DEATH AND HUMAN DIGNITY

• DIGNITY IN DEATH AND DYING

• DYING WITH DIGNITY = MOVEMENT THAT PROMOTES THE ABILITY TO
MEET DEATH ON YOUR OWN TERMS
• Death is more complicated than it used to be; it is a time of ethical conflict

• The moral issue of euthanasia revolves around the preservation of human dignity in death
even to the individual's last breath. This issue has a positive and negative side

• This is the crossroads of the moral issue: whereas the positive side insists that mercy killing
preserves human dignity, the negative side claims the opposite since this act hastens the
death of an individual.
• Euthanasia - derived from the Greek word eu (good) and thanatos (death). It
etymologically signifies good death, a pleasant, gentle death, without awful suffering.
Euthanasia may be defined as an action or omission, that by its very nature, or intention,
causes death, for the purpose of eliminating pain.

Kinds of Euthanasia:

• Voluntary: When euthanasia conducted with consent. It is currently legal in Belgium,

Luxembourg, The Netherlands, Switzerland, and the states of Oregon and Washington in
the U.S.

• Non-voluntary: When euthanasia is conducted on a person who is unable to consent due

to their current health condition. In this scenario the decision is made by another
appropriate person, on behalf of the patient, based on their quality of life and suffering.

• 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

INVIOLABILITY OF HUMAN LIFE/ Sanctity of Life

• The concept of inviolability is an important tie between the ethics of religion and the ethics
of law, as each seeks justification for its principles as based on both purity and natural
concept, as well as in universality of application. In religion and ethics, the inviolability or
sanctity of life is a principle of implied protection regarding aspects of sentient life that are
said to be holy, sacred, or otherwise of such value that they are not to be violated

1
• Sanctity of life refers to the idea that human life is sacred, holy, and precious, argued
mainly by the pro-life side in political and moral debates over such controversial issues as
abortion, contraception, euthanasia, embryonic stem-cell research, and the "right to die" in
the United States, Canada United Kingdom and other English-speaking countries.
• SUICIDE derived from Latin suicidium, is "the act of taking one's own life". Attempted
suicide or non-fatal suicidal behavior amounts to self-injury with at least some desire to
end one's life that does not result in death.

• Assisted suicide, which is also called physician-assisted suicide, is when a doctor gives a
person the means to commit suicide when requested for
• Obligatory Assisted Suicide: A category that includes individuals who must be put to death.
Examples might be inmates on death row

• Obligatory Suicide: These would be individuals who are irrevocably condemned to kill
themselves. An example might be followers of the Jim Jones religious cult of Guyana.

• Optional Suicide: This would be a category of individuals who are in no way ill but who
have arbitrarily and irrevocably decided upon death.

• Optional Assisted Suicide: The individual would not be ill but would be facing a situation
in which death was preferable to living. A historical example might be the Zealots of
Masada.

• Suicide by Proxy: This category would be for those who are incapable of giving in formed
consent. The decision would be that of another. Fetuses, infants, and minor children would
fall into this class.

• Dysthanasia is the opposite of Euthanasia and means "bad death". It often occurs in
modern medicine when a terminally ill person is kept alive beyond their natural period,
thus prolonging their suffering. Is a term generally used when a person is seen to be kept
alive artificially in a condition where, otherwise, they cannot survive; sometimes for some
sort of ulterior (intentionally hidden/future) motive.

• 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. Passive euthanasia,
see there.

2
 PALLIATIVE SEDATION

● Also referred to as terminal sedation, is considered therapy that can be utilized to manage
intractable suffering.

For instance, it is employed when patients are experiencing severe and uncontrolled
symptoms, such as pain, dyspnea (difficulty breathing), delirium, or extreme anxiety, which
are not effectively managed by standard symptom-specific therapies.

● Is the practice of titrating medications (usually sedatives or analgesics) to reduce individual

awareness of distressing symptoms that are insufficiently controlled by symptom-specific
therapies for individuals with severe and refractory symptoms (AAHPM, 2014).

In this case, the medications are given in doses sufficient to reduce the patient's awareness
of their distressing symptoms. This can help alleviate suffering and improve the patient's
overall well-being.

● The goal of palliative sedation is not the cessation of life; rather, it is a clinical decision
intended to relieve refractory pain and the individual’s awareness of suffering (Bruera,
2012; Bruinsma et al., 2012).

In other words, the intent of palliative sedation is not to hasten death. It is not a form of
euthanasia or assisted suicide. The primary aim is to alleviate refractory symptoms and to
improve the patient's comfort during their final days or hours. The medical team continually
assesses and adjusts the medication to ensure the patient's comfort while respecting their
autonomy.

Moreover, since palliative sedation is a medically and ethically complex procedure, it is

essential for healthcare providers to have thorough discussions with patients and their families
about the potential benefits and risks of palliative sedation. Patients must provide informed
consent when possible, and decisions should be made in accordance with their wishes and best
interests.

Palliative care, including palliative sedation, is grounded in patient-centered care. The

healthcare team should consider the patient's values, preferences, and goals of care when
making decisions about the use of palliative sedation. Open communication with the patient
and their family is vital to ensure that the patient's wishes are respected.

In summary, Palliative sedation is a medical option of last resort, reserved for situations
where severe suffering cannot be otherwise relieved. It is performed with the utmost respect
for the patient's dignity and autonomy, with the goal of enhancing their comfort and quality of
life during the dying process.

3
 ADVANCE DIRECTIVES

● Are instructions that indicate health care interventions to initiate or withhold, or that
designate someone who will act as a surrogate in making such decisions in the event that
the patient loses decision-making capacity.

Basically, these documents are created by individuals to communicate their preferences for
future medical care, particularly in situations where they may not be able to make decisions
for themselves.

● Can be considered as a kind of informed consent for future interventions.

While traditional informed consent is provided by a patient before a specific medical

procedure, advance directives provide consent in advance for a range of potential medical
interventions. They outline the individual's preferences and instructions regarding their
medical care, thus guiding healthcare providers in making decisions on their behalf.

● Support people in making decisions on their own behalf, and help to ensure that patients
have the kind of end-of-life care that they want.

By documenting their wishes in advance, individuals ensure that their preferences for end-
of-life care are known and respected. This helps patients have a say in their medical care, even
when they can no longer express their wishes due to incapacity.

Types of Advance Directives

1. Living will
● A living will is a legal document that expresses the client’s wishes regarding medical
treatment in the event the client becomes incapacitated and is facing end‑of‑life issues.

The primary purpose of a living will is to outline an individual's specific healthcare wishes.
This can include preferences for life-sustaining treatments, resuscitation (CPR), mechanical
ventilation, artificial nutrition and hydration, and other medical interventions. It allows the
individual to provide clear instructions regarding the types of care they do or do not want to
receive in specific situations.

Living wills come into effect when the individual becomes incapacitated and is no longer
able to make medical decisions. Incapacity can result from various circumstances, such as
coma, advanced dementia, or other conditions that render the person unable to communicate
their healthcare choices.

Living wills are particularly relevant in situations involving end-of-life care. They are
designed to guide medical professionals and family members when the individual is in a critical

4
condition with a poor prognosis. The document helps ensure that the person's preferences for
the use of life-sustaining treatments and the overall approach to care align with their values
and wishes.

● Most state laws include provisions that protect health care providers who follow a living
will from liability.

Living wills have legal standing, meaning that healthcare providers are bound by law to
follow the instructions outlined in the document. However, there may be limitations and
specific requirements depending on local laws and regulations.

2. Durable power of attorney for health care

● A durable power of attorney for health care is a document in which clients designate a
healthcare proxy to make healthcare decisions for them if they are unable to do so.

The person creating the document (referred to as the "principal") designates someone they
trust to act as their representative in making healthcare decisions if the principal becomes
incapacitated and is unable to make those decisions themselves. This designation is a crucial
aspect of advance care planning.

● The proxy can be any competent adult the client chooses.

The proxy, also known as the attorney-in-fact or healthcare agent, is usually any competent
adult chosen by the principal. This means the principal can select a family member, friend, or
any other trusted individual to act as their healthcare decision-maker. The proxy should be
someone who understands the principal's values and preferences and is willing to advocate for
their wishes.

The healthcare proxy has the authority to make a wide range of healthcare decisions on
behalf of the principal. This may include choices regarding medical treatments, surgery,
medication, end-of-life care, and other healthcare matters. The proxy's role is to ensure that the
principal's healthcare preferences, as well as any previously expressed wishes or values, are
respected.

3. Provider’s orders
● Unless a provider writes a “do not resuscitate” (DNR) or “allow natural death” (AND)
prescription in the client’s medical record, the nurse initiates cardiopulmonary
resuscitation (CPR) when the client has no pulse or respirations.
● The provider consults the client and the family prior to administering a DNR or AND.

5
 DNR OR END OF LIFE CARE PLAN

A. Palliative care
● Consists of comfort care measures that patients may request instead of aggressive medical
treatments when their condition is terminal.

These comfort care measures prioritize the relief of suffering, enhancement of comfort, and
the overall well-being of the patient. This is in contrast to curative or life-prolonging
treatments.

● An approach that improves the quality of life of patients (adults and children) and their
families who are facing problems associated with life-threatening illness. It prevents and
relieves suffering through the early identification, correct assessment and treatment of pain
and other problems, whether physical, psychosocial or spiritual (WHO, 2020).

This approach seeks to address the physical, emotional, social, and spiritual aspects of well-
being. It is not just about prolonging life but ensuring that the patient's remaining time is as
comfortable, fulfilling, and meaningful as possible. It aims to optimize the patient's physical
and emotional comfort.

All in all, palliative care takes a holistic approach, recognizing that a patient's well-being
is influenced by various factors. It addresses the physical, emotional, social, and spiritual needs
of the patient. This encompasses pain management, emotional support, counseling, assistance
with practical matters, and addressing existential questions.

● Understanding what quality of life means to the dying patient is an important part of end-
of-life care for nurses, and no matter what stage of dying the patient is experiencing, the
main goals of palliative care are to prevent and relieve suffering and allow for the best care
possible for patients and families.

B. Do Not Resuscitate Orders (DNR)

● Are written directives placed in a patient’s medical record

These directives are typically signed by a physician, reflecting the patient's informed and
expressed wishes regarding resuscitation measures.

● A written physician’s order placed in a patient’s chart that says hospital personnel are not
to carry out any type of CPR or other resuscitation measures should the client’s heart or
breathing cease from an irreversible underlying condition

A DNR order, when placed in a patient's chart, is a written physician's order that specifies
that hospital personnel should not carry out any form of cardiopulmonary resuscitation (CPR)

6
or other resuscitation measures if the patient's heart or breathing stops due to an irreversible
underlying medical condition.

In essence, it instructs healthcare providers not to attempt life-saving interventions such as

chest compressions, defibrillation, or intubation in the event of cardiac or respiratory arrest.

● It is essential to understand that DNR Is not the same as “do nothing” and decisions to
withhold or withdraw treatment are separate from DNR decisions.

It does not mean that no medical care or treatment will be provided to the patient. Decisions
to withhold or withdraw treatment, such as ventilator support, tube feeding, or other medical
interventions, are separate from DNR decisions.

In simple terms, a DNR order is specifically about whether or not to initiate CPR in the
event of cardiac or respiratory arrest. Other medical treatments and interventions may still be
provided as appropriate based on the patient's overall care plan and preferences

GOOD DECISIONS are both ETHICAL and EFFECTIVE

● In the realm of nursing, ethical decisions concerning death and dying are of paramount
importance, requiring a delicate balance between medical expertise and profound empathy.
Ethical decisions in these situations generate and sustain trust among patients, their
families, and the healthcare providers involved. Respect for the dignity of the individual,
responsibility towards providing the best possible care, fairness in treatment options, and
genuine caring are the ethical principles that guide nurses in end-of-life scenarios.
● Effective decisions are effective if they accomplish what we want to accomplish, 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 long-term goals.
○ Immediate and Short-Term Goals:
Immediate decisions may involve adjusting medication dosages to alleviate
pain, providing comfort measures, and offering psychological support to patients
and their families. These decisions aim to ensure the patient's immediate comfort
and dignity during the final stages of life.
○ Long-Term Goals:
Long-term goals in end-of-life care encompass a broader perspective. They
involve discussions about advance care planning, respecting patients' wishes
regarding resuscitation, organ donation, and hospice care. Effective decisions in
this realm require careful consideration of the patient's values, beliefs, and cultural
background. Nurses play a vital role in facilitating these conversations, ensuring
that the patient's choices align with their deeply held beliefs and preferences for
their final moments and afterlife arrangements.

7
The Process of Making Ethical Decisions Requires: COMMITMENT, CONSCIOUSNESS,
AND COMPETENCY
● COMMITMENT
The commitment to ethical decision-making signifies a strong resolve to adhere to
moral principles, even when faced with challenges or personal sacrifices. It means
prioritizing what is right and just, irrespective of the cost or difficulty involved. In nursing
practice, commitment to ethical decisions might manifest in advocating for a patient's best
interests, even if it means challenging the decisions of others, to ensure quality care.
● CONSCIOUSNESS
Consciousness in ethical decision-making refers to being aware and mindful of
one's actions, consistently applying moral convictions to daily behavior. It involves a deep
understanding of ethical guidelines and a continuous effort to align actions with these
principles. For nurses, consciousness means being sensitive to the emotional needs of dying
patients and their families, maintaining open and honest communication, and respecting
cultural and religious beliefs during end-of-life care.
● COMPETENCY
Ethical decision-making requires competence, the ability to collect and evaluate
information objectively, develop alternatives, and foresee potential consequences and
risks. Competency involves not only having a strong knowledge base, but also the critical
thinking skills to assess complex situations. In nursing, competency is demonstrated by
accurately assessing a patient's pain levels, understanding the implications of different
treatment options, and effectively communicating these options to patients and their
families, ensuring they can make informed decisions aligned with their values and wishes.

DECISION-MAKING APPROACH TO ETHICAL PROBLEMS:

1. Determine the problem
2. Identify appropriate decision makers
3. Determine the context
4. Frame the issue
5. Determine possible options and implications
6. Select a course of action
1. Determine the Problem:
The first step in addressing ethical problems is to clearly define the issue at hand. This involves
identifying the ethical dilemma, understanding the conflicting values or principles involved, and
recognizing the potential impact on all parties involved.

2. Identify Appropriate Decision Makers:

Ethical decisions often involve multiple stakeholders. Identifying the appropriate decision-makers,
including healthcare professionals, patients, families, and sometimes legal experts, is crucial. Each

8
stakeholder may have different perspectives and should be included in the decision-making
process.

3. Determine the Context:

Understanding the broader context of the ethical dilemma is essential. This includes considering
cultural, social, religious, and legal factors that might influence the situation. Contextual
understanding helps in appreciating the complexity of the problem and informs the decision-
making process.

4. Frame the Issue:

Ethical dilemmas are often multifaceted. Framing the issue involves breaking it down in specific
questions or concerns. By clearly defining the aspects of the problem, decision-makers can address
each component individually, making it easier to analyze and resolve.

5. Determine Possible Options and Implications:

Brainstorming and evaluating potential options are critical. Decision-makers need to consider
various courses of action, weighing their pros and cons, and assessing the ethical, legal, and
practical implications of each option. This step involves considering the short-term and long-term
consequences of each decision.

6. Select a Course of Action:

Once all options and their implications have been thoroughly examined, a course of action is
selected. The decision should align with ethical principles, legal obligations, and the best interests
of the patient. It should also consider the preferences of the patient and the family, ensuring that
the chosen action is respectful, compassionate, and patient-centered.

Strategies to Enhance Ethical Decisions and Practice

1. Become aware of our own values and the ethical aspects of nursing
Understanding our own values and beliefs is fundamental to making ethical
decisions. Self-reflection helps nurses recognize their biases and prejudices, allowing for
more objective and ethical decision-making. Being aware of personal values also enables
nurses to respect the values and beliefs of their patients and colleagues.

2. Be familiar with nursing codes of ethics

Nursing organizations worldwide have established codes of ethics that outline the
profession's values and standards. Familiarity with these codes provides nurses with a clear
framework for ethical decision-making. By adhering to these guidelines, nurses ensure that
their actions align with the core principles of nursing ethics.

9
 3. Seek continuing education opportunities
Ethical dilemmas in healthcare are constantly evolving. Continued education
equips nurses with up-to-date knowledge about emerging ethical issues, allowing them to
navigate complex situations more effectively. Staying informed empowers nurses to make
informed decisions, particularly in the face of new medical technologies and changing
societal norms.

4. Respect the values, opinions, and responsibilities of other healthcare professionals

Interdisciplinary collaboration is essential in healthcare. Respecting the viewpoints
of other healthcare professionals, even when they differ from our own, fosters a
collaborative environment. It ensures that decisions are made with a comprehensive
understanding of the diverse perspectives within the healthcare team, leading to more
ethical and well-rounded outcomes.

5. Participate in or establish ethics rounds

Ethics rounds provide a platform for healthcare professionals to discuss ethical
aspects of patient care. By analyzing real or hypothetical cases, participants can explore
various ethical dimensions, perspectives, and potential solutions. These discussions
enhance ethical awareness and decision-making skills, encouraging a more nuanced
understanding of complex ethical issues.

6. Strive for collaborative practice

Collaborative practice involves effective teamwork and communication among
healthcare professionals. In a collaborative environment, nurses can share their ethical
concerns openly, seek input from colleagues, and collectively arrive at ethically sound
decisions. Collaboration not only enriches the decision-making process, but also fosters a
culture of mutual respect and support, enhancing ethical practice in healthcare.

By implementing these strategies, nurses can enhance their ethical decision-making skills and
contribute to a healthcare environment characterized by compassion, respect, and integrity. These
practices not only benefit patients, but also promote a positive and ethical workplace culture among
healthcare professionals.

10
 BIOETHICS AND RESEARCH

Bioethics in the context of research involves the ethical considerations and principles applied to
studies involving living organisms, human subjects, and the broader implications of scientific
inquiry. It encompasses ethical decision-making, integrity, and responsibility in the design,
conduct, and dissemination of research.

-Bioethics in research is like making sure scientists follow the rules and play fair when they study
living things or people. It's about making good choices and being honest in how we learn new
things

I. Bioethics:

Definition: Bioethics is a multidisciplinary field of study that explores the ethical issues and
dilemmas arising in the realms of biology, medicine, and healthcare. It involves the examination
of moral principles and values in the context of biological sciences, medical practice, research, and
the broader implications for society

-Is like the referee of science and medicine. It's a field that looks at the rules and fairness in
biology, medicine, and healthcare. Bioethics helps us figure out what's right or wrong when it
comes to experiments, treatments, and health practices. It's like the moral compass for the
scientific world.

II. Research:

Research is a systematic and organized process of inquiry aimed at expanding knowledge,

discovering new information, or verifying existing theories. In various fields, including science,
social science, and humanities, research involves the collection and analysis of data to generate
insights, develop theories, or contribute to the understanding of a particular subject

-Is like being a detective for knowledge. It's a way of asking questions and finding answers in a
very organized and careful manner. Imagine it as a journey of exploration where we collect and
study information to discover new things or check if what we already know is correct.

III. Principles of Ethics in Research:

1. Nuremberg Code:

The Nuremberg Code is a set of ethical guidelines for human experimentation established during
the Nuremberg Trials following World War II. It emphasizes the importance of voluntary and
informed consent, the avoidance of unnecessary harm, and the requirement for scientific and
societal value in research involving human subjects.

11
The Nuremberg Code is like a set of rules made after somethings happened during experiments. It
says that before scientists can study people, they must ask for permission, make sure people want
to join, and make sure the study won't hurt them too much.

Key Principles:

Informed Consent: Participants must give voluntary, informed, and unequivocal consent.

It's like saying, "Maam/Sir, we want to study you. Are you okay with that?"

Voluntary Participation: Participants should willingly choose to participate without coercion.

Nobody should force participant to be in a study. It should be participant will to join.

Minimization of Risks: Researchers must take measures to minimize risks and ensure that the
benefits of the research outweigh potential harm.

Scientists should try to make sure their study doesn't hurt people that much. The good stuff we
learn should be more than the bad stuff that might happen.

2. Declaration of Helsinki:

The Declaration of Helsinki is a set of ethical principles and guidelines developed by the World
Medical Association. It provides a framework for conducting biomedical research, emphasizing
the well-being and rights of research participants.

The Declaration of Helsinki is like a handbook for doctors and researchers. It tells them how to
do studies in a good and fair way. It's about making sure people in studies are safe and treated
well.

Key Principles:

Beneficence and Non-Maleficence: Research should maximize benefits and minimize harm to
participants.

Research should try to help people, not harm them.

Scientific and Social Value: Research should have scientific and social value, contributing to
knowledge and societal well-being.

Studies should teach us important things and be good for society.

12
Independent Review: Ethical review by independent committees is essential for the protection of
participants.

Other people, not just the researchers, should check if a study is okay and safe for the participants.

3. Belmont Report:

The Belmont Report is a seminal document outlining ethical principles and guidelines for research
involving human subjects. It was produced by the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research in response to ethical concerns in
research.

The Belmont Report is like a guidebook that tells researchers how to be fair and good when
studying people.

Key Principles:

Respect for Persons: Emphasizes individual autonomy and the protection of those with
diminished autonomy.

Treat people in studies with respect and protect those who can't fully decide for themselves.

Beneficence: Requires maximizing benefits and minimizing harm to participants.

Make sure the study helps people, and don't let it harm them too much.

Justice: Demands fair distribution of the benefits and burdens of research.

Be fair - everyone should have a chance to benefit from research.

Conclusion:

Understanding Bioethics in Research: Knowing about bioethics in research is really important. It

helps us make sure that when scientists are trying to discover new things, they do it in a way that's
fair, respectful, and safe for everyone involved. The Nuremberg Code, Declaration of Helsinki,
and Belmont Report are like the referees or guidebooks that help scientists do their work the right
way. They remind us to be careful, ask for permission, and always do our best to help and not
harm.

13
 ETHICAL ISSUES IN AN EVIDENCE-BASED PRACTICE

Integrates the latest research evidence, clinical expertise, and patient preferences to inform
decision-making and guide nursing interventions. By basing their practice on solid evidence,
nurses can optimize patient care.

Evidence based practice focuses on searching and appraising available evidence on the advantages
and disadvantages of various interventions. Ethical issues Include:

Status of evidence

Available evidence in health care areas consists mostly of expert opinions where despite important
advances in research, only few have amassed sufficient data to enable research-based confidence
in treatment interventions

Client Autonomy

Patient and family participation in planning intervention (autonomy) is an important dimension of

rehabilitation. This participation should also include decision making under difficult
circumstances by the client when competing interests are decided.

Conflict of Interest

May be represented when clinical trials are subjected to questions about the validity of their
conclusions. Although studies designed with high levels of control for competing hypotheses are
emphasized as necessary for achieving valid conclusions, the ethical threats involved in conducting
such research are sometimes understated. Again, scientists rather than patients mostly determine
decisions about who participates in studies and whether intervention continues, thus creating a
conflict of interest. This may also lead to bias tendencies which may affect the client's autonomy.

Informed Consent

The idea of informed consent is again grounded in the principle of autonomy. This principle
respects the right of a person to weigh the pros and cons of a decision and to make a choice on the
basis of his or her consideration of alternatives. To make a fully informed choice, potential
participants must be advised of the expected benefits and risks.

- Ethical issues are a natural part of the health care community, they represent themselves in
the form of ethical dilemmas in clinical decisions.

14
 ETHICO-MORAL OBLIGATIONS OF A NURSE IN AN EVIDENCE-BASED
PRACTICE

Evidence-based practice reduces reliance on outdated information and personal biases.

Incorporating the latest research findings into practice allows nurses to confidently deliver care
that’s been proven safe and effective. It helps ensure that patients receive care based on the current
state of knowledge.

Access to the latest Research

Evidence-based practice in nursing involves providing holistic, quality care based on the most up-
to-date research and knowledge rather than traditional methods, advice from colleagues, or
personal beliefs.

Evidence-Informed Practice

An approach to patient care that incorporates the best research, clinical expertise, and patient input
to provide the best in patient care. This leads to greater transparency and accountability as the
patient is brought into the conversation and decision-making process.

Patient Advocacy

Promoting and protecting the rights, interests, and well-being of patients. It involves actively
advocating for patients' needs, preferences, and concerns, and ensuring that they receive safe,
quality, and compassionate care.

- Also, these ethical principles guides nurses in an evidence based practice it includes respect
for autonomy (self-determination), beneficence (do good), nonmaleficence (do no harm),
justice (fairness), fidelity (keep promises), and veracity (tell the truth).

INTRODUCTION TO GOOD CLINICAL PRACTICE GUIDELINES

GCP is a set of guidelines that form the cornerstone of clinical research, ensuring that the
rights, safety, and well-being of participants are protected.

Before we dive into the key principles of GCP, it's important to understand the context in
which these guidelines were developed. The history of clinical trials is marked by instances of
unethical conduct, where participants were exposed to unnecessary risks, and their rights were
violated. In response to these ethical breaches, the international community came together to
establish a set of principles that would safeguard participants and ensure the integrity of clinical
research

15
 Good Clinical Practice (GCP) is an international quality standard provided by the
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH). GCP guidelines include standards on how clinical trials should be conducted,
defining the roles and responsibilities of clinical trial sponsors, clinical research investigators, and
monitors.

GOOD CLINICAL PRACTICE, it is an international ethical and scientific quality standard

for designing, conducting, recording, and reporting trials involving human subjects. and; It aims
to ensure that the rights, safety, and well-being of trial subjects are protected and that the trial
results are credible and accurate.

Key principles of GCP guidelines:

1. Ethical Considerations: The rights, safety, and well-being of trial subjects should take
precedence over the interests of science and society. Ethical principles outlined in the Declaration
of Helsinki should be followed. Researchers must ensure that their studies are ethically sound and
that the rights and dignity of participants are respected throughout the research process

Example:
A clinical trial on a new cancer drug must prioritize the safety and well-being of the patients
over the scientific interest. It must adhere to the ethical principles outlined in the
Declaration of Helsinki.

The Declaration of Helsinki is mentioned under ethical considerations in the principles of

Good Clinical Practice (GCP) guidelines because it is a foundational document that provides
ethical guidance for medical researchers conducting clinical trials and research involving human
subjects. Developed by the World Medical Association (WMA) in 1964, and updated multiple
times since, the Declaration of Helsinki outlines the ethical principles that should guide physicians
and researchers in their work.

The Key ethical principles outlined in the Declaration of Helsinki includes:

Respect for Autonomy: Researchers should respect the autonomy and dignity of research
participants. This includes obtaining voluntary and informed consent, allowing participants
the freedom to withdraw from the study at any time without penalty, and ensuring that
participants are fully informed about the research.

Beneficence and Non-Maleficence: Researchers should strive to maximize the benefits of

the research and minimize the risks and harms to participants. This involves conducting a
thorough risk-benefit analysis before initiating the research.

16
 Justice: The benefits and burdens of research should be distributed fairly among
participants. Vulnerable populations should not be exploited, and participants should not
be subjected to undue risks or burdens.

Scientific Integrity: Research should be based on a clear scientific rationale, and the
design and conduct of the research should adhere to high scientific and ethical standards.

Transparency and Accountability: Researchers are accountable for the ethical conduct
of their research, and they should be transparent in their communication about the research,
including reporting results and any conflicts of interest.

By referencing the Declaration of Helsinki in the ethical considerations of the GCP

guidelines, researchers are reminded of the importance of upholding these ethical principles in the
conduct of their clinical trials and research involving human subjects. This helps to ensure the
protection of research participants and the integrity of the research

2. Informed Consent: Trial subjects must be fully informed about the nature of the trial, its
purpose, duration, required procedures, potential risks, and potential benefits. They should
voluntarily provide written informed consent before participating in the trial. The process of
obtaining informed consent should be respectful and should ensure that participants understand
the information provided to them, allowing them to make informed decisions about their
participation.

Example:
Before enrolling in a clinical trial for a new diabetes medication, patients must be provided
with detailed information about the trial, including its purpose, duration, procedures, risks,
and benefits. They must then voluntarily sign an informed consent form.

3. Protocol: A detailed protocol or plan must be developed and followed, specifying the objectives,
design, methodology, statistical considerations, and organization of the trial. Any changes to the
protocol must be documented and justified. The protocol ensures that the trial is conducted in a
systematic and organized manner, and that the results are reliable and valid.

Example:
A research team develops a detailed protocol for a clinical trial on a new hypertension drug.
This protocol outlines the objectives, design, methodology, and statistical considerations.
Any subsequent changes to the protocol are documented and justified

17
4. Investigator Qualifications: The investigator(s) must be qualified by education, training, and
experience to conduct the trial. They must also comply with the GCP guidelines and the applicable
regulatory requirements. The investigator is responsible for the overall conduct of the trial,
ensuring that the rights and well-being of participants are protected, and that the trial is conducted
ethically and scientifically.

Example:
Dr. Smith, a cardiologist with extensive experience in hypertension research, is chosen as
the principal investigator for a clinical trial on a new antihypertensive drug. Dr. Smith has
completed GCP training and is familiar with the applicable regulatory requirements.

5. Adequate Resources: The sponsor must provide the investigator with adequate resources,
including time, staff, facilities, and financial support, to conduct the trial. Adequate resources are
essential for ensuring that the trial is conducted properly and that the data generated is reliable.

Example:
The sponsor provides the research team with sufficient time, staff, facilities, and financial
support to conduct a clinical trial on a new migraine medication. This includes funding for
lab tests, patient recruitment, data analysis, and staff salaries.

6. Institutional Review Board (IRB)/Independent Ethics Committee (IEC):

The protocol, written informed consent form, recruitment process, and any other relevant
documents must be reviewed and approved by an Institutional Review Board (IRB) or Independent
Ethics Committee (IEC) before the trial begins. The IRB/IEC is responsible for protecting the
rights and well-being of trial subjects and ensuring that the research is conducted ethically.

Example:
Before starting a clinical trial on a new arthritis drug, the research team submits the
protocol, informed consent form, and other relevant documents to an Institutional Review
Board (IRB) for review and approval.

7. Confidentiality: Information about trial subjects must be kept confidential, and their identities
must not be disclosed without their consent. Confidentiality is crucial for maintaining the trust of
participants and ensuring their privacy.

Example:
The research team ensures that the personal information of the participants in a clinical
trial on a new asthma inhaler is kept confidential. Participants' identities are not disclosed
without their consent.

18
8. Data Handling and Record Keeping: The trial data must be recorded, handled, and stored in
a way that ensures its accuracy, reliability, and integrity. Data should be backed up and stored
securely to prevent loss or damage.

Example:
The data collected during a clinical trial on a new antidepressant is recorded accurately,
handled securely, and stored in a way that ensures its reliability and integrity. The data is
also backed up regularly.

9. Adverse Events: All adverse events, especially those that are serious or unexpected, must be
reported promptly to the sponsor, the IRB/IEC, and the regulatory authorities, as applicable. Proper
reporting of adverse events is essential for ensuring the safety of trial subjects and for assessing
the risk-benefit ratio of the trial.

Example:
During a clinical trial on a new cholesterol-lowering drug, a participant experiences a
serious allergic reaction. The research team promptly reports this adverse event to the
sponsor, the IRB, and the regulatory authorities.

10. Quality Assurance: Quality assurance processes must be in place to ensure that the trial is
conducted, data is generated, and reports are produced in compliance with GCP guidelines.
Regular audits and inspections are conducted to ensure that the trial is conducted according to the
protocol and GCP guidelines, and that the data generated is accurate and reliable.

Example:
A pharmaceutical company conducts regular audits of a clinical trial on a new vaccine to
ensure that the trial is conducted in compliance with GCP guidelines and that the data
generated is reliable and accurate.

In conclusion, GCP guidelines play a crucial role in ensuring that clinical trials are
conducted ethically and that the data generated from these trials is reliable and can be trusted by
healthcare professionals, regulatory authorities, and the public.
These principles provide a framework for the ethical and scientific conduct of clinical
trials, ensuring the protection of trial subjects and the integrity of the research data.
As we move forward in the realm of medical research, it's essential to uphold and
continually refine these guidelines, safeguarding the future of healthcare and the well-being of
individuals around the globe.

19
SUMMARY: BIOETHICS AND RESEARCH

There are 3 Principles of ethics in research

● Nuremberg Code: Developed post World War II, it emphasizes informed consent, well-
designed scientific experiments, and benevolence and justice in research. It mandates
voluntary participation and full disclosure of risks.
● Declaration of Helsinki: Established in 1964, it's a set of ethical principles for medical
researchers, emphasizing the need for ethical review and informed consent. It requires
research protocols to be reviewed by an ethics committee and written consent from
participants.
● Belmont Report: Produced in 1979, it identifies three principles: respect for persons,
beneficence, and justice. It emphasizes autonomy, informed decisions, and fair distribution
of research benefits and burdens.
Ethical Issues in Evidence-based Practice (EBP): Issues include the reliability and validity of
evidence, applicability to specific populations, and conflicts between research findings and patient
values. Clinicians may face dilemmas when patients refuse evidence-supported treatments due to
cultural beliefs.
Ethico-moral Obligations of the Nurse in EBP: Nurses must stay current with research, ensure
care is evidence-informed, and advocate for patient preferences and values. They must
communicate if an intervention is ineffective based on recent research.
Introduction to Good Clinical Practice (GCP) Guidelines: GCP is an international quality
standard by ICH. It outlines how clinical trials should be conducted, defining roles and
responsibilities. It requires ethical conduct of trials, prioritizing well-being of trial subjects, and
accurate data reporting.

20