HEALTH ETHICS MIDTERM
PRINCIPLES IN BIOETHICS practice to integrating a virtue based practical
Bioethics
- A holistic, rational appraisal of our place
in the world and how best we can live
for the good of the life community on
the planet.
- It mandates that equal and fair
consideration be given to human rights
issues, animal rights issues and
environmental concern.
PRINCIPLES USED IN BIOETHICS
1. Principle of Stewardship
Stewardship- The job of supervising or taking
care of something, such as an organization or
property. WE are responsible for it’s care.
2 great gifts that a wise and loving God has
given to us;
1. the earth, with all the natural resource
2. human nature, with its biological,
psychological, social and spiritual capacities.
• Human creativity should be used to cultivate
nature, recognizing our limitation and the risk of
destroying these gifts.
• Gifts of human life and environment MUST
be used with profound respect.
Stewardship in Healthcare Practice
• refers to the expression of one’s responsibility
to take care , nurture and cultivate what has
been entrusted to him.
• In healthcare practice, STEWARDSHIP refers to
the execution of responsibility of the health
care practitioners to look after, provide
necessary health care services, and promote the
health and life of those entrusted to their care.
Roles of Nurses as Stewards
a. Personal- The nurse steward ought to
structure educational opportunities that
encourage nurses to shift their epistemology of
reasoning.
b. Social
1. Nurses advocate for the health promotion to
educate patients and public on the prevention
of illness and injury, provide care and assist in
cure, participate in rehabilitation and provide
support.
2. Nurses help families become healthy by
helping them understand the range of
emotional, physical, mental and cultural
experiences they encounter during health and
illness.
3. Nurses help people and their families to
cope with their illness and deal with it and if
necessary live with it, so that their normal life
can continue.
c. Ecological- Nurses can help with waste
management. Health care sectors generates
tons of waste from the hospitals and since
nurses are the frontlines of care, they can be
helpful in coming up with policies about
hospital waste segregation and recycling.
Nurses can lead a way for communities to have
a more sustainable way of living.
d. Biomedical
1. A nurse should be familiar and well versed
with new equipment and tools that are being
used in the hospital and other clinical setting.
• According to the theory of Locsin, entitled
Technological competency as caring in nursing,
a nurse can be a steward of patients if they
know how to use technology to their advantage.
2. Principle of Totality and Its Integrity
• The principle of totality states that all
decisions in medical ethics must prioritize the
good of the entire person, including physical,
psychological and spiritual factors.
3. Supporting Patient Rights and Choices
1. Respect the dignity and worth of individual
patients.
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2. Preserves and protects patient autonomy and
human rights.
3. Be knowledgeable about the moral and legal
rights of their patients and to protect and
support those rights.
4. Individual rights to self‐ determination in
health care should be overridden temporarily to
preserve the life of the community.
Self Determination VS. Public Safety
• For example, during a bioterrorism attack,
victims infected with transmissible organisms
(eg, small pox, covid 19) require infection
control measures to prevent transmission to
others.
• These infection control measures may require
isolation, resulting in restricting a patient's
right to freedom of movement to protect
others.
5. Supporting patient's participation in decision
making, confirming informed consent, and
implementing advance directive policies.
6. Provide patients with honest and accurate
answers to their questions.
7. Perioperative nurses should explain the
procedures and OR environment before
initiating actions.
8. Respect patients' wishes in regard to advance
directives and end‐ of‐life choices.
9. Patients have the right to self‐ determination
(ie, the ability to decide for oneself what course
of action will be taken in various circumstances)
10. Nurses can empower patients by providing
opportunities for them to make autonomous
decisions about their health care.
11. When dealing with informed consent, the
nurse's role is to validate that the patient has
been given the information and understands as
much as possible about the surgical
intervention.
12. The principle of autonomy provides for
patients to make decisions freely, even if those
decisions are against medical advice.
13. Even if the surgeon and nurse believe that
surgery is in the best interest of the patient, the
patient has the right to refuse the procedure at
any time, regardless of whether he or she
signed the surgical consent form.
14. Nurses ethically should support patients in
their choices, regardless of whether they agree
with the patient's decision.
15. Nursing assessment and care also applies to
situations in which patients identify advance
directive choices or decisions related to do‐not‐
resuscitate orders. It is the nurse's role to
ensure that surgical team members are aware
of a patient's wishes in these matters.
16. It is important that all team members and
the patient discuss and identify a plan of care
before beginning the surgical procedure.
4. Ethico-moral Responsibility of Nurses in
Surgery • An ethical dilemma (ethical paradox
or moral dilemma) is a problem in the decision-
making process between two possible options,
neither of which is absolutely acceptable from
an ethical perspective
• Ethical dilemma happens when a patient is
anxious because he or she does not
understand fully what is going to happen in
surgery and the nurse is being pressured for a
fast turnover time.
• Nurses must realize that they are not being
asked to provide informed consent for the
patient.
• The nurse is merely acting as a witness to the
identity of the patient and to the patient's
signature on the consent form.
• Assess the patient's level of understanding
and see if he or she wishes to further discuss
the proposed intervention with the physician.
Sterilization- refers to any process that
eliminates, removes, kills, or deactivates all
forms of life and other biological agents.
Mutilation- Female genital mutilation (FGM)
comprises all procedures that involve partial or
 HEALTH ETHICS MIDTERM
total removal of the external female genitalia,
or other injury to the female genital organs for
non-medical reasons.
Preservation of Bodily Functional Integrity
Principle of Integrity- refers to every
individual’s duty to preserve the view of the
human person in which the order/function of
the body and its systems are respected and not
duly compromised by medical interventions.
• Anatomical- material or physical integrity of
the body
If one organ is missing from the person’s body
= lack of anatomical integrity
• Functional- systemic efficiency or functionality
of the body
But if one kidney is healthy, present and
functioning well =functional integrity is
preserved
Issues on Organ Donation
• Organ donation is when a person allows an
organ of their own to be removed and
transplanted to another person, legally, either
by consent while the donor is alive or dead with
the consent of the next of kin
• Donation may be for research or, more
commonly, healthy transplantable organs and
tissues may be donated to be transplanted into
another person.
• Some organs and tissues can be donated by
living donors, such as a kidney or part of the
liver, part of the pancreas, part of the lungs or
part of the intestines, but most donations occur
after the donor has died.
• Common transplantations include kidneys,
heart, liver, pancreas, intestines, lungs, bones,
bone marrow, skin, and corneas.
5. Principle of Ordinary and Extraordinary
Measures
Ordinary measures are those that are based on
medication or treatment which is directly
available and can be applied without incurring
severe pain, costs or other inconveniences
• Ordinary means must be taken to preserve life
• Ordinary means are those “means of
treatment available are objectively
proportionate to the prospects for
improvement.”
• For example, a feeding tube is an ordinary
means of preserving life
Extraordinary means are “medical procedures
which no longer correspond to the real situation
of the patient, either because they are by now
disproportionate to any expected results or
because they impose an excessive burden on
the patient and his family. • Ordinary means
must be taken to preserve life, and
extraordinary means can be morally refused
6. Principle of Personalized Sexuality
Sex is a social necessity for the procreation of
children and their education in the family so as
to expand the human community and
guarantee its future beyond the death of
individual members. Teaches that God created
persons as male and female and blessed their
sexuality as a great and good gift
BIOETHICS AND ITS APPLICATION IN VARIOUS
HEALTH CARE SITUATIONS
1. Human Sexuality and its Moral Evaluation
• Human sexuality refers to people’s sexual
interest in and attraction to others, as well as
their capacity to have erotic experiences and
responses.
• People’s sexual orientation is their emotional
and sexual attraction to particular sexes or
genders, which often shapes their sexuality.
• Sexuality may be experienced and expressed
in a variety of ways, including thoughts,
fantasies, desires, beliefs, attitudes, values,
behaviors, practices, roles, and relationships.
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Moral Evaluation
- Christian ethics has centered its
consideration of human sexuality in
committed monogamous lifelong
heterosexual Christian marriage
- Marriage, is seen biblically and
theologically, to signify Christ's union
with the Church.
- In Christian marriage, sexuality is only
good insofar as it is open to
PROCREATION.
- Sexuality is both a good in itself and a
means of achieving other goods and
purposes, including for example such
things as commitment, fidelity, mutual
joy, and comfort.
- The basic criteria for evaluating any
relationship have to do with the extent
to which key relational components are
present and expressed in ways
appropriate to the particular
relationship.
- Mutual regard, respect, and
truthfulness are minimums for any
relationship.
- Relationships that are more than
fleeting ought also to involve
responsibility, loyalty, accountability,
attentiveness, and availability.
- Long-enduring relationships require
commitment, fidelity, reciprocity,
forgiveness, and generativity.
2. Marriage
• Marriage is defined differently, and by
different entities, based on cultural, religious,
and personal factors.
• A commonly accepted and encompassing
definition of marriage is the following:
• a formal union and social and legal contract
between two individuals that unites their lives
legally, economically, and emotionally.
• The contractual marriage agreement usually
implies that the couple has legal obligations to
each other throughout their lives or until they
decide to divorce.
• Being married also gives legitimacy to sexual
relations within the marriage.
• Traditionally, marriage is often viewed as
having a key role in the preservation of morals
and civilization.
Marriage as a Moral Act
- Marriage is sacred and was ordained of
God from before the foundation of the
world thus, it affirmed the divine origins
of marriage
• Commitment Respect
• Fidelity Understanding
• Loyalty
• Sacrifice
- The sacred nature of marriage was
closely linked to the power of
procreation.
- Marriage is a vital institution for rearing
children and teaching them to become
responsible adults.
Under the Family Code of the Philippines (FC),
marriage is defined as a special contract of
permanent union between a man and a woman
entered into in accordance with law for the
establishment of conjugal and family life.
Fundamentals of marriage
Husband- A married man considered in relation
to his spouse.
Wife- A married woman considered in relation
to her spouse
Marriage License- A license that a couple must
obtain before getting married
PERSONAL OBLIGATIONS OF THE SPOUSES TO
EACH OTHER
•Live together;
•To observe mutual love, respect, and fidelity;
and
•To render mutual help and support.
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Issues on sex outside Marriage
Premarital sex is a sexual activity that is
practiced by people before they are married.
Historically, premarital sex has been considered
a moral issue that is taboo in many cultures and
it is also considered a sin by a number of
religions, but since the sexual revolution of the
1960s, it has become accepted by certain liberal
movements, especially in Western countries.
Extra Marital Sex- occurs when a married
person engages in sexual activity with someone
other than their spouse.
• Where extramarital sexual relations do breach
a sexual norm, it may be referred to as adultery
or non-monogamy (sexual acts between a
married person and a person other than the
spouse), fornication (sexual acts between
unmarried people), philandery, or infidelity.
• These terms imply moral or religious
consequences, whether in civil law or religious
law.
Adultery and Concubinage
• Philippines' law criminalizes adultery and
concubinage. Both are deemed “crimes against
chastity” under the Revised Penal Code of the
Philippines and are treated as sexual infidelity in
the Family Code.
• The law discriminates against wives. The
crime of adultery can be committed only by a
wife and her paramour. The husband need only
prove that his wife had sexual intercourse with
a man other than him.
• The crime of concubinage can be committed
only by a husband and his concubine, but it
requires that the wife must prove that her
husband has kept a mistress in the conjugal
dwelling or has had sexual intercourse under
“scandalous circumstances” or lived together
with his mistress in any other place
Methods of Contraception
1. Folk methods – “bato-balani” (magnetic
stone)
2. Mechanical methods – Condom, Diaphragm,
Sponge
3. Chemical methods - Vaginal suppositories
and tablets Vaginal jellies, creams, and foams
4. Hormonal methods – Contraceptive pills
Injections and implants
5. Surgical methods - Tubal ligation, Vasectomy,
Hysterectomy
6. Natural or behavioral methods - Rhythm or
calendar method Temperature method
7. Ovulation (Mucus) Method / Sympto-
thermal method – sex relations during
menstruation
- The moral issue of contraception is
concerned with the rightness or
wrongness of the use of various
methods by which contraception can be
prevented in the conjugal union of the
sperm and egg thus prevented the born
of a fetus.
- If personhood begins with God’s
thought of a person, using
contraception therefore it would seem
to go against God’s will. (Gerber 2013)
- On this view, it interferes with God’s
plan for that potential human being.
Contraception leads to “Immoral Behaviour"
Contraception makes it easier for people to
have sex outside marriage
Contraception leads to widespread sexual
immorality
Contraception allows people (even married
people) to have sex purely for enjoyment
Ethico-Moral Responsibility of Nurses in
Contraception
Primary Concern- Welfare of the patient and
respecting the autonomy of the patient
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Secondary Concern- Make sure the patient gets ➢ Male - Low sperm count/sperm not strong
all the information and advice that they need to enough
be able to choose wisely. ➢ Female – endometriosis
3. Issues on Artificial Reproduction, its morality,
and Ethico-moral responsibility of Nurses TYPES OF ARTIFICIAL INSEMINATION
• According to one study, the nurse is the • Homologous
professional who spends the most time with ➢ Husband’s sperm is used
donors as compared with physicians and mental ➢ It generally involves masturbation on the
health professionals part of the man
• ART (assisted reproductive technology) is an •Heterologous
expertise that is part of the highquality
➢ A donor’s sperm is used
healthcare available in highly civilized countries
➢ It seems to involve adultery, since the
inclusive of the Philippines, thus making our
woman and the donor are having a sort of
country at par with global standards of
intercourse without being married to one
healthcare
another.
• Patients are briefed with all the necessary
information they need to be able to understand
MORAL ISSUES on Artificial Insemination
the methods and procedure, the safety, risks,
•Human procreation dissociated from sexual
success or failure factors, and even the financial
partners
support necessary to carry out the medical and
• Not therapeutic; does not cure infertility or
surgical steps needed. The doctors also explain
reserve infertility
in detail what different moral and ethical
• Women alone can chose to have a child even
concerns may be involved.
without a husband or a boyfriend. All they need
• Why are there people who go for artificial
is a sperm donor. In a situation like this, it is said
reproduction? The number one reason is
to create a paradox on the right to reproduction
infertility.
since it is supposed to be a couple decision.
People question the welfare of the child in this
Artificial Insemination
situation also. The child has the right to have a
• Medical procedure of injecting semen into the
mother AND a father.
vagina or uterus.
• The use of a donor in Artificial Insemination
• It refers to an assisted method of
introduces a new genetic material to the family,
reproduction in which a man’s semen is
which is foreign to the couple. There is a great
deposited into the woman’s reproductive tract
chance that, in this same sperm bank, will be
through the use of instruments to bring about
used to multiple inseminations, therefore those
conception unattained or unattainable by
children will be half-brothers.
natural fertile intercourse.
• This involves harvesting sperm and inserting it
Ethico-Moral Responsibility of Nurse in
into the woman’s vagina by means of a syringe.
Artificial Insemination
The sperm may originate from the woman’s
• Informed consent
husband (called homologous AI) or from a
➢ The physician or advanced practice nurse is
donor (heterologous AI).
responsible for informing the client about the
• Doctor places the sperm in the uterus.
procedure and obtaining consent by providing a
• First method for treatment.
detailed description of the procedure or
 HEALTH ETHICS MIDTERM
treatment, its potential risks and benefits, and
alternative methods available.
• Assesses the couple's emotional status
relative to infertility.
• Counsels and informs about the side effects of
the procedure.
➢ S/E: Nausea, vomiting, ovarian enlargement,
occurrence of ovarian cysts
• Describes the legal ramifications of the
procedure.
➢ The laws on the subject frequently provide
that the children of the insemination can be
told the identity of the donor when they reach
age 18
• Assists in interviewing donors for the
program. ➢ Thorough medical histories must
be taken of all candidates for anonymous
semen donation. All potential donors must also
be screened for infectious or inheritable
diseases which could adversely affect the
recipient or the resultant child. Frozen semen
should be used for artificial insemination
because it enables the donor to be tested for
communicable disease agents and diseases at
the time of donation, and again after an interval
before the original semen is used, thus
increasing the likelihood that the semen is free
of blood-borne pathogens.
IN-VITRO FERTILIZATION (IVF)
•Homologous IVF- Involves the gametes from
both spouses; no third party is involved.
•Heterologous IVF- Involves the gametes of a
donor (a third party supplies necessary
gametes).
• One of the main problems in IVF are about the
left over embryos.
• For the clinic to store the frozen embryos, the
couple have to pay a fee. There are couples who
do not know what to do about the left over
embryos that they just stop paying. For ethical
and legal reasons, most clinics are reluctant to
throw away the embryos without the consent
of the couple.
Surrogate Motherhood
• Practice in which a woman (the surrogate
mother) bears a child for a couple unable to
produce children in the usual way, usually
because the wife is infertile or otherwise unable
to undergo pregnancy.
• Surrogacy is one of the most controversial
methods of parenthood and infertility
treatment in which a surrogate carries a fetus
for another woman.
• Surrogacy is an arrangement where a
surrogate mother bears and delivers a child for
another couple or person.
• Surrogate- A woman who becomes pregnant,
carries, and delivers a child on behalf of another
couple.
• FULL surrogacy (Gestational Surrogacy)-
gestating woman has NO genetic link to the
child • PARTIAL surrogacy (Traditional
Surrogacy)- Gestating woman has a genetic link
by providing the oocyte
MORAL ISSUES on Surrogate Motherhood
• The rights of the children produced.
➢ Both parties involved should have voluntarily
accepted certain restrictions on their autonomy.
They cannot change their minds after the start
of pregnancy or if they had already implanted
the embryo.
• The ethical and practical ramifications of the
further commodification of women's bodies.
➢ The surrogate mother is expected to behave
as a responsible woman (adopt a healthy
lifestyle, etc) and to confirm with the
agreement of the commissioning parents to
testing and prenatal screening. It is included
here a possibility of terminating the pregnancy
in case there is a severe malformation on the
fetus.
➢ Using a woman's body as some kind of
"womb-renting". It takes away the specialness
of pregnancy.
 HEALTH ETHICS MIDTERM
• The exploitation of poor and low income
women desperate for money.
➢ There are several arguments that are
surrounding this area in surrogacy. Those who
are opposed to surrogacy say that paying
someone to carry a baby for you is an insult to
human dignity, it is an instrumentalization of
the human body, potential exploitation of
vulnerable women and inappropriate
inducement/coercion of women.
➢ Most of those who agree to be surrogate
mothers are in desperate need of money
especially here in the Philippines, there are a
number of women who have also agreed to
this.
4. Morality of Abortion, Rape and Other
Problems related to destruction of Life
•Abortion – is the termination of pregnancy by
the removal or expulsion from the uterus of a
fetus or embryo.
•An abortion can occur spontaneously, or it can
be purposely induced.
The two side of Abortion:
AGAINST:
• A new person is killed.
• Women should be careful and don’t do things
without thinking.
IN FAVOUR:
• There are situations, where women don’t
choose if they get pregnant or not.
• An embryo is not considered a human being
yet.
ABORTION AND PHILIPPINE LAWS
•Illegal in the Philippines and is not permitted.
•Criminalized by the Revised Penal Code
•Articles 256, 258 and 259 of the Code mandate
imprisonment:
•For the woman who undergoes
•Person who assists in the procedure
Classification of the Expulsion of Human Fetus
1. DIRECT ABORTION – if intentionally or
deliberately done
2. INDIRECT ABORTION – if unintentionally and
the fetus is aborted indirectly.
3. SPOTANEOUS ABORTION – if accidentally
occurs.
DIFFERENT TYPES OF ABORTION
1. Complete Abortion – when all contents of
uterus such as the pre-born child and the
placenta have been expelled from the uterus.
2. Incomplete Abortion – may be intentional or
unintentional abortion I which parts of the pre-
born child or placenta remain within the uterus.
Treatment: surgical uterine evacuation due to
risk of infection and/or continued and excessive
bleeding
3. Induced Abortion – is an intentional abortion
brought about mechanical (surgical) or chemical
means.
4. Infected Abortion – possibly caused by an
infection of the uterus or the genital tract.
Treatment: operation should be delayed unless
excessive uncontrolled blood loss, and
antibiotics are administered
5. Spontaneous Abortion – is an abortion
caused by a disease or accident. Sometimes
vitamin deficiencies are the cause. Common
cause is said to be sexual intercourse in the
early months of pregnancy.
6. Threatened Abortion – includes vaginal
bleeding and the prognosis for it may or may
not rebound to inevitable abortion. Treatment:
treated at home/hospitalized. Medical
treatment–progesterone/synthetic
progestational agents, IM or orally.
7. Inevitable Abortion – commonly known as
miscarriage. This may be brought about by
pathologic condition or accident causing
definite expulsion. Treatment: surgical uterine
evacuation (with suction technique or surgical
 HEALTH ETHICS MIDTERM
procedure) + reducing blood loss and pain
Types of Surgical Abortion:
• Suction abortion: This is the most common
method of abortion. This method involves
gentle suction to empty your womb (uterus).
It’s done until about 14 to 16 weeks after the
first day of your last period.
• Dilation and evacuation (D&E): Suction and
medical tools are used to empty the uterus. This
is normally done for pregnancies that are
further along (more than 16 weeks).
• Dilation and curettage (D&C) is a short
surgical procedure that removes tissue from
your uterus (womb). You may need this
procedure if you have unexplained or abnormal
bleeding, or if you have delivered a baby and
placental tissue remains in your womb. D&C
also is performed to remove pregnancy tissue
remaining from a miscarriage or an abortion.
RISK FACTORS AFTER ABORTION
•Severe bleeding and infection
•Having problems in future pregnancy
•Becoming sterile
•Needing a Hysterectomy
•Death
IS IT ETHICAL TO GIVE BIRTH TO AN
UNWANTED CHILD? Ethical to force women to
carry pregnancies to term; unethical to force
the birth of children who are unwanted and
cannot be cared for.
IS ABORTION MORAL?
• As long as it is direct – that is performed
deliberately ad wilfully, ABORTION IS
IMMORAL. • Abortion is a blatant transgression
of natural law that is inscribed both in hearts of
men and in Decalogue (10 Commandments). It
is against the order of right reason which
dictates, regardless of religious beliefs and
social orientation, the innocent life must not be
taken directly, deliberately, and wilfully for
whatever reasons.
RAPE AND INCEST
• Rape – is a form of sexual assault, but not all
sexual assault is rape. The term rape is often
used as a legal definition to specifically include
sexual penetration without consent.
• Incest – term used when persons that are
closely related to each other or forbidden by
law to marry had sexual intercourse.
MORALITY OF RAPE AND INCEST
• The innocent victim of a criminal attack is
allowed to eject or destroy the sperm before
conception takes place. Unjust aggression is the
moral basis which justifies the victim. The
sperm maybe removed from the vagina at any
time after the attack since conception does not
take place there. However if any means is used
to remove it from the uterus or fallopian tube it
must be employed before there is any
probability that an impregnated (fertilized)
ovum is already existing. Otherwise, it would
take the form of direct abortion which is never
permissible
•A gestation that is caused by rape and incest
cannot justify any procurement of abortion. The
innocent human life should not suffer
punishment for the crime committed by the
perpetrator.
MORAL TEACHING ON THE INVIOLABILITY OF
HUMAN LIFE
• The church affirms that human life begins to
exist at the moment of conception or
fertilization. It must be respected and protected
absolutely from the moment of conception.
From the first moment of his existence, a
human being must be recognized as having the
rights of a person – among which is the
inviolable right of every innocent being to life.
From its conception, the child has the right to
life.
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Dignity in Death and Dying Discussion Outline:
-Euthanasia and Prolongation of Life
-Inviolability of Human Life –Suicide
-Dysthanasia
-Orthothanasia
-Administration of drugs to the dying
-Advance directives
-DNR or End of Life Care Plan
DYING WITH DIGNITY = Movement that
promotes the ability to meet Death on your
own terms.
EUTHANASIA
• A doctor is allowed by law to end a person’s
life by a painless means, as long as the patient
and their family agree.
TYPES:
Voluntary – when euthanasia is conducted with
consent.
• Currently legal in Belgium, Luxembourg,
Netherlands, Switzerland, and the states of
Oregon and Washington in the U.S.
Involuntary – when euthanasia is performed on
a person who would be able to provide
informed consent, but does not, either because
they do not want to die, or because they were
not asked. This is called murder, as it’s often
against the patient’s will.
Non-voluntary – when euthanasia is conducted
on a person who is unable to consent due to
their current health condition. The decision is
made by another person, on behalf of the
patient, based on their quality of life and
suffering.
INVIOLABILITY OF HUMAN LIFE
• The inviolability of life principle, as
conventionally understood, permits the
withholding and withdrawing of lifeprolonging
treatment that is not worthwhile because it is
futile or too burdensome for the patient even
though it is wrong to withhold treatment
because the patient's life was thought to be
worthless, it would be acceptable to withhold
treatment based on the fact that the treatment
itself was deemed to be worthless.
SUICIDE
• Assisted suicide is suicide undertaken with the
id of another person. The term usually refers to
PHYSICIAN-ASSISTED SUICIDE (PAS), which
suicide is assisted by a physician or other
healthcare provider.
• Once it is is determined that the person’s
situation qualifies under PAS laws for that place,
the physician’s assistance is usually limited to
writing a prescription for a lethal dose of drugs.
• In most of those states or countries, to qualify
for legal assistance, individuals who seek a
physician-assisted suicide must meet certain
criteria including: having terminal illness,
proving they are of sound mind, voluntarily and
repeatedly expressing their wish to die, and
taking the specified, lethal dose by their own
hand.
DYSTHANASIA
• Dysthanasia – a term generally used when a
person is seen to be kept alive artificially in a
condition where, otherwise they cannot survive.
• The term for futile or useless treatment,
which does not benefit a terminal patient. A
process through which one merely extends the
dying process and not life.
ORTHOTHANASIA
• A normal or natural manner of death and
dying. Sometimes used to denote the deliberate
stopping of artificial or heroic means of
maintaining life.
• Orthothanasia refers to the art of promoting
humane and correct death.
ADMINISTRATION OF DRUGS TO THE DYING
• In medicine, specifically in end-of-life care,
palliative sedation is the practice of relieving
distress in a terminally ill person in the last
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hours or days of a dying patient’s life, usually by
means of a continuous intravenous or
subcutaneous infusion of a sedative drug, or by
means of a specialized catheter designed to
provide comfortable a discreet administration
of ongoing medications via the rectal route.
• Palliative sedation is an option of last resort
for patients whose symptoms cannot be
controlled by any other means.
• It is not a from of euthanasia, as the goal of
palliative sedation is to control symptoms,
rather than to shorten the patient’s life.
ADVANCE DIRECTIVES
• Advance Directives are legal documents that
allow you to spell out decisions about end-of-
life care ahead of time. It gives a way to tell
your wishes to family, friend, and health care
professionals and to avoid confusion later on.
1. THE LIVING WILL – a legal document used to
state certain future health care decisions only
when a person becomes unable to make the
decision and choices on their own
2. Healthcare Power of Attorney/Medical
Power of Attorney – a legal document in which
you name a person to be a proxy (agent) to
make all your health care decisions if you
become unable to do so.
END OF LIFE CARE PLAN OR DNR (Do not
Resuscitate)
• End of life care include palliative care. If you
have an illness that can’t be cured, based on the
understanding that death is inevitable, palliative
care makes you as comfortable as possible, by
managing your pain and other distressing
symptoms.
• It also involves psychological, social and
spiritual support for you and your family or
careers.
The process of making ethical decision
requires: • Commitment: The desire to do the
right thing regardless of the cost.
• Consciousness: The awareness to act
consistently and apply moral convictions to
daily behaviour
• Competency: The ability to collect and
evaluate information, develop alternatives, and
foresee potential consequences and risks.
Good decisions are both ethical and effective:
• Ethical decisions generate and sustain trust;
demonstrate respect, responsibility, fairness
and caring; and are consistent with good
citizenship. These behaviours provide a
foundation for making better decision by setting
the ground rules for our behaviour.
• Effective decisions are effective if they
accomplish what we want accomplished and if
they advance our purposes. The key to making
effective decisions is to think about choices in
terms of their ability to accomplish our most
important goals. This means we have to
understand the difference between immediate
and short-term goals and longer-range goals.
RESEARCH ETHICS
- Rules and guides that defines the
conduct of the researcher.
- Researchers should protect the dignity
of their subjects and
- Provides guidelines for the responsible
conduct of biomedical research
- Educates and monitors scientists
conducting research to ensure a high
ethical standard
NUREMBERG CODE: 10 ETHICAL PRINCIPLES
1. Research participants must voluntarily
consent to research participation
2. Research aims should contribute to the good
of society
3. Research must be based on sound theory and
prior animal testing
4. Research must avoid unnecessary physical
and mental suffering
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5. No research projects can go forward where
serious injury and/or death are potential
outcomes
6. The degree of risk taken with research
participants cannot exceed anticipated benefits
of results
7. Proper environment and protection for
participants is necessary
8. Experiments can be conducted only by
scientifically qualified
9. Human subjects must be allowed to
discontinue their participation
10. Scientists must be prepared to terminate
the experiment if there is cause to believe that
continuation will be harmful or result in injury
or death
Belmont Report of 1979
Respect for Persons
• provide enough information so that an
informed, voluntary decision can be made
• voluntary informed consent to participate in
research
- Information
- Comprehension
- Voluntariness
Beneficence
•to do nonce harm, minimize risk of harm and
maximize the benefits of research to protect
human welfare
•analyzing the risks and benefits
Justice
• fair and equitable distribution justice of
benefits and burdens of research
• research participants are selected fairly, with
all segments of the population having an
opportunity to be included in a study, provided
that inclusion is scientifically and ethically
justifiable
The Nuremberg, Helsinki, and Belmont
guidelines provided the foundation of more
ethically uniform research to which stringent
rules and consequences for violation were
attached.
INTRODUCTION TO GOOD CLINICAL PRACTICE
GUIDELINES
GCP
▶ A standard for designing, conducting,
recording and reporting of studies involving
human subjects.
▶ Public assurance that the rights, safety and
wellbeing of trial subjects are protected.
Research regulatory
Not regulated
- Basic research
- Disease recovery
- Drug recovery
GLP- preclinical development
GCP- clinical trials
GMP- manufacturing
Evolution of GCP
1930s – US Food Drug & Cosmetic Act 1947 –
Nuremberg Code
1962 - Kefauver Amendments (US) (following
Thalidomide tragedy)
1964 – Declaration of Helsinki
1974 – National Research Act
(US) 1979 - Belmont Report (US)
1986 – England – ABPI Guideline
1987 - France - Bonnes Pratiques Clinique
1989 – Scandinavia - Nordic Guidelines , Good
Clinical Trial Practice
1990 – France – Huriet Law 1990 - EC - Good
Clinical Practice for Trials on Medicinal Products
in the European Community
1992 - WHO Guidelines, Australian Guidelines
ICH
International Conference on Harmonisation of
Technical Requirements for Pharmaceuticals for
Human Use
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▶ Realization to have independent evaluation
of medical products mostly driven by tragedy
▶ 1960-1970s - rapid increase in laws,
regulations and guidelines for reporting and
evaluating the data on safety, quality and
efficacy
▶ Varied from country to country – need to
harmonise
▶ Pioneered by European Community (EC)
(now the European Union) in 1980s
▶ WHO Conference of Drug Regulatory
Authorities (ICDRA), in Paris, in 1989
▶ ICH was initiated on April 1990, in a meeting
hosted by EFPIA (European Federation of
Pharmaceutical Industries and Associations) in
Brussels
▶ Main outcome - Tripartite ICH Guidelines on
Safety, Quality and Efficacy
Principles of ICH GCP
- Clinical trials should be conducted in
accordance with the ethical principles
that have their origin in the Declaration
of Helsinki, and that are consistent with
GCP and the applicable regulatory
requirement(s).
- Before a trial is initiated, foreseeable
risks and inconveniences should be
weighed against the anticipated benefit
for the individual trial subject and
society. A trial should be initiated and
continued only if the anticipated
benefits justify the risks.
- The rights, safety, and well-being of the
trial subjects are the most important
considerations and should prevail over
interests of science and society.
Clinical Research Team
Institutional Review Board/ Ethics committee
- An IRB/IEC should safeguard the rights,
safety, and well being of all trial
subjects. Special attention should be
paid to trials that may include
vulnerable subjects
- The IRB/IEC should review a proposed
clinical trial within a reasonable time
- The IRB/IEC should conduct continuing
review of each ongoing trial at intervals
appropriate to the degree of risk to
human subjects, but at least one per
year
- Adequately addresses relevant ethical
concerns and meets applicable
regulatory requirements for such trials
- The IRB/IEC should review both the
amount and method of payment to
subjects to assure that neither presents
problem of coercion or undue influence
on the trial subjects. Payments to a
subject should be prorated and not
wholly contingent on completion of the
trial by the subject
Investigator
▶ The investigator should be qualified by
education, training, and experience to assume
responsibility for the proper conduct of the
trial, should meet all the qualifications specified
by the applicable regulatory requirements
▶ The investigator should be thoroughly
familiar with the appropriate use of the
investigational product(s), shoulld be aware of,
and should comply with, GCP and the applicable
regulatory requirements
▶ Should permit monitoring and auditing by
the sponsor, and inspection by the appropriate
regulatory authorities
▶ A qualified physician, who is an investigator
or a sub-investigator for the trial, should be
responsible for all trial related medical decisions
▶ Should comply with the sponsors for timely
completion of the project and recording of all
clinical and non clinical data.
▶ Adverse drug reactions must be manages
appropriately followed by reporting to
regulatory authority, IRB/IEC and sponsor
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Sponsor
- Sponsor takes the responsibility for the
initiation, management and/or
financing of a clinical trial
- A sponsor can be:
- An Individual
- A Company
- An Institution
- An Organization

Monitor
▶ Acts as main line of communication between
the sponsor and investigator
▶ Should be appointed by the sponsor
▶ Should be appropriately trained, and should
have the scientific and/or clinical knowledge
needed to monitor the trial adequately