1. How to develop a
Research Protocol ?
Dr. Farzana Saleh Ph.D.
Associate Professor of CN
Bangladesh University of Health
Sciences

2. Differences between Research
Protocol and Research Proposal
 A research protocol is a detailed set
of activities for the proposed project
and these activities are supported
by evidence from
other research and from the
preliminary investigations.
 A research proposal is a concise
and clear summary of the proposed
research. SYNOPSIS.

3. What is Research?
 A methodical investigation, involving
the collection of information (data),
to solve a problem or contribute to
knowledge about a theory or
practice.
 Research is critical in medicine
because it leads to new discoveries
and can change peoples’ lives by
improving health and well being.

4. What is Research?
 Research helps to provide scientific
understanding and solves practical
problems.
 Relies on methods and principles
that will produce reliable and
supportable results.
 All research starts with an idea or
question based on personal
experiences.

5. Research (cont.)
 careful or attentive search
 studious inquiry or examination
 especially : investigation or
experimentation aimed at the discovery
and interpretation of facts, revision of
accepted theories or laws in the light of
new facts, or practical application of
such new or revised theories or laws
 the collecting of information about a
particular subject

6. Scientific Approach
 The most sophisticated method of
acquiring knowledge is - scientific
approach.
Combines important features of
induction and deduction together with
other methods to create a system of
acquiring knowledge.
 Generally more reliable than other
methods.
 Approach used most often to perform
medical or public health research.

7. Scientific research
is an integrated approach of deduction
and induction
Deduction
Hypothesis generation
Testing the hypothesis
Induction
(Inference on hypothesis)
generalization of the results
In sample
population
Universe
known truths

8. Causal model of risk factors for CVDCausal model of risk factors for CVD
Morbidity and Mortality
(Stroke, MI)
Biological Risk Factors
(Hypertension, Blood Lipids, Homocysteine)
Genetic Risk Factors
(Family History)
Behavioral Risk Factors
(Cigarette, Diet, Exercise)
Environmental Factors
(Socioeconomic Status, Work Environment)

9. Protocol writing

10.  What is your question ?
 Why is your study important ?
 How are you going to do it ?39
Key Points of Your Proposal

11. Choosing a topic
 Should be interesting – to investigator,
funding agency, journal editors,
consumers (colleagues, public health
researcher)
 Relevance- add new information to the
scientific world
 Simple and manageable in scope
(feasibility in terms of money, time,
manpower)
 Expected results likely to alter clinical or
health policy decisions in future

12. The GOOD IDEA must be
 Feasible
 Do-able by you
 Do-able at your institution, hospital
& community
 Acceptable to your institution
 In conformity with human welfare
policies
 Conceptually significant

13. Steps in conduct of research
planning and execution
The first and foremost is
formulating a research question,
the most challenging part

14. Identify the Question
Sources for identifying the question
or problem:
Personal experiences
Literature review
Theories
Ideas from others

15. Identify the Question
Criteria for evaluating the
question:
Significance
Convenience
Feasibility
Interest to researcher

16. Research question
 IT SHOULD BE A SINGLE SENTENCE
IN THE FORM OF A QUESTION.
 IT SHOULD BE CLEAR DEFINITE AND
SPECIFIC.

17. What to have in a complete
study protocol ?
 Title
 Abstract
 Introduction
a)Rationale
b)Hypothesis/ Research question
 Literature Review
 Study Objectives

18. What to have in a complete
study protocol ?
 Methods and materials
a)Ethical consideration
 Time line/ Plan of work
 Reference
 Budget

19. Title must reflect the central
theme: selling point
Attractive and easy to understand
Concise and Informative: avoid
non-informative words like “ A
study of---”
Title

20. Bioavailability and Health Effects
of Isoflavones from Bangladeshi
Soybean and Lentils in
Postmenopausal Women
Example of a Title

21. 1. Title of your Research Proposal
2. Name of the Supervisor (s)
3. Name of the Principal
Investigator (PI)
4. Name of the Co-investigators (if
you want or have)
5. Place of the Study
6. Duration of the Study
Contents of a Title Page

22. Thesis protocol should have
abstract section.
The abstract should-
a)Provide a brief overview of the
proposal that gives a reader a
basic understanding of the
proposal and encourages her or
him to read more.
Abstract

23. b) Summarize
− Introduction
− Statement of the Problem
− Research Questions or
Hypotheses
− Methods
− Expected Results
− Expected Conclusions
Abstract

24. Example of a Abstract

25. Introduction
 Study protocol should have
introduction/Background section.
 The introduction helps put your
project in conversation with other
projects on similar topics.
 Generally, the introduction provides
necessary background information to
your study and provides readers with
some sense of your overall research
interest.

26. Introduction
A good introduction should:
Establish the general ground (real
world or research) in which the
research is placed.
Describe the broad foundations of
your study, including some references
to existing literature and/or empirically
observable situations.

27. Introduction
 In other words, the introduction needs
to provide sufficient background for
readers to understand where your
study is coming from.
 Indicate the general scope of your
project, but do not go into so much
detail that later sections
(purpose/literature review) become
irrelevant.

28. Literature Review: In your review of literature
you are expected to do the following:
1. Place one's original work in the
context of existing literature.
2. Interpret the major issues surrounding
your topic.
3. Describe the relationship of each
work to the others under
consideration.
4. Identify new ways to interpret, and
shed light on any gaps in previous
research.

29. Literature Review: In your review of literature
you are expected to do the following:
5. Resolve conflicts among seemingly
contradictory previous studies.
6. Determine which literature makes a
significant contribution to the
understanding of your topic.
7. Point the way to further research on
your topic.

30. Literature Review: Contents
 The Literature Review
must be well structured
 your ideas must flow logically from one
point to the next.
 Ensure sources and references are
current and relevant, cited appropriately
according to your discipline.
 Present terminology and viewpoints on
the topic in an balanced and
comprehensive manner.

31. Literature Review: Contents
Include the following content in your
Literature Review:
Provide an overview of the subject, issue, or
theory under consideration.
Divide outside works into categories and
concepts.
Connect the works to what has come
before your work and ideas.
Provide conclusions about those works that
make the greatest contribution to the
understanding and development of your
subject.

32. Literature Review: Considering the points
 Qualifications: What are the author's
credentials to make the judgments
he or she has made?
 Neutrality: Is the author's perspective
even-handed or biased?
 Credibility: Which of the author's
theses are convincing and why?
 Worth: Do the author's conclusions
add to the value of your own?

33. Literature Review: Considering the points
 Your transitions between ideas
analyze, synthesize, and assess
these outside perspectives, and do
not simply summarize or translate
them.

34. Literature Review: Way of the presentation
 Selecting and quoting only the most
relevant material for your subject and
argument.
 Making sense of the quotation within
the context of your argument.
 Introducing and integrating only
relevant quotations into your literature
review.
 Focusing on the language of
quotations in the interpretations.

35.  Every research work must have
research question (s)/hypothesis.
 A Research question is a statement
that identifies the phenomenon to
be studied
 Many studies have more than one
research question.
Hypothesis/ Research questions

36.  Research Question:
What is the quantity of total isoflavones in
locally available soybean (Glycine max)
and lentils [Mung bean (Vigna radiata) and
Masoor dahl (Lens culinaris)]?
 Hypothesis:
Isoflavones from Bangladeshi soyabean
and lentils have beneficial effects on
health among postmenopausal women
and it has an association with the levels of
follicular stimulating hormone (FSH).
Example: Hypothesis/
Research questions

37.  In this section you need to explain
why your research is important?
 Any novel ideas or contributions that
the proposed project offers should
also be discussed.
Rationale and significance

38.  The rationale includes the (1) reasons
for focusing on your stated objectives,
and hypotheses and (2) reasons for
choosing the materials and methods
you propose to use.
 The significance includes both the
applied and basic significance of your
research—that is, how will the world be
different after your research is
completed?
Rationale and significance

39. Objectives
 Objectives are the achievable,
outcome-based aims of your research,
and should be presented as concise
statements that describe what you plan
to accomplish by your research
activities. The objectives describe what
you will do to determine whether your
hypotheses are true.
 Under this heading you need to write
create two sub heading, general
objective and specific objective.

40. Example of the Objectives
 To analyze the quantity of total
isoflavones in soybean (Glycine
max) and lentils [Mung bean
(Vigna radiata) and Masoor dahl
(Lens culinaris)].
 To investigate the association of
the Follicular stimulating hormone
(FSH), with the type and quantity
of isoflavones.

41. Methods and Materials
 The methods section will vary
depending on the type of research or
project you propose (e.g., field
research, laboratory study, computer
simulation, case study, etc.)
 In general, should describe the
techniques you will use in sufficient
detail to allow the reader to judge
whether the project will achieve the
stated objectives.

42. Methods and Materials
 This may include
a description of your study area
type of equipment or software you
will use
laboratory procedures
statistical methods
experimental design (e.g., variables
to be measured, randomization
scheme, and replication).

43. Methods and Materials
The methods section must describe the:
Proposed experiments or
investigations.
Materials and techniques that you will
use, including their feasibility.
Statistical techniques and other
methods used to analyze the data

44. Methods and Materials
 It can be include following sub
headings
−Study type
−Study place and population
−Sample size and sampling procedure
−Data collection procedure
−Analysis plan

45. Ethical consideration
 In this section will describe the
ethical issues you need to
address. How those ethical issues
will be addressed. In this section
you need to mention the ethical
review board, from where your
proposal will be reviewed.

46. Conceptual Framework
 A conceptual framework is used to
illustrate what you expect to find
through your research, including
how the variables you are
considering might relate to each
other. You should construct one
before you actually begin your
investigation. Sample conceptual
framework

47. Conceptual Framework

48. References
 The list of references should be
at the end of the proposal
 List names of all authors, the
title of the publication, the
name of journal, year, volume,
page numbers

49. Referencing Styles
The following are the most popular:
APA (American Psychological
Association). APA is an author/date based
style. This means emphasis is placed on the
author and the date of a piece of work to
uniquely identify it.
MLA (Modern Language
Association). MLA is most often applied by
the arts and humanities, particularly in the
USA. It is arguably the most well used of all

50. Referencing Styles
The following are the most popular:
Harvard. Harvard is very similar to APA. Where
APA is primarily used in the USA, Harvard
referencing is the most well used referencing
style in the UK and Australia, and is encouraged
for use with the humanities.
Vancouver. The Vancouver system is mainly
used in medical and scientific papers.
Chicago and Turabian. These are two
separate styles but are very similar, just like
Harvard and APA. These are widely used for
history and economics.

51. Referencing Styles
Student should use the style of the university and tutor
recommend and must not mix-and-match.
Plagiarism
If you quote or paraphrase another author's work without
including a reference to it you are plagiarising. Not only is it
very easy to detect plagiarism using online services like Turn
It In, but it is also very easy for your tutor to spot it just by
reading your work. Remember - you are not being marked
on your ability to write facts or show off what you know.
Any assumptions or facts you state must have someone
else's credible work to back you up. Plagiarism does not
only mean cheating, it is mainly used to describe forgetting
or not realizing to include a reference to other's work or
theories.

52. Timeline/Plan of Work
 Many proposals also include a schedule
with anticipated completion dates for
specific parts of the dissertation.
 This timeline helps your committee
determine if your project is realistic given
available methods and institutional
requirements (such as deadlines for
submission, etc.).
 Setting a schedule can also help you
manage your time more effectively by
setting specific goals for yourself.

53. Example of Timeline/Plan of Work

54. Budget
 In this section will describe the
budget you need to carry out for
your research.
Instructions for text development
 Font Name: Times New Roman
 Font size: 12pt
 Line space: 1.5pt
 Paragraph space: 6pt up
 Upper, lower and right margin: 1”
 Left margin: 1.25”
Document size will be maximum 12 pages

55.  Allow you to review and critically
evaluate the published literature of
your interested topic.
 Develop novel ideas during writing
proposal.
 Convince yourself and others that your
research is worth doing.
 Keep you focused on your research
work.
Benefits of Writing Proposal

56. Writing Stages
2. Writing the First Draft2. Writing the First Draft
4. Finishing4. Finishing
3. Revising, Revising, Revising3. Revising, Revising, Revising
1. Getting in the Mood1. Getting in the Mood
Save multiple copies
of your draft

57. Assessment of thesis proposal
 Proposal will be asses through formative
assessment.
 All of the students will give a formal
presentation on their protocol.
 Department will arrange the date and
venue of the presentation. Along with
departmental assessor an examiners will
be present in the presentation session
from other related department.

58. Assessment of thesis proposal
 Student will acquire 4 credits by
successful completion of presentation
and discussion.
 After completion formal presentation
student need submit their proposal to
the institutional review board (IRB) of
the Institute for ethical approval of the
research.
 Data collection can be started after
getting ethical clearance from the IRB

59. Conclusions
 Developing, and communicating a
research protocol is a sophisticated
and time-consuming process.
 It is important to understand the
steps in developing a research
protocol in order to perform an
appropriate study and obtain
reliable results.

60. Thank YouThank You