Teaching Ethical Issues in Biomedical Engineering

Int. J. Engng Ed. Vol. 15, No. 4, pp. 276±281, 1999
0949-149X/91 $3.00+0.00
Printed in Great Britain.
# 1999 TEMPUS Publications.
Teaching Ethical Issues in Biomedical
Engineering*
JORGE E. MONZON
Facultad de Ciencias Exactas y Naturales y Agrimensura, Universidad Nacional del Nordeste,
Casilla de Correo 445, (3400) Corrientes, Argentina. E-mail: jemonzon@exa.unne.edu.ar
In many places throughout the world, Biomedical Engineering (BME) still awaits formal
recognition as a profession. Its intrinsically multi and interdisciplinary characteristics partly
account for that delay. This is aggravated by the lack of precise ethical rules that delineate and
delimit the professional responsibility of biomedical engineers. In this paper, some of the ethical
issues that are of interest to biomedical engineers and how they can be integrated in biomedical
engineering education are discussed. A program outline for bioethics, which includes the topics that
should be addressed in engineering schools, is presented.
INTRODUCTION
work on substances that do not show a pre-
established order as the living organism does.
IN MANY PLACES throughout the world, Bio-
Technology can alter the essence of a living
medical Engineering (BME) still awaits formal
organismÐa working unitÐwhen affecting its
recognition as a profession. Its intrinsically multi
components; these are arranged according to a
and interdisciplinary characteristics partly account
predetermined scheme in preparation for a
for that delay. This is aggravated by the lack of
particular function. It is difficult then to clearly
precise ethical rules that delineate and delimit the
identify the set of moral principles that govern
professional responsibility of biomedical engineers.
biomedical engineers, moreover, if these principles
Thoughtful attention must be paid to the factors
only conform to the standards of traditional
that actively contribute to the lack of recognition
engineering. Thus, three questions arise for BME
of BME as a profession. Some of this may be due
Ethics educators: what to teach, when to teach,
to the confusion that is created through the over-
and how to teach. The following sections are
lap of professional roles between biomedical engi-
intended to address these questions.
neers and other health care personnel. Professional
ethics is one of the areas in which this overlap
occurs. Medical ethic postulates are frequently
considered by extension to encompass biomedical
ETHICAL ISSUES
engineering ethics, although the moral obligations
of medicine and BME differ due to the nature of
Bioethics integrates social as well as ethical and
both activities [1]. On the other hand, these two
legal issues. It must be noted, however, that
disciplines share a number of professional issues,
bioethics is strongly biased to medical issues [3].
and the consequences of their actions are common
Due to its political and social implications,
since they both may affect human life.
biotechnology, an area that is closely linked to
Over the last decades, scientific and techno-
BME, plays a leading role in defining moral
logical developments in medicine and engineering
standards of professional activity. However, bio-
have contributed to coining the term `bioethics'.
technology represents only a partial view of BME.
This `ethics of life' is everybody's responsibility
It is imperative that biomedical engineers think
and not just a matter of a specific professional
of all possible consequences of their profession.
morality [2]. Thus, teaching ethics in biomedical
Whether a basic researcher or a clinical engineer,
engineering must now conform to the broader
the biomedical engineer must be able to answer for
scope of `bioethics', a concept that implies a
his or her conduct, i.e. they must be responsible for
community concern.
their professional behaviour before the community
Traditionally, engineering education has been
and within the provisions of the law. In general,
oriented towards inert material, a material lacking
legal responsibility for the use of procedures,
usual or anticipated action from a chemical or
techniques, and devices remains a medical issue
biological point of view. Problems arise when
even though the basic research and design that led
engineers deal with living material either directly
to those procedures was performed by engineers
or indirectly. Classical tools were `designed' to
who followed professional guidelines.
Any course in bioethics should include the
* Accepted 15 May 1999.
basic methodology to distinguish what is right
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Teaching Ethical Issues in Biomedical Engineering
277
We, the members of the IEEE, in recognition of the importance of our technologies in affecting the quality of life throughout
the world, and in accepting a personal obligation to our profession, its members and the communities we serve, do hereby
commit ourselves to the highest ethical and professional conduct and agree:
to accept responsibility in making engineering decisions consistent with the safety, health and welfare of the public,
and to disclose promptly factors that might endanger the public or the environment;
to avoid real or perceived conflicts of interest whenever possible, and to disclose them to affected parties when they
do exist;
to be honest and realistic in stating claims or estimates based on available data;
to reject bribery in all its forms;
to improve the understanding of technology, its appropriate application, and potential consequences;
to maintain and improve our technical competence and to undertake technological tasks for others only if qualified by
training or experience, or after full disclosure of pertinent limitations;
to seek, accept, and offer honest criticism of technical work, to acknowledge and correct errors, and to credit properly
the contributions of others;
to treat fairly all persons regardless of such factors as race, religion, gender, disability, age, or national origin;
to avoid injuring others, their property, reputation, or employment by false or malicious action;
to assist colleagues and co-workers in their professional development and to support them in following this code of
ethics.
Approved by the IEEE Board of Directors, August 1990
Fig. 1. The Institute of Electrical and Electronics Engineers Code of Ethics.
from what is wrong and the principles of moral
moral obligation will help engineers to focus on the
philosophy used to qualify an action as good or
moral dimension of their activities.
bad. This normative ethics leads to the codes of
Due to cost and complexity, many of the new
ethics that synthesise the responsibilities of each
advances in health care technology must be con-
profession. Numerous professional organisations
sidered scarce. The ethical allocation of these
have elaborated their codes of ethics [4]. Figure 1
scarce resources is one of the most difficult
shows the Institute of Electrical and Electronics
problems facing health care workers, including
Engineers (IEEE) Code of Ethics. The Hippocratic
biomedical engineers [6±8]. The traditional sense
Oath, perhaps authored by the Greek physician
of health care is changing, and so is bioethics [9].
Hippocrates (4th century BC), has been adopted
What in the past was a medical issue has turned
by the World Medical Association as the central
into an interdisciplinary team decision involving
point of medical ethics [5]. As amended in 1994,
biomedical engineers. In some organisations
its text appears in Fig. 2. The Engineering in
biomedical engineers actively participate in allo-
Medicine and Biology Society of the IEEE is
cating new technologies. Technology assessment,
currently preparing an international code of
i.e. identification and evaluation of the impli-
ethics for biomedical engineers. Teaching clear
cations of technology used to improve health
and practical concepts of biomedical engineering
and life quality, represents a direct link between
At the time of being admitted as a member of the medical profession:
I solemnly pledge myself to consecrate my life to the service of humanity;
I will give to my teachers the respect and gratitude which is their due;
I will practice my profession with conscience and dignity;
The health of my patient will be my first consideration;
I will respect the secrets which are confided in me, even after the patient has died;
I will maintain by all the means in my power; the honor and the noble traditions of the medical profession;
My colleagues will be my sisters and brothers;
I will not permit considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation,
race, sexual orientation, or social standing to intervene between my duty and my patient;
I will maintain the utmost respect for human life from its beginning even under threat and I will not use my medical
knowledge contrary to the laws of humanity;
I make these promises solemnly, freely and upon my honor.
Fig. 2. The Hippocratic Oath, adopted by the 2nd General Assembly of the World Medical Association (Geneva, 1948) and amended
by the 46th WMA General Assembly (Stockholm, 1994).

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278
J. Monzon
biomedical engineers and policy makers. It allows
generalÐwhose technological limitations may be
engineers to demonstrate the contributions of
well known to engineers, could give rise to ethical
health care technology [10], but they must also
conflict with physicians seeking the immediate
now confront more responsibility for cost-effective
recovery of their patients. Education in bioethics
designs and complete testing and review during the
should thus emphasise the comparison of ethical
development of medical devices [11]. Needless to
issues familiar to those working in certain pro-
say, the bioethical issue of resource allocation has
fessions (medicine, nursing) with parallel ethical
global implications.
issues arising in other professions like engineering
Bioethics addresses the general standards for
[14].
respecting human dignity and for protecting indi-
viduals within the context of the clinical appli-
cations of biomedical research and development.
ETHICS IN THE BME CURRICULUM
There are some fundamental values that must be
understood:
The first purpose of teaching ethics in engi-
. human dignity and integrity,
neering schools is to make students understand
. freedom and responsibility,
that ethical issues are integral to engineering.
. solidarity and social justice [12],
Students must be able to recognise ethical
problems, and they must develop the necessary
as well as concepts of risk, consent, autonomy, and
skills to deal with those problems. Also, by under-
privacy.
standing a code of ethics and by agreeing to act
There are some fields in bioethics that are more
according to it, students will build a strong identity
directly related to medical research, e.g.
as professionals [15].
. medically assisted procreation;
Several years ago, the Accreditation Board
. the human genome project;
for Engineering and Technology (ABET) in the
. brain research;
United States recommended that all engineering
. end of life issues;
programs should address ethical issues. It has been
. transplantations;
argued that ethics should be taught by engineering
. patient's consent;
professors as a way of showing students that ethics
. truth telling;
is central to engineering and not peripheral to it, as
. research methodologies.
students might assume if all ethical issues were
taught by philosophy faculty [16]. Either approach
Other fields, however, have a social impact.
is insufficient for an integrated ethics education.
Biomedical engineers cannot ignore these fields.
Studies have shown that beginning students who
They must understand and answer public attitudes
took fundamental ethics courses that were taught
regarding the perception of ethical issues, espe-
by ethicists scored higher on Rest's Defining Issues
cially with regard to fundamental values. For
Test (DIT), a test designed to assess the develop-
example, automatic data transfer by computerised
ment of moral judgement, when they took the test
information systems affects confidentiality and
later in their educational program [17, 18].
privacy in medical data and requires responsible
Ethics education for biomedical engineers should
data management. Health care budgets create a
cover both the study of the fundamental values of
social dimension for the choices to be made in
bioethics and those topics that are related more
resource allocations. As already mentioned, bio-
specifically to the biomedical engineering profes-
medical engineers are generally involved in pre-
sion. Therefore, it is recommended that students be
paring budgets and determining priorities in health
introduced, as early as possible, to ethics values
care [13]. Bioethical issues for biomedical engineers
from a philosophical point of view. Hopefully, this
also include the use of human and animal subjects
knowledge would prevent even highly motivated
for experimentation and misconduct in science.
student from developing rather narrow ideas
Bioethics education cannot concentrate only
about how good or bad a professional action is [19].
on issues specific to a particular profession. The
Of primary importance in traditional engineer-
wide scope of bioethics points to the study of
ing education is the issue of safety, a concept
ethical issues that might be compatible with a
strongly tied to engineering culture and one that
given professional practice but unacceptable for
is transmitted to students at the beginning of their
an interdisciplinary group. The occasion and
career and in every course they take [15, 20].
conditions for using medical technology may be
Experienced engineering faculty are role models
contradictory for physicians and engineers. The
for students at least until graduation. In profes-
legal use of medical devices in their prototype
sional life, engineers must follow the professional
phase, although oriented toward urgently solving
standards of their employers. This may eventually
the health problem of a patientÐthe primary
give rise to ethical dilemmas if those standards are
consideration of physiciansÐmay conflict with
oriented mainly to production.
engineers seeking appropriate application of tech-
Addressing professional issues for BME
nology and knowing its potential consequences. In
students at engineering schools is not a straight-
emergency situations, the use in adults of pae-
forward process. BME is conceptually dynamic
diatric instrumentsÐor life supporting devices in
and its scope widens frequently to incorporate

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Teaching Ethical Issues in Biomedical Engineering
279
new disciplines and specialities. This pushes
that their concerns are generally shared by their
biomedical engineers on a continuous search for
instructor and classmates [15]. Another widely
a professional identity, as shown by the numerous
used approach to understand ethical reasoning
published definitions of the activity. Also, students
involves case studies, either real or fictional.
are not fully aware of the potential for their
Through these examples, students can identify
professional knowledge to affect health and
the morality underlying professional attitudes [19].
human life. The biological system, in fact the
Of relevance for biomedical engineers is the study
`final user' of the BME student's work, is distant,
of the BjoÈrk±Shiley heart valve failure case. The
complicating the identification of the ethical
BSCC (BjoÈrk±Shiley Convexo±Concave) mechani-
issues that accompany engineering research and
cal prosthetic heart valve is famous for a history of
development of procedures and devices.
failure, after its introduction in 1976 to become the
Strong qualifications are required of BME
most popular prosthetic valve for over a decade.
faculty if they are going to act as models for
During clinical trials, the valve showed a material
their students and help them narrow the gap
fatigue leading to weld fractures. While the manu-
between academia and practice, i.e. between
facturer modified welding and quality control
instruction and real-world applications. For BME
procedures, the valves were not withdrawn from
students heading either to research and develop-
the market, nor were patients notified of eventual
ment or to the health care system, faculty experience
failures. Additionally, the FDAÐas regulatory
is key to learning. Teachers must help students to
agencyÐwas ineffective at ensuring public health
develop the skills they need to think critically
as shown by a delay in recommending valve
about ethical issues.
removal from the market, lack of investigation of
Medical students also experience some distance
the manufacturer and failure to enforce patient
between the ethics of classrooms and the ethics of
notification [25, 26]. For students, this case study
hospitals. Since they face ethical dilemmas when
would be highly illustrative and a good example of
they are in contact with patients, the best time to
ethical violations involving several parties.
teach ethics to medical students is during the
Classroom work in ethics will certainly follow
residency years when integration of academician
the general procedure used elsewhere in engi-
and practitioner is possible [21, 22].
neering schools, i.e. problem solving. The deci-
No biomedical engineer can ignore the biologi-
sion-making process is not foreign to ethics since
cal world or the patient, even if he or she is not
the first step in this process is problem identifi-
directly working in the health care field. Ethical
cation, a main issue in ethics and one that is
issues closer to medicine than to engineering
sometimes not clearly achieved. Once the problem
should also be addressed by BME students, parti-
is known, the student must be aware that it has a
cularly by those who will not face ethical dilemmas
solution. Students must solve this moral problem
associated with close contact with patients, e.g. in
and not be surprised when they find that the
clinical engineering. There is no equivalence to the
essence of some solving strategies is common to
residency period in hospitals for all the specialities
other disciplines like physics or math [15, 19, 20].
of biomedical engineering. Thus, for instructional
purposes, medical ethicists and clinicians must be
part of the faculty for teaching bioethics to BME
ETHICS PROGRAM OUTLINE
students. Bioengineers need to gain a better
understanding of medical education and medical
It is difficult to find ethics courses that address
practice. Medical ethics is fundamental to this [23].
every ethical issue of interest for BME students
Professional issues are usually summarised in
[14, 16, 27±29]. This section lists the topics that
the obligations of moral conduct represented by
should be covered by an ethics education program
the codes of ethics, although it is worth mentioning
for biomedical engineers. The list is not intended to
that not every code of behaviour claims to have
represent a course syllabus but rather a program
ethical justification. On the other hand, some
outline describing the topics that are to be
codes support the right of the professional to
addressed in biomedical engineering education.
refuse work that compromises the professional's
References [30±37] represent valuable textbooks.
personal ethical values, even if the act in question
1. BIOETHICS FUNDAMENTALS
is not morally objectionable by the profession as a
1.1 Metaethics. Ethics as a discipline. Study of the
whole [24].
basic concepts of right and wrong, good and
If one accepts that a code is the first word in
bad.
identifying ethical problems for the practising
1.2 Descriptive Ethics. Analysis of morality within
professional [20], then discussing the statements
different cultures.
of ethical codes is an appropriate classroom exer-
1.3 Normative Ethics. The morality of an action.
cise for instructors and students (see Figs 1 and 2).
Nature, motives or consequences of an action.
This group discussion methodology is essential in
Divine command. Value theory. Utilitarian-
biomedical engineering ethics education. It raises
ism.
the student's self-confidence in ethical values by
2. RESEARCH ETHICS
making public each individual's moral questions
Human subjects and animals for experi-
and concerns and by allowing individuals to learn
mentation. Control of science and technology.

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J. Monzon
Conflicts of interests in research. Scientific mis-
case studies, group/panel discussions, debates, role
conduct. Ethics committees. Data management.
playing, writing assignments, and seminars. Upon
3. PROFESSIONAL ETHICS
completion of the program, biomedical engineer-
3.1 Engineering ethics. Public health and public
ing students should have learned the fundamental
safety. Conflicts of interests. Ethical issues in
values of ethics and achieved the necessary skills
design and manufacture. Risk analysis. Cost-
for solving moral problems.
benefit analysis. Resources allocation. Negli-
gence. Professional restrictions and profes-
sional responsibility. Rights of engineers. The
ethics of engineering organisations. Codes of
CONCLUSIONS
ethics.
3.2 Medical ethics. The patient±physician relation-
The growing field of biomedical engineering
ship. Autonomy and privacy of patients.
requires that institutions that authorise lawful
Informed consent. Professional conduct and
registration of engineers accept BME as an inde-
confidentiality. Truth telling. Biotechnologies.
pendent profession. Specialised accreditation
Reproductive techniques. Genetic engineering.
boards for the technical assessment of professional
Clinical trials. Resources allocation. Euthana-
abilities and eventual registration of biomedical
sia. Conflicts of interests. The Hippocratic oath.
engineers should be constituted everywhere.
4. SOCIAL ETHICS
Modern health care represents the integration of
4.1 Social morality and personal ethics. Public poli-
medicine, management, and engineering, each
cies. Ethical criteria for resources allocation.
with different roles and comparable hierarchies.
Governmental, inter and intra-institutional
All of these require an understanding of funda-
allocation policies. Legal ethics. Scientific
mental moral values and the existence of a BME
advances and legal changes. Health and welfare.
professional code of ethics.
Environmental ethics. World population and
As for any other calling, the conduct, aims, and
natural resources. Rural development.
qualities that characterise biomedical engineering
must be openly and precisely declared to the
As mentioned above, this program would require
community. Bioethics is a social concern, and
highly qualified instructors with different back-
teaching and learning ethics should be a daily
grounds and experience, e.g. ethicists, research
commitment for biomedical engineers and a way
and field engineers, and research physicians and
of strengthening biomedical engineering as a
clinicians. Pedagogical methodologies may include
profession.
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Jorge E. Monzon received the Electronics Engineer degree from the National University of
Tucuman, Argentina (1978) and the MSEE and MSBME degrees from the University of
Wisconsin-Madison in 1986. He is currently a full professor at the Northeastern National
University (Corrientes, Argentina), and his research interests include digital signal pro-
cessing, electrodes, electrical safety, clinical engineering and professional issues. He his
co-editor of the book Cardiac Fibrillation-Defibrillation (Intermedica, Buenos Aires) and
contributing author to Interfacing Sensors to the IBM PC (Prentice-Hall, NJ). He has
been guest co-editor of the IEEE/EMB Magazine. He is the president of the Latin
American Regional Council on Biomedical Engineering (CORAL), and he was the
founding president of the Argentine Society of Bioengineering. A member of the New
York Academy of Sciences, he is listed in Who's Who in the World, Who's Who in Science
and Engineering, Who's Who in America, and Who's Who in Medicine and Healthcare.
jemonzon@exa.unne.edu.ar

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