justification in research project

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How to Write the Rationale of the Study in Research (Examples)

What is the Rationale of the Study?

The rationale of the study is the justification for taking on a given study. It explains the reason the study was conducted or should be conducted. This means the study rationale should explain to the reader or examiner why the study is/was necessary. It is also sometimes called the “purpose” or “justification” of a study. While this is not difficult to grasp in itself, you might wonder how the rationale of the study is different from your research question or from the statement of the problem of your study, and how it fits into the rest of your thesis or research paper. 

The rationale of the study links the background of the study to your specific research question and justifies the need for the latter on the basis of the former. In brief, you first provide and discuss existing data on the topic, and then you tell the reader, based on the background evidence you just presented, where you identified gaps or issues and why you think it is important to address those. The problem statement, lastly, is the formulation of the specific research question you choose to investigate, following logically from your rationale, and the approach you are planning to use to do that.

Table of Contents:

How to write a rationale for a research paper , how do you justify the need for a research study.

• Study Rationale Example: Where Does It Go In Your Paper?

The basis for writing a research rationale is preliminary data or a clear description of an observation. If you are doing basic/theoretical research, then a literature review will help you identify gaps in current knowledge. In applied/practical research, you base your rationale on an existing issue with a certain process (e.g., vaccine proof registration) or practice (e.g., patient treatment) that is well documented and needs to be addressed. By presenting the reader with earlier evidence or observations, you can (and have to) convince them that you are not just repeating what other people have already done or said and that your ideas are not coming out of thin air. 

Once you have explained where you are coming from, you should justify the need for doing additional research–this is essentially the rationale of your study. Finally, when you have convinced the reader of the purpose of your work, you can end your introduction section with the statement of the problem of your research that contains clear aims and objectives and also briefly describes (and justifies) your methodological approach. 

When is the Rationale for Research Written?

The author can present the study rationale both before and after the research is conducted. 

• Before conducting research : The study rationale is a central component of the research proposal . It represents the plan of your work, constructed before the study is actually executed.
• Once research has been conducted : After the study is completed, the rationale is presented in a research article or  PhD dissertation  to explain why you focused on this specific research question. When writing the study rationale for this purpose, the author should link the rationale of the research to the aims and outcomes of the study.

What to Include in the Study Rationale

Although every study rationale is different and discusses different specific elements of a study’s method or approach, there are some elements that should be included to write a good rationale. Make sure to touch on the following:

• A summary of conclusions from your review of the relevant literature
• What is currently unknown (gaps in knowledge)
• Inconclusive or contested results  from previous studies on the same or similar topic
• The necessity to improve or build on previous research, such as to improve methodology or utilize newer techniques and/or technologies

There are different types of limitations that you can use to justify the need for your study. In applied/practical research, the justification for investigating something is always that an existing process/practice has a problem or is not satisfactory. Let’s say, for example, that people in a certain country/city/community commonly complain about hospital care on weekends (not enough staff, not enough attention, no decisions being made), but you looked into it and realized that nobody ever investigated whether these perceived problems are actually based on objective shortages/non-availabilities of care or whether the lower numbers of patients who are treated during weekends are commensurate with the provided services.

In this case, “lack of data” is your justification for digging deeper into the problem. Or, if it is obvious that there is a shortage of staff and provided services on weekends, you could decide to investigate which of the usual procedures are skipped during weekends as a result and what the negative consequences are. 

In basic/theoretical research, lack of knowledge is of course a common and accepted justification for additional research—but make sure that it is not your only motivation. “Nobody has ever done this” is only a convincing reason for a study if you explain to the reader why you think we should know more about this specific phenomenon. If there is earlier research but you think it has limitations, then those can usually be classified into “methodological”, “contextual”, and “conceptual” limitations. To identify such limitations, you can ask specific questions and let those questions guide you when you explain to the reader why your study was necessary:

Methodological limitations

• Did earlier studies try but failed to measure/identify a specific phenomenon?
• Was earlier research based on incorrect conceptualizations of variables?
• Were earlier studies based on questionable operationalizations of key concepts?
• Did earlier studies use questionable or inappropriate research designs?

Contextual limitations

• Have recent changes in the studied problem made previous studies irrelevant?
• Are you studying a new/particular context that previous findings do not apply to?

Conceptual limitations

• Do previous findings only make sense within a specific framework or ideology?

Study Rationale Examples

Let’s look at an example from one of our earlier articles on the statement of the problem to clarify how your rationale fits into your introduction section. This is a very short introduction for a practical research study on the challenges of online learning. Your introduction might be much longer (especially the context/background section), and this example does not contain any sources (which you will have to provide for all claims you make and all earlier studies you cite)—but please pay attention to how the background presentation , rationale, and problem statement blend into each other in a logical way so that the reader can follow and has no reason to question your motivation or the foundation of your research.

Background presentation

Since the beginning of the Covid pandemic, most educational institutions around the world have transitioned to a fully online study model, at least during peak times of infections and social distancing measures. This transition has not been easy and even two years into the pandemic, problems with online teaching and studying persist (reference needed) . 

While the increasing gap between those with access to technology and equipment and those without access has been determined to be one of the main challenges (reference needed) , others claim that online learning offers more opportunities for many students by breaking down barriers of location and distance (reference needed) .  

Rationale of the study

Since teachers and students cannot wait for circumstances to go back to normal, the measures that schools and universities have implemented during the last two years, their advantages and disadvantages, and the impact of those measures on students’ progress, satisfaction, and well-being need to be understood so that improvements can be made and demographics that have been left behind can receive the support they need as soon as possible.

Statement of the problem

To identify what changes in the learning environment were considered the most challenging and how those changes relate to a variety of student outcome measures, we conducted surveys and interviews among teachers and students at ten institutions of higher education in four different major cities, two in the US (New York and Chicago), one in South Korea (Seoul), and one in the UK (London). Responses were analyzed with a focus on different student demographics and how they might have been affected differently by the current situation.

How long is a study rationale?

In a research article bound for journal publication, your rationale should not be longer than a few sentences (no longer than one brief paragraph). A  dissertation or thesis  usually allows for a longer description; depending on the length and nature of your document, this could be up to a couple of paragraphs in length. A completely novel or unconventional approach might warrant a longer and more detailed justification than an approach that slightly deviates from well-established methods and approaches.

Consider Using Professional Academic Editing Services

Now that you know how to write the rationale of the study for a research proposal or paper, you should make use of our free AI grammar checker , Wordvice AI, or receive professional academic proofreading services from Wordvice, including research paper editing services and manuscript editing services to polish your submitted research documents.

You can also find many more articles, for example on writing the other parts of your research paper , on choosing a title , or on making sure you understand and adhere to the author instructions before you submit to a journal, on the Wordvice academic resources pages.

How to Write the Rationale for a Research Paper

• Research Process
• Peer Review

A research rationale answers the big SO WHAT? that every adviser, peer reviewer, and editor has in mind when they critique your work. A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at the purpose of a research rationale, its components and key characteristics, and how to create an effective research rationale.

Updated on September 19, 2022

The rationale for your research is the reason why you decided to conduct the study in the first place. The motivation for asking the question. The knowledge gap. This is often the most significant part of your publication. It justifies the study's purpose, novelty, and significance for science or society. It's a critical part of standard research articles as well as funding proposals.

Essentially, the research rationale answers the big SO WHAT? that every (good) adviser, peer reviewer, and editor has in mind when they critique your work.

A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at:

• the purpose of a research rationale
• its components and key characteristics
• how to create an effective research rationale

What is a research rationale?

Think of a research rationale as a set of reasons that explain why a study is necessary and important based on its background. It's also known as the justification of the study, rationale, or thesis statement.

Essentially, you want to convince your reader that you're not reciting what other people have already said and that your opinion hasn't appeared out of thin air. You've done the background reading and identified a knowledge gap that this rationale now explains.

A research rationale is usually written toward the end of the introduction. You'll see this section clearly in high-impact-factor international journals like Nature and Science. At the end of the introduction there's always a phrase that begins with something like, "here we show..." or "in this paper we show..." This text is part of a logical sequence of information, typically (but not necessarily) provided in this order:

Here's an example from a study by Cataldo et al. (2021) on the impact of social media on teenagers' lives.

Note how the research background, gap, rationale, and objectives logically blend into each other.

The authors chose to put the research aims before the rationale. This is not a problem though. They still achieve a logical sequence. This helps the reader follow their thinking and convinces them about their research's foundation.

Elements of a research rationale

We saw that the research rationale follows logically from the research background and literature review/observation and leads into your study's aims and objectives.

This might sound somewhat abstract. A helpful way to formulate a research rationale is to answer the question, “Why is this study necessary and important?”

Generally, that something has never been done before should not be your only motivation. Use it only If you can give the reader valid evidence why we should learn more about this specific phenomenon.

A well-written introduction covers three key elements:

• What's the background to the research?
• What has been done before (information relevant to this particular study, but NOT a literature review)?
• Research rationale

Now, let's see how you might answer the question.

1. This study complements scientific knowledge and understanding

Discuss the shortcomings of previous studies and explain how'll correct them. Your short review can identify:

• Methodological limitations . The methodology (research design, research approach or sampling) employed in previous works is somewhat flawed.

Example : Here , the authors claim that previous studies have failed to explore the role of apathy “as a predictor of functional decline in healthy older adults” (Burhan et al., 2021). At the same time, we know a lot about other age-related neuropsychiatric disorders, like depression.

Their study is necessary, then, “to increase our understanding of the cognitive, clinical, and neural correlates of apathy and deconstruct its underlying mechanisms.” (Burhan et al., 2021).

• Contextual limitations . External factors have changed and this has minimized or removed the relevance of previous research.

Example : You want to do an empirical study to evaluate the effects of the COVID-19 pandemic on the number of tourists visiting Sicily. Previous studies might have measured tourism determinants in Sicily, but they preceded COVID-19.

• Conceptual limitations . Previous studies are too bound to a specific ideology or a theoretical framework.

Example : The work of English novelist E. M. Forster has been extensively researched for its social, political, and aesthetic dimensions. After the 1990s, younger scholars wanted to read his novels as an example of gay fiction. They justified the need to do so based on previous studies' reliance on homophobic ideology.

This kind of rationale is most common in basic/theoretical research.

2. This study can help solve a specific problem

Here, you base your rationale on a process that has a problem or is not satisfactory.

For example, patients complain about low-quality hospital care on weekends (staff shortages, inadequate attention, etc.). No one has looked into this (there is a lack of data). So, you explore if the reported problems are true and what can be done to address them. This is a knowledge gap.

Or you set out to explore a specific practice. You might want to study the pros and cons of several entry strategies into the Japanese food market.

It's vital to explain the problem in detail and stress the practical benefits of its solution. In the first example, the practical implications are recommendations to improve healthcare provision.

In the second example, the impact of your research is to inform the decision-making of businesses wanting to enter the Japanese food market.

This kind of rationale is more common in applied/practical research.

3. You're the best person to conduct this study

It's a bonus if you can show that you're uniquely positioned to deliver this study, especially if you're writing a funding proposal .

For an anthropologist wanting to explore gender norms in Ethiopia, this could be that they speak Amharic (Ethiopia's official language) and have already lived in the country for a few years (ethnographic experience).

Or if you want to conduct an interdisciplinary research project, consider partnering up with collaborators whose expertise complements your own. Scientists from different fields might bring different skills and a fresh perspective or have access to the latest tech and equipment. Teaming up with reputable collaborators justifies the need for a study by increasing its credibility and likely impact.

When is the research rationale written?

You can write your research rationale before, or after, conducting the study.

In the first case, when you might have a new research idea, and you're applying for funding to implement it.

Or you're preparing a call for papers for a journal special issue or a conference. Here , for instance, the authors seek to collect studies on the impact of apathy on age-related neuropsychiatric disorders.

In the second case, you have completed the study and are writing a research paper for publication. Looking back, you explain why you did the study in question and how it worked out.

Although the research rationale is part of the introduction, it's best to write it at the end. Stand back from your study and look at it in the big picture. At this point, it's easier to convince your reader why your study was both necessary and important.

How long should a research rationale be?

The length of the research rationale is not fixed. Ideally, this will be determined by the guidelines (of your journal, sponsor etc.).

The prestigious journal Nature , for instance, calls for articles to be no more than 6 or 8 pages, depending on the content. The introduction should be around 200 words, and, as mentioned, two to three sentences serve as a brief account of the background and rationale of the study, and come at the end of the introduction.

If you're not provided guidelines, consider these factors:

• Research document : In a thesis or book-length study, the research rationale will be longer than in a journal article. For example, the background and rationale of this book exploring the collective memory of World War I cover more than ten pages.
• Research question : Research into a new sub-field may call for a longer or more detailed justification than a study that plugs a gap in literature.

Which verb tenses to use in the research rationale?

It's best to use the present tense. Though in a research proposal, the research rationale is likely written in the future tense, as you're describing the intended or expected outcomes of the research project (the gaps it will fill, the problems it will solve).

Example of a research rationale

Research question : What are the teachers' perceptions of how a sense of European identity is developed and what underlies such perceptions?

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology , 3(2), 77-101.

Burhan, A.M., Yang, J., & Inagawa, T. (2021). Impact of apathy on aging and age-related neuropsychiatric disorders. Research Topic. Frontiers in Psychiatry

Cataldo, I., Lepri, B., Neoh, M. J. Y., & Esposito, G. (2021). Social media usage and development of psychiatric disorders in childhood and adolescence: A review. Frontiers in Psychiatry , 11.

CiCe Jean Monnet Network (2017). Guidelines for citizenship education in school: Identities and European citizenship children's identity and citizenship in Europe.

Cohen, l, Manion, L., & Morrison, K. (2018). Research methods in education . Eighth edition. London: Routledge.

de Prat, R. C. (2013). Euroscepticism, Europhobia and Eurocriticism: The radical parties of the right and left “vis-à-vis” the European Union P.I.E-Peter Lang S.A., Éditions Scientifiques Internationales.

European Commission. (2017). Eurydice Brief: Citizenship education at school in Europe.

Polyakova, A., & Fligstein, N. (2016). Is European integration causing Europe to become more nationalist? Evidence from the 2007–9 financial crisis. Journal of European Public Policy , 23(1), 60-83.

Winter, J. (2014). Sites of Memory, Sites of Mourning: The Great War in European Cultural History . Cambridge: Cambridge University Press.

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Rationale for the Study

It is important for you to be able to explain the importance of the research you are conducting by providing valid arguments. Rationale for the study, also referred to as justification for the study, is reason why you have conducted your study in the first place. This part in your paper needs to explain uniqueness and importance of your research. Rationale for the study needs to be specific and ideally, it should relate to the following points:

1. The research needs to contribute to the elimination of a gap in the literature. Elimination of gap in the present literature is one of the compulsory requirements for your study. In other words, you don’t need to ‘re-invent the wheel’ and your research aims and objectives need to focus on new topics. For example, you can choose to conduct an empirical study to assess the implications of COVID-19 pandemic on the numbers of tourists visitors in your city. This might be previously undressed topic, taking into account that COVID-19 pandemic is a relatively recent phenomenon.

Alternatively, if you cannot find a new topic to research, you can attempt to offer fresh perspectives on existing management, business or economic issues. For example, while thousands of studies have been previously conducted to study various aspects of leadership, this topic as far from being exhausted as a research area. Specifically, new studies can be conducted in the area of leadership to analyze the impacts of new communication mediums such as TikTok, and other social networking sites on leadership practices.

You can also discuss the shortcomings of previous works devoted to your research area. Shortcomings in previous studies can be divided into three groups:

a) Methodological limitations . Methodology employed in previous study may be flawed in terms of research design, research approach or sampling.

b) Contextual limitations . Relevance of previous works may be non-existent for the present because external factors have changed.

c) Conceptual limitations . Previous studies may be unjustifiably bound up to a particular model or an ideology.

While discussing the shortcomings of previous studies you should explain how you are going to correct them. This principle is true to almost all areas in business studies i.e. gaps or shortcomings in the literature can be found in relation to almost all areas of business and economics.

2. The research can be conducted to solve a specific problem. It helps if you can explain why you are the right person and in the right position to solve the problem. You have to explain the essence of the problem in a detailed manner and highlight practical benefits associated with the solution of the problem. Suppose, your dissertation topic is “a study into advantages and disadvantages of various entry strategies into Chinese market”. In this case, you can say that practical implications of your research relates to assisting businesses aiming to enter Chinese market to do more informed decision making.

Alternatively, if your research is devoted to the analysis of impacts of CSR programs and initiatives on brand image, practical contributions of your study would relate to contributing to the level of effectiveness of CSR programs of businesses.

Additional examples of studies that can assist to address specific practical problems may include the following:

• A study into the reasons of high employee turnover at Hanson Brick
• A critical analysis of employee motivation problems at Esporta, Finchley Road, London
• A research into effective succession planning at Microsoft
• A study into major differences between private and public primary education in the USA and implications of these differences on the quality of education

However, it is important to note that it is not an obligatory for a dissertation   to be associated with the solution of a specific problem. Dissertations can be purely theory-based as well. Examples of such studies include the following:

• Born or bred: revising The Great Man theory of leadership in the 21 st century
• A critical analysis of the relevance of McClelland’s Achievement theory to the US information technology industry
• Neoliberalism as a major reason behind the emergence of the global financial and economic crisis of 2007-2009
• Analysis of Lewin’s Model of Change and its relevance to pharmaceutical sector of France

3. Your study has to contribute to the level of professional development of the researcher . That is you. You have to explain in a detailed manner in what ways your research contributes to the achievement of your long-term career aspirations.

For example, you have selected a research topic of “ A critical analysis of the relevance of McClelland’s Achievement theory in the US information technology industry ”.  You may state that you associate your career aspirations with becoming an IT executive in the US, and accordingly, in-depth knowledge of employee motivation in this industry is going to contribute your chances of success in your chosen career path.

Therefore, you are in a better position if you have already identified your career objectives, so that during the research process you can get detailed knowledge about various aspects of your chosen industry.

My e-book, The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline.

John Dudovskiy

7 Examples of Justification (of a project or research)

The justification to the part of a research project that sets out the reasons that motivated the research. The justification is the section that explains the importance and the reasons that led the researcher to carry out the work.

The justification explains to the reader why and why the chosen topic was investigated. In general, the reasons that the researcher can give in a justification may be that his work allows to build or refute theories; bring a new approach or perspective on the subject; contribute to the solution of a specific problem (social, economic, environmental, etc.) that affects certain people; generate meaningful and reusable empirical data; clarify the causes and consequences of a specific phenomenon of interest; among other.

Among the criteria used to write a justification, the usefulness of the research for other academics or for other social sectors (public officials, companies, sectors of civil society), the significance in time that it may have, the contribution of new research tools or techniques, updating of existing knowledge, among others. Also, the language should be formal and descriptive.

Examples of justification

• This research will focus on studying the reproduction habits of salmon in the Mediterranean region of Europe, since due to recent ecological changes in the water and temperatures of the region produced by human economic activity , the behavior of these animals has been modified. Thus, the present work would allow to show the changes that the species has developed to adapt to the new circumstances of its ecosystem, and to deepen the theoretical knowledge about accelerated adaptation processes, in addition to offering a comprehensive look at the environmental damage caused by growth. unsustainable economic, helping to raise awareness of the local population.
• We therefore propose to investigate the evolution of the theoretical conceptions of class struggle and economic structure throughout the work of Antonio Gramsci, since we consider that previous analyzes have overlooked the fundamentally dynamic and unstable conception of human society that is present. in the works of Gramsci, and that is of vital importance to fully understand the author’s thought.
• The reasons that led us to investigate the effects of regular use of cell phones on the health of middle-class young people under 18 years of age are centered on the fact that this vulnerable sector of the population is exposed to a greater extent than the rest of society to risks that the continuous use of cell phone devices may imply, due to their cultural and social habits. We intend then to help alert about these dangers, as well as to generate knowledge that helps in the treatment of the effects produced by the abuse in the use of this technology.
• We believe that by means of a detailed analysis of the evolution of financial transactions carried out in the main stock exchanges of the world during the period 2005-2010, as well as the inquiry about how financial and banking agents perceived the situation of the financial system, it will allow us to clarify the economic mechanisms that enable the development of an economic crisis of global dimensions such as the one that the world experienced since 2009, and thus improve the design of regulatory and counter-cyclical public policies that favor the stability of the local and international financial system.
• Our study about the applications and programs developed through the three analyzed programming languages ​​(Java, C ++ and Haskell), can allow us to clearly distinguish the potential that each of these languages ​​(and similar languages) present for solving specific problems. , in a specific area of ​​activity. This would allow not only to increase efficiency in relation to long-term development projects, but to plan coding strategies with better results in projects that are already working, and to improve teaching plans for teaching programming and computer science.
• This in-depth study on the expansion of the Chinese empire under the Xia dynasty, will allow to clarify the socioeconomic, military and political processes that allowed the consolidation of one of the oldest states in history, and also understand the expansion of metallurgical and administrative technologies along the coastal region of the Pacific Ocean. The deep understanding of these phenomena will allow us to clarify this little-known period in Chinese history, which was of vital importance for the social transformations that the peoples of the region went through during the period.
• Research on the efficacy of captropil in the treatment of cardiovascular conditions (in particular hypertension and heart failure) will allow us to determine if angiotensin is of vital importance in the processes of blocking the protein peptidase, or if by the On the contrary, these effects can be attributed to other components present in the formula of drugs frequently prescribed to patients after medical consultation.

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The rationale for one’s research is the justification for undertaking a given study. It states the reason(s) why a researcher chooses to focus on the topic in question, including what the significance is and what gaps the research intends to fill. In short, it is an explanation that rationalises the need for the study. The rationale is typically followed by a hypothesis/ research question (s) and the study objectives.

When is the rationale for research written?

The rationale of a study can be presented both before and after the research is conducted. 

• Before : The rationale is a crucial part of your research proposal , representing the plan of your work as formulated before you execute your study.
• After : Once the study is completed, the rationale is presented in a research paper or dissertation to explain why you focused on the particular question. In this instance, you would link the rationale of your research project to the study aims and outcomes.

Basis for writing the research rationale

The study rationale is predominantly based on preliminary data . A literature review will help you identify gaps in the current knowledge base and also ensure that you avoid duplicating what has already been done. You can then formulate the justification for your study from the existing literature on the subject and the perceived outcomes of the proposed study.

Length of the research rationale

In a research proposal or research article, the rationale would not take up more than a few sentences . A thesis or dissertation would allow for a longer description, which could even run into a couple of paragraphs . The length might even depend on the field of study or nature of the experiment. For instance, a completely novel or unconventional approach might warrant a longer and more detailed justification.

Basic elements of the research rationale

Every research rationale should include some mention or discussion of the following: 

• An overview of your conclusions from your literature review
• Gaps in current knowledge
• Inconclusive or controversial findings from previous studies
• The need to build on previous research (e.g. unanswered questions, the need to update concepts in light of new findings and/or new technical advancements). 

Example of a research rationale

Note: This uses a fictional study.

Abc xyz is a newly identified microalgal species isolated from fish tanks. While Abc xyz algal blooms have been seen as a threat to pisciculture, some studies have hinted at their unusually high carotenoid content and unique carotenoid profile. Carotenoid profiling has been carried out only in a handful of microalgal species from this genus, and the search for microalgae rich in bioactive carotenoids has not yielded promising candidates so far. This in-depth examination of the carotenoid profile of Abc xyz will help identify and quantify novel and potentially useful carotenoids from an untapped aquaculture resource .

In conclusion

It is important to describe the rationale of your research in order to put the significance and novelty of your specific research project into perspective. Once you have successfully articulated the reason(s) for your research, you will have convinced readers of the importance of your work!

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What (Exactly) Is A Research Proposal?

A simple explainer with examples + free template.

By: Derek Jansen (MBA) | Reviewed By: Dr Eunice Rautenbach | June 2020 (Updated April 2023)

Whether you’re nearing the end of your degree and your dissertation is on the horizon, or you’re planning to apply for a PhD program, chances are you’ll need to craft a convincing research proposal . If you’re on this page, you’re probably unsure exactly what the research proposal is all about. Well, you’ve come to the right place.

Overview: Research Proposal Basics

• What a research proposal is
• What a research proposal needs to cover
• How to structure your research proposal
• Example /sample proposals
• Proposal writing FAQs
• Key takeaways & additional resources

What is a research proposal?

Simply put, a research proposal is a structured, formal document that explains what you plan to research (your research topic), why it’s worth researching (your justification), and how  you plan to investigate it (your methodology). 

The purpose of the research proposal (its job, so to speak) is to convince  your research supervisor, committee or university that your research is  suitable  (for the requirements of the degree program) and  manageable  (given the time and resource constraints you will face). 

The most important word here is “ convince ” – in other words, your research proposal needs to  sell  your research idea (to whoever is going to approve it). If it doesn’t convince them (of its suitability and manageability), you’ll need to revise and resubmit . This will cost you valuable time, which will either delay the start of your research or eat into its time allowance (which is bad news). 

What goes into a research proposal?

A good dissertation or thesis proposal needs to cover the “ what “, “ why ” and” how ” of the proposed study. Let’s look at each of these attributes in a little more detail:

Your proposal needs to clearly articulate your research topic . This needs to be specific and unambiguous . Your research topic should make it clear exactly what you plan to research and in what context. Here’s an example of a well-articulated research topic:

An investigation into the factors which impact female Generation Y consumer’s likelihood to promote a specific makeup brand to their peers: a British context

As you can see, this topic is extremely clear. From this one line we can see exactly:

• What’s being investigated – factors that make people promote or advocate for a brand of a specific makeup brand
• Who it involves – female Gen-Y consumers
• In what context – the United Kingdom

So, make sure that your research proposal provides a detailed explanation of your research topic . If possible, also briefly outline your research aims and objectives , and perhaps even your research questions (although in some cases you’ll only develop these at a later stage). Needless to say, don’t start writing your proposal until you have a clear topic in mind , or you’ll end up waffling and your research proposal will suffer as a result of this.

Need a helping hand?

As we touched on earlier, it’s not good enough to simply propose a research topic – you need to justify why your topic is original . In other words, what makes it  unique ? What gap in the current literature does it fill? If it’s simply a rehash of the existing research, it’s probably not going to get approval – it needs to be fresh.

But,  originality  alone is not enough. Once you’ve ticked that box, you also need to justify why your proposed topic is  important . In other words, what value will it add to the world if you achieve your research aims?

As an example, let’s look at the sample research topic we mentioned earlier (factors impacting brand advocacy). In this case, if the research could uncover relevant factors, these findings would be very useful to marketers in the cosmetics industry, and would, therefore, have commercial value . That is a clear justification for the research.

So, when you’re crafting your research proposal, remember that it’s not enough for a topic to simply be unique. It needs to be useful and value-creating – and you need to convey that value in your proposal. If you’re struggling to find a research topic that makes the cut, watch  our video covering how to find a research topic .

It’s all good and well to have a great topic that’s original and valuable, but you’re not going to convince anyone to approve it without discussing the practicalities – in other words:

• How will you actually undertake your research (i.e., your methodology)?
• Is your research methodology appropriate given your research aims?
• Is your approach manageable given your constraints (time, money, etc.)?

While it’s generally not expected that you’ll have a fully fleshed-out methodology at the proposal stage, you’ll likely still need to provide a high-level overview of your research methodology . Here are some important questions you’ll need to address in your research proposal:

• Will you take a qualitative , quantitative or mixed -method approach?
• What sampling strategy will you adopt?
• How will you collect your data (e.g., interviews, surveys, etc)?
• How will you analyse your data (e.g., descriptive and inferential statistics , content analysis, discourse analysis, etc, .)?
• What potential limitations will your methodology carry?

So, be sure to give some thought to the practicalities of your research and have at least a basic methodological plan before you start writing up your proposal. If this all sounds rather intimidating, the video below provides a good introduction to research methodology and the key choices you’ll need to make.

How To Structure A Research Proposal

Now that we’ve covered the key points that need to be addressed in a proposal, you may be wondering, “ But how is a research proposal structured? “.

While the exact structure and format required for a research proposal differs from university to university, there are four “essential ingredients” that commonly make up the structure of a research proposal:

• A rich introduction and background to the proposed research
• An initial literature review covering the existing research
• An overview of the proposed research methodology
• A discussion regarding the practicalities (project plans, timelines, etc.)

In the video below, we unpack each of these four sections, step by step.

Research Proposal Examples/Samples

In the video below, we provide a detailed walkthrough of two successful research proposals (Master’s and PhD-level), as well as our popular free proposal template.

Proposal Writing FAQs

How long should a research proposal be.

This varies tremendously, depending on the university, the field of study (e.g., social sciences vs natural sciences), and the level of the degree (e.g. undergraduate, Masters or PhD) – so it’s always best to check with your university what their specific requirements are before you start planning your proposal.

As a rough guide, a formal research proposal at Masters-level often ranges between 2000-3000 words, while a PhD-level proposal can be far more detailed, ranging from 5000-8000 words. In some cases, a rough outline of the topic is all that’s needed, while in other cases, universities expect a very detailed proposal that essentially forms the first three chapters of the dissertation or thesis.

The takeaway – be sure to check with your institution before you start writing.

How do I choose a topic for my research proposal?

Finding a good research topic is a process that involves multiple steps. We cover the topic ideation process in this video post.

How do I write a literature review for my proposal?

While you typically won’t need a comprehensive literature review at the proposal stage, you still need to demonstrate that you’re familiar with the key literature and are able to synthesise it. We explain the literature review process here.

How do I create a timeline and budget for my proposal?

We explain how to craft a project plan/timeline and budget in Research Proposal Bootcamp .

Which referencing format should I use in my research proposal?

The expectations and requirements regarding formatting and referencing vary from institution to institution. Therefore, you’ll need to check this information with your university.

What common proposal writing mistakes do I need to look out for?

We’ve create a video post about some of the most common mistakes students make when writing a proposal – you can access that here . If you’re short on time, here’s a quick summary:

• The research topic is too broad (or just poorly articulated).
• The research aims, objectives and questions don’t align.
• The research topic is not well justified.
• The study has a weak theoretical foundation.
• The research design is not well articulated well enough.
• Poor writing and sloppy presentation.
• Poor project planning and risk management.
• Not following the university’s specific criteria.

Key Takeaways & Additional Resources

As you write up your research proposal, remember the all-important core purpose:  to convince . Your research proposal needs to sell your study in terms of suitability and viability. So, focus on crafting a convincing narrative to ensure a strong proposal.

At the same time, pay close attention to your university’s requirements. While we’ve covered the essentials here, every institution has its own set of expectations and it’s essential that you follow these to maximise your chances of approval.

By the way, we’ve got plenty more resources to help you fast-track your research proposal. Here are some of our most popular resources to get you started:

• Proposal Writing 101 : A Introductory Webinar
• Research Proposal Bootcamp : The Ultimate Online Course
• Template : A basic template to help you craft your proposal

If you’re looking for 1-on-1 support with your research proposal, be sure to check out our private coaching service , where we hold your hand through the proposal development process (and the entire research journey), step by step.

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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51 Comments

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You’re most welcome. We don’t have any research proposals that we can share (the students own the intellectual property), but you might find our research proposal template useful: https://gradcoach.com/research-proposal-template/

Cheruiyot Moses Kipyegon

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• v.62(5); Sep-Oct 2017

Summary and Synthesis: How to Present a Research Proposal

Maninder singh setia.

From the MGM Institute of Health Sciences, Navi Mumbai, Maharashtra, India

Saumya Panda

1 Department of Dermatology, KPC Medical College, Kolkata, West Bengal, India

This concluding module attempts to synthesize the key learning points discussed during the course of the previous ten sets of modules on methodology and biostatistics. The objective of this module is to discuss how to present a model research proposal, based on whatever was discussed in the preceding modules. The lynchpin of a research proposal is the protocol, and the key component of a protocol is the study design. However, one must not neglect the other areas, be it the project summary through which one catches the eyes of the reviewer of the proposal, or the background and the literature review, or the aims and objectives of the study. Two critical areas in the “methods” section that cannot be emphasized more are the sampling strategy and a formal estimation of sample size. Without a legitimate sample size, none of the conclusions based on the statistical analysis would be valid. Finally, the ethical parameters of the study should be well understood by the researchers, and that should get reflected in the proposal.

As we reach the end of an exhaustive module encompassing research methods and biostatistics, we need to summarize and synthesize the key learning points, to demonstrate how one may utilize the different sections of the module to undertake research projects of different kinds. After all, the practical purpose behind publishing such a module is to facilitate the preparation of high quality research proposals and protocols. This concluding part will make an attempt to provide a window to the different sections of the module, underlining the various aspects of design and analysis needed to formulate protocols applicable to different kinds of clinical research in dermatology.

Components of a Research Proposal

The goal of a research proposal is to present and justify the need to study a research problem and to present the practical ways in which the proposed study should be conducted. A research proposal is generally meant to be presented by an investigator to request an agency or a body to support research work in the form of grants. The vast majority of research proposals, in India, however, are not submitted to agency or body for grants, simply because of the paucity of such agencies, bodies, and research grants. Most are academic research proposals, self-financed, and submitted to scientific and ethics committee of an institution. The parts of a proposal include the title page, abstract/project summary, table of contents, introduction, background and review of literature, and the research protocol.

The title page should contain the personal data pertaining to the investigators, and title of the project, which should be concise and comprehensive at the same time. The table of contents, strictly speaking, is not necessary for short proposals. The introduction includes a statement of the problem, purpose, and significance of the research.

The protocol is the document that specifies the research plan. It is the single most important quality control tool for all aspects of a clinical research. It is the instrument where the researcher explains how data will be collected, including the calculation for estimating sample size, and what outcome variables to measure.

A complete clinical research protocol includes the following:

Study design

• Precise definition of the disease or problem
• Completely defined prespecified primary and secondary outcome measures, including how and when these will be assessed
• Clear description of variables
• Well-defined inclusion and exclusion criteria
• Efficacy and safety parameters
• Whenever applicable, stopping guidelines and parameters of interim analyses
• Sample size calculation
• Randomization details
• Plan of statistical analysis
• Detailed description of interventions
• A chronogram of research flow (Gantt chart)
• Informed consent document
• Clinical research form
• Details of budget; and
• References.

(Modified from: Bagatin et al ., 2013).

Project Summary

The project summary is a brief document that consists of an overview, and discusses the intellectual merits, and broader impacts of the research project. Each of these three sections is required to be present and must be clearly defined. The project summary is one of the most important parts of the proposal. It is likely the first thing a reviewer will read, and is the investigators’ best chance to grab their interest, and convince them of the importance, and quality, of their research before they even read the proposal. Though it is the first proposal element in order, many applicants prefer to write the project summary last, after writing the protocol. This allows the writer to better avoid any inconsistencies between the two.

The overview specifies the research goal and it should demonstrate that this goal fits with the principal investigator's long-term research goals. It should specify the proposed research approach and the educational goal of the research project.

The intellectual merits (the contribution your research will make to your field) should specify the current state of knowledge in the field, and where it is headed. It should also clarify what your research will add to the state of knowledge in the field. Furthermore, important to state is what your research will do to enhance or enable other researches in the field. Finally, one should answer why your research is important for the advancement of the field.

The broader impacts (the contribution the research will make to the society) should answer the questions on the benefit to the society at large from the research, and the possible applications of the research, and why the general public would care. It should also clarify how the research can benefit the site of research (medical college or university, etc.) and the funding agency.

Background and Review of Literature

This is an important component of the research protocol. The review should discuss all the relevant literature, the method used in the literature, the lacunae in the literature, and justify the proposed research. We have provided a list of the useful databases in the section on systematic reviews and meta-analysis (Setia, 2017). Some of these are PubMed, Cochrane database, EMBASE, and LILACS.

Provide a critical analysis of the literature

The researcher should not provide a descriptive analysis of literature. For instance, the literature reviews should not be a list of one article followed by the next article. It should be a critical analysis of literature.

A study by XXXX et al . found that the prevalence of psoriasis was 20%. It was a hospital-based study conducted in North India. The prevalence was 35% in males and 12% in females.

Another study by YYYYY et al . found that the prevalence of psoriasis was 14%. The study was conducted in a private clinic in North India. The prevalence was 8% in males and 18% in females.

A third study by ZZZZZ et al . found that the prevalence of psoriasis was 5%. This study was a community-based study. The prevalence was 7% in males and 3% in females.

In this type of review, the researcher has described all the studies. However, it is useful to understand the findings of these three studies and summarize them in researcher's own words.

A possible option can be “ The reported prevalence of psoriasis in the Indian population varied from 5% to 20%. In general, it was higher in hospital-based studies and lower in community-based studies. There was no consistent pattern in the prevalence of psoriasis in males and females. Though some studies found the prevalence to be higher in males, others reported that females had a higher prevalence .”

Discuss the limitations and lacunae of these studies

The researcher should discuss the limitations of the studies. These could be the limitations that the authors have presented in the manuscript or the ones that the researcher has identified. Usually, the current research proposal should try to address the limitations of a previous study.

A study by BBBB et al : “ One of the main limitations of our study was the lack of objective criteria for assessing anemia in patients presenting with psoriasis. We classified the patients based on clinical assessment of pallor .”

The present proposal can mention “ Though previous studies have assessed the association between anemia and psoriasis, they have not used any objective criteria (such as hemoglobin or serum ferritin levels). Furthermore, pallor was evaluated by three clinicians; the authors have not described the agreement between these clinicians .”

In the above example, the authors have stated the limitation of their research in the manuscript. However, in the review of literature, the researcher has added another limitation. It is important to convince the reviewers that the researcher has read and understood the literature. It is also important that some or most of these lacunae should be addressed in the present proposal as far as possible.

Justify the present proposal by review

The researcher should adequately justify the present proposal based on the review of literature. The justification should not only be for the research question, but also the methods, study design, variables of interest, study instruments or measurements, and statistical methods of choice. Sometimes, the justification can be purely statistical. For example, all the previous studies have used cross-sectional data or cross-sectional analysis of longitudinal data in their manuscripts. The present proposal will use methods used for longitudinal data analysis. The researcher should justify the benefit of these methods over the previous statistical methods.

In short, the review should not be a “laundry list” of all the articles. The review should be able to convince the reader that the present research is required and it builds on the existing literature (either as a novel research question, new measurement of the outcome, a better study design, or advanced and appropriate statistical methods).

Kindly try to avoid this justification: “ It has not been done in our center .”

Aims and Objectives

The “aim” of the study is an overarching goal of the study. The objectives are measurable and help the researcher achieve the overall aim.

For example, the overall aim of our study is to assess the long-term health of patients of psoriasis.

The specific objectives are:

• To record the changes in Psoriasis Area and Severity Index (PASI) score in patients with psoriasis over a period of 5 years
• To study the side effects of medications in these patients over a period of 5 years.

It is important to clearly state the objectives, since the research proposal should be designed to achieve these objectives.

For example, the methods should describe the following:

• How will the researcher answer the first objective?
• Where will the researcher recruit the study participants (study site and population)?
• Which patients of psoriasis will be recruited (inclusion and exclusion criteria)?
• What will be the design of the study (cohort, etc.)?
• What are all the variables to be measured to achieve the study outcomes (exposure and outcome variables)?
• How will the researcher measure these variables (clinical evaluation, history, serological examination, etc.)?
• How will the researcher record these data (clinical forms, etc.)?
• How will the researcher analyze the data that have been collected?
• Are there any limitations of these methods? If so, what has the researcher done to minimize the limitations?

All the ten modules on research methodology have to be read and grasped to plan and design any kind of research applicable to one's chosen field. However, some key areas have been outlined below with examples to appreciate the same in an easier manner.

The study setting must be specified. This should include both the geographical location and the population from which the study sample would be recruited.

“The study took place at the antiretroviral therapy clinic of Queen Elizabeth Central Hospital in Blantyre, Malawi, from January 2006 to April 2007. Blantyre is the major commercial city of Malawi, with a population of 1,000,000 and an estimated HIV prevalence of 27% in adults in 2004” (Ndekha et al ., 2009).

This is a perfect example of description of a study setting which underscores the importance of planning it in detail a priori .

Study population, sampling strategy, and sample size

Study population has to be clearly and precisely defined. For example, a study on atopic dermatitis may be conducted upon patients defined according to the UK Working Party's modified diagnostic criteria, or the Hanifin and Rajka's criteria, or some other criteria defined by the investigators. However, it should always be prespecified within the protocol.

Similarly, the eligibility criteria of the participants for the study must be explicit. One truism that is frequently forgotten is that the inclusion and exclusion criteria are mutually exclusive, and one is not the negative image of the other. Eligible cases are included according to a set of inclusion criteria, and this is followed by administration of the exclusion criteria. Thus, in fact, they can never be the negative image of each other.

“Eligible participants were all adults aged 18 or over with HIV who met the eligibility criteria for antiretroviral therapy according to the Malawian national HIV treatment guidelines (WHO clinical stage III or IV or any WHO stage with a CD4 count < 250/mm 3 ) and who were starting treatment with a BMI < 18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding program” (Ndekha et al ., 2009).

To put in perspective the point we made about inclusion and exclusion criteria, in the above example, “age above 18 years” or “CD4 count >250/mm 3 ” cannot be exclusion criteria, as these have already been excluded.

Sampling strategy has been adequately discussed in the Module 5 of the Methodology series (Setia, 2016). A few points are worth repeating:

• The sampling strategy should never be misrepresented. Example: If you have not done random sampling, no big deal. There are other legitimate sampling strategies available for your study. But once you have mentioned “random sampling” in your protocol, you cannot resort to purposive sampling
• Sometimes, the researcher might want to know the characteristics of a certain problem within a specific population, without caring for generalizability of results. In such a scenario, purposive sampling may be resorted to
• Nonprobability sampling methods such as consecutive consenting sampling or any such convenience sampling are perfectly legitimate and easy to do, particularly in case of dissertations where time and resources are limited.

Sample size is one of the most misunderstood, yet fundamentally important, issues among clinicians and has to be addressed once the study objectives have been set and the design has been finalized. Too small a sample means that there would be a failure to detect change following test intervention. A sample larger than necessary may also result in bad quality data. In either case, there would be ethical problems and wastage of resources. The researcher needs just enough samples to draw accurate inferences, which would be adequately powered (Panda, 2015).

Estimation of sample size has been dealt with adequately in the Module 5 biostatistics series (Hazra et al ., 2016), including the different mathematical derivations and the available software. Sample size determination is a statistical exercise based on the probability of errors in testing of hypothesis, power of the sample, and effect size. Although, relatively speaking, these are simple concepts to grasp, a large number of different study designs and analytical methods lead to a bewilderingly large number of formulae for determining sample size. Thus, the software are really handy and are becoming increasingly popular.

The study design defines the objectives and end points of the study, the type and manner of data collection, and the strategy of data analysis (Panda 2015). The different types of clinical studies have been depicted in Figure 1 . The suitability of various study designs vis-à-vis different types of research questions is summarized in Table 1 .

Types of study (Source: Panda, 2015)

Research questions vis-a-vis study designs

In our previous series of ten modules on methodology, we have discussed all these different kinds of studies and more. Some key issues that require reiteration are given below:

• The control of a case–control study and that of a randomized controlled trial is more different from each other than chalk is from cheese. The former is an observational study, while the latter is an interventional one. Every study with a control group is not a case–control study. For a study to be classified as a case–control study, the study should be an observational study and the participants should be recruited based on their outcome status (Setia, 2016). Apparently, this is not so difficult to understand, yet even now we have publications which confuse between the different kinds of controls (Bhanja et al ., 2015)
• Due to the fact that the outcome and exposure are assessed at the same time point in a cross-sectional study, it is pretty difficult, if not impossible, to derive causal relationships from such a study. At most, one may establish statistical association between exposures and outcomes by calculating the odds ratio. However, these associations must not be confused with causation.
• It is generally said that a cohort design may not be efficient for rare outcomes. However, if the rare outcome is common in some exposures, it may be useful to follow a cohort design. For example, melanoma is a rare condition in India. Hence, if we follow individuals to study the incidence of melanoma, it may not be efficient. However, if we know that, in India, acral lentiginous melanoma is the most commonly reported variant, we should follow a cohort of individuals with acral lentiginous and study the incidence of melanoma in this group (Setia, 2016).

Clinical researchers should also be accustomed with observational designs beyond case–control, cohort, and cross-sectional studies. Sometimes, the unit of analysis has to be a group or aggregate rather than the individual. Consider the following example:

The government introduced the supplementation of salt with iodine for about 20 years. However, not all states have used the same level of iodine in salt. Certain hilly states have used higher quantities compared with other states. Incidentally, you read a report that high iodine levels are associated with psoriasis. You are intrigued to find if introduction of iodine has altered the picture of psoriasis in the country. You feel compelled to design a study to answer this question .

It is obvious that here the unit of study cannot be individuals, but a large population distributed in a certain geographical area. This is the domain of ecologic studies. An allied category of observational studies is named “natural experiments,” where the exposure is not assigned by the investigator (as in an interventional study), but through “natural processes.” These may be through changes in the existing regulations or public policies or, may be, through introduction of new laws (Setia, 2017).

Another category of research questions that cannot be satisfactorily captured by all the quantitative methods described earlier, like social stigma experienced by patients or their families with, say, vitiligo, leprosy, or sexually transmitted infections, are best dealt with by qualitative research. As can be seen by the examples given above, this is a type of research which is very relevant to medical research, yet to which the regular medical researcher has got a very poor exposure, if any. We shall encourage interested researchers to take a look at the 10 th Module of the Methodology series that specifically deals with qualitative research (Setia, 2017).

Clinical studies are experiments that are not conducted in laboratories but in controlled real-life settings on human subjects with some disease. Hence, designing a study involves many pragmatic considerations aside pure methodology. Thus, factors to consider when selecting a study design are objectives of the study, time frame, treatment duration, carryover effects, cost and logistics, patient convenience, statistical considerations, sample size, etc. (Panda, 2015).

Certain truisms regarding study designs should always be remembered: a study design has to be tailored to objectives. The same question may be answered by different designs. The optimum design has to be based on workforce, budgetary allocation, infrastructure, and clinical material that may be commanded by the researchers. Finally, no design is perfect, and there is no design to provide a perfect answer to all research questions relevant to a particular problem (Panda, 2015).

Variables of interest and collection of these variables

Data structure depends on the characteristics of the variables [ Figure 2 ]. A variable refers to a particular character on which a set of data are recorded. Data are thus the values of a variable (Hazra et al ., 2016).

Types of data and variables (Source: Panda, 2015)

Quantitative data always have a proportional scale among values, and can be either discrete (e.g., number of moles) or continuous (e.g., age). Qualitative data can be either nominal (e.g., blood groups) or ordinal (e.g., Fitzpatrick's phototypes I-VI). Variables can be binary or dichotomous (male/female) or multinomial or polychotomous (homosexual/bisexual/heterosexual) (Panda, 2015).

Changing data scales is possible so that numerical data may become ordinal and ordinal data may become nominal. This may be done when the researcher is not confident about the accuracy of the measuring instrument, is unconcerned about the loss of fine detail, or where group numbers are not large enough to adequately represent a variable of interest. It may also make clinical interpretation easier (Hazra et al ., 2016).

The variables whose effects are observed on other variables are known as independent variables (e.g., risk factors). The latter kind of variables that change as a result of independent variables are known as dependent variables (i.e., outcome). Confounders are those variables that influence the relation between independent and dependent variables (e.g., the clinical effect of sunscreen used as part of a test intervention regimen in melasma). If the researcher fails to control or eliminate the confounder, it will damage the internal validity of an experiment (Panda, 2015).

Biostatistics begins with descriptive statistics that implies summarizing a collection of data from a sample or population. An excellent overview of descriptive statistics has been given in the Module 1 of the Biostatistics series (Hazra et al ., 2016). We would encourage every researcher to embark on designing and collecting data on their own to go through this particular module to have a clear idea on how to proceed further.

Statistical methods

As briefly discussed earlier, the “methods” section should also include a detailed description of statistical methods. It is best to describe the methods for each objective.

For example: Which statistical methods will the researcher use to study the changes in PASI score over time?

It is important to first identify the nature of the outcome – will it be linear or categorical?

• It may be noticed that the PASI is a score and can range from 0 to 72. The researcher can measure the actual score and assess the changes in score. Thus, the researcher will use methods for statistical analysis of continuous data (such as means, standard deviations, t -test, or linear regressions)
• However, the researcher may choose to cut off the PASI score at 60 (of course, there has to be justification!) and call it severe psoriasis. Thus, the researcher will have an outcome variable with two outcomes (Yes: >60 PASI, and No: <60 PASI). Thus, in this case, the researcher will use methods for statistical analysis of categorical data (proportions, Chi-square test, or logistic regression models).

The statistical methods have been described in detail in the Biostatistics section of the series. The reader is encouraged to read all the sections to understand these methods. However, the key points to remember are:

• Identify the nature of the outcome for each objective
• Describe the statistical methods separately for each objective
• Identify the methods to handle confounding and describe them in the statistical methods
• If the researcher is using advanced statistical methods or specific tools, please provide reference to these methods
• Provide the name of the statistical software (including the version) that will be used for data analysis in the present study
• Do not provide a laundry list of all the statistical methods. It just shows that the researcher has not understood the relevance of statistics in the study design.

Multivariate models

In general, multivariate analyses are used in studies and research proposals. These analyses are useful to adjust for confounding (though these are also useful to test for interaction, we shall discuss confounding in this section). For example, we propose to compare two different types of medications in psoriasis. We have used secondary clinical data for this study. The outcome of interest is PASI score. We have collected data on the type of medication, age, sex, and alcohol use. When we compare the PASI score in these two groups, we will use t -test (if linear comparison) or Chi-square test (if PASI is categorized – as described earlier). However, it is possible that age, sex, and alcohol use may also play a role in the clinical progression of psoriasis (which is measured as PASI score). Thus, the researcher would like to account for differences in these variables in the two groups. This can be done using multivariate analytical methods (such as linear regression for continuous variables and logistic regression for categorical dichotomous variables). This is a type of mathematical model in which we include multiple variables: the main explanatory variable (type of drug in this study) and potential confounders (age, sex, and alcohol use in this study). Thus, the outcome (PASI score) after multivariate analyses will be “adjusted” for age, sex, and alcohol use after multivariate analysis. We would like to encourage the readers to consult a statistician for these methods.

TRIVIA: The singular for “data” is “datum,” just as “stratum” is the singular for “strata.” Thus, “ data were analyzed …,” “ data were collected …,” and “ data have been ….”

Clinical Record Forms

We have discussed designing of questionnaires and clinical record forms (CRFs) in detail in two modules. We shall just highlight the most important aspects in this part. The CRF is an important part of the research protocol. The CRF should include all the variables of interest in the study. Thus, it is important to make a list of all parameters of interest before working on the CRF. This can be done by a thorough review of literature and discussion with experts. Once the questionnaire/CRF has been designed, the researcher should pilot it and change according to the feedback from the participants and one's own experience while administering the questionnaire or recording data in the CRF. The CRF should use coded responses (for close-ended questions), this will help in data entry and analysis. If the researcher has developed a scale, the reliability and validity should be tested (methods have been discussed in earlier sections). The CRF can be paper based or computer based (it will depend on the resources).

It is very important to describe the ethics for the present study. It should not be restricted to “ The study will be evaluated by an Institutional Review Committee …” The researcher should demonstrate that s/he has understood the various ethical issues in the present study. The three core principles for ethics are: autonomy (the participants have a right to decide whether to participate in the study or opt out), beneficence/nonmaleficence (the study should not be harmful to participants and the risk–benefit ratio should be adequately understood and described), and justice (all the risks and benefits of the present study should be equally distributed).

The researcher should try to address these issues in the section of “Ethics.” Currently, the National Institutes of Health has proposed the following seven principles of “Ethics in Clinical Research:” social and clinical value, scientific validity, fair subject selection, favorable risk–benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects. The Indian Council of Medical Research has also published guidelines to conduct biomedical research in India. We strongly encourage the readers to be familiar with these guidelines. Furthermore, the researchers should keep themselves updated with changes in these regulations. If it is a clinical trial, the researcher should also be familiar with Schedule Y and Consent form requirements for these types of clinical trials.

Concluding Remarks

This module has been designed as a comprehensive guide for a dermatologist to enable him/her to embark on the exciting journey of designing studies of almost any kind that can be thought to be of relevance to clinical dermatology. There has been a conscious attempt to customize the discussion on design and analysis keeping not only dermatology, but also Indian conditions in mind. However, the module can be of help to any medical doctor embarking on the path to medical research. As contributors, it is our ardent hope that this module might act as a catalyst of good-quality research in the field of dermatology and beyond in India and elsewhere.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

Bibliography

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Utilize the "Customize Your Path" feature to refine the information displayed in myRESEARCHpath based on your role, project inclusions, sponsor or funding, and management center.

Develop the budget and justification

Need assistance with budgets or budget justifications?

Get help with budgets or budget justifications.

Contact the Office of Research Support (Provost Area or University Campus):

• Department specialist directory

Contact the Research Navigators (School of Medicine or School of Nursing):

• Email:  [email protected]

It is essential to the success of the project to carefully and accurately assess all of the financial needs of the research project, and to be able to justify the necessity of these expenses.  Developing an accurate budget can take time, particularly if the project includes Key Personnel from other departments, will involve external consultants, involves technologies or international activities, or includes sub-awards or agreements with other institutions or partners. 

Principal investigators (PIs) should work closely with their grant manager or financial practice manager as early as possible when developing budgets and justifications. PIs should contact [email protected] to find out who to contact or if they do not have departmental resources available.

Budgeting personnel effort and salary

For all personnel on the research project, budgeted effort must be adequate to complete the responsibilities associated with the scope of work. 

• Access the Budget and manage effort commitments page for additional information and special considerations for effort commitments. 

Additional guidance

• Access the ORS guide on  salaries and wages .
• Access the Plan the project or methodology page to connect to support offices about appropriate effort needs in the project's budget.
• Access the Design analysis plan page to connect to support offices about appropriate statistical support needs in the project's budget. 
• Access the Hire and engage personnel, students, and volunteers  page for information about the hiring process and allowable activities by role.

Institutional Base Salary (IBS) is the basis for both calculating salaries when developing a proposal budget and for managing effort on a funded project regardless of the appointment type (9 months, 10 months, 12 months). All salary costs applied to sponsored projects are based on the total amount of effort available after taking into account other commitments in support of Duke University activities only. These activities may include instruction, research, administrative activities (committees, chair, director, etc.), and clinical trials and exclude supplemental/extraordinary pay, outside consulting, and study section honoraria.

Duke Appointment Model

Effective July 1, 2022, Duke University School of Medicine (SoM) and School of Nursing (SoN) implemented a Faculty Appointment Model which represents a faculty member’s efforts in support of Duke University as a percent of 12 calendar months.

SoM and SoN Faculty will have 100% appointments unless they also have additional professional effort that includes: outside clinical obligations (PDC), VA Appointments, formally approved Flexible Work arrangements, direct-paid DKU Appointments, direct-paid NUS Appointments, or other reduced schedules.

Access guidance and resources about the Duke Appointment Model .

Campus faculty appointments are generally 9-month appointments with the ability to recover up to, but no more than, 3 summer months. (An academic year runs from September to August and is not tied to the Duke fiscal year.) Duke spreads the 9-month IBS across the 12-month fiscal year, which can impact the calculation of 1 month.

Converting person months

A “person month” is the metric for expressing the effort (amount of time) principal investigators (PIs), faculty and other key personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year (CY), academic year (AY), and/or summer term (SM); and the organization’s definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment. Access this guide to  calculating person months .

As of September 2021, SAP salary and effort information feeds into SPS so that all relevant parties working on grant applications can access salaries for individuals participating in research.

For step-by-step guidance and how-to videos on entering salaries in SPS, visit the  Managing Salaries in SPS guide . This is mandatory training for SOM/SON SPS users with editing/viewing rights.

Additional budget and cost considerations

When developing the budget, consider how each proposed cost relates to the scope of work of the proposed project.

Types of costs that should be included in a proposal for funding:

Fringe benefits

Subrecipients, subawards, vendors and consultants, equipment costs.

• Access the  Determine compute and data storage solutions  page to connect with support offices about budget needs for data storage and computing.
• Access the  Find equipment, resources, and Service Centers   page to connect with support offices about budget needs for equipment and utilizing Duke Service Centers. 

Supplies and materials

Travel costs.

• May include participation in conferences to present project specific results

Conference related costs

• Primary purpose is the dissemination of technical information
• Must be necessary and reasonable for the successful performance of the award and managed to minimize costs to the award
• Allowable costs may include rental of facilities, speakers’ fees, costs of meals and refreshments, local transportation, and other items incidental to the conference
• Refer to Code of Federal Regulations Part 200 and specifically, §200.432 Conferences for additional information

Participant support costs

Participant incentives.

To connect with support offices about budget needs for participant compensation and recruitment costs visit the  Participant recruitment, retention, and engagement  page. 

Other direct costs

• equipment and computer maintenance or user fees
• extended warranties for equipment
• publication costs and page charges
• photocopying
• communication costs such as long-distance telephone and facsimiles
• fees for shared resources
• incentives for human subjects
• tuition remission

Cost sharing

Funder-specific guidance on budgets and justifications.

Select the type of project for more detailed guidance on developing a research budget and preparing a budget justification:

Commercial or industry sponsored clinical trial budgets

• Work with the business manager for all commercial or industry sponsored non-clinical trial budgets. Additional guidance coming soon!

Federally sponsored budgets

Foundations and other budgets.

Developing the budget can be an involved process - particularly if the project includes complexities. 

Common complexities include:  

personnel from other departments   

external consultants 

technology development  

international activities 

sub-awards or agreements with collaborators at other institutions or organizations 

Most sponsors provide guidelines and/or specific forms for budget preparation.  Duke also provides guidance and resources to help investigators ensure that all project costs are 1) budgeted accurately based on the needs of the project and 2) used in accordance with the approved budget. 

The best advice to avoid common errors in budgeting is: 

Start early and seek guidance.   Work with you grants administrator, research development professional, foundation relations representative, or myRESEARCHnavigators early in the process to understand the costs needed for the proposed activities. Begin developing the budget as early as possible. 

Ensure Costs are Budgeted Compliantly.   Costs may vary widely based on the type of project, sponsor, and resources required to conduct the work. Carefully and accurately assess all financial needs of the project and be able to justify the necessity of the costs. The following general principles described in the  Uniform Guidance  apply generally to costs budgeted in Duke sponsored activities: 

Allowable – a cost is allowable if it 1) is necessary and reasonable for the performance of the project, 2) is verifiable with sufficient detail and supporting documentation, 3) conforms to any limitations by the sponsor  Allocable – a cost is allocable if it 1) is necessary to carry out the activities of the project and 2) is assignable to the project (at least in part) with a high degree of accuracy  Reasonable – a cost is reasonable if it 1) does not exceed what is generally recognized as ordinary and necessary for the proper and efficient performance of the project and 2) does not exceed in its nature an amount that which would be incurred by a prudent person in like circumstances  Consistently-treated – for federally funded budgets, a cost may not be assigned as a direct cost if any other cost for the same purpose in like circumstances has been allocated as an indirect cost 

Be a good steward of Duke’s grant funding.   When accepting funds from external sponsors, Duke agrees to follow rules and regulations and to comply with sponsor terms and conditions. 

As a non-profit institution, it is not within Duke’s mission to seek profit from its research activities; therefore, it is important that the budget represent true costs necessary to conduct the work.  All project costs should be included in the budget and be expended within the project period of the award.  To ensure proper accounting of project costs, verify all project expenses are allocated during the project period and to the appropriate funding source.  You can access financial reports for your funded projects by visiting  myRESEARCHhome  and navigating to the myReports widget.  Here you will find various reports ranging from summary financial data to fund balances to expense projections and more. The information in these reports will reflect planned expenses or changes that have not been entered in Duke’s financial systems, so make sure you are working closely with your grant administrator for the most accurate financial information. 

For foundation budgets, please be in touch with the appropriate Foundation Relations office:

• Office of Foundation Relations  (Campus Schools or Provost Area)
• Office of Foundation Relations and Strategic Partnerships at Duke Health  (School of Medicine or Nursing)

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Appendix C: Sample Budget Justification

Costs for project budgets - appendix c.

The budget justification is one of the most important non-technical sections of the proposal, and it is often required by the sponsor. In this section, the Principal Investigator (PI) provides additional detail for expenses within each budget category and articulates the need for the items/expenses listed. The information provided in the budget justification may be the definitive criteria used by sponsor review panels and administrative officials when determining the amount of funding to be awarded.

The following format is a sample only; not all components will apply to every proposal. Many sponsors prefer that budget justifications follow their own format. In all cases, however, it is best to present the justification for each budget category in the same order as that provided in the budget itself.

Salaries and Wages:

Note: The quantification of  unfunded  effort (e.g., "The PI will donate 5% effort...") in the proposal narrative, budget, or budget justification is considered Voluntary Committed Cost Sharing. This is a legal commitment which must be documented in the University's accounting system. Consider quantifying effort  only  for the requested salary support. See  http://www.dfa.cornell.edu/treasurer/policyoffice/policies/volumes/academic/costsharing.cfm  for additional information.

• Principal Investigator:  This proposal requests salary support for _______% of effort during the academic year and 100% of effort for _______months during the summer.
• Other Professional Support:  List title and level of effort to be proposed to be funded. Other personnel categories (Research Associates, Postdoctoral Associates, Technicians) may be included here.
• Administrative and Clerical:  List the circumstances for requiring direct charging of these services, which must be readily and specifically identifiable to the project with a high degree of accuracy. Provide a brief description of actual job responsibilities, the proposed title, and the level of effort. (See note at the end of this Appendix regarding direct charging costs that are normally considered indirect.)
• Graduate Students:  List number and a brief description of project role. Include stipend, GRA allowance (tuition), and health insurance.
• Undergraduate Students:  List number and a brief description of project role.
• Employee Benefits have been proposed at a rate of ______% for all non-student compensation as approved by the Department of Health and Human Services. See  https://www.dfa.cornell.edu/capitalassets/cost/employee .

Capital Equipment:  The following equipment will be necessary for the completion of the project: Include item description(s), estimated cost of each item, and total cost. Provide a brief statement on necessity and suitability.

Travel:  For each trip, list destination, duration, purpose, relationship to the project, and total cost. Indicate any plans for foreign travel.

Technical Supplies and Materials:  Include type of supplies, per unit price, quantity, and cost. When the cost is substantial, provide a brief statement justifying the necessity.

Publications:  Page charges (number of pages multiplied by the per-page charge).

Services:  Include type of services, cost per type, and total cost.

Consultants : Include the consultant's name, rate, number of days, total cost per consultant, and total consultant cost. Provide a brief statement outlining each individual's expertise and justifying the anticipated need for consultant services. Note: Justifying a specific consultant in the proposal may avoid the need to competitively bid consulting services.

Subcontracts:  Include the subcontractor's name, amount, and total cost. Provide a brief description of the work to be performed and the basis for selection of the subcontractor. A separate budget and corresponding budget justification should be completed by the subcontractor, and is required by many agencies. Note: Justifying a specific subcontractor in the proposal may avoid the need to competitively bid subcontracted services. Post-award changes to subcontracts (additions, deletions, scope or budget modification) may require sponsor approval.

Other Expenses:  May include conferences and seminars (see  Appendix D ), Repair and Maintenance, Academic and User Fees.

Facilities and Administrative Costs (F&A) : F&A costs have been proposed at a rate of _____% of Modified Total Direct Cost (MTDC) as approved in Cornell's rate agreement with the Department of Health and Human Services. A copy of this agreement may be found at  https://www.dfa.cornell.edu/capitalassets/cost/facilities . MTDC exclusions include Capital Equipment, GRA Allowance and Health Insurance, and Subcontract costs in excess of $25,000 per subcontract.

Annual escalations are proposed in accordance with University policy as outlined HERE .

Special information for direct charging costs that are normally considered indirect.  Many costs such as administrative and clerical salaries, office supplies, monthly telephone and network charges, general purpose equipment, and postage are not typically considered direct costs. These may be proposed as direct costs where "unlike and different" circumstances exist. In such cases a budget justification detailing the request must be submitted to OSP for review and approval. Please read the University policy at  https://www.dfa.cornell.edu/sites/default/files/policy/vol3_14.pdf  or contact your  Grant and Contract Officer  for additional assistance.

Overview of Costs for Project Budgets (Budget and Costing Guide)

Appendix a: sample budget format showing major categories, appendix b: facilities and administrative (f&a) cost calculation detail, appendix d: sample budget for conferences and seminars, appendix e: cost sharing allowability matrix.