Guevarra, Destine Brian Brantt October 27, 2024

BSN2 – Orlando

PRINCIPLES OF ETHICS.

Autonomy is defined by the right to self-determination and respects the individual’s right to make informed
decisions. Examples include:

 Employees viewed as valuable assets and part of the decision-making.

 Access to information about toxic exposures and their long-term consequences for
safe decision-making.
 Complete and full disclosure of work-related harm.
 Worker notification, right to know, informed consent regarding health screening
and surveillance activities.
 Privacy and confidentiality of health records and information.

Nonmaleficence is often referred to as the “no harm principle” that is inherent in professional standards,
licensure, and codes of ethics and with an obligation not to place employees at risk of harm without
protection. Examples include:
 Avoid placing workers in dangerous working conditions including technology with
unknown/uncertain risks.
 Do not offer hazard pay for dangerous work which may create bias for doing the
work.
 Aggressively address bullying, and physical and non-physical violence.
 Avoid placing an employee with known health considerations (e.g., pregnant
employee, known disability, asthma) into harmful exposure work conditions.
 Develop positive leadership and policy practices to prevent unsupportive work
organization behavior.
 Avoid creating too much stress where workers feel little or no control over the
work, and where workers have poor interpersonal relationships with supervisors
and co-workers, heavy workloads, long work hours, and poor wages.
Beneficence relates to mitigating or preventing harm and creating practices and environments that help
others achieve their maximum health potential. Examples include:
 Team walk-throughs to identify potential hazards and stress drivers and make
recommendations for hazard abatement.
 Health screenings that may identify early disease or disease interactive agents
(e.g., noise exposure and presbycusis or age-related hearing loss).
 Health protective programs like immunizations (e.g., influenza vaccine) or a back
injury prevention program.
 Management and workers’ obligations for an effective safety culture like safety
compliance and reporting unsafe practices and non-compliance.
Justice is directed toward treating employees equally and without discrimination with regards to their
health status, gender, ethnicity, social aspects, and the like. Examples include:
  Non-punitive environment for incident/error reporting to improve work practice
(hiring/firing practices).
 Balancing costs and benefits and divided loyalties.
 Not singling out workers or work groups to perform unpleasant or hazardous
duties.

NUREMBERG CODE
The Nuremberg Military Tribunal’s decision in the case of the United States v Karl Brandt et al. includes
what is now called the Nuremberg Code, a ten point statement delimiting permissible medical
experimentation on human subjects. According to this statement, humane experimentation is justified only if
its results benefit society and it is carried out in accord with basic principles that “satisfy moral, ethical, and
legal concepts.”
—“Permissible Medical Experiments.” Trials of War Criminals before the Nuremberg Military Tribunals
under Control Council Law No. 10. Nuremberg October 1946 – April 1949, Washington. U.S. Government
Printing Office (n.d.), vol. 2., pp. 181-182.
1. The voluntary consent of the human subject is absolutely essential. This means that the person
involved should have legal capacity to give consent; should be situated as to be able to exercise
free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-
reaching, or other ulterior form of constraint or coercion, and should have sufficient knowledge and
comprehension of the elements of the subject matter involved as to enable him to make an
understanding and enlightened decision. This latter element requires that before the acceptance of
an affirmative decision by the experimental subject there should be made known to him the nature,
duration, and purpose of the experiment; the method and means by which it is to be conducted; all
inconveniences and hazards reasonably to be expected; and the effects upon his health or person
which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual
who initiates, directs or engages in the experiment. It is a personal duty and responsibility which
may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by
other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a
knowledge of the natural history of the disease or other problem under study that the anticipated
results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering
and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or
disabling injury will occur; except, perhaps, in those experiments where the experimental
physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the problem to be solved by the experiment.
 7. Proper preparations should be made and adequate facilities provided to protect the experimental
subject against even remote possibilities of injury disability or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of
skill and care should be required through all stages of the experiment of those who conduct or
engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment
to an end if he has reached the physical or mental state where continuation of the experiment
seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the
experiment at any stage, if he has probable cause to believe, in the exercise of the good faith,
superior skill and careful judgement required by him that a continuation of the experiment is likely
to result in injury, disability, or death to the experimental subject.

DECLARATION OF HELSINKI
PREAMBLE
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of
ethical principles for medical research involving human participants, including research using
identifiable human material or data.
The Declaration is intended to be read as a whole, and each of its constituent paragraphs should
be applied with consideration of all other relevant paragraphs.
2. While the Declaration is adopted by physicians, the WMA holds that these principles should be
upheld by all individuals, teams, and organizations involved in medical research, as these
principles are fundamental to respect for and protection of all research participants, including both
patients and healthy volunteers.

GENERAL PRINCIPLES
3. The WMA Declaration of Geneva binds the physician with the words, “The health and well-being of
my patient will be my first consideration,” and the WMA International Code of Medical Ethics
declares “The physician must commit to the primacy of patient health and well-being and must offer
care in the patient’s best interest.”
4. It is the duty of the physician to promote and safeguard the health, well-being and rights of
patients, including those who are involved in medical research. The physician’s knowledge and
conscience are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include participants.
Even well-proven interventions should be evaluated continually through research for their safety,
effectiveness, efficiency, accessibility, and quality.
6. Medical research involving human participants is subject to ethical standards that promote and
ensure respect for all participants and protect their health and rights.
Since medical research takes place in the context of various structural inequities, researchers
should carefully consider how the benefits, risks, and burdens are distributed.
Meaningful engagement with potential and enrolled participants and their communities should
occur before, during, and following medical research. Researchers should enable potential and
enrolled participants and their communities to share their priorities and values; to participate in
research design, implementation, and other relevant activities; and to engage in understanding and
disseminating results.
7. The primary purpose of medical research involving human participants is to generate knowledge to
understand the causes, development and effects of diseases; improve preventive, diagnostic and
therapeutic interventions; and ultimately to advance individual and public health.
These purposes can never take precedence over the rights and interests of individual research
participants.
8. While new knowledge and interventions may be urgently needed during public health emergencies,
it remains essential to uphold the ethical principles in this Declaration during such emergencies.
9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity,
integrity, autonomy, privacy, and confidentiality of personal information of research participants.
The responsibility for the protection of research participants must always rest with physicians or
other researchers and never with the research participants, even though they have given consent.
10. Physicians and other researchers must consider the ethical, legal and regulatory norms and
standards for research involving human participants in the country or countries in which the
research originated and where it is to be performed, as well as applicable international norms and
standards. No national or international ethical, legal or regulatory requirement should reduce or
eliminate any of the protections for research participants set forth in this Declaration.
11. Medical research should be designed and conducted in a manner that avoids or minimizes harm to
the environment and strives for environmental sustainability.
12. Medical research involving human participants must be conducted only by individuals with the
appropriate ethics and scientific education, training and qualifications. Such research requires the
supervision of a competent and appropriately qualified physician or other researcher.
Scientific integrity is essential in the conduct of medical research involving human participants.
Involved individuals, teams, and organizations must never engage in research misconduct.
13. Groups that are underrepresented in medical research should be provided appropriate access to
participation in research.
14. Physicians who combine medical research with medical care should involve their patients in
research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic
value and if the physician has good reason to believe that participation in the research will not
adversely affect the health of the patients who serve as research participants.
 15. Appropriate compensation and treatment for participants who are harmed as a result of
participating in research must be ensured.
Risks, Burdens, and Benefits
16. In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human participants may only be conducted if the importance of the
objective outweighs the risks and burdens to the research participants.
17. All medical research involving human participants must be preceded by careful assessment of
predictable risks and burdens to the individuals and groups involved in the research in comparison
with foreseeable benefits to them and to other individuals or groups affected by the condition under
investigation.
Measures to minimize the risks and burdens must be implemented. The risks and burdens must be
continuously monitored, assessed, and documented by the researcher.
18. Physicians and other researchers may not engage in research involving human participants unless
they are confident that the risks and burdens have been adequately assessed and can be
satisfactorily managed.
When the risks and burdens are found to outweigh the potential benefits or when there is
conclusive proof of definitive outcomes, physicians and other researchers must assess whether to
continue, modify or immediately stop the research.
Individual, Group, and Community Vulnerability
19. Some individuals, groups, and communities are in a situation of more vulnerability as research
participants due to factors that may be fixed or contextual and dynamic, and thus are at greater risk
of being wronged or incurring harm. When such individuals, groups, and communities have
distinctive health needs, their exclusion from medical research can potentially perpetuate or
exacerbate their disparities. Therefore, the harms of exclusion must be considered and weighed
against the harms of inclusion. In order to be fairly and responsibly included in research, they
should receive specifically considered support and protections.
20. Medical research with individuals, groups, or communities in situations of particular vulnerability is
only justified if it is responsive to their health needs and priorities and the individual, group, or
community stands to benefit from the resulting knowledge, practices, or interventions. Researchers
should only include those in situations of particular vulnerability when the research cannot be
carried out in a less vulnerable group or community, or when excluding them would perpetuate or
exacerbate their disparities.
Scientific Requirements and Research Protocols
21. Medical research involving human participants must have a scientifically sound and rigorous
design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid
research waste. The research must conform to generally accepted scientific principles, be based
on a thorough knowledge of the scientific literature, other relevant sources of information, and
adequate laboratory and, as appropriate, animal experimentation.
The welfare of animals used for research must be respected.
 22. The design and performance of all medical research involving human participants must be clearly
described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and should indicate
how the principles in this Declaration have been addressed. The protocol should include
information regarding aims, methods, anticipated benefits and potential risks and burdens,
qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to
protect privacy and confidentiality, incentives for participants, provisions for treating and/or
compensating participants who are harmed as a consequence of participation, and any other
relevant aspects of the research.
In clinical trials, the protocol must also describe any post-trial provisions.
Research Ethics Committees
23. The protocol must be submitted for consideration, comment, guidance, and approval to the
concerned research ethics committee before the research begins. This committee must be
transparent in its functioning and must have the independence and authority to resist undue
influence from the researcher, the sponsor, or others. The committee must have sufficient
resources to fulfill its duties, and its members and staff must collectively have adequate education,
training, qualifications, and diversity to effectively evaluate each type of research it reviews.
The committee must have sufficient familiarity with local circumstances and context, and include at
least one member of the general public. It must take into consideration the ethical, legal, and
regulatory norms and standards of the country or countries in which the research is to be
performed as well as applicable international norms and standards, but these must not be allowed
to reduce or eliminate any of the protections for research participants set forth in this Declaration.
When collaborative research is performed internationally, the research protocol must be approved
by research ethics committees in both the sponsoring and host countries.
The committee must have the right to monitor, recommend changes to, withdraw approval for, and
suspend ongoing research. Where monitoring is required, the researcher must provide information
to the committee and/or competent data and safety monitoring entity, especially about any serious
adverse events. No amendment to the protocol may be made without consideration and approval
by the committee. After the end of the research, the researchers must submit a final report to the
committee containing a summary of the findings and conclusions.
Privacy and Confidentiality
24. Every precaution must be taken to protect the privacy of research participants and the
confidentiality of their personal information.
Free and Informed Consent
25. Free and informed consent is an essential component of respect for individual autonomy.
Participation by individuals capable of giving informed consent in medical research must be
voluntary. Although it may be appropriate to consult family members or community representatives,
individuals capable of giving informed consent may not be enrolled in research unless they freely
agree.
26. In medical research involving human participants capable of giving informed consent, each
potential participant must be adequately informed in plain language of the aims, methods,
anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of
funding, any potential conflicts of interest, provisions to protect privacy and confidentiality,
incentives for participants, provisions for treating and/or compensating participants who are
harmed as a consequence of participation, and any other relevant aspects of the research.
The potential participant must be informed of the right to refuse to participate in the research or to
withdraw consent to participate at any time without reprisal. Special attention should be given to
the specific information and communication needs of individual potential participants as well as to
the methods used to deliver the information.
After ensuring that the potential participant has understood the information, the physician or
another qualified individual must then seek the potential participant’s freely given informed consent,
formally documented on paper or electronically. If the consent cannot be expressed on paper or
electronically, the non-written consent must be formally witnessed and documented.
All medical research participants should be given the option of being informed about the general
outcome and results of the research.
27. When seeking informed consent for participation in research the physician or other researcher
must be particularly cautious if the potential participant is in a dependent relationship with them or
may consent under duress. In such situations, the informed consent must be sought by an
appropriately qualified individual who is independent of this relationship.
28. In medical research involving human participants incapable of giving free and informed consent,
the physician or other qualified individual must seek informed consent from the legally authorized
representative, considering preferences and values expressed by the potential participant.
Those persons incapable of giving free and informed consent are in situations of particular
vulnerability and are entitled to the corresponding safeguards. In addition to receiving the
protections for the particularly vulnerable, those incapable of giving consent must only be included
if the research is likely to either personally benefit them or if it entails only minimal risk and minimal
burden.
29. When a potential research participant who is incapable of giving free and informed consent is able
to give assent to decisions about participation in research, the physician or other qualified
individual must seek that assent in addition to the consent of the legally authorized representative,
considering any preferences and values expressed by the potential participant. The potential
participant’s dissent should be respected.
30. Research involving participants who are physically or mentally incapable of giving consent (for
example, unconscious patients) may be done only if the physical or mental condition that prevents
giving informed consent is a necessary characteristic of the research group. In such circumstances
the physician or other qualified individual must seek informed consent from the legally authorized
representative. If no such representative is available and if the research cannot be delayed, the
research may proceed without informed consent provided that the specific reasons for involving
participants with a condition that renders them unable to give informed consent have been stated in
the research protocol and the research has been approved by a research ethics committee.
 Free and informed consent to remain in the research must be obtained as soon as possible from a
legally authorized representative or, if they regain capacity to give consent, from the participant.
31. The physician or other researcher must fully inform potential participants which aspects of their
care are related to the research. The refusal of a patient to participate in research or the patient’s
decision to withdraw from research must never adversely affect the patient-physician relationship
or provision of the standard of care.
32. Physicians or other qualified individuals must obtain free and informed consent from research
participants for the collection, processing, storage, and foreseeable secondary use of biological
material and identifiable or re-identifiable data. Any collection and storage of data or biological
material from research participants for multiple and indefinite uses should be consistent with
requirements set forth in the WMA Declaration of Taipei, including the rights of individuals and the
principles of governance. A research ethics committee must approve the establishment and
monitor ongoing use of such databases and biobanks.
Where consent is impossible or impracticable to obtain, secondary research on stored data or biological
material may be done only after consideration and approval of a research ethics committee.
Use of Placebo
33. The benefits, risks, burdens, and effectiveness of a new intervention must be tested against those
of the best proven intervention(s), except in the following circumstances:
 If no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
 If for compelling and scientifically sound methodological reasons the use of any intervention other
than the best proven one(s), the use of placebo, or no intervention is necessary to determine the
efficacy or safety of an intervention; and the participants who receive any intervention other than
the best proven one(s), placebo, or no intervention will not be subject to additional risks of serious
or irreversible harm as a result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.
Post-Trial Provisions
34. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to
be provided by themselves, healthcare systems, or governments for all participants who still need
an intervention identified as beneficial and reasonably safe in the trial. Exceptions to this
requirement must be approved by a research ethics committee. Specific information about post-
trial provisions must be disclosed to participants as part of informed consent.
Research Registration, Publication, and Dissemination of Results
35. Medical research involving human participants must be registered in a publicly accessible
database before recruitment of the first participant.
36. Researchers, authors, sponsors, editors, and publishers all have ethical obligations with regard to
the publication and dissemination of the results of research. Researchers have a duty to make
publicly available the results of their research on human participants and are accountable for the
timeliness, completeness, and accuracy of their reports. All parties should adhere to accepted
guidelines for ethical reporting. Negative and inconclusive as well as positive results must be
 published or otherwise made publicly available. Sources of funding, institutional affiliations, and
conflicts of interest must be declared in the publication. Reports of research not in accordance with
the principles of this Declaration should not be accepted for publication.
Unproven Interventions in Clinical Practice
37. When an unproven intervention is utilized in an attempt to restore health or alleviate suffering for
an individual patient because approved options are inadequate or ineffective and enrollment in a
clinical trial is not possible, it should subsequently be made the object of research designed to
evaluate safety and efficacy. Physicians participating in such interventions must first seek expert
advice, weigh possible risks, burdens, and benefits, and obtain informed consent. They must also
record and share data when appropriate and avoid compromising clinical trials. These interventions
must never be undertaken to circumvent the protections for research participants set forth in this
Declaration.

THE BELMONT REPORT

Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The Belmont Report was written 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. Informed by monthly discussions that
spanned nearly four years and an intensive four days of deliberation in 1976, the Commission published
the Belmont Report, which identifies basic ethical principles and guidelines that address ethical issues
arising from the conduct of research with human subjects.

ETHICO-MORAL OBLIGATIONS OF A NURSE IN EVIDENCE-BASED (EBP) PRACTICE

Nurses are advocates for patients and must find a balance while delivering patient care. There are four
main principles of ethics: autonomy, beneficence, justice, and non-maleficence. Each patient has the right
to make their own decisions based on their own beliefs and values.[4]. This is known as autonomy.

GOOD CLINICAL PRACTICE GUIDELINES

Good clinical practice (GCP) guidelines are an internationally recognized standard for clinical trials that
include ethical and quality requirements that must be adhered to for any clinical trial that involves people. It
specifies good clinical practice guidelines for all aspects of a study, from trial documentation and protocol
amendments to reporting lines for adverse events and medical care available for participants in trials
testing pharmaceuticals for human use.
The good clinical practice guidelines provide detailed standards for all facets of clinical trials, including:
 Design
 Conduct
 Performance
 Monitoring
 Auditing
 Documentation
 Analysis
 Reporting
 Termination