1. WRITING A HEALTH RESEARCH
PROPOSAL
Presented by:
Dr. Soha Rashed Aref Mostafa
Professor of Community Medicine
Alexandria Faculty of Medicine
Egypt

2. What is research ?
Research is the systematic collection,
analysis and interpretation of data to
answer a certain question or solve a
problem.

4. Characteristics of a good
research
 It demands a clear statement of the problem.
 It requires clear objectives and a plan (it is not aimlessly
looking for something in order to come across a solution).
 It builds on existing data, using both positive and negative
findings.
 New data should be systematically collected and analyzed to
answer the original research questions/objectives.

5. The proposal is the detailed plan of the research study
Why every research study should have a written proposal?
The written proposal:
• assists the investigators to clarify their thoughts and to think about all
aspects of the study
• is a necessary guide if a team (not a single investigator) is working on the
research
• is essential if the study involves research on human subjects or is on
experimental animals, in order to get the institution’s ethical approval
• is an essential component of a research proposal submitted for funding

6. A well-thought out and well-written proposal
can be judged according to three main
criteria:
1. Is it adequate to answer the research question(s),
and achieve the study objective?
2. Is it feasible in the particular set-up for the study?
3. Does it provide enough detail (methodology) that
can allow another investigator to do the study and
arrive at comparable conclusions?

7. Outlines of RP may vary according to the
preference of each investigator. However,
the scientific community has agreed that all
proposals should at least contain:
The problem statement and justification for the
research (the rationale for the study), the general
and specific objectives, methodology, the plan of
analysis, and the timetable and budget. It should
also highlight how ethical issues will be considered.

8. BASIC COMPONENTS OF A
RESEARCH PROTOCOL
 Title of the Research Project
 Project Summary
 Statement of the Problem (scientific justification)
 Applicability and Use of the Results (type of knowledge expected to be obtained and
the intended purpose of its application)= Expected outcome of the study,
dissemination & publication
 Theoretical Framework (argumentation, possible answers, hypothesis)
 Research Objectives (general and specific)
 Methodology
− Operational Definitions (operationalization)
− Type of Study and General Design
− Study subjects, Sample Selection and Size, Unit of Analysis and Observation,
Selection Criteria
− Proposed Intervention (if applicable)
− Data Collection Procedures, Instruments Used, and Methods for Data Quality Control
− Procedures to Ensure Ethical Considerations in Research with Human Subjects
− Pretesting the methodology (Pilot study)
 Plan for Analysis of Results
‒ Methods and Models of Data Analysis according to Types of Variables
‒ Programs to be Used for Data Analysis
 Bibliographic References
 Timetable (Work plan)
 Budget
 Annexes

9. Title of the Research Project
 A good title should be short, accurate, and concise.
 It may need to be revised after completion of the proposal writing
to reflect more closely the sense of the study.
 The title should be descriptive. It should make the central
objectives and variables of the study clear to the reader
(reviewer).
 The title provides the "key words" for the classification and
indexing of the project.
 It is important to specify what population or universe will be
investigated.

10. Criticize the following
research titles !!
 Heart failure in diabetes
 Tuberculosis in HIV infected children
 Predicting mortality in patients with bleeding peptic ulcers after
therapeutic endoscopy
 Cardiovascular comorbidities and blood pressure control in stroke
survivors
 Prevalence and determinants of Protein Energy Malnutrition among
under-fives in a semi-rural community in Alexandria, Egypt.
 Urinary incontinence among Alexandrian women: an outpatient study of
prevalence, comorbidity, risk factors, and quality of life.
 Influence of interleukin-6 G-174C gene polymorphism on coronary
artery disease, cardiovascular complications and mortality in dialysis
patients

11. Project Summary
 Like the abstract of a research paper, the project
summary, should be concise (no more than 300
words) and at the most a page long (font size 12,
single spacing). Provided preferably on a separate
page.
 It should summarize all the central elements of the
protocol, for example the rationale, objectives,
methods, populations, time frame, and expected
outcomes.
 It should stand on its own, and not refer the reader to
points in the project description.

12. Statement of the Problem
 This constitutes the scientific justification for the study; i.e., the
basis of the need for research to generate further knowledge
that will contribute to existing knowledge.
 The problem statement should make a convincing
argument that there is not sufficient knowledge available to
explain the problem and its possible alternative solutions , or it
should make a convincing argument for the need to test
what is known and taken as fact, if it is called into question by
new findings or conditions.
 This section should show that the investigator has
documented this problem and performed an exhaustive
bibliographic review of the subject.

13. Literature review
 It prevents the duplication of work that has
been done before.
 It helps the researchers to find out what
others have found and reported on the
problem.
 It helps the researcher to become more
familiar with the various types of
methodology that could be used in the
study.
 It should provide convincing arguments why

14. A logical sequence for presenting
the statement would be:
 Magnitude, frequency, and distribution. Affected geographical areas
and population groups affected by the problem. Ethnic and gender
considerations.
 Probable causes of the problem: What is the current knowledge of the
problem and its causes? Is there consensus? Is there controversy? Is there
conclusive evidence?
 Possible solutions: In what ways have solutions to the problem been
attempted? What has been proposed? What are the results?
 Unanswered questions: What remains to be answered? What areas have
not been possible to understand, determine, verify, or test?

15. Applicability and Use of the
Results
This section describes the type of knowledge expected to be obtained and the
intended purpose of its application.
It should indicate the strategy for disseminating and using the research findings
according to the potential users of the knowledge generated.
The justification should answer the following:
 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 disseminated?
 How will the results be used, and who will be the beneficiaries?
The justification, which can be included as part of the
statement of the problem or in a separate section, should
make a convincing argument that the knowledge
generated will be useful and generally applicable within
the regional context.

16. Expected Outcomes of the Study
 The protocol should indicate how the study will contribute to
advancement of knowledge, how the results will be utilized, not only
in publications but also how they will likely affect health care, health
systems, or health policies.
Dissemination of Results and Publication Policy
 The protocol should specify not only dissemination of results in the
scientific media, but also to the community and/ or the participants,
and consider dissemination to the policy makers where relevant.
 Publication policy should be clearly discussed- for example who will
take the lead in publication and who will be acknowledged in
publications, etc.

17. Theoretical Framework = Background
(argumentation, possible answers,
hypothesis)
This is derived from the statement of the problem. It also requires an
exhaustive bibliographic review.
The theoretical framework, considered the "grounds“/”basis” that support
the central question of the study, states the investigator's reasoning
and arguments for the attempt to find the evidence that will offer an
answer to the question and/or hypothesis.
 Establishment of relationships (identification of the relationships
between the independent variable and the response variables). What
is known, and how has it been explained? Are the results conclusive?
What are the bases of the question?
 How are the possible answers to the question explained and
defended? What are the assumptions? What are the relationships?
What are the working hypotheses?

18. Research hypothesis
Study hypotheses serve to direct and guide the research. They
indicate the major independent (PREDISPOSING/ RISK
FACTORS) and dependant variables (OUTCOME/
CONDITION/ DISEASE) of interest.
They suggest the type of data that must be collected and the type
of analysis that must be conducted in order to measure the
relationship among the variables.

19. Why should research
hypotheses be developed?
 Study hypotheses serve to direct and guide the research.
 They indicate the major independent and dependant variables of interest.
 They suggest the type of data that must be collected and the type of
analysis that must be conducted in order to measure the relationship
among the variables.
A single hypothesis might state that variable A is associated with
variable B, or that variable A causes variable B.
Direct
relationship
Sometimes a hypothesis will specify that, under condition X, Y and Z,
variable A is associated with variable B. A well-written hypothesis
focuses the attention of the researcher on specific variables.
Indirect
relationship
Intervening/Control variables

20. Research objectives
Why should research objectives be
developed?
The formulation of objectives will help you
to:
1. Focus the study (narrowing it down to
essentials)
2. Avoid the collection of data which are
not strictly necessary for
understanding and solving the problem
you have identified; and
3. Organize the study in clearly defined
parts or phases.
Properly formulated, specific objectives will
facilitate the development of your
research methodology and will help to
orient the collection , analysis ,
interpretation and utilization of data.

21. What are the characteristics of
well-constructed objectives?
Objectives should be:
 Logical and coherent
 Feasible
 Realistic, considering local conditions
 Defined in operational terms that can be
measured
 Phrased to clearly meet the purpose of the
study (relevant)

22. How should objectives be
stated?
 Objectives should be stated using “action
verbs” that are specific enough to be
measured:
e.g. To determine …, To compare…, To
verify…, To calculate…, To describe…, etc.
 Do not use vague non-action verbs
such as: T o appreciate … To
understand… To believe

23. Research Objectives
(General and Specific)
These should be defined after the theoretical framework has been
developed, and the sequence is clear between the central question
and possible responses to the questions and/or working hypotheses.
 General Objective : This should specify what kind of knowledge
the study is expected to obtain. It should give a clear notion of what is
to be described, determined, identified, compared, and, in the cases
of studies with working hypotheses, confirmed.
 Specific Objectives : These disaggregate and follow logically from
the general objective. They are a preliminary view of the research
design.
N.B. It is recognized that not all research requires the formulation of a
hypothesis for subsequent empirical verification. However, all
research should explain its general and specific objectives.

24. Example: A study looking into factors influencing
utilization of maternal health care services in X District
has the following objectives:
General objective: To assess factors influencing utilization of
maternal healthcare services in District X.
Specific Objectives:
1. To assess the knowledge, attitude and practice of pregnant
women regarding antenatal care, and TT vaccination,
2. To identify factors that influence women’s attendance at antenatal
care (ANC) and institutional delivery care services,
3. To identify the sources of delivery service and mothers’ preference
of place of delivery,
4. To determine coverage with ANC and TT vaccination among
mothers.

25. Methodology
 The methodology section has to be thought out carefully and written in
full detail.
 It is the most important part of the protocol.
 The methodology explains the procedures that will be used to achieve
the objectives.
 In this section the operational definition for the variables used should be
specified in detail, along with the type of variables and the ways to
measure them.
 In addition, the methodology should consider the study design and the
techniques and procedures used to achieve the proposed objectives.
A description is given below of what the investigator is expected to specify
in the methodology:

26. Operational Definition of
Variables
 Based on the concepts that may be made explicit in the
theoretical framework, the variables should be made
operative; i.e. the investigator should clearly describe what
is understood by each variable, what type of variable is being
considered, and the way its values are to be reported
(quantitatively, when the variable is numerical and
qualitatively, when the variables do not have numerical
values).
 Operationalization is a process that will vary in accordance
with the type of research and research design. However, the
variables should be clearly defined and appropriately
operationalized.

27. Protocols will be considered incomplete if
their operational aspects are vaguely
formulated:
e.g.,
"The pertinent and relevant variables will be studied"
"demographic and social variables will be considered"
or when the statement is so imprecise that it does not
allow the relevance of the variables and their use to
be appraised.

29. Examples of variables with different options for indicators

30. Type of Study and General
Design
 The type of study and its design should be decided on the
basis of its proposed objectives and the availability of
resources, in addition to ethical considerations.
 The investigator should clearly state the type of study that will
be conducted and provide a detailed explanation of its design.
 On this point, the investigator should also state the strategies
and mechanisms that will be used to reduce or eliminate
threats to the validity of the results, i.e. the so-called
confounding factors (in the selection and assignment of
subjects, the loss of cases, and the control of instruments and
observers, etc.).

31. Ideal study designs
according to purpose of study

32. Summary of research fields and recommended study designs

34. Study subjects or participants,
Selection Criteria,
Sample Selection and Size,
Unit of Analysis and Observation

35. Research subjects or
participants (cont.)
Depending on the type of the study, the
following questions should be
answered:
– What are the criteria for inclusion or
selection?
– What are the criteria for exclusion?
– In intervention studies, how will subjects be
allocated to index and comparison groups?
– What are the criteria for discontinuation?

36. Observations
Information should be provided on the observations to be made,
how they will be made, and how frequently will they be made.
If the observation is made by a questionnaire, this should be
appended to the protocol. Laboratory or other diagnostic and
investigative procedures should be described.
For established procedures, reference to appropriate published
work is enough.
For new or modified procedures, an adequate description is
needed, with a justification for their use.

37. Sample size
The protocol should provide information and justification about sample
size.
A larger sample size than needed to test the research hypothesis
increases the cost and duration of the study, and will be unethical if it
exposes human subjects to any potential unnecessary risk without
additional benefit.
A smaller sample size than needed can also be unethical if it exposes
human subjects to risk with no benefit to scientific knowledge.
The basis on which sample size is calculated should be explained in the
methodology section of the protocol.
Calculation of sample size has been made easy by computer software
programs. But the principles underlying the estimation should be well
understood.

38. Proposed Intervention (if applicable)
 This section should be prepared when the
research objectives and design provide for
an evaluation of the results of an
intervention (educational program, vaccine,
treatment, etc.).
 Generally, these are comparative studies
with experimental or quasi-experimental
designs, before and after, where
assessment is made of results attributable
to the intervention.

39.  There should be a full description provided of the intervention and an
explanation given of the activities in their order of occurrence
 It is essential that the description of the intervention
answer three fundamental questions:
1. Who will be responsible for the intervention?
2. Where will it take place?
3. What activities will be performed, and with what frequency and
intensity?
 Many research efforts that include interventions involving human
subjects require an ethical review. In these cases, the investigator
will be required to include a section in reference to this area.

40. Data Collection Procedures,
Instruments Used, and Methods for
Data Quality Control
 The investigator should write up:
- the procedures that will be used (population survey, in-depth
interviews, non-participant observation, focus group dynamics,
content analysis, etc.),
- how and when the procedures will be used, and the instruments that
will be used to collect information (questionnaire, interview guide,
observation recording form, guide for a focus group moderator,
content analysis guide, etc.).
- Procedures or techniques that are standardized and/or documented
in the literature should be described briefly, and bibliographic
references should be given to sources where the details of these
procedures and techniques can be found.

41.  This section must describe in detail the procedures to be used to
control the factors that undermine the validity or reliability of the
results (controls for observers or persons responsible for compiling
the information, and controls for the instruments).
 If the use of secondary data is required, the investigator will describe
their sources, content, and quality so that it will be clear that the
information required for the study is available. If use is made of
historical, journalistic, or other similar types of documentary sources,
indication should be provided of the sources and techniques that will
be used to collect and analyze the information.
 The protocol should have an annex containing the
instruments that will be used (questionnaires, interview
guides, moderator guides, registration forms, etc.), and it
should indicate their stage of preparation.

42. Procedures to Ensure Ethical
Considerations in Research with
Human Subjects
When the research involves human subjects, this section should
explicitly provide for the following aspects:
 The known benefits and risks or disadvantages for the subjects in the study.
 Exact description of the information to be delivered to the subjects of the study
and when it will be communicated orally or in writing.
Examples of this information include:
- the objectives and purposes of the study,
- any experimental procedures,
- any known short- or long-term risks, possible discomforts,
- expected benefits of the procedures used,
- duration of the studies,
- alternative methods for treatment if the study is a clinical trial,
- suspension of the study if a finding is made of negative effects or if there is
sufficient evidence of positive effects that do not justify continuing with the study,
and
- the freedom of subjects to withdraw from the study whenever they want.

43.  When appropriate, indicate any special incentive or treatment
that subjects will receive through their participation in the
study. If there is any type of payment/reward, specify the
amount, method of delivery, time, and reason why payment is
required.
 Indicate how the information obtained from participants in the
study will be kept confidential.
 List the drugs, vaccines, diagnoses, procedures, or
instruments to be used, whether they are registered,
unregistered, new, or currently in use in the country.

44. Moreover, responses are required for other ethical aspects,
such as:
 In studies where personal information will be obtained from the subjects,
indicate how the information will be kept confidential.
 For studies involving the participation of subjects in an experiment
(experimental or quasi-experimental trials, studies of interventions, etc.),
information should be provided on the free and informed consent of
the participants and the strategy that will be used to obtain it.
 Brief synopsis of how the research findings will be reported and delivered
to the subjects involved in the study or to other interested parties.
 Indicate and justify the inclusion, as appropriate, of children, the elderly,
physical challenged, and pregnant women. Justify the non-inclusion in
the study group, if appropriate, of women (of any age), an ethnic
minority, racial group, etc.
 When appropriate, indicate how the appropriate balance of the two sexes
will be ensured in the study groups. In addition, indicate, when
appropriate, how gender inequities and discrimination and disadvantages
can affect women's involvement in the research.

45. Ethical considerations
All research protocols in the biomedical field, particularly if it involves
human subjects, must include a section addressing ethical
considerations.
This includes two components:
1. The first is a written approval of the appropriate ethics review
committee, together with a written form for informed consent, where
appropriate.
2. The second is a special section, preferably in the format of a
checklist, to address all possible ethical concerns. Simply getting the
ethical approval is not enough.

46. 1. Approval by ethics review committees
For studies in humans (or involving human biological materials),
the protocol must be approved by the local, institutional or
equivalent ethics committee and/or national ethics committee.
For animal studies approval is required from the animal welfare
committee of the institute or its equivalent.
If no such committee exists, a statement signed by the principal
investigator(s) should indicate that the research will be carried
out in accordance with the International Guiding Principles for
Biomedical Research involving Animals.

47. 2. Informed decision-making
A consent form, where appropriate, must be developed and
attached to the protocol.
It should be written in the prospective subjects’ mother tongue.
The consent form has two parts:
a) a statement describing the study and the nature of the
subject’s involvement in it; and
b) a certificate of consent attesting to the subject’s consent.
Both parts should be written in simple language so that the
subject can easily understand the contents. As much as
possible, the use of medical terminology in writing up the
consent form should be avoided. Special care is needed when
subjects are illiterate.

48. 3. Ethics checklist
A checklist must address ethical
concerns that could be raised about
the methodology, including the
research design, selection of subjects,
the interventions introduced and the
observations to be made.

49. Ethics checklist (cont.)
• Is the research design adequate to provide answers to the research question? It is
unethical to expose subjects to research that will have no value.
• Is the method of selection of research subjects justified? The use of vulnerable
subjects as research participants needs special justification. Vulnerable subjects
include those in prison, minors and persons with mental disability. Particularly in
international research, it is important to ensure that the population in which the
study is conducted will benefit from any potential outcome of the research. They
should not be doing it to the benefit of another population. Justification is needed
for any inducement, financial or otherwise, for participants to be enrolled in the
study.
• Are interventions justified, in terms of risks/benefits ratio? Risks are not limited to
physical harm. Psychological and social risks must also be considered.
• For observations made, have measures been taken to ensure confidentiality?

50. Data management and
analysis
 The protocol should provide
information on how the data will be
managed, including data coding for
computer analysis, monitoring and
verification.

51. Plan for Analysis of Results
Although this item is considered under the methodology, it is suggested that
the investigator treat it as a separate section.
What is expected from a plan of analysis:
 Methods and Models of Data Analysis according to Types of
Variables
In accordance with the proposed objectives and based on the types of
variables, the investigator should specify how the variables will be
measured and how they will be presented (quantitative and/or qualitative),
indicating the analytical models and techniques (statistical, non-statistical,
or analytical techniques for non-numeric data, etc.).
The investigator should provide a preliminary scheme for tabulating the data
(especially for variables that are presented numerically).
It is recommended that special attention be given to the key variables that will
be used in the statistical models.

52.  Programs to Be Used for Data Analysis:
Briefly describe the software packages that will be
used and their anticipated applications.
 Power of the study, level of significance to be used,
procedures for accounting for any missing or
spurious data, etc.
 For projects involving qualitative approaches,
specify in sufficient detail how the data will be
analyzed.

53. Pretesting the methodology
(Pilot study)
 It may be possible to pre-test:
• The reactions of respondents to the research procedures and to
questions related to sensitive issues.
• The appropriateness of study type and research tools selected for the
purpose of the study.
• The appropriateness of format and wording of questionnaires and
interview schedules and the accuracy of the translations.
• The time needed to carry out interviews, observations or
measurements.
• The feasibility of the designed sampling procedures.
• The feasibility of the designed procedures for data processing and
analysis.

54. References
 References should be written in Vancouver style.
 Citing References
1. Number references consecutively throughout the
body of the text in the order in which they are first
mentioned.
2. DO NOT include references in your abstract.
Identify references in text, tables and legends by
numerals in parenthesis e.g. (1), (2,3) or (3-6).
3. Some journals require references to be indicated in
superscript which makes typing more difficult.

55. References
4. DO NOT use abstracts as your source of
information, you must consult the full text of the
article before using it as a cited reference.
5. When citing authors in the text, acknowledge only
the first author where there are three or more
authors, e.g. Williams et al. (1994) stated that .....
(1). Where there are two authors cite both, e.g.
Jones and Smith (1997) reported that ....(2). Note
that a reference at the end of a sentence is
included before the period.
6. The list of references must begin on a new page
and they are cited by number and sequenced by
order of citation. Include all authors in the list of
references.

56. How to format various
reference sources?
Journals
Harrison KL, Forster TH. Instruction to
authors. Aust J Med Sci 1996; 17: 45-
47.
Author(s) of a book
Murray-Smith S. Right Words: A guide to
English usage in Australia. 2nd ed.
Melbourne: Penguin Books; 1990.

57. How to format various
reference sources?
 Author(s) of a chapter in a book
Bogduk N. Spinal pain: backache and
neck pain. In: Gandevia SC, Burke D,
Anthony M, editors. Science and
practice in clinical neurology.
Melbourne: Cambridge University
Press; 1993; 39-57.

58. How to format various
reference sources?
 Internet referencing
1. Document/Individual Work
Tyner R. Sink or Swim: Internet search
tools and techniques (version 3) [WWW
document]. Okanagan University College,
7 July 1998.
http://oksw01.okanagan.bc.ca/libr/connect
96/search.htm [accessed 19 July 2008].

59. How to format various
reference sources?
2. Journals
Zorn P, Emanoil M, Marshall L,
Panek M. Advanced searching:
Tricks of the trade. Online [WWW].
1996 May; 9 pages.
http://www.onlineinc.com/onlinemag/
MayOL/zorn5.html [accessed 19 July
1998].

60. Duration of the Project
 The protocol should specify the time
that each phase of the project is likely
to take, along with a detailed month by
month timeline for each activity to be
undertaken.

61. Timetable (Work plan)
 A work plan is a schedule that
summarizes, in a clear fashion,
various components of a research
project and how they fit together.
 It should include:
1. The various tasks to be performed
2. When the tasks will be performed
3. Who will perform the tasks

63. Budget
 The budget section should contain a
detailed item-wise breakdown of the
funds requested for, along with a
justification for each item.

64. A HYPOTHETICAL PROPOSAL BUDGET

65. Annexes (Appendices)
Include in the appendices of your proposal any
additional information you think might be helpful
to a proposal reviewer.
 Biographical data on the principal investigator
 The study questionnaire (and/or other data
collection tools)
 The informed consent form
 A copy of the approval from the Institutional
Review Board.

66. Will the project be funded?
Funding organizations receive many more proposals than what they can
fund. The selection process is very competitive.
The following factors are generally taken into consideration
in deciding whether the proposal is to be funded:
• importance and relevance of the research question to the declared
interests of the agency; success in obtaining a grant depends on
matching the proposal with the interests of a granting agency
• quality of the research design
• ability of the investigators to carry out the project

67. Will the project be funded?
(cont.)
• capacity of the research facility to carry out the
project, ability of the institution to handle the
administrative and financial procedures
• satisfactory ethical considerations
• realistic and justifiable budget, within the limits set
by the agency, and normally with no expectations
for continued funding after the completion of the
project

68. Will the project be funded?
(cont.)
• reasonable time-frame for completion of the project
• understanding of anticipated problems
• clarity and style of the written proposal.
Writing with enthusiasm is a good idea, but
overstatements should be avoided.
The applicant should be realistic about the limitations
of the study.

69. Thank you