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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 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?

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?

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. 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?

Dr. Trotter is a molecular geneticist who applies Darwin’s
principle “survival of the fi ttest” to his laboratory environment. Each year,
he hires two new postdoctoral students for one year. He assigns them both to
work on the same experiment. Whoever fi nishes the work fi rst, with
reproducible results, will get to be an author on a paper; the loser will not.
He runs several such contests during the year. At the end of the year, the
postdoctoral student who has the best results will be hired for a three-year
position, and the loser will be terminated. What do you think about this Dr.
Trotter’s policy? Is it ethical?

A large pharmaceutical company awards a $6 million contract
for three years to a researcher at a university to conduct trials on patients.
The company’s proposed conditions are as follows:
1. Six-month delay in publication of research outcomes
2. First rights of patenting and licensing of the
discoveries
3. The researcher serves on its scientifi c advisory board
4. The researcher will conduct the research
• What is the role of the university in this arrangement?
• Should the university accept the terms as they are offered
or make a counteroffer? What should the counteroffer be?
• How would you manage the confl ict, if one exists?

A large pharmaceutical company pays a researcher at a
university consulting fees of $10,000 per year, and once or twice a year an
honoraria of about $3,000 to give a talk. The same researcher also serves on
one of the FDA advisory councils.
• Do you have any concerns? What are they?
• How should these concerns, if any, be managed?

A fi fth-year graduate student about to receive her doctoral
degree discovers through gossip at a national meeting that her research has
been tapped by a company. After talking to her mentor, she learns he has been
discussing patents and obtaining a contract to develop the discovery into a
patent. The student was told that all this would occur in the future and that
she has nothing to do with it. She was also told that her data will earn her
the PhD she sought and that is what the work was for.
• Do you see any problem?
• Does the student have any grievance toward her mentor?
• What should the student do, if anything?
• How you would have dealt with this situation if you were
the mentor?

Five large industrial plants near a university are planning
to give $12 million each to endow a Center for Environmental Science (CES). The
total gift to the university will be $60 million. As a condition of the gift,
the companies require the following:
1. The CES will have a governing board consisting of 10
members of academia and industry; fi ve members of the board will represent the
companies giving the gift.
2. The governing board will have the power to appoint a
director of the CES and will also approve all faculty appointments to the CES.
3. The governing board will also have the power to approve
course development activities, conferences, guest lectureships, and research
projects sponsored by the CES.
• Do you see any problems with this arrangement?
• Should the university accept this gift?