NCM108 Bioethics FINALS

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St.

Paul University Philippines 3) RIGHT TO PRIVACY


- The subject has the right to decide the time, the
NCM108 - Health Care Ethics
extent and circumstances he/she will willingly
ETHICAL CONCERNS IN RESEARCH
share his/her presence, thoughts, and behaviors
- Ethics in nursing research can be defined as the
with others.
act of moral principles that the researcher has to
4) RIGHT TO CONFIDENTIALITY OR ANONYMITY OF
follow while conducting nursing research to
DATA
ensure the rights and welfare of the individuals.
- Data shall not be used other than for the specific
purpose for which the subject gave consent and
ETHICAL PRINCIPLES IN RESEARCH
shall not be made public or available to others.
1. BENEFICENCE
5) RIGHT TO BE PROTECTED FROM HARM
o Promoting good or doing good for
- There shall be appropriate balance between
others.
potential benefits of the researcch and the risks
o One of the most fundamental ethical
assumed by the subjects.
principle.
- Referral to counselling shall be included in the
2. RIGHT TO FREEDOK FROM HARM AND
study protocol if necessary.
DISCOMFORT
o Researchers have the obligation to avoid
IMPORTANCE OF ETHICS IN NURSING RESEARCH
or minimize harm in studies with
- Protect the vulnerable goups and other study
humans.
prticipants from harmful events.
▪ Physical harm
- Sfeguard the participants from exploitaton fro,
▪ Social harm
researchers.
▪ Emotional harm
- Establish the risk-benefit ration for the study
▪ Financial harm
subjects.
- Ensure the fullest respect, dignity, privacy,
3. RESPECT FOR HUMAN DIGNITY
disclose of information, and fair treatmemt for
o Includes “right to self-determination”
study subjects.
and “right to full disclosure.”
- Build the capability of subjects to accept or reject
o Autonomy
particiption in the study.
• A patient/participant has the
right to make decision about
his/her care.
3.1 RIGHT TO FULL DISCLOSURE
o The researcher has fully described the
nature of the study.
o 2 MAJOR ELEMENTS OF INFORMED
CONSENT
• Self-determination
• Right to full disclosure
4. JUSTICE
o The right to fair treatment and their right
to privacy.
o The risk and benefits should be equally
divided.
o Participants should not be chosen based
on gender, religion, wealth, or any other
differentiator.

Human subjects are essential to the conduct of research


intended to improve human health. As such, the
relationship between investigators and human usbjects is
critical and should be based on honesty, trust, and
respect.

BASIC HMAN RIGHTS OF RESEARCH SUBJECTS


1) RIGHT TO INFORMED CONSENT
- Recognition of self-determination and thorough
comprehension of the proposed participation
are the two components of self-determination.
- The subjects must understand the risks involved,
the benefits anticipated, time and energy
requirements and any anticipated loss.
2) RIGHT TO REFUSE AND OR WITHDRAWAL FROM
PARTICIPATION
- There shall be neither recrimination for refusal
nor for withdrawing from participation.
- Refusal to participate can be minimized, if at the
onset the subject has been given careful and
honest opinion on what is to be done.
St. Paul University Philippines o According to their main goal, these
biobanks are meant to help science
NCM108 - Health Care Ethics
move forward and help create new tests
INTRODUCTION TO RESEARCH
and treatments for specific diseases.
RESEARCH
- Scientific methods are used to carefully study a
3) The researcher gets samples from people at a
certain issue or research problem.
biobank that is connected to a university,
- Involved inductive (qualitative) and deductive
hospital, or charity. (SampleSmart, 2021)
(quantitative) method.
o These companies connect people with
EARL ROBERT BABBIE
hospitals and doctors, and they also handle
- American sociologist
all the issues of ethics and safety.
- Research is a systematic inquiry to describe,
o In order to make money, the companies offer
explain, predict, and control the observed
the service of finding biospecimens.
phenomenon.
• That’s why the costs of getting
- Research uses both intuitive and deducive
samples this way are usually higher.
reasoning.
o This is the main way that life science
companies get data.
PHASES IN RESEARCH
ARE YOU CONDUCTING HUMAN SUBJECTS RESEARCH?
(Jae Joseph Russell B. Rodriguez, 2022)
- This is a complicated research with lots of rules.

Ethical guidelines for human genetic research in the


Philippines (Jae Joseph Russell B. Rodriguez, 2022)
- Human research in the Philippines requires
compliance with national ethical rules and
guidelines

The Republic Act No. 10532, or the Philippine National


Health Research System Act of 2013
- Mandates that all health and health-related
research should adhere to the guidelines of the
Philippine Health Research Ethics Board (PHREB)
(Philippine National Health Research System,
2013).
WHERE TO GET HUMAN SAMPLES FROM PEOPLE FOR
RESEARCH? Philippine Health Research Ethics Board (PHREB)
1) Scientists work with a clinician who works in their - Adopts the WHO definition of health.
specific area to get biological samples from o “A state of complete physical, mental,
people for research. (SampleSmart, 2021) and social well-being and not merely the
o If the researcher needs samples from people absence of disease or infirmity.”
who have ovarian cancer, they will probably o Thus, studies involving human subjects
work with a gynecologic doctor, who treats conducted in the country, including
people with this kind of cancer all the time. human population genetic research, are
o Many times, hospitals will require their within its purview even if not necessarily
clinicians to take part in or work with medical in scope.
research projects as part of their job. o “Must undergo ethical review and
o This means that the doctors and nurses need clearance before implementation to
to take part in research projects and clinical ensure the safety, dignity, and well being
trials. of research participants.”
• By making these studies possible,
authors are advancing science INFORMED CONSENT IN RESEARCCH
research, which will probably help - Researchers must obtain the voluntary, informed
patients in the future. consent of individuals participating in their
o Due to the low cost of getting the samples, studies.
this way of getting biospecimens is very - A key principle of ethical human subjects study is
popular in academic research. getting informed consent.
2) The researcher gets biospecimens from a o Researchers must make sure that people
business whose main job is to provide who want to take part in the study get
researchers with human biological samples. information about it that is detailed
(SampleSmart, 2021) enough to allow them to make an
o The idea of biobanks came about to informed decision and presented in a
make it easier for experts to get way that makes it easy for them to
biospecimens. choose not to participate.
o Biobanks can either get new - This includes provifing detailed information
biospecimens or collect and store about the:
samples that are okay to use for study, o Purpose
depending on the biobank. o Procedures
o Risks, benefits of the research
o Ensuring that participatns have the
capacity to understnd and make an
informed decision.

WHY IS INFORMED CONSENT IMPORTANT IN A STUDY?


(NATIONAL HUMAN GENOME, 2022)
- In the United States, the requirements for
obtaining informed consent from research
participants are stipulated by several regulations
and policies.
o Informed Consent= the “Common Rule.”
▪ 1930 – the origin of modern
regulations for informed
consent in the U.S., when Nazi
physicians conducted horrific
experiments on human subjects
without their consent before
and during WWII.
▪ A set of 10 ethical principles for
physicians and researchers to
follow when conducting
experimentation on humans,
one of which was informed
consent.
- With limited exceptions, the Common Rule
o Mandates that researchers obtain
informed consent for federally funded
research that involves "a living individual
about whom an investigator (whether
professional or student) conducting
research:
▪ Obtains information or
biospecimens through
intervention or interaction with
the individual, and uses, studies,
or analyzes the information or
biospecimens; or
▪ Obtains, uses, studies, analyzes,
or generates identifiable private
information or identifiable
biospecimens."
- Not all research that involves human samples or
data requires informed consent.
- According to the current definition of "human
subject" in the Common Rule
o Informed consent is not required for use
of samples and data that do not identify
the person/donor (such as those stored
in biobanks and data repositories for
future research use) or
o Informed consent is not required for use
of samples and data from people who
are deceased.

HUMAN SUBJECTS RESEARCH


GRANTS AND FUNDING IN PHILIPPINES
- Stages of basic academic research among
Philippine Indigenous cultural
communities/Indigenous peoples (ICCs/IPs) (Jae
Joseph Russell B. Rodriguez, 2022)
St. Paul University Philippines confident that the risks have been adequately
assessed and can be satisfactorily managed.
NCM108 - Health Care Ethics
DECLARATION OF HELSINKI
VULNERABLE SUBJECTS
- The Helsinki Declaration of 1964 issued
- Medical researcg with a vulnerable groups is only
guidelines on medical research.
justified if the research is responsive to the
- Created in 1964 by the World Medical
health needs or priorities of this group and the
Association (WMA). The WMA was established
research cannot be carried out in a nom-
seventeen years before in 1947, and was created
vulnerable group.
to handle the growing concern of unethical
- Subjects who are mentally ill or legally
medical practice which became more apparent
incompetent such as the unconscious, or are in
during and after World War II.
unique situations, like fetuses, require special
- Therefore, the declaration of Helsinki is an
attention. Those who are mentally ill, mentally
international legal implictions. The declaration
retarded, unconscious andminors are incapable
set the standard for ethicl humm experimenttion
of evaluating the risks involved and cannot be
conducted by researchers.
given consent in their own behalf. Consent of
- The Declaration of Helsinki has been revised six
parents or guardians are required.
times, in 1975, 1983, 1989, 1996, 2000, and
- Investigative studies regarding fetuses shall have
2008. The fifth revision, in 2000, caused
the consent in the presence of a third person
considerable controversy regarding issues such
because of the possible danger or injury to it.
as whether the document should be revised at
- The Philippine Constitution guarantees the
all, the restating of Article 29 which dealt with
protection of the life of the mother and the life
placebo use, and what the medical community
onf the unborn.
should be required to do to treat patients after
- Students are vulnerable as their participation or
they have undergone a medical trial.
non-participation may affect their grades.
- After this revision, the U.S. FDA refused to refer
Employees may participate because of the
to the new version and instead continued using
influence it may bring to their promotion, salary
the document from 1989. In 2006, the U.S. FDA
increases or bonuses. It must be explained to
discontinued referring to the Declaration at all.
them that this is not so.
Also, the European Commission only uses an
older version from 1996. This lack of cohesion
INVESTIGATIVE STUDIES AND MEDICAL REGIMEN
has weakened the Declaration of Helsinki’s
- When the medical regimen of a research subject
influence over the years. However, it is still
will be affected, it is best that there be proper
viewed as a pioneering effort to ensure that
coordination with the physician in charge. The
patients involved in clinical trials are treated with
investigative study shall not, in any way, be
the fairness around the world.
conflict with the medical regimen.
- Drugs to be used by the investigators must have
GUIDING PRONCIPLES
a medical prescription. An example of this was an
- Medical research is subject to ethical standards
experiment done in a government hospital
that promote and ensure respect for all human
where banana leaves were used to promote
subjects and protect their health and rights.
healing of decubitus ulcers of bedridden
- No national lr interntionl ethical, legal, lr
patients. This study was coordinated with the
regulatory requirement should reduce or
physicians in the unit.
eliminate any of the protections for research
- Even though the treatment method which
subjects set forth this declaration.
consisted of cleaning, massaging the area around
- Medical research involving human subjects must
the wound, relief of pressure, and putting
be conducted only by individuals with the
banana leaves beneath the area with ulcer were
appropriate ethics and scientific education,
all within the scope of nursing practice, the
training and qualifications.
success of the study was further enhanced since
- Appropriate compensation and treatment for
the doctors refrained from ordering topically-
subjects who are harmed as a result of
applied medications.
participating in research must be ensured.
RESPONSIBILITIES OF THE NURSE TO THE PHYSICIAN
BASIC HUMAN RIGHTS OF RESEARCH SUBJECTS
- Provide nursing care through the utilization of
1. RIGHT TO INFORMED CONSENT
the nursing process. It is therefore expected that
2. THE RIGHT TO REFUSE AND/OR WITHDRAW
nurses will not only carry out doctor’s order but
FROM PARTICIPATION
help plan and implement patient care as well.
3. RIGHT TO PRIVACY
- Shall familiarize themselves with the various
4. RIGHT TO CONFIDENTIALITY OR ANONYMITY OF
routines, methods of physicians, so that smooth
DATA
relationships can me maintained.
5. RIGHT TO BE PROTECTED FROM HARM
- Shall remember that any medical act relegated to
them is illegal because it is specified in the
RISKS, BURDENS, BENEFITS
Medical Law that any licensed nurse who does
• Medical research involving human subjects may
this, even if supervised, can be held for illegal
only be conducted if the importance of the
practice of medicine.
objective outweighs the risks and burdens to the
research subjects.
RESPONSIBILITIES OF A NURSE TO OTHER COLLEAGUES
• Physicians may not be involved in a research - Shall adjust themselves to the organization and
study involving human subjects unless they are know its policies and procedures. They shall
establish good working relationships with co-
workers.
- It is important that nurses must know their place
in the total organization so that they may
cooperate, coordinate, and maximize their work.

RESPONSIBILITIES OF NURSES TO THEMSELVES


- Maintaining competence by continuous learning,
it is expected that every possible means shll be
utilized by them to develop their skills.
- Act in a manner that is worth emulation. Sincere
and compassionate attitude towards parienrs are
caught by those around them.

CONCLUSION
- Research in hjman subjects requires careful
ethical considerations. The declartion of Helsinki
is an important set of guidelines that inform
these reflections. It is the foundation for
scientific efforts the world over, protecting those
who nobly participate in medical research to
benefit not only the health of themselves but
also others who may be similarly afflicted. These
ethical principles and protections ensure
research is done in a way that ensures the best
possible outcomes for all.
St. Paul University Philippines RESEARCH
- Designates an activity designed to test an
NCM108 - Health Care Ethics
hypothesis, permit conclusions to be drawn, and
BELMONT REPORT
thereby to develop or contribute to generalizable
- Written by the National Commission for the
knowledge (expressed, for example, in theories,
Protection of Human Subjects of Biomedical and
principles, and statements of relationships).
Behavioral Research.
- It is usually described in a formal protocol that
- Developed from discussions at the Belmont
sets forth an objective and a set of procedures
Conference Center in February 1976 and four
designed to reach that objective.
years of monthly Commission deliberations.
- Identifies basic ethical principles and guidelines
The general rule is that if there is any element of research
that address ethical issues arising from the
in an activity, that activity should undergo review for the
conduct of reseearch with human subjects.
protection of human subjects.
- Priority: Welfare of clients/subjects.

NATIONAL RESEARCH (Pub. L. 93-348)


BASIC ETHICAL PRINCIPLES
- Enacted on July 12, 1974, establishing the
1) RESPECT FOR PERSON
National Commission for the Protection of
o Informed consent
Human Subjects of Biomedical and Behavioral
o Right for full disclosure
Research.
o Right for self-determination
- Commission was tasked with identifying ethical
o ETHICAL CONVICTIONS
principles and developing guidelines for
▪ Individuals should be treated as
biomedical and behavioral research involving
autonomous agents.
human subjects.
▪ Persons with diminished
- In carrying out the above, the Commission was
autonomy are entitled to
directed to consider:
protection.
o The boundaries between biomedical and
o SEPARATE MORAL REQUIREMENTS
behavioral research and the accepted
▪ Requirement to acknowledge
and routine practice of medicine.
autonomy.
o The role of assessment of risk-benefit
▪ Requirement to protect those
criteria in the determination of the
with diminished autonomy.
appropriateness of research involving
2) BENEFICENCE
human subjects.
o Do no harm
o Appropriate guidelines for the selection
o Risk-benefit assessment
of human subjects for participation in
- Persons are treated in an ethical manner not only
such research.
by respecting their decisions and protecting
o The nature and definition of informed
them from harm, but also by making efforts to
consent in various research settings.
secure their well-being.
- The term "beneficence" is often understood to
ETHICAL PRINCIPLES AND GUIDELINES FOR RESEARCH
cover acts of kindness or charity that go beyond
INVOLVING HUMAN SUBJECTS
strict obligation.
- Three principles, or general prescriptive
- In this document, beneficence is understood in a
judgments, that are relevant to research
stronger sense, as an obligation.
involving human subjects are identified in this
- GENERAL RULES
statement.
o Do no harm
- These three are comprehensive, however, and
o Maximize possible benefits and minimize
are stated at a level of generalization that should
possible harms (risk-benefit
assist scientists, subjects, reviewers and
assessments).
interested citizens to understand the ethical
issues inherent in research involving human
3) JUSTICE
subjects.
o Privacy/confidentiatlity
- These principles cannot always be applied so as
o Fair treatment
to resolve beyond dispute particular ethical
- There are several widely accepted formulations
problems.
of just ways to distribute burdens and benefits.
- The objective is to provide an analytical
Each formulation mentions some relevant
framework that will guide the resolution of
property on the basis of which burdens and
ethical problems arising from research involving
benefits should be distributed.
human subjects.
- These formulations are:
o To each person an equal share.
BOUNDARIES BETWEEN PRACTICE AND RESEARCH
o To each person according to individual
PRACTICE
need.
- Refers to interventions that are designed solely
o To each person according to individual
to enhance the well-being of an individual
effort.
patient or client and that have a reasonable
o To each person according to societal
expectation of success.
contribution.
- The purpose of medical or behavioral practice is
o To each person according to merit.
to provide diagnosis, preventive treatment or
therapy to particular individuals.
APPLICATION improper reward or other
INFORMED CONSENT overture in order to obtain
- Application of respect for persons. compliance.
- Respect for persons requires that subjects, to the
degree that they are capable, be given the ASSESSMENT OF RISKS AND BENEFITS
opportunity to choose what shall or shall not - Application of bemeficence.
happen to them. This opportunity is provided - Requires a careful arrayal of relevant data,
when adequate standards for informed consent including, in some cases, alternative ways of
are satisfied. obtaining the benefits sought in the research.
3 ELEMENTS OF INFORMED CONSENT 1) The Nature and Scope of Risks and Benefit
- Information o RISK - refers to a possibility that harm
o Items for disclosure intended to assure may occur
that subjects are given sufficient o BENEFIT - used in the research context to
information: the research procedure, refer to something of positive value
their purposes, risks and anticipated related to health or welfare.
benefits, alternative procedures (where o RISK-BENEFIT ASSESSMENTS -
therapy is involved), and a statement concerned with the probabilities and
offering the subject the opportunity to magnitudes of possible harm and
ask questions and to withdraw at any anticipated benefits.
time from the research. Additional items 2) The Systematic Assessment of Risks and
have been proposed, including how Benefits
subjects are selected, the person o It is commonly said that benefits and
responsible for the research, etc. risks must be "balanced" and shown to
o In all cases of research involving be "in a favorable ratio."
incomplete disclosure (some features o Assessment of the justifiability of
will not be revealed until the research is research should reflect at least the
concluded), such research is justified following considerations:
only if it is clear that: ▪ Brutal or inhumane treatment of
▪ Incomplete disclosure is truly human subjects is never morally
necessary to accomplish the justified
goals of the research ▪ Risks should be reduced to those
▪ There are no undisclosed risks to necessary to achieve the
subjects that are more than research objective.
minimal ▪ When research involves
▪ There is an adequate plan for significant risk of serious
debriefing subjects, when impairment, review committees
appropriate, and for should be extraordinarily
dissemination of research insistent on the justification of
results to them. the risk.
o Information about risks should never be ▪ When vulnerable populations
withheld for the purpose of eliciting the are involved in research, the
cooperation of subjects, and truthful appropriateness of involving
answers should always be given to direct them should itself be
questions about the research. demonstrated.
- Compensation ▪ Relevant risks and benefits must
o Manner manner and context in which be thoroughly arrayed in
information is conveyed is as important documents and procedures used
as the information itself. For example, in the informed consent process.
presenting information in a disorganized
and rapid fashion, allowing too little time SELECTION OF SUBJECTS
for consideration or curtailing - Application of justice.
opportunities for questioning, all may - Principle of justice gives rise to moral
adversely affect a subject's ability to requirements that there be fair procedures and
make an informed choice. outcomes in the selection of research subjects.
- Justice is relevant to the selection of subjects of
- Voluntariness research at two levels:
o An agreement to participate in research o Individual justice in the selection of
constitutes a valid consent only if subjects would require that researchers
voluntarily given. This element of exhibit fairness: thus, they should not
informed consent requires conditions offer potentially beneficial research only
free of: to some patients who are in their favor
▪ COERCION - occurs when an or select only "undesirable" persons for
overt threat of harm is risky research.
intentionally presented by one o Social justice requires that distinction be
person to another in order to drawn between classes of subjects that
obtain compliance. ought, and ought not, to participate in
▪ UNDUE INFLUENCE - occurs any particular kind of research, based on
through an offer of an excessive, the ability of members of that class to
unwarranted, inappropriate or bear burdens and on the
appropriateness of placing further
burdens on already burdened persons.

REFLECTIVE QUESTIONS
1) How does the Belmont Report influence your
understanding of research ethics and its
application?
2) What role does the concept of respect for
persons play in shaping ethical research
practices?
3) How does the principle of beneficence guide
researchers in conducting ethically responsible
research?
4) In what ways does the principle of justice
influence the selection of research subjects and
the distribution of research benefits?
5) Reflect on a situation where ethical
considerations outlined in the Belmont Report
might conflict. How would you address such a
conflict?
the participant's autonomy and decision-making
St. Paul University Philippines throughout the study.
NCM108 - Health Care Ethics
EXPERTISE OF THE INVESTIGATOR
NUMERG CODE
- Adequate preparations and facilities should be
- The NUREMBERG CODE in 1947 w a s t h e first
provided to protect participants against any
international code of ethics for the biomedical
potential harm. The experiment should be
research.
conducted by individuals with the necessary
- The Nuremberg Code is a set of ethical guidelines
skills and expertise.
and principles for conducting human
experimentation, established in response to the
NO EXPERIMENT WITHOUT ANTICIPATED RESULTS
unethical and inhumane medical experiments
- Experiments should be designed ot yield
conducted by Nazi physicians during World War
meaningful results, and researchers should have
II.
a reasonable expectation that the experiment wil
contribute valuable information.
NAZI HUMAN EXPERIMENTATION
- It is a series of medical experiments on prisoners
THE SUBJECT’S RIGHT TO END THE EXPERIMENT
by Nazi Germany in its concentration camps
- Participants should have the right to terminate
mainly between 1942 and 1945. There were
their involvement ni the experiment fi they reach
15,754 documented victims, of various
a point where continuation becomes impossible
nationalities and age groups. Many survived,
due to physical or mental reasons.
with only a quarter of documented victims killed.
Survivors generally experienced severe
SCIENTIST RESPONSIBILITY
permanent injuries.
- The scientist ni charge must be prepared to
- Thus, the Nuremberg Code was published later in
terminate the experiment at any stage fi there is
1947 and highlighted 10 ethicalprinciples,
probable cause to believe that continuing ti could
underscoring the importance of respecting
resultni injury, disability, or death to the
individual autonomy, minimizing harm, ensuring
participant.
scientific rigor, and prioritizing the well- being of
participants in any research involving human
subjects.
SIGNIFICANCE OF NUREMBERG CODE
- The Nuremberg Code is one of several
VOLUNTARY INFORMED CONSENT
foundational documents that influenced the
- Individuals must provide voluntary, informed,
principles of Good Clinical Practice (GCP).
and unambiguous consent before participating in
- God Clinical Practice si na atitude of excelence ni
any research. They should be fuly aware of the
research that provides astandard for study
nature, purpose, risks, and potential benefits of
design, implementation, conduct and analysis.
the study.
More than a single document, ti is a compilation
of many thoughts, ideas and lessons learned
YIELDING FRUITFUL RESULTS FOR SOCIETY
throughout the history of clinical research
- The research should aim to produce results for
worldwide.
the benefit of society that cannot be obtained
- Several other documents further expanded upon
through other means. The societal value of the
the principles outlined ni hte Nuremberg Code,
research should justify any potential risks to
including the Declaration of Helsinki, the
participants.
Belmont Report and the Common Rule.
- The goal has always been—and always will be—
AVOIDANCE OF UNNECESSARY SUFFERING
to conduct ethical clinical trials and protect
- The research should aim to produce results for
human subjects.
the benefit of society that cannot be obtained
through other means. The societal value of the
CONCLUSION
research should justify any potential risks to
- In any experiment/ research involving human
participants.
experiments, theresearchermustmakesure that
the individuals understand and consent to
NO ANTICIPATED DEATH OR DISABILITY
participate voluntarily.
- Researchers should not conduct experiments
- The outcome of the research should benefit the
where there is a priori reason to believe that
participants and researchersmustbe scientifically
death or disabling injury wil occur. The well-being
qualified.
of participants must be a top priority.
- Participants are free to withdraw any time during
the course of research, and researchers have the
QUALIFIED SCIENTISTS
obligation to stop the study as soon as they
- Scientifically qualified individuals should conduct
observe that continuation could b e fatal.
the experiments. Researchers should have the
expertise and qualifications necessary to carry
out the study safely and effectively.

FREEDOM TO WOTHDRAW
- Participants should have the freedom to
withdraw from the experiment at any time fi they
feel it is necessary. The researcher must respect
St. Paul University Philippines - However, in certain situations the risks of harm
may outweigh a nurse’s moral obligation or duty
NCM108 - Health Care Ethics
to care for a given patient.
ETHICO-MORAL OBLIGATIONS OF THE NURSE IN
EVIDENCE-BASED PRACTICES
ENSURING ETHICO-MODAL NURSING PRACTICE
MORALITY
- Organize an ethics committee or identify ethical
- Refers to “traditions or beliefs about right and
champions in everyday life. Develop ethics-
wrong conduct” and is influenced by social and
friendly policies and procedures.
cultural practices. It is what a person has been
- Provide continuing education and training in
taught within society and her or his own culture.
ethical decision making
ETHICS
- Promote open discussions among staff nurses
- Is “the study of social morality.” It is how a person
and managers regarding ethical patient care.
makes judgments between right and wrong.
BENEFITS OF EVIDENCE-BASED PRACTICE IN NURSING
WHAT IS EVIDENCE-BASED PRACTICE?
- Besides keeping health care practices relevant
- Evidenced-based practice (EBP) is applying or
and current, evidence-based practice in nursing
translating research findings in our daily patient
offers a range of other benefits to the nurse and
care practices and clinical decision-making.
the patients:
- EBP also involves integrating the best available
o Promotes positive patient outcomes
evidence with clinical knowledge and expertise,
o Reduces health care costs by preventing
while considering patients’ unique needs and
complications
personal preferences. If used consistently,
o Contributes to the growth of the science
optimal patient outcomes are more likely to be
of nursing
achieved.
o Allows for incorporation of new
- Using EBP means abandoning outdated care
technologies into health care practice
delivery practices and choosing effective,
Increases nurse autonomy and
scientifically validated methods to meet
confidence in decision-making
individual patient needs. Health care providers
o Ensures relevancy of nursing practice
who use EBP must be skilled at discerning the
with new interventions and care
value of research for their specific patient
protocols
population.
o Provides scientifically supported
research to help make well- informed
BEFORE THERE WAS EVIDENCE…
decisions
- As health care providers, delivery of patient care
o Fosters shared decision-making with
should stimulate questions about the evidence
patients in care planning Enhances
behind our daily practice.
critical thinking
- For instance, there was a time when neutropenic
o Encourages lifelong learning
patients were placed in strict isolation to protect
them from developing life-threatening
CONCLUSION
infections. Research findings were evaluated for
- When you use the principles of evidence-based
best evidence and it was noted that using strict
practice in nursing to make decisions about your
isolation precautions did not result in more
patient's care, it results in better outcomes,
favorable patient outcomes when compared to
higher satisfaction, and reduced costs.
proper handwashing procedures coupled with
Implementing this method promotes lifelong
standard precautions—and it seemed that we
learning and lets you strive for continuous quality
unnecessarily subjected patients to the negative
improvement in your clinical care and nursing
psychological effects caused by extreme
practice to achieve nursing excellence.
isolation.
- As clinicians, we sometimes follow outdated
THINK OUTSIDE THE BOX!
policies or practices without questioning their
- Consider the basic principles of ethics and
relevance, accuracy, or the evidence that
morality, what basic principle shapes your
supports their continued use.
decisions?
- How will your morals shape ethical decisions
ETHICO-MORAL RESPONSIBILITY OF NURSES
related to your nursing practice?
- The ethical principles that nurses must adhere
to:
o Justice
o Beneficence
o Nonmaleficence
o Accountability
o Fidelity
o Veracity
o Autonomy

MORAL OBLIGATION IN NURSING


- “The nurse’s primary commitment is to the
recipient of nursing and health care services...”
(ANA, 2015, p.5);
St. Paul University Philippines
NCM108 - Health Care Ethics
EVIDENCE-BASED PRACTICE
- Combination of scientific evidence, patient
preferences, and clinician expertise when
making decisions for patient care.
- It leads to the “development of best practices to
meet the need of clients efficiently and
effectively” (Carter, Mastro, Vose, Rivera, &
Larson, 2017)

ETHICAL CONCERNS ON EBP (ALLMARK, 2015)


- Some types of knowledge are not included in EB
o EBP downgrades or discounts types of
knowledge that are used by practitioners
and which are important for good
practice; these include experience,
intuition and anecdote (Barker 2000;
Bax 2008; Milton 2007; Tonelli 1998)
▪ A patient would be better served
- Levels of evidence in healthcare research can be
by an experienced practitioner
grouped into four categories according to how
rather than one well-versed in
credible the information is:
recent research evidence.
o Randomized controlled trials.
- EBP runs counter to patient-centered care
o Evidence from cohort, case-control, or
o By insisting that all practice is based on
observational studies.
up- to-date research evidence where it is
o Expert opinions that are supported by
available, patient-centered care, which
experience, studies, or reports.
requires case-specific knowledge and
o Personal experience.
intuition, is undermined.
- “Five A’s of evidence based practice” in health
o Patients lose choice.
science, these steps include:
▪ They are constrained to have
o Ask: Formulate answerable clinical
what the evidence tells them to,
questions about a patient, problem,
a phenomen on that has been
intervention, or outcome.
described as evidence-based
o Acquire: Search for relevant evidence to
paternalism (Rysavy 2013;
answer questions.
Slowther et al. 2004; Liberati
o Appraise: Determine whether or not the
2004).
evidence is high-quality and valuable.
- “Testable by RCT" is not the same as "most
o Apply: Make clinical decisions utilizing
effective}”
the best available evidence.
o EBP pyramid can lead practitioners to
o Assess: Evaluate the outcome of
prefer treatments that are testable by
applying the evidence to the patient’s
RCT but which may in fact be less
situation.
effective than others which are not.
o
- Equipoise
o The state in which the practice
community is genuinely unsure as to
whether one treatment is superiod to
another.
o It is considered to be an ethically
necessary condition prior to any
randomization.
- Decisions based on EBP can be unjust
o Preference for RCT-testable
interventions easily mutates into a
preference for funding such
interventions (Ashcroft & ter Meulen
2004; Vos et al. 2004; Kerridge et al.
1998; Jansen 1997; Hughes 1996; Hope
1995).
o Rare conditions are difficult to test via
RCTs as there are insufficient cases to run
a trial likely to reach statistical
significance.
o Other conditions are common but are
such that it is difficult to find funding to
run expensive RCTs of their treatment
because the conditions.

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