Biomedical Engineering Reference
In-Depth Information
1.
Is this an example of nonvalidated practice?
2.
Is informed consent still required?
A week after the operation, Barney Clark began having seizures from head to toe. Suffering a
seizure, Clark's unconscious body quivered for several hours. The seizures and spells of mental
confusion continued throughout the next months. As a result, Clark expressed a desire to die.
Although he did issue a positive statement during a videotaped interview, Clark was not a
happy man, tethered to a huge machine, barely conscious, and in some pain. In March 1983,
Barney Clark died of multiple organ collapse.
3.
Discuss in detail the notions of “criteria for success” and quality of life in this case.
4.
Barney Clark suffered a great deal. In response to this, who should be the responsible party in
deciding what is right for the patient? When both sides hope for positive results, is it possible
to make an unbiased decision based on what's best for the patient?
One such intervention is “nonvalidated practice,” which may encompass prevention as
well as diagnosed therapy. The primary purpose of the use of a nonvalidated practice is
to benefit the patient while emphasizing that it has not been shown to be safe and effica-
cious. For humans to be subjected to nonvalidated practice, they must be properly informed
and give their consent.
2.8 INFORMED CONSENT
Informed consent has long been considered by many to be the most important moral
issue in human experimentation. It is the principal condition that must be satisfied in order
for human experimentation to be considered both lawful and ethical. All adults have the
legal capacity to give medical consent (unless specifically denied through some legal
process). As a result, issues concerning legal capability are usually limited to minors. Many
states, if not all, have some exceptions that allow minors to give consent.
Informed consent is an attempt to preserve the rights of individuals by giving them the
opportunity for self-determination—that is, to determine for themselves whether they wish
to participate in any experimental effort. In 1964, the World Medical Association (WMA) in
Finland endorsed a code of ethics for human experimentation as an attempt to provide
some guidelines in this area. In October 2000, the 52nd WMA General Assembly in Edin-
burgh, Scotland, revised these guidelines.
Because it is often essential to use the results obtained in human experiments to further
scientific knowledge, the World Medical Association prepared the following recommenda-
tions to serve as a guide to physicians all over the world. However, it is important to point
out that these guidelines do not relieve physicians, scientists, and engineers from criminal,
civil, and ethical responsibilities dictated by the laws of their own countries.
2.8.1 Basic Principles
Biomedical research involving human subjects must conform to generally accepted
scientific principles and should be based on adequately performed laboratory and
animal experimentation and on a thorough knowledge of the scientific literature.
