PRELIM: HEALTH CARE ETHICS (BIOETHICS)

TOPIC 1:

ETHICS
● Greek word “ethos” which means moral duty, character or custom.
● It refers to the practices or values that distinguish one person, organization, or
society from others. It pertains to the knowledge of what to study about-that is the
Goodness or evil of human conduct.
● Ethics is not feelings
● Ethics is not religion
● Ethics is not following culturally accepted norms
● Ethics is not a science
● Ethics is not equal to law and some laws are not morally accepted
● Ethics is not equal to accepted social behavior

3 descriptions of what ethics is all about:

1. Well-founded standards of right and wrong
2. What humans ought to do in terms of right
3. Obligations to benefit others. To give beneficial care

Morality is..
- Greek word “moralis”
- A social consensus about moral conduct. A practice of ethics. Application of ethical
knowledge in doing an act.

What is Healthcare Ethics?

- Division of ethics that relates to human health. Deals with the conduct and moral
issues that arise in the practice of healthcare professionals

What is Healthcare Ethics for?

➔ Strives to resolve ethical issues that confront health care professionals.

BIOETHICS - a subpart of healthcare ethics that focuses on moral issues in relation to life in
healthcare
➔ Greek word “bios”
➔ Ethics of LIFE
- The application of ethics in the field of medicine and healthcare
★ We need bioethics because we felt the need to justify our own behavior.

➔ All of LIFE Ethics

- Science that deals with the study of the morality of human conduct
concerning human life in all its aspects from the moment of its conception to
its natural end.
What is an Emergency Use Authorization?
EUA is a mechanism to facilitate the availability and use of medical countermeasures,
including vaccines, during public health emergencies, such as the current COVID-19
pandemic.

Health Ethics
Moral issues on how we understand life; provide tools for analysis and will help us think
about core options in the resolution of the dilemma

Health Care Ethics /Action: prevention, treatment and management of illness and the
preservation of that well being through the services offered by the medical and allied health
professions.

Health care ethics

- “Medical Ethics” a formulation of ethical norms for the conduct of health care
professional in the treatment of patients

The Hippocratic Oath

➔ Hippocrates “Father of medicine”
➔ An oath historically taken by physician and other health care professionals swearing
to practice medicine honestly

Hippocratic Oath (3) lines:

1. Relieve pain
2. Reduce violence of disease
3. Refrain from trying to cure whom the disease has conquered

Ethical Theories
Normative ethics or Approaches
1. Deontology 2. Teleology

- “Deon” = duty, necessary - A.K.A. Utilitarianism - “the end

- Determines the goodness or justifies the means” “greatest good
badness of the action by examining for the greater number”
the action itself - ‘Utility’ means ‘good’
- Jeremy Bentham (1748-1832) - Advocates actions that foster
happiness or pleasure and opposes
A.k.a Nonconsequentialist Theory actions that causes harm
- Does not consider the consequence - Focuses on happiness, well being,
of the actions first rather it examines and the material outcomes of our
the action first. actions
- Immanuel Kant (1724-1804) Greek word “Telos” = goal, end
- Expressed the concept of - The goodness or badness of an
morality as the right thing is action by examining its
to do one’s duty by each consequences
person Actions are “Right or Wrong” according to
- “Morality is based on the the balance of their good or bad
person’s action and not on consequences.
their motive”
- advocating the highest good
 for everybody Consequentialist Theory /Ethics
- Can do good but can do wrong as - a reason or explanation for
well something as a function of its end,
- Principle of obligation must be purpose, or goal, as opposed to as a
followed by all irregardless of the function of its cause.
consequences - Consequence of an action
- The basic rightness or wrongness of - Situation Ethics that considers the
an act depends on its intrinsic end
nature rather upon the situation or John Stuart Mill (1806-1873) and Jeremy
consequence Bentham (1748-1832)
- Their ethical doctrines state that the
Rightness and Wrongness of actions
is determined by the goodness and
badness of their consequences.
- Judge morality of action by the good
or bad consequences of an act
- Good is the general good will or
love for humanity
- Decisions are often made through
risk-benefit analysis

Virtue (Aretaic) Ethics

➔ Simply what you believe in your motive for doing something
➔ Aristotle (384 - 322 BC)
- Happiness must not be only for some people but the society
- Explain the highest good for humans that bringing the potential of that good is
significant for character development and actualization. This concept of the
character is in the area of virtue ethics because its goal is the development of
those virtues in the person and in the body.
➔ Virtue = Gk. arete, excellence
- Focus is on excellence primarily on the heart of the person doing the act
➔ A Way of Living
- Develop one's character to make good ethical decisions when needed. The
decision made must not be for some happiness of some people but for the
flourishing of society.
➔ Heart-focused
- Good traits that are naturally right and useful for getting what one wants.
➔ Cardinal virtues
- Wisdom (more than knowledge), courage (confident), temperance
(moderation), justice (right or wrong)
➔ Christian Virtues
- Faith, Hope, Love (1st Corinthians Chapter 13)
Virtue
The Mean (Average) of the two extremes

Deficiency ← Virtue → Excess

Eudaimonia
- Not Just personal happiness but Human Flourishing
- A perfection of character nurtured in engaging in virtuous acts over a life of
experience
- Aristotle (384-322 BC)
- Contented state of being happy, healthy, contended and prosperous.

Florence Nightingale (1820-1910)

● Founder of modern era or nursing
● Recognized the importance of personal character and virtue.

Nightingale identified several characters/character traits:

1. Truthfulness/ Honesty
2. Integrity (closely related to honesty)
3. Humility (being humble)
4. Thankfulness
5. Compassion (or Sympathy)

Core values for Professional Nurses (according to Florence)

1. Care (Heart of Nursing)
2. Compassion
3. Competence
4. Courage (combination of compassion + competence)
5. Commitment
6. Communication

Health care - The prevention, treatment, and management of illness and the preservation of
well-being through the services offered by the medical and allied health professions.

Topic 2: Ethics and Ethical Principles

7 Universal principles
1. Autonomy
2. Confidentiality
3. Veracity
4. Fidelity
5. Nonmaleficence
6. Justice
7. beneficence

AUTONOMY - A strong sense of personal responsibility and moral decision for one’s own
life. Decision comes from the patient

Principle of Autonomy applied

refuse treatment, disclose his or her ailment, choose the mode of treatment, maintain
confidentiality of treatment, determine what should be done to his or her body, informed
consent

CONFIDENTIALITY - State of keeping or being kept secret or private

VERACITY- Practice of telling the truth

3 strong reasons to apply veracity:

1. Obligation of respect
2. Promise keeping
3. Trust building

FIDELITY - Altruism, Loyalty, caring and honesty, Commitment , Faithfulness and practice of
keeping promises and commitments

NONMALEFICENCE
★ Duty to refrain from causing damage (trying to remove the harm)
★ Principle stated: “Do No Harm”
★ An extension of this is the obligation to protect from harm those who cannot protect
themselves such as children, mentally ill people, and unconscious clients.
★ Expressed in the Hippocratic oath: I will use treatment to help the sick according to
my ability and judgement, but will never use it to injure or harm them.

Typical examples according to Bernard Gert, a bioethicist:

➔ Do not kill.
➔ Do not cause pain or suffering to others.
➔ Do not incapacitate others
➔ Do not deprive others of the goods of life.
➔ More Practically for nurses,
➔ Do not assist in performing abortion
➔ Do not assist someone who wants to commit suicide
➔ Do not willfully subject patients to experimental drugs whose potential harm may be
greater than the benefit
 ➔ Do not harm a person’s reputation by revealing confidential information.

BENEFICENCE
Maxim: Do good
Actions that promote the wellbeing of others

JUSTICE
- Fair, equitable and appropriate treatment to others.
- Focuses on equitable access to health care

Article XIII
National Health Insurance Act of 1995
- “The state shall adopt an integrated and comprehensive approach to health
development and shall endeavor to make essential goods, health and social services
available to all people at affordable cost.”

Republic Act 7432

Senior Citizen’s Act
- give honor and justice to the elderly by giving them a 20% discount in public
establishments like restaurants, pharmacies, jeepneys, hospitals, free medical and
dental check-ups, and free hospitalization in government hospitals.

Hospital Triage is an example of justice.

➔ The way hospitals determine who should be served first should be based on their
health condition.

Patient’s rights
- Refers to the moral and inviolable power vested in a patient as a person to do, hold
or demand something as his/her own.
- Informed consent: refers to knowledge or information about and the consent to a
particular form of medical treatment before the treatment is administered.
- Informed decision: refers to the necessary information of and the decision on a
medical treatment before to be carried out.
- Informed choice: refers to the necessary information a patient should know about a
medical treatment or experiment so that a moral choice can be made.
- Refusal treatment: The patient has the right to refuse treatment to the extent
permitted by law and to be informed of the medical consequences of his action

Elements of informed consent

1. Competence - Capacity for decision making
2. Disclosure - the content of what a patient is told or informed about

Disclosure includes:
1. Necessary information
 2. Awareness of outcomes
3. Preparation for moral decision

Comprehension - refers to whether the information given has been understood or not.
Voluntariness - Consent must be voluntary
Voluntariness Includes:
1. Freewill
2. Free from pressure
3. Preparation for moral decision

Methods of obtaining these informed consent:

1. Written
2. Verbal
3. Third Party

Other forms of consent:

1. By presumption
2. By Proxy
3. When in an emergency
★ Not required for informed consent:
➔ hindered: language barriers
➔ Incapacitation - comatose, blind or illiterate
➔ incomprehension: underage or unable to understand the circumstances

FILIPINO PATIENT’S BILL OF RIGHTS

BILL 812 (Sen. Ramon “Bong” Revilla, Jr)
July 3, 2007

“Magna Carta of Patient’s Rights and Obligations”

- Obligate the patient to take a huge part in the management of their health.

Objectives of the policy:

- Serves as protection and maintain the dignity of the patient
- Healthcare should be available to everyone whatever the status of the patient; the
care must be rendered equally and affordable.
- To provide free medical care to Vulnerable people

Patient’s Right
1. Right appropriate medical care and humane care
2. Right to informed consent
3. Right to privacy and confidentiality
4. Right information
5. Right to choose health care provider and facility
6. Right to self-determination
7. Right to religious belief
8. Right to medical records
9. Right to leave
10. Right to refuse participation in medical research
 11. Right to correspondence and to receive visitors
12. Right to express grievances
13. Right to be informed of his rights and obligations as patients

Societal Rights of Patients

1. Right to health
2. Right to Access to quality public health care
3. Right to healthy and safe workplace

Patient’s Obligations
1. Know the rights
2. Provide accurate and complete information
3. Report unexpected health changes
4. Understand purpose and cost of treatment
5. Accept consequences of own informed consent
6. Settle financial obligations
7. Relation to others
8. Exhaust Grievance Mechanism

Principles of Bioethics
1. Principle of Stewardship and Role of Nurses as Stewards
- Personal: Cultivate your character by doing virtues habitually. A good person will
make good decisions. Learn from your experiences.
- Social: Nurses can advocate for health promotion, educate patients and the public in
the prevention of illness and injury.
- Ecological: As nurses, we have the skills and we can take the lead for a more
sustainable, health communities and environments.
- Biomedical: Nurses take charge of the treatments of the patient, under collaboration
with the physician.
2. Principle of Totality and its Integrity
- Properly applied to the individual or the human person who is an embodied spirit with
all the functions and capacities he naturally possesses.
3. Principle of Ordinary Means and Extraordinary means
- Principle of proportionate and disproportionate means an important approach to the
analysis of ethical questions arising from the general obligation to preserve human
life and the limits of that obligation
4. Principle of Personalized Sexuality
Sexuality – a person’s sexual feelings, thoughts, attractions, and behaviors towards other
people; diverse and personal.
Personalized sexuality - takes notes of a humanized sexuality, one that represents
fulfilment or physical and sensual need but also evidenced with love and sacramental
mystery.

Hugh J. O’Connell
“Stewardship consist in the practical recognition that Man is not the absolute master of
himself or his possessions. He has received every gift and grace from God. He must use
them in a responsible manner to promote the interest of God.”

Stewardship
- In health care, 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 Steward

- To be just and honest with exercise of his duties and obligations to uphold goodness
of human life as God’s creation.
- To make all health care facilities and technologies serve the well-being of the
patients and prevent unnecessary pains.
- To respect life from the moment of conception until its natural expiration and defend it
from any unnatural proceedings meant to contradict its nature and destroys its
dignity.
- To recognize dependency not so much on its own capacity but on God- the Giver of
that capacity and to God ambassador of service for the sick.

Ethico -Moral Responsibility of Nurses - refers to the binding principles which is the
moral and the rules and practices which is ethics.

Moral Principles
1. Golden Rule - Do to others as you would have them do to you
2. The Principle of Totality- The whole is greater than its parts.
- Individual acts in nursing care when put together, do good for the wholeness
of the person.
3. Epikia or “Epikeia” - There is always an exception to the rule.
● The reasonable presumption that the authority making the law would not wish
to bind a person in some particular case, even though the case is covered by
the letter of the.
4. The one who acts through as agent is herself responsible- The instrument to a
crime is part of the crime.
- An act done cannot be completed by one person. Any person who becomes a
part of what was done, regardless if it is small, is part of the act.
5. No one is obliged to betray herself - You cannot betray yourself. Say only what you
can say.
- When you testify before a court, no one can force any person to answer a question
● Ex. the right to remain silent until mandated by court
6. The end does not justify the means- The method is as important as the goal.
7. Defects of nature may be corrected
➔ Given the proper means and resources we may be able to repair a natural defect.
8. If one is willing to cooperate in the act, no injustice is done to him
➔ The method is as important as the goal.

9. A little more or a little less does not change the substance of an act.
 ➔ The act defines itself not the “amount”.
10. No one is held to impossible
➔ Not a false promise. The nurse should not give false assurance

ETHICO - MORAL RESPONSIBILITY OF NURSES

Principle of Totality and its integrity.

- These principles dictate that the well-being of the whole person must be taken into
account in designing any therapeutic intervention or use of technology.
- Except to save life itself, the fundamental functional capacity which constitutes the
human person should not be destroyed but preserved, developed, and used for the
good of the whole person and of the community.

TOTALITY
Refers to the duty to preserve intact the physical component of the integrated bodily
and spiritual nature of human life.
- Organ transplantation is justified when the functional integrity of the donor is
maintained. Organ transplants are permissible as long as the life of the donor
is not placed at risk.
- Functional integrity - the ability of the body to function in a healthy manner.

For example, the principle of totality would justify the amputation of a gangrenous
limb, because the person could die if the gangrene spreads.

INTEGRITY
Refers to each individual's duty to preserve a view of the whole human person. In
which, the values of intellect , will, conscience, and fraternity are pre imminent
(supreme, very significant).

APPLICATIONS in some SPECIFIC PROCEDURES

A . SURGERY
Is a medical or dental procedure that uses operative manual and instrumental techniques on
a person (1) to investigate or treat a pathological condition such as a disease or injury, (2) to
help improve bodily function, appearance, or (3) to repair unwanted ruptured areas.
The Registered Nurse (RN) has ethical and moral responsibility to represent the patient's
interests, to respect and protect the patient's autonomy and preserve the patient's dignity
(ICN, 2013).

B. MUTILATION
Refers to the procedure that diminishes or destroys the functional integrity of the human
body

2 TYPES OF MUTILATION
MAJOR MUTILATION
destroys the functional integrity of the human body so that it becomes incapacitated of its
natural functions. This may also be done in means of surgical procedures.

MINOR MUTILATION
DOES NOT destroy the functional integrity of the human body. For instance, circumcision or
tooth extraction.

3 CONDITIONS ON SURGICAL REMOVAL OF A HEALTHY ORGAN THAT IS MORALLY

ALLOWED:
1. That the preservation or functioning of a particular organ provokes serious damage
or constitutes a threat to the whole body
2. That the damage cannot be avoided or at least notably diminished
3. That it can reasonably be foreseen that the negative effect will be compensated by
the positive effect

Organ Transplant - Surgical operation where a falling or damaged organ in the human body
is removed and replaced with a new one

Graft
- It is the process of removing tissue from one part of a person’s body (or another
person’s body) and surgically re- implanting it to replace or compensate for damaged
tissue.

The Transplant Process

The doctor first assesses whether the person is medically eligible for a transplant. If so, the
doctor then refers the individual to a local transplant center. The transplant center evaluates
the patient’s health and mental status as well as the level of social support to see if the
person is a viable candidate for an organ transplant.

There are two sources for donor organ

- Cadaveric organs - Organs taken from recently deceased people
- Living Organ - living organs are often related to the patient, but that is not always
the case. Spouses and close friends frequently donate organs to ailing loved ones.

Living people who wish to donate their organs can donate in two ways:
- Donate one-half of a paired organ set.
- Donate a portion of an organ that will still be able to function without it.

C. STERILIZATION - Refers to any technique that renders one sterile or unable to exercise
the power to reproduce during the sexual intercourse

TYPES OF STERILIZATION
 1. VOLUNTARY OR DIRECT STERILIZATION
2. INVOLUNTARY OR INDIRECT STERILIZATION.
3. THERAPEUTIC STERILIZATION
4. CONTRACEPTIVE STERILIZATION
5. EUGENIC AND SOCIAL STERILIZATION
6. PUNITIVE STERILIZATION

CONTINUING EDUCATION PROGRAMS ON ETHICO-MORAL PRACTICE IN NURSING

Continuing Education Program

a specific learning activity generally characterized by the issuance of a certificate or

Continuing Education Units (CEU). For the purpose of documenting attendance at a
designated seminar or course of instruction.

Board of Nursing
● Encourages continuing education requirements on members who hold licenses to
practice.
● These requirements are intended to encourage professionals to expand their
knowledge, and stay updated to new trends and development..
- compose of 6 members

Duties and Responsibilities

Board of Nursing:
● Conduct licensure exam for nurses
● Issue, suspends, revokes certificates of registration for the practice of nursing
● Monitor and enforce quality standards of nursing practice in the Philippines
● Ensure quality nursing education by examining prescribed facilities of Universities or
Colleges of Nursing, or Departments of Nursing
● Conducts hearings and investigations to resolve complaints against nurse
practitioners for unethical and unprofessional conduct.
● Conducts hearings and investigations to resolve complaints against nurse
practitioners for unethical and unprofessional conduct.
● Promulgate a Code of ethics
● Recognize nursing specialty organizations
● Prescribe, adopt, promulgate guidelines, regulations and measures, and decisions as
may be necessary for the improvements of the nursing practice and advancements
of the profession.

PURPOSE
● Tends to meet high performance level needs of the nurses
● Strengthen knowledge, skills and attitude.

SCOPE
● Professional and Personal Growth and Development that relates to professional and
organizational development

OBJECTIVES
● Promote development of KSA for enhancement of nursing practice
NURSING ETHICS
● a branch of moral science that refers to the conduct and behavior of nursing
practitioners which by reason of public approval has become customary among
professional nurses.

Code of Ethics
● Written list of profession's values and standards of conduct and framework of
decision making for nursing profession framework of decision making for nursing
profession
● Non negotiable standards

International Council of Nurses (ICN)

● Operated by nurses and leading nurses internationally.
● Founded in 1899, ICN is the world’s first and widest reaching international
organization for health professionals and is headquartered in Geneva, Switzerland.
● To ensure quality nursing care for all (should be effective)
● A sound health policies globally
● Advancement of nursing knowledge
● The presence worldwide of a respected nursing profession.
● A competent and satisfied nursing workforce.

Ethical conduct ଘ(੭*ˊᵕˋ)੭* ੈ♡‧₊˚

● Essential to the practice of professional nursing
● Described in the nursing code of ethics
● Formal statement that determines the standards of conduct of a professional nurse

Code of Good governance

● Promulgated by the PRC on July 23, 2003:
➔ hallmark of all professionals is their willingness to accept a set of professional and
ethical principles which they will follow in the conduct of cheir daily lives.

General Principles of the Code of Good Governance:

1. Service to others.
2. Integrity and Objectivity.
3. Professional Competence
4. Solidarity and Teamwork
5. Social and Civic Responsibility
6. Global Competitiveness
7. Equality of all Professions

Code of Ethics for Filipino Nurses

- provides direction for nurses to act morally
Four fold responsibility of nurses:
● to promote health
● to prevent illness
● to alleviate suffering
● to restore health
AMENDED CODE OF ETHICS FOR FILIPINO NURSES
● Section 3, Republic Act No. 877 "Philippine Nursing Law" - An Act to Regulate the
Practice of Nursing in the Philippines, and for Other Purposes.
● Section 6 of P.D. No. 233 - "Amended Code of Ethics for Nurses" was adopted
● October 23, 2003, Ilo-ilo City consultation was done together with the accredited
professional organization of RN, PNA and other affiliate organizations of RN's
decided to adopt a NEW Code of Ethics under R.A. 9173
● July 14, 2004, a new Code of Ethics for Filipino nurses was adopted under R.A. 9173
and was promulgated by the BON. The Code of Ethics for Filipino Nurses embodies
ethical principles and guidelines to be observed.
● R.A 9173 known as, "Philippine Nursing Act of 2002." was enacted in 2002 to
provide a comprehensive definition and understanding of the nursing profession.
○ adheres to the universal principle as enunciated in the Universal Declaration
of Human Rights that “Health is the fundamental right of every individual

The most important articles as summarized below are:

1. Registered Nurses and People
2. Registered Nurses and Practice
3. Registered Nurses and co-workers
4. Registered Nurses, society and environment
5. Registered Nurses and the profession

FILIPINO NURSES CODE OF ETHICS

ARTICLE 1: PREAMBLE
● Sec 1: Health is a fundamental right of every individual.
● Sec 2: Nurses have to gain knowledge and understanding of man's cultural, social,
spiritual, psychological, and ecological aspects of illness, utilizing the therapeutic
process.
● Sec 3: The desire for respect and confidence for clientele, colleagues, co-workers,
and the members of the community provides incentive to attain and maintain the
highest possible degree of ethical conduct.

ARTICLE 2: REGISTERED NURSES AND PEOPLE

Section 4
Ethical Principles:
● Values, customs, & spiritual beliefs are to be respected
● Freedom to make rational and unconstrained decisions will be respected
● Personal information acquired shall be held in strict confidence

Section 5
Guidelines To Be Observed:
REGISTERED NURSES must
● consider the individuality and totality of patients when they administer care.
● respect the spiritual beliefs and practices of patients regarding diet and treatment.
● uphold the rights of individuals.
 ● take into consideration the culture and values of patients in providing nursing care.
However, in the event of conflicts, their welfare and safety must take precedence.

ARTICLE 3: REGISTERED NURSES AND PRACTICE

Section 6
Ethical Principles:
● Human life is inviolable
● Quality and excellence in care are the goals of nursing practice.
● Accurate documentation of actions and outcomes is the hallmark of nursing
accountability.
● Aware that their actions have professional, ethical, moral and legal dimensions

Section 7
Guidelines to be observed:
REGISTERED NURSES must
● Know the definition and scope of nursing practice which are in the provisions of R. A.
No. 9173, known as the “Philippine Nursing Act of 2002” and Board Res. No. 425,
Series of 2003, the “Rules and Regulations Implementing the Philippine Nursing Act.
of 2002”, (the IRR).
● Be aware of their duties and responsibilities in the practice of their profession as
defined in the “Philippine Nursing Act of 2002” and the IRR.
● Acquire and develop the necessary competence in knowledge, skills, and attitudes to
effectively render appropriate nursing services through varied learning situations.
● If they are administrators, be responsible in providing favorable
● Environment for the growth and developments of Registered Nurses in their
charge.
● Be cognizant that professional programs for specialty certification by the BON are
accredited through the Nursing Specialty Certification Council (NSCC).
● See to it that quality nursing care and practice meet the optimum standard of safe
nursing practice.

ARTICLE 4: REGISTERED NURSES AND CO-WORKERS

Section 12
Ethical Principles:
● RNs in solidarity with other members of the healthcare team in working for the
patient's best interest.
● RN maintains collegial and collaborative working relationships with colleagues and
other healthcare providers

Section 13
Guidelines to be observed:
REGISTERED NURSES must
● maintain their professional role/identity while working with other members of the
health team.
● conform with group activities as those of a health team should be based on
acceptable, ethico-legal standards.
● contribute to the professional growth and development of other members of the
health team.
 ● actively participate in professional organizations.
● not act in any manner prejudicial to other professions.
● honor and safeguard the reputation and dignity of the members of nursing and other
professions; refrain from making unfair and unwarranted comments or criticisms on
their competence, conduct, and procedures; or not do anything that will bring
discredit to a colleague and to any member of other professions.
● respect the rights of their co-workers.

ARTICLE 5: REGISTERED NURSES, SOCIETY AND ENVIRONMENT

Section 14
Ethical Principles:
● Preservation of life, respect for human rights, and promotion of a healthy
environment shall be a commitment of a RN.
● Establishment of linkages with the public in promoting local, national, and
international efforts to meet health and social needs of people as a contributing
member of society is a noble concern of a RN.

Section 15
Guidelines to be observed:
REGISTERED NURSES must
● be conscious of their obligations as citizens and, as such, be involved in community
concerns.
● be equipped with knowledge of health resources within the community, and take
active roles in primary health care.
● actively participate in programs, projects, and activities that respond to the problems
of society.
● lead their lives in conformity with the principles of right conduct and proper decorum.
● project an image that will uplift the nursing profession at all times.

ARTICLE 6: REGISTERED NURSES AND THE PROFESSION

Section 16
Ethical Principles:

● Maintenance of loyalty to the nursing profession and preservation of its integrity are
ideal.
● Compliance with the by-laws of the accredited professional organization (PNA), and
other professional organizations of which the Registered Nurse is a member is lofty
duty.
● Commitment to continual learning and active participation in the development and
growth of the profession are commendable obligations.
● Contribution to the improvement of the socio-economic conditions and general
welfare of nurses through appropriate legislation is a practice and a visionary
mission.

Section 17
Guidelines to be observed:
REGISTERED NURSES must
● be members of the Accredited Professional Organization (PNA).
 ● strictly adhere to the nursing standards.
● participate actively in the growth and development of the nursing profession.
● strive to secure equitable socio-economic and work conditions through appropriate
legislation and other means.
● Assert for the implementation of labor and work standards.

ARTICLE 7: ADMINISTRATIVE PENALTIES, REPEALING CLAUSE, AND EFFECTIVITY

Section 18
● The Certificate of Registration of a Registered Nurse shall either be revoked or
suspended for violation of any provisions of this Code pursuant to Sec. 23 (f), Art. IV
of R. A. No. 9173 and Sec. 23 (f), Rule III of Board Res. No. 425, Series of 2003, the
IRR.

Section 19
● The Amended Code of Ethics promulgated pursuant to R. A. No. 877 and P.D. No.
223 is accordingly repealed or superseded by the herein Code.

Section 20
● This Code of Ethics for Nurses shall take effect after fifteen (15) days from its full and
complete publication in the Official Gazette or in any newspapers of general
circulation.

NEGLIGENCE
Negligence indicates a deficiency in perception or when the wrongful act may be avoided by
paying proper attention and using due diligence in foreseeing them.
Commission or omission of an act, pursuant to a duty, that a reasonably prudent person in
the same or similar circumstance would or would not do.

The Elements of Professional Negligence:

1. Duty of Care – existence of a duty on the part of the person charged to use due care
under circumstances
2. Breach of Duty – failure to meet the standard of due care
3. The Injury – the foreseeability of harm resulting from failure to mee the standard
4. Causation – the fact that the breach of this standard result in an injury to the plaintiff.

SPECIFIC EXAMPLES OF NEGLIGENCE

● Failure to report observation to attending physicians.
● Failure to exercise the degree of diligence which the circumstances of the particular
case demands.
● Mistaken identity
● Wrong medicine, wrong concentration, wrong route, wrong dose.
● Defects in equipment such as stretchers and wheelchairs may lead to falls thus
injuring the patients.
● Errors due to family assistance.
● Administration of medicine without a doctor's prescription.

Negligence in the administration of a drug which causes injury to the patient may be
attributed to:
1. Drug reaction:
-failure to note history of allergy
-Failure to test for signs of reaction
-failure to stop treatment when drug reactions has been observed.
-failure to provide adequate therapy to encounter a reaction
-Treatment with a drug not proper for the illness
-overdose of the drug administered.
-wrong route,wrong medicine,wrong person

THE DOCTRINE OF RES IPSA LOQUITUR

Res Ipsa Loquitur means "the thing speaks for itself".
Three conditions:
1. nature of injury was that it would not normally happen or occur unless there was a
negligent act on the part of someone
2. injury caused by an agency within control of the defendant.
3. plaintiff himself did not engage in any manner that would tend to bring about injury.
Examples:
- Sponge left in abdomen at the time of C Section
- A surgeon stitching a wound on a patient's cheek allows the needle to enter the
patient’s eye.
- Removal of a wrong tooth.

MALPRACTICE
improper or unskillful care of a patient by a nurse; stepping beyond one's authority with
serious consequences

DOCTRINE OF FORCE MAJEURE

"Force Majeure" - irresistible force; unforeseen or inevitable.
Civil code: no person shall be responsible for those events which cannot be foreseen, or
which though foreseen, are inevitable except in cases specified by law.
floods, earthquakes, fire, accidents

DOCTRINE OF RESPONDEAT SUPERIOR

"let the master answer for the acts of the subordinate"; liability is expanded to include the
master as well as the employee and not a shift of liability from the subordinate to the master.
Subordinate still fully responsible

THE DOCTRINE OF RESPONDEAT SUPERIOR-”Captain of the Ship doctrine”

A defendant surgeon had delivered a baby boy by Caesarian section. The mother developed
a hemorrhage. While he was attending to her immediate needs, he asked an intern to apply
drops to the baby’s eyes. The intern used the wrong solution, as a result, the baby’s eyes
were damaged. The surgeon was held liable for the intern’s negligence, the intern was under
his direct supervision and control.”

THE DOCTRINE OF RESPONDEAT SUPERIOR-”Captain of the Ship doctrine”

A defendant surgeon had delivered a baby boy by Caesarian section. The mother developed
a hemorrhage. While he was attending to her immediate needs, he asked an intern to apply
drops to the baby’s eyes. The intern used the wrong solution, as a result, the baby’s eyes
were damaged. The surgeon was held liable for the intern’s negligence, the intern was under
his direct supervision and control.”

INCOMPETENCE
lack of ability or legal qualifications and being unfit to discharge the required duty.

Ethical issues related to technology in the delivery of healthcare

Has your privacy ever been breached? How did you feel about it?

Data breaches.. - Incident where our information is stolen without the knowledge or
authorization of the owner.

Did you know?

Filipinos spend an average of 10 hours and 2 minutes each day online. (January 2019 study)

Republic Act No. 10173: DATA PRIVACY ACT

- “To protect the fundamental human right to privacy of communication while ensuring
free flow of information to promote innovation and growth… inherent obligation to
ensure that personal information in information and communications systems in
government and private sectors are secured and protected.”
- The “data privacy act”
- To protect all forms of information, be it private, personal, or sensitive.
- To cover both natural and juridical persons involved in the processing of personal
information.
Juridical person - Any person or entity that has the capacity to act legally. Eg. government,
corporations, agencies

Processing of personal information

Section 3 of RA 10173
"Processing refers to any operation or any set of operations performed upon personal
information including, but not limited to, the collection, recording, organization, storage,
updating or modification, retrieval, consultation, use, consolidation, blocking, erasure, or
destruction of data."
“Processing refers to any operation or any set of operations performed upon personal
information including, but not limited to, the collection, recording, organization, storage,
updating or modification, retrieval,

Personal Information
Section 3 of RA 10173:
"Personal Information refers to any information whether recorded in a material form or not,
from which the identity of an individual is apparent or can be reasonably and directly
ascertained by the entity holding the information, or when put together with other information
would directly and certainly identify an individual."

Privileged Information
Section 3 of RA 10173:
"Privileged information refers to any and all forms of data which under the Rules of Court
and other pertinent laws constitute privileged communication.

Sensitive Information
1. Person's race, ethnic origin, marital status, age, color, religious, philosophical, and
political affiliations.
2. Person's health, education, genetic or sexual life, past offenses committed or
allegedly committed by a person, or a court cases.
3. Social security numbers, health records, licenses, suspensions, tax returns.
4. Information established to be kept private by law.

The Data Privacy Act explicitly states that its provisions are not applicable in the
following cases:
A. Person who IS or WAS an officer or an employee of a government institution that
relates to the position or functions of the individual.
B. Information about an individual who is or was performing service under contract for a
government institution that relates to the services performed, including the terms of
contract, and the name of the individual given in the course of the performance of
those services.
C. Information related to any discretionary benefit of a financial nature such as the
granting of a license or permit given by the government to an individual, including the
name of the individual and the exact nature of the benefit.
D. Personal information processed for journalistic, artistic, literary, or research purposes
E. Information necessary for banks and other financial institutions under the jurisdiction
of the independent, central monetary authority or BangkoSentralngPilipinasto comply
with Republic Act No. 9510 and Republic Act No. 9160, known as the Anti-Money
Laundering Act and other applicable laws.
F. Personal information originally collected from residents of foreign jurisdictions in
accordance with the laws of those foreign jurisdictions, including any applicable data
privacy laws, which is being processed in the Philippines.

R. A. NO 10173 applies to:

● If the person, either an individual or an institution, involved in the processing of

personal data is located in the Philippines.
● The act or practice involves personal data of a Philippine citizen or Philippine
resident.
● The processing of personal data is done in the Philippines.
● The act, practice or processing of personal data is done by an entity with links to the
Philippines, subject to international law and comity.
NATIONAL PRIVACY COMMISSION(NPC)

Mission
We shall continuously delivery services t o :
(1) Be the authority on data privacy and protection, providing knowledge, know-how, and
relevant technology.
(2) Establish a regulatory environment that ensures accountability in the processing of
personal data and promotes global standards for data privacy and protection.
(3) Build a culture of privacy, through people empowerment, that enables and upholds the
right to privacy and supports free flow of information.

VISION
A world-class regulatory and enforcement agency upholding the right to privacy and data
protection while ensuring the free flow of information, committed to excellence, driven by a
workforce that is highly competent, future-oriented and ethical, towards a competitive,
knowledge-based, and innovative nation.

Benefits and Challenges of Technology

TECHNOLOGY
- the application of scientific knowledge to the practical aims of human life or, as it is
sometimes phrased, to the change and manipulation of the human environment.

1. COMMUNICATION
Benefits - Messaging is easy and there are plenty of options for these easy ways. (Not to
mention, cheap.)
Challenges - Some things get lost in translation. Communication becomes more distant,
cold, and it can be easily misunderstood. It has made people impatient.
2. DATA COLLECTION
Benefits - For sellers, it's easy to get data from customers and potential customers. Social
media also makes it easy for sellers to get to know their market and make it easier to reach
out. Anybody can make a form now that asks to fill up your name, address, age, birthday,
etc.
Challenges - There is lesser privacy. W e 've heard of data breaches or scams where
people can make their own website that looks like a legit bank website . It pays to be
vigilant! We also have hackers , not only social media accounts , but even banks and big
companies can be hacked.

3. INFORMATION ACCESS

Benefits - It's not only a person's data that is easy to acquire, but Google has also made it
easier for everyone to learn and search for things
Challenges - Misinformation Can easily spread. Patients nowadays can easily search their
symptoms or research about a subject which leads some to just self-diagnose and don't get
immediate treatment. Also misinformation about certain medications and vaccines which is
of course, potentially dangerous.

4. DISTANCE WORK AND SCHOOL FROM HOME

Benefits - Attending classes or meetings through Zoom or Microsoft Teams has been the
new classroom. It made us more creative and forced us to work smarter.
Challenges - It has become more stressful because there is now no boundary between
school, work and home. Most people right now report fatigue of being online almost 18 hours
a day.

5. Patient Care
Benefits - Technologies help us keep track of our health. Tele-health or E-Health provides
doctors that can hold virtual consultations, allowing the patient to be safe at home. Modern
technology also allows us to provide better patient service.
Challenges - Less physical assessment of the patient Some information gets lost in the call.

6. DATA STORAGE
Benefits - A large like a terabyte of information can be hand carried. It saves space as well.
Digital information is also easier to find, all you need is a search bar and a click of a mouse.
It saves you time! If a hospital has a universal data system, one doctor can input in program
and another doctor can see his input in real time from another venue. Easy data transfer and
passing it on to another health care worker.
Challenges - Personal data nowadays is very attractive to hackers. There have been
multiple cases wherein big companies, even Facebook, experienced a data breach. It has
been said that these stolen personal data are being sold online in the deep web for who
knows what purpose! If your computer gets wet and if you didn't back up your data, it could
be gone in a flash especially in cases wherein it gets wet or a virus corrupts it.

HEALTH INFORMATION TECHNOLOGY

- supports decision-making and promotes quality health care delivery

INCREASED CYBER ATTACKS

- Hacker will lock up the data, making it inaccessible.
- There are also some medical devices which are vulnerable due to manufacturer
negligence when it comes to providing adequate security protections and the use of
legacy equipment by health care providers.

Non-traditional healthcare delivery

TELEHEALTH -
The hospital and the patient's home should both have high-speed internet be able to
provide/sendexcellentvideo/photos/diagnostic data transmission between two. Aside from
That,it should also be affordable especially for the patients.

Application Management
- Those in charge of healthcare IT systems/programs/applications have to manage a
lot, and also there's only a limited number of staff who are knowledgeable about this
area.
- Experienced/knowledgeable staff require higher salaries which makes it harder for
hospitals to retain the staff to help them achieve their IT goals.
- LACK OF KNOWLEDGEABLE STAFF
Dignity of Death and Dying

Dignity
The quality of a person that makes him or her deserving of respect, sometimes shown in
behavior or appearance; a state or a quality of being worthy of honor or respect.

Death
The total cessation of life processes that eventually occurs in all living organisms

Dying
Approaching death

Signs of Death
1) ALGOR MORTIS- Cooling of the body
- Is translated from Latin as “ cold death” and described as the postmortem
temperature change after someone has died.

2) RIGOR MORTIS- Stiffening of the joints and muscles

- Is the stiffening of the joints and muscles, resulting in rigidity of a body a few hours
after death lasting from one to four days..
3) Livor Mortis- known as lividity; “purple discoloration”
- Is the settling of blood after death in gravity- dependent portions of the body

Principle: Life is inviolable.

“All human life from the moment of conception, and through all subsequent is SACRED, It is
a gift of GOD, and the fruit of love.”
The principle recognizes that Death is a natural end of life and Biological life is not the
highest value.”

1) It is never to be broken.
2) It is never to be infringed.
3) It is never to be dishonored.

ISSUES OF DEATH AND DYING (Sit Dolor Amet)

➢Is also called “MERCY KILLING”
➢Act or practice of painlessly putting to death, persons suffering from painful and incurable or
incapacitating physical disorder or allowing them to die by withholding treatment or
withdrawing artificial life support measures.
➢In theory, this affirms the individual’s right to die in a painless and peaceful manner.

Euthanasia (Easy death)

2 TYPES OF EUTHANASIA
1) SELF-ADMINISTERED
• Active – act of commission
• Passive – act of omission
2)OTHER-ADMINISTERED
• Active and voluntary – the person-in- charge—doctor or closest kin allows a
procedure
• Passive and voluntary - the person-in- charge—doctor or closest kin allows death to
take its toll

Vegetative state*

Safeguards and Guidelines for Assisted Death

1. Illness must be terminal.
2. All measures have been tried.
3. Patient repeatedly requests without being coerced
4. Doctor ensures patient‘s judgment is not distorted.
5. Procedure is carried in a meaningful physician-patient relationship
6. Other physicians are considered in the decision
7. Documentation to assure of the previous steps

Dysthanasia - Bad death

- In theory, this affirms taking all means to preserve life even beyond recovery

Orthothanasia - Natural death

● A normal or natural way of death and dying
● name given to the process by which one chooses not to subject a terminal patient to
invasive procedures that postpone his death, but, at the same time, compromise his
quality of life.
● Thus, orthothanasia focuses on the adoption of palliative procedures, seeking to
control pain and other.

Should we be allowed to cut life when the weight of pain, suffering, and hopelessness
becomes unbearable?
● NO. It is MURDER.
● LEGITIMATE under certain circumstances

WHAT DOES THESE SYMBOLS MEAN?

Most common drug used to end life
Barbiturates (secobarbital, nembutal)

ADVANCE DIRECTIVES
● A written statement of the patient‘s wishes regarding medical treatment, often
including a living will, made to ensure those wishes are carried out should the person
be unable to communicate them to a doctor.
● Legal documents that allow the person to spell out his decisions about end of life
care ahead of time.
● **LIVING WILL- This tells which treatments a person wants if he is dying or
permanently unconscious. He or she can accept or refuse medical care.
● Durability power of attorney

DNR
● “Do not resuscitate”
This is a medical order by a doctor according to the wishes of the patient or the
patient‘s family. This is usually included in the patient‘s advanced directives.

NURSE SYMBOLS
● CAP- goal of the nurse- to provide service to those in need; sign of dedication,
honesty, wisdom, faith;
● CADUCEUS - most recognized Nursing symbol
○ associated with Hermes” Greek God of boundaries
● OIL LAMP- in reference to Florence Nightingale, she is the founder of modern
nursing practice.
● WHITE UNIFORM
○ Purity, honesty cleanliness
 ENDTERM
Topic: Resource Allocation

Resource - Stock or supply of money, materials and assets where we draw from for
provision. (money, equipment, manpower, etc.)

Allocation - Process for assigning resources.

Resource Allocation
➢ The process of assigning and managing assets in a manner that supports an
organization strategic goals
➢ Includes managing tangible assets such as hardware to make the best use of softer
assets such as human capital

Handling Assets
a. Accounting Assets - identify hard (tangible) and soft (human) assets.
i. Hard Assets - equipments, beds, lights, etc.
ii. Soft Assets - people working in the facility

b. Growing Assets - from available resources to expanding resources

c. Managing Assets - to support strategic goals. Have SMART plans

Levels of Allocation
1. Healthcare versus other social needs - equal allocation of healthcare in the society
2. Within healthcare - vaccinations, immunizations, prevention
3. Individual patient - every person can be a patient
P500,000 is the given government budget. 55% of the P500,000 should be allocated to
health. 55% of P500,000 is P275,000

55% of the P275,000 should be allocated for vaccines. 55% of P275,000 is P151,250.
Principles of Allocation
1. Improve people’s health - the goal of allocating resources
2. Information of allocation for members
3. Consent or denial of members
4. Minimize conflicts of interest

Ethical Questions
1. If healthcare resources are scarce, how should they be distributed?
2. Who determines who will receive the resources?
3. What values should guide these choices?
4. Is the current distribution of healthcare resources in the Philippines wise and
efficient?
Issues on Access to Care
1. Limited Appointment Availability - ex. Wait two hours to see a doctor
2. Clinicians Shortage - ex. Rural and geographical; few specialists
3. Trasportation - ex. Fewer ambulance in secluded areas

Possible Solution: Telehealth

➢ Patient sets appointment at a convenient time
➢ Patient doesn’t have to leave work or home
➢ Doctor may ask patient to come only if necessary

For Additional Readings:

https://www.ncbi.nlm.nih.gov/books/NBK435786/
https://hta.doh.gov.ph/universal-healthcare-act/
Topic: Bioethics and its Application in Various Health Care Situations

Bioethics
➢ The Greek bios meaning “life”
➢ Ethikos, ithiki meaning “ethics”
➢ the systematic study of the moral dimensions – including moral vision, decisions,
conduct and policies – of the life sciences and health care, employing a variety of
ethical methodologies in an interdisciplinary setting.

SEXUALITY and HUMAN REPRODUCTION

1. ON CONTRACEPTION (Issues, Its Morality and Ethico-Moral Responsibility Of
Nurses)
- BIRTH OR FERTILITY CONTROL
- the deliberate use of artificial methods and other techniques to prevent
pregnancy as a consequence of sexual intercourse.
- Different types of Contraception
- Condom
- Contraceptive Diaphragm
- Contraceptive Injection
- Combined Pill
- Contraceptive Implant
- Intrauterine Device
- Permanent Sterilization
- Natural Family Planning
- ARE CONTRACEPTIONS ANTI-LIFE?
- Contraceptives are unnatural
- Contraceptions are a form of abortion
- Contraceptions weaken marriage
- Contraceptions are against the procreation of human life
- ETHICO-MORAL RESPONSIBILITY OF NURSES IN CONTRACEPTION
a. Welfare of the patient and respect for the autonomy of the patient
b. Make sure the patient gets all the information and advice that they
need to be able to choose wisely.

2. ON ABORTION (Morality and other Problems Related To Destruction Of Life)

- Abortion - the expulsion or removal of a nonviable fetus
- Two Principal Moral Considerations
a. Status of the fetus - when is a fetus considered as a person?
 b. Status of the mother - does the mother have the right to decide if she
is to carry the baby to term or not?
- Comprehensive Legal Moral Grounds
a. Threat to the mother’s life - How is the status of the baby endangering
the life of the mother?
b. Threat to the mother’s health - How is the status of the baby affecting
the health of the mother?
c. Unwanted Pregnancy - As a result of rape or incest
d. Threat to the baby - Fetal impairment
e. Economic and social reasons - How will the baby affect the family’s
needs? How will society accept this?
f. On Request - The mother desires to abort
- Guiding Principles for Health Care Workers
a. Provide Information
b. Offer Counseling
c. Provide follow-up care

3. ON ARTIFICIAL REPRODUCTION (Issues and the Ethico-Moral Responsibility of

Nurse)
- ARTIFICIAL REPRODUCTION - the creation of new life by other than the
natural means available to an organism.
- ARTIFICIAL INSEMINATION - Medical procedure of injecting semen into
the vagina or uterus. [Intrauterine Insemination] (IUI)
- TYPES of ARTIFICIAL INSEMINATION
a. Donor of the sperm is the husband [Homologous Artificial
Insemination]
b. Donor of the sperm is not the husband [Heterologous Artificial
Insemination]
- ETHICO-MORAL RESPONSIBILITY OF NURSES IN ARTIFICIAL
INSEMINATION
a. Take informed consent
b. Assess couple’s emotional status relative to infertility
c. Counsel and inform side effects of procedure
d. Describe legal ramifications of the procedure
e. Assist in the interview of donors to the program
- IN-VITRO FERTILIZATION - Process of fertilization where an egg is
combined with sperm outside the body.[IVF]
- TYPES of IN-VITRO FERTILIZATION
a. involves the gametes from both spouses; no third party is
involved. [HOMOLOGOUS IVF]
b. involves the gametes of a donor (a third party supplies
necessary gametes). [HETEROLOGOUS IVF]
- SURROGATE MOTHERHOOD - Practice in which a woman (surrogate
mother) bears the child for a couple unable to produce children in the usual
way.
- TYPES of SURROGACY
a. TRADITIONAL - the surrogate mother is impregnated through
artificial insemination with the sperm of the husband.
 b. GESTATIONAL - the wife’s ova and the husband’s sperm are
subjected to in-vitro fertilization, and the resulting embryo is
implanted in the surrogate mother.
- COMPENSATED SURROGACY - Form of surrogate pregnancy in
which a gestational carrier is paid to carry a child to maturity in her
womb and is usually resorted to by well off infertile couples who can
afford the cost involved.
- ISSUES on SURROGATE MOTHERHOOD
a. RIGHTS - Rights of the child
b. MOTHER’S BODY - Practical effect on the mother’s body
c. EXPLOITATION - Poor women may be used
d. BODY FOR MONEY - Normal function into commercial
e. OTHERS - More complicated issues

GENERAL ROLES OF NURSES in CLINICAL ETHICAL DECISION-MAKING

1. Recognize responsibilities and rights to care for the whole person
2. Be aware of personal values and how they relate to professional practice
3. Develop and grow knowledge of ethical principles and concepts
4. Understand processes and resources available to assist patients in ethical decision
making

SEXUALITY
● about your sexual feelings, thoughts, attractions and behaviours towards other people.
● a word we use to talk about how we understand our bodies and how we understand our
relationships.
Components:
- biological gender - in born gender
- gender identity - during the peak of puberty, identifying as a male, female, lesbian, or gay
- gender role - wife, mother, husband, etc.
- sexual orientation.

SEXUALITY
● Sexual being
● Condition of having sex
● Sexual activity
● Expression as a sexual being

Two General Views of Sex

1. Traditional View - sex is for procreation
2. Liberal View - sex is like any other act

The Human Reproductions - The union of femal and male sex cells

Reproduction - the process by which living beings transmit their genese and give birth to a
new generation of living beings.

Topic: Bioethics and Research

Bioethics
Study of the ethical, social, and legal issues that arise from biomedicine and biomedical
research.

Bioethics Include:
1. Medical Ethics - issues in healthcare
2. Clinical Ethics - issues “at the bedside” when caring for the patient
3. Nursing Ethics - issues in daily nursing practice and ethical judgements
4. Research Ethics - issues when conduction research
5. Evironmental Ethics - issues in environmental and human activities
6. Public Health Ethics - issues in health that concerns the general public

Overview
A. Principles of Ethics in Research
a. Nuremberg Code - The modern code of ethics after the end of World
War II in order to deal with war crimes trials in Nuremberg. There were horrific
and unethical experiments that were carried out during the World War II at
Nazi war camps by German physicians.
- PRINCIPLES DRAWN from the nuremberg trials FOR THE
NUREMBERG CODE
1. Voluntary Consent - of the human subject is absolutely essential
2. Results for Society’s Good - this should be the purpose of an
experiment—to yield fruit to advance medicine and not for self-
interest
3. Prior Animal Experimentation - History of problem under study to
justify performance of experiment.
4. Avoid Unnecessary Pain - Conduct experiment by all means
avoiding necessary physical and mental suffering or injury.
5. Not When Death May Occur - No experiment should be conducted
where there is a prior reason to believe that death or disabling
injury will occur; except, perhaps, in those experiments where the
experimental physicians also serve as subjects
6. Degree of Risk - Should not exceed that which is determined by the
humanitarian importance of the problem to be solved by the
experiment.
7. Preparations - Proper preparations should be made and adequate
facilities be provided to protect the experimental subject against
even the remote possibilities of injury, disability, or death.
8. Qualified - The experiment should be conducted only by
scientifically qualified persons. The highest degree of skill and care
should be required through all stages of the experiment of those
who conduct or engage in the experiment.
9. Liberty - During the experiment, the human subject should be at
liberty to bring the experiment to an end if he/she has reached the
physical or mental state where continuation of the experiment
seems to him/her to be impossible.
 10. Termination - During the experiment the scientist in charge must be
prepared to terminate the experiment at any stage, if he/she has
probable cause to believe, that a continuation of the experiment is
likely to result in injury, disability, or death to the experimental
subject.

b. Declaration of Helsinki - Ethical principles for medical research involving

human subjects. Developed by the World Medical Association. Initially
adopted in June 1964 in Helsinki, Finland. Set of ethical Principles for the
medical community regarding human experimentation. Developed from the 10
principles of Nuremberg Code (1947) and incorporated the elements from the
Declaration of Geneva (1948), drawing a statement of the ethical duties of
physicians.
- Research with humans should be based on the results from laboratory
and animal experimentation
- Research protocols should be reviewed by an independent committee
before initiation.
- Research should be conducted by medically/scientifically qualified
individuals.
- Informed consent from research participants is necessary.
- Risks should not exceed the benefits.

c. Belmont Report - Created by the National Commission for the Protection of

Human Subjects of Biomedical and Behavioral Research.
- BIG 3 FUNDAMENTAL PRINCIPLES OF RESEARCH ETHICS
1. Respect for Persons - informed consent
2. Beneficence - assessment of risks and benefits
3. Justice - selection of subjects

B. Ethical issues in evidenced-based practice

Evidence-based practice is a conscientious, problem-solving approach to clinical practice
that incorporates the best evidence from well-designed studies, patient values and
preferences, and a clinician's expertise in making decisions about a patient's care.
Terms:
- Ethical Issues - When a decision creates conflict with society’s moral principles
- Evidence - something legally submitted to ascertain in the truth of matter
- Practice - use of the current best evidence in making decisions about the patients
Issues and Concerns:
- Missed knowledge - Some types of knowledge are not included in the evidence-
based practice
- Counter-care - Evidence-based practice runs counter to patient-centered care
- Most Effective - Testable by Randomized Controlled Trials is not the same as "most
effective".
- Unjust - Decisions based on Evidencebased practice can be unjust.
 C. Ethico-moral obligations of the nurse in evidence-based practice

Clinical Practice Guidelines

1. Abide by the international, ethical and scientific quality standards for the design and
conduct of clinical trials.
2. Protect the rights, integrity, and confidentiality of trial subjects

Ethico-moral Aspects of Nursing Practice

1. Develop sensitivity to the ethical dimensions of nursing practice
2. Examine own and client’s value
3. Understand how values influence decisions
4. Think ahead about the moral problems they are likely to face

EthicaL Issues
1. Moral Dilemma - Two or more clear principles apply but they support inconsistent
courses of action
2. Moral Uncertainty and Conflict - When the nurse is unsure which moral principle to
apply, or even what the problem is. Common with new nurses
3. Moral Distress - When the nurse knows the right thing to do but organizational
constraints keep them from doing it
4. Moral Outrage - An individual witnesses an immoral act by another but feels
powerless to stop it.

Historical Background of Good Clinical Practice

460 BC - Oath of Hippocrates
1930’s - US Food, Drugs and Cosmetic Act
1947 - The Nuremberg Code
1948 - Declaration of Human Rights
1962 - Kefauver-Harris Amendment
1964 - Declaration of Helsinki
1979 - The Belmont Report
1982 - International Guidelines for Biomedical Research Involving Human Subjects

1996 - ICH-GCP guidelines issued

1997 - ICH0GCP guidelines becomes law in some countries
Present

13 PRINCIPLES OF GOOD CLINICAL PRACTICE GUIDELINES

1. Clinical trials should be conducted in accordance with ethical principles that have
their origin in the Declaration of Helsinki, and that are consistent with GCP and the
applicable regulatory requirement(s).
2. Before a trial is initiated, risks and inconveniences should be weighed against
anticipated benefit for the individual trial subject and society.
3. The rights, safety and wellbeing of the trial subjects are the most important
considerations and should prevail over interest of science and society.
4. The available non-clinical and clinical information on an investigational product
should be adequate to support the proposed clinical trial.
 5. Clinical trials should be scientifically sound, and described in clear, detailed protocol.
6. A trial should be conducted in compliance with the protocol that has received prior
institutional review board (IRB)/ independent ethics committee (IEC)
approval/favorable opinion.
7. The medical care given to, and medical decisions made on behalf of subjects should
always be the responsibility of a qualified physician or, when appropriate, of a
qualified dentist.
8. Each individual involved in conducting a trial should be qualified by education,
training, and experience to perform his or her respective task(s).
9. Freely given informed consent should be obtained from every subject prior to clinical
trial participation.
10. All clinical trial information should be recorded, handled, and stored in a way that
allows its accurate reporting, interpretation and verification.
11. The confidentiality of records that could identify subjects should be protected,
respecting the privacy and confidentiality rules in accordance with the applicable
regulatory requirement(s).
12. Investigational products should be manufactured, handled and stored in accordance
with applicable Good Manufacturing Practice (GMP). They should be used in
accordance with the approved protocol.
13. Systems with procedures that assure the quality of every aspect of the trial should be
implemented.

Guidelines + Protocols in Documentation + Health Care Records

Nursing documentation must be aligned with the Nursing Process and reflect the principles
of assessment, planning, implementation, and evaluation.
1. Each page in the record contains the patient's name or patient number.
2. Personal biographical data includes the address, employer, home and work
numbers, and marital status.
3. All entries in the medical record contain the author's identification.
4. All entries are dated.
5. Legible to everyone.
6. Significant illnesses and medical conditions are indicated.
7. The history and physical examination identifies appropriate subjective and objective
information pertinent to the patient's presenting complaints.
8. Laboratory and other studies are ordered, as appropriate.