Ethical issues in

Biomedical
Engineering
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What are Ethics?
• moral principles that govern a person's behaviour
or the conducting of an activity.
(https://en.oxforddictionaries.com)
• the discipline dealing with what is good and bad
and with moral duty and obligation
(https://www.merriam-webster.com)

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What is Moral?
• Concerned with the principles of right and wrong
behaviour.
(https://en.oxforddictionaries.com)
• of or relating to principles of right and wrong in
behavior
(https://www.merriam-webster.com)

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Human Experimentation
• the development of the Salk and Sabin vaccines
for polio to the development of artificial organs.
• To determine their effectiveness and value,
however, these new drugs and medical devices
eventually are used on humans.
• The issue is, not only whether humans should be
involved in clinical studies designed to benefit
themselves or their fellow humans but also
clarifying or defining more precisely the
conditions under which such studies are to be 4

permitted.
Definition And Purpose of Experimentation
• human experimentation occurs whenever the
clinical situation of the individual is consciously
manipulated to gather information regarding the
capability of drugs and devices.
• A therapeutic experiment is one that may have
direct benefit for the patient,
• but the goal of nontherapeutic research is to
provide additional knowledge without direct
benefit to the person.
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Therapeutic Research
• there have been numerous examples of therapeutic
research projects.
• The use of nonconventional radiotherapy to inhibit the
progress of a malignant cancer,
• pacemakers to provide the necessary electrical
stimulation for proper heart function,
• artificial kidneys to mimic nature’s function and remove
poisons from the blood
• 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 6
patient but also for humankind.
Nontherapeutic Research
• Nontherapeutic research has been another important
vehicle for medical progress.
• Experiments designed to study the impact of infection
from the hepatitis virus or the malarial parasite or the
procedures involved in cardiac catheterization
• they had significant effects on the advancement of
medical science and the ultimate development of
appropriate medical procedures for the benefit of all
humans.

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Informed Consent
• the most important moral issue in human experimentation.
• It is the principal condition that must be satisfied 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).
• issues concerning legal capability are usually limited to
minors. Many states have some exceptions that allow minors to
give consent.
• Informed consent preserves 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.

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Code of Ethics For Human Experimentation
• In 1964 the World Medical Association(WMA) in Helsinki,
Finland endorsed a code of ethics for human experimentation
as an attempt to provide some guidelines in this area, which is
known as “WMA-Declaration of Helsinki”.
• Later it is amended by WMA in several general assemblies.
• Because it is often essential to use the results obtained in
human experiments to further scientific knowledge, the World
Medical Association prepared the following recommendations
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.

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Basic Principles
1) 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.
2) The design and performance of each experimental procedure
involving human subjects should be clearly formulated in an
experimental protocol, which should be transmitted to a
specially appointed independent committee for consideration,
comment and guidance.
3) Biomedical research involving human subjects should be
conducted only by scientifically qualified persons and under the
supervision of a clinically competent medical person. The
responsibility for the human subject must always rest with a
medically qualified person and never rest on the subject of the
research, even though the subject has given his or her consent. 10
Basic Principles
4) Biomedical research involving human subjects cannot
legitimately be carried out unless the importance of the
objective is in proportion to the inherent risk to the subject.
5) Every biomedical research project involving human subjects
should be preceded by careful assessment of predictable risks in
comparison with foreseeable benefits to the subject or to others.
Concern for the interests of the subject must always prevail
over the interests of science and society.
6) The right of the research subject to safeguard his or her
integrity must always be respected. Every precaution should be
taken to respect the privacy of the subject and to minimize the
impact of the study on the subject’s physical and mental
integrity and on the personality of the subject.

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Basic Principles
7) Doctors should abstain from engaging in research projects involving
human subjects unless they are satisfied that the hazards involved are
believed to be predictable. Doctors should cease any investigation if
the hazards are found to outweigh the potential benefits.
8) In publication of the results of his or her research, the doctor is
obliged to preserve the accuracy of the results. Reports of
experimentation not in accordance with the principles laid down in this
Declaration should not be accepted for publication.
9) In any research on human beings, each potential subject must be
adequately informed of the aims, methods, anticipated benefits, and
potential hazards of the study and the discomfort it may entail. He or
she should be informed that he or she is at liberty to abstain from
participation in the study and that he or she is free to withdraw his or
her consent to participation at any time. The doctor should then obtain
the subject’s freely given informed consent, preferably in writing.

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Basic Principles
10) When obtaining informed consent for the research project, the
doctor should be particularly cautious if the subject is in a dependent
relationship to him or her or may consent under duress. In that case, the
informed consent should be obtained by a doctor who is not engaged in
the investigation and who is completely independent of this official
relationship.
11) In the case of legal incompetence, informed consent should be
obtained from the legal guardian in accordance with national
legislation. Where physical or mental incapacity makes it impossible to
obtain informed consent, or when the subject is a minor, permission
from the responsible relative replaces that of the subject in accordance
with national legislation.
12) The research protocol should always contain a statement of the
ethical considerations involved and should indicate that the principles
enunciated in the present Declaration are complied with

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Nontherapeutic Biomedical Research Involving Human
Subjects (Nonclinical Biomedical Research)
1) In the purely scientific application of medical research
carried out on a human being, it is the duty of the doctor to
remain the protector of the life and health of that person on
whom biomedical research is being carried out.
2) The subjects should be volunteers (i.e., either healthy
persons or patients for whom the experimental design is not
related to the patient’s illness).
3) The investigator or the investigating team should
discontinue the research if in his/her or their judgment it
may, if continued, be harmful to the individual.
4) In research on humans, the interest of science and
society should never take precedence over
considerations related to the well-being of the subject.
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 Six basic requirements for ethically sound
human experimentation.
1) research on humans must be based on prior laboratory
research and research on animals, as well as on established
scientific fact, so that the point under inquiry is well
focused and has been advanced as far as possible by
nonhuman means.
2) research on humans should use tests and means of
observation that are reasonably believed to be able to
provide the information being sought by the research.
Methods that are not suited for providing the knowledge
sought are pointless and rob the research of its scientific
value.
3) research should be conducted only by persons with the
relevant scientific expertise.
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 Six basic requirements for ethically sound
human experimentation.
4) All foreseeable risks and reasonably probable benefits, to the subject
of the investigation and to science, or more broadly to society, must be
carefully assessed, and the comparison of those projected risks and
benefits must indicate that the latter clearly outweighs the former.
Moreover, the probable benefits must not be obtainable through other
less risky means.
5) participation in research should be based on informed and voluntary
consent.
6) participation by a subject in an experiment should be halted immediately if
the subject finds continued participation undesirable or a prudent investigator
has cause to believe that the experiment is likely to result in injury, disability, or
death to the subject. Conforming to conditions of this sort probably does limit
the pace and extent of medical progress, but society’s insistence on these
conditions is its way of saying that the only medical progress truly worth
having must be consistent with a high level of respect for human dignity. Of
these conditions, the requirement to obtain informed and voluntary consent
from research subjects is widely regarded as one of the most important
protections. 16
Why are Ethics Important in
Biomedical Engineering?
• Any medical fields deal with serious and personal issues.
• Integrity and confidentiality are necessary to allow
engineering to conduct research with patients and for
results to be deemed relevant and progressive

• As technology advances so does our capabilities in

engineering and medical fields.
• These capabilities can allow us to achieve things people
may deem as science crossing into nature
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How are Codes of Ethics Created in
Biomedical Engineering?
• Combines ethics from both the medical field and
engineering fields.
• Examples:
• Medical: Hippocratic Oath
• Engineering: ABET & other organizations

• Biomedical engineers may not be medical practitioners

but they are considered indirect practitioners.
• Work closely with practitioners.
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“Types” of Ethics in Biomedical
Engineering
• Professional Ethics
• Being honest and impartial
• Not publishing false reports

• Patient Ethics
• Confidentiality
• Full disclosure

• Natural & Human ethics

• Not interfering with natural life and/or nature.
• Not crossing the line between improving quality of life and changing
life. 19
Consequences of Breaking the Codes
of Ethics
• Ethic standards are not necessarily legally prosecuted when
broken

• You lose credibility in your field.

• From peers and & elite organizations.

• May be sued in the form of torts, personal injury law suits.

(torts: A wrong that is committed by someone who is legally obligated to
provide a certain amount of carefulness in behavior to another and that
causes injury to that person, who may seek compensation in a civil suit for
damages.)
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Professional Ethics
Case Study Example
• Stem Cell Case (2005-2006)
• Dr. Hwang Woo-Suk, a researcher and
professor at Seoul National University,
published two papers in the journal
Science that claiming his team had
succeeded in creating human
embryonic stem cells through cloning.
• Allegations followed from a co-worker
that these paper was based on
fabricated data.
• As a result:
• the papers were editorially retracted.
• Dr. Hwang lost his position at Seoul
National University.
• The South Korean government ended
its financial and legal support of his 21
research.
Patient Ethics
Case Study Example
• James Wilson (1999)
• Gene therapy researcher at the
University of Pennsylvania in
Philadelphia.
• Working in gene therapy for OTC
deficiency (A genetic disorder of
resulting in a mutated and ineffective
form of the enzyme Ornithine
transcarbamylase)
• Directed a clinical trial involving gene
therapy that led to the death of 18-year-
old Jesse Gelsinger
• He failed to report the extent of the 22
adverse reactions .
Ethics Associations
• Accreditation Board for Engineering and Technology (ABET)

• National Society of Professional Engineers (NSPE)

• Biomedical Engineering Society (BMES)

• Institute of Electrical and Electronic Engineers (IEEE)

• American Society of Mechanical Engineers (ASME)

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ABET Code of Ethics of
Engineers
The Fundamental Principles
Engineers uphold and advance the integrity, honor,
and dignity of the engineering profession by:

• Using their knowledge and skill for the

enhancement of human welfare.

• Being honest and impartial, and serving with

fidelity the public, their employers, and their
clients.

• Striving to increase the competence and prestige

of the engineering profession.

• Supporting the professional and technical 24

societies of their disciplines.
BMES Code of Ethics
Biomedical engineering is a learned profession that combines expertise and responsibilities in
engineering, science, technology, and medicine. Mindful that public health and welfare are
paramount considerations in each of these areas, the Society identifies in this Code principles of
ethical conduct in professional practice, health care, research, and training. This Code reflects
voluntary standards of professional and personal practice recommended for biomedical engineers.

Biomedical Engineering Professional Obligations

Biomedical engineers in the fulfillment of their professional engineering duties shall:
1. Use their knowledge, skills, and abilities to enhance the safety, health, and welfare of
the public.
2. Strive by action, example, and influence to increase the competence, prestige, and
honor of the biomedical engineering profession.

Biomedical Engineering Health Care Obligations

Biomedical engineers involved in health care activities shall:
1. Regard responsibility toward and rights of patients, including those of confidentiality
and privacy, as a primary concern.
2. Consider the broader consequences of their work in regard to cost, availability, and 25
delivery of health care.
BMES Code of Ethics(Cont.)
Biomedical Engineering Research Obligations
Biomedical engineers involved in research shall:
1. Comply fully with legal, ethical, institutional, governmental, and other applicable
research guidelines, respecting the rights of and exercising the responsibilities to
human and animal subjects, colleagues, the scientific community and the general
public.
2. Publish and/or present properly credited results of research accurately and clearly.

Biomedical Engineering Training Obligations

Biomedical engineers entrusted with the responsibilities of training others shall:
1. Honor the responsibility not only to train biomedical engineering students in proper
professional conduct in performing research and publishing results, but also to model
such conduct before them.
2. Keep training methods and content free from inappropriate influence of special
interests.
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Ethics & Education!
• Ethics influence how and what we are taught in school.

• ABET accredits schools however in order to receive

accreditation programs must meet standards and teach their
students required material.

• That means ethics is influencing everything we are learning

right now!

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