Biomedical Engineering Reference
In-Depth Information
blankets. The incubator also aids in preventing infection, as well as in stabilizing the humidity of
the child's environment. By keeping the temperature and humidity levels of the newborn's envi-
ronment static, the baby remains well hydrated and water loss is kept to a minimum.
A complication that many preterm infants suffer from is the inability to breathe normally on
their own. The child may be completely unable to breathe for himself, or he may suffer from a
condition known as apnea, where the breathing pattern is either aperiodic or irregular.
In these cases, children susceptible to an apneic event are closely monitored so if they stop
breathing, nurses can rush to the bedside and wake them up. However, it is often minutes before
the nurse can arrive at the scene. To facilitate the process of waking the infant experiencing an
apneic event, biomedical engineers developed a tactile vibrator that when triggered by such an
event vibrates against the infant's foot and wakes her. In order to prove that the device is effective
and safe, a human experiment must be initiated. In this case, the following questions need to
be resolved:
1.
Who is responsible for proposing the conduction of this study?
2.
What should the process of approval of such a study include?
3.
What should the policy be related to informed consent?
4.
Should changes that were made in the device during the course of the study, which would alter
the nature of the initially proposed device, be allowed?
2.7 D
EFINITION AND PURPOSE OF EXPERIMENTAT
ION
One may ask, what exactly constitutes a human experiment? Although experimental
protocols may vary, it is generally accepted that human experimentation occurs whenever
the clinical situation of the individual is consciously manipulated to gather information
regarding the capability of drugs and devices. In the past, experiments involving human
subjects have been classified as either therapeutic or nontherapeutic. A
therapeutic experi-
ment
is one that may have direct benefit for the patient, while the goal of
nontherapeutic
research
is to provide additional knowledge without direct benefit to the person. The central
difference is a matter of intent or aim rather than results.
Throughout medical history, there have been numerous examples of therapeutic research
projects. The use of nonconventional radiotherapy to inhibit the progress of a malignant
cancer, of pacemakers to provide the necessary electrical stimulation for proper heart func-
tion, or of artificial kidneys to mimic nature's function and remove poisons from the blood
were all, at one time, considered novel approaches that might have some value for the
patient. In the process, they were tried and found not only to be beneficial for the individual
patient but also for humankind.
Nontherapeutic research has been another important vehicle for medical progress. Experi-
ments designed to study the impact of infection from the hepatitis virus or the malarial para-
site or the procedures involved in cardiac catheterization have had significant impacts on
the advancement of medical science and the ultimate development of appropriate medical
procedures for the benefit of all humans.
In the mid-1970s, the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research offered the terms
practice
and
research
to replace the
