01

HOW TO DEVELOP A
RESEARCH PROTOCOL

KSU COLLEGE OF MEDICINE

2019 - 2020

ACKNOWLEDGMENTS
TEAM LEADER
SARAH ALENEZY
TEAM MEMBERS
Still RECRUITING, JOIN US!
REVIEWER
Yazeed Al-dossare
 Original, refrased. Our notes. Doctors notes. Golden notes.

RESEARCH PROTOCOL PAGE 02

TABLE OF CONTENTS

WORKPLAN METHODOLOGY OBJECTIVES HYPOTHESES

PROBLEM TITLE

PROTOCOL
LITERATURE SUMMARY
REVIEW

ETHICAL
BUDGET CONSIDERATIONS
ANNEXUS REFERENCES

LECTURE OBJECTIVES

By the end of this lecture, I am able to:

Understand the different steps of a research protocol.
QU

Understand the importance of a research protocol.

IZ

Develop a research protocol on my topic of interest.

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RESEARCH
Definition
Answering a question, or solving a problem using a systematic collection, analysis and
interpretation of data.

RESEARCH PROTOCOL
Definition
A document proposing a research project, consisting of a request for sponsorship.
Unlike proposals, protocols are detailed, consisting of a step-by-step guideline.

Components
Components of research protocols vary according to your study.
The Anatomy of research: What it’s made of (Question, Sample, Variables.. etc.)
The Physiology of research: How it works (Measurements).

Click the linked-texts below for great, relevant resources:

1. Protocol Writing in Clinical Research.
2. Fifteen Common Mistakes Encountered in Clinical Research.
3. A Guide to Using Qualitative Research Methodology.
4. What Is the Meaning of Variables in Research?
5. How to Use EndNote for Windows.
6. How to Use EndNote for Macintosh.
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Why a Protocol
● Clarify your research question. ● Compile existing knowledge.
● Formulate hypotheses and objectives. ● Clarify ethical considerations.
● Decide a study design. ● Apply for funding.
● Refer to as guideline and tool for the research.

A Good Protocol
● Answers research question(s), and achieves the study objective(s).
● Feasible on its particular set-up i.e. timeframe.
● Provides enough detail (methodology) allowing other investigators to adapt the study.
● Delivers comparable conclusions.

PROTOCOL TITLE
Definition
The name. It is where you summarize your main idea(s) with fewest words possible to
describe the content and purpose of your research paper.

Good Title
● Catchy and interesting. ● Inclusive of the target population.
● Descriptive, clarifying the main objective(s). ● Not too elaborative.
● Inclusive of keywords (for referencing). ● Accurate, short, and concise.

TB in HIV – infected children.

Incidence of TB in HIV- infected children in North Uganda 2017-2018.
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PROTOCOL SUMMARY
Definition
A summary of something is a short account of it, that gives main points, not details.

Good Summary
● Concise to one page (≈300 words).
● Stands on its own – no reference to protocol content.
● Summarizes central elements
i.e. Rationale, methodology, populations, timeframe, and expected outcomes.

PROTOCOL PROBLEM
Definition
An inquiry starting from given conditions to investigate or demonstrate a fact or result.
Answers why your research is needed, and what the relevance of your results is.
Also called your ‘Rationale’ or ‘Justification’.

Logical Flow
1. Magnitude, frequency, and distribution: Who is affected (Age-group, ethnic, gender
considerations), and Where (geographical considerations)?
2. Probable causes: What is the current knowledge of the problem and its causes? Is
there consensus? Is there controversy? Is there conclusive evidence?
3. Possible solutions: In what ways have solutions to the problem been attempted?
What has been proposed? What are the results?
4. Unanswered questions: What remains to be answered? What areas have not been
possible to understand, determine, verify, or test?

5. Based on the points you will mention above, you develop your objectives.
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PROTOCOL LITERATURE REVIEW

Definition
A summary of previous research done on a topic.

Aims To
● Prevent duplication of work that was already done.
● Clarify what others already found.
● Familiarize writers with potential methodologies, and methodological errors.
● Determine what you are going to add.
● Convince the need of your research.

PROTOCOL JUSTIFICATIONS

Definition
A convincing statement for the need to do this research.

Answers
● How does the research relate to the priorities of the region and the country?
● What knowledge and information will be obtained?
● What is the ultimate purpose that the knowledge obtained from the study will serve?
● How will the results be used, and who will be the beneficiaries?
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PROTOCOL OBJECTIVES
Definition
Description of what you expect to achieve by a research.

Aim To
● Focus the study, narrow it down to essentials. ● Solving the problem you identified.
● Avoid the collection of unnecessary data. ● Organize the study in defined parts.
● Derive specific objectives from a general objective.

Good Objectives
● Three objectives; One primary objective, and up to two secondary objectives.
● Logical, feasible, and realistic.
● Relevant, phrased to clearly meet the purpose of the study.
● Defined in operational terms that can be measured.
● Stated in action verbs that illustrate their purpose:
e.g. to determine, to compare, to verify, to calculate, to reduce, to describe.. etc.

PROTOCOL HYPOTHESES
Definition
Assumptions that you can prove or disprove by the end of your study.
● Describes the relationship between independent variables (e.g. risk factors) and
dependant variables (e.g. outcome of predisposing to these risk factors).
● Determines the type of data to collect, and the type of analysis to conduct.

Intervention
Independent Observation Dependant
Variable Control Variable
Variable
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PROTOCOL METHODOLOGY
Definition
Techniques adopted in your research process to collect, assemble and evaluate data.
● proves or disproves hypotheses, using the right tools.
● Presents a detailed strategy on achieving objectives.

Study Designs
● Deciding a study design is based on: Ethics, logistic considerations, economic
aspects, scientific thoroughness, and relevance to your objectives.
● Prime concerns defining the study design are: Validity of the results, including:
potential bias, confounding, and generalizability.

Observational Cross- Case-

Cohorts
Study Sectional Control

Interventional Experimental
Study

Definition of Variables

Variables are anything that can affect, or change the results of a study. Every study has
variables as these are needed in order to understand differences.
The definition of variables looks like:

Conceptual Definition Operational Definition Scale of Measurement

Age Age at last birthday Continuous: In months

Family Size Number of family members Discrete

Religion As reported Nominal

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Measurement of
Observation
● Attach the questionnaire to your protocol.
● Type of interview, and describe its structure.
● Refer to literature, personal knowledge, or describe in detail any lab tests.
● Describe gadgets and procedures any clinical examinations.
● Refer to specific literature and regulations for interventions (i.e. drug trials).

Participants (Subjects)

Depending on the type of study, answer the following questions:

● What are the criteria for inclusion?
● What are the criteria for exclusion?
● What are the criteria for discontinuation?
● In intervention studies, how will subjects be allocated to index and comparison
groups (i.e. Randomization procedure)?

Sample Size
● Sample size calculation is recommended for economical and ethical reasons.
● Simple statistical packages in the internet.
● Level of error, power, and expected impact of exposure have to be set.

Data
Measurnment and Analysis

Based on objectives consider:

● Coding and type of variables. ● Analysis plan depending on type of variables.

● Appropriate Statistical tests. ● Style of presentation (e.g. tables, graphs.. etc.)

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PROTOCOL ETHICAL CONSIDERATIONS

Why?
Ethics searches for reasons for acting or refraining from acting; for approving or not
approving conduct; for believing or denying something about virtuous or vicious conduct
or good or evil rules.

Informed Consent
Outline how, when and where will the participant be consented.
Information form should contain:
● Justification for research. ● Responsibility (Who).

● Outline of study. ● Confidentiality (legal framework).

● A separate consent form is required.

Ethics Checklist
● Potential questions regarding the ethics.
● Pros and cons of research design, subject selection, measurement, and outcome.
● Advantages and disadvantages of the subject involved.
● Physical, social and psychological implications of the research.
● Confidentiality.

PROTOCOL WORKPLAN
Why?
Split tasks into: Who, When, and Where.
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PROTOCOL REFERENCES
Referencing Systems

Harvard Style: Name and publication year in text; Alphabetical bibliography.

E.g. Brown, D. (1998). Digital fortress. New York: St. Martin's Press.

Vancouver Style: Numbered references; Continuous referencing in text (more used).

E.g. Within the body of your article: (1), then, within your citations: 1. Digital
fortress. New York: St. Martin's Press (USA): Brown, D; 1998.

Software Referencing

● Endnote.
● Reference manager.

PROTOCOL BUDGET
Broken Down By
● Items: Personnel, consumables, equipment, communication, data processing.. etc.
● Justification: Use of each item, considering the workplan.

PROTOCOL ANNEXUS
As In
Attachments:
Case record forms, questionnaires, and consent forms (in required languages).
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FINAL POINTS
Practical Hints
● Demonstrate your expertise.
● Strictly follow guidelines.
● Be realistic about the time things take.
● Strictly comply to deadlines.
● No typographical or other errors.
● Discuss research proposal with your collaborators well in advance.
● Ask your colleagues to read your proposal prior to submission.

Common Mistakes
● Insufficient details for proposed projects.
● Insufficient justification for the significance of problem.
● Proposing far more work than can be reasonably done during the grant period.

The Reviewer
● Has an interest in ranking the applications in an unbiased, fair, scientifically rigorous
way, giving the best scores to those grants that are most likely to contribute to our
body of knowledge.
● May not be extremely familiar with all techniques. All parts of the grant must be clear
and written in such a way that a non-expert can understand them.
● May not know the applicant personally. It is the job of the applicant to convince the
reviewer.
● May not fully understand the significance of the research area without a clear,
compelling argument presented in the application.
● Is capable of understanding and interpreting preliminary data if well-presented.
● Must read 10 to 15 applications in great detail and form an opinion about all of them.

The successful proposal is clear and precise, is easy to read, has a detailed experimental
design section, and is free of typographical and other errors.