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 descriiptive, 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
Research subjects or participants: Depending on the type of your study, the following questions
should be answered3 , 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
– 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 descriiptive 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
Interventions: If an intervention is introduced, a descriiption 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 pre-clinical 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 issues3: 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.
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?
Research setting5: 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.
Study instruments3 , 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. Descriiptions 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 descriiption is necessary with justification for the same.
Collection of data: A short descriiption 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 descriiption 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?
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?
Budget: A proposal budget with item wise/activity wise breakdown and justification for the
same. Indicate how will the study be financed.
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.
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