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1. How would you introduce quality assurance and integrity
into your steps for carrying out research?
2. Can you give an example of how data can be “modifi ed” to
suit inappropriate goals in steps of research?

1. Give an example of an experimental design that would bias
the data
2. When would you be justifi ed in refusing to share data?
3. How many of these GRPs do people follow (or fail to
follow) in your research environment? Why?

How do you ensure that peer review/data audit is workable,
and how would you modify it to accomplish its purpose in your research
environment? Can you suggest a whole new system to ensure the quality and
integrity of research data?

A medical student has a summer job with a faculty mentor at
a research university. The student is bright, hard working, and industrious and
hopes to publish a paper at the end of the summer. He is the son of a colleague
of the mentor at a distant university. The student is working on a cancer cell
line that requires three weeks to grow in order to test for the development of
a specifi c antibody. His project plan is to identify the antibody by the end
of the summer. The student has written a short paper describing his work. The
mentor went over the raw data and found that some of the data were written on
pieces of yellow pads without clearly identifying from which experiment the
data came. She also noticed that some of the experiments shown in the paper’s
table were repeated several times without an explanation as to why. The mentor
was not happy about the data or the paper, but she likes the student and does
not want to discourage him from a potential career in research.
• What is the primary responsibility of the mentor?
• Should the mentor write a short paper and send it for
publication?
• Should the student write a short paper and send it for
publication?
• If you were the mentor, what would you do?
• Should the mentor or her representative have paid more
attention to the student’s work during the course of the summer? Should the
student been taught some quality control and/or GRP during the summer?

A graduate student at a research university fi nished her
dissertation and graduated with honors. Her mentor gave the continuation of the
project to a new graduate student. As usual, the mentor gave the entire
laboratory notebook (or computer disk) to the new graduate student, who had to
repeat the isolation of the newly discovered chemical entity with high-pressure
liquidchromatography (HPLC) in order to follow up the chemical and physical
characterization of the new compound. The new graduate student found that if he
follows the exact method described in the laboratory notebooks and published by
the previous student, he obtains the new chemical entity not at the same HPLC
location as published, but slightly shifted to the left, and there was a
different peak at the location stated. However, the new student discovered that
if the ionic strength is doubled, he could fi nd the same chemical at the same
location in accordance with the previous student’s dissertation. The new
student discussed with the mentor how he should proceed. The mentor replied,
“Why make a fuss about it? Just proceed with your slightly different method and
we can move on.”
• What are the responsibilities of the new student? Should
the new student refuse to accommodate the mentor’s request?
• Should the new student have read more thoroughly the
relevant laboratory notebooks prior to starting the experiment? Should there
have been a paper trail of the error in the laboratory notebook? Do you think
the error was intentional, and does it matter?
• If the laboratory notebook does not reveal the error, is
it then misconduct? Does it indicate that a better recording of the data would
have been helpful?
• Should the mentor have had training and education in
responsible conduct of research (RCR)? If the mentor has had the necessary
training in RCR, what actions would you suggest?
• Can you propose a reasonable resolution to the problem?

A new postdoctoral fellow in a genetic research laboratory
must sequence a 4-kDa fragment. After the sequence, he is to prepare a 200-base
unit to use as a potential regulator of a DNA-related enzyme. The 4-kDa
fragment is suspected to contain the 200-base unit. The sequence of the
200-base unit is already known in the literature, but not as part of the 4-kDa
fragment, and not as a potential regulator. The fact that the 200-base unit is
known is what gave the mentor the idea that it may have a functional role. The
new postdoctoral fellow tried for three months to sequence the 4-kDa fragment,
without success, and so simply proceeded to synthesize the 200-base unit without
locating it within the fragment. After two years of research, the 4-kDa
fragment appeared to play a key regulatory role in an important discovery, but
at this time the mentor learned that the postdoc never sequenced the original
4-kDa fragment. The mentor could never fi nd a “good” record of the attempts to
sequence the 4-kDa fragment.
• What impression do you gather about how this mentor runs
the laboratory?
• Should there be records of sequence attempts of the 4-kDa
fragment?
• How should the mentor proceed?
• If you were the new postdoc, what steps you would take to
ensure proper records of your work?

A graduate student prepared for her thesis a table showing
that a toxic substance inhibits an enzyme’s activity by about 20%. She has done
only six experiments. The mentor looked at the data and found that one of the
data points showed a stimulation of 20% and that this point is the one that
skewed the results to a low level of inhibition with a large standard of
deviation. The mentor further determined with the student that the outlier is
outside the mean by 2.1 times the standard derivation and that it is reasonable
not to include it with the rest of the data. This would make the inhibition
about 30% and thus make the potential paper more in line with other research
results and hence more “respectable.” The mentor instructed the student to do
so.
• Should the student simply proceed with the mentor’s
instructions?
• Should the mentor have been more specifi c regarding what to
do with the outlier? In what way?
• Can you propose a resolution? Should the outlier be
mentioned in the paper?
• How should this laboratory handle similar issues in the
future? Should each laboratory have an agreed-upon SOP for such a statistical
issue?

A social scientist is conducting an anonymous survey of
college students on their opinions on various academic integrity issues. The
survey is administered in four different sections of an introduction to
sociology. The survey includes 20 questions in which respondents can use a
Likert scale to answer various questions: 1 = strongly agree, 2 = agree, 3 =
neither agree nor disagree, 4 = disagree, and 5 = strongly disagree. The survey
also includes 10 open-ended questions that ask for respondents to state their
opinions or attitudes. The social scientist distributes 480 surveys and 320
students respond. A graduate student is helping the social scientist compile
the survey data. When examining the surveys, the student encounters some
problems. First, it appears that eight surveys are practical jokes. The persons
fi lling out these surveys wrote obscene comments and for many questions added
extra numbers to the Likert scale. Although some of the 20 Likert-scale
questions in these surveys appear to be usable, others are not. Second, in 35
surveys, the respondents appeared to have misunderstood the instructions on how
to use the Likert scale. They answered “5” on questions where it would seem
that “1” would be the most logical answer, given their answers to other
Likert-scale questions and their written comments. Third, on 29 surveys, the
respondents wrote their names on the survey, when they were instructed not to
do so
• How should the researchers deal with these issues with
their data?
• Should they try to edit/fi x surveys that have problems?
• Should they throw away any surveys? Which ones?
• How might their decisions concerning the disposition of
these surveys affect their overall results?

A pharmaceutical company conducts fi ve different phase I
studies on a new drug to establish its safety in healthy individuals. Three of
these studies had a p-value < 0.05,="" indicating="" signifi="" cant="" results;="" two="" had="" a="" p-value=""> 0.05, indicating nonsignifi cant results. As it so happens,
undesirable side effects were observed in one of the studies with the
nonsignifi cant results. None of the studies with signifi cant results had a
signifi cant proportion of side effects. The researchers report these results
to the U.S. Food and Drug Administration and in a publication, but they do not
mention the nonsignifi cant results.
• Is there an ethical responsibility to report all of the
data? Would it make a difference if the subjects were not human (i.e.,
animals)?
• What are the responsibilities of the researchers to this
company, to themselves, and to society?
• Should there be a federal mandate to report all side
effects?
• How could the GRP help in this case? Would a quality
assurance program be helpful?

A graduate student is planning to write a thesis on the affects
of exercise in managing diabetes in dogs. He is planning to do a trial with
dogs with diabetes, control matched with respect to age, breed, sex, and other
factors. One group will receive no extra exercise; another group will receive
30 minutes of exercise a day; and another group will receive two 30-minute
periods of exercise per day. He will measure blood sugar levels in all of these
dogs, as well as the quantities of drugs used to control diabetes. The graduate
student is also conducting a literature review on the subject as a background
to his research. In conducting this review, he searches various computer
databases, such as the Science Citation Index and MEDLINE, for the past fi ve
years. He gathers many abstracts and papers. For much of the research, he reads
only abstracts and not the full papers. Also, he does not include some of the
important work on diabetes in dogs that took place more than fi ve years ago.
• Should the graduate student read articles, not just
abstracts?
• If he cites an article in a publication or in his thesis,
should he read the full article?
• If he cites a book, should he read the full book or only
the part that he uses?
• Should the graduate student include articles published
more than fi ve years ago?