Category: Writing

Dr. Barnes has been telling dirty jokes in his anatomy and
physiology class for as long as anyone can remember. He is a very friendly,
outgoing teacher, gets excellent evaluations on his teaching, and has won
several teaching awards. Dr. Barnes has three teaching assistants who help with
various aspects of the course. During one of the labs for the course, one of
his teaching assistants, Heather, overhears two female students complaining
about his jokes. They fi nd his jokes both rude and offensive. Heather talks to
the two students. She says that she also found his jokes rude and offensive at
fi rst, but that she got used to them and they don’t bother her anymore. They
say that they do not want to get used to his jokes and that they are planning
to talk to the dean of students. What should Heather do?

Drs. Kessenbaum and Wilcox are conducting a long-term,
observational study of the health of pesticide applicators. The protocol calls
for an initial health assessment, including a health history, physical exam,
and blood and urine tests. The researchers will also collect a DNA sample from
cheek scrapings and collect dust samples from their clothing and hair and
underneath their fi ngernails. After the initial health assessment, the
applicators will complete yearly health surveys and undergo a full health
assessment every four years. The researchers will follow the subjects for at least
25 years. Their work is funded by the NIH. Drs. Kessenbaum and Wilcox have been
conducting their study for 15 years, and they have compiled an impressive
database. They have already published more than a dozen papers from the
database. Whenever they share data, they require researchers who request it to
sign elaborate data-sharing agreements, which spell out clearly how the data
will be used. In the past month, they have received some requests to access
their database. One request has come from a pesticide company, another has come
from a competing research team also studying the health of pesticide
applicators, and another has come from a radical environmental group with an
anti-pesticide agenda.
• How should Drs. Kessenbaum and Wilcox handle these requests
to access their database?
• Is it ethical to require people who request data to sign
elaborate data sharing agreements?

Dr. Reno is a junior investigator who has just received her
fi rst major NIH grant. She has used NIH funds to create a transgenic mouse
model to study depression. The mouse has a genetic defect the leads to an
underproduction of serotonin. She has used the model to show how a compound
found in an herbal medicine increases serotonin levels in mice and also
produces effects associated with normal (i.e., nondepressed) behavior, such as
normal levels of exercise and normal sleep patterns. Dr. Reno applies for a
patent on this compound with the intent of eventually testing it on human
subjects. She also publishes a paper in a high-impact journal describing her
work with the mouse model. Almost immediately after the paper appears in print,
she receives dozens of requests from researchers who would like to use
hertransgenic mice in their own research. Dr. Reno is fl attered but also
overwhelmed. She has barely enough mice for her own work, and she doesn’t want
to turn her laboratory into a factory for producing mice for someone else’s
research.
• How should Dr. Reno deal with these requests to share
transgenic mice?
• Does she have an obligation to the share the mice?

A pesticide company conducts a small study (25 human
subjects) on the adverse effects associated with one of its products. In the
study, the researchers observe the subjects for 48 hours after they ingest a
trace amount of the pesticide. The amount of pesticide ingested is barely large
enough to show up in a urine test. The researchers measure vital signs and
collect blood and urine samples. They perform chemical tests on the blood and
urine to measure biomarkers associated with toxicity and damage to various body
tissues (e.g., heart, liver, kidney). At the end of the study, the researchers
fi nd that the pesticide produced no measurable adverse effects at the dose
level administered to the subjects. The company plans to submit data from the
study to the U.S. Environmental Protection Agency (EPA) to argue that the EPA
should allow pesticide applicators to increase the amount of the chemical they
apply to fruit trees. What are some of the statistical, methodological, and
ethical issues in this case?

Two physicians in a department of emergency medicine
reviewed the medical records of all patients admitted for diabetic crisis to
the hospital in the last fi ve years. They correlated several different
variables, such as length of hospital stay, survival, cost of care,
rehospitalization, age, race, and family history. If they found any
statistically signifi cant trends (p-values ≤ 0.05), they planned to
publish those results, and they planned to ask a statistician to help them
determine if any of their correlations are signifi cant.
• Do you see any potential methodological or ethical
problems with this study design?
• Does it conform to the rules described in this chapter?
• Would it be unethical for the researchers to publish their
results if they do not make it clear in the paper that they have mined the data
for signifi cant trends?
• Would you be more confi dent in their research if they had
a hypothesis prior to conducting the study?

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?

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 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 graduate student was studying at a university where his
faculty mentor is also a full-time employee of the affi liated hospital. He and
his mentor discovered a major environmental airborne toxin, and the media
covered the story. The mentor then died suddenly of a heart attack. They had a
manuscript already written and about to be submitted for publication in a
prestigious journal. The chair of the department, who worked in a closely
related area, became the new student’s mentor. She took the manuscript and put
her name as the senior author (last) and eliminated the name of the deceased.
She had no involvement in the project prior to the death of the former mentor.
The paper was published after minor revision.
• What should the student do?
• What should the mentor do?

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?