RHM 312: Research process

LESSON 3: Protocol Development in Research

Lesson Learning Outcome

• Explain the components of research protocol.
• Discuss the importance of research protocol.
• Describe how to develop a protocol in research
By
Solomon Cheboi (PhD)
MNU
@2025
 Introduction
• Definition: a research protocol or proposal is a written detailed plan of
a study.
• It informs on
i. What will be done?
ii. When
iii. Where
iv. Who
v. Why
vi. How
• It clarifies ideas and directs focus to all aspects of the investigation.
• It guides research, especially if there are multiple investigators.
• It is necessary for institutional ethical approvals.
• It is necessary for fund application.
 Criteria for a good research protocol
• A good research protocol should:
i. Answer the study question(s)

ii. Achieve the study objectives

iii. Be doable/feasible

iv. Be replicable, that is, the information provided should be

sufficient enough to permit study replicability

v. Convincingly show the importance of the research, the

research process and the competence of the investigators
 Elements of a research protocol
1. Project title
2. Project Summary / Abstract
3. Project description (Chapters)
4. Dissemination of results and publication
5. Ethical considerations
6. Timetable
7. Problems anticipated
8. Budget
9. References
10. Research team
11. Annexes
 Project description (Chapter based)
1. Preliminaries

2. Chapter II – introduction

3. Chapter II- literature review

4. Chapter III - materials and methods

5. Chapter IV: results

6. Chapter V: discussion, conclusions and recommendations

7. References

8. Appendices
 Preliminaries
i. Cover page

ii. Student Declaration Page

iii. Dedication Statement (thesis or project)

iv. Acknowledgement

v. Table of contents

vi. Abbreviations and Acronyms

vii. Definition of Terms, Limitations, Scope etc.

viii. Abstract
 Chapter 1.
i. Background to the study- Gives specific gaps that are considered to
be the root of the problem. This should be maximum one and half
pages
ii. Problem statement- To be precise and focused
iii. Justification (Precise and focused)
iv. Research Questions-To relate to objectives and testable
v. Hypotheses
vi. Objectives-Should be clearly stated and achievable
vii. Significance and Anticipated Output - To explain the benefits and
the beneficiaries of the findings of the study
viii. Delimitation and limitation- Gives the extent to which the study will
be carried out
ix. Conceptual/Theoretical Framework- (where applicable) Some
s t u d i e s e s p e c i a l l y l a b o ra t o r y o r i e n t e d m a y n o t f i t i n t o
Conceptual/Theoretical frames). Where applicable it gives
conceptualized view of the study problem. If a certain theory fits into
the study, it should be indicated and discussed.
 Study goals and objectives
Study goal
• Aim/ General objective
• Informs broadly on what the research proposal will do
An ideal study goal:
• Should be clear
• Should state the purpose of the study, that is, what it aims to achieve and
why
• Should define what will be described, determined, identified, compared,
and, where there are hypotheses, it should indicate what will be confirmed
Specific study objectives:
• Statements of the research questions
• Should be formulated before starting the research
• Indicate how the study will accomplish its goals
• Introduce the study design
• Should be simple, concise and specific
 Example of study goal and objectives
General objective (study goal)
“To verify the differences in the length of time low-risk primiparous
women breast-feed when they participate in the program for rooming-
in at home as compared to those who do not participate.”

Specific objectives:
1. “To estimate the prevalence of breast-feeding in low-risk
primiparous women covered by the program for rooming-in at
home and the prevalence of breast-feeding in primiparous women
that receive standard health care.”
2. “To determine the existence of statistically significant differences in
the prevalence of breast-feeding in the group of women who
receive standard health care and the group treated at home.”
3. “To identify the protective factors that from the women's
perspective help to explain the differences in the prevalence of
breast-feeding according to the type of attention received.”
 Examples
Study purpose:
“The purpose of this study is to determine if there are differences in
pain control with nurse versus patient administered analgesia
following surgery.”

Research question:
“Does the administration of analgesic by nurses vs. by patients
themselves affect pain intensity during postoperative recovery in
older adults?”

Hypothesis:
“Patients who self-administered narcotics will be more satisfied
than patients who receive narcotics administered by nurses.”
 Expected Outcomes of the Study
Should answer the following questions

1. What new evidence will be obtained from the study?

2. How will the evidence contribute to improvement in knowledge?

3. Who will benefit or use the findings?

4. Any effect on health care, health systems or policies?

 CHAPTER II - LITERATURE REVIEW
• A summary of the critical review of literatures on the research problem

• Puts the research problem into perspective

• Justifies the new research by identifying gaps and weaknesses in existing

literature

• Should be thorough, logical and well organized

• Should include current and relevant literature

• Should focus on original research and systematic reviews

• Should include literatures that supports or disproves researcher’s point of

view
 CHAPTER II - LITERATURE REVIEW
• Aim- demonstrate evidence of understanding of current research on
the subject under investigation and show clear gaps in knowledge
that will be discussed.
• Appropriate themes for this chapter can be developed using
conceptual framework content.
• Thus, relevant themes to the study and derived review should be
consistent with the requirements of the title (internal consistency)
and aspects of the introduction e.g. background to the study.
Example
2.1 introduction
2.2 objective 1
2.3 objective 2
2.4 objective 3
2.5 objective 4
2.6 summary of literature review and gaps for the study
 CHAPTER III - MATERIALS AND METHODS
• This chapter highlights methodological details appropriate to the study.
i. Research Design- State and justify the chosen design
ii. Variables
iii. Location of the Study
iv. Study Population
v. Sampling Techniques
vi. Sample Size Determination
vii. Construction and Research Instruments (
viii. Pilot Study or Pre-Testing
ix. Validity and Reliability
x. Data Collection Techniques
xi. Data Analysis
xii. Logistical and Ethical Considerations
 CHAPTER FOUR: RESULTS
• This chapter should present the interpretation and explanation of the
findings of the study with regard to the stated hypotheses and
research questions.
• The results should be reduced.
Example
4.1 introduction
4.2 objective 1
4.3 objective 2
4.4 objective 3
4.5 objective 4
4.6 summary of finding
CHAPTER V: DISCUSSION, CONCLUSIONS AND RECOMMENDATIONS
• Introduction
• Discussion: Discuss the results and compare with other similar studies
Example
a) 5.1.1 introduction
b) 5.1.2 objective 1
c) 5.1.3 objective 2
d) 5.1.4 objective 3
e) 5.1.5 objective 4
f) 5.2 Conclusion-emphatic, strong conclusion based on the study
findings should be stated here and should be base on the specific
objectives
g) 5.3 Recommendations-To be based on the conclusions
h) 5.4 Further Research-What is considered to be gaps left out by the
study, which would need further investigation through research,
should be given. The references and then appendices should follow
this chapter.
 Dissemination and publication of study findings
§ How will research findings be communicated and to who?
§ Should include dissemination to participants or communities and
policy makers as applicable.

§ Findings can be disseminated through:

§ Internal seminars

§ Regular reporting to stakeholders

§ Publications, for example journal articles, reviews or book chapters

§ Conference presentations

§ Exhibitions

§ Outreaches and public engagement events

 Project title
• A preview of the project

• Concise but detailed (15-20 words)

• Accurately expressed to reflect the study

• Describes what is to be done, the study population and the

variables of interest

Example:
“Effects of the program for rooming-in at home on breast-feeding
indicators: Experimental test with low-risk primiparous women
attended at Mama lucy Hospital in Kenya.
 Project summary /abstract
A brief outline of the entire project of about 300 words
Should stand alone
Should briefly and clearly state:
• The research problem
• The main research questions and or hypotheses
• The justification for the research- how will it differ from existing studies
• The research objectives
• The study design- what will be done? by whom? to who? when? how? and for how
long?
• The outcomes (results)
• Conclusion
• Importance of the study
• Anticipated problems- scientific, ethical, managerial
 Ethical Considerations
Based on the principles of autonomy, beneficence (doing good), non-
maleficence (avoiding harm) and justice.
Should consider:
• Study validity

• Recruitment

• Ethical approval for the study- local, institutional, national ethic

committee

• Informed consent process

• Other issues that may be of ethical concern especially when the study
involves human subjects
 Ethical Considerations
The following should be clearly stated:
• Known benefits, risks and disadvantages

• Information to be provided to subjects and how

• Extent and alternative to participation

• Incentives to be provided to subjects if any

• Treatment to be provided to subjects if any

• Information confidentiality
 Referencing
• Cite relevant and current literatures

• All sources of information must be cited - avoid plagiarism

• All cited authors in the text should be in the reference list

• All listed references must have been cited in the text

• References should be cited and listed sequentially

• Reference style should be uniform

• Formatting should be consistent

 Budget
• Itemize and justify the budget.

• For long-term projects, provide detail budget for at

least the first year and outline budget for subsequent
years.

• Realistic budget- too much or too little may lead to

unsuccessful funding application.

• Types of expenses include: personnel (include names

and contributions to project), equipment, supplies,
patient care and costs, travel, data processing,
communications, secretarial expenses,
publication/dissemination of research findings
 Work plan
• Specifies the duration for each project
• Provides the detailed monthly timeline for each activity

• Consider:
1. Preparatory stage- training of research workers, equipment
procurement,

2. Pilot studies

3. Data collection

4. Data analysis

5. Report writing

6. Milestones- for long-term projects

 Research team
• Describe the role and responsibility of each
member of the team.

• Include information on previous studies or

preliminary work done on the research problem
by the investigators.

• Attached Curriculum vitae (CV) of investigators of

investigators: this shows the competence of the
investigator to conduct the research.
 Annexes
Include the following as appropriate:
• Interview protocols
• Sample of informed consent forms
• Cover letters sent to appropriate stakeholders
• Official letters for permission to conduct research
• Original study instrument, written permission to re-
reproduce instrument or proof of purchase of instrument
• Other support for the project
• Collaboration with other scientists or research institutions
• Link to other projects
• Financing and insurance
 Proposal review criteria
Funding for research is competitive and is determined by researcher’s
qualification, experience and research goals.
The following questions are usually considered:
1. Is the research question important?

2. Is the study relevant to the funders’ interest?

3. What is the quality of the research design ?

4. Are the investigators competent enough to conduct the

research?

5. Is the research facility capable of conducting the research?

6. can the institution manage the research administratively
and financially?

7. Have all ethical issues been considered?

8. Is the budget realistic and justifiable?

9. Is the budget within the budgetary limit of funders?

10.Is the time-line reasonable?

11.Anticipation and good plan to manage potential problems?

12.Is the proposal clearly and well written?

 General considerations
1. Include table of contents
2. Include list of acronyms/ abbreviations in alphabetical
order
3. Explain technical terms if used
4. Be logical in flow of thoughts and use section headings
5. Keep tense and voice consistent- present versus past
tense and active versus passive voice
6. Keep sentences short and use paragraphs
appropriately
7. Avoid repetitions
8. Be consistent in formatting- font size, font style
9. Make effective use of tables, figures and charts
10.Make sure your proposal stand out
THANK YOU