This document provides guidance on writing a health research proposal. It discusses the key components of a research proposal including an introduction justifying the importance and significance of the study, a literature review to establish the background and rationale, clear research objectives and hypotheses, a description of the study methodology including definitions of variables and measures, details on data collection and analysis, a timeline, and consideration of ethical issues. The document emphasizes that a well-written proposal with adequate methodological details is necessary to obtain approval and funding to conduct the proposed research study.

1. WRITING A HEALTH RESEARCH
PROPOSAL
Presented by: Assoc.Professor.ir.Faisal
Adjunct Research Advisor at Nan Yang Academy of Sciences. (NAS)
Singapore

2. Learning objectives
 Basic concepts of research proposal.
 Relationship of research proposal with
research.
 Steps of research proposal development.
 The main elements in research proposal.
 Importance of research proposal.

3. What is the proposal?
The proposal is the detailed plan of
the research process.
• Proposal is the plan but research is the action.
• Research proposal is a schedule and research is the
activity.
• Its compulsory to accept the proposed research.

5. Why I need a research proposal?
 Keep you focused on your research.
 A document contract between the researcher and
supervising committee.
 Its essential to get fund to support your research.
 Its essential in order to get the institution’s ethical
approval, especially if the study involves research
on human subjects or experimental animals.
 It is prerequisite for academic degree.

6. A well-written proposal can be judged
According to three main criteria:
3. Is it adequate to answer the research question(s),
and achieve the study objectives?
5. Is it feasible and applicable?
7. 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 component of research
proposal
1-Title
2-Introduction that includes:
-Summery of the project
-Statement of the problem
-Significance of study
-Hypothesis or research questions
-Objectives
-Conceptual or theoretical framework
3-Review of related literature
4-Methodology(type of study & research design).
5. Methods or programs of data analysis
6.Expected outcomes
7.Buget
8. Time table
9.Refrences
10.Appendices

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. 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.


11. 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.

12. 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
this particular research project is needed.

13. 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.

14. 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

15. Research objectives
Why should research objectives be
developed?
The formulation of objectives will help you to:



Focus the study (narrowing it down to
essentials)
Avoid the collection of data which are
not strictly necessary for understanding
and solving the problem you have
identified; and
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.

16. 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)

17. 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: To appreciate … To understand…
To believe

18. 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.

19. 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.

20. 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:

21. 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
not have numerical
qualitatively, when the variables do
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.

22. 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.

24. Examples of variables with different options for indicators

25. 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.).

26. Ideal study designs according
to purpose of study

27. Summary of research fields and recommended study designs

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

30. 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?

31. 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.

32. 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.

33. 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.

34.  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:
4. Who will be responsible for the intervention?
5. Where will it take place?
6. 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.

35. 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.

36.  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.

37. 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.

38.  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.

39. 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.

40. 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:
8. The first is a written approval of the appropriate ethics review
committee, together with a written form for informed consent,
where appropriate.
10. 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.

41. 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
will be
Guiding
investigator(s) should indicate that the research
carried out in accordance with the International
Principles for Biomedical Research involving Animals.

42. 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.

43. 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.

44. 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.
• 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?

45. 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.

46. 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.

47.  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.

48. 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.

49. References
 References should be written in Vancouver style.


Citing References
Number references consecutively throughout the body
of the text in the order in which they are first
mentioned.
 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).
 Some journals require references to be indicated in
superscript which makes typing more difficult.

50. References
 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.
 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.
 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.

51. 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.

52. 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
practice
M, editors. Science and
in clinical neurology.
Melbourne: Cambridge University
Press; 1993; 39-57.

53. How to format various
reference sources?


Internet referencing
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].

54. How to format various
reference sources?
 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].

55. 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.

56. 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:
 The various tasks to be performed
 When the tasks will be performed
 Who will perform the tasks

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

60. A HYPOTHETICAL PROPOSAL BUDGET

61. 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.

62. 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

63. 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

64. 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.

65. Thank you