MARIANO MARCOS STATE UNIVERSITY

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CHAPTER 6
BIOETHICS AND RESEARCH

“When people are invited to participate in research, there is a strong belief that it should be
their choice based on their understanding of what the study is about, and what the risks and
benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of
Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health.
However, it is important to remember the individuals who volunteer to participate in research.
There are precautions researchers can take – in the planning, implementation and follow-up of
studies – to protect these participants in research. Ethical guidelines are established for clinical
research to protect patient volunteers and to preserve the integrity of the science.

The following lessons will be discussed within the

chapter: Lesson 1. Principles of Ethics in Research

Lesson 2. Ethical Issues in Evidenced Based Practice
Lesson 3. Ethico-Moral Obligations of the Nurse in Evidence Based Practices

LESSON 1. PRINCIPLES OF ETHICS IN RESEARCH

LEARNING OUTCOMES:
Upon completion of this chapter and with further self-directed learning you must have:
Explained comprehensively the principles of ethics in research
Identified well the Nuremberg Code, Declaration of Helsinki and Belmont Report

WARM-UP ACTIVITY:
For a short period of time, take time to internalize and answer these questions:
1. What do you think is the importance of ethics in research?
2. What fundamental principles are applied in researches?

After answering these questions, you try to discuss your insights with your classmates
for a while before starting the learning inputs.

LEARNING INPUTS:
Research is defined as an activity that inquire into a particular subject with the aim to contribute
to generalizable knowledge (theories, principles and relationships) or any accumulation of
information using scientific methods, observation, inference and analysis.

The scope of health research in human entails any social science, biomedical or epidemiologic
activity that entails systematic collection or analysis of data with the intent to generate new
knowledge in which human beings are exposed to manipulation, intervention, observation or other
interaction with investigators either directly or through alteration of their environment or become
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individually identifiable through investigator’s collection, preparation, or use of biological material or
medical or other records. (WHO, 2019)

Ethics in Research is a framework applying broad ethical principles to the responsible conduct of
research and to the use of any outcomes resulting from research. Ethical norms serve the aims or
goals of research and apply to people who conduct scientific research or other scholarly or creative
activities. Here are several reasons why it is important to adhere to ethical norms in research.
1. First, norms promote the aims of research, such as knowledge, truth, and avoidance of error.
2. Second, since research often involves a great deal of cooperation and coordination among
many different people in different disciplines and institutions, ethical standards promote the
values that are essential to collaborative work, such as trust, accountability, mutual
respect, and fairness.
3. Third, many of the ethical norms help to ensure that researchers can be held accountable to
the public.
4. Fourth, ethical norms in research also help to build public support for research.
5. Finally, many of the norms of research promote a variety of other important moral and
social values, such as social responsibility, human rights, animal welfare, compliance with
the law, and public health and safety.

The Researcher
• The vigilant conscientious researcher has ultimate responsibility and accountability for the
ethical soundness of the research.
• In conducting clinical investigation, the investigator should demonstrate the same concern
and caution for the welfare, safety, and comfort of the person involved as is required of a
physician who is furnishing medical care to a patient independent of any clinical
investigation

Research ethics are based on three fundamental principles:

1. Respect for Persons
- This principle incorporates two elements that deal with respecting people in
regard to research:
a. People should be treated as autonomous

b. People with diminished autonomy should be protected

o respecting their privacy and keeping their private
information confidential
o respecting their right to change their mind, to decide that
the research does not match their interests, and to
withdraw without a penalty
o informing them of new information that might emerge in
the course of research, which might change their
assessment of the risks and benefits of participating
o monitoring their welfare and, if they experience adverse
reactions, unexpected effects, or changes in clinical
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status,

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ensuring appropriate treatment and, when necessary,
removal from the study
o informing them about what was learned from the research

2. Beneficence
- The definition of beneficence is action that is done for the benefit of others.
This principle states that research should:
a. Do no harm
b. Maximize benefits for participants and minimize risks for participants

3. Justice
- This principle deals with the concept of fairness.
- Researchers designing trials should consider what is fair in terms of
recruitment of participants and choice of location to conduct a trial.
- People who are included in research should not be included merely because
they are a population that is easy to access, available, or perhaps vulnerable
and less able to decline participating.
- An experimental strategy that is likely to be used by many types of people
should be tested in the very populations of people who are likely to use it, to
ensure that it is safe, effective, and acceptable for all of the potential users.
- The principle of justice also indicates that questions being asked in trials
should be of relevance to the communities participating in the study.

Nuremberg Code
- The Nuremberg Code was introduced in August 1947, after the Nuremberg trials. In
these trials, Nazi doctors were convicted of the crimes committed during human
experiments on concentration camp prisoners. It attempted to give clear rules about
what was legal and what was not when conducting human experiments.
- The code also gives rules for running the experiments.

The Nuremberg Code aimed to protect human subjects from enduring the kind of
cruelty and exploitation the prisoners endured at concentration camps. 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
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Declaration of Helsinki
- 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.
- Although the Declaration is addressed primarily to physicians, the WMA encourages
other participants in medical research involving human subjects to adopt these
principles.

Human subject
 is any living person that a researcher obtains data from, including data
obtained through interacting with the person and identifiable information
about the person or their opinion.

Principles for All Medical Research

1. It is the duty of physicians who participate in medical research to protect the life,
health, dignity, integrity, right to self-determination, privacy, and confidentiality of
personal information of research subjects.
2. Medical research involving human subjects 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.
3. Appropriate caution must be exercised in the conduct of medical research that may
harm the environment.
4. The design and performance of each research study involving human subjects must be
clearly described 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
funding, sponsors, institutional affiliations, other potential conflicts of interest,
incentives for subjects and provisions for treating and/or compensating subjects who
are harmed as a consequence of participation in the research study. The protocol
should describe arrangements for post-study access by study subjects to interventions
identified as beneficial in the study or access to other appropriate care or benefits.
5. The research protocol must be submitted for consideration, comment, guidance and
approval to a research ethics committee before the study begins. This committee must
be independent of the researcher, the sponsor and any other undue influence. It must
take into consideration the laws and regulations 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 subjects set forth in this Declaration. The committee must have the right
to monitor ongoing studies. The researcher must provide monitoring information to
the committee, especially information about any serious adverse events. No change to
the protocol may be made without consideration and approval by the committee.

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6. Medical research involving human subjects must be conducted only by individuals
with the appropriate scientific training and qualifications. Research on patients or
healthy volunteers requires the supervision of a competent and appropriately
qualified physician or other health care professional. The responsibility for the
protection of research subjects must always rest with the physician or other health
care professional and never the research subjects, even though they have given
consent.
7. Medical research involving a disadvantaged or vulnerable population or community is
only justified if the research is responsive to the health needs and priorities of this
population or community and if there is a reasonable likelihood that this population or
community stands to benefit from the results of the research.
8. Every medical research study involving human subjects must be preceded by careful
assessment of predictable risks and burdens to the individuals and communities
involved in the research in comparison with foreseeable benefits to them and to other
individuals or communities affected by the condition under investigation.
9. Every clinical trial must be registered in a publicly accessible database before
recruitment of the first subject.
10. Physicians may not participate in a research study involving human subjects unless
they are confident that the risks involved have been adequately assessed and can be
satisfactorily managed. Physicians must immediately stop a study when the risks are
found to outweigh the potential benefits or when there is conclusive proof of positive
and beneficial results.
11. Medical research involving human subjects may only be conducted if the importance
of the objective outweighs the inherent risks and burdens to the research subjects.
12. Participation by competent individuals as subjects in medical research must be
voluntary. Although it may be appropriate to consult family members or community
leaders, no competent individual may be enrolled in a research study unless he or she
freely agrees.
13. Every precaution must be taken to protect the privacy of research subjects and the
confidentiality of their personal information and to minimize the impact of the study
on their physical, mental and social integrity.
14. In medical research involving competent human subjects, each potential subject must
be adequately informed of the aims, methods, sources of funding, any possible
conflicts of interest, institutional affiliations of the researcher, the anticipated benefits
and potential risks of the study and the discomfort it may entail, and any other
relevant aspects of the study. The potential subject must be informed of the right to
refuse to participate in the study or to withdraw consent to participate at any time
without reprisal. Special attention should be given to the specific information needs of
individual potential subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the
physician or another appropriately qualified individual must then seek the potential
subject’s freely- given informed consent, preferably in writing. If the consent cannot
be expressed in writing, the non-written consent must be formally documented and
witnessed.
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15. For medical research using identifiable human material or data, physicians must
normally seek consent for the collection, analysis, storage and/or reuse. There may be

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situations where consent would be impossible or impractical to obtain for such
research or would pose a threat to the validity of the research. In such situations the
research may be done only after consideration and approval of a research ethics
committee.
16. When seeking informed consent for participation in a research study the physician
should be particularly cautious if the potential subject is in a dependent relationship
with the physician or may consent under duress. In such situations the informed
consent should be sought by an appropriately qualified individual who is completely
independent of this relationship.
17. For a potential research subject who is incompetent, the physician must seek
informed consent from the legally authorized representative. These individuals must
not be included in a research study that has no likelihood of benefit for them unless it
is intended to promote the health of the population represented by the potential
subject, the research cannot instead be performed with competent persons, and the
research entails only minimal risk and minimal burden.
18. When a potential research subject who is deemed incompetent is able to give assent
to decisions about participation in research, the physician must seek that assent in
addition to the consent of the legally authorized representative. The potential
subject’s dissent should be respected.
19. Research involving subjects 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 population. In such circumstances the physician should seek informed
consent from the legally authorized representative. If no such representative is
available and if the research cannot be delayed, the study may proceed without
informed consent provided that the specific reasons for involving subjects with a
condition that renders them unable to give informed consent have been stated in the
research protocol and the study has been approved by a research ethics committee.
Consent to remain in the research should be obtained as soon as possible from the
subject or a legally authorized representative.
20. Authors, editors and publishers all have ethical obligations with regard to the
publication of the results of research. Authors have a duty to make publicly available
the results of their research on human subjects and are accountable for the
completeness and accuracy of their reports. They should adhere to accepted
guidelines for ethical reporting. Negative and inconclusive as well as positive results
should be published or otherwise made publicly available. Sources of funding,
institutional affiliations and conflicts of interest should be declared in the publication.
Reports of research not in accordance with the principles of this Declaration should
not be accepted for publication.

Additional Principles for Medical Research Combined with Medical Care

1. The physician may combine medical research with medical care only to the extent that
the research is justified by its potential preventive, diagnostic or therapeutic value and
if the physician has good reason to believe that participation in the research study will
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not adversely affect the health of the patients who serve as research subjects.

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2. The benefits, risks, burdens and effectiveness of a new intervention must be tested
against those of the best current proven intervention, except in the following
circumstances:
 The use of placebo, or no treatment, is acceptable in studies where no current
proven intervention exists; or
 Where for compelling and scientifically sound methodological reasons the use
of placebo is necessary to determine the efficacy or safety of an intervention
and the patients who receive placebo or no treatment will not be subject to
any risk of serious or irreversible harm. Extreme care must be taken to avoid
abuse of this option.
3. At the conclusion of the study, patients entered into the study are entitled to be
informed about the outcome of the study and to share any benefits that result from it,
for example, access to interventions identified as beneficial in the study or to other
appropriate care or benefits.
4. The physician must fully inform the patient which aspects of the care are related to
the research. The refusal of a patient to participate in a study or the patient’s decision
to withdraw from the study must never interfere with the patient-physician
relationship.
5. In the treatment of a patient, where proven interventions do not exist or have been
ineffective, the physician, after seeking expert advice, with informed consent from the
patient or a legally authorized representative, may use an unproven intervention if in
the physician's judgement it offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, this intervention should be made the object of
research, designed to evaluate its safety and efficacy. In all cases, new information
should be recorded and, where appropriate, made publicly available.

Declaration of Helsinki:
Basic Principles
1. Conform to accepted scientific principles.
2. Design formulated in experimental protocol, reviewed by IEC.
3. Conducted by qualified and trained persons.
4. Importance in proportion to inherent risk.
5. Assessment of risks vs. benefits.
6. Safeguard subject’s integrity (privacy).
7. Abstain unless hazards are predictable.
8. Preserve accuracy when publishing.
9. Adequately inform or right to withdraw.
10. Obtain true informed consent in writing.
11. Reliance on legal guardian.
12. State compliance with Declaration.

Belmont Report

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- was written by the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research.

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o 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.
- which identifies basic ethical principles and guidelines that address ethical issues
arising from the conduct of research with human subjects.

The Belmont Report also serves as an ethical framework for research. There are 3
major components: (1) respect for persons, (2) beneficence, and (3) justice.

1. Respect for Persons.

- Respect for persons incorporates at least two ethical convictions:
a. first, that individuals should be treated as autonomous agents
b. second, that persons with diminished autonomy are entitled to
protection.
- The principle of respect for persons thus divides into two separate moral
requirements:
a. the requirement to acknowledge autonomy
b. the requirement to protect those with diminished autonomy

2. Beneficence
- Persons are treated in an ethical manner not only by respecting their
decisions and protecting them from harm, but also by making efforts to
secure their well-being.
- beneficence is understood in a stronger sense, as an obligation.
- Two general rules have been formulated as complementary expressions of
beneficent actions in this sense:
(1) do not harm, and
(2) maximize possible benefits and minimize possible harms
- The principle of beneficence often occupies a well-defined justifying role in
many areas of research involving human subjects.

3. Justice
- Who ought to receive the benefits of research and bear its burdens? This is a
question of justice, in the sense of "fairness in distribution" or "what is
deserved."
- An injustice occurs when some benefit to which a person is entitled is denied
without good reason or when some burden is imposed unduly.
- Another way of conceiving the principle of justice is that equals ought to be
treated equally.
- There are several widely accepted formulations of just ways to distribute
burdens and benefits. Each formulation mentions some relevant property on

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the basis of which burdens and benefits should be distributed. These
formulations are:
(1) to each person an equal share
(2) to each person according to individual need
(3) to each person according to individual effort
(4) to each person according to societal contribution, and
(5) to each person according to merit

WARP-UP ACTIVITY: After knowing all of the essential principles of ethics in research, how do you
integrate these principles in conducting researches?

POST-ASSESSMENT: Your instructor thru MVLE will give a summative test on the lessons of the
chapter. Please wait for further instructions. Good luck!

REFERENCE:

Cannon, S. & Delahoyde, T. 2017. Ethics for Nursing Research and Evidence-Based Practice.
Jones & Bartlett Learning, LLC.
Scott, P. Anne 2017. Key Concepts and Issues in Nursing Ethics. Springer International
Publishing.
https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm

LESSON 2. ETHICAL ISSUES IN EVIDENCED BASED PRACTICE

INTRODUCTION:
Evidence-based practice is rooted in medicine but has quickly been embraced by the entire
health care community. As defined by leading authorities (Sackett, Rosenberg, Gray, Haynes, &
Richard-son, 1996), evidence-based practice is “the conscientious, explicit, and judicious use of
current best evidence in making decisions about the care of individual patients” (p. 71). As Holm
(2000)noted, the process of evidence-based practice involves being aware of the various levels of
existing evidence underlying a given intervention approach and carefully appraising that evidence as
it applies to a specific patient encounter. Typically, the method involves carefully formulating a
clinical question, finding evidence that bears on the question, and evaluating the evidence without
bias and applying it as appropriate to a given patient (Tickle-Degnen, 1999).

Implementing the process of evidence-based practice has implications for resource use, for
professional credibility, and for improving outcomes. These worthwhile benefits are often
emphasized without sufficient attention to the underlying ethical principles involved. One can argue
that the primary reason for implementing evidence-based practice is a moral one. Professional
caregivers are responsible for practicing in a manner that keeps the patient’s interest foremost by
achieving the greatest good and avoiding harm in the process. In their pledges to practice ethically,
professionals already commit to making decisions that are right for a given patient at a given time.
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Rogers (1983)

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stated it thusly, “The ultimate question we, as clinicians, are challenged to answer is: What, among
the many things that could be done for this patient, ought to be done? This is an ethical question”
(p. 602).
Given the widespread and growing interest in evidence-based practice, it might appear to an
outside observer as though the health care community had just realized that the careful and
objective examination of evidence provides a sounder basis for making decisions than tradition,
conjecture, or authority. However, although a professional’s obligation to stay fully informed has
existed for centuries, only recently has a practical means for doing so (e.g., the personal computer,
the World Wide Web) created the environment of expectation and accountability necessary to drive
the evidence-based practice movement to its current level of influence. As with so many endeavors
pursued with enthusiasm, the fervor that accompanies evidence-based practice may cause us to
overlook its limitations. We may neglect to apply to evidence-based practice the fundamental
principles of objective analysis that are so central to the process itself. In our zeal to be objective and
informed, we may forget that clinical decision making, at its core, is an ethical matter, and we may
lose sight of the ethical dilemmas hidden beneath our efforts to produce the most effective medical,
rehabilitation, and health outcomes.

LEARNING OUTCOMES:
Upon completion of this chapter and with further self-directed learning you must have:
Identified the ethical issues in evidence based practice
Enumerated the principal elements of International Council of Nurses (ICN)

WARM-UP ACTIVITY:
What deliberations do you think are needed before any research project on human
subjects can be considered as ethically acceptable?

LEARNING INPUTS:
The core ethical issue in medical research is the need for voluntary consent of the potential
research subject so that a fully informed individual participates. Many efforts have been made to
address this issue, but perhaps the most significant progress came from the Nuremberg Trials, in
which the Nazi war crimes were investigated.

Four Principal Elements ICN (2012):

1. nurses and people
2. nurses and practice
3. nurses and the profession
4. nurses and co-workers

As a social science, nursing research must demonstrate ethical values that reflect the values
of the profession at any one time. Human rights, equity, and justice are stressed specifically in
relation to educators and researchers. The “nurses and the profession” element of the ICN’s code of
ethics states that the researcher must “conduct, disseminate and utilize research to advance the
nursing profession”

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Code of Ethics for Nurses by ANA (2015) in which specific vulnerable populations are
identified. These populations include children, the elderly, prisoners, students, and the poor. It also
indicates that the nurse clinician identifies clinical problems that need examining, and the researcher
designs the study in association with the clinician. What is clear in this statement is that research
topics in nursing should be focused on practice, which in itself should provide an ethical
underpinning for nursing research.

1. Environment for Ethical Research

Institutional review board (IRB)
- Most nurse researchers are associated with institutions that already have
ethical regulations in place that the researcher is required to follow. This
offers protection to the institution, the researcher, and the human subjects.
The research institution housing the project typically has an office for
reviewing all research proposals.
- main purpose of an IRB is to protect human subjects, especially vulnerable
populations such as children, prisoners, pregnant women, handicapped or
mentally disabled persons, or economically and/or educationally
disadvantaged persons. The IRB is charged with reviewing a proposal in
advance as well as with periodic monitoring of the research while it is being
conducted, all in an effort to protect the rights and welfare of the human
subjects

2. Developing a Researchable Topic

- When developing a researchable topic, the nurse researcher is called on to
utilize “ethical sensitivity” to decide what is appropriate, to have the “ability to
perceive rightness and wrongness”, and to know what one is doing affects the
welfare of another person either directly or indirectly.
- The topic that the nurse researcher chooses should be one of real interest to
him or her. The researcher should be willing to allocate the preparatory time
and effort to ensure that the project meets all of the institution’s ethical
guidelines. Ethical behavior requires intellectual honesty of the researcher—
giving credit due to others, not using ideas from others without
acknowledgment, and not initiating data collection before institutional approval
has been given.

3. Developing Researchable Questions

- Although the nurse researcher may have a burning interest in a particular topic,
developing the question(s) appropriately is most important when gearing up for
a formal study. This development is necessary to narrow the topic to a specific
focus, clarify the methodology, determine whether the topic has embedded in it
useful questions that will give shape to the study, and ensure that significant
research results will emerge and add to the body of nursing knowledge. The
questions should be broad enough to obtain results yet not so broad as to yield
diffuse and possibly meaningless results.
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- Thorough reading on the subject can assist in developing questions that meet
these criteria.

4. Participant Recruitment and Informed Consent

- Vulnerable populations are always a concern for all research regulatory bodies,
but some populations are particularly vulnerable—the very young, the frail
elderly, prisoners, the mentally incompetent, and women.
- The researcher must be sensitive to these issues and to the points specifically
outlined in federal regulations.
- The key ethical issue embedded in informed consent is that the individual
always has the freedom of choice to participate or not participate, and the
individual may withdraw from the study at any time.
- the researcher should regularly check with the subject to ensure that he or she
is still a willing and informed participant
- The only payment or compensation allowed includes the costs of transportation
or loss of earnings due to participation in the research project.
- Research using child participants encompasses all the usual ethical issues
relating to informed consent, privacy, and confidentiality, but it includes several
other factors that may compound these issues.

5. Data Collection and Data Analysis

- Protection of vulnerable human subjects remains the critical ethical issue with
data collection and analysis.
- In addition, concern for the welfare of the vulnerable human subjects is negated
when misconduct occurs. Scientific misconduct, an extremely serious issue as
follows:

WARP-UP ACTIVITY: Determine if your school has an IRB. Which criteria do the board members use
when approving a research project?

POST-ASSESSMENT: Your instructor thru MVLE will give a summative test on the lessons of the
chapter. Please wait for further instructions. Good luck!

REFERENCE:

Cannon, S. & Delahoyde, T. 2017. Ethics for Nursing Research and Evidence-Based Practice.
Jones & Bartlett Learning, LLC.
Lou, J. & Christiansen, C. 2001. Ethical Considerations Related to Evidence-Based Practice.
Available from:
https://www.researchgate.net/publication/11631736_Ethical_Considerations_Related_to_E
vidence-Based_Practice [accessed Nov 16 2020].

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LESSON 3. ETHICO-MORAL OBLIGATIONS OF THE NURSE IN EVIDENCE BASED PRACTICES

LEARNING OUTCOMES:
Upon completion of this chapter and with further self-directed learning you must have:
Enumerated the ethico-moral obligations of the nurse in evidence based
practices
Be guided with the good clinical practice guidelines

WARM-UP ACTIVITY:
You are sitting on the panel of a research ethics committee. A nursing colleague presents a
research proposal about supporting children from families in which a parent has been diagnosed
with alcoholism. The aim of the study is to ascertain how children behave after finding out about the
disease and if they encounter any problems at school.
 How would you react to this proposal?
 How can you ensure that the children come to no harm from the project?

LEARNING INPUTS:

Ethical Considerations in Evidence-Based Practice

A. Selecting and Using Intervention for a Given Patient

1. Base decision on best evidence for given patient, condition, and setting
2. Involve patients in the choice of intervention
3. Appreciate the importance of research evidence over tradition or expert opinion
4. Recognize the psychological and resource costs of ineffective intervention
5. Avoid the use of unethical studies

B. Participating in or Advocating for Research

1. Monitor ethical practices in research in which one participates
2. Assure complete and appropriate informed consent
3. Advocate for research balancing survival with quality of life
4. Respect the right of participant autonomy
5. Involve consumers in strategic decisions about research directions

Good Clinical Research Practice (GCP)

- is a process that incorporates established ethical and scientific quality standards
for the design, conduct, recording and reporting of clinical research involving the
participation of human subjects.
- The responsibility for GCP is shared by all of the parties involved, including
sponsors, investigators and site staff, contract research organizations (CROs),
ethics committees, regulatory authorities and research subjects.

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WHO Principles of GCP
 Principle 1: Research involving humans should be scientifically sound and
conducted in accordance with basic ethical principles, which have their origin in
the Declaration of Helsinki. Three basic ethical principles of equal importance,
namely respect for persons, beneficence, and justice, permeate all other GCP
principles.
 Principle 2: Research involving humans should be scientifically justified and
described in a clear, detailed protocol.
 Principle 3: Before research involving humans is initiated, foresee-able risks and
discomforts and any anticipated benefit(s) for the individual trial subject and
society should be identified. Research of investigational products or procedures
should be supported by ad-equate non-clinical and, when applicable, clinical
information.
 Principle 4: Research involving humans should be initiated only if the anticipated
benefit(s) for the individual research subject and society clearly outweigh the
risks. Although the benefit of the results of the trial to science and society should
be taken into account, the most important considerations are those related to
the rights, safety, and well-being of the trial subjects.
 Principle 5: Research involving humans should receive independent ethics
committee/institutional review board (IEC/IRB) approval/favorable opinion prior
to initiation.
 Principle 6: Research involving humans should be conducted in compliance with
the approved protocol
 Principle 7: Freely given informed consent should be obtained from every subject
prior to research participation in accordance with national culture(s) and
requirements. When a subject is not capable of giving informed consent, the
permission of a legally authorized representative should be obtained in
accordance with applicable law.
 Principle 8: Research involving humans should be continued only if the benefit-
risk profile remains favorable.
 Principle 9: Qualified and duly licensed medical personnel (i.e., physician or, when
appropriate, dentist) should be responsible for the medical care of trial subjects,
and for any medical decision(s) made on their behalf.
 Principle 10: Each individual involved in conducting a trial should be qualified by
education, training, and experience to perform his or her respective task(s) and
currently licensed to do so, where required.
 Principle 11: All clinical trial information should be recorded, handled, and stored
in a way that allows its accurate reporting, interpretation, and verification.
 Principle 12: The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality rules in accordance with the
applicable regulatory requirement(s).

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 Principle 13: Investigational products should be manufactured, handled, and
stored in accordance with applicable Good Manufacturing Practice (GMP) and
should be used in accordance with the approved protocol.
 Principle 14: Systems with procedures that assure the quality of every aspect of
the trial should be implemented.

ACTIVITY 1:

Critical Discussion: Ethical Issues in Nursing Research and EBP Projects

1. A research study of incarcerated women who are human immunodeficiency virus
(HIV) positive or have acquired immunodeficiency syndrome (AIDS) is being
conducted. You are not the principal investigator, but you are one of the
researchers who has received permission to interview some of the women who
volunteered to participate. One woman gives you inappropriate information about
another prisoner, whom she states propositioned her for sex; the interviewee
claims this prisoner has AIDS. As you leave the prison, the warden asks you to
relate what happened during this interview. Discuss your responsibilities as a
researcher in this sensitive study. A number of critical elements must be taken into
account: the interviewee divulging information about another prisoner’s possible
HIV/AIDS status and behaviors, confidentiality and protection of human subjects,
the warden’s request, and your ethical responsibility to the study and to your
institution.
2. You are the principal investigator studying young teenagers (10–14 years old) who
are receiving aggressive treatment for life-threatening cancers. One 11-year-old
boy has had many bouts of chemotherapy, which have made him acutely ill. His
parents would like the child to participate in the study, but he refuses. What he
shares could potentially be of use in treating other young teenagers. Clearly, there
are some issues of consent here. Discuss what you should do.
3. You are one of a group of nurse researchers who is participating in a multinational
study. The sample will include people of many different ethnic groups, all of whom
speak different languages, and will include women and children. You understand
the process of IRB review in your own institution, but many other issues arise when
one is participating in international studies. Among the issues of concern here are
the need for an interpreter, confidentiality, local permission requirements,
management of the study in the foreign country, recruitment of persons into the
study, and protection of human subjects in a different country. How can these
issues be resolved so that the study may be conducted?
4. Your hospital wants to decrease the rate of falls in patients older than 65 years of
age. You have been asked to conduct an EBP project regarding these patient
outcomes. What are some ethical considerations you must incorporate into this
project?

POST-ASSESSMENT: Your instructor thru MVLE will give a summative test on the lessons of the
chapter. Please wait for further instructions. Good luck!
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REFERENCES:
Cannon, S. & Delahoyde, T. 2017. Ethics for Nursing Research and Evidence-Based Practice.
Jones & Bartlett Learning, LLC.
Lou, J. & Christiansen, C. 2001. Ethical Considerations Related to Evidence-Based Practice.
Available from:
https://www.researchgate.net/publication/11631736_Ethical_Considerations_Related_to_E
vidence-Based_Practice [accessed Nov 16 2020].

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