This document provides guidance on developing a research protocol. It explains that a protocol establishes the design and methodology for a research study. The key components of a protocol include the title, introduction/background, objectives, study design, population and recruitment, variables, data collection tools, analysis plan, timeline, and dissemination strategy. Developing a clear protocol is important to gain approval, plan the study, avoid mistakes, and evaluate the research. It should provide enough detail that the study could be replicated by others.

2. How to develop a
Research Protocol ?
Research methodology workshop 2015
Dr Sushma Sharma

3. This session ---------
By the end of this session, you will be able to:
• Understand what is Research ?
• Identify the components of a research protocol
• Explain the role of each part within the overall
process of protocol development
• Understand the importance of research protocol
• Able to write a research protocol

4. What is Research?
A systematic 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.
Research helps to provide scientific
understanding and solves practical problems.

5. Research (cont.)
Relies on methods and principles that will
produce credible and verifiable results.
All research starts with an idea or question
based on personal experiences.

6. Scientific Approach
The most sophisticated method of acquiring
knowledge is by 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 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. Policy making,
planning,
Management
evaluation
Health
systems
research
Epidemiological
Biomedical
Statistical
Behavioral
Social &
economic
MODEL OF THE RELATIONSHIP BETWEEN DIFFERENT TYPES OF RESEARCH

9. Protocol writing

10. Getting started:
• Title
– Clear
– Concise
– Understandable
• Introduction / Project
outline:
– What?
– Why is this research
needed?

11. What is the purpose of a proposal?
• Let me do the study?
• Plan, then do
• Provide a road map
• Opportunity for advice
• Check quality / rigour
/ do-ability
• Avoid costly mistakes
• Convince lecturers and
you

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

13. Practicalities
• When / Time lines
• Problems / issues
• Resources
– Costing
– Materials
• Outcomes / Outputs /
Significance
• References
• Writing up – include drafts
and revisions

14. Choosing a topic
• Should be interesting – to investigator, funding agency,
journal editors, consumers (colleagues, public, medical
community), etc.
• 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

15. 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

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

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

18. Identify the Question
Criteria for evaluating the question:
Significance
Practicality
Feasibility
Interest to researcher

19. RESEARCH QUESTION
IT SHOULD BE A SINGLE SENTENCE IN THE
FORM OF A QUESTION.
IT SHOULD BE CLEAR ,UNAMBIGUOUS AND
SPECIFIC

20. RESEARCH QUESTION
• IS DRUG “A” BETTER THAN DRUG “B” IN THE
MANAGEMENT OF HEPATIC FAILURE IN
PATIENTS WITH CIRROSIS?
• IS ALCOHOLISM RELATED TO THE
DEVELOPMENT OF CIRROSIS LIVER?

21. What to have in a complete study
protocol ?
• Title
• Summary
• Background (Literature Review), Preliminary Studies,
and Justification/Rationale
• Study Objectives and/or Questions
• Testable Hypotheses
• Study Design
• Study Population and Methods of Recruitment
• Variables List and Sample Size

22. • Methods of Data Collection
• Data Collection Tools
• Plan of Analysis
• Timeline
• Issues for Ethical Review & Approvals
• Operational Planning and Budgeting
• Plan of Dissemination/Results Reporting
• References

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

24. Background
• Briefly sketch the background of the proposal.
• Critically evaluate the existing knowledge
– What is the general situation and how is the
problem developing?
– Will it grow rapidly if unchecked?
– What has been done so far to address the
problem and with what effect?
• Specifically identify the gaps the proposed research is
intended to fill.
– What do you propose to do?
– Explain why it is a good idea ?
• State concisely the importance of your research

25. Significance
• State concisely and clearly the importance of
your study.
• Emphasize on any novelty or innovation
• Convey the significance of your research to
– 1) scientific contribution
– 2) improving in public health
– 3) change in health policies
– 4) change in patient care
– etc.,

26. Study Objectives
State the objectives of the proposal:
Describe concisely and realistically what the
specific research is intended to accomplish
Avoid grandiose designs- Over-ambitious
proposals that aim to do everything
– burdens, determinants, prevention and control
of….

27. • Objective -examples
• To study whether SNP markers are
associated with obesity and hypertension
phenotypes.
To assess the general population
knowledge & attitude towards Organ
donation
To identify the risk factors for Type-II
diabetes
• Hypotheses
Any hypotheses to be tested.
• • Have clear hypotheses

28. Hypothesis and Specific Aims
• List the specific aims one by one concisely
• Not too many aims; 2-4 best
• Be specific, no general and ambiguous statements
• Be realistic, no unachievable aims
• Aims should be logically linked and arranged accordingly; testing your
hypothesis

29. When you divide a section into subsections,
all the pieces should be of the same pie

30. • Hypothesis-example
• We hypothesize that standard care plus new intervention
(additional drug) will be superior to standard care alone in
reducing CVD mortality among patients with preexisting
heart disease.
• We hypothesize that prophylaxis with inhaled
drug A will be superior to oral preparation of
drug B in preventing acute exacerbation of
reactive airway disease.
• We hypothesize that low birth weight is an
independent risk factor for type II diabetes.

31. What is your question
Hypothesis
Why is your study important
 Significance
How are you going to do it
 Research design
Key Points of Your Proposal

32. Develop the Study Design
• A study design is the researcher’s
overall plan
to obtain the answer (s) to the question
being
asked and the hypothesis being tested
• It spells out strategies to develop
information
that is accurate, objective and
meaningful

33. • Study Design
• Describe the overall design of the study,
example:
• This is a randomized, double blind placebo
controlled trail.
• This is a cross sectional survey

34. Research Designs
Purpose Study Design
To determine frequency & burden
of a disease
* Cross sectional survey (Prevalence)
* Cohort study (Incidence)
To identify the risk factors * Cohort study
* Case-Control study
To determine prognosis of a
disease
* Cohort study
To determine efficacy/
effectiveness of new treatment
* Clinical trials
*Community intervention
To evaluate community programs * Evaluation

35. Feasibility- Study subjects
• What is the estimated sample size?
• Who is the study subject (case definition)?
• Selection criteria (inclusion & exclusion)
• How they are sampled ? (sampling)
• Time span for meeting the sample size

36. Can we meet the sample size?
• Estimated sample size (based on the research
hypothesis, outcome variable)
• Estimated subjects likely to be available for
recruitment
• Estimated subjects likely to refuse
• Estimated subjects likely to be lost to follow up

37. Study Population and Method of
Recruitment
-- Describe clearly what type of subjects will be studied
-- How will they be identified
-- Inclusion and Exclusion criteria
-- Describe each step involved in recruitment of study subjects
-- Describe the role of research personnel in this process
-- Mention “informed consent”

38. Variables List
• State all the information that is to be
collected
(demographic data, clinical and lab data) in
detail.

39. Method of data collection
• Explain precisely when and how the data will
be collected, and measured (units).
• Explain method of ensuring quality control

40. Data Collection Tools
• Explain why a particular tool is being used to
collect the data. For instance, if a survey
questionnaire is being used explain reliability
and validity of the instrument.
• Pretest

41. Analyzing the Data
Upon completion of the study, data should be
analyzed
List out the appropriate statistical tests based
on the type of data

42. Plan of analysis
• List the names of variables that will be
used in the analyses.
• State the name of statistical analysis that
will be
performed to assess the outcome.

43. Problems may not be where you think
they are…

44. 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.

45. Your role as the researcher?
Proposal reviewer role?
Exercise: What are the
criteria for evaluating
research proposals?

46. Benefits of Writing Proposal
• 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.

47. Planning your project:

48. Burden and Balance

49. Look out for the unexpected: positive and
negative

50. Writing Stages
2. Writing the First Draft
4. Finishing3. Revising, Revising, Revising
1. Getting in the Mood
Save multiple copies
of your draft

51. 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.

52. Thank You