NCM 208 Bioethics
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UNIVERSAL BIOETHICAL PRINCIPLE
A. AUTONOMY
● Making own decisions
● Freedom or independence
● Requires decision making skills or critical thinking,
responsibility, self-awareness
● This principle marks the significance of individual
autonomy which mandates a strong sense of
personal responsibility for one’s own life.
● Autonomy is concerned with self-determination,
making one’s own decisions without any coercion
from others and being able to act on those decision
○ Motivation or intention
○ Understanding
○ Freedom or independence
○ Decision-making skills or critical thinking
○ Responsibility
○ Self-awareness
○ Able to communicate decisions
Elements of Autonomy
A. Person should be respected
B. He should be able to determine his personal
goals
C. He should have the ability to decide on plans of
action
D. He should have the freedom to act upon his
choice
PATERNALISM
● From Greek word “pater” or “paternos” which means
being fatherly
● The act of being fatherly to someone as if the latter
was one’s offspring
● Does not need to be blood-related
● Acting in a way that is believed to protect or advance
the interest of a person, even if acting in this way
goes against the person’s own immediate desires or
limits the person’s freedom
● It violates the principle of autonomy
○ If an unconscious patient has no ID and no
immediate family member, the physician acts
like a father and decide for the patient who is
unconscious
Types of Paternalism
1. With regards to the recipient’s welfare
A. Pure paternalism - justifies interventions into a
person’s life for the sole welfare of that person
B. Impure paternalism - not only for the welfare of
that person but also for others
2. With regards to recipient’s defects and safety
A. Restricted paternalism – support intervention
which overrides and individual’s action because of
some defects or weaknesses
B. Extended paternalism – an individual is
restricted from doing something because it is too
risky or dangerous
3. With regards to promotion of good and
prevention of harm
A. Positive paternalism – for the promotion of good
B. Negative paternalism – for the prevention of
harm
4. With regards to patient’s sense of values
A. Soft paternalism – patient’s values are used to
justify the intervention
B. Hard paternalism – patient’s values are not used
to justify paternalistic acts
5. With regards to the recipient of the benefit
A. Direct paternalism – the individual who should
receive the said benefit is the one whose values
are disregarded for his own good
B. Indirect paternalism – a particular individual will
benefit if he is restricted from doing something
6. Personal paternalism
● When an individual decides on the basis of his
best knowledge and capacity for the good of
another person
7. State paternalism
● Refers to the control exerted by the legislature,
agency, or any governmental bodies over a
particular practice and procedure
PATIENT’S RIGHT
● The moral and inviolable power vested in a person to
do, hold, or demand something as his own.
● Something that by nature belongs to a patient
Types of Patients Rights
1. RIGHT TO INFORMED CONSENT
● Relates to a process by which patients are
informed of the possible outcomes, alternatives,
and risks of treatments, and patients are required
to give their consent freely
● Patient has the right to receive information
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● No coercion
Types of Consent
2. RIGHT TO INFORMED DECISION
❖ Blood Transfusion Form
● Refers to the necessary information of and
❖ Consent for Referral
understanding so a genuine deliberation is carried
❖ In case of AMA
out before making moral decision on a medical
○ Against medical advice
treatment
○ Decision is on the patient
● Our role is to help patients achieve the right
○ Doctor and nurse will not be held accountable
decision but they are the ones to decide
❖ Do not Resuscitate (DNR) Order
❖ Consent for Chemotherapy 3. RIGHT TO INFORMED CHOICE
❖ Consent for Restraint Applications ● The patient has the right to be informed about all
❖ Consent for admission to ICU possible alternative courses of action to be taken,
❖ Consent for Surgery together with the possible consequences.
○ Physician must be the one to explain
❖ Consent for Minor 4. RIGHT TO REFUSE TREATMENT
❖ Consent for Procedures ● The patient has the right to refuse treatment to the
○ Nurses must explain to the patient since extent permitted by law and to be informed of the
nurses are involved here, as they perform medical consequences of his action.
nursing interventions to the pt
❖ Informed Consent 5. RIGHT TO SELF-DETERMINATION
● The patient as an autonomous individual has the
○ The nurse’s role is to witness the patient signing on moral right to determine what is good for himself,
the consent paper usually upon the advice of a health care provider
○ Make sure the patient understands the consent
○ If the patient refuses to sign, explain the risks, and
made them sign the refusal consent
○ Use thumbmark, if unable to write to patients who are
blind or illiterate (unable to write)
Functions of Informed Consent

1. To avoid fraud and duress

2. To encourage self-scrutiny by professionals
3. To foster rational decision-making
4. To involve the larger society in the debate

Elements of Informed Consent

1. Competence
● This refers to a patient’s capacity for
decision-making
● A competent individual is:
a. Can make decision
b. Able to justify the decision
c. Able to justify decisions in a reasonable
manner
2. Disclosure
● This refers to the content of what a patient is told
or informed about during the consent negotiation
● Their conversation stays between them
● If minor, parents are included
3. Comprehension
● This refers to whether the information given has
been understood
4. Voluntariness
● This means that the consent must be from his
own free will without being forced
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Patient’s Bill of Rights from DOH
1) Right to appropriate Medical care and Humane
treatment
2) Right to informed consent
3) Right to privacy and confidentiality
4) Right to information
5) Right to choose a health care provider and facility
6) Right to self-determination
7) Right to religious belief
8) Right to medical records
○ Owner of the chart is the hospital
○ Owner of the content is the patient
9) Right to leave
○ Can leave and refuse treatment as long as
you signed the AMA consent
○ Abscond refers to the patient who leaves the
hospital without permission or consent
10) Right to refuse participation in medical research
11) Right to correspondence and to receive visitors
12) Right to express grievances
○ Be a listener
13) Right to be informed of his rights and obligations
as a patient
LIMITATIONS OF PATIENT’S RIGHTS
1. Patient’s rights do not include the patient’s rights to
be allowed to die
○ For DNR, it must be written with proof and
consent
○ Verbal consent is not allowed here
2. Patients in a moribund condition does not possess
the necessary mental, physical, or emotional stability
to make decision
○ Patients who are minor, mentally ill, coma
3. Patient’s rights are not absolute
Fundamental constraints on this delegation:
1. The person making the delegation must have the
right to consent
2. The person must be legally and medically competent
to delegate the right to consent
○ Legal age of 18 years and above
3. The right to consent must be delegated to a legally
and medically competent adult
○ Immediate family
A. BENEFICENCE
● the practice of doing acts of goodness, kindness and
charity.
● the beneficence principle states “do no harm and
produce the good” or “do good and do no harm”.
● involve the action to help someone
B. NONMALEFICENCE
● Hippocratic oath: “I will never use treatment to
injure or wrong the sick”.
● if for some reason they cannot do good, they are
required to at least do no harm.
● intentional avoidance of action that causes harm
C. VERACITY
● relates to the practice of telling the truth (HONESTY)
● binds both health practitioner and patient in an
association of truth.
Justification of Truth Telling
1. It is argued that our human and moral quality as
persons is taken away from us if we are denied
whatever knowledge is available about our condition
as patients.
2. As patients, we have entrusted to the physician any
knowledge he has about ourselves, so the facts
(findings) are ours and not his, hence to deny them to
us is to steal from us.
3. The highest conception of the physician-patient
relationship is a personalistic one which is based on
mutual confidence and respect for each other’s
rights.
4. To deny a patient pertinent knowledge about himself,
especially in a life-and-death situation, is to deprive
him ample time to prepare for his own death or to
carry out responsibilities that are based solely on his
decisions or actions.
Note:
○ When asked with difficult questions such as choosing
between life and death, give present data on the
chart, lab test results, VS, etc. Do not diagnose.
Dwell only with the info that is in your hands.
BENEVOLENT DECEPTION
● Practitioner is allowed to intentionally withhold
information based on his/her “sound medical
judgment” that to divulge the information might
potentially harm the depressed and unstable
patient for an unpleasant fact.
● Delay relaying information to prevent patient from
possibly harming themselves
Two Approaches of Truth Telling
● Person-centered – considers the patient as a
person with a problem, but not as a problem
himself/herself
● Problem-centered – considers the patient’s
condition, illness or diseases
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○ A registered nurse caring for Vivian Bearing, a
patient who was dying of cancer, at a large research
hospital. Vivian was getting large doses of cancer
chemotherapy without any success of remission. In
fact, the cancer was progressing at an alarming rate.
She was near death, but the research physicians
wanted to challenge her body with chemotherapy for
as long as possible to observe the outcome effects.
Everyone on the staff had been cold, indifferent, and
technically minded, and no one had shown any
concern for Vivian except for Susie. Vivian had not
been informed about the chemotherapy failure, her
prognosis, or the likelihood of her dying. One night,
Susie found Vivian crying and in a state of panic.
Susie first helped to calm her, and then she shared a
popsicle with Vivian at the bedside while she
disclosed the full truth to Vivian about her
chemotherapy, her prognosis, her choices between
Code Blue or DNR, and her imminent death.
○ Susie affectionately explained, You can be “full code,”
which means that if your heart stops, they’ll call a
Code Blue and the code team will come and
resuscitate you and take you to Intensive Care until
you stabilize again. Or you can be “Do Not
Resuscitate,” so if your heart stops we’ll…we’ll just
let it. You’ll be “NR.” You can think about it, but I
wanted to present both choices.
○ Susie felt the urge to be truthful and honest. By
demonstrating respect for Vivian, Susie was showing
her capacity to be human.
D. CONFIDENTIALITY
● is an important aspect of the trust that patients place
in health care professionals.
Confidentiality and Privacy are interrelated
● Confidentiality – is the nondisclosure of private or
secret information about another person with which
one is entrusted. It requires that one maintain the
privacy of another.
● Privacy – the right of the individual to control the
personal information or secrets that are disclosed to
others. It is a fundamental right of individuals.
Justifications for violation of Confidentiality
a. When keeping the secret would be detrimental to the
common good.
b. When the subject of the secret intends to inflict grave
injury upon an innocent third party.
c. When it is necessary for the subject of the secret to
avert grave injury.
d. When it is necessary for the one keeping the secret
to avoid grave injury.
EXAMPLE
○ A child's immunization may cause discomfort during
administration, but the benefits of protection from
disease, both for the individual and society, outweigh
the temporary discomforts. Which principle is
involved in this situation?
1. Fidelity
2. Beneficence
3. Nonmaleficence
4. Respect for autonomy
PRINCIPLE OF FIDELITY
● Refers to the concept of faithfulness to our duties,
obligations, vows, or pledges
● Refers to one’s loyalty to a worthy cause
● Telling the truth as the situation demands it
● Keeping actual and implicit promises, and not
representing fiction as truth.
PRINCIPLE OF JUSTICE
● Relates to fair, equitable, and appropriate
treatment in light of what is due or owed to persons,
recognizing that giving to some will deny receipt to
others.
Distributive justice
● Application of the principle focuses on distribution
of goods and services.
● Relevant basic areas of health care:
1. What percentage of resources is reasonable to
spend on health care
2. Which aspects of health care should receive the
most resources
3. Which patients should have access to the limited
health care staff, equipment, etc.
- Equality vs. Equity
- Equity gives boost to those at disadvantage
● Some believe that all should receive equally
regardless of need.
● Friedrich Nietzsche - a German Philosopher believe
that there are superior individuals, so the choice of
distribution will depend on the present or future social
contribution to the person
Two types of justice:
1. Comparable justice
○ What a particular patient receives is determined
by the gravity of the condition or need.
2. Non-comparable justice
○ Distribution of goods/ resources is determined by
a certain standard.
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CRITERIA OF DISTRIBUTION
1. Criteria of inclusion - selection of candidates
a. Constituency – is the person a member of the
community?
b. Progress of science – can new knowledge be
gained from the case?
c. Success – is the treatment effective?
2. Criteria of comparison
a. The likelihood of successful treatment compared
with others in the group
b. Life expectancy of the person
c. The person’s family role
d. The potential of the person in making future
contribution.
e. The person’s record of services or contribution.
3. Random selection (James Childress)
a. First come first serve basis
b. lottery
PRINCIPLE OF DOUBLE EFFECT
● An act is foreseen to have both good and bad
effects
● This applies to a situation in which a good effect and
an evil effect will result from good cause. Under
certain conditions, some evil effect – voluntary in
cause – may be permitted to occur. The secondary
effects may be foreseen, but can never be intended
outcomes
The Act must be Ethically Good or atleast Indifferent
● ETHICAL CONSIDERATIONS:
a. Good effect must be directly intended.
b. Good effect or bad effect must occur
simultaneously or bad effect must follow the good
effect.
c. Bad effect may be permitted to occur after the
intention of good effect.
Four Principles of Double Effect
1. The action intended must be good in itself, or at least
morally indifferent; otherwise, the act is evil at the
very outset
2. The good effect must follow the action at least as
immediately as the evil effect, or the good and evil
effect must occur simultaneously
3. The foreseen evil effect should not be intended or
approved, but merely permitted to occur
4. There must be a proportionate and sufficient reason
for allowing the evil effect to occur while performing
the action
PRINCIPLE OF LEGITIMATE COOPERATION
● Cooperation comes from the latin word cum which
means “with,” and operari which means “to work”
● To achieve a well formed conscience, one should
always judge it unethical to cooperate formally with
an immoral act
● Formal cooperation
○ The one that which is identified with the purpose
of an objectively evil act.
○ The one who cooperates has a direct intention
for the evil object itself
● Cooperation is working with another in the
performance of an action.
○ Example:
■ The formal agent identifies itself with purpose of
evil act.
■ Immediate - directly does it
■ Agree to the act; or condole “don’t worry about
it, its nothing”
■ Advising or counseling
● Doing the act itself, agreeing with the act,
counselling, advising, promoting, provoking the evil
act
● Legitimate – refers to moral acceptability
● Moral object – refers to the objective goal of the
action
● Intention – reasons why you choose to act (ex.
Giving money to charity)
● Cooperation with evil does not mean working
together despite disagreement about the ends or
means of the act. Thus, cooperation does not imply
condoning evil
● Wrongdoer – the party who initiated the wrongdoing
● Formal cooperation – occurs when the evil end are
directly chosen by means of encouragement, praise.
Advice or any other support.
● Material cooperation – occurs when the evil end are
indirectly chosen by the person who has chosen
good end.
● Mediate cooperation – when the involvement is only
accidental.
● Immediate cooperation – the cooperators
involvement is necessary for the evil to continue.
PRINCIPLE OF COMMON GOOD AND
SUBSIDIARY
● Common Good – the sum total of social conditions
which allows people, either as group or as
individuals, to reach their fulfilment more fully or more
easily. Primary goal of society is the good of the
people and of the whole person.
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● Subsidiary – Every task of society should be
assigned to the smallest possible group that can
perform it, If the smaller group is unable to resolve
the problem itself, a group at a higher level assume
responsibility.
○ Solidarity - fair and just; and obligations are justly
shared between members
PRINCIPLE OF STEWARDSHIP
● A steward is a selfless servant who manages
assets and possessions without owning them,
foresees future trends and creates plans and
interventions.
● When one is entrusted with something of value, there
is an obligation to improve on it.
STEWARDSHIP
● Stigwaerd = Warden of a house
● Health Care Practice
○ to look after, provide necessary health care
services, and promote the health and life of those
entrusted to their care.
● State-Oriented Definition
○ Responsible for the welfare and interests of the
population, especially the trust and legitimacy with
which its activities are viewed by the general
public.
Nurse Leaders as Stewards
Oriented to self
● reflects the value of individualism.
● Perceive themselves as the decision makers and
others as implementers.
Oriented to the organization or system
● reflects the value of collectivism.
● Leaders in health care organization that will hold
the point of service as their priority and seek the
input of nurses in setting collective values.
Role of Nurses as Stewards
The Stewardship of Self (personal)
● It is crucial that nurse leaders engage with the
development of self, refining skills and improving
competencies.
● A person is a narrative self who seeks purpose, or
good for the self, through interpretations of
everyday experiences.
● Virtues are important, they affect perceptual
judgements about what is relevant in an
experience.
Social
● Nurses help people and their families cope with
illness and deal with it.
● Nurses innovate
● Nurses provide ongoing assessment of people’s
health
Ecological
● The nursing profession is well positioned to tackle
the challenges of waste reduction within the
hospital. Nurses educate, research, and leading in
waste reduction
Biomedical
● Deals with the ethical implications especially in
medicine.
● It involves issues relating to the beginning and end
of human life.
Other examples Role of Nurses
● Nurse leaders or stewards are finding themselves
collaborating with regulatory boards to improve on
standards of practice, certification and accreditation
● nursing managers in all disciplines of nursing will
be the chief, patient and safety officers and
stewards for their organizations and institutions.
● is responsible for the welfare and interests of the
population, especially the trust and legitimacy with
which its activities are viewed by the general public.
● nurse leaders will have to engage in developing,
assessing and refining innovative and fresh modes
of care delivery.
● nurse leaders or stewards to influence
decision-making at the point of service that uphold
value-based nursing practice by utilizing character,
dialogue and shared meanings and values.
● Nurse stewards hold the potential to inform
meaningful change in nursing practice, owing to
their capacity to act upon their character qualities,
including self-discipline and courage , as well as
engage in practical reasoning, by which the intrinsic
value or good of a situation is preserved and
promoted.
PRINCIPLE OF TOTALITY AND ITS
INTEGRITY
Definition
● The human body is an integral part of the human
person and is therefore worthy of human dignity. It
must be kept whole. No body part should be
removed, mangled or debilitated unless doing so is
necessary for the health of a more essential body
part or the body of a whole. An unessential or
redundant body part may be removed for the good of
another person.
Principle of Totality by Philosopher Thomas Aquinas
● All of the organs and other parts of the body exist for
the sake of the whole person. Because the purpose
of the part is to serve the whole, any action that
damages a part of the body or prevents it from
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fulfilling its purpose violates the natural order and is
morally wrong.
● However, a single part may be sacrificed if the loss is
necessary for the good of the whole person.
● Ex: the principle of totality would justify the
amputation of a gangrenous limb, because the
person could die if the gangrene spread.
Explanation
● Human nature is an integration of body and spirit.
These two dimensions can never be separated (in
fact, separation of the spirit from the body is the
definition of death). The human body shares in the
dignity of the human person. To dismember the body
or to otherwise deface it abuses that dignity by
treating the human person as a machine or as a thing
to be used and discarded.
Applications
● Surgeries that needlessly remove body parts or
organs are immoral
● Tattoos and piercings are not inherently immoral but
they may be immoral if they deface the body by
quantity or content.
● Torture is a moral evil because it seeks to
dis-integrate the body and the spirit
● Self-mutilation is self-hatred expressed through spite
of the body
● That chemical contraception effectively shuts down a
healthy bodily system is part of what makes it
immoral.
● Even if the pro-choice argument that an embryo is
part of the woman’s body rather than an independent
human person is true, it should not be removed
except when its presence endangers the woman’s
life.
PRINCIPLE OF ORDINARY AND
EXTRAORDINARY MEANS
● It is generally held that one can forgo extraordinary
means of continuing life but is obliged to continue
ordinary means of care.
● “Life, health and earthly actions are allocated, and
thus subordinate, to spiritual purposes. Death is seen
as an integral element of life, since according to
Christian beliefs death is not the end but transition of
new life – Pope Pius XII
Ordinary vs. Extraordinary
● Ordinary means are all medicines, treatments and
operations that offer a reasonable hope of benefit
and that can be obtained without excessive
expense, pain or other inconvenience.
● Extraordinary means are all medicines, treatments
and operations that cannot be obtained or used
without excessive expense, pain or other
inconvenience or that, if used, would not offer a
reasonable hope of benefit.
EXAMPLES:
1. An infant with Down’s syndrome; who needs
low-risk surgery to correct intestinal defect; the
parents refuse surgery stating that mental
retardation will mean less meaningful life of the
baby.
2. A 7 year old who meet an accident with severe
internal bleeding. Her parents refuse consent of
blood transfusion because its forbidden in their
religion.
3. An 87 year old incompetent woman with congestive
heart and kidney failure, has primary cancer of the
intestine. Surgery is the usual management, but the
family refused and the doctor decided against it
4. A baby is born with spina bifida, and
hydrocephalus. A surgery is needed for the closure
of the spine and prevent dangerous infection. The
parents refused saying the child is physically
handicap involving hardship for the child and
parents. = ordinary
5. Same case of the baby except that in addition,
there is no Kidney- a rare disease which has no
treatment. = extraordinary
PRINCIPLE OF PERSONALIZED SEXUALITY
● Is based on the understanding of sexuality as one of
the basic traits of the human person and must be
developed in ways consistent with enhancing human
dignity
● This element of human character often leads to a
loss of human dignity and an inability to pursue the
truly fulfilling goals of human life
● Takes note of a humanized sexuality, one that
represents the fulfillment of physical and sensual
need but also evidenced with love and sacramental
mystery.
Genesis 1-3
○ Teaches that God created persons as male and
female and blessed their sexuality as a great and
good gift
○ Jesus confirmed this teaching and perfected it by
affirming that men must be faithful in marriage as
women.
○ Nevertheless, Jesus also taught that although
sexuality is a great gift, its use in marriage is only
a relative value, which can be freely sacrificed for
the sake of higher values “for the kingdom of
GOD”
1 Cor 7:25-35
○ For the Christian, the celibate or single life, with
its freedom from domestic cares to be of service
to others, can be a personally mature and
fulfilling as married life.
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Jewish-Christian Tradition
○ Sexuality is always seen in relation to the family
as the basic unit of the community into which we
are born and educated to and on which the
community is built.
The Principle of Human Sexuality
may be stated as follows:
● The gift of human sexuality must be used in marriage
in keeping with its intrinsic, indivisible, specifically
human teleology.
● It should be a loving, bodily, pleasurable expression
of the complimentary, permanent selfgiving of a man
and a woman to each other, which is open to fruition
in the perpetuation and expansion of this personal
communion through the family they beget and
educate.
2 norms of Moral Sexuality
1. Laws or social attitude that hinder human freedom to
achieve these values in ways the individual desires
are unjust and oppressive.
2. Sexual behavior, at least among consenting adults is
entirely a private matter to be determined by personal
choice, free from any moral guilt.
PRINCIPLE OF ETHICS IN RESEARCH
1. Minimizing the risk of harm
Types of Harm:
A. Physical harm to participants
B. Psychological distress and discomfort
C. Social disadvantage
D. Harm to participants? Financial status
E. An invasion of participants? Privacy and
anonymity
To minimize harm:
A. Obtaining informed consent from participants
B. Protecting the anonymity and confidentiality of
participants
C. Avoiding deceptive practices when designing your
research
D. Providing participants with the right to withdraw
from your research at any time
2. Obtaining informed consent
● Participants should be volunteers, taking part
without having been coerced and deceived.
● Participants should understand:
A. They are taking part in research
B. What the research requires of them
C. Purpose of the research, the methods being used,
the possible outcomes of the research, as well as
associated demands, discomfort, inconveniences,
and risks that the participants may face
3. Protecting anonymity and confidentiality
● participants will typically only be willing to volunteer
information, especially information of a private or
sensitive nature, if the researcher agrees to hold
such information in confidence.
4. Avoiding deceptive practices
● In most circumstances, dissertation research should
avoid any kinds of deceptive practices
● Deception is sometimes a necessary component of
covert research, which can be justified in some
cases where:
(a) the identity of the observer
(b) the purpose of the research is not known to
participants
5. Providing the right to withdraw
● Research participants should always have the
right to withdraw from the research process.
● Participants should have the right to withdraw at
any stage in the research process.
● They should not be pressured or coerced in any
way to try and stop them from withdrawing
NUREMBERG CODE
● Formulated in August 1947, in Nuremberg, Germany
● By American judges sitting in judgment of Nazi
doctors accused of conducting murderous and
torturous human experiments in the concentration
camps (the so-called Doctor’s trial)
1. The voluntary consent of the human subject is
absolutely essential
● This means that the person involved should have
legal capacity to give consent
2. The experiment should be such as to yield fruitful
results for the good of society, unprocurable by other
methods or means of study, and not random and
unnecessary in nature
3. The experiment should be so designed and based on
the results of animal experimentation and a
knowledge of the natural history of the disease or
other problem under study, that the anticipated
results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid
all unnecessary physical and mental suffering and
injury
5. No experiment should be conducted, where there is
an a priori reason to believe that death or disabling
injury will occur; except, perhaps, in those
experiments where the experimental physicians also
serve as subjects.
6. The degree of risk to be taken should never exceed
that determined by the humanitarian importance of
the problem to be solved by the experiment.
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7. Proper preparations should be made and adequate

GOOD CLINICAL PRACTICE (GCP)
facilities provided to protect the experimental subject
against even remote possibilities of injury, disability, ● is an international ethical and scientific quality
or death. standard for the design, conduct, performance,
8. The experiment should be conducted only by monitoring, auditing, recording, analyses and
scientifically qualified persons. The highest degree of reporting of clinical trials
skill and care should be required through all stages of ● It also serves to protect the rights, integrity and
the experiment of those who conduct or engage in confidentiality of trial subject
the experiment.
9. During the course of the experiment, the human
subject should be at liberty to bring the experiment to
an end, if he has reached the physical or mental
state, where continuation of the experiment seemed
to him to be impossible.
10. During the course of the experiment, the scientist in
charge must be prepared to terminate the experiment
at any stage, if he has probable cause to believe, in
the exercise of the good faith, superior skill and
careful judgment required of him, that a continuation
of the experiment is likely to result in injury, disability,
or death to the experimental subject.

DECLARATION OF HELSINKI

● Developed by World Medical Association (WMA) at

Helsinki, Finland, June 1964
● ethical principles for medical research involving
human subjects
● the Declaration is addressed primarily to physicians

THE BELMONT REPORT

● written by the National Commission for the Protection

of Human Subjects of Biomedical and Behavioral
Research
● Three basic principles, among those generally
accepted in our cultural tradition, are particularly
relevant to the ethics of research involving human
subjects:
○ the principles of respect of persons
○ beneficence
○ justice.

ETHICS AND EVIDENCE-BASED PRACTICE

● Evidence-based practice is roughly the use of

current best evidence in making decisions about
the care of patients (Sackett et al. 1996)
● Ethical Concerns
1) Some types of knowledge are not included in EBP
2) EBP runs counter to patient-centered care
3) "Testable " is not the same as "most effective“
4) Decisions based on EBP can be unjust