Research Methodology

Dr. Melsew Getnet

(PhD, Ass. Professor)
[email protected]
+251920258142
Location: SPHMMC, Addis Ababa
Office hour: Up on request
 Course Description
• The research methods course is designed to
assist students in developing research proposal
and report, which they are required to be
undertaken as part of the bachelor Program.

– Students are expected to take the lead in

identifying and pursuing the research area of their
choice.

– Each student shall identify a research area at the

beginning of the course.
 Course Objectives
By the end of the course students will acquire
knowledge and skills of:
• Developing research proposal
• Searching literature related to their research area
• Data collection and data analysis
• Handling ethical issues
• Writing research report.
 Research Methods Course Schedule May, 2024
Topic
Course Introduction
Definition and types of research
Research topic selection criteria
Literature review
Searching literatures from different sources
Formulation of research objective
Choosing study design

Data collection methods/techniques

Questionnaire design
Choosing sampling technique & sample size calculation
Planning data analysis & choosing statistical techniques
Research ethics
Writing a project proposal &Reviewing project proposal
Reviewing project report

Proposal presentation and submission

 Methods of Instruction
• Lectures

• Case studies

• In-class practical exercises

• Group discussions.

• Attendance of classes and group discussions is

strictly compulsory
• Course pre-requisite
-Epidemiology
-Biostatistics
• Attendance criteria
-Attendance of the lectures, group work, topic and
proposal development sessions is strictly
compulsory
 Assessment criteria
– Class assignment------------------------------(30%)
• Research title selection ------5%
• Introduction ------------------5%
• Formulation of Objectives---5%
• Methods ------------------------5%
• Ethics ---------------------------5%
– Proposal submission -------------------------(30%)
– Written exam-----------------------------------45%
– Total --------------------------------------------100%
 References
• Bowling A. Research Methods in Health. Investigating Health and
Health Services. Open University Press, 2000
• John W. Creswell. Research Design. Qualitative, Quantitative, and
Mixed Method Approaches (third edn). SAGE Publications, Inc.,
2009
• Davies M. Brett. Doing a successful research project. Using
Qualitative or Quantitative Methods. Palgrave macmillan, 2007
• Davies M. Brett. Doing a successful research project. Using
Qualitative or Quantitative Methods. Palgrave macmillan, 2007
• Ann Aschengrau, George R. Seage III. Essentials of Epidemiology in
Public Health (2nd edn). Jones and Bartlet Publishers,2008
• Getu D., Tegbar Y., 2006: Research methodology for HSS
Comments/Questions?
Research Methodology
Introduction and Definitions
Lecture-1
Melsew G. (MPH, PhD)
 Learning Objectives
At the end of this session the student will be able
to:

• Define health research, research design, and

research methods
• Understand the different types of research
• Develop research objectives of different forms
Introduction
 What is Health Research?
• The process of obtaining systematic knowledge
which can be used for the improvement of the
health of individual groups.
(Davies 1991)
• It provides the basic information on the state of
health and diseases of the population;
• It attempts to devise better approaches to health
care for the individual and community
Definition:
• Health Research is a systematic collection,
analysis and interpretation of data to solve a
health problem
 Types of Health Research
Based on population:
• Biomedical, clinical......individual
• Epidemiologic, Health Systems
research....population
Based on Objective:
Basic (Fundamental) or traditional research: is necessary
to generate new knowledge & technologies
Applied (action) research: to identify priority problems and
to design and evaluate Policies and programs.
 Types of Health Research
Based on data type utilized:
• Quantitative: phenomena that can be expressed in
terms of quantity
• Qualitative: Qualitative phenomena (those relating
to involving quality or kind)
Based on study design used and results obtained in
the study:
 Descriptive research
 Analytic research
 Basic Vs Applied .
Basic research is conducted to address fundamental
questions about
the biological,
Behavioral, and
social mechanisms,
which underlie wellness and disease
Applied research
 Is a research that seeks to solve practical problems
 Purpose of Health Research

• To generate knowledge essential to effectively promote

the health of the population

• Without that knowledge, effective action is impossible

because it has no logical or empirical basis.
 Research must be:-
• Purposeful: what do you want to be able to
contribute?
• Targeted: Who are the audiences?
• Credible: consider sources information, method
of data collection, personnel involved.
• Timely: Is the information needed?

Research is done to find solutions to health problems.

 Problem Identification
Where do we get research questions (topics)?
 Observation (work place, others)
 Reading literatures
 Reports from health institutions
 Results of other researches
 How do we choose a research topic?
 Career development
 Priority research areas
 Relevance
 Avoidance of duplication
 Feasibility
 Political acceptability
 Urgency of data needed
 Ethical acceptability
 Resource availability
 Topic Selection...
• The research topic or title should be specific
and clear.
• The topic should indicate the WHO/WHAT,
WHEN, WHY, WHERE and HOW clearly. It is
the focus of your research.
 Topic selection
• A good title is usually a compromise between
conciseness and explicitness.
• Titles should be comprehensive enough to indicate the
nature of the research.
• One good way to cut the length of titles is to avoid words
that add nothing to a reader’s understanding, such as
 "Studies on...’’
 "Investigations...," or
 "Research on Some Problems
 in...."
 Titles Formulation Tips

Titles should: Titles should Not:

• Describe contents clearly • Include wasted words such
and precisely, so that as "studies on," "an
readers can decide whether investigation of“
to read the report • Use abbreviations and
• Provide key words for jargon
indexing
 Assignment 1
• Think of three possible area of research which you
feel that there is a problem
• Identify one of the problem and formulate the
research topic that potentially is used in your
undergraduate fulfillment work
• Write the title of the research
Summary of the Research Process
 Summary of the research Process
What is the problem?

Define your initial objective

Search literature

Modify your objective based on the information you get

from literature

Write the full proposal guided by the objective

 Components of Research Proposal
1. Title 8. Dissemination and
2. Acknowledgement Utilization of Results.
3. Acronyms and abbreviations 9. Work plan
4. List of tables and figures 10. Cost of the Project
2. Summary 11. References
4. Introduction 12. Assurance of the
 Statement of the Problem
investigator
 Literature review
 Justification 13. Advisor (approval)
5. Objectives 14. Annex
6. Methodology
7. Ethical Considerations
 Summary
Should reflect:
 Problem Statement
 Research objectives
 Research design
 Duration
 Total Budget
 Keep to about 250-300 words
 Introduction
• Can be divided into 3 sections or the concepts of
the 3 sections can be merged together
Sections:
• Statement of the problem
• Literature review
• Justification of the study
 Statement of the problem
Includes:
• Brief description of the socio-economic & cultural
characteristics
• Overview of health status and health care system
• The nature of the problem; and the discrepancy
 Information that should be included
1. Socio-economic and cultural characteristics
2. Nature of the problem : Discrepancy, size,
distribution and severity of the problem.
3. Major factors that may influence the problem
4. Any solutions attempted to solve the problem
5. Type of information expected
 Literature review
• Search widely Electronic search engines (Pubmed,
POPLINE.) Grey literature
• Reference all literature that you refer to in your review
• Evaluate the relevance of the literature to your study
• Include information directly relevant to your study
• There should be logical sequence in writing literature
review
• Be concise
 Literature review...
Include:
• Detailed account of the subject matter you
want research
• Entertain confounding factors and other
related matter only pertaining to the current
research
Avoid repetitions and lengthy statements.
(Max 3-4 pages)
 Purposes of Literature Review
• It prevents duplicating work
• It shares with the reader the results of other studies that
are closely related to the study being reported.
• filling in gaps of the study
• Acts as a benchmark for comparing the results of a study
with other findings
• It "frames" the problem earlier identified.
• Convincing arguments
 Literature Review: advantages

• Avoid reinventing the Wheel/avoidance of

duplicating previous work
• Learn the gaps
• Learn the various methods used

An opportunity to develop professional confidence

in the field of study!!
 Steps of literature review
Step 1: Begin by identifying key words or phrases useful in
locating materials in an academic library at a college/university
and/or websites

Step 2: With these key words or phrases in mind, next go to

the library and begin searching the library catalog for holding
(i.e. journals and books). Or go to internet center for searching

Step 3: You would initially try to locate about 20 reports of

research in articles or books related to research on your topic.
 Steps of literature review...
Step 4: Using this initial group of articles, you would then look at the
articles and select those central to your topic. In the selection
process, you would look over the abstract and skim the article or
chapter.

Step 5: As you identify useful literature, you may begin designing the
literature map on your topic
Step 6: Organize the literature into your literature map.

• Continue to draft summaries of the most relevant articles.

• Summaries are then combined into the final literature review that
you write for proposal.
 Justification of the Study
Questions addressed before writing the significance of the study:
 Are there gaps in evidence?
 Will results influence programs, methods, and/or interventions?
 Will results contribute to the solution of the problems?
 Will results influence the decision making of organizations or
companies?
 What will be improved or changed as a result of the research?
 How will results of the study be implemented, and what
innovations will come about?
Assignment 2
• For the proposed topic of research write
• Statement of the problem
• Review literatures and write the section
• Justify the proposed research
Session II
FORMULATION OF
• RESEARCH OBJECTIVES,
• RESEARCH QUESTIONS, AND
• RESEARCH HYPOTHESIS
 Learning Objectives
At the end of this session the student will be able
to:

• Develop research objectives of different forms

• Formulate research hypothesis
 Objectives
• A research objective summarize what is to be
achieved by the study.

• Commonly, research objectives are classified

into
 General objectives and
 Specific objectives.
 Objectives...
General objective:

 Summarizes what is to be achieved by the

study
 Should be clearly related to the statement of
the problem
Specific objectives:
are logically connected parts of the
general objective
focus the study on the essentials
direct the design of the investigation
orient collection, analysis and
interpretation of the data
Use action verbs
 Criteria for setting research objectives
• Focused, each covering a single point
• Ordered in a logical sequence
• Realistic and feasible to answer
• Operational, using action verbs such as:
-Determine - verify -identify
-describe - assess - compare
-calculate - establish -explore
• Measurable outcomes at the end of the
research
 Importance of developing objectives
• Focus the study
• Avoid the collection of data which are not strictly
necessary
• Properly formulated specific objectives facilitate
the development of research methodology and
help to orient the collection, analysis,
interpretation and utilization of data.
• Helps for evaluating the project
 Assignment 3
 For your proposed research topic
 Formulation the objective using appropriate
format
METHODOLOGY
At the end of this session the student will be
able to:

• Analyze the circumstances for appropriate use

of the different study designs
• Use appropriate study designs which properly
answer the research question/ objective
 Methods....
• . Variables of the study
• . Dependent/outcome/Response variable
• . Independent/explanatory variables
• Data collection: what type, how (tool/procedure), who
(enquires/responds), where (geography/enquiry place), when
(period/time)
• Data quality control issues
• Data management: coding, entering, cleaning, storing,
recoding (software to be used)
• Data analysis: choice of statistical methods
 Methods
Possible sub-sections of the methodology:
• . Study design
• . Study setting
• . Population
• . Source population
• . Study population
• . Inclusion/Exclusion Criteria
• . Sample size and Sampling strategies
 study design
• A study design is a specific plan or protocol for
conducting the study, which allows the investigator
to translate the conceptual hypothesis into an
operational one.
 Design options
• Quantitative
 Case report
 Case series
 Ecological
 Cross-sectional
 Cohort study
 Case-control study
• Qualitative
• Mixed
Criteria for selecting a research design
1) The research problem
2) Personal experience
3) Audience
4) Resources available for the study
 Criteria for selecting cont..
• If a concept or phenomenon needs to be
understood because little research has been
done on it, qualitative approach is preferred
If the problem calls for:
a) the identification of factors that influence
an outcome
b) the evaluation of an intervention
Then quantitative approach is preferred
 Quantitative designs
• Since quantitative studies are traditional mode of
research, carefully worked out procedures and rules
exist for them
• Researchers may be more comfortable with the
highly systematic procedures of quantitative research
 Hierarchy of Epidemiologic Study Design

Case report Generate hypothesis

Case series
Ecological studies
Cross-sectional studies
Case- control studies
Cohort studies
Randomized control trials Establish causality
 Case report & case series
• A case report is a descriptive study of a single individual
(case report)
• case series is a descriptive study of small group
• Ecologic Studies: The unit of analysis is the group, not the
individual.
Example:
• Mean systolic blood pressure levels and stroke mortality
rates in the Seven Countries Study.
 Cross-sectional study
 A type of prevalence study.
 Exposure and disease measures obtained at the
individual level.
 Single period of observation.
 Exposure and disease histories collected
simultaneously.
 Both probability and non-probability sampling used.

Example: Prevalence of congenital malformations across

maternal age groups.
 Uses of cross-sectional study
• Hypothesis generation
• Intervention planning
• Estimation of the magnitude and distribution of a
health problem
 Cohort Studies
• In a cohort study, subjects with an exposure to a
causal factor are identified and the incidence of a
disease over time is compared with that of
controls;
• In a longitudinal study, subjects are followed over
time for health outcomes.
 Case-control studies
• Case-Control Studies identify existing
disease/s and look back in previous years to
identify previous exposures to causal factors.
 Cases are those who have a disease

 Controls are those without a disease

 Qualitative designs
• Preferred if a concept or phenomenon needs to be
understood because little research has been done on it,
• useful when the researcher does not know the important
variables to examine
This type of approach may be needed When:
 the topic is new,
 the topic has never been addressed with a certain
sample or group of people, and
 Mixed methods
• Mixed methods are becoming popular
• Better to address complex problems
• Utilize the strengths of both qualitative &
quantitative research
 Mixed methods...
Eg. Researcher wanted to both generalize the
findings to a population as well as develop a
detailed view of the meaning of a phenomenon
or concept for individuals
 The researcher first explores generally to
learn what variables to study and then
 studies those variables with a large sample
of individuals
 Setting
• Health institutions
• Schools
• community
 Study Population
• Who are your study subjects?
• Inclusion and exclusion criteria
 Assignment 4
• Choose appropriate design for your proposed
research topic?
SAMPLING AND SAMPLE SIZE
 Sample
• In research terms a sample is a group of people,
objects, or items that are taken from a larger
population for measurement.

• The sample should be representative of the

population to ensure that we can generalize the
findings from the research sample to the population
as a whole.
 Key sampling concepts
Who do you want The theoretical population
to generalize to?

What population can The study population

you get access to?

How can you get access The sampling frame

to them?

Who is in your study? The sample

What is Sampling?
 Types of sampling
• A great deal of work has been done over the
years in developing sampling methods that
provide representative samples for the
general population.
There are different methods of sampling,
broadly two:
 Probability & non probability sampling
 Classification of Sampling Techniques

Probability sampling
1. Simple Random Sampling
2. Systematic random sampling technique
3. Stratified random sampling
4. Cluster Sampling
5. Multi-stage Sample Designs
 1. Simple random Sampling
A sample size ‘n’ is drawn from a population ‘N’ in
such a way that every possible element in the
population has the same chance of being selected.
Assumption of the population:
 Homogeneity with respect to the variable of
interest
 If all members of a population were identical,
the population is considered to be homogenous.
 Availability of frame
 2. Systematic random sampling
• Here are the steps you need to follow in order to
achieve a systematic random sample:
 number the units in the population from 1 to
N
 decide on the n (sample size) that you want
or need
 k = N/n = the interval size
 randomly select an integer between 1 to k
 then take every kth unit
 3. Stratified random sampling
• Divide the population into non-overlapping groups (i.e.,
strata) N1, N2, N3, ... Ni, such that N1 + N2 + N3 + ... +
Ni= N.
• Then do a simple random sample depending on the type
of allocation
• Elements within each strata are homogeneous, but are
heterogeneous across strata.
• A simple random or a systematic sample is taken from
each strata relative to the proportion of that stratum to
each of the others
 Stratified random sampling.
• There are different sample allocation methods in order to
select sample from each strata:
1. Proportional allocation: allocating sampling proportional to
the total population of each strata using the formula:
ni = n *Ni
N
Where n=total sample size to be selected
 N=total population
 Ni = total population of each strata
 ni=sample size from each strata
2. Equal allocation: allocating equal sample for each strata
 4. Cluster Sampling
 A cluster sample is a simple random sample of
groups or clusters of elements (vs. a simple random
sample of individual objects).

 This method is useful when it is difficult or costly to

develop a complete list of the population members
or when the population elements are widely
dispersed geographically.
 5. Multi-stage Sample Designs
• Many surveys use complex sample designs that combine
several of the above elements in a multistage sampling
framework
• Sometimes the population is too large and scattered for it
to be practical to make a list of the entire population
from which to draw a SRS.
• Suppose that each unit in the population can be divided
into a number of smaller units, or subunits
 Non-probability sampling
1. Convenience sampling
• Drawn at the convenience of the researcher.
Common in exploratory research.
• Does not lead to any conclusion.
2. Judgmental sampling
• Sampling based on some judgment, gut-feelings or
experience of the researcher.
• If inference drawing is not necessary, these samples
are quite useful.
3. Quota sampling
• An extension of judgmental sampling.
• It is something like a two-stage judgmental sampling.
• Quite difficult to draw.
4. Snowball sampling
• Used in studies involving respondents who are rare to find.
• To start with, the researcher compiles a short list of sample
units from various sources.
• Each of these respondents are contacted to provide names of
other probable respondents.
 Conclusions
• Probability samples are the best
 Ensure Representativeness
• Precision
• ...within available constraints
 Sample Size Determination
• How Big is Big Enough?
• Generally the larger the better, but that takes
more time and money.
• Answer depends on:
 How different or dispersed the
population is.
 Desired level of confidence.
 Desired margin of error
 Sample size ...
• Which variables should be included in sample
size calculation?
 It should relate to the study’s primary outcome
variable
 If the study have secondary outcome variables
which are considered important, the sample size
should also be sufficient for the analysis of these
variables.
 Sample size determination
Depends on
 Objective of the study
 Design of the study
 Plan for statistical analysis
 Degree of precision required for
generalization
 Degree of confidence
 Confidence interval approach
Single population proportion

n=
2
 Variables
• Dependent/independent variables
• Operationalizing variables (making them
measurable)
Operational definitions
• Many variables can easily be measured

• For some variables, it is some times not possible to

find meaningful categories unless the variables are
made operational with one or more indicators

• Operationalizing variables means that you make

them measureable;
 Operational ...
Ex1- determining level of knowledge
• There is a need to develop a series of questions to assess
knowledge
• The answer to these questions form an indicator of someone’s
knowledge on the issue, which can then be categorized
E.g. If 10 questions were asked, you might decide that the knowledge
of those with:
 0 to 3 correct answers is poor
 4 to 6 correct answers is reasonable, and
 7 to 10 correct answers is good
 Assignment 5
For your proposed topic of research:
• Define the target population
• Define the study population
• What is the appropriate sampling method
• Determine sufficient sample size
 DATA COLLECTION TECHNIQUES
Overview of data collection techniques
 Using available information
 Observing
 Interviewing (face-to-face)
 Administering written questionnaires
 Focus group discussions
 Using available information
• For ex- analysis of the information routinely collected by
health facilities can be very useful for identifying problems
• . Use of key informants is another
Advantage of available data:
• collection is inexpensive
Disadvantage of existing data:
• It is some times difficult to gain access to records or reports
• Data may not always be complete and precise enough, or too
disorganized
 Observation
• A technique that involves systematically selecting,
watching and recording behavior and characteristics
of living beings, objects or phenomena
A) participant observation . observer takes part in the
situation he or she observes
Eg. A doctor hospitalized with a broken hip, who now
observes hospital procedures from within.
B) Non-participant observation . observer
watches the situation, openly or concealed, but
does not participate
Ex. of concealed observation, mystery clients
trying to obtain antibiotics without medical
prescription
• Observation can give additional, more accurate
information on behavior of people than interviews or
questionnaires
 Interviewing
• It involves oral questioning of respondents,
either individually or as a group
• Answers can be recorded by writing them down
or by tape recording the responses, or by a
combination of them
 Self-administered questionnaire
• Written questions are presented that are to be
answered by the respondents in written form
• A written questionnaire can be administered in
different ways, such as by:
 Sending questionnaires by mail
 Gathering all or part of the respondents in one place at one time,
giving oral or written instructions, and letting them fill out the
questionnaires
 Hand-delivering questionnaires to respondents and collecting them
later
 Focus group discussions (FGDs)
• FGDs allow a group of 8-12 informants to
freely discuss a certain subject with the
guidance of a facilitator or reporter
 Differences between data collection
techniques and data collection tools
Data collection techniques Data collection tools
Using available information Checklist; data compilation
forms
Observation Eyes and other senses,
pen/paper, watch, scales,
microscope, etc..

Interviewing Interview guide, checklist,

questionnaire, tape recorder

Administering written Questionnaire

questionnaire
 QUESTIONNAIRE DESIGN
• The 2 important procedures at the outset of
constructing a questionnaire are planning &
piloting
• In the planning of the questionnaire, it is
important to:
 list the topics of interest in relation to the aims of the study,
 collect appropriate and tested questions and scales,
 finally relate the questions back to the survey aims
 Issues to be addressed in the pilot study

• Is each question measuring what it is intending to

measure?
• Is the wording understood by all respondents, and
is the understanding (meaning) similar for all
respondents?
• Are the instructions on self-administered
questionnaires understood by all respondents?
• For closed (pre-coded) questions, are all reasonable
alternatives included?
• Are any questions systematically or frequently missed?
• Do some questions regularly elicit un-interpretable
answers?
• Does the questionnaire and covering letter motivate
people to respond?
 Question forms
• Response choices to questions can be left
open or they can be closed or ‘pre-coded’
• Closed questions can be:
• dichotomized (e.g. yes/no response choices),
• multiple response (no restrictions on the number of
responses that can be ticked) or
• scaled (with one response code per response frame
permitted)
 Open questions
• Open-ended questions are essential where replies
are unknown, too complex or too numerous to pre-
code
• The information collected is only limited by the
respondent’s willingness to provide it
 Open questions cont.
Disadvantages of open questions:
• replies can be distorted by the coding process back in
the office
• They can be time consuming and difficult to analyze
• require more skilled interviewers and coders
• Most interview qes will include a combination of
open & closed qes;
 Closed questions
• Are preferable for topics about which much is known
• Are quicker and cheaper to analyze
• Pre-coded responses always carry the risk that respondents’
replies are forced into inappropriate categories
• There should be a category to fit every possible response, plus
• ‘other’ category if it is felt that there may be some unknown
responses
 Closed questions cont.
Pre-coded numbers (such as financial
information, age groups and time periods) need
to be:
 mutually exclusive,

 Comprehensive
 Examples of open questions

• What are the five most important areas of your life

that have been affected by your illness?
• What are the qualities, the things about the nurse in
the health center, that you appreciate?
• Any thing else?
 Closed questions: Examples
Dichotomous:
In the past six months, have you stayed overnight in a
hospital?
 Yes__
 No___
Multiple choice:
Is your pain
• Flickering_
• Throbbing_
• Tingling_
• Intense_
 Data Quality Control Issues
Describe/provide:
• Selection and training of field workers/research staff
• Field testing the research methods and tools
• Supervision and quality control
• Pretest-:usually refers to a small-scale trial of particular research
components
• Pilot study-:is the process of carrying out a preliminary study,
going through the entire research procedure with a small sample
 Assignment 6
Prepare appropriate data collection tool for your
research topic?
 Data management
• Data processing refers to:
 data entry into a computer
 data checks and correction
 Variable coding
 Data cleaning
• The aim of this process is to produce a relatively
clean data set
Data entry
• Data entry concerns the transfer of data from
a questionnaire to a computer file.
• Before analysis, data must be checked for
errors, information that needs coding must be
coded and missing values must be dealt with
Data coding
• Coding is assigning a separate (non-
overlapping) numerical code for separate
answers and missing values.
Eg. Instead of using ‘Male’ and ‘Female’ for the variable
sex, it can be indicated as 1 = Male and 2 = Female.
Data Cleaning
• No matter how carefully the data have been
entered some errors are inevitable.
• The aim of this process is to produce a clean
set of data for statistical analysis.
Data analysis
• A plan for data analysis should include the following
information:
 Identification of staff needed
 Identification of the analysis tasks to be completed
 Identification of the statistical software to be used for
the analysis
 A schedule or work plan for the analysis of the data
 Components of Data Analysis
Data processing
 Data entry
 Coding
 Cleaning
Descriptive /exploratory
 Frequencies,
 Tables and graphs
 Cross tabulations
 Measures of central tendency and variations
 Proportions/percentages
 Components of analysis
Analytic /inferential
 Estimation
 Confidence intervals (P-value, OR,.)
 Hypothesis testing
 Statistical models
 Assignment 7
• What will be the appropriate methods for data
analysis.
 General Ethical Principles
1. Respect for autonomy
• a norm of respecting the decision-making capacities of
autonomous persons
2. Beneficence
• a group of norms for providing benefits and balancing
benefits against risks and costs
3. Non-maleficence
• -a norm of avoiding the causation of harm
4Justice
• - a group of norms for distributing benefits, risks, and costs
fairly
 Informed consent
Process of informed consent consists of:
 transfer of information
 understanding of its significance, followed by
 explicit consent of the person (or responsible proxies) to
take part in the intervention/research
Elements of informed consent
1. competence
2. disclosure
3. understanding
4. voluntariness
5. Consent
In other words,
One gives an informed consent if (and perhaps only if) one:
 is competent to act,
 receives a thorough disclosure,
 comprehends the disclosure,
 acts voluntarily, and
 consents to take part in the research
Disclosure
• the subject’s right to withdraw, without
penalty, from the research
 Consent by surrogates cont...
• Parents are considered surrogates for their minor
children
• Spouses for one another
• Adult children for parents when parents are lacking
• Adult grand children for grand parents
 Contents of the consent form
The consent form need to include the following
(Sarantakos, 2005)
 Identification of the researcher
 Identification of the sponsoring institution
 Indication of how the participants were selected
 Identification of the purpose of the research
 Identification of the benefits for participating
 Identification of the level and type of participant involvement
 Contents of IC..
 Notation of risks to the participant
 Guarantee of confidentiality to the participant
 Assurance that the participant can withdraw at
any time
 Provision of names of persons to contact if
questions arise
 Confidentiality
• Confidentiality is necessary in diagnostic,
therapeutic and research context
• If research subject authorizes release of the
information to others, then there is no
violation of rights or confidentiality
 Work plan
• Work plan summarizes (in a table, chart, graph) the various
components of a research project and how they fit together.
It Includes:
 Tasks to be performed
 When the task will be performed
 Who will perform the task (identify human resource
needed for each task)
 Number of staff needed to perform the task
 Work plan cont..
A work plan can serve as:
• a tool in planning the details of the project
activities and later the project funds.
• A visual outline or illustration of the sequence of
the project operations.
• a management tool for the principal investigator
and/or members of his/her team,
• a tool for monitoring and evaluation,
 Work plan cont..
Ways of presenting a work plan
 Work schedule
 GANNT chart...
 Work plan cont..
The Work Schedule
• Is a table
• Summarizes:
 tasks to be performed
 duration of each activity, and
 staff responsible.
 Work plan cont..
The GANTT Chart
• Depicts graphically the order in which various tasks must
be completed and their duration of activity.
A typical Gantt chart includes the following information:
• The tasks to be performed
• Who is responsible for each task; and
• The time each task is expected to take.
• The length of each task is shown by a bar that extends over the
number of days, weeks or months the task is expected to take.
 Dissemination and Utilization of
Results
Briefly describe the dissemination plan
• Feedback to the community
• Feedback to local authorities
• Identify relevant agencies that need to be
informed
• Scientific publication
• Presentation in meetings/conferences
 Budget
How should a budget be prepared?
• It is necessary to use the work plan as a starting
point.
• Specify, for each activity in the work plan, what
resources are required.
• Determine for each resource needed the unit cost
and the total cost.
• The budget for the fieldwork component of the work
plan will include funds for personnel, transport and
supplies.
Advice on budget preparation
• Include a 5%-10% contingency fund
• If inclusion of a contingency fund is not allowed, an
alternative is to slightly over-budget in major
categories.
• Ask the supervising agency to agree that, if necessary
there may be some transfer between ‘line items’ in
the budget.
Budget justification
• It is not sufficient to present a budget without
explanation.
• Make sure you give clear explanations concerning why
items that may seem questionable or that are
particularly costly are needed and discuss how
complicated expenses have been calculated.
• If a strong budget justification has been prepared, it is
less likely that essential items will be cut during proposal
review.
 References
Methods of citations in preparing literature review:
A) Vancouver system
B) Harvard system
Vancouver system
This system have been adopted as standard by over 300
biomedical journals
• For an article the following information should be noted:
• Author(s)’ Surname followed by initials. Title of article. Name
of Journal. Year, Volume(number): page numbers of article.
 References cont...
• For a book the following information should be
noted:
 Author(s)’ Surname followed by initials. Title of book.
Place: Publisher, Year, Edition
• Example: Abramson JH. Survey methods in
community medicine. Edinburgh: Churchill
Livingstone, 1990, 4th ed.
• When you use the Vancouver system, you will
use consecutive numbers in the text to
indicate your references
• At the end you will then list your references in
that order, using the format described above
 Annex
Include in the appendices of your proposal any additional
information you think might be helpful to a proposal
reviewer.
For example, include:
• Biographical data on the principal investigator
• The study questionnaire if you have it.
• The consent form.
• A copy of the approval from the Institutional Review
Board.
REPORT/SCIENTIFIC PAPER WRITING
 Sections of scientific articles
 Title
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Reference
 Acknowledgement
 Cover page
Should contain:
→the title
→ name of the authors with their titles and
positions
→ the institution that is publishing the report
→ the month and year of publication
 Title
• Purpose: To provide a brief , informative
summary that will attract your target audience
What goes with the title?
 The topic(T) being studied is always included
 In addition, choose one or two of the following:
→ Methods (M)
→ Specific named data base (D)
→ Results (R)
→ Conclusions (C)
 Abstract
• The abstract will be the first (and for busy decision
makers most likely the only) part of your study that
will be read
• Writing abstracts demands thorough reflection and is
time consuming
Purpose : To highlight key points from the major
sections of the abstract
 Components of the abstract
Component of abstract Abstracted from
Brief description of the Introduction
problem (Why this study was
needed)
Main objectives of the study Introduction

Place of the study Methods

Type of the study & methods Methods
used
Main findings Results
Conclusions and Discussion
recommendations
• Abstract can be structured or unstructured
(always check the instruction of the journal)
• Remember that only few words are allowed to
be included in the abstract (usually 250-300
words)
• Emphasize on what is new and useful
 Introduction
 Purpose → to explain why your study is
needed
 Often requires just three paragraphs
 Objectives are usually the last part of the
introduction
 Introduction..

Component Purpose
Problem statement What do we need to learn

Literature review What do we already know

Purpose statement What will we learn from

the
study
 Methods
• Purpose → to describe how you collected, organized
and analyzed data that are relevant to the purpose of
the study
• Organize into logical subsections that illustrate the
steps you took to collect, organize and analyze the
data
• Describe what you did, not what you found
 Possible subsection headings of the
methods
 Study design
 Study area
 Study population
 Sample size and sampling method(s)
 Variables of the study
 Data collection procedures
 Data analysis
 Ethical considerations
 Results
• Purpose → to describe the results of data
analysis that are relevant to the study
• Systematic presentation of your findings in
relation to the research objective is crucial
 Sequence of presentation of findings
• The 1st section is usually description of the
study population
• Provide information on the problem you
studied (size, distribution, characteristics)
• In analytic study, the degree to which different
independent variables influence the problem
 Use of tables & figures
• Tables & figures need numbers & clear title
• Include only those tables & figures that present main
findings & need more elaborate discussion in the text
• Use tables to highlight individual values
• Use figures to highlight trends/relationships
• Check the numbers; provide consistent row & column
summations
• In tables, keep lines to a minimum; avoid vertical lines
• Use footnotes to clarify points of potential ambiguity
 Discussion
• Purpose → to interpret your results & justify
your interpretation
Guidelines for constructing the discussion

 Focus on the main results

 Emphasize on what is new or different
 Restate the main finding
 Interpret the result in context of literature
 State conclusions & recommendations
 Conclusions & recommendations
• Conclusions should be short, as they have
been elaborately discussed in the discussion
section
• Recommendations are usually placed in
roughly the same sequence as the conclusion
 Conclusions & recommendations cont...

• Recommendations may at the same time be

summarized according to the groups towards
which they are directed
Example
 Policy makers
 Managers at district or lower level
 Staff who could implement the activities
 The community at large
 References
• Check the style of reference writing which is
recommended by the journal where you want
to submit your manuscript
 Annex
• Findings which are less important to be
presented in the main section of the paper
will be presented here
MANY THANKS!!!!