Course Title: PGC 601

Research Methodology In Medical &

Environmental Sciences

Lecturer: Professor F.E. Ejezie PhD

Dept. of Medical Biochemistry
Faculty of Basic Medical Sciences
College of Medicine
 Introduction
• Search: To search is to examine something
thoroughly; to look into or over something
carefully – to look for information
• Research: To research is to search again; to
examine further – to look for further
information
• Research: A methodical investigation into a
subject in order to discover/establish more facts
or information
 What is Research?
• There has been a continuous search for knowledge by
man
• But gaps still remain;
• many questions still remain unanswered;
• many problems remain unsolved
Definition: Research may be defined as a systematic search
for new facts, new knowledge and getting additional
information. It involves the identification of a problem
and proffering solutions through planned and systematic
collection, analysis and interpretation of data.
 Research Areas
• Research is obtained in ALL disciplines
• Health research/Medical research
• Research in the Environmental Sciences
• Research in the Social Sciences
• Arts
• Engineering
• Agriculture
• Multi-disciplinary research etc
The Process of Research (Major Steps)
• The process is initiated with a question or problem
(step 1)
• Next, goals and objectives are formulated to deal
with the question or problem (step 2)
• Then the research design is developed to achieve
the objectives (step 3)
• Results are generated by conducting the research
using specific methods (step 4)
• Interpretation and analysis of results follow (step 5)
 The Process of Research

2
5

4 3
 Biomedical Research
• This refers to health related research
• What is health? –Health is a state of complete
physical, mental and social well being and not
just the absence of diseases or infirmitities.
• Objectives of health-related research
-To promote and protect well being of man so as
to attain and sustain an optimal quality of life
-To prevent diseases at all levels –1o, 2o, 3o levels
 Environmental Research
• Environmental science is the academic field that takes
physical, biological and chemical sciences to study the
environment and discover solutions to environmental
problems.
• Objectives of environmental research :
• To recognize that environmental problems such as climate
change, global warming, ozone layer depletion, acid rains,
and impacts on biodiversity and marine life
• To protect the environment and human health through
improved sanitation, hygiene, health education, and reduce
the burden of infectious diseases
Environmental Research (objectives contd)

• To study of interaction between human

systems (the population) and natural systems
(the earth and life)
• To understand the impacts of development on
environment
• To discover sustainable ways of living
• To utilize natural resources efficiently
• to help protect and preserve the environment
 Application of Research
• Research reports are used (pre-requisite) in
the award of
– Degrees
– Diplomas
– Fellowships
– Certificates
– Promotion
– Improvement of quality of human life
And development in different spheres of life
 Characteristics of Research
A good research requires the following:
• Clear statement of the problem and a purpose

• A good plan (study design)

• Knowledge of existing data/information

• Organised collection of new data

 Types of Research
There are two main types:

• Basic research – eg determination of causes

and risk factors of diseases; comparison of
treatment regimens or chemotherapy

• Applied Research – eg Evaluation of health

policies, programmes etc
 Basic research
• Basic – to determine or establish fundamental facts and
relationships within a discipline or field of study. It is
usually considered to involve the search for knowledge
without a defined goal of utility or specific purpose.
• E.g. The microbiologist, whose expertise is the
identification of pathogenic microorganisms may conduct
research in-vitro, in a laboratory on bacterial reproduction,
growth and endotoxin production without any direct
application to clinical medicine. Probably, the researcher is
interested in monitoring endotoxins produced over the life
cycle of bacteria to determine its pathogenecity.
 Applied Research
• Applied – undertaken specifically for the purpose of
obtaining information to help resolve a particular problem
• It is problem oriented and is directed towards a defined
and purposeful end.
• Eg. An oral health researcher investigating the relationship
between periodontal disease and myocardial infarction
may use the findings of the microbiologist as a theoretical
framework to test the relationship between bacterial
endotoxins, periodontal disease and myocardial infarction
in animal and then in human subjects
 Distinction between Basic and Applied
Research
• The distinction between them is in the
application
- Basic has little application to real world policy
and management but could be done to guide
applied research
- Basic research is usually considered to involve
the search for knowledge without a defined
goal of utility or specific purpose - unlike
applied research.
 Research Project
• This is a well structured process with set rules
for carrying it out, which all researchers must
be conversant with and adhere to.
• It is conducted in a logical manner with
relevant references.
• Benefits of Research Project include the
provision of necessary information to improve
the quality of human life generally
 Stages of a Research Project
• Problem identification
• Prioritization
• Development of a project title
• Statement of the problem
• Review of existing literature
• Formulation of research objectives
• Hypothesis framing
• Selection of research method (s)
Stages of a Research Project cont’d
• Selection of subjects
• Collection of data
• Data analysis
• Result presentation
• Discussion
• Conclusion & recommendation
• Compilation of references
• Appendix
• Report writing
The stages must not be followed strictly in this order
 Problem Identification
•Investigator must identify a problem whose solution
requires research
•A problem could be identified through:
review of literature (vast reading)
observation of events
discussions/consultations with older researchers

The problem identified in one study could unfold another

research topic
 Prioritization
• There are usually more than one problem at any given time
• Limited resources/duration (time) may not allow all
problems to be handled at the same time
• Factors used for setting up priority of the problems
identified include:
-Feasibility, relevance, avoidance of duplication,
need/urgency of need, cost effectiveness, ethical
acceptability, time, manpower, materials/equipment,
replication, application/implementation of results, interest
of investigator.
 Development of Project Title
• This gives focus and scope of the project being
formulated
• Title may not be concluded at the initial stages
• May change as the project progresses
• (for UNN, approval of title/synopses is the
final step in PhD projects)
 Literature Review
• This is a very important aspect of project
formulation
• May be continuous throughout the project
execution
• Helps to find available information on the topic
• Should be extensive and focused
• Helps to know what others have done or
reported
 Literature Review cont’d
• Prevents duplication
• Identifies contested issues
• Provides facts for the justification of research
project
• Helps in formulation of objectives and
research questions
• Provides a guide for choice of methods,
sample size, & statistical analysis (design)
 Sources of Literature
• Interview: name of interviewer, and date of interview
(Interaction with researchers in the area).
• Books: author(s), book title, publisher, date of
publication, and page number(s) if appropriate.
• Journals: author(s), article title, journal title, date of
publication, and page number(s).
• Abstracts
• Newspapers/magazines: author(s), article title, name of
newspaper, section title and page number(s) if desired,
date of publication.
 Sources of Literature cont’d
• Technical reports
• Conference proceedings
• Thesis reports
• Indexes – eg Index Medicus (Nat. Lib. of Medicine
USA)
• Web sites: author(s), article and publication title
where appropriate, as well as a URL, and date
when the site was accessed (internet searches).
• Most of these are found in Libraries
Statement of Problem(Justification)
• Enables researcher to systematically point out
what the problem is
• Why the problem should be solved
• What is to be achieved by doing so
• It justifies the study.
• A good literature search is very useful in the
statement of problem.
 Research Objectives(Aims)
• Means what the research/researcher wishes
to achieve/accomplish
• Should facilitate the development of methods
• Should be specific- action verbs are to be used
eg to determine, identify, verify, calculate,
describe, reduce, identify, compare,
measure .......etc (no ambiguity)
 Research Objectives(Aims) cont’d
• Should be measurable- avoid such verbs as : to
appreciate, understand ,believe,
realise ........etc
• Should be achievable/practicable
• Should be realistic
• Should be time-bound
• May be put into: general and specific
objectives
 Hypothesis
• Is a prediction of a relationship between two or
more variables and the problem under study
• Data analysis tests this supposition
• Interpretation of data will either disprove
(reject) or support (uphold) the hypothesis
• Hypothesis translates the problem statement
into a precise, unambiguous prediction of
expected outcomes
 Hypothesis (2)
• It should be stated in testable terms

• Conventionally stated as “null hypothesis” –

which states that there is no difference b/w
groups or no association b/w variables

• Hypothesis may also be stated as a positive

declaration
 Hypothesis Framing
• Ways to Express Hypotheses:(no association)

• Suggest No relationship between specific

exposure and health-related events…

• A high cholesterol intake is not associated

with the development (risk) of coronary
heart disease.
 Hypothesis Framing (2)
• Ways to Express Hypotheses: (positive
declaration)

• Suggest cause-effect relationship….

• Cigarette smoking is a cause of lung cancer

Research Method &Research Methodology

Methodology and Method are often (incorrectly)

used interchangeablly. Research Method is a
step in a Research process or Methodology
• Methodology – the study of the general
approach to inquiry in a given field (sciences,
arts, law, humanities etc).
 Research Methods (1)
• Method s– the specific techniques, tools or
procedures applied to achieve a given objective.
Here the research or study design is laid out.
- Science – involves the Lab, equipment, animals,
humans, chemicals, other tools. (Materials/patients
and methods)
– Research methods in economics include
regression analysis, mathematical analysis,
operations research, surveys, data gathering, etc.
 Research Methods (2)
• The choice of a research method depends on:
– Research Questions
– Research Goals
– Researcher Beliefs and Values
– Researcher Skills
– Time and Funds
• A research method shows how the study is
designed
 Research Methods (3)
• The method to be used in a study may be
 Qualitative – descriptive in nature eg Case study,
participatory action research , data gathering etc
 Quantitative – involves
experiments/measurements, observations or
surveys
 Mixed Methods - draw from qualitative and
quantitative methods
Ethical Considerations In Health Research

• To protect humans and animals from possible abuses

• Involves use of humans subjects/animals in research
and clinical trials
• Use of human subjects makes animal studies clinically
useful
• Risk is justified in terms of benefits and contribution
to human knowledge
• Aims to improve quality of life
• To prolong life of human
 General Ethical Principles
• Respect for the human person
• Ensure no harm to human subjects used
• Maximum benefits and minimum harm
• Ensure justice – equal treatment to all
• Ensure respect for privacy and human dignity
• Informed consent (verbal or written) must be
obtained – parents for minors/pregnancy
• Qualified personnel is involved
• Ethical Committee Certificate must be obtained
 Subject Selection (1)
• This is dependent on some factors:
– Level of precision desired
– Type of study design
– Prevalence of condition from previous
studies
– Available time and funds
– Personnel
– Inclusion & exclusion criteria stated
 Sampling techniques
 Simple random - eg lucky dip
 Systematic random - eg even nos, odd nos etc
 Stratified random
 Cluster
 Multi-stage etc
 Sample Size Estimation
• Sample size should be large enough for
-appropriate analysis
- desired level of accuracy
- validity of significant tests
- confidence level
• On the basis of the above considerations, the
researcher can calculate the sample size needed
• Different formulae are given/used on different
settings
 Sample Size Estimation (eg 1)
•For populations greater than 10,000
n = z2pq/d2
where: n = desired sample size (population greater than 10,000)

z = normal standard deviation usually set at 1.96 (or more simply at 2.0) which corresponds to
the 95% confidence level

p = the proportion in the target population estimated to have a particular characteristic. If there
is no reasonable estimate, then use 50% (ie 0.50)

q = 1.0 - p

d = degree of accuracy desired ,usually at 0.05 or occasionally at 0.02

 Sample Size Estimation (eg 2)
• For populations less than 10,000

nf = n/1+(n)/(N)

• Where:
– nf = the desired sample size when population is less than 1,000
– n = the desired sample size when population is more than 1,000
– N = the estimate of the population size
 Sample Size Estimation (eg 3)
• Sample size for comparison groups (eg test and control)
n = 2z2pq/d2
where:
n = desired sample size for comparison groups (equal in test and control groups)
z = normal standard deviation usually set at 1.96 (or more simply at 2.0) which
corresponds to the 95% confidence level
p = the proportion in the target population estimated to have a particular characteristic.
If there is no reasonable estimate, then use 50% (ie 0.50)
q = 1–p

If you cannot assume equal sub-sample sizes or if the sizes of the populations from
which the samples are drawn are much less than 1,000, the procedure for sample size
estimation may become more complicated.
In such and other cases, please consult a statistician.
 Sample Size Estimation

• In all, a large sample size will yield

more accurate results but may be
more costly than a smaller sample
size.
Sampling Method - Probability Method
– Simple Random – Table of Random numbers, Basket
method
– Systematic method – may be random but systematic
– Stratified method – stratification by characteristics
b4 selection
– Multistage method – for large scale surveys.
Selection done in stages
– Cluster method – population first divided into
heterogeneous clusters eg families, villages, tribes,
level of education etc
Sampling Method - Non-Probability method

• (not based on known probabilities)

– Convenience (also haphazard/accidental)
– Quota – pre-determined eg based on sex, age, ethnic group etc
– Judgemental (also purposive – investigator believes or
presumes that samples are good representation of population
for study) eg some states as representation of Nigerian
population
– Snowball - Data is collected from a small group of people with
same the characteristics. This group then assists to identify
other people like them. This continues in turns, until the
required sample size is attained.
 Data Collection
• There are 2 major types
– Quantitative data
– Qualitative data
– study design determines mode of data collection
– based on variables to be measured
 Quantitative data
• Obtained from measures of quantity or
frequency
• Obtainable from:
questionnaires
interviews
experimental results
observations,
diaries etc
 Qualitative data
•Collected from social surveys
•Recorded in prose form
•Obtained from:
group interviews
focus group discussions (FGDs)
telephone interviews
face to face interviews
In-depth and key informant interviews etc
 Data Processing

–PROFESSOR AGUWA E.
 Discussion
• Major findings in the research are outlined and
discussed
• May also mention findings from other related
studies
• References and comparisons are made to past
knowledge and reports
• Inferences are also drawn from the results/data
• Major contributions to knowledge are stated
• Limitations of the study may also be discussed
 Conclusions/Recommendations
• The findings in relation to the research
questions and/or objectives are summarized
as conclusion
• Recommendations are made based on
research results/data and the problem the
research project is addressing
• Recommendations should follow logically from
the discussion of the findings
 References
• There are different reference styles
– The Vancouver system
– Harvard system
– American Psychological Association (APA) system
– American Chemical Society (ACS) style
– American Mathematical Society (AMS) style etc
– Institute of Electrical &Electronics Engineers (IEEE) system
The Vancouver system, recommended by the
Council of Science Editors (CSE), is used in medical and
scientific papers and research.
Style may vary from institutions, faculties, departments etc
 Journal References
• If authors’ names are used in the text, followed by year of publication in
brackets (eg. Ejezie, 2011); (Onyekwelu, et al 2017) – the references
should be listed in alphabetical order by authors’ last names.

• Ejezie F.E, Nwagha U.I. Zinc concentrations during pregnancy and

lactation in Enugu, South-East Nigeria. Annals of Medical and Health
Sciences Research. 2011. 1(1): 69-76.

• Onyekwelu ,K .C., Ejezie, F.E., Eze, A.A., Ikekpeazu , J.E., Isaac ,C., Ibegbu ,
D.M., Ogbunude ,P.O.J. Molecular Identification of Trypanosomes in
Tsetse Flies trapped from Onicha Ugbo in Delta State of Nigeria.
Biomedical Research .2017. 28(12): 5463 – 5467.
• Any style used must be consistent
 Book References
• Ejezie, F.E. & Ikekpeazu, J.E. (2017).
Fundamentals of Metabolism. (2nd edition).
Enugu. Ezu Books Ltd. pp 150-163.
• Pegrum, M. (2009).From blogs to bombs: The
future of electronic technologies in education.
Crawley, W.A: UWA Publishing. pp 78 – 82.
 Online (Website) Reference
• Citing a general website article with an author
Author, A. (Year of Publication). Article title.
Retrieved from URL, date retrieved.
• Australian Environmental Society (2007).
Improve indigenous housing now, government
told..
http://www.architecture.com.au/i-cms?page=1
0220
(retrieved 20th Sept. 2007).
 Appendix
• For additional information and contains:
– Raw data
– Relevant tables/graphs used in the project design
– Relevant pictures - eg plants used in study, special
equipment
– Documents eg ethical committee certificate
– Items help to clarify issues in research report
– Items help to authenticate/validate research process
– Numbered in Roman numerals – I, II, III, IV etc
– May be optional in some cases
 Dissemination
• Research report is written for:
– Presentation/examination
– Publication in peer-reviewed journals
 Format for Research Report –Preliminary
pages
• Title or cover page
• Certification page
• Dedication
• Acknowledgement
• Abstract or summary
• Table of contents
• List of tables, figures
• List of abbreviations
 Format for Research Report – Main Report
Sequence
• Introduction
• Objectives
• Literature review (Justification)
• Materials/patients and methods
• Results
• Discussion
• Conclusion
• Limitations(if any)
• Recommendations
• References
• Appendix
 Chapters of Research Project Report

• Chapter 1 – Introduction/objectives
• Chapter 2 – Literature review
• Chapter3 - Materials & Methods
• Chapter 4 - Results
• Chapter 5 – Discussion
• Chapter 6 - Conclusion & Recommendations
• References
• Appendix
 References
• Creswell, J.W. (2003). Research design qualitative, quantitative and mixed methods
approaches. Sage publications London. 2nd Ed. p. 19
https://ucalgary.ca/paed/files/paed/2003_creswell_a-framework-for-design.pdf
(retrieved 12/7/17)
• Denzin ,N.K., Lincoln, Y.S. (2000). Handbook of Qualitative Research. 2 nd ed. Sage
publications
• Johnson, G.L. (1986). Research Methodology for Economists: Philosophy and
Practice. Macmillan, New York. pp 11 – 27
• Research and Methodology (2014) - University of Hawaii at Manoa: Lecture 2 slides.
www.manoa.hawaii.edu/ctahr/aheed/.../Lecture2_Research_&_Methodology_Chap
2
. (retrieved 23/4/16)
• Saunders, M., Lewis, P. & Thornhill, A. (2000). Research methods for business
students.2nd edition. Harlow: Pearson Education.
• Onwasigwe, C.N. (2004). Medical Research Project: A Practical Guide. Enugu. El
‘Demak Publishers.
Thank You