Edgewood Campus Howard College Campus Nelson R Mandela Pietermaritzburg Westville Campus

Campus Campus

Research Protocol
2023 HMBC7MRM1

Dr S Mahomed
 Components of a Research Protocol
• Title • Title
• Summary
• Introduction
• Table of contents
• Acronyms and abbreviations
• Focused background to the current study that must
include:
1. Introduction
• Problem Statement
2. Literature review
• Research question/s, that is what is unknown and/or
3. Aim of the study remains to be answered
4. Objectives • Rationale/Significance
5. Type of research • Hypothesis
6. Definitions • Aim/Objectives
7. Research methods • Review of Literature
8. Ethical considerations
• Methodology
9. Work Plan
10.References • Plan of Work (time frame)
11.Appendices • Budget
• References
2
What is a research protocol?
• Detailed plan of the study
• Operationalizes the conceptual idea
• Acts as a “guide”
• Should provide enough detail that can allow another investigator to
do the study and arrive at comparable conclusions

3
Research Protocol
• presented at a publishable level
• reviewers should find it easy to read and understand
• well-written and prepared protocol is likely to receive rapid approval

4
Title
• What is to be studied, where, when and in whom
• 10-15 words
• Clear and succinct
• Title page includes:
• Student name and number
• Supervisor details
• Purpose of the research – as in toward what qualification

5
Summary/Abstract
• Refer to your supervisor re word count (150-300 words)
• Structured abstract format
• Background
• Objectives
• Methods: study design, study setting, study population, study sample, data
collection, data analyses

6
Table of contents
• Use MS Word
• References  Insert Table of Contents
• Pages must be numbered

7
Acronyms and Abbreviations
• List of acronyms and abbreviations used in the protocol
• Alphabetically
• Use internationally accepted acronyms and abbreviations
• E.g. MDR TB: multi-drug resistant

8
Introduction
• What is the problem, importance
• Can include a brief definition/description
• Epidemiology – global, national and local
• magnitude, frequency, affected geographical areas, ethnic and gender considerations
• What needs to be known
• How will the study assist in solving the problem or will contribute to
addressing the problem
• What is the research question/s or hypothesis?

9
Introduction (1)
Topic: Patients knowledge of tuberculosis in ????
• What is the problem, importance
• TB prevalence and TB treatment outcomes globally, SA, KZN, in specific
district; Link between HIV and TB
• High prevalence of TB treatment interruption in the area where you plan to
do your research
• Consequences of poor TB treatment outcomes
• Drug resistance
• Transmission
• Increased morbidity and mortality

10
Introduction (1)
• What needs to be known
• Is there sufficient awareness and education on TB in communities

• How will the study assist in solving the problem

11
Rationale
• Why are you doing this study
Hypothesis
• What is the idea/phenomenon that you are testing in your study?
• Denotes the relationship between the dependent and independent
variables….
• e.g. a phone that is switched off will charge faster than a phone that is
switched on
• e.g. patients who completed high school are more likely to complete
their anti-tb treatment compared to patients who have not
completed high school
• e.g. ??
Literature Review
• Review of studies that have looked at same problem
• Prevents duplication of work
• Establish what others have learned and reported on the problem
• Identifies types of methodology that could be used in the study
• Motivation for this particular research project

14
Aim of the study
• Clear and concise statement of the overall intention of this research
• What you hope to achieve
• What is being studied, where, when an in whom
• Also referred to as Purpose
• E.g.
• The aim of the study is to determine the risk factors for TB treatment
interruption among patients in eThekwini District in 2018

15
Objectives
• Investigative ‘steps’ to be done to achieve the research aim
• Specific statements which define measurable outcomes
Objectives
• SMART
• Specific, Measurable, Achievable, Relevant and Time-related
• Present in a logical sequence
• To describe the socio-demographic profile of patients with TB in eThekwini
District in 2018;
• To assess the proportion of patients who interrupt their TB treatment; and
• To determine the demographic and clinical factors associated with TB
treatment interruption

17
Type of Research
• Basic Sciences/Biomedical/Laboratory
• Clinical
• Epidemiological
• Health Systems Research

18
Definitions
• Terms used in the study
• Not standard dictionary or textbook definitions

19
Research Methods
• Study Setting: specify where the study will take place (where you will
be collecting data)
• Study Design: to be covered
• Target Population: To which population will your results apply to?
• Study Population: selected from the target population
• Inclusion criteria
• Exclusion criteria

20
Research Methods
• Sampling: to be covered later
• Probability (random)
• Non-probability
• Describe the sampling method you will be using in this study
• Sample size

21
Research Methods
• Data sources:
• Type of data: quantitative or qualitative
• Primary data vs secondary data
• Patient, patient medical records, patient registers, patient specimens - specify

22
 Research Methods
• Measurement Instruments and Data Collection
Techniques
• Describe how data collection will be done
• Interviews, observations, questionnaire, physical
measurements, taking of blood/sputum/urine specimens
• What tools will be used
• How will it be administered

23
 Research Methods
• Measurement Instruments and Data Collection
Techniques
• Laboratory investigations:
• describe the handling and processing of specimens: collection,
transport
• describe investigations/tests to be carried out
• culture, gram stain, susceptibility testing
• including quality control
• timing of these investigations/tests

24
Research Methods
• Measures to ensure reduction of selection and information bias
• What are the possible biases in your study and what steps have you taken to
reduce this bias?

• External validity/Generalizability
• To whom will the results of your study be applicable?

• Pilot study
• Try out your questionnaire/lab test on a small sample and process the data
• Is it giving you the information that will allow you to meet your objectives?
25
Research Methods
• List of variables
• What variables are you collecting?
• E.g. age, gender, employment status, TB treatment outcome, weight, height

• Data Management

• Describe what you will be doing with the data

26
Research Methods
• Data analysis
• Descriptive statistics
• Percentages, proportions
• Mean, median, mode
• Presented using tables, figures
• Analytical statistics
• What test will you use to compare groups?
• Depends on type of data – categorical of numerical?
• 95% confidence intervals; p-value

27
Ethical Considerations
• Institutional Ethical Review Board
• Which ethic committee will the protocol be submitted to?
• Biomedical Research and Ethics Committee
• Animal Ethics Committee
• Human and Social Sciences Research Ethics Committee
• ?Expedited approval

• Permissions
• Permission from the hospital/clinic manager
• Permission from the KZN DoH Research Committee

28
Ethical Considerations
• Informed Consent and Participant Information
• Does the study involve human participants
• How will you obtain informed consent
• Confidentiality

29
Work Plan
• Budget
• What resources will you be requiring, and cost thereof
• Who will cover these costs?
• Do you have funding?
• Study Period/ Timelines
• Draft protocol:
• Submission of protocol to ethics committee:
• Data collection:
• Data analysis:
• Write-up:
• Research presentation:
30
• Reporting: to whom will the results of the study be communicated to
• References
• ensure consistent style
• Appendices
• In order of how it is referred to in the protocol
• Turnitin report
• Data collection tool
• Letters requesting permission
• Participant Information and Informed Consent

31
Additional documents required
• CV of researcher/s and supervisor/s
• Template available on BREC website
• Ethics certificate of researcher/s and supervisor/s
QUESTIONS??