preparation of a research proposal on any educational topic pdf

Research Proposal Example/Sample

Detailed Walkthrough + Free Proposal Template

If you’re getting started crafting your research proposal and are looking for a few examples of research proposals , you’ve come to the right place.

In this video, we walk you through two successful (approved) research proposals , one for a Master’s-level project, and one for a PhD-level dissertation. We also start off by unpacking our free research proposal template and discussing the four core sections of a research proposal, so that you have a clear understanding of the basics before diving into the actual proposals.

• Research proposal example/sample – Master’s-level (PDF/Word)
• Research proposal example/sample – PhD-level (PDF/Word)
• Proposal template (Fully editable) 

If you’re working on a research proposal for a dissertation or thesis, you may also find the following useful:

• Research Proposal Bootcamp : Learn how to write a research proposal as efficiently and effectively as possible
• 1:1 Proposal Coaching : Get hands-on help with your research proposal

PS – If you’re working on a dissertation, be sure to also check out our collection of dissertation and thesis examples here .

FAQ: Research Proposal Example

Research proposal example: frequently asked questions, are the sample proposals real.

Yes. The proposals are real and were approved by the respective universities.

Can I copy one of these proposals for my own research?

As we discuss in the video, every research proposal will be slightly different, depending on the university’s unique requirements, as well as the nature of the research itself. Therefore, you’ll need to tailor your research proposal to suit your specific context.

You can learn more about the basics of writing a research proposal here .

How do I get the research proposal template?

You can access our free proposal template here .

Is the proposal template really free?

Yes. There is no cost for the proposal template and you are free to use it as a foundation for your research proposal.

Where can I learn more about proposal writing?

For self-directed learners, our Research Proposal Bootcamp is a great starting point.

For students that want hands-on guidance, our private coaching service is recommended.

Psst… there’s more!

This post is an extract from our bestselling short course, Research Proposal Bootcamp . If you want to work smart, you don't want to miss this .

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Home » How To Write A Research Proposal – Step-by-Step [Template]

How To Write A Research Proposal – Step-by-Step [Template]

Table of Contents

How To Write a Research Proposal

Writing a Research proposal involves several steps to ensure a well-structured and comprehensive document. Here is an explanation of each step:

1. Title and Abstract

• Choose a concise and descriptive title that reflects the essence of your research.
• Write an abstract summarizing your research question, objectives, methodology, and expected outcomes. It should provide a brief overview of your proposal.

2. Introduction:

• Provide an introduction to your research topic, highlighting its significance and relevance.
• Clearly state the research problem or question you aim to address.
• Discuss the background and context of the study, including previous research in the field.

3. Research Objectives

• Outline the specific objectives or aims of your research. These objectives should be clear, achievable, and aligned with the research problem.

4. Literature Review:

• Conduct a comprehensive review of relevant literature and studies related to your research topic.
• Summarize key findings, identify gaps, and highlight how your research will contribute to the existing knowledge.

5. Methodology:

• Describe the research design and methodology you plan to employ to address your research objectives.
• Explain the data collection methods, instruments, and analysis techniques you will use.
• Justify why the chosen methods are appropriate and suitable for your research.

6. Timeline:

• Create a timeline or schedule that outlines the major milestones and activities of your research project.
• Break down the research process into smaller tasks and estimate the time required for each task.

7. Resources:

• Identify the resources needed for your research, such as access to specific databases, equipment, or funding.
• Explain how you will acquire or utilize these resources to carry out your research effectively.

8. Ethical Considerations:

• Discuss any ethical issues that may arise during your research and explain how you plan to address them.
• If your research involves human subjects, explain how you will ensure their informed consent and privacy.

9. Expected Outcomes and Significance:

• Clearly state the expected outcomes or results of your research.
• Highlight the potential impact and significance of your research in advancing knowledge or addressing practical issues.

10. References:

• Provide a list of all the references cited in your proposal, following a consistent citation style (e.g., APA, MLA).

11. Appendices:

• Include any additional supporting materials, such as survey questionnaires, interview guides, or data analysis plans.

Research Proposal Format

The format of a research proposal may vary depending on the specific requirements of the institution or funding agency. However, the following is a commonly used format for a research proposal:

1. Title Page:

• Include the title of your research proposal, your name, your affiliation or institution, and the date.

2. Abstract:

• Provide a brief summary of your research proposal, highlighting the research problem, objectives, methodology, and expected outcomes.

3. Introduction:

• Introduce the research topic and provide background information.
• State the research problem or question you aim to address.
• Explain the significance and relevance of the research.
• Review relevant literature and studies related to your research topic.
• Summarize key findings and identify gaps in the existing knowledge.
• Explain how your research will contribute to filling those gaps.

5. Research Objectives:

• Clearly state the specific objectives or aims of your research.
• Ensure that the objectives are clear, focused, and aligned with the research problem.

6. Methodology:

• Describe the research design and methodology you plan to use.
• Explain the data collection methods, instruments, and analysis techniques.
• Justify why the chosen methods are appropriate for your research.

7. Timeline:

8. Resources:

• Explain how you will acquire or utilize these resources effectively.

9. Ethical Considerations:

• If applicable, explain how you will ensure informed consent and protect the privacy of research participants.

10. Expected Outcomes and Significance:

11. References:

12. Appendices:

Research Proposal Template

Here’s a template for a research proposal:

1. Introduction:

2. Literature Review:

3. Research Objectives:

4. Methodology:

5. Timeline:

6. Resources:

7. Ethical Considerations:

8. Expected Outcomes and Significance:

9. References:

10. Appendices:

Research Proposal Sample

Title: The Impact of Online Education on Student Learning Outcomes: A Comparative Study

1. Introduction

Online education has gained significant prominence in recent years, especially due to the COVID-19 pandemic. This research proposal aims to investigate the impact of online education on student learning outcomes by comparing them with traditional face-to-face instruction. The study will explore various aspects of online education, such as instructional methods, student engagement, and academic performance, to provide insights into the effectiveness of online learning.

2. Objectives

The main objectives of this research are as follows:

• To compare student learning outcomes between online and traditional face-to-face education.
• To examine the factors influencing student engagement in online learning environments.
• To assess the effectiveness of different instructional methods employed in online education.
• To identify challenges and opportunities associated with online education and suggest recommendations for improvement.

3. Methodology

3.1 Study Design

This research will utilize a mixed-methods approach to gather both quantitative and qualitative data. The study will include the following components:

3.2 Participants

The research will involve undergraduate students from two universities, one offering online education and the other providing face-to-face instruction. A total of 500 students (250 from each university) will be selected randomly to participate in the study.

3.3 Data Collection

The research will employ the following data collection methods:

• Quantitative: Pre- and post-assessments will be conducted to measure students’ learning outcomes. Data on student demographics and academic performance will also be collected from university records.
• Qualitative: Focus group discussions and individual interviews will be conducted with students to gather their perceptions and experiences regarding online education.

3.4 Data Analysis

Quantitative data will be analyzed using statistical software, employing descriptive statistics, t-tests, and regression analysis. Qualitative data will be transcribed, coded, and analyzed thematically to identify recurring patterns and themes.

4. Ethical Considerations

The study will adhere to ethical guidelines, ensuring the privacy and confidentiality of participants. Informed consent will be obtained, and participants will have the right to withdraw from the study at any time.

5. Significance and Expected Outcomes

This research will contribute to the existing literature by providing empirical evidence on the impact of online education on student learning outcomes. The findings will help educational institutions and policymakers make informed decisions about incorporating online learning methods and improving the quality of online education. Moreover, the study will identify potential challenges and opportunities related to online education and offer recommendations for enhancing student engagement and overall learning outcomes.

6. Timeline

The proposed research will be conducted over a period of 12 months, including data collection, analysis, and report writing.

The estimated budget for this research includes expenses related to data collection, software licenses, participant compensation, and research assistance. A detailed budget breakdown will be provided in the final research plan.

8. Conclusion

This research proposal aims to investigate the impact of online education on student learning outcomes through a comparative study with traditional face-to-face instruction. By exploring various dimensions of online education, this research will provide valuable insights into the effectiveness and challenges associated with online learning. The findings will contribute to the ongoing discourse on educational practices and help shape future strategies for maximizing student learning outcomes in online education settings.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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How to choose an Appropriate Method for Research?

• Faculty of Social Sciences
• School of Education
• Research degrees

Writing a research proposal

As part of the process of applying for a research degree, you will need to prepare an outline of your proposed research. This must be 5-10 pages long (font 11pt minimum) excluding the bibliography.

Please see our guidance on what to include below:

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

11.2 Steps in Developing a Research Proposal

Learning objectives.

• Identify the steps in developing a research proposal.
• Choose a topic and formulate a research question and working thesis.
• Develop a research proposal.

Writing a good research paper takes time, thought, and effort. Although this assignment is challenging, it is manageable. Focusing on one step at a time will help you develop a thoughtful, informative, well-supported research paper.

Your first step is to choose a topic and then to develop research questions, a working thesis, and a written research proposal. Set aside adequate time for this part of the process. Fully exploring ideas will help you build a solid foundation for your paper.

Choosing a Topic

When you choose a topic for a research paper, you are making a major commitment. Your choice will help determine whether you enjoy the lengthy process of research and writing—and whether your final paper fulfills the assignment requirements. If you choose your topic hastily, you may later find it difficult to work with your topic. By taking your time and choosing carefully, you can ensure that this assignment is not only challenging but also rewarding.

Writers understand the importance of choosing a topic that fulfills the assignment requirements and fits the assignment’s purpose and audience. (For more information about purpose and audience, see Chapter 6 “Writing Paragraphs: Separating Ideas and Shaping Content” .) Choosing a topic that interests you is also crucial. You instructor may provide a list of suggested topics or ask that you develop a topic on your own. In either case, try to identify topics that genuinely interest you.

After identifying potential topic ideas, you will need to evaluate your ideas and choose one topic to pursue. Will you be able to find enough information about the topic? Can you develop a paper about this topic that presents and supports your original ideas? Is the topic too broad or too narrow for the scope of the assignment? If so, can you modify it so it is more manageable? You will ask these questions during this preliminary phase of the research process.

Identifying Potential Topics

Sometimes, your instructor may provide a list of suggested topics. If so, you may benefit from identifying several possibilities before committing to one idea. It is important to know how to narrow down your ideas into a concise, manageable thesis. You may also use the list as a starting point to help you identify additional, related topics. Discussing your ideas with your instructor will help ensure that you choose a manageable topic that fits the requirements of the assignment.

In this chapter, you will follow a writer named Jorge, who is studying health care administration, as he prepares a research paper. You will also plan, research, and draft your own research paper.

Jorge was assigned to write a research paper on health and the media for an introductory course in health care. Although a general topic was selected for the students, Jorge had to decide which specific issues interested him. He brainstormed a list of possibilities.

If you are writing a research paper for a specialized course, look back through your notes and course activities. Identify reading assignments and class discussions that especially engaged you. Doing so can help you identify topics to pursue.

• Health Maintenance Organizations (HMOs) in the news
• Sexual education programs
• Hollywood and eating disorders
• Americans’ access to public health information
• Media portrayal of health care reform bill
• Depictions of drugs on television
• The effect of the Internet on mental health
• Popularized diets (such as low-carbohydrate diets)
• Fear of pandemics (bird flu, HINI, SARS)
• Electronic entertainment and obesity
• Advertisements for prescription drugs
• Public education and disease prevention

Set a timer for five minutes. Use brainstorming or idea mapping to create a list of topics you would be interested in researching for a paper about the influence of the Internet on social networking. Do you closely follow the media coverage of a particular website, such as Twitter? Would you like to learn more about a certain industry, such as online dating? Which social networking sites do you and your friends use? List as many ideas related to this topic as you can.

Narrowing Your Topic

Once you have a list of potential topics, you will need to choose one as the focus of your essay. You will also need to narrow your topic. Most writers find that the topics they listed during brainstorming or idea mapping are broad—too broad for the scope of the assignment. Working with an overly broad topic, such as sexual education programs or popularized diets, can be frustrating and overwhelming. Each topic has so many facets that it would be impossible to cover them all in a college research paper. However, more specific choices, such as the pros and cons of sexual education in kids’ television programs or the physical effects of the South Beach diet, are specific enough to write about without being too narrow to sustain an entire research paper.

A good research paper provides focused, in-depth information and analysis. If your topic is too broad, you will find it difficult to do more than skim the surface when you research it and write about it. Narrowing your focus is essential to making your topic manageable. To narrow your focus, explore your topic in writing, conduct preliminary research, and discuss both the topic and the research with others.

Exploring Your Topic in Writing

“How am I supposed to narrow my topic when I haven’t even begun researching yet?” In fact, you may already know more than you realize. Review your list and identify your top two or three topics. Set aside some time to explore each one through freewriting. (For more information about freewriting, see Chapter 8 “The Writing Process: How Do I Begin?” .) Simply taking the time to focus on your topic may yield fresh angles.

Jorge knew that he was especially interested in the topic of diet fads, but he also knew that it was much too broad for his assignment. He used freewriting to explore his thoughts so he could narrow his topic. Read Jorge’s ideas.

Conducting Preliminary Research

Another way writers may focus a topic is to conduct preliminary research . Like freewriting, exploratory reading can help you identify interesting angles. Surfing the web and browsing through newspaper and magazine articles are good ways to start. Find out what people are saying about your topic on blogs and online discussion groups. Discussing your topic with others can also inspire you. Talk about your ideas with your classmates, your friends, or your instructor.

Jorge’s freewriting exercise helped him realize that the assigned topic of health and the media intersected with a few of his interests—diet, nutrition, and obesity. Preliminary online research and discussions with his classmates strengthened his impression that many people are confused or misled by media coverage of these subjects.

Jorge decided to focus his paper on a topic that had garnered a great deal of media attention—low-carbohydrate diets. He wanted to find out whether low-carbohydrate diets were as effective as their proponents claimed.

Writing at Work

At work, you may need to research a topic quickly to find general information. This information can be useful in understanding trends in a given industry or generating competition. For example, a company may research a competitor’s prices and use the information when pricing their own product. You may find it useful to skim a variety of reliable sources and take notes on your findings.

The reliability of online sources varies greatly. In this exploratory phase of your research, you do not need to evaluate sources as closely as you will later. However, use common sense as you refine your paper topic. If you read a fascinating blog comment that gives you a new idea for your paper, be sure to check out other, more reliable sources as well to make sure the idea is worth pursuing.

Review the list of topics you created in Note 11.18 “Exercise 1” and identify two or three topics you would like to explore further. For each of these topics, spend five to ten minutes writing about the topic without stopping. Then review your writing to identify possible areas of focus.

Set aside time to conduct preliminary research about your potential topics. Then choose a topic to pursue for your research paper.

Collaboration

Please share your topic list with a classmate. Select one or two topics on his or her list that you would like to learn more about and return it to him or her. Discuss why you found the topics interesting, and learn which of your topics your classmate selected and why.

A Plan for Research

Your freewriting and preliminary research have helped you choose a focused, manageable topic for your research paper. To work with your topic successfully, you will need to determine what exactly you want to learn about it—and later, what you want to say about it. Before you begin conducting in-depth research, you will further define your focus by developing a research question , a working thesis, and a research proposal.

Formulating a Research Question

In forming a research question, you are setting a goal for your research. Your main research question should be substantial enough to form the guiding principle of your paper—but focused enough to guide your research. A strong research question requires you not only to find information but also to put together different pieces of information, interpret and analyze them, and figure out what you think. As you consider potential research questions, ask yourself whether they would be too hard or too easy to answer.

To determine your research question, review the freewriting you completed earlier. Skim through books, articles, and websites and list the questions you have. (You may wish to use the 5WH strategy to help you formulate questions. See Chapter 8 “The Writing Process: How Do I Begin?” for more information about 5WH questions.) Include simple, factual questions and more complex questions that would require analysis and interpretation. Determine your main question—the primary focus of your paper—and several subquestions that you will need to research to answer your main question.

Here are the research questions Jorge will use to focus his research. Notice that his main research question has no obvious, straightforward answer. Jorge will need to research his subquestions, which address narrower topics, to answer his main question.

Using the topic you selected in Note 11.24 “Exercise 2” , write your main research question and at least four to five subquestions. Check that your main research question is appropriately complex for your assignment.

Constructing a Working ThesIs

A working thesis concisely states a writer’s initial answer to the main research question. It does not merely state a fact or present a subjective opinion. Instead, it expresses a debatable idea or claim that you hope to prove through additional research. Your working thesis is called a working thesis for a reason—it is subject to change. As you learn more about your topic, you may change your thinking in light of your research findings. Let your working thesis serve as a guide to your research, but do not be afraid to modify it based on what you learn.

Jorge began his research with a strong point of view based on his preliminary writing and research. Read his working thesis statement, which presents the point he will argue. Notice how it states Jorge’s tentative answer to his research question.

One way to determine your working thesis is to consider how you would complete sentences such as I believe or My opinion is . However, keep in mind that academic writing generally does not use first-person pronouns. These statements are useful starting points, but formal research papers use an objective voice.

Write a working thesis statement that presents your preliminary answer to the research question you wrote in Note 11.27 “Exercise 3” . Check that your working thesis statement presents an idea or claim that could be supported or refuted by evidence from research.

Creating a Research Proposal

A research proposal is a brief document—no more than one typed page—that summarizes the preliminary work you have completed. Your purpose in writing it is to formalize your plan for research and present it to your instructor for feedback. In your research proposal, you will present your main research question, related subquestions, and working thesis. You will also briefly discuss the value of researching this topic and indicate how you plan to gather information.

When Jorge began drafting his research proposal, he realized that he had already created most of the pieces he needed. However, he knew he also had to explain how his research would be relevant to other future health care professionals. In addition, he wanted to form a general plan for doing the research and identifying potentially useful sources. Read Jorge’s research proposal.

Before you begin a new project at work, you may have to develop a project summary document that states the purpose of the project, explains why it would be a wise use of company resources, and briefly outlines the steps involved in completing the project. This type of document is similar to a research proposal. Both documents define and limit a project, explain its value, discuss how to proceed, and identify what resources you will use.

Writing Your Own Research Proposal

Now you may write your own research proposal, if you have not done so already. Follow the guidelines provided in this lesson.

Key Takeaways

• Developing a research proposal involves the following preliminary steps: identifying potential ideas, choosing ideas to explore further, choosing and narrowing a topic, formulating a research question, and developing a working thesis.
• A good topic for a research paper interests the writer and fulfills the requirements of the assignment.
• Defining and narrowing a topic helps writers conduct focused, in-depth research.
• Writers conduct preliminary research to identify possible topics and research questions and to develop a working thesis.
• A good research question interests readers, is neither too broad nor too narrow, and has no obvious answer.
• A good working thesis expresses a debatable idea or claim that can be supported with evidence from research.
• Writers create a research proposal to present their topic, main research question, subquestions, and working thesis to an instructor for approval or feedback.

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How to prepare a Research Proposal

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 essential concepts to the students and beginning researchers and sensitize and motivate the readers to access the vast literature available on research methodologies.

Most 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 prick’s 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

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’.

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

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 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 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.

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 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.

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.

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?

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.