Biomedical Engineering Reference
In-Depth Information
Safety
Standard
Research
Testing
Clinical
Use
Medical
Device
MATERIALS
Ethical
Issues
Technical
Issues
Figure 11.1
Compliance issues in biomedical practice.
this chapter, the basics of biomedical ethics and basic internal review boards are
described. Further, some of the safety standards to be adhered to are also discussed.
11.2 Fundamentals of Bioethics
11.2.1 Classical Ethical Theories
Ethics as a philosophical discipline is the study of morality as distinguished from the
scientific study of morality. Ethics as applied to medical practice dates back to the
ancient civilization by the symbolic adherence to the Hippocratic oath. With the ad-
vancement of biomedical technology, ethics in medicine or “bioethics” has become
an autonomous discipline. The topic of ethics is usually subdivided into normative
ethics and metaethics, although the precise relationship of these two branches is
a matter of some dispute. Normative ethics attempts to establish what justifiable
moral right is and what morally wrong is with regard to human action. General
normative ethics deals with the “right” moral theory and applied normative ethics
deals with particular moral problems such as biomedical ethics, business ethics, and
legal ethics. Bioethics could be considered as a form of general normative ethics.
Metaethics is concerned with tasks such as analyzing the nature of moral judgments
and specifying appropriate methods for the justification of particular moral judg-
ments and theoretical systems (e.g., duty, rights, and moral reasoning).
Classical ethical theories are broadly classified into two categories: teleological
and deontological. Teleologists (
telos
means goal, end, or purpose in Greek) base
their moral theory on the tenet that there are some things such as pleasure, hap-
piness, ideals (including freedom, knowledge, justice, and beauty) and preferences
which do not have instrumental measurements, but have value in themselves. This
is called intrinsic value. An example of the teleological system is utilitarianism,
developed by British philosopher Jeremy Bentham. According to utilitarians, the
purpose of morality is to guide people's actions in such a way as to produce a better
world. According to Bentham's hedonistic theory, pleasure has a positive intrinsic
value and pain has a negative intrinsic value. Others refined the utilitarian principle
to a systematic way of calculating goods. Many utilitarian thinkers embrace more
