BIOETHICS AND ITS APPLICATION IN VARIOUS

HEALTH CARE SITUATIONS.

 ETHICAL DECISION-MAKING
PROCESS
The steps of the ethical decision -making process:

• Problem Definition
• Data Collection
• Data Analysis
• The Identification, Exploration and Generation of Possible Solutions to the Problem and the
Implications of Each
• Selecting the Best Possible Solution.
• Performing the Selected Desired Course of Action to Resolve the Ethical Dilemma
• Evaluating the Results of the Action.
 WEEK 3-4: UNIT LEARNING OUTCOMES
(ULO): AT THE END OF THE UNIT, YOU ARE EXPECTED TO:

• Explain terms such as evidence, evidence -based practice, good clinical practice.
• Explain principles of ethics in research.
• Discuss guidelines and protocol in documentation and health care records.
• Explain the importance of documentation in nursing.
 THE NUREMBERG CODE'S ETHICAL
GUIDELINES FOR RESEARCH

• The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation.
The 10 elements of the code are: 
1. Voluntary consent is essential
2. The results of any experiment must be for the greater good of society
3. Human experiments should be based on previous animal experimentation
4. Experiments should be conducted by avoiding physical/mental suffering and injury
5. No experiments should be conducted if it is believed to cause death/disability
6. The risks should never exceed the benefits
7. Adequate facilities should be used to protect subjects
8. Experiments should be conducted only by qualified scientists
9. Subjects should be able to end their participation at any time
10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur
 DECLARATION OF HELSINKI
1. The World Medical Association has developed the Declaration of Helsinki as a statement
of ethical principles to provide guidance to physicians and other participants in medical
research involving human subjects. Medical research involving human subjects includes
research on identifiable human material or identifiable data.
2. It is the duty of the physician to promote and safeguard the health of the people. The
physician’s knowledge and conscience are dedicated to the fulfillment of this duty.
3. The Declaration of Geneva of the World Medical Association binds the physician with the
words, ‘‘The health of my patient will be my first consideration,’’ and the International
Code of Medical Ethics declares that, ‘‘A physician shall act only in the patient’s interest
when providing medical care which might have the effect of weakening the physical and
mental condition of the patient.’’
 DECLARATION OF HELSINKI
4. Medical progress is based on research which ultimately must rest in part on
experimentation involving human subjects.
5. In medical research on human subjects, considerations related to the well-being of the human subject
should take precedence over the interests of science and society.
6. The primary purpose of medical research involving human subjects is to improve prophylactic,
diagnostic and therapeutic procedures and the understanding of the etiology and pathogenesis of disease.
Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged
through research for their effectiveness, efficiency, accessibility and quality.
7. In current medical practice and in medical research, most prophylactic,
diagnostic and therapeutic procedures involve risks and
burdens.
 DECLARATION OF HELSINKI
8. Medical research is subject to ethical standards that promote respect for all human
beings and protect their health and rights. Some research populations are vulnerable and need
special protection. The particular needs of the economically
and medically disadvantaged must be recognized. Special attention is also required for those who
cannot give or refuse consent for themselves, for those who may be subject to giving consent under
duress, for those who will not benefit personally from the research and for those for whom the research
is combined with care.
 
9. Research Investigators should be aware of the ethical, legal and regulatory requirements for research
on human subjects in their own countries as well as applicable international requirements. No national
ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections
for human subjects set forth in this Declaration.
 
 THE BELMONT REPORT
• Was issued in April 1979 by the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research.
• The Commission, created as a result of the National Research Act of
1974, was charged with identifying the basic ethical principles that
should underlie the conduct of biomedical and behavioral research
involving human subjects and developing guidelines to assure that such
research is conducted in accordance with those principles.
 THE BELMONT REPORT
The principles of this report are as follows:
1. Respect for Persons: This principle acknowledges the dignity and
freedom of every person. It requires obtaining informed consent from
research subjects (or their legally authorized representatives)
2. Beneficence: This principle requires that researchers maximize benefits
and minimize harms associated with research. Research-related risks
must be reasonable in light of the expected benefits.
3. Justice: This principle requires equitable selection and recruitment and
fair treatment of research subjects.
 DEFINITION OF TERMS:
Evidence – it is something that furnishes proof or testimony or something legally
submitted to ascertain in the truth of matter.
 
Evidenced based practice- it is systemic interconnecting of scientifically generated
evidence with the tacit knowledge of the expert practitioner to achieve a change
in a particular practice for the benefit of a well – defined client/ patient group (French 1999).
 
Evidenced based nursing-it is a process by which nurses make clinical decisions
using the best available research evidence, their clinical expertise and patient
preferences (Mulhall, 1998).
 ETHICAL ISSUES IN EVIDENCES BASED
PRACTICE

• EBP in nursing is an integration of research evidence, clinical expertise and a patient's

preferences. This problem-solving approach to clinical practice encourages nurses to provide
individualized patient care.
• EBP in nursing- is a way of providing nursing care that is guided by the integration of the
best available scientific knowledge with nursing expertise. This approach requires nurses to
critically assess relevant scientific data or research evidence and to implement high quality
interventions for their nursing practice (NLM PubMed).
 ETHICAL ISSUES IN EVIDENCES BASED
PRACTICE

• Need for EBP

• For making sure that each client get the best possible services
• Update knowledge ad is essential for lifelong learning
• Provide clinical judgement.
• Improvement care provided and save lives.
• Providing practicing nurse the evidence based data to deliver effective care.
• Resolve problem in clinical setting
• Achieve excellence in care delivery
• Reduces the variations in nursing care and assist with effeicient and affective decision making.
 NURSING ETHICAL CONSIDERATIONS
The Code of Ethics for Nurses is divided into nine provisions to guide the nurse.

1. The nurse practices with compassion and respect for the inherent dignity, worth, and unique
attributes of every person. 

2. The nurse’s primary commitment is to the patient, whether an individual, family, group,
community, or population.

3. The nurse promotes, advocates for, and protects the rights, health, and safety of the patient.

4. The nurse has authority, accountability, and responsibility for nursing practice; makes
decisions; and takes action consistent with the obligation to provide optimal patient care.
 NURSING ETHICAL CONSIDERATIONS
The Code of Ethics for Nurses is divided into nine provisions to guide the nurse.

5. The nurse owes the same duties to self as to others, including the responsibility to promote health and
safety, preserve wholeness of character and integrity, maintain competence, and continue personal and
professional growth.

6. The nurse, through individual and collective effort, establishes, maintains, and improves the ethical
environment of the work setting and conditions of employment that are conducive to safe, quality health
care.

7. The nurse, in all roles and settings, advances the profession through research and scholarly inquiry,
professional standards development, and the generation of both nursing and health policy.

8. The nurse collaborates with other health professionals and the public to protect human rights, promote
health diplomacy, and reduce health disparities. 

9. The profession of nursing, collectively through its professional organization, must articulate nursing
values, maintain the integrity of the profession, and integrate principles of social justice into nursing and
health policy.
 GOOD CLINICAL PRACTICE
(GCP)
• is an international ethical and scientific quality standard for the design, conduct,
performance, monitoring, auditing, recording, analyses and reporting of clinical trials.
• It also serves to protect the rights, integrity and confidentiality of trial subjects.
• GCP provides assurance that the data and reported results are credible and accurate, and that
the rights, integrity and confidentiality of trial subjects are respected and protected.
 GOOD CLINICAL PRACTICE
(GCP)
Principles:
 All clinical trials should be conducted in accordance with ethical principles, sound scientific
evidence and clear detailed protocols.
 The benefits of conducting trials should outweigh the risks.
 The rights, safety and well-being of trial participants are of paramount importance and these
should be preserved by obtaining informed consent and maintaining confidentiality.
 The care must be given by appropriately qualified personnel with adequate experience.
 Records should be easily accessible and retrievable for accurate reporting, verification and
interpretation.
 Investigational products should be manufactured according to Good Manufacturing Practice.
 IV. GUIDELINE AND PROTOCOL IN
DOCUMENATION AND HEALTH CARE
RECORDS
Standards and Guidelines:

• A patient’s medical record is the historical account of the patient/provider encounter and
serves as a legal document for use in legal proceedings.

• Good healthcare decision making is dependent upon a provider’s ability to retrieve accurate
and complete facts from the patient’s record.
 PROFESSIONAL DOCUMENTATION INCLUDES:

• Any and all forms of documentation by a clinician recorded in a professional capacity in

relation to the provision of patient care.
• This documentation may include:
 written and electronic health records,
 audio and video tapes,
 emails, facsimiles, images (photographs and diagrams),
 observation charts, check lists,
 communication books,
 shift/management reports,
 incident reports and clinical anecdotal notes or personal reflections (held by the clinicians personally or
any other type or form of documentation pertaining to the care provided.
 PURPOSE OF PROFESSIONAL DOCUMENTATION

• Communication

• Accountability

• Legislative requirements

• Quality improvement

• Research

• Funding and resource management

 GUIDING PRINCIPLES FOR DOCUMENTATION

1. Comprehensive and complete record

2. Patient centered and Collaborative

3. Ensure and maintain confidentiality

END OF SECOND EXAM TOPICS