Introduction to nursing research

Gugsa Nemera
(RN, BScN, MScN,Aasst. Prof, PhD fellow )
Feb, 2017
Jimma, Ethiopia

3/2/2017 GN, Feb 2017, PG nursing 1

 Outline
Objective
Introduction to scientific research
Description of scientific method
Goals of scientific research
Nursing research and scope
Importance of nursing research
The Consumer–Producer Continuum in Nursing Research
History of nursing research
Paradigm and nursing research
Paradigms and Methods
Purpose of nursing research
Type of nursing research
Choosing research topic
Elements and ethics in research
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 Objective

• At the end of this session the learner will be able to

1. Discuss scientific methods and its application in nursing

2. Describe basic concepts and terms in undertaking

research

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 Introduction to scientific research

• RE – SEARCH
– The word was derived from the old French word
cerchier, meaning to“seek or search”.

– The prefix re means “again” and signifies

replication of the search.

– One seeks new knowledge or to directly utilize

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 Introduction to scientific research
Research

– Advances science

– Systematic ways of thinking and gathering evidence to:-

• Answer questions

• Acquire new knowledge

• Solve problems.

– Have the same general goals and defining characteristics

across the diverse discipline/field of study

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Purpose of scientific research in all discipline

Inventing new knowledge

Describing Event/thing
Explanation of things
Discovering relationship between phenomena
Making predication about future event
Expansion of our understanding
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 Defining characteristics of scientific research

Scientific method
Testing

Hypotheses

Careful observation and measurement

Systematic evaluation of data

Drawing valid conclusions.

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 Overview of science and scientific method
Science
• A methodological and systematic approach to
the acquisition of new knowledge
• Scientists attempts to gain new knowledge
– Through causal observation
– By making careful observation
– Using systematic, controlled, and methodical
approaches

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 Overview of science and scientific method ..

Scientific knowledge
• Not based on the opinions, feelings, or
intuition of the scientist
• Based on objective data that were reliably
obtained in the context of a carefully designed
research study

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 Overview of science and scientific method ..
Scientific method

• Distinguishes science from non science

• Deals with general approach to research than content

• Provides a set of clear and agreed upon guidelines for

gathering, evaluating, and reporting information in the
context of a research study

• Evolutes through time

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 Overview of science and scientific method ..

Origin of scientific method

• Confusing

• Some usually credited to Roger Bacon (13th-century

England philosopher and scientist)

• Some credited it to Italian scientist Galileo Galilei.

• Later to philosophers Francis Bacon and René

Descartes.

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 Overview of science and scientific method ..
Element of scientific methods
• There is some disparity among scientists on exact
characteristics of the scientific method
• Most agreed on are following elements:
1. Empirical approach
2. Observations
3. Questions
4. Hypotheses
5. Experiments
6. Analyses
7. Conclusions
8. Replication
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 Element of scientific methods..
Empirical approach:
– An evidence-based approach that relies on direct
observation and experimentation for
• Acquisition of new knowledge.

• Making scientific decisions

– The best thought as the guiding principle behind

all research conducted

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 Element of scientific methods..

Observation:
• Refers to two distinct concepts
– Being aware of the world around us
– Making careful measurements

• Require measurement device that has a high

degree of accuracy and reliability

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 Element of scientific methods..
Operational definition:
• An important aspect of observation measurement that Helps
to :-
– Define key concepts and terms in the context specific
research.
– Create understanding among researchers on a given
phenomenon.
– Ensures that the researcher’s study can be replicated by
other researchers

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 Element of scientific methods..
Questions:
• Research title/problem
• Research process next to research idea
• Should be answerable research question.
• But not this question,” Is there an exact replica of
me in another universe?”

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 Element of scientific methods..
Hypothesis:
• An educated and testable guess to answer research question
• Often described as an attempt by the researcher to explain the
phenomenon of interest
• Can take various forms depending on the type of research design
used
• For example correlation study hypothesis describe how two things
may be related.

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 Element of scientific methods..
Key feature of all hypotheses
• Make prediction
– Explanation of variables understudy
– Testing Variable through gathering and analyzing
data

• Can either be supported or refuted

• Typically phrased as if…. Then…. Statement
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 Element of scientific methods..
Types of hypothesis
1. Null hypothesis
 Predicts absence of difference between two
groups
2. Alternative hypothesis
 Predicts presence of difference between two
groups

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 Element of scientific methods..

Experiment:

• Caring out an actual research on the field

• Next step after articulating the research

hypothesis

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 Element of scientific methods..
Analysis:

• Use of statistical technique to analyze the gathered data

• The type of statistical technique to be used depends on the

type of data being gathered; study design used and
question being asked

• Even though conclusion on deference between two groups

is based on statistical analysis, during making decision the
can make two types errors

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 Element of scientific methods..
Type I error:
• Made when the researchers conclude difference and in fact no
difference
• Sometimes called as false positive (significant result that occurs by
chance (error) in fact no deference.
Type II error:
• Made when researcher conclude absence of difference and
between in fact there is deference.

• Sometimes called false negative.

• No statistical significance in fact there is deference

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 Element of scientific methods..
Conclusion:
– Made only when supported by analyzed data

Replication:
– One of the most important elements of the scientific method
– Getting the same result on second time study on another subject

Methodology:
– Principles , procedures, and practices that govern research
– Encompasses entire process of conducting research.

Research design:
– Plan used to examine the question of interest (ways in which research
can be conducted to answer the research question).
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 Goals of scientific research
• Ultimate goal
– To develop, refine, and expand a body of
knowledge/ acquire new knowledge
through
• Description
• Prediction
• Understanding /explanation

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 Goals of scientific research…
Description:
– The most basic and easily understood goal of scientific
research
– Refers to classifying, defining and categorizing
phenomenon of interest
– A researcher may have a goal to describe phenomena
or relationship between two phenomenon
– Descriptive research provides information regarding
the average member of the group.

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 Goals of scientific research ..

Prediction:

• Involve predicting one thing based on

knowledge of something else

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 Goals of scientific research …

Understanding/ explanation: -
– Describing and identifying cause or causes of
phenomenon

– Establishing Causal inferences depends on type

of research design

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 Goals of scientific research ….
• Prerequisite for establishing causal inference include:

– There must be correlation (covary) between two

events

– One event (the cause) must precede the other

event (effect)- sometimes called time-order
relationship

– Alternative explanation for observed relationship

must be ruled out
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 Nursing research and scope
• Is systematic inquiry designed to develop knowledge
about issues of importance to the nursing profession:-
– Nursing practice
– Nursing education
– Nursing administration
– Nursing/health care delivery system
– Nursing informatics
– Nursing history .

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 Importance of nursing research
• Adopting evidence based practice
• Developing new knowledge
• Solving problem
• Clarifying concepts
• Providing information’s for effective decision
making

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 The Consumer–Producer Continuum in Nursing
Research

• It is every nurse’s responsibility to engage in

one or more roles along a continuum of
research participation

• Involvement of each nurse in research can be

indirect (consumers) or direct (producers).

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 Consumers of nursing research
• Read research reports to develop new skills
and to keep up to date on relevant findings
that may affect their practice.

• Research utilization (use research findings in

a practice setting)

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 Producers of nursing research

• Nurses who actively participate in designing

and implementing research studies

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 Research activities between continuum of producing and consuming

• Participation in regular meetings among nurses to discus and

criticizing research article
• Attending research presentations
• Discussing the implication and relevance of research findings for
client, nursing, education and leadership
• Assisting in collection of data
• Reviewing proposed research plan
• Collaborating in development of idea in research project
• Participating in IRB
• Evaluating research output for its practical applicability
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 Nurse’s role in research
(ANA-1989)

BSN Degree -
• Critiquing & synthesizing research findings from
nursing profession and other discipline for use in
practice.

• Provide valuable assistance in identifying

research problems and collecting data for studies.

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 Nurse’s role in research……
Master's Degree
• Lead health care teams
 Making essential changes in nursing practice
 Health care system based on research

• Conduct investigations
• Initiate studies in collaboration with other
investigators
• Facilitate research and provide consultation
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 Nurse’s role in research……
Doctoral Degree

• Assume a major role in the conduct of research.

• Generation of nursing knowledge in a selected

area of interest.
o Extend scientific basis

o Develop methods to measure nursing phenomena

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 Nurse’s role in research……
Post Doctoral Degree

• Assumed a full researcher role and has a funded

program of research

• Develop and coordinate funded research programs

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 History of nursing research
1. Early years
– From Florescence Nightingale to 1950’s

2. In 1960’s

3. In 1970s

4. in 1990s

5. Future research

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 Early years- Nightingale to 1950’s
• Nursing research starts with Florescence Nightingale.
• In 1859 Nightingale published note on nursing which
describes her interest on environmental factors that
promote the physical and emotional well-being.
• Nightingale’s most widely known research contribution
involved her data collection and analysis relating to factors
affecting soldier mortality and morbidity during the
Crimean War

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 Early years- Nightingale to 1950’s
• Between 1900& 1940 are related to nursing
education.
• In 1923 a committee of nursing education
issued Gold mark report which identified
inadequacies in educational back ground.
• In 1948 Brown again repotted the
inadequacies in nursing education.

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 Early years- Nightingale to 1950’s
In 1950’s –in nursing research due to:
1. Increased number of nurses with advanced
degree
2. The establishment of nursing research center
at Walter Reed Army Institute of Research
3. Availability of funds from both government
and privative organization
4. Inception of American nurse’s foundation

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 Early years- Nightingale to 1950’s
In 1950’s –self study
1. Who is the nurse?

2. What does the nurse do?

3. Why do individuals choose to enter nursing?

4. What are the characteristics of the ideal nurse?

5. How do other groups perceive the nurse?

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 In 1960’s
• Practice oriented research emerged
• Conceptual framework
• Conceptual model
• Nursing process
• Theoretical base of nursing practice began to appear
• Nursing advanced worldwide (IJN-1963, CJNR-1968)

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 In 1970s

• Focus of research change from teaching,

curriculum and nurses themselves to
improvement of client care

• Utilization of research began

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 In 1990s
• Nursing science come into maturity
• Nursing become visible at national level (national
institute of nursing research established-NINR)
• Several journals established
• Future direction of nursing research
• Promotion of excellence in nursing science

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 Future research
1.Outcome research
• Assess and document the effectiveness of
health care service
• Stimulate cost effective outcome without
compromising quality
• Focus on patient and overall delivery system

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 Future research …

2.Biophysiologic research
• Biologic and physiologic phenomenon
– Anxiety
– Pain
– Stress
– Aging

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 Future research …..
3. Evidence based practice
• Understanding, critiquing and using study results

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 Future research …..
4.Development of a stronger knowledge base

• Through multiple, confirmatory strategies.

– Deliberate replication of study in different setting, client
and time to ensure robust finding

– Conducting multiple site investigation by researcher in

different location

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 Future research …..

5.Strengthening of multidisciplinary
collaboration

6.Expanded dissemination of research findings

7.Increasing the visibility of nursing research

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 Paradigm and nursing research
Paradigm
• A world view
• A general perspective on complexities of real world
• Paradigms for human inquiry characterized in terms of
the ways response to basic philosophical questions:
1. Ontologic:
• What is the nature of reality?
2. Epistemologic:
• What is the relationship between the inquirer and that being
studied?
3. Axiologic:
• What is the role of values in the inquiry?
4. Methodologic:
• How should the inquirer obtain knowledge?
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 Types of paradigm

1. Positivist paradigm

2. Naturalistic paradigm

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 Positivist paradigm

• 19th century thought guided philosophers like

Comte, Mill, Newton, and Lucke.

• Reflects modernism (rational and scientific)

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 Positivist paradigm-Ontologic assumption

• There is reality out there that can be studied and known

• Nature is basically ordered and regular

• Objective reality exists independent of human observation

• World is assumed not to be merely a creation of the human mind

• Phenomena are not haphazard or random events but rather

have antecedent causes- determinism (related assumption)

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 Positivist paradigm-Epistemologic assumption

• Positivists seek to be as objective as possible

in their pursuit of knowledge

• Researchers are Independent of those studied

• Finding is not influenced by researcher

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 Positivist paradigm-Axiologic

• Hold personal values and biases to prevent

contamination

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Positivist paradigm-Methodologic assumption
• Scientific approach involves the use of orderly, disciplined
procedures

• Deductive processes

• Emphasis on discrete, specific concepts

• Verification of researchers hunches

• Fixed design

• Tight controls over context

• Emphasis on measured, quantitative information; statistical analysis

• Seeks generalization

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 Naturalistic paradigms
• Began with countermovement to positivism by Weber
and Kant
• An outgrowth of the pervasive cultural transformation(
postmodernism)
• Postmodern thinking emphasizes the value of
– Deconstruction (taking apart old ideas and structures)
– Reconstruction( putting ideas and structures together in
new ways)

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 Naturalistic paradigms-Ontologic assumption
• Reality is not a fixed entity but rather a
construction of the individuals participating in the
research
• Reality exists within a context, and many
constructions are possible
• Reality is multiple and subjective mentally
constructed by individuals
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 Naturalistic paradigms-Epistemologic assumption
• Naturalists take the position of relativism

• Knowledge is maximized when the distance between the inquirer

and the participants in the study is minimized.

• The voices and interpretations of those under study are crucial to

understanding the phenomenon of interest

• Subjective interactions are the primary way to access them.

• The findings from a naturalistic inquiry are the product of the

interaction between the inquirer and the participants.

• The inquirer interacts with those being researched

• Findings are the creation of the interactive

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 Naturalistic paradigms-Axiologic assumption

• Subjectivity and values are inevitable and

desirable

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 Naturalistic paradigms-Methodologic assumption

• Inductive processes
• Emphasis on entirety of some phenomenon, holistic
• Emerging interpretations grounded in participants’
experiences
• Flexible design
• Context-bound
• Emphasis on narrative information; qualitative analysis
• Seeks patterns
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 Paradigms and Methods
• Research methods:-Techniques used to structure a study, gather data
and analyze information relevant to research question

• Paradigms should be viewed as lenses that help to sharpen our focus

on a phenomenon of interest

• Two alternative paradigms have strong implications for the research

methods to be used

– Quantitative research: Most closely allied with the positivist

tradition

– Qualitative research : Most often associated with naturalistic

inquiry

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 Quantitative research/traditional, scientific method/

• Use deductive reasoning to generate hunch that are

tested in the real world

• Use mechanisms designed to control the study to

minimize biases and maximize precision and validity

• Take place both in natural and artificial setting

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 Quantitative research……
• Quantitative researchers gather empirical evidence
– Rooted in objective reality and gathered directly or
indirectly through the senses
– Consists observation through sight, hearing, taste, touch,
or smell
– Basis for knowledge means that findings are grounded in
reality rather than in researchers’ personal beliefs

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 Quantitative research……
• Information gathered are quantitative ( numeric,
analyzed by statistical procedure)

• Goal :
– To understand phenomena in broad or general sense
than specific circumstance

• Focus on generalizability

• Widely used by nurse scholars but it does not means it

solve all nursing problems
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 Quantitative research……
• Limitation:
– Cannot be used to answer moral or ethical questions
– Sometimes also accused of a narrowness and
inflexibility of vision
– Sedimented view of the world that does not fully
capture the reality of human experience
– Qualitative promoter claim it as reductionist

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 Naturalistic paradigm and Qualitative research

• Deal with the issue of human complexity by exploring it

directly

• Heavily emphasis on understanding the human

experience as it is lived

• Careful collection and analysis of qualitative materials

that is narrative and subjective

• Capture aspects in their entirety within the context

• Flexible method
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 Qualitative research….
• Always takes place in the field ( naturalistic setting)

• The process of data collection and analysis take place

simultaneous, new emerging idea will be covered

• Apply inductive process

• Serve as a crucial starting point for more controlled

quantitative studies

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 Communalities of paradigm beside difference
1.Ultimate goals:
– to gain understanding about the truth of phenomena of
interest
2.External evidence:
– Information is gathered from others in a deliberate fashion than
armchair analyst
3.Reliance on human cooperation:-
– Because evidence for nursing research comes primarily from
human participants, the need for human cooperation is
inevitable

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 Communalities….

5.Ethical constraints:
– Ethical dilemmas often confront researchers,
regardless of their paradigmatic orientation

6.Fallibility of disciplined research:-

– no paradigm with free of limitation, question can
be answered in so many different ways

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 Purpose of nursing research
• To answer questions or solve problems of relevance to the nursing
profession

• The specific purposes of nursing research include

– Identification

– Description

– Exploration

– Explanation

– Prediction

– Control

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 Purpose…..
Purpose Description Quantitative Qualitative
inquiry inquiry
Identification Applied when little is Type and name

Description known or Prevalence, Variation,

inadequately defined frequency and dimension and
or conceptualized characteristics importance
phenomena

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 Purpose…..
Purpose Quantitative inquiry Qualitative inquiry

Exploration Related factors and Full nature, current

antecedents reality, process of
evolvement, real
experience/d

Explanation Measurable association Occurrence, existence,

between, causes and how it work and
theoretical explanation meaning

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 Purpose…..
Purpose Quantitative inquiry Qualitative inquiry
Predication What will happen if we alter?
Intervention
Control How can we make the
phenomenon alter its nature,
happen or prevalence

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 Type of nursing research
Based on purpose
1. Basic research:
2. Applied research:
3. Action research
Based on inquiry/method
1. Quantitative research
2. Qualitative research
3. Mixed research( convergence???)-DTTP
4. Knowledge search

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 Basic research
• Undertaken to extend the base of knowledge in a

discipline (formulate or refine a theory)

• For discovering general principles

• Done for the intellectual pleasure of learning to search

for knowledge for its own sake and eventually filter

down the result into real life situation.

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 Applied research
• Focuses on finding solutions to existing problems.
• Results from present problems/socially disorganized
situations.
• Frequently raises theoretical questions that must be
answered by basic/ pure research.
• Purpose
• To solve a problem
• To make a decision
• To develop a new program, product, and methods

• To evaluate program and methods

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 Action research

• The process involves the study of certain problem

and from that experience, decisions, actions and

conclusion are drawn.

• Findings are limited to settings actually studied

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 Quantitative research
• A formal, objective and systematic process in which
the numerical data are used to obtain information
• Used to describe variables, examine relationships
among variables.
• Requires the use of: structured interviews,
questionnaires , or observations; scales; and
physiological instruments that generate numerical data

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 Types of quantitative study
1.Analytical method B. Experimental studies
A. Observational studies Randomized Controlled clinical trial/
Cross-sectional study: (RCT)
•Investigate the mare effect of behavioral
• awareness/perception intervention or new treatment
• Prevalence
• description
Intervention studies
• complex, natural or artificial intervention
• related factors
Case control method :-
• etiology
Cohort study design 2.Descriptive method
• Etiology a) Cross-sectional
• contributing internal & b) Correlational
eternal factors c) case series
• incidence rate d) case report
• prognoses oDescribe related problems as it occurs
oServe to generate hypothesis
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 Qualitative research
• A systematic , interactive and subjective approach
• Used to describe life experiences and give them meaning
• Describe and promote understanding of human experience
such as pain, caring and comfort.
• An interpretative methodological approach to produce more of

a subjective science .
• Type
– Phenomenological research
– Grounded theory
– Ethnographic research
– Historical case study
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 Mixed research

• Methodological triangulation of
– Qualitative and quantitative

– Qualitative and qualitative

– Quantitative and quantitative

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 Knowledge research
1.Systematic review.

• Generate evidence and knowledge through study of studies

• Addresses what already known about phenomenon. E.g. . Summarize results on

1. Effects of intervention/therapy from RCTs

2. Causes ( etiology) from cohort or case control studies

3. Prevalence from cross-sectional studies

4. Prognosis /consequences from all cohort studies

5. Living experiences/understanding qualitative studies.

2.Meta-analysis.

• Systematically integrate several quantitative evidences of the same research question

3.Met synthesis.

• Systematically integrate several qualitative evidences of the same research

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 Planning a research study
• Deciding to conduct research study can be rewarding and
frightening

• Much of the work involved in conducting a research study actually

takes place prior to conducting the study itself

• Beginners usually pay less attention to this part

• Some of the work takes place before actual data collection includes

– Preliminary work of getting research started

– Understanding context of research area

– Considering logistic &administrative issue

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 Choosing research topic/title

• Creative process that depends on imagination and

ingenuity

• Jot down all ideas (abstract, concise, broad , specific

)comes to mind- process

• Short (one line), sweet and succinct

• between 10-15 Words long

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 Source of nursing research topic
1. Scientific field with in which the researcher works
2. Interest
3. Problem solving:
– Situation or thing that has caught our attention in both our private and
professional lives and need of change or improvement
4. Previous research/nursing literature :
5. Theory
6. Experience and Clinical Fieldwork
7. Social Issues
8. Ideas From External Sources( friends, teachers, funder , posted
information, nursing priority areas, brain storming session
9. Other sources like
– Senior professional recommendation
– Media
– Public discussion
– Conferences
– Teaching
10. Practical experiences
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 Quality of research idea
Judged by answering the following questions

1. Is the research idea is Creative?

2. Will the result have significant contribution to literature and

practice in specific field?

3. Does the research study address a question that is

considered important in the field?

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 Nursing research priority area
1. Health promotion and disease prevention

2. Promotion of health of vulnerable and marginalized communities

3. Patient safety and quality of healthcare

4. Development of EBP and translational research

5. Promotion of health and well-being of older people

6. Patient-centered care and care coordination

7. Palliative and end of life care

8. Care implication of genetic testing and therapeutics

9. Capacity development of nurse researchers

10. Working environments for nurses

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 Concepts and terms in research
• Research has its own language and terminology (jargon).

• Most terms used in both qualitative and quantitative research

and some still defer

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 Concepts and terms…..
Researching
• Doing
– A study
– An investigation
– A research project

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 Concepts and terms…..
• Personnel in research
1. Subjects/study participants/respondent
2. Informant/key informants
3. Sample
4. Researcher/investigator/scientist
5. Collaborative research
6. Project director or principal investigator (PI)
7. Co-investigators
8. Consultant/s
9. Funder or sponsor.
10. Reviewers
11. Peer reviewers
12. Mentor/s
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 Concepts and terms….
Subjects/study participants/respondent
– A person who contribute information in quantitative research by
answering question or filling questioner or being examined
– People who are being studied
– Play passive role

Informant/key informants/ study participant

– A person who contribute information in qualitative research by
participating during in-depth interview or FGD
– Play active role

Sample
– Study participants
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 Concepts and terms….
• Researcher/investigator/scientist
– A person who undertake
• Collaborative research
– When a research is conducted several people ( team)
• Project director or principal investigator (PI)
– A person who directing an investigation in
collaborative research
• Co-investigators
– Persons who equally contributing in a study
• Consultant/s
– Specialized expertise involved in study for short period
of time
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 Concepts and terms….
Funder or sponsor
– A person/ Organization providing the money for the
study
Reviewers
– People who criticize various aspect of the study and
provide feedback
Peer reviewers
– People who criticize various aspect of the study and
provide feedback and hold equal level with researcher/s
Mentor/s
– A person who advice and support students or young
researcher and model standards of excels in research
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 Concepts and terms….

Research Settings

1. Site/multisite /

2. Settings

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 Concepts and terms….
Site/multisite /

• Overall location for the research

– Institution based

– Community based

– Simulated environment

Settings
• More specific places where data collection occurs

• In some cases site and settings are the same( in hospital )

• Can influence the way people behave or feel and how they respond to questions

• Some study conducted in naturalistic setting( field- peoples home or office)

• Human or nonhuman study can be conducted in laboratory setting

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 Concepts and terms….
Concepts/phenomena/constructs
• Building block of the study
• Abstractions of particular aspects of human behavior
and characteristics
• The abstractions are called Phenomenon for qualitative
• More complex abstraction refers to constructs

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 Concepts and terms….
Theories and Conceptual Models

• Theory refers to systematic explanation of some aspect of

reality

• Quantitative researchers usually began with theory or

conceptual model

• True theory used to make prediction

• In qualitative research, theory used as sensitizing framework

• In some qualitative study theory is the product of research

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 Concepts and terms….
Conceptual frame work

• A written or visual presentation that explains the

main things to be studied – the key factors, concepts
or variables either graphically, or in narrative form,
and the presumed relationship among them

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 Concepts and terms….
Variables
• Something that varies or take on different value
• Quantitative researchers seek to understand how or why things
vary
• Variable with value represented on continuum- continuous
variable
• Variables with a finite number of values between any two points-
discrete variable
• Discrete with non quantitative value- categorical variable
• Variable with only two value –dichotomous variable
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 Concepts and terms….
Variables …..

• Variable representing characteristics of research

subject- attribute variable

• Variable that the researcher create- active variable

• An active variable in one study can be attribute

variable in another study

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 Concepts and terms….
Variables …..

• Presumed cause of phenomena-independent variable

• Presumed effect –dependant/outcome/criterion( multiple) variable

• Variability in the dependent variable is presumed to depend

on variability in the independent variable.

• Dependant and independent indicate direction of influence

than causal links

• Variables are not inherently dependent or independent

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 Concepts and terms….
Heterogeneity

• When an attribute is extremely varied in the group under

investigation, then the group is heterogeneous with respect to the
variable

• If there is no variation on variable, now the group called

homogenous

Conceptual definition

• Abstract or theoretical meaning of the concepts being studied.

Data

• Pieces of information obtained in the course of the investigation

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 Concepts and terms….
Relationship
• A bond or a connection between phenomena

• Usually expressed in quantitative terms, such as more than,

less than in quantitative study

• Cause -and-effect (or causal) relationship exist ( if one is the

reason for existence of the other

• Relationship in the absence of cause effect is refers to

functional relationship (or an associative relationship)

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 Challenges of conducting research
Conceptual challenges Ethical challenges
• Defining key concepts •Conducting the study without
• Supporting theories infringing right of the subjects
Financial challenges
Clinical challenges
• Fund
• Adequacy of resources •Research goals vs clinical goals
Administrative challenges conflict
• Time •Doing research with vulnerable or
• Management of tasks
frail patients
Practical challenges
• Enough sample Methodologic challenges
• Getting corporation •Methods used yield accurate and
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 Designing ethical research:

Elements and ethics in research

No one shall be subjected to torture or to cruel, inhuman or degrading
treatment or punishment. In particular, no one shall be subjected
without his free consent to medical or scientific experimentation
(International Covenant on Civil and Political Rights, Article 7, 1966)

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 The need for ethical guidelines

• Protection of the right of human subject

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 Historical background of research ethics
Nazi medical experiments (1930s and1940s)
• Most famous example of disregard of ethical conduct
• Use of prisoners of war and racial “enemies” in numerous
experiments
– Testing the limits of human endurance
– Testing the limits human reaction to diseases
– Testing the limits human reaction to untested drugs

• Subjects were
– subjected to Physical harm and Death
– Unable to refuse participation

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 Historical background…….
Ethical transgression in US (1932 – 1972)
• Tuskegee Syphilis Study
– sponsored by the U.S. Public Health Service
– Investigated the effects of syphilis among 400 men from a poor
African-American community
– Medical treatment was deliberately withheld to study the course of
the untreated disease

• Injection of live cancer cells into elderly Jewish patients without

consent
• Radiation experiments on prisoners or elderly hospital patients

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 Ethical Dilemmas in Conducting Research
• Occur when the research is potentially life-saving or beneficial to

others in the long run but difficult to comply with ethical values

• Examples

• Studying coping mechanisms of parents with terminal ill children

– Probing could be painful and even traumatic yet parents’ coping

mechanisms might help to design more effective ways of

dealing with parents’ grief and anger

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 Codes of ethics
1. Nuremberg Code (1947)
 Developed after the Nazi atrocities were made public in the Nuremberg trials

 First internationally recognized efforts to establish ethical standards

 Developed for regulating experimentation on human subjects

2. Helsinki Declarations (1964, 2000)

– provide guidance to the medical research community

3. Ethical Guidelines in the Conduct, Dissemination, and Implementation of

Nursing Research (ANA-1995)

4. Belmont Report (1978)

 National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research (1978)

 Articulated three primaries ethical principles: beneficence, respect for human dignity, and
justice.

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 Reason for Increased ethical concerns in health research

• Major expansion in health research

• The significant public investment in research
• The increasing need for experimentation on human subjects
• Publicized cases of ethical violation
• Internationalization of research
• The expanding role of private industry
• New areas of research and ethical concern

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 Ethically unexplored area

• Areas of medical research and society not yet

been fully prepared morally, legally and socially
– Organ transplantation

– Assisted conception

– Advances in fertility regulation

– The new era of genomics

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 General ethical principles

• Ethics are principles of right conduct

• Ethical principle represent basic human values

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 General ethical principles…..
1.Beneficence
• Maximize benefit to subjects

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 General ethical principles…..
2.non-maleficence Freedom from Exploitation
• Do good • do not expose participants to un
• Above all do no harm
prepared situations
Freedom from Harm •example
• Minimize all types of harm
•Describing economic circumstance
•Minimize all types discomfort
losing medical benefit
•Balance risk and benefit
•Example of harm Benefits From Research
•Physical (e.g., injury, fatigue) •Maximize benefits
•Psychological (e.g., stress, fear) •communicate potential benefits
•Social (e.g., loss of friends) The Risk/Benefit Ratio
•Economic (e.g., loss of wages) •Minimize/avoid risk
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 General ethical principles…..
3.Respect study subject

• The Right to Self-Determination (autonomy)

– voluntary Participation

– informed consent

– participation without coercion

• The Right to Full Disclosure-full description

• Protect privacy of individual subject-confidentiality

• Respect to the community by respecting its values and having its approval
for the research

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 General ethical principles…..
4.Justice (distributive justice)
– Participation in the research should correlate with expected
benefits
– No population group should carry an undue burden of research
for the benefit of another group

5.Mercy is an ethical imperative when research involves

animal experimentation
6.Honesty is an indispensable value in research

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Responsibility for ethics in health research

1. Investigators

2. Research institution

3. National Drug Regulatory Agency

4. Editors of journals

5. Funding agencies and organization

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 Investigators

• No research protocol is complete or

acceptable if it does not discuss the ethical
aspects of a study involving human subjects or
experimental animals

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 Research institution
• Responsible for the ethical quality of the research performed
by its staff and in its facilities
• Should have an institutional ethics review committee/board
(IRB)
• There should be nurse and representative of community in
IRB
• IRB should be independent body
• Any member with a direct interest in a proposal should not
participate in its assessment
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 National Drug Regulatory Agency

• New drugs or devices that are not yet approved in

the country should not be used on human subjects
without approval being obtained for their use under
the conditions of the study.

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 Editors of journals

• Reports of research not complying with ethical

standards should not be accepted for publication

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 Funding agencies and organizations

• No research proposal should be funded by a national

or international agency unless it has clearly outlined
the ethical aspects of the study

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 Ethics committee
• Established, as appropriate, at the national, regional
and institutional levels
• Use national, international and WHO guideline to
review ethical standards of the study
• Task
– Evaluate all ethical aspects of the research projects
– Execute free from any bias and influence that could affect
their independence
• Multidisciplinary and multi-sectoral in composition
• Established in
– Accordance with the applicable laws and regulations of
the country
– Accordance with the values and principles of the
communities they serve
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 Elements of ethical review
1. Scientific design and conduct of the study
2. Subject/participant recruitment
3. Care and protection of research participants
4. Protection of participant confidentiality
5. Informed consent process
6. Community considerations

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 Ethics and research process
• Ethical considerations should apply throughout the research process,

1. Choice of the research topic

2. selection of the appropriate research design

3. Development of the research protocol

4. Submitting a research proposal for funding

5. submitting a research proposal for IRB

6. Implementing the study

7. Description and analysis of the research results

8. Interpretation of the research results,

9. communicating the research, including its publication

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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 (time).
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.
16. Documentation and use of information
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 Informed consent

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 VULNERABLE SUBJECTS
• Use additional standards to protect the subject
• They may be
• Example of vulnerable subjects
1. Children
2. Mentally or emotionally disabled people
3. Severely ill or physically disabled people
4. The terminally ill
5. Institutionalized people
6. Pregnant women

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 Children
• Legally and ethically, children do not have the competence
to give informed consent

• Obtain informed consent of children’s parents or legal

guardians

• For at least 7 years old children obtain the child’s assent.

• Obtain written consent for developmentally mature

children ( 13 years and above)

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 Mentally or emotionally disabled people

• Includes mental retardation, senility, mental illness, or

unconsciousness

• Incapable of giving fully informed consent

• Have difficulties to weigh Risks and benefits of

participation and make an informed decision

• Obtain the written consent of a legal guardian

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Severely ill or physically disabled people

• Assess ability to consent

The terminally ill

• Carefully assess the risk and benefit ratio

• They may not expect benefit

Institutionalized people

• Make sure that they are not pressurized to participate as they directly depend on health
care personal

Pregnant women

• At high risk of unintended side effects because of their circumstances

• Make sure that the study safeguards the health of the mother and fetus

• They should not be involved in a study unless the purpose of the research meets their
health needs

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 Thank You!
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