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FACULTY OF NURSING AND ALLIED HEALTH SCIENCE

NMNR 5104 – RESEARCH METHODOLOGY

ASSIGNMENT 1

Topic: 1) Discussion of the General Ethics Principles and Procedures for Protecting
Participants in a Nursing Research

2) Critical Evaluation of the Major Characteristics of a Conceptual Framework

that Related to a Research

Name of the Student : J.A.D.S.Tharangani

Matrix Number :

NIC : 787440878V

Telephone Number : +96891454682/0717620231

E-mail Address : sitharajayatunga@gmail.com

Facilitator’s Name : Dr. Gorge Perera

International Institute of Health Sciences

Learning Centre :
– IIHS Sri Lanka

Current Semester : September 2017 Semester

Date of submission : 31.01.2018

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Table of Contents

Topic Page No

Introduction 3

Chapter 1 General Ethics Principles and Procedures for Protecting

Participant in a Nursing Research

1.1 Historical Background 4

1.2 Examples of Ethical Dilemmas in Conducting Research 4
1.3 Code of Ethics 5
1.4 Ethical Principles 6
1.5 Ethical Procedures 13

Chapter 2 Major Characteristics of a Conceptual Framework that

Related to a Research

2.1 Introduction of conceptual Framework 20

2.2 Variables 22

2.3Designing a Conceptual Framework 23

2.4Expandng the Conceptual Framework 24

2.5The Position of the Conceptual Frame work 28

2.6How to develop Conceptual Frame work 28

2.7 Why is Conceptual Frame Work Useful 29

2.8What are the Limitations of Conceptual Frame Work 29

2.9A Sample Evaluation of Conceptual Frame Work 30

Conclusion 40

Reference 41
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Introduction

Ethics in nursing research can be defined as the act of moral principles which the researcher has
to follow while conducting nursing research to ensure the rights & welfare of individuals, groups
or community understudy. Ethics in nursing research protect the vulnerable group & other study
participants from harmful effects of the experimental interventions. Participants are safeguarded
from exploitation researchers. Establish risk – benefit ratio for the study subjects ensure the
fullest respect, dignity, privacy, disclose of information & fair treatment for study subjects. Build
the capability of subjects to accept or reject participation in study & to have access to informed
or written consent for participation in research. (www.drjayeshpatidar.blogspot.com). Broadly
speaking, your dissertation research should not only aim to do well (i.e., beneficence), but
also avoid doing any harm (i.e., non-malfeasance). Whilst ethical requirements in research can
vary across countries, these are the basic principles of research ethics. This is important not only
for ethical reasons, but also practical ones, since a failure to meet such basic principles may lead
to your research being (a) criticized, potentially leading to a lower mark, and/or (b) rejected by
your supervisor or Ethics Committee, costing you valuable time. In the paper, the writer will
discuss the five of the main practical ethical principles that stem from these basic principles.

A conceptual framework is used to illustrate what you expect to find through your research,
including how the variables you are considering might relate to each other. Understanding what
variables mean is crucial in proposal because you will need these in constructing your conceptual
framework and in analyzing the data that you have gathered. Therefore, it is a must that you should be
able to grasp thoroughly the meaning of variables and ways on how to measure them. Yes, the variables
should be measurable so that you will be able to use your data for statistical analysis. (Swaen,B., 2017).In
this paper, the writer will introduce the conceptual framework, dependent and independent variables by
developing a conceptual model to the thesis of feto-infant mortality in late and low fertility context.
Additionally, will be discussed inter-relationship of the variables through Moderator variables, Mediator
variables and Control variables.
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Chapter 1

The General Ethical Principles and Procedures for Protecting Participants in a Nursing
Research

1.1 Historical Background

 As modern, civilized people: systematic violations of moral principles within a research

context occurred centuries ago rather than in recent times – False.
 The Nazi Medical Experiments (1930s & 1940s).
 The Tuskegee Syphillis Study (1932-1972) Injection of Live Cancer Cells into elderly
patients at the Jewish Chronic Disease Hospital in Brooklyn, without the consent of those
patients .
 1993 – U.S Federal agencies had sponsored radiation experiments since the 1940s on
hundreds of people (prisoners/elderly hospital patients). (Cabanto,J,C.,& Padua,G.M.,
2013).

1.2 Examples of Ethical Dilemmas in Conducting Research

1. Research question: How empathic are nurses in their treatment of patients in the
intensive care unit (ICU)?
Ethical Dilemma: Awareness of the subjects’ normal vs. controlled behaviour
invalid findings.
2. Research question: What are the coping mechanisms of parents whose children have a
terminal illness?
Ethical Dilemma: probing into the psychological state of parent at a vulnerable time in
their lives = traumatic vs. identifying coping mechanisms used that will help design more
effective ways of dealing with grief and anger.
3. Research question: Does a new medication prolong life in patients with cancer?
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Ethical Dilemma: control vs. experimental group – exposing the group receiving the
medication to potential hazard while group NOT receiving the drug may be denied a
beneficial treatment.
4. Research question: What is the process by which adult children adapt to the day-to-day
stresses of caring for a terminally ill parent?
Ethical Dilemma: close involvement of researcher to participants sharing of
secrets.

 It is precisely because of such conflicts and dilemmas that codes of ethics

have been developed to guide the efforts of researchers. (Cabanto,J,C.,&
Padua,G.M., 2013).

1.3 Code of Ethics

1. Nuremberg Code
a. developed after the Nazi atrocities were made public in the Nuremberg trials.
b. One of the first internationally recognized efforts to establish ethical standards
2. Declaration of Helnski
a. Adopted in 1964 by the World Medical Association
b. Revised in 2000
3. American Nurse Association
a. Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing
Research (Silva, 1995)
4. American Sociological Association
a. Published a revised Code of Ethics (1997)
5. American Psychological Association
a. Ethical Principles of Psychologists and Code of Conduct (1992)
6. National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research (1978)
a. Belmont Report :
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 served as the basis for regulations affecting research

sponsored by the federal government
 Articulated three primary ethical principles on which standards of ethical
conduct in research are based: beneficence, respect for human dignity,
and justice. (Cabanto,J,C.,& Padua,G.M., 2013).

1.4 Ethical Principles

1) THE PRINCIPLE OF BENEFICENCE

“Above all, do no harm”

1. Freedom from harm

a. Physical
b. Psychological
c. Social
d. Economic
e. Minimize all types of harm and discomfort
f. Achieve balance between potential benefits and risks of being a participant
g. Qualified people only to conduct potentially dangerous technical equipment or
specialized procedures
h. Termination of research: injury, death, disability, undue distress
i. Experiment with animals or tissue cultures prior human testing (Cabanto,J,C.,&
Padua,G.M., 2013).

Example of Risk Reduction

1. Varda and Behnke (2000) studied the effect of the timing of an initial bath (1 hour
vs. 2 hours after birth) on newborn temperature.
2. Psychological consequences/harm -debriefing sessions. (Cabanto,J,C.,&
Padua,G.M., 2013).
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Example of Referrals

1. Study by Polit, London, and Martinez (2001) of the health of nearly 4000 poor
women in 4 major cities; interviewers had an information sheet with contact
information for local service providers who could assist with any issue about
which a participant mentioned a need for help.
2. Qualitative researchers, regardless of the underlying research tradition, must thus
be especially vigilant in anticipating such problems (Polit and Beck, 2004).
(Cabanto,J,C.,& Padua,G.M., 2013).

Example of an Issue of Risk in a Qualitative Study:

Caelli (2001) conducted a phenomenological study to illuminate nurses’
understandings of health, and how such understandings translated into nursing
practice. One participant, having explored her experience of health with the
researcher over several interview sessions, resigned from her city hospital job as a
result of gaining a new recognition of the role health played in her life.
(Cabanto,J,C.,& Padua,G.M., 2013).

2. Freedom from Exploitation

a. Research study should not place participants at a disadvantage or expose them
to situations for which they have not been prepared.
b. Participants need to be assured that their participation or information they
might provide will not be used against them in any way.
c. Study participants enter into a special relationship with researchers, and it is
crucial that this relationship not be exploited i. Exploitation may be overt and
malicious, but it might also be more subtle
d. Nurse researchers may have a nurse-patient (in addition to a researcher
participant) relationship.
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e. Qualitative research: Emergence of pseudo therapeutic relationship is

uncommon - imposes additional responsibilities researchers and additional risks
that exploitation could inadvertently occur.
f. Munhall (2001) – qualitative nurse researchers have the responsibility of
ensuring that the “therapeutic imperative of nursing (advocacy) takes precedent
over the research imperative (advancing knowledge) if conflict develops”.
(Cabanto,J,C.,& Padua,G.M., 2013).

3. Benefits from Research

a. Participants may perceive direct personal benefits.
b. Any benefits from the research accrue to society in general or to other
individuals.
c. Researchers should strive insofar as possible to maximize benefits and to
communicate potential benefits to participants. (Cabanto,J,C.,& Padua,G.M.,
2013).

4. The Risk/Benefit Ratio

a. The degree of risk to be taken by those participating in the research should
never exceed the potential humanitarian benefits of the knowledge to be gained.
b. The selection of a significant topic that has the potential to improve patient-care
is the first step in ensuring that research is ethical.
c. Minimal Risk – risks anticipated being no greater than those ordinarily
encountered in daily life or during routine physical or psychological tests or
procedures
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2) THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY

A. Right to Self-Determination
 Prospective participants have the right to decide voluntarily whether to
participate in the study, without risking any penalty or prejudicial
treatment.
 People have the right to ask questions, to refuse to give information, to ask
for clarification, or to determine their participation.
 Freedom from coercion of any type:

 explicit or implicit threats of penalty from failing to participate in a

study or excessive rewards from agreeing to participate.
 position of authority
 generous monetary incentive (or stipend). (Cabanto,J,C.,&
Padua,G.M., 2013).

B. Right to Full Disclosure

 The researcher has fully described the nature of the study, the person’s
right to refuse participation, the researcher’s responsibilities, and likely
risks and benefits.
 There is often a need for further disclosure at a later point of the study,
either in debriefing sessions or in written communication.
(Cabanto,J,C.,& Padua,G.M., 2013).

C. Issues relating to the Principle of Respect

 Inability of some individuals to make well-informed judgments about the
risks and benefits of study participation.
 Full disclosure can sometimes create two types of bias:
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I. Subjects provide inaccurate information.

II. Representative sample is not recruited.
Example:
 Research Study: Relationship between high school students’
substance abuse and their absenteeism
 Hypothesis: Students with a high rate of absenteeism are more
likely to be substance abusers than students with a good
attendance record.
 Techniques that researchers sometimes use in conflicting situations
I. Covert data collection or concealment
II. Deception

ANA Guidelines offer advice about deception and concealment:

The investigator understands that concealment or deception in research is controversial,

depending on the type of research. Some investigators believe that concealment or deception in
research can never be morally justified. The investigator further understands that before
concealment or deception is used, certain criteria must be met:

(1) The study must be of such small risk to the research participant and of such great significance
to the advancement of the public good that concealment can be morally justified.

(2) The acceptability of concealment or deception is related to the degree of risks to research
participants

(3) Concealment or deception are used only as last resorts, when no other approach can ensure
the validity of the study’s findings

(4) The investigator has a moral responsibility to inform research participants of any
concealment or deception as soon as possible and to explain the rationale for its use (Silva,
1995).
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 Collection of data from people over the internet.

 Example: Some researchers are analyzing the content of messages posted

to chat rooms or list serves.
 Issue: Whether such messages can be used as data without the authors’
permission and their informed consent.
 Researchers, before collecting electronic data, negotiate their
entry into an electronic community (e.g., chat room) with the list
owner (Schrum, 1995).
 Obtaining consent from list moderators does not necessarily mean
that every member of the list serve or chat room has provided
consent (Sixsmith and Murray, 2001). (Cabanto,J,C.,&
Padua,G.M., 2013).

3) THE PRINCIPLE OF JUSTICE

“Participants’ right to fair treatment and their right to privacy”

a) The Right to Fair Treatment – Participants have the right to fair and equitable
treatment before, during and after their participation in the study (Polit and Beck,
2004). Fair treatment includes the following features:
 The fair and non-discriminatory selection of participants.
 Participants should be selected based on research requirements and not on
the vulnerability or compromised position of certain people.
 Respect for cultural and other forms of human diversity.
 The no prejudicial treatment of those who decline to participate or who
withdraw from the study after agreeing to participate.
 The honoring of all agreements between researchers and participants,
including adherence to the procedures described to them and payment of
any promised stipends.
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 Participants’ access to research personnel at any point in the study to

clarify information.
 Participants’ access to appropriate professional assistance if there is any
physical or psychological damage.
 Debriefing, if necessary, to divulge information withheld before the study
or to clarify issues that arose during the study.
 Courteous and tactful treatment at all times. (Cabanto,J,C.,& Padua,G.M.,
2013).

b) The Right to Privacy

 participants have the right to expect that any data they provide will be kept in
strictest confidence
I. Anonymity – occurs when even the researcher cannot link participants to their
data
EXAMPLE: Thomas, Stamler, Lafrenier, and Dumala (2001) used the Internet to
gather data from an international sample of women about their perceptions of
breast health education and screening. A website with a questionnaire was
established. No identifying information was sought from respondents, and so their
anonymity was guaranteed.
II. Confidentiality Procedures – implemented when anonymity is impossible.

 A promise of confidentiality is a pledge that any information participants

provide will not be publicly reported in a manner that identifies them and
will not be made accessible to others.
 Research information should not be shared with strangers or with people
known to the participants (e.g. family members, physician, and other
nurses) unless the researcher has been given explicit permission to share it.
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Steps to avoid occurrence of breaches of confidentiality:

• Obtain identifying information (e.g., name, address) from participants only

when essential

• Assign an identification (ID) number to each participant and attach ID

number rather than other identifiers to the actual data.

• Maintain identifying information in a locked file.

• Restrict access to identifying information to a small number of people on a

need to-know basis.

• Enter no identifying information as quickly as practical.

• Make research personnel sign confidentiality pledges if they have access to

data or identifying information.

• Report research information in the aggregate; if information for a specific

participant is reported, take steps to disguise the person’s identity, such as
through the use of a fictitious name. (Cabanto,J,C.,& Padua,G.M., 2013).

1.5 Ethical Procedures

1. INFORMED CONSENT

 Participants have adequate information regarding the research, are capable of

comprehending the information, and have the power of free choice, enabling them
to consent to or decline participation voluntarily. (Cabanto,J,C.,& Padua,G.M.,
2013).
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The Content of Informed Consent

1. Participant Status

2. Study Goals

3. Type of data

4. Procedures

5. Nature of the Commitment

6. Sponsorship

7. Participant selection

8. Potential risks

9. Potential benefits

10. Alternatives

11. Compensation

12. Confidentiality Pledge

13. Voluntary consent

14. Right to withdraw and withhold information

15. Contact information (Cabanto,J,C.,& Padua,G.M., 2013).

 In some Qualitative studies, especially those requiring repeated contact with the same

participants, it is difficult to obtain a meaningful informed consent at the outset. Qualitative

researchers do not always know in advance how the study will evolve.

Process Consent: researcher continually renegotiates the consent, allowing

participants to play a collaborative role in the decision-making process regarding ingoing

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participation. (Cabanto,J,C.,& Padua,G.M., 2013).

Comprehension of Informed Consent

 Normally presented to prospective participants while they are being recruited, either
orally or in writing
 A written notice should not, however, take the place of spoken explanations
 Researchers must assume the role of teacher in communicating consent information
 Written statement should be consistent with the participants’ reading levels and
educational attainment (For participants from a general population (for example; patients
in a hospital), the
 Statement should be written at about seventh or eighth grade reading level.
(Cabanto,J,C.,& Padua,G.M., 2013).

Documentation of Informed Consent

 Signing a consent form

 Document should be signed by the researcher, and a copy should be retained by both
parties

Guidelines in developing consent form:

1. Organize the form coherently so that prospective participants can follow the logic of

what is being communicated.

2. Use a large enough font so that the form can be easily read, and use spacing that

avoids making the document appear too dense.

3. In general, simplify. Use clear and consistent terminology, and avoid technical terms if

possible.
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4. If possible, use a readability formula to estimate the form’s reading level, and make

revisions to ensure an appropriate reading level for the group under study.

5. Test the form with people similar to those who will be recruited, and ask for feedback
(Cabanto,J,C.,& Padua,G.M., 2013).

2. VULNERABLE SUBJECTS

 may be incapable of giving fully informed consent or may be at high risk of

unintended side effects because of their circumstances

1. Children

 informed consent of children’s parents or legal or legal guardians should be

obtained
 it is appropriate, however to obtain the child’s (at 7 years old) assent as well
 Assent: child’s affirmative agreement to participate.

2. Mentally or emotionally disabled people

 Researchers should obtain the written consent of a legal guardian (may not
necessarily have the person’s best interest in mind). (Cabanto,J,C.,& Padua,G.M.,
2013).

3. Severely ill or physically disabled people

 assess their ability to make reasoned decisions about study participation

Example: Assessment of decisional capacity of mechanically ventilated patients

(Higgins and Daly, 1999)

 special procedures for obtaining consent from participants with certain disabilities

Example: Deaf participants, People with physical impairment, Participants who cannot read
and write. (Cabanto,J,C.,& Padua,G.M., 2013).
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4. The terminally ill

 Careful assessment of risk/benefit ratio

 Health care and comfort of participants are not compromised
 Special procedures in obtaining consent if mentally/physically incapacitated
 Institutionalized people
 Researchers need to emphasize the voluntary nature of participation (Cabanto,J,C.,&
Padua,G.M., 2013).

6. Pregnant women

 Requirements reflect to safeguard both the pregnant women and the foetuses.
 A pregnant woman cannot be involved in a study unless the purpose of the research is
to meet the health needs of the pregnant woman and risks to her and the fetus are
minimized or there is only a minimal risk to the fetus. (Cabanto,J,C.,& Padua,G.M.,
2013).

Example: Anderson, Nyamathi, McAvoy, Conde, and Casey (2001) conducted a study to
explore perceptions of risk for human immunodeficiency syndrome among adolescents in
juvenile detention. (Cabanto,J,C.,& Padua,G.M., 2013).

3. EXTERNAL REVIEWS AND THE PROTECTION OF HUMAN RIGHTS

 Institutional Review Board

 Philippine Health Research Ethics Board
 Philippine Council for Health Research and Development (Cabanto,J,C.,&
Padua,G.M., 2013).

4. BUILDING ETHICS INTO THE DESIGN OF THE STUDY

Research Design:
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 Will participants get allocated to different treatment groups fairly?

 Will research controls add to the risks participants will incur?
 Will the setting for the study be selected to protect against participant discomfort?

Intervention:

 It the intervention designed to maximize good and minimize harm?

 Under what conditions a treatment might be withdrawn or altered?

Sample:

 Is the population defined so as to unwittingly and unnecessarily exclude important

segments of people
 Is the population defined in such a way that especially high-risk people could be
excused from the study?
 Will potential participants be recruited into the study equitably?

Data collection:

 Will data be collected in such a way as to minimize respondent burden?

 Will procedures for ensuring confidentiality of data be adequate?
 Will data collection staff be appropriately trained to be sensitive and courteous?
Reporting:
 Will participants’ identities be adequately protected?

5. RESEARCH MISCONDUCT

Fabrication – making up data or results and recording or reporting it.

Examples of Fabrication: According to Assessing Research Misconduct Allegations
Involving.
Clinical Research, fabrication would be alleged in the following scenarios:
 Completing a questionnaire for a fictitious subject that was never interviewed
 Creating a data set for an experiment that was never actually conducted;
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 Adding fictitious data to a real data set collected during an actual experiment
for the purpose of providing additional statistical validity; and
 Inserting a clinical note into the research record to indicate compliance with
an element of the protocol.
Fabrication of data is rendered punishable when the false data is incorporated into
the official study notebook; submitted to a funding agency; or publicly disseminated
through the process of publication, patent application, or at a public forum such as a
professional meeting, seminar, or symposium; regardless of whether the data is
subsequently published or not.
Falsification is manipulating research materials, equipment, or processes, or
changing or omitting data or results such that the research is not accurately
represented in the research record. Falsification also includes the selective
omission/deletion/suppression of conflicting data without scientific or statistical
justification. (Cabanto,J,C.,& Padua,G.M., 2013).
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Chapter 2

Major Characteristics of a Conceptual Framework that Related to a Research

2.1 Introduction of Conceptual framework

A conceptual framework represents the researcher’s synthesis of literature on how to explain a

phenomenon. It maps out the actions required in the course of the study given his previous
knowledge of other researchers’ point of view and his observations on the subject of research. (
Regoniel,P.A., 2015).

In other words, the conceptual framework is the researcher understands of how the
particular variables in his study connect with each other. Thus, it identifies the variables
required in the research investigation. It is the researcher’s “map” in pursuing the investigation. (
Regoniel,P.A., 2015).

As McGaghie et al. (2001) put it: The conceptual framework “sets the stage” for the presentation
of the particular research question that drives the investigation being reported based on the
problem statement. The problem statement of a thesis presents the context and the issues that
caused the researcher to conduct the study. ( Regoniel,P.A., 2015).

A conceptual framework is used to illustrate what you expect to find through your research,
including how the variables you are considering might relate to each other.

You should construct one before you actually begin your investigation. (Swaen,B., 2017).

Figure 1.Sample Conceptual Framework. (Swaen,B., 2017).

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To conclude; Conceptual Framework:

a) Often labeled the “literature review”

b) Why is this potentially dangerous?
 Your theory of what is happening is something you build, it is not found
 Uncritical “literature review” can make your conceptual framework overly descriptive
 “The literature” is not the authority; it is a fallible source of ideas and ways of seeing the
world.
 You need to think about what is useful and what is not, what is missing, and how can you
fill the gap?
c) Logically linking the components the research design
 Goals: What do you want to know and why?
 Research Questions: What specifically do you want to know?
 Methods: How will you answer your questions
 Interpretation: How will you understand your results?
d) Developing your Conceptual Framework
 Try to answer these questions:
 What do you think is going on with the issues, setting or people you plan
to study (what is your theory)?
 What established theories, beliefs, and prior research findings inform your
current understanding of what is going on?
 What literature, preliminary studies, and personal experiences will you
draw on in your research and why?
e) As you develop your conceptual framework keep in mind:
 How are my goals influencing this framework?
 Am I introducing bias
 Can we think of an example where this would be the case?
 What do you know and what do you need to find out? What are the gaps?
 This will move you toward specific questions.
 Will help you to think critically about the existing theories/literature.
(Regoniel,P.A., 2015).

Testing research

Whether constructing a conceptual framework will be a helpful exercise depends on the type of
research you are doing. Conceptual frameworks are particularly common when the research
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involves testing. In this situation, a framework can be used to review your hypotheses or explore
if you can scientifically prove a particular idea. (Swaen,B., 2017).

Cause-effect relationship

The basis of testing research – and thus the start of constructing a conceptual framework – is
often a cause-effect relationship. If your dissertation involves this kind of research, your goal is
to try to prove such a relationship. (Swaen,B., 2017).

Example of a cause-effect relationship

Ben, a student, gets a perfect 100% on the big exam, which surprises his classmates. However,
Ben has a very good explanation: he studied for many hours (the cause) and therefore scored
well (the result).

Ben is so excited when he realizes that his hard work has resulted in a great score that he decides
he wants to write his dissertation on the experience. His goal is to demonstrate scientifically that
his high score was not just the result of luck, but rather of a cause-effect relationship.
(Swaen,B., 2017).

2.2 Variables

The first step in scientifically demonstrating a cause-effect relationship is to map your

expectations using a conceptual framework. Before doing so, it’s important to identify the
relevant variables. (Swaen,B., 2017).

Variables are simply the characteristics that the cause-effect relationship is describing. In our
example, the two variables are “hours of study” and “exam score.” (Swaen,B., 2017).

Independent and dependent variables

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A cause-effect relationship always involves two types of variables: independent and dependent.
In our example, “hours of study” is the independent variable, while “exam score” is the
dependent variable. In other words, “exam score” depends on “hours of study.”

Cause-effect relationships frequently include several independent variables that affect the
dependent variable. Another independent variable that we could add to our example would be
“enough time to answer all of questions during the exam period.” However, to keep things
simple we’ll work with just one independent variable, namely “hours of study.”

2.3 Designing a Conceptual Framework

Now that we have identified both an independent variable and a dependent variable, we can
begin constructing a conceptual framework. The basic design components are boxes, arrows, and
lines.

Create a box for each variable. Use arrows to indicate cause-effect relationships. Each arrow
should start from the variable that has causal influence and point to the variable that is being
affected. Use a line when you expect a correlation between two variables, but no cause-effect
relationship.

These components can be summarized as follows:

Component Meaning

Box Variable

Arrow Causal influence (cause-effect

relationship)

Line Connection (correlation)

Here is a sample conceptual framework that represents the relationship between the independent
variable of “hours of study” and the dependent variable of “exam score” from the example with
Ben:
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Figure 2. Sample conceptual framework using an independent variable and a dependent

variable. (Swaen,B., 2017).

2.4 Expanding the Conceptual Framework

A conceptual framework doesn’t have to be limited to just independent and dependent

variables; other types of variables can be incorporated as well. Depending on your
research, you may wish to show additional facets of a cause-effect relationship by
introducing one or more of the following:

 Moderator variables
 Mediator variables
 Control variables (Swaen,B., 2017).

 Moderator variables

If you create a conceptual framework to explore a cause-effect relationship, you often need to
deal with moderators. Moderators are special variables.

Moderator variables in a conceptual framework

This is a continuation of a research that explained what independent and dependent variables
are and what a conceptual framework should contain. The example used in that paper was the
story of Ben, a student who put in many hours of studying (independent variable) in order to
 25

get a higher score on his exam (dependent variable). Now it will expand the original
framework by adding a moderator variable.

A moderator variable alters the effect that an independent variable has on a dependent
variable, on the basis of the moderator’s value. The moderator thus changes the effect
component of the cause-effect relationship between the two variables. This moderation is
also referred to as the interaction effect.

Figure 3.Sample conceptual framework with a moderator variable (Swaen,B., 2017).

In the example we introduced in the conceptual framework article, the number of hours Ben
studies is related to the score he will get on the exam. It seems logical that the more he
prepares, the higher his score will be. (Swaen,B., 2017).

 Mediator variables

A mediator (or mediating) variable is an integral part of a cause-effect relationship. It makes

it easier to understand how the independent variable is affecting the dependent variable and
what is governing that relationship.

Mediator variables in a conceptual framework

This is a continuation of a research that explained what independent and dependent variables
are and what a conceptual framework should contain. The example we used in this paper was
the story of Ben, a student who put in many hours of studying (independent variable) in order
 26

to get a higher score on his exam (dependent variable). Now it will expand the original
framework by adding a mediator variable.

A mediator variable comes between an independent variable and a dependent variable in a

cause-effect relationship and allows that relationship to be better explained. Mediator
variables can be very difficult to interpret and care must be taken when conclusions are being
drawn from them. It is therefore critical that mediator variables are always underpinned by
statistical analysis.

The complexity involved is beyond the scope of the paper, so it will not go into great detail.
Instead it will focus on helping to develop a basic understanding of what a mediator variable
is and when it may need to be considered.

Going back to our example of Ben and his exam preparation, here is how the conceptual
framework might look if a mediator variable were involved:

Figure 4. Sample conceptual framework with a mediator variable. (Swaen,B., 2017).

The more hours Ben studies, the more practice problems he will complete; the more practice
problems he completes, the higher his exam score will be. By adding the mediator variable of
“number of practice problems completed,” could be strengthen the cause-effect relationship
between the two main variables being explored. (Swaen,B., 2017).
 27

 Control variables

While it may be helpful to incorporate control variables into your research, they are generally not
a main area of focus. They have an effect on the dependent variable and by extension on the
independent variable.

If you omit control variables from your study, the results will be less accurate. This is
particularly relevant if you are planning to prove a particular cause-effect relationship by
undertaking a statistical analysis.

Control variables in a conceptual framework

This is a continuation of a research that explained what independent and dependent variables are
and what a conceptual framework should contain.

In the example of Ben and his exam, a control variable could be “health.” It could be argued that
if Ben is feeling ill, he will get a lower score on his exam (i.e. health will influence the dependent
variable). The below figure illustrates how the revised conceptual framework would look in this
case.

Figure 5. Sample conceptual framework with a control variable

If you wanted to conduct a survey among students to demonstrate statistically that there is indeed
a cause-effect relationship between “hours of study” and “exam score,” it would be wise to ask
about each student’s health. If you did not, you would not be able to consider “health” as a
control variable in your research and it could be much harder to demonstrate the cause-effect
relationship. (Swaen,B., 2017).
 28

2.5 The Position of Conceptual Framework

Conceptual Framework is like pre-planning wherein we define what the research will include.
However, the position of conceptual framework within Qualitative and Quantitative Research
varies. The table below explains the difference in position. (How to Define the Conceptual
framework; retrived from https://mail.google.com).

Figure 6. Position of the Conceptual Framework

2.6 How to Develop Conceptual Framework?

There are several inputs which are essential when working on a conceptual framework. The two
main elements are;

1. Experiential Knowledge: technical knowledge, research background and personal

experience.
2. Literature Review: related theory, related research and other theories and research
related to the topic.
 29

The key steps for development of conceptual framework are:

1. Identify the key variables used in the subject area of your study.
2. Draw out key variables within something you have already written about the subject area
i.e. literature review.
3. Take one key variable and then brainstorm all the possible things related to the key
variable.
4. After all the variables have been defined, focus on number of relationships they can
form with each other to determine the inter-relationships between all.

It can be presented in the form of; flow diagrams, tree diagrams, mind maps or even shape
based diagrams. (How to Define the Conceptual framework; retrived from
https://mail.google.com).

2.7 Why are Conceptual Framework Useful?

 Conceptual frameworks provide researchers with:

– The ability to move beyond descriptions of ‘what’ to explanations of ‘why’ and

‘how’.
– A means of setting out an explanation set that might be used to define and make
sense of the data that flow from the research question.
– An filtering tool for selecting appropriate research questions and related data
collection methods.
– A reference point/structure for the discussion of the literature, methodology and
results.
– The boundaries of the work (Vaughan,R., 2008).

2.8 What are the Limitations of Conceptual framework?

 The conceptual framework encapsulates the research as it:

 30

– Sets out the focus and content.

– Acts as the link between the literature, the methodology and the results
(regardless of when in the PhD process it is produced).
– Thus it can be/will be the focus/starting point of the evaluation of originality in
terms of the criteria outlined by Hart (1998). For example:
– Is what has been focussed on entirely new?
– Is the way the subject been investigated different to the ‘normal’ approaches?
– Has new light been shed on previously explored issues. (Vaughan,R., 2008)
–

2.9 A Sample Evaluation of a Conceptual Framework

A CONCEPTUAL MODEL OF FETO-INFANT MORTALITY IN LATE AND LOW

FERTILITY CONTEXT

Introduction

Many researches have been undertaken in order to detect the influence of social and biological
factors on feto-infant mortality. The epidemiological and medical literature focuses more on
the biological factors while the demographic literature focuses on social factors. The awareness
by social scientists of the importance of linking both types of factors in order to understand the
feto-infant mortality process is not new however (e.g. Gortmaker (1979), Mosley and Chen
(1984), Cramer (1987)). In other words, authors generally recognize that the search for the
determinants of feto-infant mortality has to pass through a conceptual framework, namely a
comprehension of the direct and indirect mechanisms leading to feto-infant death.
Simplifying the pathway, socio-economic factors influence biological factors which ultimately
play a role on feto-infant mortality. The general idea behind the construction of a conceptual
framework is to highlight the causal mechanisms leading to a particular event, in this present
case to feto-infant death. Based on a conceptual framework, any relation has to be interpreted
from a causal point of view rather than a simple association between two or more variables.

In the context of the developed countries, some studies set up their empirical model of the
determinants of infant mortality on a conceptual model. Due to the huge number of socio-
 31

economic factors affecting infant mortality and the risk of detecting spurious association (due to
the high correlation between potential social factors), Cramer (1987) has developed a conceptual
model of infant mortality. Based on this conceptual model, his objective is to use a causal
modeling approach in order to detect direct and indirect effects of the socio-economic factors.
Hopeless Cramer limited his conceptual framework on the indicators he has access to (birth and
infant death records from single live births in California - 1978). More precisely he considers
that maternal age, marital status, race and education (socio-economic factors) influence
birth order, birth weight and prenatal care (intervening variables which finally influence the
infant mortality). A statistical tool (hierarchical log-linear model) is applied in order to control
for spurious association and to test interaction. Cramer does not at all control for the impact of
the unobserved variables however. He can consequently not interpret his results from a causal
perspective. Indeed, unobserved factors might again lead to spurious association. Sharma (1998)
limits also his conceptual framework to the available variable of interests. His conceptual
framework is composed of two social factors (maternal education and marital status) and
several proximities determinants (health care, gestation duration, birth weight, maternal age,
birth intervals and intergenerational risk). Based on this model, nested logistic regression is used
to implement the causal structure proposed in the conceptual framework. Analyzing infant
survival in the Czech Republic, Rychtaˇryk´ ova´ and Demko (2001) highlight also the direct and
indirect mechanisms through which socio-demographic factors (maternal age, birth order,
marital status, maternal education and region of living) influence infant mortality. They consider
only gestation duration and birth weight as proximate variables. The same comment as earlier
can be made...the conceptual model is limited to available information! Before making use of
any statistical tools, Matteson et al. (1998) think about a conceptual model of infant mortality
independently of the indicators they are going to use in the empirical model. The framework is
made of three main components: the approximate determinants (biological determinants), the
background determinants (the mother’s social, demographic and economic characteristics) and
the community factors (the characteristics of the community in which the mother and the child
live). The suggested model is however too broad and there is a lack of information on the
different mechanisms through which each determinant influences directly or indirectly infant
mortality. The conceptual model is consequently not useful to study the determinants of infant
mortality from a causal point of view.
 32

Known as high indicators of infant morbidity/mortality, numerous researches have been

interested in the risk factors of preterm birth and of low birth weight. In such a context, some
conceptual framework has also been proposed. For example, Misra et al. (2001) include three
main concepts in the causal chain leading to preterm delivery. Social factors (such as socio-
economic status and race) influence the psychosocial factors (stress, pregnancy locus of control,
depression) which ultimately influence biomedical factors (chronic diseases, complications of
pregnancies and health behaviours). Finally, the biomedical factors influence the risk of preterm
birth. Note that the authors include also a direct effect of the social factors on the biomedical
factors. The impact of these factors on the risk of preterm birth is obtained using multiple
logistic regression (sequential model building) and by comparing parameters of these
regressions. Kramer et al. (2001) suggest also a causal pathway from socio-economic status to
preterm birth. They emphasize two particular pathways. The first one going through chronic and
acute stress factors, the second one through the combined effect of a genetic defect and low
folate intake. Their model, while quite documented and well-constructed, appears however too
narrowly targeted to these two intermediary factors. Other important factors (such as prenatal
care) are not integrated in the model, which can leads to spurious associations. Other
researchers present conceptual model of preterm birth or of low birth weight but limit
themselves to the impact of certain biological factors or of particular selected behaviours on the
risk of preterm birth (e.g. Sheehan (1998): impact of stress on low birth weight).

This example shows that the suggested conceptual models of feto-infant mortality or morbidity
generally focus on specific variables of interests and, more damaging, are limited the available
information, namely the indicators available from a particular database. This last argument
makes it difficult to distinguish between the conceptual framework and the so-called operational
framework, precludes interpretation in terms of causal effects and makes difficult the
decomposition of the effects of the determinants of feto-infant mortality into direct and indirect
effects. The objective of this paper is consequently to propose a conceptual framework of feto-
infant mortality, in a late fertility context. The model must of course simplify the reality in
order to highlight the main relevant causal mechanisms and make the model testable. It must
also be independent upon the indicators which will be used later on in order to estimate causal
effects. In such a way, it will become possible to detect the impact of the non-observed
 33

concepts on the causal interpretation. Being aware of the complete theoretical pathway allows
to detect, in the estimation, the presence of spurious association due to non-observed variables
and to interpret the results consequently.

The set of causal pathways leading to feto-infant death is based on a review of the demographic,
epidemiological and medical literature on the determinants of feto-infant mortality in late and
low fertility countries. The intention is clearly not to make a meta-analysis of the determinants of
feto-infant mortality but clearly to highlight the main causal mechanisms. ( Vandresse,M.).

Conceptual Framework

Figure 7. Conceptual Framework ( Vandresse,M.).

I. Deptndant Variables:
 Feto-infant mortality: Feto-infant mortality refers to deaths coming from
clinically identified pregnancies until the first year of life of the infant (from
birth). ( Vandresse,M.).The Feto- infant mortality rate will depend on the below
mentioned independent variables.
 34

II. Independent Variables:

 Socio- economic characteristics:
 A low socio-economic status are more exposed, not only to acute (life
events) and chronic (difficult life conditions) stressors but also to less social
support. These elements influence the mother’s health status and of the
newborn’s health. . For example a higher degree of education allows for a
better knowledge of health practices, for a better comprehension of the
advices given by the medical staff and make parents aware of the importance
of the medical follow-up.
 The access to adequate medical care during and after the pregnancy might
depend on couple’s income.
 Socio-economic characteristics influence also the timing and frequency of
prenatal consultations.
 An increasing risk of preeclampsia and hypertension with characteristics of
the work such as long working hours, strenuous physical activity or heavy
work.
 Maternal education is seen as an important determinant of maternal age at
conception.
 Family education.
 Lifestyle (e.g. stress at work or at home, poverty) might influence the
consumption of alcohol and tobacco.
 Income level .Financial access to prenatal care is easier for couples with a
certain level of income. The access to adequate medical care during and after
the pregnancy might depend on couple’s income. Women who do not have
enough money for food or housing are more at risk of depressive symptoms or poor
physical functioning. ( Vandresse,M.).
 35

 Maternal age
 For example, older women (> 35) have a higher risk of hypertension or
diabetes. In a late fertility context, an older mother could also envisage to
reduce birth interval in order to attain the desired number of children.
However, the impact of maternal age is more important on the risk of
congenital anomalies.
 The increase in biological weaknesses directly related to maternal age such
as loss of elasticity of the pelvic joints (which increases the resistance of the
birth canal during the second stage of the labour) or a reduction of the
expulsion force is the second one.
 Down’s syndrome is the most famous congenital anomaly linked to maternal
age. Other abnormalities; congenital heart defects. Congenital anomalies and
genetic diseases.
 On the risk of spontaneous abortions. Spontaneous abortion appears from 35
years of age.
 An increasing risk of of fetal loss with maternal age (from 30 years old
 Older women are more at risk of fetal deaths.
 Maternal age is a risk factor of infant mortality.
 An increasing risk of low birth weight has also been observed for younger or
older women.
 Young mothers <18 years) and elderly (>40 years) are at higher risk of
preterm birth.
 Similarly, general health status of the mother decreases with age (large
number of chronic diseases such as hypertension or diabetes) which may lead
to an increasing risk of preterm birth. ( Vandresse,M.).
 Parental age
 Quality or the quantity of spermatozoa. (Higher frequency of sperm
chromosome aberrations in older men).
 Paternal ageing leads to new dominant autosomic mutations13 causing
congenital anomalies, such as achondroplasia, Marfan syndrome.
 36

 Paternal age also influences the genetic capital of the offspring: there is an
increasing risk of genetic diseases with higher paternal age, and as a
consequence, an increasing risk of congenital anomalies or fetal deaths. (
Vandresse,M.).
 Behavioral characteristics
 The behavioural characteristics combine several behaviours of the parents
during pregnancy and after delivery: smoking and drinking habits, nutrition
etc.
 Maternal smoking has been detected as risk factor for limb reduction
defects and low birth weight, Intra Uterine Growth Retardation (IUGR) or
infant Death Syndrome (SIDS).
 Exposure to environmental cigarette smoke (such as smoking habits of the
father) might also influence birthweight. Passive smoking (such as reduced
placental blood flow due to nicotine).
 Prenatal consultations might also influence maternal health states. One of
the objectives of prenatal care is to prevent and detect major complications.
 Exposition to chemical environment is often cited as risk factors of
congenital anomalies.
 And anxiety also associated with spontaneous preterm delivery and low
birth weight and IUGR, even after adjustment for the socio-demographic
variables.
 Attendance of pre- and post-natal care consultations (frequency and
calendar). ( Vandresse,M.).

 Environmental characteristics
 Environmental characteristics gather the characteristics of the region of
living (or of working), such as housing conditions, pollution (around home
or at work), climate.
 Environmental risk factors for congenital anomalies, including among others the
chemical factors and occupational exposures.
 Increasing risk of genetic diseases with ionizing radiation (IR) exposures.
 37

 Chemical exposures as a risk factor of congenital anomalies. They limit the

chemical exposures to environmental pollution such as drinking water
contamination, waste disposal, pesticides in agricultural areas, air and
industrial pollution and food contamination.
 Few environmental pollution exposures significantly influence the risk of
congenital anomalies. ( Vandresse,M.).
 Biological characteristics
a. Maternal characteristics
The maternal characteristics are grouped into two categories.
 Reproductive history (number of previous live births, the number of
previous stillbirths or the number of previous spontaneous abortions.
 The general health state of the mother during pregnancy and (possible)
breastfeeding is the second category. (Deficiency in vitamins B-12, obesity
or diabetes, optimal metabolic control, drugs used to treat epilepsy).
 Increasing risk of congenital anomalies with maternal epilepsy is partly
attributable to the teratogenicity of the drugs used to treat epilepsy.
 Mother’s health state has an impact on the risk of congenital anomalies.
 The effect is still present after controlling for maternal age, race,
education and family income.
 On preterm birth, mention past obstetrical history and prenatal care as two
important factors influencing preterm birth.
 Biological mechanisms linking induced abortions to preterm births are
namely incompetency of the cervix, infections.
 Previous spontaneous abortion being a risk factor of preterm delivery and
growth retardation.
 Birthweight might also be influenced by the mother’s weight and the last
interpregnancy intervals.
 Excessive maternal weight gain and obesity are two risk factors of fetal
macrosomy.
 38

 Low maternal weight gain and low prepregnancy weight as two major risk
factors of low birth weight and preterm birth. ( Vandresse,M.).

b. Fetal characteristics
 Congenital abnormalities(due to chromosome abnormalities)
 Physical disability
 Mental disability ( Vandresse,M.).

 Physical characteristics

 Weight. In case of macrosomy, the risk of a difficult delivery or of a

caesarean increases. Consequently, the infant mortality (and early neonatal
mortality more particularly)
 Gestation duration. (Gestation duration of at least 22 weeks is the minimal
thresholds recommended for declaration by the World Health
Organization).
 Weight at birth ( Vandresse,M.).
c. Obtetrical characteristics
The obstetrical characteristics include all variables linked to complications
occurring during the delivery and to the conditions of the delivery. (For
example, the mode of delivery of the previous pregnancies influences the
current pregnancy and obesity and gestational diabetes are risk factors of
shoulder dystocia). ( Vandresse,M.).
 Some of particular relations: (Moderator variables, Mediator variables and Control
variables)

The potential links between parental age, socio-economic variables and the three main biological
variables.(moderate and mediator variables) The socio-economic variables might have an effect
on the behavioural characteristics, on the maternal characteristics, on the fetal characteristics and
on the obstetrical characteristics.(Control variables).Paternal age seems to influence the fetal
characteristics only. Maternal age influences the maternal characteristics, the obstetrical
 39

characteristics and the fetal characteristics. In this figure, the behavioural characteristics have a
direct effect on mortality.

Congenital anomalies are one of the main causes of feto-infant mortality. Statistics for Brussels
(Belgium), for the period 1998-2002, show that 20% of feto-infant mortality is linked to
congenital anomalies (Observatoire de la sante´ et du social, 2004). Furthermore, an important
risk factor of congenital anomalies is maternal age. While, until recently, interest lies exclusively
on maternal age, interest for paternal age as risk factor of congenital anomalies takes more and
more interest. In order to take these facts into account, the fetal characteristics are decomposed
into two groups of variables: the congenital anomalies and the physical characteristics of the
newborn. The physical characteristics of the child at birth include ”observable” characteristics of
the newborn, such as weight, sex, parity, multiple births or gestation duration, that are not
associated to congenital anomalies. ( Vandresse,M.).

To conclude:

This note presents a conceptual model of feto-infant mortality which has been constructed step
by step according to the context of interest, namely the delayed fertility observed in numerous
developed countries. First, the conceptual model is based on a review of the literature gathering
the actual theoretical knowledge of the process and past empirical results. A conceptual
framework can definitely not be restricted to the available data. Secondly, the conceptual
framework simplifies reality. All concepts and their multiple interactions cannot be inserted, at
the risk of becoming untestable. It is consequently necessary to select the most relevant (groups
of) variables and their relationships. Thirdly, the framework is adapted to the context. As
example, the problematic of feto-infant mortality is not identical in the developed and developing
countries. Some concepts are highlighted according to the context. In the present context, namely
late and low fertility, both parental ages and congenital anomalies have been underlined.
Fourthly, a conceptual framework should be falsifiable, namely confortable with reality. This
confrontation is of course restricted to the available data. Finally, the interpretation of the
mechanisms presented in the model. The construction of this conceptual framework is the first
necessary condition for analyzing the variables of feto-infant mortality from a causal point of view, with
the distinction between direct and indirect effects.
 40

Conclusion

A There are a number of ethical principles that should be taken into account when performing
undergraduate and master's level dissertation research. At the core, these ethical principles stress
the need to (a) do good (known as beneficence) and (b) do no harm (known as non-malfeasance).
In practice, these ethical principles mean that as a researcher, you need to: (a) obtain informed
consent from potential research participants; (b) minimize the risk of harm to
participants; (c) protect their anonymity and confidentiality; (d) avoid using deceptive practices;
and (e) give participants the right to withdraw from your research. This article discusses these
five ethical principles and their practical implications when carrying out dissertation research.

A conceptual framework is the system of concepts, assumptions, expectations, beliefs, and

theories that support and inform your research. Furthermore it explains either graphically or in
narrative forms the main things to be studied, the key factors, concepts or variable and the
presumed relationships between them (Miles and Huberman 1994).

By doing this assignment the writer was able to identify the general principles and procedures for
protecting participants in a nursing research. It is imperative that human beings who are
involving in research should be guided by ethical principles.

Next, by critically evaluating the major characteristics of a conceptual framework that related to
a nursing research, the writer could be able to identified clarity on the relationship among the
variables of a research related to a conceptual framework.
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References

Cabanto,J,C.,& Padua,G.M. (2013). Ethical Principles in Nursing

Researchhttps://mail.google.com/mail/u/0/#inbox/16138cd14a017c8b.

Ethics in Nursing Research. https://www.slideshare.net/drjayeshpatidar/ethics-in-nursing-

research

Gortmaker, S. L. (1979). Poverty and infant mortality in the United States. American
Sociological Review, 44(2):280–297.

How to Define the Conceptual framework. (n.d.).

https://mail.google.com/mail/u/0/#inbox/1612122209742ce7?projector=1&messagePartId=0.1.

Kramer, M., Goulet, L., Lydon, J., et al. (2001). Socio-economic Disparities in Preterm Birth:
causal pathways and mechanisms. Paediatric and Perinatal Epidemiology, 15(suppl.2):104–132

Misra, D., O’Campo, P., and Strobino, D. (2001). Testing a Sociomedical Model for Preterm
Delivery. Paediatric and Perinatal Epidemiology, 15:110–122.

Regoniel,P.A. (2015). Definition of Conceptual Framework.

http://simplyeducate.me/2015/01/05/conceptual-framework-guide/.

Sitko,N.J. (2013). Conceptual Framework and Research Questions.

file:///C:/Users/hp/Downloads/Conceptual_Framework_and_Research_Questions.pdf.

Swaen,B. ( 2017). Conceptual framework. https://www.scribbr.com/dissertation/conceptual-

framework/.

Vandresse,M. (n.d.). A Conceptual Model of FetoInfant Mortality.

file:///C:/Users/hp/Desktop/DT_26_vandresse.pdf.

Vaughan,R. (2008). conceptual framework.

https://mail.google.com/mail/u/0/#inbox/1611e6a24c35f7c8.