in the development process
for policy and public opinion.”

Acknowledging the above as the fundamental understanding, the “Code of Conduct for
Scientists” based on the autonomy of scientists has been formulated as minimum requirements
common to all academic disciplines, in order for scientists to gain the public trust and the
mandate of the people, advance independent and autonomous scientific research and promote the
healthy development of science. The contents include Basic Responsibilities of Scientists,
Attitude of Scientists, Scientists in Society, Research that Answers to Social Wishes,
Accountability and Disclosure, Dual Use of Scientific Research Outcomes, Research Activities,
Establishing Sound Research Environments and Thorough Educational Enlightenment,
Consideration for Human and Animal Research Subjects, Relations with Others, Dialogue with
Society, Scientific Advice to Policy Planners and Decision Makers, Compliance with Laws and
Regulations, Rejection of Discrimination and Avoiding Conflicts of Interest.

The statement of the Council is accessible from the website of the Science Council of Japan.
Government Regulations

In Japan, the conduct of scientists has been regulated by the government, in a framework that has
been developed referring to the regulations in other countries, in particular, the U.S. The history
of Japanese regulation is unique. Although the core of government regulation is legislation in the
U.S., administrative guidelines play an important role in Japan. In the following, we will outline
the development in the U.S., and then discuss the government regulations in Japan, comparing
with the U.S. case.
In the U.S.
Laws and Regulations
Public support for research grew after World War II and the public became more interested in
the way that the research is practiced. Over time, concerns began to surface about some practices
that initially on the use of animals and humans in research and later on research misconduct.
When it appeared that the research community was not doing enough to address these concerns,
government turned to regulation. The Animal Welfare Act (1966), the National Research Act
(1974) and the Health Research Extension Act (1985) were established, respectively, to protect
research animals, research subjects and to deal with research misconduct. The administrative
agency stipulates the implementing regulations based on the laws established the Congress in
US. This process proceeds according to Federal Administrative Procedure Act, and official
procedures are taken as implementation of public comments and listing on the Code of Federal
Regulations.

For example, in 1989 the Department of Health and Human Services responded to the Health
Research Extension Act by establishing the Office of Scientific Integrity (OSI) and the Office of
Scientific Integrity Review (OSIR). In 1992, these two organizations were merged to form the
Office of Research Integrity (ORI) whose role was to respond to research misconduct in the life
sciences and to promote research integrity.

Agency policies and guidelines:

Whereas laws and regulations are established through official procedures including deliberation
in the Congress, each federal agency can formulate rules and guidelines at their own authority.
The National Institutes of Health (NIH), for example, has the authority to establish policies for
grant awards. The policies are amended in timely fashion in order for the grants to be used
effectively and properly. It is in this capacity that NIH added in 1989 “Training Grant
Requirement”, a new requirement for grant applicants to receive training for responsible
conduce of conduct. Applicants are currently required to undergo at least eight hours of research
ethics training every four years, which must be comprised of both e-learning modules and
participative work such as group discussions. Further, in 2000, NIH has mandated researchers
who involve in clinical research to receive ethical education on human subject research. These
new requirements reminded research institutions that education and training should be
emphasized to promote policies in order to protect human research subjects and they have their
responsibility for supervising their researchers and members of the Institutional Review Board
(IRB).

Federal agencies also issue guidelines which recommend and a particular course of action is not
required. To help research institutions handle allegations of research misconduct, Office of
Research Integrity (ORI), established in the US Department of Health & Human Services, issued
as guidelines a “Model Policy and Procedures for Responding to Allegations of Scientific
Misconduct”. In this case, the model policy is intended to provide guidance and does not impose
binding requirements on institutions.[4] It is important for research institutions to pursue
proactive initiatives including creating their own relevant rules with references to the guidelines.
In Japan
(1) Rules in the life science area:
The following is an overview of four areas of Japanese government regulations in the field of
life sciences.

(1-1) Recombinant DNA experiments

The first government regulations on research activities in the life science area started in 1979, by
the “Guidelines on Recombinant DNA Experiment” (issued by the Ministry of Education,
Science and Culture) and regulations on the handling of radioactive materials etc. are even older.
These Guidelines were non-binding as they were not legislation and set forth containment
procedures for the prevention of biohazard resulted from the conduct of genetic engineering
from the standpoint of environmental protection. It established based on discussion of the
academic council of the Ministry of Education, Science and Culture. The method taken in the
process of developing these Guidelines, which includes discussion in the academic council and
formulation of restriction of research based on the discussion, has also been carried over in other
governmental regulations in various areas developed thereafter.

The “Administrative Procedure Act” of 1993 was developed referring to the U.S. Federal
Administrative Procedure Act and it stipulates the process of “public comment” before
establishing a new regulation. In the process of these Guidelines, public inputs are obtained
before finalizing, similarly to the establishment and revision of the U.S. federal regulations.
In addition, the “Act on the Conservation and Sustainable Use of Biological Diversity through
Regulations on the Use of Living Modified Organisms” (2003, as amended in 2007; “Cartagena
Act”), which was established as domestic provisions to enforce the Cartagena Protocol, an annex
to the international treaty “Convention on Biological Diversity”, at the time of ratification,
regulates genetic engineering both in research and commercial settings. The Act controls
activities by classifying the use into two categories; Type I Use, which uses living modified
organisms (LMOs) in the environment without containment measures, and Type II Use, which
uses LMOs with containment measures. The “Recombinant DNA Experiment Guidelines”,
which are administrative guidelines formally applied to the latter, were abolished and penal
codes have been added.

(1-2) Human subject research

Since the year 2000, Japan has started to develop guidelines in the area of human subject
research, an area in which countries including the U.S. were early to address problems. The
following set of guidelines is currently the most wide-ranging:

Ethical Guidelines for Medical and Health Research Involving Human Subjects
(December 22 2014 Public Notice by MEXT/MHLW integrated from two sets of former
guidelines)

These guidelines apply generally to all types of human subject research.

By contrast, the following sets of research guidelines apply to research in specific fields:

Guidelines for Gene-therapy Clinical Studies

(2002 Public Notice by MEXT/MHLW, as amended in 2014)
Ethical Guidelines for Human Genome/Gene Analysis Research
(2001 Public Notice by MEXT/MHLW/METI, as amended in 2014)

Also the following Act applies only to human subject research related to regenerative medicine:

Act on the Safety of Regenerative Medicine

(effective from November 25 2014)
 When this Act came into effect, the regulations which were the focus of the Guidelines on
Clinical Research Involving Human Stem Cells (“Human Stem Cell Guidelines”, issued by the
Ministry of Health, Labour and Welfare in 2006, revised in 2010, abolished in 2014) gave way
to these legal regulations alongside regenerative medicine.

In addition, the following Ethical Guidelines apply to the production and use of fertilized
embryo:

 Guidelines on the Derivation of Human Embryonic Stem Cells

(2014 Public Notice by MEXT)

 Guidelines on the Distribution and Utilization of Human Embryonic Stem Cells

(2014 Public Notice by MEXT)
 Guidelines on Research into Producing Germ Cells from Human Induced Pluripotent
Stem Cells or Human Tissue Stem Cells
(2015 Public Notice by MEXT)
 Ethical Guidelines on Assisted Reproductive Technology Studies Involving Production
of Human Fertilized Embryo
(2010 Public Notice by MEXT/MHLW as amended in 2017)

As we have seen, the majority of the administrative regulations on human subject research in
Japan are in the form of guidelines. The following four requirements are set forth in all of these
Ethical Guidelines:
1) Protecting patients and other people who participate in the research and provide information and
samples.
2) Obtaining informed consent.
3) Protecting personal information.
4) Review by the Institutional Review Board (IRB).

Ethical Guidelines are classified into the category of “administrative guidance (or legally non-
binding recommendation)” and lacks penalties such as penal codes.[5] The researchers and
institutions are expected to follow provisions of the Ethical Guidelines voluntarily. In other
words, these are rules for research activities that scientists must comply with but should not be
forced by penalties. However, in some cases, researchers who have failed to meet these
Guidelines may be requested to return the research fund by statutes instead of administrative
guidance, or may not be permitted to apply for future grants, or may be punished by their
institution.[6] Therefore, if a researcher actually violates Ethical Guidelines, it would make it
difficult for him/her to continue the research. This means that Ethical Guidelines are
substantially binding for researchers in Japan.

(1-3) Human cloning, etc.

As we have seen, research in the life sciences in Japan is generally regulated by guidelines,
however, some of the research activities in Japan are regulated by statutes. An example of which
is the “Act on Regulation of Human Cloning Techniques” of 2000 (“Cloning Technique
Regulation Act”) and it aims at regulating research that can lead to production of cloned,
chimeric or hybrid organisms and the instruments delegated by the Act, the “Guidelines on the
Handling of Specific Embryo” of 2001 (“Specific Embryo Guidelines”).

(1-4) Animal experiments

As for experimental animals, the following rules have been in force in 2006 based on the “Act
on Welfare and Management of Animals” as amended in 2005, which incorporated new
provisions regarding so-called “3R”, that includes Refinement, i.e., minimizing pain,
Replacement, i.e., using an alternative method to the use of animal wherever applicable and
Reduction, i.e., minimizing the number of animals for the use. All of these rules provide
standards for the use of experimental animals and appropriate breeding and housing thereof:

 Standards for Breeding and Housing of and Pain Alleviation for Experimental Animals
(Ministry of the Environment)
 Basic Guidelines for Proper Conduct of Animal Experiment and Related Activities in
Academic Research Institutions (MEXT)
 Basic Guidelines for Proper Conduct of Animal Experiment and Related Activities in
Academic Research Institutions Administered by MHLW (MHLW)

(2) Guidelines for research misconduct:

In this regard, MEXT Council for Science and Technology has set out the Special Committee on
Research Activities and formulated a Report in 2006.[2]

The committee states in the report that research misconduct is “against ethics for scientists and
distorts the essence or whole idea of publication of research activities and results, which is
exactly the act of impeding healthy scientific communication among researchers in the scientific
community. Specifically, typical examples of such misconduct are fabrication of obtained data
or results, falsification and plagiarism of research results of the others etc.” and further provides
research institutions with guidelines on procedures for dealing with misconduct including
establishment of a contact office in case of allegations of research misconduct, investigation or
review procedures, procedures relating to reimbursement of research fund and subsequent
measures.
Institutional Policies
To conduct human and animal research, many ethical guidelines require research institutions
such as universities and research centers to establish an institutional review board for research.
They must adequately implement and manage all research budgets and must have procedures for
investigating and reporting conflicts of interest and research misconduct. Also they must
supervise research conduct to ensure compliance with research safety rules and adequate use of
hazardous substances in research in accordance with statutes etc.

Furthermore, research institutions require to provide their members with appropriate

opportunities for learning in order to protect research subjects and experimental animals, prevent
research misconduct and elevate researchers’ ethics. “The Guidelines for Responding to
Misconduct in Research” exhort research institutions to take responsibility for preventing
research misconduct by, for instance, organizing the working environment in a way that deters
misconduct.
Personal Responsibility

Following the rules of the road for research is important for the responsible conduct of research
however, it has two important limitations. The responsible conduct of research cannot be
achieved simply by abiding to the rules which is the point to be emphasized repeatedly.

Firstly, rules generally set minimum standards for behavior rather than strive for the ideal. The
rules say that you can drive at 100 km per hour over a stretch of road but there may be times or
circumstances when 80 km would be better. If you use human subjects in research, you must
follow specific rules, although there may be situations in which you should strive for a higher
standard of conduct. Responsible research requires more than simply following rules.

Secondly, rules will not resolve some of the personal conflicts and moral dilemmas that arise in
research. They are not designed to give researchers the wisdom to recognize how to respond to
the problems ethically in the course of their work including many complex issues and conflicts
of interest they might confront in research involving human or animal subjects. Journals have
rules against listing undeserving authors on papers (individuals who have not made significant
contributions to the research described in the paper). However, these rules do not provide
definitive answers as to who made enough contribution to justify being named as an author on a
paper or where multiple authors are named and in what order those names should appear. Some
organizations have been trying to clarify authorship criteria, one example being the
“Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in
Medical Journals” issued by the International Committee of Medical Journal Editors [7], but
since each field has its own customary criteria for determining authorship and the order in which
authors are named, very often there are more than one right answer. While there have in recent
years been more and more efforts on the level of academic journals and societies to clearly
define criteria for what constitutes responsible research conduct in such situations above,
researchers will still face ethical dilemmas in research. They should be able to recognize these
dilemmas and know how to resolve these problems.

The rules of the road for research therefore need to be supplemented with good judgment and a
strong sense of personal integrity. When meeting deadlines, you can cut corners by filling in a
few missing data points without actually running the experiments or adding a few references to
your notes that you have not read. You can resist sharing data with colleagues or leave some
information on method out of a publication to slow down the competition. You can ignore your
responsibilities to students or a mentor in order to get your own work done. You can do all of
these things and more, but should you?

In the final analysis, whatever decision you make when you confront a difficult decision about
responsibility in research, you are the one who has to live with the consequences of that
decision. When making such decisions, you may obtain some clues from the code of conduct or
code of ethics of an academic society in your field or from the submission guidelines or style
guide of an academic journal (for example, “Recommendations for the Conduct, Reporting,
Editing, and Publication of Scholarly Work in Medical Journals” [7]). You may also find useful
information in relevant units of the CITI Japan e-learning materials or in educational guides to
research ethics such as “For the Sound Development of Science: Advice for Conscientious
Scientists” [8]. Although you might still be unsure what to do even after referring to these
materials, if you are uncertain whether a particular course of action is responsible, subject it to
one simple test. Imagine what you are preparing to do will be reported the next day on the front
page of your local newspaper. If you are comfortable having colleagues, friends, and family
know what you have done, chances are you acted responsibly and provided, of course, you also
understand your responsibilities as a researcher. Needless to say, before embarking on that
course of action, it is essential to acquire a minimum amount of knowledge about what it means
to act responsibly as a researcher.
There is no need to shoulder the problem alone and it can be worthwhile seeking advice from
your labmates, colleagues from nearby labs and other researchers in your field. They will look at
your problems from a different perspective and might come up with a solution that you would
not have thought of on your own. You can also make use of the consultation services that are
available at your research institution. The most important thing is to always act out of an
awareness of what it means to act conscientiously as a researcher.

Questions for discussion:

 Where and when do researchers learn about the responsible conduct of research?
 How do researchers learn about the responsible conduct of research?
 How should researchers learn about the responsible conduct of research?
 What factors influence researchers’ attitudes toward the responsible conduct of research?
 How is integrity in research monitored?
 Is self-regulation of integrity in research effective?
 What are some examples of unconscientious research conduct in your field of research?
How do you think you should react when you encounter this kind of conduct?