COLLEGE OF NURSING AND PHARMACY

C-NCM 108: HEALTHCARE ETHICS

2nd Semester | AY 2021-2022

Module 9: PRINCIPLES OF ETHICS IN RESEARCH

Time Frame: Week 13 (3 hours)
Schedule of synchronous sessions: Monday 11:00 a.m. - 2:00 p.m. (Section 2B)
3 p.m. – 6 p.m. (Section 2A)

Mapped Learning Outcomes and Course Content for C-NCM 108 Healthcare Ethics, Module 9
Target Learning Content and Activities
Hour Outcomes Online Session Offline Session
(At the close of the period
allotted, students should
have :)
3 hours  Explain the importance Virtual Lecture  See the detailed instructions in the
of Ethics in Research. Discussion Assessment Section (Assignment).
 Discuss ethical Bioethics and Research
principles and A. Principles of
considerations in the Ethics in
conduct of research. Research
 Explain the implication 1. Nuremberg
of evidence – based code
practice in health care 2. Declaration
ethics through an of Helsinki
essay. 3. Belmond
Report
B. Ethical issues in
Evidenced
Based Practice
C. Ethico-moral
Obligations of
the Nurse in
Evidence Based
Practices

1. Content / Discussion / Learning Resources / Link

PRINCIPLES OF ETHICS IN RESEARCH

RESEARCH ETHICS
• Provides guidelines for the responsible conduct of biomedical research.
• It involves the application of fundamental ethical principles to a variety of topics involving research,
including scientific research.
• Educates and monitors scientists conducting research to ensure a high ethical standard.
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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

IMPORTANCE OF ETHICS IN RESEARCH

• It keeps the researcher from committing errors while seeking knowledge and truth.
• It promotes essential values that help researchers working on a topic to have a common understanding
of how things should go about.
• Since research may involve experts coming from different fields of expertise, Ethics binds them together
by considering the important values such as accountability, cooperation, coordination, mutual respect
and fairness among others.

RESEARCH ETHICS RULES

1. Be Honest – a researcher should maintain intellectual honesty in all times especially in reporting findings
in our investigation.
2. Be Objective - it means avoiding bias in research at all times.
3. Be a Person of Integrity – researcher should be consistent with all his thoughts and actions. He should
act with sincerity and should be able to keep his words true.
4. Be Caring – researcher should be after the welfare and benefit of his subjects especially when dealing
with human participants or animal subjects.
5. Be Open – researcher should be willing to share his ideas, results ad resources. Also, be willing to accept
suggestions and comments for the improvement of his work.
6. Be Careful – ideas of others must be acknowledged. He should treat his colleagues fairly and justly.
7. Be Trustworthy – researcher should keep confidently of all data and information contained in his
research unless otherwise needed to be known by the public.
8. Be Responsible - researcher consider the legalities, rules and regulations of an institution or government
when conducting a study. Be of help in publishing research which aim to advance knowledge and which
could help promote social welfare, minimize harm and risk and maximize the benefits for the target
population.

ETHICAL FRAMEWORK FOR ASSESSING RESEARCH ON HUMAN BEINGS

A. Motive
The motive of the research activity must be of potential significance for the good of society especially the good
of person. Any research contrary to the true good of the human person is immoral.
B. Topic
Medical research is justified if there is a reasonable likelihood that the population in which the research is
carried out stand to benefit from the results of the research. The topic must be appropriate for the heath priorities
of the country where the research is carried out and respond to health needs of the population from which
participants are drawn.

C. Respect for Personal Dignity of Subjects

Central to any research is the promotion of respect for the inherent and unique dignity of the subjects, with
equal rights and freedom for all. Participants must be treated as ends not as a means, as a person not object, as
contributory partners not mere subjects of work.
Respect for self-determination and preference is practiced in free and informed consent. Participants are
invited not required or demanded to join the project.
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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

D. Benefits/ Risk Ratio

Assessment of foreseeable benefits and predictable risks and burdens to subjects and to others should precede
the actual research. Benefits must outweigh and justify risks which must be proportionate to the humanitarian
purpose of the research. Distribution of benefits and risks must follow the tenets of distributive justice.
A. BENEFITS
 Participants – should receive free standard care for their specific health needs. Whether this should include
diseases other than the disease being studies should be agreed upon and made known before the start of the
research. At the conclusion of the study every patient entered into the study who could benefit, should have
access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study including
sustained therapy for as long as medically necessary beyond the termination of the trial and reasonably
available within resources of the majority of larger community. When research into preventive measures is
conducted, participants who develop the disease studied should be offered a universal standard of care for
the disease or at least the best available in their setting. Justice demands not only free health care and service
but compensation proportionate to their contribution, the project budget and local conditions.
 Community/ Country – there should be optimum use of local skills, practitioners and systems. Interventions
tested and shown to be successful should be made available to the wider community or country. This means
it should be within the financial resources and in conformity with the culture or religion of the majority of its
citizens. There should also be return of helpful information discovered, to promote concrete responses to
particular problems. Influx of resources and enhancement of local expertise in healthcare and research are
required.
B. HARMS/ RISKS
 Prior to the research, risks must be adequately assessed, means to monitor considered and protection
and safeguards against exposure to harm put into place.
 Minimum unavoidable harm forbids endangering life, equilibrium, health, integrity or aggravation of
illness of subjects. There should be no acts of destruction, mutilation or grave danger. Neither should
there be social stigma and discrimination.
 Privacy and confidentiality of all material must be maintained.
 Once continuing the study may result in injury, disability or death, or if risks outweigh benefits, or if
conclusive proof of positive or beneficial results are made, the research must be stopped. The problem
arises with double blind and multicentric studies where partial results are not known.
 Long term monitoring for possible deleterious outcomes beyond research completion for an agreed
period of time should be in place.
 Any injury that occurs must be justly compensated. There should also be caution against harming the
environment and welfare of animals used.

BRIEF HISTORY OF RESEARCH ETHICS

The most cited violations of human rights in research are

those that were done by the Nazis during World War II.

 The birth of modern Ethics – Biomedical Ethics desires to protect human subjects.

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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

 Doctors Trial 1946-1947/ Nuremberg Trials

December 9, 1946 when an American tribunal opened criminal proceedings against 23 leading
German Nazi physicians and administrators who willingly participated in war crimes and crimes
against humanity (Kour, 2014).
Charged with conducting abhorrent and torturous medical experiments on thousands of prisoners
without their consent who were held captive in the concentration camps during the World War II.
Experiments led to many of these subjects dying, while others were crippled permanently.
Gathering scientific information about the limits of the human body by exposing victims to extreme
temperatures and altitudes.
Experiments tested how quickly a human could be euthanatized in order to carry out the Nazi racial
purification policies most efficiently.
Results of the trial led to the establishment of the NUREMBERG CODE in 1948 because human beings
were being exploited in various cases.

https://www.history.com/topics/world-war-ii/the-holocaust

NUREMBERG CODE (1947)

 A set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg
Trials at the end of the Second World War.

NUREMBERG CODE: 10 ETHICAL PRINCIPLES

1. Research participants must voluntarily consent to research participation.
2. Research aims should contribute to the good of society.
3. Research must be based on sound theory and prior animal testing.
4. Research must avoid unnecessary physical and mental suffering.
5. No research projects can go forward where serious injury and/ or death are potential outcomes.
6. The degree of risk taken with research participants cannot exceed anticipated benefits of results.
7. Proper environment and protection for participants is necessary.
8. Experiments can be conducted only by scientifically qualified persons.
9. Human subjects must be allowed to discontinue their participation at any time.

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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will
be harmful or result in injury or death.

TUSKEGEE EXPERIMENT: THE INFAMOUS SYPHILIS STUDY (1932-1972)

 In 1932, the U.S. Public Health Service began working with the Tuskegee institute to track the natural
progression of untreated syphilis.
 Six hundred poor, illiterate, male sharecropper were found and hired in Macon County, Alabama. Of the
600 men, only 399 had previously contracted syphilis, and none were told they had a life threatening
disease. Instead, they were told they were receiving free healthcare, meals and burial insurance in
exchange for participating.
 Even after penicillin was proven an effective cure for syphilis in 1947, the study continued until 1972. In
addition to the original subjects, victims of the study included wives who contracted the disease and
children born with congenital syphilis.
 In 1997, President Bill Clinton formally apologized to those affected by what is often called the “most
infamous biomedical experiment in U.S. history.

BELMONT REPORT (1978)

 Prompted in part by problems arising from the Tuskegee Syphilis Study (1932–1972)
• Policies developed by the United States National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research.
• Created as a result of the National Research Act 1974, was charged with identifying the basic ethical
principles involving human subjects and developing guidelines to assure that such research is conducted
in accordance with those principles.
• The ethical principles with human subjects.
• Boundaries between medical practice and research.
• The concepts and application of these Three Ethical Principles:
1. Respect for persons – informed consent
2. Beneficence – assessing risks and benefits
3. Justice – subject selection

RESPECT FOR PERSONS

 Provide enough information so that an informed, voluntary decision can be made.
• Voluntary informed consent to participate in research.
 Information
 Comprehension
 Voluntariness

BENEFICENCE
• To do good, to do no harm, minimize risk of harm and maximize the benefit of research to protect human
welfare.
• Analyzing the risks and benefits.

JUSTICE
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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

• Fair and equitable distribution of benefits and burdens of research.

• Research participants are selected fairly, with all segments of the population having an opportunity to be
included in a study, provided that inclusion is scientifically and ethically justifiable.

DECLARATION OF HELSINKI (1964)

 A set of ethical principles regarding human experimentation developed for the medical community by the
World Medical Association (WMA).
• It is widely regarded as the cornerstone document of human research ethics.
• Employing a medically qualified person to supervise the research and assume responsibility for the health
and welfare of a human research.
• The necessity of using an independent investigator to review potential research projects.
• Suggestions on how to obtain informed consent from the research participants.
• Rules concerning research with children and mentally incompetent persons.
• Evaluating and using experimental treatments on patients.
• The importance of determining which medical situations and conditions are appropriate and safe for
research.
• The importance of preserving the accuracy of research results.

Principles of beneficence, respect for human dignity, and

justice underlie the ethical conduct of research.

The NUREMBERG, HELSINKI and BELMONT guidelines

provided the foundation of more ethically uniform research to
which stringent rules and consequences for violation were
attached

ISSUES FOR RESEARCHERS TO ADDRESS

1. Respect for participants
2. Adequate information on which to base choices
3. Understanding and evaluating the issues involved
4. Perceived or actual coercion
5. Freedom from undue social restriction
6. Gaining consent
8. Maintaining confidentiality
9. Vulnerable individuals and groups

VULNERABLE INDIVIDUALS AND GROUPS

1. Physically, mentally or emotionally disabled or challenged persons
2. Children or elderly persons
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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

3. Those who are dying, sedated, or unconscious

4. Persons who are institutionalized or incarcerated
5. Pregnant women
6. Fetuses

RESEARCH ETHICS COMMITTEE

 Reviews proposed studies with human participants to ensure that they conform to internationally and
locally accepted ethical guidelines
• Monitor studies once they have begun and, where relevant, take part in follow-up action and surveillance
after the end of the research.
• Committees have the authority to approve, reject or stop studies or require modifications to research
protocols.

The main responsibility of a research ethics committee is to

protect potential participants in the research, but it must also
take into account potential risks and benefits for the
community in which the research will be carried out.

HEALTH CARE ETHICS COMMITTEE

 Ethics committees are local committees of specific healthcare institutions.
• Three major functions:
1. providing clinical ethics consultation
2. developing and/or revising policies pertaining to clinical ethics and hospital policy (e.g., advance
directives, withholding and withdrawing life-sustaining treatments, informed consent, organ donation)
3. facilitating education about topical issues in clinical ethics

COMPOSITION OF ETHICS COMMITTEE

• The only requirement is diversity; most effective with people from a variety of disciplines and theoretical
backgrounds
• People respected by their peers.
ETHICAL ISSUES IN EVIDENCED BASED PRACTICE

Evidence-Based Practice - is a method by which practitioners across the healthcare professions review and
assess the most current, highest-quality research to inform their delivery of care.

THREE COMPONENTS OF EVIDENCED-BASED PRACTICE

1. Best external evidence: Evaluate and implement the most current, clinically relevant, and scientifically
sound research.
2. Individual clinical expertise: Draw on your personal experience of what has worked and not worked in
your clinical practice.
3. Patient values and expectations: Consider and value the preferences of your individual patients.

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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

Nurses use the principles of evidence-

based practice to make optimal
decisions about patient care. When
nurses integrate the best available
science into their practice, they work
from a holistic, patient-centered
approach.

https://www.usa.edu/blog/evidence-based-practice
ADVANTAGES OF EVIDENCED-BASED PRACTICE IN NURSING
1. Improves patient outcomes through superior care
2. Maximizes provider’s time and reduces costs
3. Adds new contributions to the science of nursing

Evidence-based practice also benefits nursing by keeping

practices current and relevant, increasing nurses’
confidence and decision-making skills, and contributing to
the science of the profession.

FOUR ETHICAL CONCERNS ON EBP

1. Some types of knowledge are not included in EBP - 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). It overrides the decisions of
practitioners borne of their knowledge gained through experience
2. EBP runs counter to patient-centered care - By insisting that all practice is based on up to-date
research evidence where it is available, patient-centered care, which requires case-specific knowledge
and intuition, is undermined. The issue arises particularly where EBP enters protocols and guidelines
which are supposed to be used as the primary decision-making aid for practitioner. It disempowers the
ability of patients to choose on the basis of their own ideas and values
3. "Testable by RCT" is not the same as "most effective" - EBP puts highest value on evidence from
randomized controlled trials (RCTs). However, this can produce unethical results (Zwitter 2001; Vos et
al. 2004; Vineis 2004; Rysavy 2013). It results in preference given for treatments that are most easily
tested by RCTs.
4. Decisions based on EBP can be unjust -It is used in rationing and allocation decisions which tend to
favor the existence of evidence over the presence of need.

SIX BROAD ETHICAL AREAS TO CONSIDER IN RESEARCH

1. Voluntary Participation - Participation should be voluntary in all research, and there should be no
coercion or deception. You should remember that participants are assisting you, and they should be

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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

invited to participate, with a clear understanding that they are under no obligation to do so and that there
will be no negative consequences for them if they do not assist you in your research.
2. Informed Consent - Potential participants must be ensured fully understanding on what they are being
asked to do and that they are informed if there are any potential negative consequences of such
participation. The most effective way to address the informed consent issue is through the use of an
information sheet, which is provided to all those who are invited to participate. In situations in which
there is a potential for participant harm to occur, participants should be given the invitation sufficiently
in advance to enable them to carefully consider whether they will participate.
3. Confidentiality and Anonymity - Anonymity requires that you do not know who the participants are.
This could be achieved through random phone surveying or having an organization distribute a survey
on behalf of the researcher. Confidentiality means that you know who the participants are, but that their
identity will not be revealed in any way in the resulting report. As we mentioned earlier, confidentiality
is very important especially when you are examining situations within a firm in which you will give
managers a copy of the report. It could also be important when undertaking an industry-based study, and
the final report will be distributed to all participants, who may be competitors. You must consider how to
protect your participants, and if there is any possibility that they will not be protected, this must be clearly
stated to potential respondents in the accompanying information letters and consent forms. If individuals
clearly know they will be identified and that the report will be distributed to managers or competitors,
there is no ethical problem associated with responses not remaining confidential or anonymous.
4. Potential for Harm - There are a number of ways in which participants can be harmed: physical harm,
psychological harm, emotional harm, embarrassment (i.e., social harm), and so on. It is important for you
to identify any potential for harm and determine how this potential for harm could be overcome. It is
researcher’s responsibility to protect the participants from any form of harm that may affect them.
5. Communicating Results - There are three broad issues that you need to be aware of when completing
your research project report and communicating results with your lecturer/ professor/supervisor and
with clients, should they exist: plagiarism, academic fraud, and misrepresenting results.
 Plagiarism – relates to work that is need to be very careful that you do not misrepresent someone
else’s work as your own. The appropriate techniques for referencing others’ ideas is a must.
 Academic Fraud - It involves the intentional misrepresentation of what has been done. This would
include making up data and/or results from the data or purposefully putting forward conclusions that
are not accurate.
 Misrepresenting the Results - making conclusions and recommendations that are inconstant or
incorrect based on what you found.
6. Other, More Specific Ethical Issues
 Conflicts of Interest - This issue arises when you or one group member is an individual employed in
the industry you are researching and you do not inform all respondents of this fact. While the research
may be a good opportunity to gain competitive information, such action would be ethically
inappropriate.
 Focus Group Participant Identification - it is important that members of the focus group sign
appropriate consent forms in situations in which this information might be used against the person
who said something or a third person who was discussed. The consent form could include a statement
regarding participants keeping the information discussed confidential. This method is not foolproof,

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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

as it is unclear that any penalties for breaching the agreement could be imposed, but at least you are
undertaking due diligence to protect participants and others.
 Deceit - This is one of the situations in which researchers might be tempted to apply a teleological
ethical view; that is, does the benefit of misleading the respondents outweigh any potential harm to
participants.
 Observation - Another ethical issue that may arise when undertaking projects involves the
observation of participants. This becomes an ethical issue especially when you are observing people
in a public or quasipublic place. Asking to observe people will modify their behavior, and therefore,
researchers may not want to explicitly ask each person if he or she can be watched. One solution to
this issue is to have notices placed at the entrance of the store indicating that researchers will be
operating in this area at these times. Individuals not wishing to participate could then avoid this area
at these times. Should you wish to videotape these encounters, it may also be advisable to seek
permission using a consent form to use the information after the participant has been taped, even if a
notice is used (if someone declines, you should erase this person’s data). B
 Permission From Organization/Location - One ethical issue that frequently overlook relates to
getting written permission from the organization in which the research is being undertaken or the
location in which the data is being collected. When getting written permission, it is also important that
the person you talk with has the ability to give that permission and that your activities are organized
well in advance.
 Video/Audio Taping - In a number of situations, you may wish to audio record or videotape the
specific intervention. This can be done for a number of reasons, such as to ensure that no verbal
information is missed in a focus group or interview. Alternatively, you may be attempting to capture
nonverbal information, such as body language.
 Consent Forms - keep the consent form as an indication of informed consent by the respondent,
should any question arise. However, it should be remember that a person who signs an informed
consent form can still rescind their consent (i.e., it is not a binding document) for any reason, and you
must not use the information they provided.

2. Assessment of Learning

ASSIGNMENT:
I. Activity Title:
Evidence- Based Practice in Healthcare Ethics
II. Learning outcomes
 Integrate relevant principles of social, physical, natural and health sciences and humanities in a given
health and nursing situation. b. Apply appropriate nursing concepts and actions holistically and
comprehensively
 Provide appropriate evidence based nursing care using a participatory approach based on research.
III. Description of the Activity
 Find a journal or article about Evidence- Based Practice in Healthcare Ethics.
 Write the abstract or the summary of the article or journal. Do not forget the reference.

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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

 Explain the implication of evidence-based practice in health care ethics. NOTE: Any output that is
plagiarized will automatically get a zero mark.
 Place your output in a presentable template and upload it on the link provided in your Google classroom.

IV. Rubrics:
Score Completion Accuracy Comprehension Organization Conventions
5 The answer is All information Content Content is well- No major
complete. provided is demonstrates a organized and easy grammatical or
accurate. deep to read. Points spelling errors. No
understanding of, follow a logical more than two minor
and engagement progression. errors.
with, the text(s).
4 The answer is All information Content Content is well- No major
missing slight provided is demonstrates organized and easy grammatical or
details accurate. understanding of, to read. Points spelling errors. No
and engagement follow a logical more than five minor
with, the text(s), progression. errors.
3 The answer is Most information Content Content is Some major and
missing multiple provided is demonstrates organized and easy minor errors that
details. accurate. basic to read. Points don’t necessarily
understanding of follow a mostly impair
the text(s). logical progression. communication.
2 Content suggests Some information Content Content may be Major and minor
lack of provided is demonstrates less unorganized and errors significantly
preparation or accurate. than basic difficult to read. weaken quality of
comprehension. understanding of Points do not follow communication,
the text(s). a solidly logical although still
progression. comprehensible.
1 Content only A small amount of Content Content is Communication
marginally related the information is demonstrates a unorganized, seriously impaired by
to the accurate. lack of illogical, and multitude of
question/prompt. understanding of difficult to read. spelling/grammatical
the text(s). errors.
0 Content fails to None of the Content Content is very Multitude of major
meet the basic information demonstrates a poorly organized, and minor errors

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 COLLEGE OF NURSING AND PHARMACY
C-NCM 108: HEALTHCARE ETHICS
2nd Semester | AY 2021-2022

requirements of provided is complete lack of illogical, and make answer

the task. accurate. understanding of difficult to read. incomprehensible.
the text(s).

3. Evaluation of Learning
For the evaluation of learning for Module 9, a scheduled quiz will be assigned in the Google Classroom and will
be taken before the start of the next Module during the Synchronous Class.

References

 Edge, Raymond & Groves Randall. Ethics of Health Care a Guide for Clinical Practice 4th edition. (2019).
Cengage Learnenig Asia Pte Ltd.
 Monge, Michael A. Ethical Practices in Health and Disease.
 Alora, Angeles T. Bioethics for Students (2006). UST Publishing House.
 Ethics Discovering Right and Wrong. Pojman, Louis P.

Congratulations for having completed this C-NCM 108 Module 9! See you in the next Module

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