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Writing a Research Strategy

This page is focused on providing practical tips and suggestions for preparing The Research Strategy, the primary component of an application's Research Plan along with the Specific Aims. The guidance on this page is primarily geared towards an R01-style application, however, much of it is useful for other grant types as well.

Developing the Research Strategy

The primary audience for your application is your peer review group. When writing your Research Strategy, your goal is to present a well-organized, visually appealing, and readable description of your proposed project and the rationale for pursuing it. Your writing should be streamlined and organized so your reviewers can readily grasp the information. If it's a key point, repeat it, then repeat it again. Add more emphasis by putting the text in bold , or bold italics . If writing is not your forte, get help.  For more information, please visit  W riting For Reviewers .

How to Organize the Research Strategy Section

How to organize a Research Strategy is largely up to the applicant. Start by following the NIH application instructions and guidelines for formatting attachments such as the research plan section.

It is generally structured as follows:

Significance

For  Preliminary Studies (for new applications) or a Progress Report (for renewal and revision applications).

• You can either include preliminary studies or progress report information as a subsection of Approach or integrate it into any or all of the three main sections.
• If you do the latter, be sure to mark the information clearly, for example, with a bold subhead.

 Helpful tips to consider when formatting:

• Organize using bold headers or an outline or numbering system—or both—that are used consistently throughout.
• Start each section with the appropriate header: Significance, Innovation, or Approach.
• Organize the Approach section around the Specific Aims.

For most applications, you need to address Rigor ous Study Design  by describing the experimental design and methods you propose and how they will achieve robust and unbiased results. See the NIH guidance for elaboration on the 4 major areas of rigor and transparency emphasized in grant review.  These requirements apply to research grant, career development, fellowship, and training applications.

Tips for Drafting Sections of the Research Strategy

Although you will emphasize your project's significance throughout the application, the Significance section should give the most details. The farther removed your reviewers are from your field, the more information you'll need to provide on basic biology, importance of the area, research opportunities, and new findings. Reviewing the potentially relevant study section rosters may give you some ideas as to general reviewer expertise. You will also need to describe the prior and preliminary studies that provide a strong scientific rationale for pursuing the proposed studies, emphasizing the strengths and weaknesses in the rigor and transparency of these key studies.

This section gives you the chance to explain how your application is conceptually and/or technically innovative. Some examples as to how you might do this could include but not limited to:

• Demonstrate the proposed research is new and unique, e.g., explores new scientific avenues, has a novel hypothesis, will create new knowledge.
• Explain how the proposed work can refine, improve, or propose a new application of an existing concept or method.

If your proposal is paradigm-shifting or challenges commonly held beliefs, be sure that you include sufficient evidence in your preliminary data to convince reviewers, including strong rationale, data supporting the approach, and clear feasibility. Your job is to make the reviewers feel confident that the risk is worth taking.

For projects predominantly focused on innovation and outside-the-box research, investigators may wish to consider mechanisms other than R01s for example (e.g., exploratory/developmental research (R21) grants, NIH Director's Pioneer Award Program (DP1), and NIH Director's New Innovator Award Program (DP2).

The Approach section is where the experimental design is described. Expect your assigned reviewers to scrutinize your approach: they will want to know what you plan to do, how you plan to do it, and whether you can do it. NIH data show that of the peer review criteria, approach has the highest correlation with the overall impact score. Importantly, elements of rigorous study design should be addressed in this section, such as plans for minimization of bias (e.g. methods for blinding and treatment randomization) and consideration of relevant biological variables. Likewise, be sure to lay out a plan for alternative experiments and approaches in case you get uninterpretable or surprising results, and also consider limitations of the study and alternative interpretations. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of select agents should appear in the Select Agent Research attachment.  Consider including a timeline demonstrating anticipated completion of the Aims. 

Here are some pointers to consider when organizing your Approach section:

• Enter a bold header for each Specific Aim.
• Under each aim, describe the experiments.
• If you get result X, you will follow pathway X; if you get result Y, you will follow pathway Y.
• Consider illustrating this with a flowchart.

Preliminary Studies

If submitting a new application to a NOFO that allows preliminary data, it is strongly encouraged to include preliminary studies.  Preliminary studies demonstrate competency in the methods and interpretation. Well-designed and robust preliminary studies also serve to provide a strong scientific rationale for the proposed follow-up experiments. Reviewers also use preliminary studies together with the biosketches to assess the investigator review criterion, which reflects the competence of the research team. Provide alternative interpretations to your data to show reviewers you've thought through problems in-depth and are prepared to meet future challenges. As noted above, preliminary data can be put anywhere in the Research Strategy, but just make sure reviewers will be able to distinguish it from the proposed studies. Alternatively, it can be a separate section with its own header.

Progress Reports

If applying for a renewal or a revision (a competing supplement to an existing grant), include a progress report for reviewers.

Create a header so reviewers can easily find it and include the following information:

• Project period beginning and end dates.
• Summary of the importance and robustness of the completed findings in relation to the Specific Aims.
• Account of published and unpublished results, highlighting progress toward achieving your Specific Aims.

Other Helpful Tips

Referencing publications.

References show breadth of knowledge of the field and provide a scientific foundation for your application. If a critical work is omitted, reviewers may assume the applicant is not aware of it or deliberately ignoring it.

Throughout the application, reference all relevant publications for the concepts underlying your research and your methods. Remember the strengths and weaknesses in the rigor of the key studies you cite for justifying your proposal will need to be discussed in the Significance and/or Approach sections.

Read more about Bibliography and References Cited at Additional Application Elements .

Graphics can illustrate complex information in a small space and add visual interest to your application. Including schematics, tables, illustrations, graphs, and other types of graphics can enhance applications. Consider adding a timetable or flowchart to illustrate your experimental plan, including decision trees with alternative experimental pathways to help your reviewers understand your plans.

Video may enhance your application beyond what graphics alone can achieve. If you plan to send one or more videos, you'll need to meet certain requirements and include key information in your Research Strategy. State in your cover letter that a video will be included in your application (don't attach your files to the application). After you apply and get assignment information from the Commons, ask your assigned Scientific Review Officer (SRO) how your business official should send the files. Your video files are due at least one month before the peer review meeting.

However, you can't count on all reviewers being able to see or hear video, so you'll want to be strategic in how you incorporate it into your application by taking the following steps:

• Caption any narration in the video.
• Include key images from the video
• Write a description of the video, so the text would make sense even without the video.

Tracking for Your Budget

As you design your experiments, keep a running tab of the following essential data:

• Who. A list of people who will help (for the Key Personnel section later).
• What. A list of equipment and supplies for the experiments
• Time. Notes on how long each step takes. Timing directly affects the budget as well as how many Specific Aims can realistically be achieved.

Jotting this information down will help when Creating a Budget  and complete other sections later.

Review and Finalize Your Research Plan

Critically review the research plan through the lens of a reviewer to identify potential questions or weak spots.

Enlist others to review your application with a fresh eye. Include people who aren't familiar with the research to make sure the proposed work is clear to someone outside the field.

When finalizing the details of the Research Strategy, revisit and revise the Specific Aims as needed. Please see Writing Specific Aims . 

comments Want to contact NINDS staff? Please visit our Find Your NINDS Program Officer page to learn more about contacting Program Officer, Grants Management Specialists, Scientific Review Officers, and Health Program Specialists.

Research Proposal

Purpose of the proposal

The research proposal is the initial plan of your thesis project and is written in conjunction with both your NIH and U.K. mentors during August and September during your time at the NIH. The research proposal is your own work. It is essential that all principal parties involved in your research achieve initial agreement on the scope of the thesis project. Writing the research proposal:

• Focuses the attention on the entire research project, not just the next experiment.
• Ensures that a comprehensive review of the literature is conducted.
• Establishes an agreement with both mentors on the scope of the thesis.
• Begins development of technical writing skills.
• Begins development of grant writing skills.

The research proposal also pushes you to think about what is known in the field, how you will contribute new information, and what logical steps must be taken to accomplish your research goals. Students are strongly advised to incorporate alternative strategies to accomplish their research goal.

Format of the research proposal

The proposal length should be no fewer than five pages and no more than ten, excluding tables, figures and references. The proposal should be clear and concise and contain specific aims of what you plan to accomplish during your thesis research.

• Actually quite important - searched and indexed
• Creates an initial impression  
• Can be thought of as a mini-proposal
• Written for a more general audience
• Written last but NOT at the last minute  
• State the explicit hypotheses and how they will be tested
• A bullet point approach is very effective to articulate exactly what you plan to do - it may include a small elaboration
• Often includes a mini-introduction
• Often the "make or break" section for proposals that go through a grant review process
• Typically 2 to 4 specific aims for a thesis
• Success of your work will be measured against whether you accomplish the aims
• Also plays the role of "tell them what you are going to tell them"  
• Sets up the "story" you want the reader to read - lead them toward your research vision
• Establishes you as an authority/ i.e. one who is well-read on the topic
• Shows that you are cognizant of the most important work already published on the topic
• Establishes for the reader the importance of the work
• Helps the reader understand the logical next steps of your specific aims
• Focuses more on what has been done, but also allows for your contributions or unique perspectives  
• Demonstrates that you are capable of deploying the proposed research methods
• Shows the quality and quantity of data already acquired
• Continues to build the case for the feasibility and logic of your proposal
• Include relevant small tables and figures as needed
• Larger data sections can be added as appendices  
• Explains the methodologies to be used to accomplish the aims
• Two separate areas must be covered; these may be interwoven or presented as distinct sections
• Conceptual and experimental design
• Details of the methods
• Should be tied absolutely and unmistakably to specific aims
• Should acknowledge potential barriers and pitfalls and how you plan to get around them
• If you are testing alternative hypotheses, make it very clear how the experiments will differentiate between them  
• Choose carefully - more is not necessarily better
• Important to have a balance between papers of historical importance and more current developments in the field  

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In this video, Annette Rid and Robert Steel offer guidance on how to develop a research proposal for one of the Department's programs that provide training in bioethics research. The video focuses on developing a bioethics research question, while also offering some practical tips for writing a research proposal. It is targeted at people with little, if any, prior training in bioethics research.

In this folder , you can access publications from our Department that illustrate the different kinds of bioethical research questions and methods discussed in the video. You can also find the slides and an overview of “key moments” in the video, in case you are interested in viewing selected sections of the video only. Finally, you can access the template for describing your bioethics research project, if you are interested in applying for training opportunities in our Department that require submission of a bioethics research project proposal.

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NCCIH Research Blog

Targeting and developing your clinical research proposal.

May 4, 2018

Wendy J. Weber , N.D., Ph.D., M.P.H.

Branch Chief

Clinical Research in Complementary and Integrative Health Branch

National Center for Complementary and Integrative Health

View biographical sketch

If you’re planning to apply for an NCCIH grant for research involving human participants and will be attending the International Congress on Integrative Medicine and Health (ICIMH) , this Pre-Congress Workshop may be for you: “Honing Your Clinical Research Proposal for NIH and NCCIH Funding Opportunities.” It’s scheduled for Tuesday, May 8 from 2 to 5 p.m.

The symposium will cover NCCIH’s human subjects research priorities, available funding opportunities available, and review the significant recent changes to the National Institutes of Health’s (NIH) clinical trial policies, application forms, and review criteria. (Blog posts about those changes were published in May and September , 2017.)

Speakers will include:

• Dr. Emmeline Edwards, Director of NCCIH’s Division of Extramural Research (DER), will provide an overview of NCCIH’s strategic priorities for human subjects research.
• Dr. Wendy Weber, Acting Deputy Director of NCCIH and Chief of the Clinical Research in Complementary and Integrative Health Branch in the Center’s Division of Extramural Research (DER) will speak on NIH’s recent policy changes for clinical trials.
• Dr. Dave Clark, a program director in NCCIH’s Clinical Research Branch, will talk about NCCIH research funding opportunities focused on clinical outcomes.
• Dr. Wen Chen, NCCIH’s Acting Branch Chief for Basic and Mechanistic Research, will talk about NCCIH’s mechanism-focused clinical research funding opportunities.
• Dr. Martina Schmidt, Chief of NCCIH’s Office of Scientific Review, will explain the changes in NIH’s grant application forms and how they affect the review process.

After the presentations, participants will split into small groups for discussion and Q&A on how to interact with NCCIH staff to find the best funding opportunity for the research you want to conduct, how to shape your aims to be responsive to NCCIH funding opportunities, and what to include in your application to address the review criteria. Small group themes will be (1) clinical outcomes research and (2) human basic and mechanistic research.

We hope you will join us! We think you’ll find this session very informative, and the panelists look forward to answering your questions.

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NIH & NIAID Sample Applications & Other Documents

Several NIAID investigators have graciously agreed to share their exceptional applications and summary statements as samples to help the research community. Refer to  NIAID's Application Samples webpage to see the full list of available sample applications, attachments, summary statements, forms, sharing plans, letters, emails, and more.  

The text of these applications is copyrighted. You may use it only for nonprofit educational purposes provided the document remains unchanged and the PI, the grantee organization, and NIAID are credited.

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Advancing Disability Research Through Community Engagement

July is Disability Pride Month, an opportunity to honor the history, achievements, experiences, and struggles of those with disabilities. This observance commemorates the July 1990 enactment of the Americans with Disabilities Act (ADA) , the federal civil rights law that prohibits discrimination against people with disabilities.

This year’s theme, We Want a Life Like Yours , reflects dreams for life experiences that people with disabilities are too often denied. We still have much to do to counter ableism—discrimination and social prejudice against people with physical, intellectual, and developmental disabilities.

As I discussed last fall , ableism is a major contributor to the health disparities experienced by people with disabilities. NICHD is committed to understanding the impact of ableism on health outcomes. Grants for research seeking to understand and mitigate health disparities caused by ableism are expected to be awarded later this summer.

We are also working to enhance community involvement in research. Becoming involved with scientific research empowers those with disabilities to take an active role in their health and the health of future generations. It also helps to ensure that the research questions asked will yield useful and applicable results. 

Recently, I have been particularly encouraged by the progress we are making in Down syndrome research, aided by community participation. People with Down syndrome, which results from having an extra copy of chromosome 21, are at risk for many other health conditions, including autoimmune disorders and Alzheimer’s disease.

Since its launch in 2013, NICHD’s DS-Connect ® : The Down Syndrome Registry has recorded important health data from nearly 6,000 people with Down syndrome. Last month, we announced selection of a new service provider to manage and improve this online registry . Data from DS-Connect ® have been instrumental for designing and recruiting for research studies, particularly those funded by NIH’s INCLUDE Project .

The INCLUDE Project, which started in 2018, seeks to further enhance inclusion of people with Down syndrome in research to examine their health and quality-of-life needs. This research also promises to improve knowledge about conditions affecting the general population. For example, researchers have found that Alzheimer’s progression in Down syndrome appears similar to other genetic, early onset forms of the disease .

Other INCLUDE-supported work has shed light on the factors underlying the symptoms and characteristics of Down syndrome. Chromosome 21 includes genes providing instructions for four interferon receptors—proteins that are critical for regulating the immune system. The extra copies of these genes in people with Down syndrome boost interferon signaling.

To delve into the link between interferon signaling and Down syndrome symptoms , investigators used genome editing to remove the extra interferon receptor genes from a mouse model of Down syndrome. Deleting these extra genes prevented heart malformations, attenuated developmental delays, and improved cognition in the mice, among other features. Although the findings have yet to be validated in people, they suggest that the additional interferon receptor genes contribute to many of the characteristics of Down syndrome.

In this context, the INCLUDE Project is funding a clinical trial evaluating whether tofacitinib, a drug that blocks interferon signaling, can safely improve immune skin conditions common in people with Down syndrome , including eczema, psoriasis, and vitiligo. Led by researchers at the University of Colorado Denver, the study also will assess the effect of tofacitinib on participants’ cognition and quality of life.

Understanding Down syndrome and other intellectual and developmental disabilities is part of the reason NICHD was established, and I am inspired by the progress being made through the INCLUDE Project and other programs. Inclusion of people with disabilities across the research enterprise—as leaders and members of the scientific workforce and as clinical research participants—is critical to ensuring that studies reflect the needs and desires of the people they seek to benefit. I look forward to further advances to benefit those with the intellectual, developmental, and physical disabilities that fall within NICHD’s purview.

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Monkeypox: House Investigators Find NIH Hiding Risky Viral Gain-of-Function Research

Dr. David Morens, seen here at a House subcommittee hearing on May 22, sought to sidestep FOIA requests for his emails relating to the origins of COVID-19. (Andrew Harnik/Getty Images)

Can there any longer be any doubt?

The behavior of senior officials at the National Institute of Allergy and Infectious Diseases, the powerful federal agency formerly run by Dr. Anthony Fauci, is intolerable.

And the performance of the Department of Health and Human Services in response to legitimate congressional inquiries has been abysmal.

The latest evidence comes to us courtesy of the House Energy and Commerce Committee. The committee recently released an interim staff report on its lengthy investigation into the NIAID-approved gain-of-function research into the MPXV, a virus that causes the deadly disease commonly known as monkeypox .

Gain-of-function research is laboratory research deliberately designed to enhance the virulence and the transmissibility of a pathogen. According to the House committee’s report, the National Institutes of Health and NIAID misled lawmakers for more than 17 months before handing over proof that they approved gain-of-function experiments to be performed on the monkeypox virus.

Dangerous Pathogen

America experienced a brief monkeypox scare in 2022 and 2023. While the infection had limited transmissibility and was thus contained, the virus is nonetheless a dangerous pathogen. The West African-based variant of the virus, which circulated in the U.S., was less lethal, however, than the Congo-based variant, which was both more transmissible and deadly.  

In September 2022, Science published an article in which a Dr. Bernard Moss was interviewed about his research on MPXV. In the October 2022 edition of Science, some scientists expressed concern that Moss’ research, if completed, could have created “a more potent version of the mpox outbreak strain,” which “could spark an epidemic that would be substantially more lethal.”

House members acted quickly.

In October 2022, the committee began investigating potential gain-of-function research into monkeypox that may have been conducted by Moss.

According to the September 2022 issue of Science, Moss had been swapping genes between two groups of organisms—“clades”—thought to have a common ancestor: clade 1 MPXV (the Congo variant), which is “lethal to more than 10 percent of the unvaccinated humans,” and the more transmissible but less deadly clade 2 MPXV (the West African variant).

Though Moss swapped genes from clade 2 into clade 1 in hopes of making it less deadly, Moss—according to the Science article—was also “planning to try the opposite, endowing clade 2 virus with genes from its deadlier relative.”

That type of experiment would qualify as gain-of-function research, thus making a deadly pathogen even more deadly to humans.

Hiding Information

It was not until March of this year that congressional investigators confirmed that Moss had, in fact, submitted a proposal to the NIH Institutional Biosafety Committee to conduct a “bidirectional transfer of genes between clades I and II of the MPXV.”

The biosafety committee had, in fact, approved that proposal on June 30, 2015, nearly nine years before investigators started their inquiry. According to the interim report , “HHS and the NIH misled the Committee in official written correspondence about the MPXV gene-transfer experiment on no fewer than five occasions over the course of 17 months.”

This deception, in the language of the report, was not only “unacceptable,” but also “potentially criminal.”

The bureaucrats’ behavior was positively weird.

It’s still not clear whether the NIAID-approved gain-of-function monkeypox experiments were, in fact, ever conducted—and NIAID officials repeatedly denied that they were carried out. Congressional investigators note, however, the NIH repeatedly refused to provide any documentary evidence that would back up their claims.

If there was nothing to hide, why the stubborn noncooperation?

So, it appears that NIH/NIAID officials simply refused lawmakers’ repeated requests for information over a 17-month period for no other reason than to evade legitimate congressional oversight. 

Concerning controversial viral gain-of-function experiments, the congressional staff investigators thus concluded : “NIAID cannot be trusted to oversee its own research of pathogens responsibly … or “be trusted to honestly communicate with Congress and the public … .”  

Chalk up another self-inflicted black eye for public health.  

Cover-Up Specialists

This latest NIH and NIAID scandal comes on the heels of reports of NIH’s poor oversight of controversial grant funding in China and in the wake of damaging revelations that Dr. David Morens, then a senior adviser to Fauci, went to great lengths to evade Freedom of Information Act inquiries relating to the origins of COVID-19, using personal emails to evade the disclosure of communications related to the origins of the pandemic and taxpayer funding for EcoHealth Alliance, the controversial firm that engaged China’s Wuhan Institute of Virology as a subcontractor.

The Wuhan Institute, which had been working closely with the Chinese military, was the epicenter of Communist China’s notorious and risky coronavirus research. Finally, HHS disbarred both EcoHealth Alliance and the Wuhan Institute from securing federal grant funding for at least three years.

Worse, according to Morens’ own February 2021 email, he was assisted in evading FOIA requests by the very person responsible for enforcing the law, Marg Moore, who heads up the NIH FOIA office: “I learned from our foia lady here how to make emails disappear after I am foia’d but before the search starts, so I think we are all safe. Plus, I deleted most of those earlier emails after sending them to Gmail,” he wrote.

After The Nation, a leftist journal, inquired into the status of Morens and Moore, the HHS resorted to standard bureaucratese about its commitment to the rule of law, responding: “HHS doesn’t comment on personnel matters.”    

In its report on the monkeypox experiment, congressional investigators concluded :

NIAID has a culture of secrecy and obfuscation regarding experiments involving pandemic and potential pandemic pathogens. HHS and the NIH are complicit in enabling NIAID’s culture of secrecy and obfuscation. This is incompatible with accountable, democratic governance and further erodes the public’s trust in government health agencies. 

Congress needs to get tough with NIH and should consider key interim staff recommendations: remove final approval of sensitive viral gain-of-function research from NIH and NIAID and consider vesting final review and perhaps veto authority over any such project in an independent body, and require any taxpayer-funded institutions that conducts research into “potentially dangerous” pathogens also to be subject to  independent oversight boards and to operate at the highest levels of lab biosafety.

Beyond that, House Energy and Commerce Committee Chairwoman Cathy McMorris Rodgers, R-Wash., has launched a broad “framework” for discussion on comprehensive NIH reform. The goal would be to streamline an overly complex organization, improve the research approval process, and facilitate better congressional oversight.

As analysts at The Heritage Foundation have detailed, the federal government’s performance during COVID-19 has damaged its standing with millions of Americans. Federal officials’ continued lack of transparency concerning the COVID-19 pandemic, mixed messaging on masks and counterproductive vaccine mandates, unscientific edicts and pronouncements, along with the repeated and scandalous refusals to respond to legitimate congressional inquiries, have all contributed to a serious loss of public trust.

In an age when global viral contagions can kill millions of people at home and abroad, America cannot afford such a loss of faith in the public health agencies whose job it is to protect them. Popular cynicism could prove deadly.

Related posts:

• What Are NIH Officials Hiding?: Fauci to Testify on America’s Response to COVID-19
• In COVID-19 Oversight, House Republicans Deliver a Win for Accountability
• Why Fauci’s House Testimony Created Fireworks

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How to plan and write a budget for research grant proposal?

Medical research can have an enormous positive impact on human health. Health research improves the quality of human lives and society which plays a vital role in social and economic development of the nation. Financial support is crucial for research. However, winning a research grant is a difficult task. A successful grant-winning application requires two key elements: one is an innovative research problem with best probable idea/plan for tackling it and appropriate planning of budget. The aim of the present paper is to give an insight on funding agencies providing funding for health research including traditional Indian medicine (from an Indian perspective) and key points for planning and writing budget section of a grant application.

1. Introduction

Why health science research is important and why should it to be funded? Science and technology innovations and health research can have an enormous impact on human health. They improve public health, quality of human lives, longevity and have made society better [1] , [2] . Healthy humans with better quality of life are crucial for the social and economical development of the nation [3] . Medical research led to the expansion of knowledge about health problems/conditions and their mechanism, risk factors, outcomes of treatments or interventions, preventive measures and proper management. Clinical studies or trials provide important information about the safety and efficacy of a drug/intervention. Innovative basic science research had led to the discovery of new technology, efficient diagnostic and therapeutic devices. So, currently, an effort with multidisciplinary approach is a demand for better understanding of clinical conditions and providing safest health care to the community [2] , [4] .

Whether it is basic or applied, clinical or non-clinical, all research needs financial support. Considering the importance of research in economic growth of a nation, many countries are increasing their budget for research and development in science. A study on impact of GDP (Gross Domestic Product) on research and development in science among Asian countries has found that one who spends more on research has more research outcomes in the form of total number of research documents, citations per documents and h-index [5] . About 95% of the NIH (National Institutes of Health, USA), budget goes directly to research awards, programs, and centers; training programs; and research and development contracts [6] . Total expenditure carried out for research in India is too less than USA and China. Percentage of GDP for research and development in India is 0.88%, while South Korea, USA and China have 4.292%, 2.742 and 2.1% respectively [7] .

Owing to the increasing competition among the researchers, especially the young ones, for their academic growth, preparing and planning a winning research proposal becomes very essential. A successful grant-winning application requires two key elements: (1) innovative research problem with best probable idea/plan for tackling it and (2) appropriate planning of budget. The aim of the present paper is to give an insight on funding agencies (from an Indian perspective) and key points for planning and writing budget section of a grant application.

2. What is the purpose of the budget plan in a grant application?

A budget is the quantitative expression of a financial plan for future expenses on the project in a given period of time [8] . Budget plan is a key element of a grant application. It demonstrates the required cost for the proposed project. It is a prediction of expenses and serves a plan for funders on how the organization will operate the project, spend the money in a given set of period and where their money will go. It shows the funders exactly what they can support and also helps the institution and investigating team in management of the project. Moreover, budget plan requires for accountability [9] .

3. Which are the funding agencies that sponsor health research in India?

Various national and international sponsoring agencies have identified health problems of priority for funding a research. Some of the leading funding agencies providing grant for health research including alternative systems of medicine in India are given in Table 1 . State Universities/deemed Universities also have a provision of funding for medical research.

Table 1

List of funding agencies those promote health research.

4. What constitutes a research project budget?

Proforma of the research grant applications and presentation of budget section may vary among the sponsoring agencies. However, major parts of budget plan in the applications of the above mentioned funding agencies are quite similar. The budget section is broadly divided into two categories: direct and indirect costs.

4.1. Direct costs:

These are the costs incurred specifically to carry out a project [10] . Direct costs include expenses towards personnel, materials, equipments, consumables and travel. These particulars are further categorized into recurring and non-recurring expenses on the basis of their occurrence during the study period. A brief description of the sub-sections under direct cost is given below:

4.1.1. Personnel:

Budget for personnel can be mentioned in this section in case human resources are required for the study and as per funding agency guidelines. Salaries with allowances can be budgeted for human resources such as site manager, research assistant, junior research fellow (JRF), senior research fellow (SRF), research associate, technician, data entry operator and attender. Most of the Indian funding agencies do not have a provision for salaries for the principal investigator (PI) and co-investigators (Co-PI). Ministry of AYUSH [11] and Rajiv Gandhi University of Health Science (RGUHS), Karnataka [12] provide one-time minimal fees for investigators and supporting staff respectively. There is a provision for salaries of investigators in Wellcome trust-DBT India alliance grants [13] .

4.1.2. Recurring expenses:

Recurring expenses are those which are variable and which keep on occurring throughout the entire project duration. Particulars categorized in this category are consumables, chemicals, glasswares, laboratory test charges, diagnostic kits, stationery, prints, photocopies, communication, postage, telephone charges, survey tools, questionnaires, publication charges, reprints, binding etc. Other expenses could be allowances for patients/participants, food charges and physician fees.

4.1.3. Non-recurring expenses:

Non-recurring expenses are those which are one-time in nature or which do not recur at regular intervals. Particulars included in this category are equipments or instruments with its accessories, software's, computer, printer, electrical and electronic items and accessories of the existing instrument in your lab. Percentage of budget allocated for equipment varies among the funding agencies from 25% to 90% of the entire budget. Some of the agencies do not have provision for equipment in budget. Vision Group on Science and Technology allocated their maximum grant (up to 90%) for development of infrastructure of laboratories [14] .

4.1.4. Traveling expenses:

Budget allocated for traveling can be used for attending meetings, conferences, workshops and training programs. Foreign travel is not allowed by any Indian funding agency. Traveling expenses for collection of data, survey and visit to other centers in multicentric study can be budgeted in this sub-section.

4.2. Indirect costs:

These are the costs which cannot be directly attributed to specific expenses of a project, but are required to run a project. It is also termed as overhead charges. Laboratory, electricity, water, library and other facilities are provided by the institution to run a proposed research project. Therefore, a fixed cost (usually) of about 5–15% of the total budget is provisioned as institutional overhead charges which goes to the institution directly. The range may, however, be flexible on the basis of the type of funding agency.

5. Budget justification

Most of the funding agencies require submission of a budget justification with all the items described above. Sometimes it is also called as budget narrative. Explanation of need for each line item in the budget with item-wise and year-wise breakdown has to be provided. Quantification of total costs of each line-item and document cost calculation should be done. When writing a budget justification, it is important to follow the same order as that in an itemized budget. For example, if equipment such as color doppler is required, then justify the need of a device with respect to the proposed methodology of the study. Similarly, for non-recurring expenses, breakdown the consumables item-wise and year-wise with its cost and calculation according to the protocol of the study and justify accordingly.

6. Budget summary

An item-wise and year wise summary of the total budget is usually required in most of the applications. Budget summary outlines the proposed grant and often (most of the format) appears at the beginning of the proposal. It should always be prepared at the end, after the grant proposal has been completely developed. A sample budget summary (as an example) for a proposed study for the duration of three years is shown in Table 2 . In the personnel section, a research fellow salary with allowances is budgeted year-wise. The salary of the research fellow for the first and second year is Rs. 2,30,000 per year (JRF) with an enhancement to Rs 2, 59,000 for the third year (SRF) as per the guidelines of the funding agency. As non-recurring expenses are one time in nature, a budget for equipment was budgeted only for the first year. Under the section of recurring expenses, more budgets are allocated in the second year for consumables because recruitment of subjects in large number will be done during the second year of the proposed study. Similarly, expenses toward travel, investigator fee and other miscellaneous costs year-wise have been budgeted. The emoluments and guidelines on service conditions for research personnel employed in research project by ICMR has been given in reference section [15] , [16] .

Table 2

Sample budget summary (year wise).

7. How to plan a simple research budget?

Planning of the research budget begins with an innovative research question, objectives and design of the study. Before starting to write a budget plan, it is essential to understand the expectations of funding agencies, University/Institute and the team of researchers. It is imperative to keep in mind that the research proposal will be reviewed by both scientific and financial (non-scientific) experts. Hence, the proposal should be prepared in such a way that it can be easily understood by even non-scientific experts.

Firstly, a list of what is essential and would add value for research such as focus of research, primary and secondary outcomes of the study, the source of the sample, study setting, sample design and sample size, techniques used to collect data, method of data analysis and available resources should be made [17] .

Secondly, the instructions, format of the application and rules of the funding agency should be read thoroughly. Budget specifications, limitations of recurring and non-recurring costs, and necessity of budget justification with cost breakdown should be checked. Note that one should not deviate or modify the proforma of the funding agency.

Thirdly, a list of items should be made and categorized into recurring and non-recurring expenses. Breakdown of the budget into item-wise and year-wise with cost calculation should be done. It should be ensured that costs are reasonable, allowable and related to the research proposal, so that the budget appears realistic. Travel expenses should be calculated as per the rules of the funding agency.

Fourthly, item-wise and year-wise justification of the requirement in a same sequence of format should be provided. A well-justified budget can enhance the evaluation of the research proposal by reviewers and funding body.

The last most important part is to review the budget and verify the costs and calculation. It is better, if other research team members can review the budget plan and re-calculate the costs thoroughly. Remember, too high budget and too low budget with respect to the research proposal are suspicious and chances of receiving a grant are less.

Sources of funding

Conflict of interest.

Peer review under responsibility of Transdisciplinary University, Bangalore.

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Highlighting Yale’s Neuroscience Research as NIH Budget Remains Uncertain

In an effort to better understand the impactful neuroscience research underway at Yale, Sen. Richard Blumenthal (D-CT) visited Yale School of Medicine (YSM) on June 26 for a tour of neuroscience laboratory facilities and a roundtable discussion with YSM researchers. His visit came at a crucial time as Congress begins making specific recommendations for the fiscal year (FY) 2025 budget, with National Institutes of Health (NIH) funding decisions of paramount importance for scientists at Yale and across the country.

One such recommendation came the very next day, June 27, when a subcommittee of the House Appropriations Committee approved a preliminary spending bill that would provide level combined funding for the NIH and the Advanced Research Projects Agency-Health (ARPA-H). But it would cut $1 billion from ARPA-H, potentially reallocating much of that funding among NIH institutes and centers. It is not clear whether some of that funding might help offset already-scheduled reductions in support for the “Brain Research Through Advancing Innovative Neurotechnologies” (BRAIN) initiative, a program that has a major impact on research done at Yale.

To go from a molecular discovery to a drug and a clinical trial takes more than 10 years, often closer to 20, and without continual and long-term support from the NIH, this kind of stuff can never happen. If funds are fluctuating year to year, things grind to a halt, and they can’t get restarted. Stephen Strittmatter, MD, PhD

The BRAIN budget already decreased by $278 million in the past year from FY 2023, a drop that reduced available funding for both new and existing grants. While the subcommittee’s recommendation, which also includes a significant reorganization of NIH, is far from the last word in what is always a complicated budget process, it is a signal of uncertain times ahead.

BRAIN grants have funded the projects of many of Yale’s neuroscientists, and more budget cuts would impede the pace of their research. These reductions are happening during a “critical state” for neuroscience research, said Michael Crair, PhD , vice provost for research and William Zeigler III Professor of Neuroscience at YSM, during Blumenthal’s visit. “It’s just now that we’re reaching the stage of developing therapeutics for many different disorders that impact the brain, and to pull back on NIH funding right when we’re reaping the benefits of many decades of research is tragic,” Crair explained.

A tour of Yale’s neuroscience facilities

Blumenthal began the morning with a tour of the shared laboratory space of Michael Higley, MD, PhD , associate professor of neuroscience, of biomedical engineering, and of psychiatry; and Jessica Cardin, PhD , associate professor and deputy chair of neuroscience, located in the new home of the Wu Tsai Institute at 100 College St. Andrew Moberly, PhD, a postdoctoral fellow in the shared lab space, showed Blumenthal neuroimaging technologies that he and his colleagues use to track brain activity in rodents. The technology monitors electrical activity in the brain by detecting light from neurons with genetically encoded fluorescent activity indicators. This allows the researchers to see in real time which areas of the brain are being used.

Moberly is using the technology to investigate how neural activity changes in response to negative stimuli, which may provide insights into the relationship between sensory processing and behavior. He was recently awarded an NIH Pathway to Independence K99/R00 award that supports postdoctoral researchers as they transition into securing independent faculty positions, and he hopes to be able to continue his work by looking at how stress can impact sensory processing, which may be helpful for understanding conditions like post-traumatic stress disorder.

Roundtable research discussion

After touring Higley and Cardin’s laboratory, Blumenthal was joined by Nancy J. Brown, MD , Jean and David W. Wallace Dean of the Yale School of Medicine and C.N.H. Long Professor of Internal Medicine, as well as a number of YSM neuroscience research faculty, for a roundtable discussion regarding the importance of NIH funding for their work.

In addition to Crair, members of the discussion included Lauren Sansing, MD, MS , professor of neurology; Nenad Sestan, MD, PhD , Harvey and Kate Cushing Professor of Neuroscience and professor of comparative medicine, of genetics, and of psychiatry; Anthony Koleske, PhD , deputy dean for research (basic science), Ensign Professor of Molecular Biophysics and Biochemistry, and professor of neuroscience; Serena Spudich, MD, MA , Gilbert H. Glaser Professor of Neurology and a director of the Yale Center for Brain & Mind Health (CMBH); Stephen Strittmatter, MD, PhD , Vincent Coates Professor of Neurology and chair and professor of neuroscience; David Hafler, MD , chair and William S. and Lois Stiles Edgerly Professor of Neurology and professor of immunobiology; Kevin Sheth, MD, professor of neurology and of neurosurgery and a director of CMBH; and Christopher Pittenger, MD, PhD , Elizabeth Mears and House Jameson Professor of psychiatry and a director of CMBH.

Sestan spoke about the technology he developed to reverse ischemic damage in pig brains up to an hour after death, work that has led to the creation of a biotech company in New Haven . The project would not have been possible without funding from the BRAIN initiative, Sestan said, emphasizing the priority that the initiative places on interdisciplinary work.

Sestan went on to explain the importance of NIH funding globally, discussing how the BRAIN initiative has set an example for other countries around the world to increase their funding for neuroscience research. “It’s a geopolitical statement, almost as much as improving our health,” he stated. Blumenthal agreed with the importance of scientific world leadership and the need to prioritize interdisciplinary work.

Strittmatter discussed his research on amyloid plaques in Alzheimer’s patients, work that has progressed from basic discovery all the way to clinical trials, with the NIH providing funding at every step. The research has also led to the development of startup biotech companies, which Strittmatter says have created new jobs for Connecticut residents.

The need for NIH support

“To go from a molecular discovery to a drug and a clinical trial takes more than 10 years, often closer to 20, and without continual and long-term support from the NIH, this kind of stuff can never happen,” Strittmatter said. “If funds are fluctuating year to year, things grind to a halt, and they can’t get restarted.”

Others mentioned how NIH funding had launched and nurtured their careers in a field where job stability is often uncertain, and referred to their NIH-supported research into areas such as viral infections in the brain, new therapies for stroke and dementia patients, and community treatments for substance abuse.

“This kind of research is exciting in terms of where it can take us in improving quality of life and length of life, but it also represents the danger of a huge missed opportunity if we fail to sustain funding and investment,” Blumenthal stated. “What I’ve seen here at Yale will inspire me to work and fight for additional federal investment. It’s imperative for our nation at this moment, and every bit as important as the hundreds of billions that we’re spending on defense.”

Featured in this article

• Nancy J. Brown, MD
• Jessica Cardin, PhD
• Michael Crair, PhD
• David A. Hafler, MD, FANA
• Michael J Higley, MD/PhD
• Anthony Koleske, PhD
• Andrew Moberly
• Christopher Pittenger, MD, PhD
• Lauren Hachmann Sansing, MD, MS, FAHA, FANA
• Nenad Sestan, MD, PhD
• Kevin Sheth, MD
• Serena Spudich, MD, MA
• Stephen Strittmatter, MD, PhD, AB

• Funding Opportunities

Clinical and Translational Science Research Program

The Clinical and Translational Science Collaborative (CTSC) CTS Research Program seeks letters of intent for 2–3-year Pilot Projects. The specific goal of the CTS Research Program is to support projects which promote health equity and reduce health disparities in chronic illness through the innovative use of technology. We are interested in proposals which are aligned with the overall goals of the collaborative including understanding health equity in addition to overcoming barriers to recruitment of underrepresented groups in clinical research, integration of community and stakeholder partners throughout the research process, and implementation of novel research programs in clinical and community settings in a manner that promotes health equity.

The technology itself needs not be innovative – it is the application of technology to populations. Examples of innovative uses of technology to improve health outcomes while ensuring access to new biomedical science and technology. That may include studies that utilize technological tools to promote self-monitoring of chronic illnesses (e.g., heart failure, asthma, HIV, diabetes), and technology-based tools to support care of patients at home. The CTS Research Program will prioritize projects involving special populations and underrepresented minorities, specifically African Americans, Hispanics, LGBT+ population, seniors older than 75, persons with disabilities or rural residents.

Eligibility and Criteria for Review : The PI is required to be a CWRU, full-time faculty member (or the equivalent) from CWRU, the Cleveland Clinic, MetroHealth, University Hospitals, or VA Northeast Ohio Healthcare System and eligible to be a PI for a NIH grant. Multiple PI applications are highly encouraged. Co-Is may include community health leaders. The research team must have representation  from at least two  CTSC affiliate sites.

Submission Process:  Investigators who have submitted a LOI proposal consistent with the goals of the CTS Program Pilot Program have been invited to submit a full application.

Full Applications need to follow the NIH R21 ( https://grants.nih.gov/grants/funding/r21.htm  ) format. This includes a one-page specific aims page and a research strategy page section of no more than 6 pages.

Please continue to use the same 4-digit SPARCRequest (“Project ID”) obtained from your LOI application.

A copy of the full RFA can also be found here:  CTSP Full RFA

RFA Release: July 2025

The CTS Program will review applications for the following aspects:

• How well is your project aligned with the overall goals of the CWRU CTSC?
• What is innovative about the use of technology for care of patients with chronic illness?

(e.g., innovative technology, or application to a novel patient population or condition, or novel approach to use of technology which complements standard of care).

• How will you engage diverse and underrepresented populations in the conduct of research and implementation of the study results?
• What is the general approach for implementation and anticipated outcomes of your project?
• How will relevant stakeholders be engaged in the project? (e.g., community groups, providers, patient-partners)?
• What is the composition and qualification of team members who will lead the project?
• How will the results of the project be disseminated?
• What are future plans for sustaining the project or advancing the project through additional research?

Budget Considerations:  CWRU will serve as the fiscal entity through which CTSC funds will be distributed and administered. The amount of the pilot award will be dependent on the scope and type of the project. Awards may involve the incorporation of novel methodologies, technology or programming for translational studies and use of CTSC resources. Budget must be well justified. Awardees are encouraged to supplement awards with additional institutional, departmental, or private funds. Funds may be allocated between $125,000-$175,000 per year depending on the duration of the project. A specific budget justification should be detailed. Although the project can span up to 3 years, investigators should include the details justifying why several years are required for the success of the project. A  budget page  and list of allowable expenses can be found on the  CTSC website .

Contact Nora Brown MSN, CNS with questions: [email protected]

View the full RFA here

Applying for the CTS Research Program is a two-step process:

• You will  first  need an ID number for your project from SPARCRequest (called a "Project ID"). Visit  SPARCRequest  and add "Clinical and Translational Science Research Program" under Pilot Funding Opportunities to your cart and continue through the prompts to complete your submission.
• Once you have obtained your "Project ID", continue to  InfoReady  to submit your LOI for the CTS Research Program.

How do I find my SPARCRequest ID (SRID)?

• Log into SPARCRequest with your CWRU Single-Sign On ID and password
• In the search bar, search “Clinical and Translational Science Research Program”
• Click on “Service: Clinical and Translational Science Research Program”, then click the green box “Yes”
• Follow the prompts to submit your request
• At the end of the prompts, you will be given a SRID (SPARCRequest ID)

For additional information about the SPARCRequest ID, please see the CTSC's website.

Mongan Institute 2024 Health Equity Research Report

The comprehensive document spans the timeline from 2021 to 2023 and features an extensive collection of research and narratives aimed at addressing health disparities. In addition to 42 publication summaries highlighting significant advancements and findings in the field of health equity, this report features 29 “Researcher’s Journey” narratives by selected Mongan Institute faculty who are leaders in the field of health equity research. Also, 49 funded project summaries showcase current research projects focused on  promoting health equity. The report concludes with current research and leadership initiatives, and our vision for a Health Equity Research and Training Collaboratory (a collaborative laboratory). The Mongan Institute is committed to advancing health equity through rigorous research, community engagement, and dedicated efforts to create a more just and inclusive healthcare system.

To stay up-to-date on important news, updates, events, and publications from MI’s researchers, visit the website  and to receive monthly updates, subscribe to their newsletter here .

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NIH-Sponsored Trial of Nasal COVID-19 Vaccine Opens

Candidate vaccine could provide enhanced breadth of protection against emerging sars-cov-2 variants.

July 1, 2024

Colorized scanning electron micrograph of a cell (blue) infected with the Omicron strain of SARS-CoV-2 virus particles (pink), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.

A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases. 

“The rapid development of safe and effective COVID-19 vaccines was a triumph of science, and their use greatly mitigated the toll of the pandemic,” said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. “While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease. With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission.”

The study aims to enroll 60 adult participants, ages 18 to 64 years old, who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine. The trial sites are Baylor College of Medicine, Houston; The Hope Clinic of Emory University, Decatur, Georgia; and New York University, Long Island. Hana M. El Sahly, M.D., at the Baylor College of Medicine Vaccine Research Center, is leading the study.

Study volunteers will be divided into three cohorts. Those in the first cohort will receive one dose of the investigational vaccine delivered in a nasal spray at the lowest dosage, with enrollees in the next two cohorts receiving progressively higher doses. During seven follow-up visits over about one year, scientists will measure how well the vaccine candidate is tolerated, and if it generates an immune response in the blood and in the nose. 

The investigational vaccine, MPV/S-2P, uses murine pneumonia virus (MPV) as a vector to deliver a version of the SARS-CoV-2 spike protein (S-2P) stabilized in its prefusion conformation. MPV does not cause disease in humans or non-human primates but does have an affinity for epithelial cells that line the respiratory tract and may be effective in delivering vaccine to the places where natural coronavirus infections begin.

In pre-clinical non-human primate studies, MPV/S-2P was safe and well tolerated. It produced robust systemic immune responses, including SARS-CoV-2-directed antibodies, as well as local immunity in cells in the mucosal tissues lining the nose and respiratory tract. Studies in humans and animals suggest that mucosal immunity is more effective than systemic immunity in controlling replication of respiratory viruses.

This is the first NIAID clinical trial to be conducted as part of the U.S. Department of Health and Human Services (HHS) Project NextGen . Led by the Biomedical Advanced Research and Development Authority, part of the HHS Administration for Strategic Preparedness and Response, and NIAID, Project NextGen is a coordinated effort between the federal government and the private sector to broaden the pipeline of new, innovative vaccines and therapeutics. Through Project NextGen, NIAID plans to facilitate clinical development of promising next-generation COVID-19 vaccines in Phase 1 and 2 trials.

More information about the trial is available at  clinicaltrials.gov using the identifier  NCT06441968 .

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