Biomedical Engineering Reference
In-Depth Information
The three-step facts/options/values path concerns the “how” of decisions, but equally
important is the “who.” Someone must make every single medical decision. Ideally it will
be made by the person most intimately involved: the patient. Very often, however, it is made
by someone else—spouse, family, physician—or a group of those people acting on behalf of
the patient. It is, therefore, important to recognize the four concentric circles of consent:
The first, and primary, circle is the patient.
The second circle is the use of advance directives—that is, choosing in advance through
the use of such documents as the living will.
The third circle is others deciding for the patient—that is, the move from personal control
to surrogate control.
The fourth and final circle is the courts and bureaucrats. It is the arena of last resort where
our society has decreed that we go when the patient may be incapacitated, where there is
no clear advance directive, and where it is not clear who should make the decision.
These three steps and four circles are simply attempts to impose some order on the chaos
that is medical decision making. They can help individuals take control.
2.6 HUMAN EXPERIMENTATION
Medical research has long held an exalted position in our modern society. It has been
acclaimed for its significant achievements that range from the development of the Salk
and Sabin vaccines for polio to the development of artificial organs. In order to determine
their effectiveness and value, however, these new drugs and medical devices eventually
are used on humans. The issue is, therefore, not only whether humans should be involved
in clinical studies designed to benefit themselves or their fellow humans but also clar-
ifying or defining more precisely the conditions under which such studies are to be
permitted.
For example, consider the case of a 50-year-old female patient suffering from severe
coronary artery disease. What guidelines should be followed in the process of experiment-
ing with new drugs or devices that may or may not help her? Should only those proce-
dures viewed as potentially beneficial to her be tried? Should experimental diagnostic
procedures or equipment be tested on this patient to evaluate their effectiveness when
compared to more accepted techniques, even though they will not be directly beneficial
to the patient?
On the other hand, consider the situation of conducting research on the human fetus.
This type of research is possible as a result of the legalization of abortion in the United
States, as well as the technological advances that have made fetal studies more practical
than in the past. Under what conditions should medical research be conducted on these
subjects? Should potentially hazardous drugs be given to women planning to have abor-
tions to determine the effect of these drugs on the fetus? Should the fetus, once aborted,
be used in any experimental studies? Although these questions are difficult to answer, clin-
ical researchers responsible for the well-being of their patients must face the moral issues
involved in testing new equipment and procedures and at the same time safeguard the
individual rights of their patients.
