How To Prepare A Research Proposal - Asya Al-Riyami

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Review Article

How to prepare a Research Proposal


Asya Al-Riyami
Abstract
Health research, medical education and clinical practice form the
three pillars of modern day medical practice. As one authority
rightly put it: Health research is not a luxury, but an essential
need that no nation can afford to ignore. Health research can and
should be pursued by a broad range of people. Even if they do not
conduct research themselves, they need to grasp the principles of
the scientific method to understand the value and limitations of
science and to be able to assess and evaluate results of research
before applying them. This review paper aims to highlight the

ost students and beginning researchers do not fully


understand what a research proposal means, nor do they understand
its importance.1 A research proposal is a detailed description of a
proposed study designed to investigate a given problem.2

A research proposal is intended to convince others that you have


a worthwhile research project and that you have the competence and
the work-plan to complete it. Broadly the research proposal must
address the following questions regardless of your research area and
the methodology you choose: What you plan to accomplish, why
do you want to do it and how are you going to do it.1 The aim of
this article is to highlight the essential concepts and not to provide
extensive details about this topic.
The elements of a research proposal are highlighted below:
1.Title: It should be concise and descriptive. It must be informative
and catchy. An effective title not only pricks the readers interest,
but also predisposes him/her favorably towards the proposal. Often
titles are stated in terms of a functional relationship, because such
titles clearly indicate the independent and dependent variables.1
The title may need to be revised after completion of writing of the
protocol to reflect more closely the sense of the study.3
2. Abstract: It is a brief summary of approximately 300 words.
It should include the main research question, the rationale for the
study, the hypothesis (if any) and the method. Descriptions of the
method may include the design, procedures, the sample and any
instruments that will be used.1 It should stand on its own, and not
refer the reader to points in the project description.3
3. Introduction: The introduction provides the readers with the
background information. Its purpose is to establish a framework for
the research, so that readers can understand how it relates to other
research.4 It should answer the question of why the research needs
to be done and what will be its relevance. It puts the proposal in
context.3

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essential concepts to the students and beginning researchers and


sensitize and motivate the readers to access the vast literature
available on research methodologies.
Received: 5 January 2008
Accepted: 27 February 2008
From the Directorate of Research & Studies, Ministry of Health, Oman.
Address correspondence and reprint request to: Dr Asya Al-Riyami, Director of
Research & Studies, Directorate of Research & Studies, Directorate General of
Planning, Ministry of Health, Muscat, Oman. E-mail: [email protected]

The introduction typically begins with a statement of the


research problem in precise and clear terms.1
The importance of the statement of the research problem:5 The
statement of the problem is the essential basis for the construction
of a research proposal (research objectives, hypotheses, methodology,
work plan and budget etc). It is an integral part of selecting a research
topic. It will guide and put into sharper focus the research design
being considered for solving the problem. It allows the investigator to
describe the problem systematically, to reflect on its importance, its
priority in the country and region and to point out why the proposed
research on the problem should be undertaken. It also facilitates peer
review of the research proposal by the funding agencies.
Then it is necessary to provide the context and set the stage
for the research question in such a way as to show its necessity
and importance.1 This step is necessary for the investigators to
familiarize themselves with existing knowledge about the research
problem and to find out whether or not others have investigated the
same or similar problems. This step is accomplished by a thorough
and critical review of the literature and by personal communication
with experts.5 It helps further understanding of the problem
proposed for research and may lead to refining the statement of
the problem, to identify the study variables and conceptualize
their relationships, and in formulation and selection of a research
hypothesis.5 It ensures that you are not re-inventing the wheel and
demonstrates your understanding of the research problem. It gives
due credit to those who have laid the groundwork for your proposed
research.1 In a proposal, the literature review is generally brief and to
the point. The literature selected should be pertinent and relevant.6
Against this background, you then present the rationale of the
proposed study and clearly indicate why it is worth doing.
4. Objectives: Research objectives are the goals to be achieved
by conducting the research.5 They may be stated as general and
specific.

Oman Medical Journal 2008, Volume 23, Issue 2, April 2008

Research Proposal ...Al-Riyami

The general objective of the research is what is to be accomplished


by the research project, for example, to determine whether or not a
new vaccine should be incorporated in a public health program.
The specific objectives relate to the specific research questions
the investigator wants to answer through the proposed study
and may be presented as primary and secondary objectives, for
example, primary: To determine the degree of protection that is
attributable to the new vaccine in a study population by comparing
the vaccinated and unvaccinated groups.5 Secondary: To study the
cost-effectiveness of this programme.
Young investigators are advised to resist the temptation to put
too many objectives or over-ambitious objectives that cannot be
adequately achieved by the implementation of the protocol.3
5. Variables: During the planning stage, it is necessary to identify
the key variables of the study and their method of measurement
and unit of measurement must be clearly indicated. Four types of
variables are important in research:5
a. Independent variables: variables that are manipulated or
treated in a study in order to see what effect differences in them will
have on those variables proposed as being dependent on them. The
different synonyms for the term independent variable which are
used in literature are: cause, input, predisposing factor, risk factor,
determinant, antecedent, characteristic and attribute.
b. Dependent variables: variables in which changes are results of
the level or amount of the independent variable or variables.
Synonyms: effect, outcome, consequence, result, condition,
disease.
c. Confounding or intervening variables: variables that should
be studied because they may influence or mix the effect of the
independent variables. For instance, in a study of the effect of
measles (independent variable) on child mortality (dependent
variable), the nutritional status of the child may play an intervening
(confounding) role.
d. Background variables: variables that are so often of relevance
in investigations of groups or populations that they should be
considered for possible inclusion in the study. For example sex, age,
ethnic origin, education, marital status, social status etc.
The objective of research is usually to determine the effect
of changes in one or more independent variables on one or more
dependent variables. For example, a study may ask Will alcohol
intake (independent variable) have an effect on development of
gastric ulcer ( dependent variable)?
Certain variables may not be easy to identify. The characteristics
that define these variables must be clearly identified for the purpose
of the study.

6. Questions and/ or hypotheses: If you as a researcher know


enough to make prediction concerning what you are studying, then
the hypothesis may be formulated. A hypothesis can be defined as a
tentative prediction or explanation of the relationship between two or
more variables. In other words, the hypothesis translates the problem
statement into a precise, unambiguous prediction of expected
outcomes. Hypotheses are not meant to be haphazard guesses, but
should reflect the depth of knowledge, imagination and experience
of the investigator.5 In the process of formulating the hypotheses,
all variables relevant to the study must be identified. For example:
Health education involving active participation by mothers will
produce more positive changes in child feeding than health education
based on lectures. Here the independent variable is types of health
education and the dependent variable is changes in child feeding.
A research question poses a relationship between two or more
variables but phrases the relationship as a question; a hypothesis
represents a declarative statement of the relations between two or
more variables.7
For exploratory or phenomenological research, you may not
have any hypothesis (please do not confuse the hypothesis with the
statistical null hypothesis).1 Questions are relevant to normative
or census type research (How many of them are there? Is there a
relationship between them?). Deciding whether to use questions
or hypotheses depends on factors such as the purpose of the study,
the nature of the design and methodology, and the audience of the
research (at times even the outlook and preference of the committee
members, particularly the Chair).6
7. Methodology: The method section is very important because
it tells your research Committee how you plan to tackle your
research problem. The guiding principle for writing the Methods
section is that it should contain sufficient information for the
reader to determine whether the methodology is sound. Some
even argue that a good proposal should contain sufficient details
for another qualified researcher to implement the study.1 Indicate
the methodological steps you will take to answer every question or
to test every hypothesis illustrated in the Questions/hypotheses
section.6 It is vital that you consult a biostatistician during the
planning stage of your study,8 to resolve the methodological issues
before submitting the proposal.
This section should include:
Research design: The selection of the research strategy is the
core of research design and is probably the single most important
decision the investigator has to make. The choice of the strategy,
whether descriptive, analytical, experimental, operational or a
combination of these depend on a number of considerations,5 but
this choice must be explained in relation to the study objectives.3

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Research Proposal ...Al-Riyami

Research subjects or participants: Depending on the type of


your study, the following questions should be answered 3, 5
- What are the criteria for inclusion or selection?
- What are the criteria for exclusion?
- What is the sampling procedure you will use so as to ensure
representativeness and reliability of the sample and to minimize
sampling errors? The key reason for being concerned with
sampling is the issue of validity-both internal and external of
the study results.9
- Will there be use of controls in your study? Controls or
comparison groups are used in scientific research in order
to increase the validity of the conclusions. Control groups
are necessary in all analytical epidemiological studies, in
experimental studies of drug trials, in research on effects of
intervention programmes and disease control measures and in
many other investigations. Some descriptive studies (studies of
existing data, surveys) may not require control groups.
- What are the criteria for discontinuation?
Sample size: The proposal should provide information and
justification (basis on which the sample size is calculated) about
sample size in the methodology section.3 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
as it exposes human subjects to risk with no benefit to scientific
knowledge. Calculation of sample size has been made easy by
computer software programmes, but the principles underlying the
estimation should be well understood.
Interventions: If an intervention is introduced, a description must
be given of the drugs or devices (proprietary names, manufacturer,
chemical composition, dose, frequency of administration) if
they are already commercially available. If they are in phases of
experimentation or are already commercially available but used for
other indications, information must be provided on available preclinical investigations in animals and/or results of studies already
conducted in humans ( in such cases, approval of the drug regulatory
agency in the country is needed before the study).3
Ethical issues:3 Ethical considerations apply to all types of health
research. Before the proposal is submitted to the Ethics Committee
for approval, two important documents mentioned below (where
appropriate) must be appended to the proposal. In additions, there
is another vital issue of Conflict of Interest, wherein the researchers
should furnish a statement regarding the same.

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- The Informed consent form (informed decision-making):


A consent form, where appropriate, must be developed and
attached to the proposal. It should be written in the prospective
subjects mother tongue and in simple language which can be
easily understood by the subject. The use of medical terminology
should be avoided as far as possible. Special care is needed
when subjects are illiterate. It should explain why the study is
being done and why the subject has been asked to participate.
It should describe, in sequence, what will happen in the course
of the study, giving enough detail for the subject to gain a clear
idea of what to expect. It should clarify whether or not the
study procedures offer any benefits to the subject or to others,
and explain the nature, likelihood and treatment of anticipated
discomfort or adverse effects, including psychological and social
risks, if any. Where relevant, a comparison with risks posed
by standard drugs or treatment must be included. If the risks
are unknown or a comparative risk cannot be given it should
be so stated. It should indicate that the subject has the right
to withdraw from the study at any time without, in any way,
affecting his/her further medical care. It should assure the
participant of confidentiality of the findings.
- Ethics checklist: The proposal must describe the measures
that will be undertaken to ensure that the proposed research is
carried out in accordance with the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical
research involving Human Subjects.10 It must answer the
following questions:
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. In
international research it is important to mention that the
population in which the study is conducted will benefit
from any potential outcome of the research and the research
is not being conducted solely for the benefit of some other
population. Justification is needed for any inducement,
financial or otherwise, for the participants to be enrolled in
the study.
Are the interventions justified, in terms of risk/benefit
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?

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Research Proposal ...Al-Riyami

Research setting:5 The research setting includes all the pertinent


facets of the study, such as the population to be studied (sampling
frame), the place and time of study.

Dissemination of the study results: How do you propose to share


the findings of your study with professional peers, practitioners,
participants and the funding agency?

Study instruments:3, 5 Instruments are the tools by which the


data are collected. For validated questionnaires/interview schedules,
reference to published work should be given and the instrument
appended to the proposal. For new a questionnaire which is being
designed specifically for your study the details about preparing,
precoding and pretesting of questionnaire should be furnished and
the document appended to the proposal. Descriptions of other
methods of observations like medical examination, laboratory tests
and screening procedures is necessary- for established procedures,
reference of published work cited but for new or modified procedure,
an adequate description is necessary with justification for the same.

Budget: A proposal budget with item wise/activity wise


breakdown and justification for the same. Indicate how will the
study be financed.

Collection of data: A short description of the protocol of data


collection. For example, in a study on blood pressure measurement:
time of participant arrival, rest for 5p. 10 minutes, which
apparatus (standard calibrated) to be used, in which room to take
measurement, measurement in sitting or lying down position, how
many measurements, measurement in which arm first (whether
this is going to be randomized), details of cuff and its placement,
who will take the measurement. This minimizes the possibility of
confusion, delays and errors.
Data analysis: The description should include the design of
the analysis form, plans for processing and coding the data and the
choice of the statistical method to be applied to each data. What will
be the procedures for accounting for missing, unused or spurious
data?
Monitoring, supervision and quality control: Detailed statement
about the all logistical issues to satisfy the requirements of Good
Clinical Practices (GCP), protocol procedures, responsibilities of
each member of the research team, training of study investigators,
steps taken to assure quality control (laboratory procedures,
equipment calibration etc)
Gantt chart: A Gantt chart is an overview of tasks/proposed
activities and a time frame for the same. You put weeks, days or
months at one side, and the tasks at the other. You draw fat lines to
indicate the period the task will be performed to give a timeline for
your research study (take help of tutorial on youtube).11
Significance of the study: Indicate how your research will refine,
revise or extend existing knowledge in the area under investigation.
How will it benefit the concerned stakeholders? What could be the
larger implications of your research study?

References: The proposal should end with relevant references


on the subject. For web based search include the date of access for
the cited website, for example: add the sentence accessed on June
10, 2008.
Appendixes: Include the appropriate appendixes in the proposal.
For example: Interview protocols, sample of informed consent
forms, cover letters sent to appropriate stakeholders, official letters
for permission to conduct research. Regarding original scales or
questionnaires, if the instrument is copyrighted then permission in
writing to reproduce the instrument from the copyright holder or
proof of purchase of the instrument must be submitted.

References
1. Wong P. How to write research proposal. International network on Personal
meaning. Available at www.meaning.ca/archives. Accessed June 18, 2008.
2. Traenkel JR, Wallen NE. How to design and evaluate research in education.
On line learning center with power web. Available at www.highered.mcgrawhill.com/sites/0072981369/student_view0/chapter24/key_terms.html.
Accessed June 18, 2008.
3. Fathalla MF, Fathalla MM. A practical guide for health researchers. WHO
Regional Publications, Eastern Mediterranean. Series 30. In: WHO 2004.
4. Wilkinson AM. The scientists handbook for writing papers and dissertations.
Englewood Cliffs, NJ: Prentice Hall, 1991.
5. Health research methodology: A guide for training in research methods.
WHO Regional publications. Western Pacific education in action. Series 5.
WHO 1992.
6. Pajares F. Elements of proposal 2007. From http://www.des.emory.edu/
mfp/proposal.html. Accessed June 18, 2008.
7. Krathwohl DR. How to prepare a research proposal: Guidelines for funding
and dissertations in the social and behavioral sciences. Syracuse, NY:
Syracuse University Press, 1988.
8. Altman DG. Practical Statistics for Medical Research. London, UK:
Chapman & Hall, 1991.
9. Shavelson RJ. Statistical reasoning for the behavioral sciences. 2nd ed.
Boston: Allyn and Bacon, 1988.
10. World Medical Association Declaration of Helsinki. Ethical Principles for
Medical Research Involving Human Subjects. Available at www.wma.net/e/
policy/b3.htm. Accessed September 7, 2008.
11. http://www.youtube.com/watch?v=CW_wGSFavTc Accessed June 18,
2008.

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