Category: Writing

1. In your opinion, should there be a difference between
informed consent for volunteering as a human subject and informed consent for
medical treatment? What would those differences be, if any? Why?
2. Do you think IRBs are doing a good job of protecting
human subjects? Can they? How would you improve the system, if you believe
improvement is needed?

1. Is the media paying too much, just enough, or too little
attention to questionable research with human subjects? Why do you think that
is so?
2. Do you think freedom of inquiry should surpass other
values? Why?
3. What risks would you and members of your family take for
public good? Why?

Dr. Murphy is studying aggression in rats. She is
experimenting with a variety of environmental and hormonal infl uences on
aggression in order to study the relationship between aggression and
overcrowding, stress, food deprivation, and levels of sex hormones. In some of
her experiments, rats will be placed in crowded cages; in others they will be
deprived of food; in others they will receive high doses of testosterone. She
will attempt to minimize pain and discomfort to the rats, but they are likely
to fi ght and injure each other. Would you allow Dr. Murphy to do this
experiment?

The aim of a study is to better understand condom use among
adolescents and the psychosocial factors that increase or decrease condom use.
The study is a survey of adolescent attitudes and beliefs about sexuality. It
will include many different questions about sexuality as well as questions
about alcohol and drug use, violence, musical tastes, and religion. The
subjects will not be told the exact purpose of the study when they take the
survey, but they will be told the results of the study. Subjects will be
recruited from three local high schools. Personal identifi ers will be removed
for data analysis and publication. High school health education teachers will
help administer the survey. Taking the survey will suffi ce as proof of
consent. Subjects may refuse to take the survey without penalty. Parents will
be notifi ed about the study and may refuse to allow their children to
participate.
• In what specifi c category of risk (discussed above) would
you place this protocol? Why?
• How would you protect the privacy of subjects?
• Why should the parents be involved?
• Should the community be concerned?

A researcher is conducting experiments on tumor suppression
with transgenic oncomice. In his experiments, he allows the mice to develop
cancerous tumors, and he then treats them with different gene therapy vectors
designed to inhibit cell cancer growth. Two graduate students and two lab
technicians work with him on his project. Last week, one of his graduate
students informed the IACUC chair that several mice had developed tumors that
impeded their free movement in the cages. The tumors were growing around their
front legs and on their chests. This was a violation of the researcher’s animal
protocol. The graduate student also reported that the researcher has been out
of town consulting with biotech companies and has not been paying close
attention to work being conducted in his lab. How should the IACUC handle this
problem?

Lead poison is a serious problem in houses built prior to 1980.
There are data to indicate that lead poisoning in children causes serious defi
cits in the neurodevelopment. Between 1995 and 1998, investigators from the
Kennedy Krieger Institute (KKI) at Johns Hopkins University enrolled 50 poor
families with very young children living in Baltimore for a lead abatement
experiment. The families were randomly assigned to receive one of three
different abatement programs to reduce lead, or to be in one of two control
groups. The three different abatement programs, which were less expensive than
complete lead abatement, ranged in cost from $1,650 to $7,000. The two control
groups included one group of families with full lead abatement and one living
in housing without lead paint. The recruited families had children ranging in
age from 6 months to 7 years. The investigators collaborated with the landlords
on this experiment. Landlords were encouraged to recruit families with young
children and in some cases were told that they must have young children. The
investigators helped the landlords apply for grants for ead abatement. The lead
level in each house was measured by wipe tests and air samples. Each house was
tested before and after abatement and while the families were living in these
houses. The blood level of lead in each child was also measured at different
time periods. The informed consent document stated that once the investigators
know the child’s blood lead level, “we would contact you to discuss a summary
of house test results and steps that you could take to reduce any risks of
exposure.” The study was sponsored by the EPA and the Maryland Department of
Housing and Community Development. Families of two children sued the KKI for
negligence. The suit alleged that the investigators failed to inform the
parents in a timely fashion about dangerous lead levels and failed to provide
adequate informed consent (Grimes v. Kennedy Krieger Institute, Inc. 2001). One
of the children, Erika Grimes, was ten months old when she fi rst lived in the
house, and the other child, Myron Higgins, was three and a half years old. The
acceptable lead level for a child is 10 µg/dl. KKI found that Erika Grimes’s
blood level was higher than normal. The allegations are that KKI waited nine
months to inform the Grimes family. Her original blood level was 9 µg/dl and
subsequently her blood level was 32 µg/dl and 22 µg/dl. Medical treatment or
intervention is indicated at 25 µg/dl. Erika then was moved out of the house.
The defendants moved to dismiss the case, on the grounds that the researchers
had no legal duties to the subjects that could justify a negligence claim. The
circuit court agreed. The plaintiffs appealed the case to the Maryland Court of
Special Appeals. The appellate court overruled the lower court’s decision on
the grounds that the investigators had legal duties to the research subjects
because they have a “special relationship” with the subjects. The appellate
court remanded the case to the circuit court for fi nding consistent with its
opinion, and opined that children can only participate in research that poses
no risk or research in which they are expected to receive a direct medical
benefi t. This opinion sent shock waves through the research community, as it
would invalidate (in the State of Maryland) research conducted in accordance
with 45 CFR 46.405–407. In response to a swell of protest from research
institutions, the appellate court issued a clarifi cation that their order does
not bar children’s participation in nontherapeutic research with minimal risk.
In discussing the case, the appellate court also stated: “There was no complete
and clear explanation in the consent agreements signed by the parents of the
children that the research to be conducted was designed, at least in signifi
cant part, to measure the success of the abatement procedure.” The court went
further and showed its dismay at the design of the study and stated that
“researchers intended that the children be the canaries in the mines, but never
clearly told the parents” (Shamoo 2002; see also Kopelman 2002).
• What regulatory rule would govern this study, and which
section?
• Were the risks minimized?
• Were the risks justifi ed in relation to benefi ts?
• Was the selection of subjects equitable?
• Was informed consent adequate?

Researchers are developing an animal model for a rare
genetic disorder known as osteogenesis imperfecta. Children born with this
disorder have a genetic mutation that prevents them from forming strong bones.
Neonates usually have many broken bones at birth and usually die within 6
months, or within a year at most. They usually also have severe brain damage,
organ damage, and a variety of infections. Researchers plan to develop a
transgenic mouse with a genetic defect that results in a condition similar to
osteogenesis imperfecta. They will study the etiology of the disease in mice as
well as a variety of treatment modalities. Do you have an ethical problem with this
experiment? Why or why not?