Identify
Explore
Discover
Discuss
Summarise
Describe
Last, format your objectives into a numbered list. This is because when you write your thesis or dissertation, you will at times need to make reference to a specific research objective; structuring your research objectives in a numbered list will provide a clear way of doing this.
To bring all this together, let’s compare the first research objective in the previous example with the above guidance:
Research Objective:
1. Develop finite element models using explicit dynamics to mimic mallet blows during cup/shell insertion, initially using simplified experimentally validated foam models to represent the acetabulum.
Checking Against Recommended Approach:
Q: Is it specific? A: Yes, it is clear what the student intends to do (produce a finite element model), why they intend to do it (mimic cup/shell blows) and their parameters have been well-defined ( using simplified experimentally validated foam models to represent the acetabulum ).
Q: Is it measurable? A: Yes, it is clear that the research objective will be achieved once the finite element model is complete.
Q: Is it achievable? A: Yes, provided the student has access to a computer lab, modelling software and laboratory data.
Q: Is it relevant? A: Yes, mimicking impacts to a cup/shell is fundamental to the overall aim of understanding how they deform when impacted upon.
Q: Is it timebound? A: Yes, it is possible to create a limited-scope finite element model in a relatively short time, especially if you already have experience in modelling.
Q: Does it start with a verb? A: Yes, it starts with ‘develop’, which makes the intent of the objective immediately clear.
Q: Is it a numbered list? A: Yes, it is the first research objective in a list of eight.
1. making your research aim too broad.
Having a research aim too broad becomes very difficult to achieve. Normally, this occurs when a student develops their research aim before they have a good understanding of what they want to research. Remember that at the end of your project and during your viva defence , you will have to prove that you have achieved your research aims; if they are too broad, this will be an almost impossible task. In the early stages of your research project, your priority should be to narrow your study to a specific area. A good way to do this is to take the time to study existing literature, question their current approaches, findings and limitations, and consider whether there are any recurring gaps that could be investigated .
Note: Achieving a set of aims does not necessarily mean proving or disproving a theory or hypothesis, even if your research aim was to, but having done enough work to provide a useful and original insight into the principles that underlie your research aim.
Be realistic about what you can achieve in the time you have available. It is natural to want to set ambitious research objectives that require sophisticated data collection and analysis, but only completing this with six months before the end of your PhD registration period is not a worthwhile trade-off.
Each research objective should have its own purpose and distinct measurable outcome. To this effect, a common mistake is to form research objectives which have large amounts of overlap. This makes it difficult to determine when an objective is truly complete, and also presents challenges in estimating the duration of objectives when creating your project timeline. It also makes it difficult to structure your thesis into unique chapters, making it more challenging for you to write and for your audience to read.
Fortunately, this oversight can be easily avoided by using SMART objectives.
Hopefully, you now have a good idea of how to create an effective set of aims and objectives for your research project, whether it be a thesis, dissertation or research paper. While it may be tempting to dive directly into your research, spending time on getting your aims and objectives right will give your research clear direction. This won’t only reduce the likelihood of problems arising later down the line, but will also lead to a more thorough and coherent research project.
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Published on October 26, 2022 by Shona McCombes . Revised on November 21, 2023.
A research question pinpoints exactly what you want to find out in your work. A good research question is essential to guide your research paper , dissertation , or thesis .
All research questions should be:
How to write a research question, what makes a strong research question, using sub-questions to strengthen your main research question, research questions quiz, other interesting articles, frequently asked questions about research questions.
You can follow these steps to develop a strong research question:
The way you frame your question depends on what your research aims to achieve. The table below shows some examples of how you might formulate questions for different purposes.
Research question formulations | |
---|---|
Describing and exploring | |
Explaining and testing | |
Evaluating and acting | is X |
Example research problem | Example research question(s) |
---|---|
Teachers at the school do not have the skills to recognize or properly guide gifted children in the classroom. | What practical techniques can teachers use to better identify and guide gifted children? |
Young people increasingly engage in the “gig economy,” rather than traditional full-time employment. However, it is unclear why they choose to do so. | What are the main factors influencing young people’s decisions to engage in the gig economy? |
Note that while most research questions can be answered with various types of research , the way you frame your question should help determine your choices.
Research questions anchor your whole project, so it’s important to spend some time refining them. The criteria below can help you evaluate the strength of your research question.
Criteria | Explanation |
---|---|
Focused on a single topic | Your central research question should work together with your research problem to keep your work focused. If you have multiple questions, they should all clearly tie back to your central aim. |
Answerable using | Your question must be answerable using and/or , or by reading scholarly sources on the to develop your argument. If such data is impossible to access, you likely need to rethink your question. |
Not based on value judgements | Avoid subjective words like , , and . These do not give clear criteria for answering the question. |
Criteria | Explanation |
---|---|
Answerable within practical constraints | Make sure you have enough time and resources to do all research required to answer your question. If it seems you will not be able to gain access to the data you need, consider narrowing down your question to be more specific. |
Uses specific, well-defined concepts | All the terms you use in the research question should have clear meanings. Avoid vague language, jargon, and too-broad ideas. |
Does not demand a conclusive solution, policy, or course of action | Research is about informing, not instructing. Even if your project is focused on a practical problem, it should aim to improve understanding rather than demand a ready-made solution. If ready-made solutions are necessary, consider conducting instead. Action research is a research method that aims to simultaneously investigate an issue as it is solved. In other words, as its name suggests, action research conducts research and takes action at the same time. |
Criteria | Explanation |
---|---|
Cannot be answered with or | Closed-ended, / questions are too simple to work as good research questions—they don’t provide enough for robust investigation and discussion. |
Cannot be answered with easily-found facts | If you can answer the question through a single Google search, book, or article, it is probably not complex enough. A good research question requires original data, synthesis of multiple sources, and original interpretation and argumentation prior to providing an answer. |
Criteria | Explanation |
---|---|
Addresses a relevant problem | Your research question should be developed based on initial reading around your . It should focus on addressing a problem or gap in the existing knowledge in your field or discipline. |
Contributes to a timely social or academic debate | The question should aim to contribute to an existing and current debate in your field or in society at large. It should produce knowledge that future researchers or practitioners can later build on. |
Has not already been answered | You don’t have to ask something that nobody has ever thought of before, but your question should have some aspect of originality. For example, you can focus on a specific location, or explore a new angle. |
Chances are that your main research question likely can’t be answered all at once. That’s why sub-questions are important: they allow you to answer your main question in a step-by-step manner.
Good sub-questions should be:
Here are a few examples of descriptive and framing questions:
Keep in mind that sub-questions are by no means mandatory. They should only be asked if you need the findings to answer your main question. If your main question is simple enough to stand on its own, it’s okay to skip the sub-question part. As a rule of thumb, the more complex your subject, the more sub-questions you’ll need.
Try to limit yourself to 4 or 5 sub-questions, maximum. If you feel you need more than this, it may be indication that your main research question is not sufficiently specific. In this case, it’s is better to revisit your problem statement and try to tighten your main question up.
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If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.
Methodology
Statistics
Research bias
The way you present your research problem in your introduction varies depending on the nature of your research paper . A research paper that presents a sustained argument will usually encapsulate this argument in a thesis statement .
A research paper designed to present the results of empirical research tends to present a research question that it seeks to answer. It may also include a hypothesis —a prediction that will be confirmed or disproved by your research.
As you cannot possibly read every source related to your topic, it’s important to evaluate sources to assess their relevance. Use preliminary evaluation to determine whether a source is worth examining in more depth.
This involves:
A research hypothesis is your proposed answer to your research question. The research hypothesis usually includes an explanation (“ x affects y because …”).
A statistical hypothesis, on the other hand, is a mathematical statement about a population parameter. Statistical hypotheses always come in pairs: the null and alternative hypotheses . In a well-designed study , the statistical hypotheses correspond logically to the research hypothesis.
Formulating a main research question can be a difficult task. Overall, your question should contribute to solving the problem that you have defined in your problem statement .
However, it should also fulfill criteria in three main areas:
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Research questions.
A research question naturally emerges from a research problem that needs to be resolved. Developing a good research question not only rests on the study of some uncertain phenomenon, but also on the rational need for investigating it. It is therefore essential that a systematic review of extant literature on the research topic be conducted, prior to formulating a research question. Awareness of current trends and latest development in the field of study will certainly assist in formulating a relevant question. There may be several research questions, whether primary or secondary, but they should all be developed during the planning stage of a study. Furthermore, it must be ensured that secondary questions do not compromise the primary research question, which forms the basis of research objectives and hypotheses. Lastly, bear in mind that the number of research questions will inevitably make the research design and data analysis more complex.
Hulley et al . (2001) suggested the use of the FINER criteria in developing a good research question:
A poorly formulated research question may thus affect the choice of study design and hamper the chance of obtaining any significant finding, besides compromising the quality of the study.
First of all, it is essential to understand that it is a hypothesis, not the data, that drives a primary research question . Otherwise, given any dataset, it would be too simple to perform several tests and apply statistical techniques to establish significant associations and/or relationships among variables and/or constructs. In such cases, it would be working backward by using the data to develop the research question, and that would defeat the entire purpose of conducting the study. To make matters worse, spuriously positive findings may result.
Hypothesis testing aims at making inferences about the targeted population on the basis of a random sample taken from that population. A hypothesis must be formulated as a null hypothesis, generally meaning that a prevailing situation has not changed (in the case of finding differences) or that there are no significant relationships among variables and/or constructs. This is the reason why each null hypoythesis must be paired with an alternative hypothesis, should the outcome be significant. The two hypotheses must be mutually exclusive and comprehensively exhaustive, i.e., the acceptance of one would automatically imply the rejection of the other. For a better understanding of the concept of hypothesis testing, you might need to consult our statistician.
At this stage, all you need to know is that the development of a research hypothesis should be supported by a good research question, as it will influence your research design. Once appropriate hypotheses have been developed, you can safely proceed to the formulation of your research objectives.
You must first learn to distinguish between a research aim and a research objective . While an aim is written in broad terms and explains what is to be achieved at the end of the study, an objective is an active statement that is defined in measurable outcomes via a strong positive statement. The primary objective of a study is paired with the hypothesis of the study, and should be clearly stated in the introduction of the research protocol. Objectives usually state exactly the outcome measures that are going to be used within their statements. Strong verbs like determine , measure , assess , evaluate , identify , examine , investigate , etc., are used in the formulation of objectives.
The importance of objectives is that they guide the development of the protocol and design of study, and play a determining role in sample size calculations. Objectives should be focused on outcomes that are important and relevant to the study.
Research aim To investigate the issue of student indiscipline and its impact on student attainment in Mauritian Secondary Schools Research question What are the various types of student indiscipline currently experienced in secondary schools of Mauritius? Research (null) hypothesis School management style does not impact on student attainment Research objective To identify the most common forms of indiscipline and their level of seriousness
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The story of a research study begins by asking a question. Researchers all around the globe are asking curious questions and formulating research hypothesis. However, whether the research study provides an effective conclusion depends on how well one develops a good research hypothesis. Research hypothesis examples could help researchers get an idea as to how to write a good research hypothesis.
This blog will help you understand what is a research hypothesis, its characteristics and, how to formulate a research hypothesis
Table of Contents
Hypothesis is an assumption or an idea proposed for the sake of argument so that it can be tested. It is a precise, testable statement of what the researchers predict will be outcome of the study. Hypothesis usually involves proposing a relationship between two variables: the independent variable (what the researchers change) and the dependent variable (what the research measures).
Research hypothesis is a statement that introduces a research question and proposes an expected result. It is an integral part of the scientific method that forms the basis of scientific experiments. Therefore, you need to be careful and thorough when building your research hypothesis. A minor flaw in the construction of your hypothesis could have an adverse effect on your experiment. In research, there is a convention that the hypothesis is written in two forms, the null hypothesis, and the alternative hypothesis (called the experimental hypothesis when the method of investigation is an experiment).
As the hypothesis is specific, there is a testable prediction about what you expect to happen in a study. You may consider drawing hypothesis from previously published research based on the theory.
A good research hypothesis involves more effort than just a guess. In particular, your hypothesis may begin with a question that could be further explored through background research.
To help you formulate a promising research hypothesis, you should ask yourself the following questions:
The questions listed above can be used as a checklist to make sure your hypothesis is based on a solid foundation. Furthermore, it can help you identify weaknesses in your hypothesis and revise it if necessary.
How to formulate a research hypothesis.
A testable hypothesis is not a simple statement. It is rather an intricate statement that needs to offer a clear introduction to a scientific experiment, its intentions, and the possible outcomes. However, there are some important things to consider when building a compelling hypothesis.
Make sure that the hypothesis clearly defines the topic and the focus of the experiment.
Follow this template: If a specific action is taken, then a certain outcome is expected.
Independent variables are the ones that are manipulated, controlled, or changed. Independent variables are isolated from other factors of the study.
Dependent variables , as the name suggests are dependent on other factors of the study. They are influenced by the change in independent variable.
Evaluate assumptions, predictions, and evidence rigorously to refine your understanding.
The types of research hypothesis are stated below:
It predicts the relationship between a single dependent variable and a single independent variable.
It predicts the relationship between two or more independent and dependent variables.
It specifies the expected direction to be followed to determine the relationship between variables and is derived from theory. Furthermore, it implies the researcher’s intellectual commitment to a particular outcome.
It does not predict the exact direction or nature of the relationship between the two variables. The non-directional hypothesis is used when there is no theory involved or when findings contradict previous research.
The associative hypothesis defines interdependency between variables. A change in one variable results in the change of the other variable. On the other hand, the causal hypothesis proposes an effect on the dependent due to manipulation of the independent variable.
Null hypothesis states a negative statement to support the researcher’s findings that there is no relationship between two variables. There will be no changes in the dependent variable due the manipulation of the independent variable. Furthermore, it states results are due to chance and are not significant in terms of supporting the idea being investigated.
It states that there is a relationship between the two variables of the study and that the results are significant to the research topic. An experimental hypothesis predicts what changes will take place in the dependent variable when the independent variable is manipulated. Also, it states that the results are not due to chance and that they are significant in terms of supporting the theory being investigated.
Research Hypothesis Example 1 The greater number of coal plants in a region (independent variable) increases water pollution (dependent variable). If you change the independent variable (building more coal factories), it will change the dependent variable (amount of water pollution).
Research Hypothesis Example 2 What is the effect of diet or regular soda (independent variable) on blood sugar levels (dependent variable)? If you change the independent variable (the type of soda you consume), it will change the dependent variable (blood sugar levels)
You should not ignore the importance of the above steps. The validity of your experiment and its results rely on a robust testable hypothesis. Developing a strong testable hypothesis has few advantages, it compels us to think intensely and specifically about the outcomes of a study. Consequently, it enables us to understand the implication of the question and the different variables involved in the study. Furthermore, it helps us to make precise predictions based on prior research. Hence, forming a hypothesis would be of great value to the research. Here are some good examples of testable hypotheses.
More importantly, you need to build a robust testable research hypothesis for your scientific experiments. A testable hypothesis is a hypothesis that can be proved or disproved as a result of experimentation.
To devise and perform an experiment using scientific method, you need to make sure that your hypothesis is testable. To be considered testable, some essential criteria must be met:
Without these criteria, the hypothesis and the results will be vague. As a result, the experiment will not prove or disprove anything significant.
What are your experiences with building hypotheses for scientific experiments? What challenges did you face? How did you overcome these challenges? Please share your thoughts with us in the comments section.
The steps to write a research hypothesis are: 1. Stating the problem: Ensure that the hypothesis defines the research problem 2. Writing a hypothesis as an 'if-then' statement: Include the action and the expected outcome of your study by following a ‘if-then’ structure. 3. Defining the variables: Define the variables as Dependent or Independent based on their dependency to other factors. 4. Scrutinizing the hypothesis: Identify the type of your hypothesis
Hypothesis testing is a statistical tool which is used to make inferences about a population data to draw conclusions for a particular hypothesis.
Hypothesis in statistics is a formal statement about the nature of a population within a structured framework of a statistical model. It is used to test an existing hypothesis by studying a population.
Research hypothesis is a statement that introduces a research question and proposes an expected result. It forms the basis of scientific experiments.
The different types of hypothesis in research are: • Null hypothesis: Null hypothesis is a negative statement to support the researcher’s findings that there is no relationship between two variables. • Alternate hypothesis: Alternate hypothesis predicts the relationship between the two variables of the study. • Directional hypothesis: Directional hypothesis specifies the expected direction to be followed to determine the relationship between variables. • Non-directional hypothesis: Non-directional hypothesis does not predict the exact direction or nature of the relationship between the two variables. • Simple hypothesis: Simple hypothesis predicts the relationship between a single dependent variable and a single independent variable. • Complex hypothesis: Complex hypothesis predicts the relationship between two or more independent and dependent variables. • Associative and casual hypothesis: Associative and casual hypothesis predicts the relationship between two or more independent and dependent variables. • Empirical hypothesis: Empirical hypothesis can be tested via experiments and observation. • Statistical hypothesis: A statistical hypothesis utilizes statistical models to draw conclusions about broader populations.
Wow! You really simplified your explanation that even dummies would find it easy to comprehend. Thank you so much.
Thanks a lot for your valuable guidance.
I enjoy reading the post. Hypotheses are actually an intrinsic part in a study. It bridges the research question and the methodology of the study.
Useful piece!
This is awesome.Wow.
It very interesting to read the topic, can you guide me any specific example of hypothesis process establish throw the Demand and supply of the specific product in market
Nicely explained
It is really a useful for me Kindly give some examples of hypothesis
It was a well explained content ,can you please give me an example with the null and alternative hypothesis illustrated
clear and concise. thanks.
So Good so Amazing
Good to learn
Thanks a lot for explaining to my level of understanding
Explained well and in simple terms. Quick read! Thank you
It awesome. It has really positioned me in my research project
Brief and easily digested
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National Institutes of Health ( NIH )
National Institute on Aging ( NIA )
National Institute on Alcohol Abuse and Alcoholism ( NIAAA )
National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS )
Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD )
National Institute of Neurological Disorders and Stroke ( NINDS )
R15 Research Enhancement Award (REA)
See Part 2, Section III. 3. Additional Information on Eligibility.
The purpose of this HEAL Initiative program is to: (1) support basic and mechanistic pain research from R15-eligible undergraduate-focused serving institutions, health professional schools or graduate schools; (2) promote integrated, interdisciplinary research partnerships between Principal Investigators (PIs) from R15-eligible institutions and investigators from U.S. domestic institutions; and (3) enhance the pain research environment at the R15-eligible institution for health professional students, undergraduate and/or graduate students through active engagement in pain research.
Applications in response to this notice of funding opportunity (NOFO) should include plans to accomplish these goals. Specifically, applications should include a rigorous plan for conducting basic and mechanistic pain research in the Research Strategy section of the application . In addition, a research partnership between the PIs institution and at least one investigator from a separate U.S. domestic institution that provides resources and/or expertise that will enhance the proposed pain research program must be included in a separate Team Management Plan. The proposed partnership will be a sub-award agreement(s) with at least one partnering institution, which does not need to be R15-eligible. The budget of all sub-awards must not exceed one third of the total budget. Furthermore, applications must include a Facilities & Other Resources document that demonstrates active involvement of health professional students, undergraduate and/or graduate students from the R15-eligible institution(s) in the proposed pain research projects.
This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).
30 days before application due date.
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
November 19, 2024 | Not Applicable | December 18, 2024 | March 2025 | May 2025 | July 2025 |
October 28, 2025 | October 28, 2025 | November 24, 2025 | March 2026 | May 2026 | July 2026 |
October 27, 2026 | October 27, 2026 | November 23, 2026 | March 2027 | May 2027 | July 2027 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Section i. notice of funding opportunity description.
Applications in response to this notice of funding opportunity (NOFO) should include plans to accomplish these goals. Specifically, applications should include a rigorous plan for conducting basic and mechanistic pain research projects in the Research Strategy section of the application. In addition, a research partnership between the PIs institution and at least one investigator from a separate U.S. domestic institution that provides resources and/or expertise that will enhance the proposed pain research program must be included in a separate Team Management Plan. The proposed partnership will be a sub-award agreement(s) with at least one partnering institution, which does not need to be R15-eligible. The budget of all sub-awards must not exceed one third of the total budget. Furthermore, applications must include a Facilities & Other Resources document that demonstrates active involvement of health professional students or undergraduate and/or graduate students from the R15-eligible institution(s) in the proposed pain research projects.
The National Institutes of Health (NIH) Helping to End Addiction Long-term ® Initiative, or NIH HEAL Initiative ® , bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the NIH HEAL Initiative is available at https://heal.nih.gov/ . Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. See the Notice of NIHs Interest in Diversity ( NOT-OD-20-031 ) for more details. Promoting diversity in the pain research workforce is crucial to promoting future scientific advances in this area and to achieve the NIH HEAL Initiatives workforce development goals.The initiative has funded multiple pain workforce enhancement programs that support early-career investigators. Despite these efforts, the NIH HEAL Initiative can benefit from additionally supporting R-15 eligible institutions that involve undergraduate, graduate or health professional school/colleges students in pain research.
Since Fiscal Year (FY) 1985, NIH has made a special effort to stimulate research at educational institutions that provide baccalaureate and/or advanced degrees for a significant number of the nations research scientists who have not been major recipients of NIH support. NIH has implemented two parent award programs, the Academic Research Enhancement Award (AREA) program ( PAR-21-155 ) and Research Enhancement Award Program (REAP) ( PAR-22-060 ), to provide research experiences to health professional or undergraduate and/or graduate students pursuing biomedical or behavioral research at U.S. higher education institutions. Utilizing these two programs will further promote a diverse pain research workforce. This Pain Research Enhancement Program (PREP) will further support meritorious collaborative pain research from designated educational levels in the NIH HEAL Initiative, using the NIH Research Enhancement Award programs as a guide. Specifically, this NOFO aims to support new scientific solutions to the national opioid public health crisis byestablishing new research partnerships that will lead to research experiences for undergraduate, graduate, and health professional students, to further enhance the pool of potential participants in the pain research pipeline.
Program Objectives:
The purpose of this HEAL Initiative program is to: (1) support basic and mechanistic pain research from R15-eligible undergraduate-focused serving institutions, health professional schools or graduate schools; (2) promote integrated, interdisciplinary research partnerships between Principal Investigators (PIs) from R15-eligible institutions and investigators from U.S. domestic institutions; and (3) enhance the pain research environment at the R15-eligible institution for health professional students, undergraduate and/or graduate students through active engagement in pain research. Successful applications will include plans detailing how they intend to accomplish all three goals. Please refer to Section III for specific R15 eligibility information. Although preliminary data are not required for an R15 application, they may be included if available. The scientific foundation for the proposed research should be based on published research and/or any available preliminary data.
Objective 1: Develop Small-Scale Basic and Mechanistic Pain Research Projects
Proposed research projects should be hypothesis driven and use a rigorous scientific design to generate research data/evidence and advance scientific knowledge. Applications should include objectives that are attainable within the 3-year grant period.
Pain research projects may include, but are not limited to, the study of: nociception and/or pain processing in non-pain populations, acute pain, cancer pain, chemotherapy-induced neuropathy, chronic pain, diabetic neuropathy, eye pain, gynecologic pain, headache, musculoskeletal pain, myofascial pain, obstetric pain, osteoarthritis, pain conditions across the lifespan (including in the context of aging), pain co-occurring with substance use disorders (SUDs), painful disorders of the orofacial region, painful neuropathy, post-stroke pain, post-surgical pain, sickle cell pain, and/or visceral pain. Innovative pain research topics that propose an interdisciplinary mechanistic pain research are considered high program priority under this initiative.
Projects may focus on basic pain research with pre-clinical ( e.g., animal or in silico ) models or involve research participants ( e.g., observational studies, epidemiological studies, secondary data analyses, or device development). Alternatively, investigators may propose a mechanistic and/or Basic Experimental Studies involving Humans (BESH) clinical trial as described below. Clinical trials designed primarily to determine the safety, tolerability, and/or clinical efficacy of an intervention will be considered non-responsive to this NOFO and withdrawn without review .
For this NOFO, only the following types of clinical trials will be supported:
NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes ( https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html ). For further clarification on how NIH defines the different types of clinical trials, please refer to the following resources:
Objective 2: Promote Integrated, Interdisciplinary Research Partnerships
A second key objective of this NOFO is to promote new research partnerships among investigators at R15-eligible institutions with separate (legally distinct) investigators at domestic research institutions. Investigators can have a multitude of research expertise that aligns with the proposed research projects and/or resources that can be shared to enhance the proposed research. Applications must propose a collaboration with at least one sub-award holder from a separate U.S. domestic research institution and should include details of how the collaboration will enhance the R15-research program must be described. Applications are permitted to have a subaward to a non-R15-eligible institution. However, it is expected that PD/PI(s) from R15-eligible institution(s) will lead the proposed project and complete most of the research at the R15-eligible institution. As such, PI(s) from R15-eligible institutions must serve as the contact program director (PD)/PI for the project. Additionally, no more than one third of the total budget for the project may be used by the identified sub-award institution.
Applications that propose new interdisciplinary are considered a high program priority under this NOFO. Interdisciplinary partnership could include, but are not limited to, any two or more areas of research expertise from the following:
In addition, a Team Management Plan is required as part of Objective 2. Studies of team science have highlighted the need for effective management structures to achieve program goals. Many resources exist to aid in developing effective team-based programs (e.g., the National Cancer Institute Collaboration and Team Science Field Guide ). The Team Management Plan focuses on management of the whole team/key personnel. Because teams will likely include individuals from widely divergent scientific backgrounds, teams must have a shared vision and a defined plan for communication and management of shared responsibilities, interpersonal interactions, and professional credit. The Team Management Plan should be included as an attachment (three pages maximum) to this application. It should address how the research team, including the PI from R15-eligible Instiution and collaborator(s), will work together to accomplish program objectives. See the application instructions for Other Attachments on the SF424(R&R) Other Project Information in Section IV.2 Instructions for Application Submission for details. The Team Management Plan should address the following points:
Objective 3: Enhance the Research Environment by Engaging Students
The third objective of this program is to enhance the pain research environment at the R15-eligible institution by engaging and providing research opportunities to health professional students or undergraduate and/or graduate students. A Facilities & Other Resources document is required to describe how the proposed research will enhance the pain research environment at the R15-eligible institution. Two-thirds of the proposed research project team should comprise personnel from the R15-eligible institutions, including health professional students, or graduate students or undergraduate students from the primary R15-eligible institution. Although the proposed research project must be led by the identified PD/PI, applications with strong and innovative student engagement are of high program priority. If participating students have not yet been identified, the number and academic stage of those to be involved should be provided. Applications should identify which aspects of the proposed research will include student participation. Student involvement may include participation in the design of experiments, collection and analysis of data, execution and troubleshooting of experiments, participation in research meetings, and discussion of future research directions. When applicable, it is highly desirable that student participation also include presentation of research at local and/or national meetings (including the HEAL Annual Scientific Meeting and "Positively Uniting Researchers of Pain to Opine, Synthesize, & Engage" {PURPOSE} meeting), publication of journal articles, and collaborative interactions. By engaging in these activities and collaborating on pain-focused research projects at early stages of training, students will be better prepared and motivated to pursue careers in pain research. Please see Section III for a list of eligible students.
This NOFO aims to support pain research grants, not training or fellowship program s. As such, applications should not include training plans such as didactic training or non-research activities related to professional development. Likewise, applications should not include independent student research projects. For applications that propose a clinical trial, the PD/PI must be the responsible individual of record for oversight of the trial though students can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the student can gain experience in all these components in conjunction with the individual leading the trial. Applications submitted to this NOFO may include additional investigators to those outlined above, including additional collaborators or consultants, or other individuals such as high school students, post-baccalaureate participants, postdoctoral fellows, or clinical fellows. However, involvement of such individuals does not fulfill the goal of enhancing the R15-eligible institutional environment and should account for less than one third of the overall proposed project team.
Additional Information
Non-responsiveness Criteria:
Applications deemed to be non-responsive will not proceed to review and will be withdrawn. Applications with one or more of the following characteristics are considered non-responsive to this NOFO:
Contacting Program Officers Prior to Submission
Applicants are strongly encouraged to consult with program staff as plans for an application are being developed.
Rigor and Reproducibility
NIH strives for rigor and transparency in all research it funds. For this reason, the NIH HEAL Initiative explicitly emphasizes the NIH application instructions related to rigor and transparency ( https://grants.nih.gov/policy/reproducibility/guidance.htm ) and provides additional guidance from individual NIH institutes and centers (ICs) to the scientific community. For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner. If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.
Proposed research projects should incorporate adequate methodological rigor where applicable, including but not limited to a clear rationale for the chosen model(s) and primary/secondary endpoint(s), clear descriptions of tools and parameters, blinding, randomization, adequate sample size, prespecified inclusion/exclusion criteria, appropriate handling of missing data and outliers, appropriate controls, pre-planned analyses, and appropriate quantitative techniques.
Applications should also clearly indicate the exploratory vs. confirmatory components of the study, consider study limitations, and plan for transparent reporting of all methods, analyses, and results so that other investigators can evaluate the quality of the work and potentially perform replications. NIH intends to maximize the impact of NIH HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications ( https://heal.nih.gov/about/public-access-data ). Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy . More details about NIH HEAL Initiative data sharing are described in Section IV.
Clinical Trial Accrual Policy:
For applications that are proposing to conduct a clinical trial, a series of clinical recruitment milestones detailing completion of the clinical trial and providing contingency plans to proactively confront potential delays or disturbances in attaining the clinical recruitment milestones must be included along with a study timeline in the PHS Human Subjects and Clinical Trials Information form. Continuation of the award is conditional upon satisfactory progress, availability of funds, and scientific priorities of the NIH HEAL Initiative. If, at any time, recruitment falls significantly below the projected milestones for recruitment, NIH will consider ending support and negotiating an orderly phaseout of the award. NIH retains the option of periodic external peer review of progress. NIH program staff will closely monitor progress at all stages for milestones, accrual, and safety.
Expected Activities of Coordination
NIH HEAL Initiative awardees are strongly encouraged to cooperate and coordinate their activities. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after post award by participating in PD/PI meetings, including:
NIH HEAL Initiative Scientific Meeting Attendance
Applicants and students are highly encouraged to attend the annual NIH HEAL Initiative Scientific Meetings. The NIH HEAL Initiative hosts an annual meeting of more than 800 NIH HEAL Initiative-funded researchers across the initiatives research portfolio and career stage spectrum, NIH staff, people with lived and living experience, community partners advising initiative-funded projects, advocacy groups, and other stakeholders to
Annual National Pain Scientists Career Development Program (PURPOSE) Meeting
Applicants and students are also highly encouraged to enroll in the HEAL Initiative: Positively Uniting Researchers of Pain to Opine, Synthesize, and Engage (PURPOSE) network and attend its annual meetings. Details can be found at https://painresearchers.com . The HEAL R24 Coordinating Center for National Pain Scientists works to improve the collaboration between basic, translational, and clinical researchers who do not regularly collaborate or work together. One function of the HEAL R24 Coordinating Center for National Pain Scientists is to organize an annual meeting for established scientists as well as early-career pain investigators. This annual meeting facilitates the creation of a network of pain research mentors and mentees as well as fostering communication between scientists and clinicians of different disciplines and providing enhanced mentorship, leadership courses, and any additional training that might be helpful for early-career scientists. R15 recipients are encouraged to attend the annual PURPOSE meeting, either virtually or in person.
See Section VIII. Other Information for award authorities and regulations.
Plan for Enhancing Diverse Perspectives (PEDP) The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status) of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review. The PEDP will be submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials .
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The NIH HEAL Initiative intends to commit an estimated total of $1.25 million to fund up to three awards per year for FY 2025, FY 2026, and FY 2027. Support for this funding opportunity is contingent upon annual NIH appropriations and the submission of a sufficient number of meritorious applications
Applicants may request up to $375,000 in direct costs for the entire project period. No more than one third of total project costs may go to non-R15-eligible institutions. Annual inflationary increases are not allowed.
The scope of the proposed project should determine the project period. The maximum project period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
1. eligible applicants eligible organizations higher education institutions public/state controlled institutions of higher education private institutions of higher education the following types of higher education institutions are always encouraged to apply for nih support as public or private institutions of higher education: hispanic-serving institutions historically black colleges and universities (hbcus) tribally controlled colleges and universities (tccus) alaska native and native hawaiian serving institutions asian american native american pacific islander serving institutions (aanapisis) in addition, applicant organizations must meet the following criteria at the time of submission: the applicant organization must be an accredited public or nonprofit private school that grants baccalaureate or advanced degrees in health professions (see section below for more details) or biomedical and behavioral sciences. the application must be submitted by the eligible organization with a unique entity identifier (such as uei or duns) and a unique nih era institutional profile file (ipf) number. at the time of application submission, determination of eligibility will be based in part on nih institutional support. a year is defined as a federal fiscal year: from october 1 through september 30. note that collaborating subawardees do not need to adhere to the r15 eligibility criteria stated above. however, they must be separate legal entities that fulfill the terms of an eligible subaward agreement. for this particular nofo, they must also be u.s. domestic institutions. more details can be found at https://grants.nih.gov/policy/subawards . undergraduate focused institutions: at the time of application submission, all the non-health professional components of the institution combined must not have received support from the nih totaling more than $6 million per year (in both direct and f&a/indirect costs) in 4 of the last 7 years. for institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of nih funding received by all the non-health professional schools and colleges within the institution as a whole. note that all activity codes are included in this calculation except the following: c06, s10, and all activity codes starting with a g. help determining the organization funding level can be found at https://grants.nih.gov/grants/funding/determing-organization-funding-levels-r15-eligibility.pdf an academic component is any school/college that is not a health professional school or college. a qualifying academic component (i.e., school/college) within an institution (e.g., school of arts and sciences) has greater undergraduate student enrollment than graduate student enrollment. all types of health professional schools and colleges are not eligible to apply and are not considered in this calculation. for institutions with multiple campuses, eligibility can be considered for each individual campus (e.g., main, satellite, etc.) only if separate ueis and nih ipf numbers are established for each campus. for institutions that use one uei or nih ipf number for all campuses, eligibility is determined for all campuses (e.g., main, satellite, etc.) combined. health professional and graduate schools at the time of application submission, all components of the institution combined must not have received support from the nih totaling more than $6 million per year (in both direct and f&a/indirect costs) in 4 of the last 7 years. for institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of nih funding received by all of the schools and colleges within the institution as a whole. note that all activity codes are included in this calculation except the following: c06, s10, and all activity codes starting with a g. a graduate school offers advanced degrees, beyond the undergraduate level, in an academic discipline including m.a., m.s., and ph.d. degrees. health professional schools and colleges are accredited institutions that provide education and training leading to a health professional degree, including but not limited to: b.s.n., m.s.n., d.n.p., m.d., d.d.s., d.o., pharm.d., d.v.m., o.d., d.p.t., d.c., n.d., d.p.m., m.o.t., o.t.d., d.p.t., m.s.-s.l.p., c.sc.d., s.l.p.d., au.d., m.s.p.o., m.s.a.t., and m.p.h. eligible health professional schools/colleges may include schools or colleges of nursing, medicine, dentistry, osteopathy, pharmacy, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy, podiatry, rehabilitation medicine, physical therapy, orthotics and prosthetics, kinesiology, occupational therapy, and psychology. accreditation must be provided by a body approved for such purpose by the secretary of education. for institutions with multiple campuses, eligibility can be considered for each individual campus (e.g., main, satellite, etc.) only if a unique identifier number and nih ipf number are established for each campus. for institutions that use one identifier number or nih ipf number for all campuses, eligibility is determined for all campuses (e.g., main, satellite, etc.) together. additional eligibility guidance a signed letter is required from the provost or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission according to the eligibility criteria indicated above. see the application instructions for other attachments on the sf424(r&r) other project information form in section iv.2 instructions for application submission. final eligibility will be validated by nih prior to award. to assist in determining eligibility, organizations are encouraged to use the nih report website under nih awards by location & organization . a prep application must provide evidence of a subaward to a separate institution , and the grantee may partner with a non-r15-eligible institution. however, applicants should keep the goals of the prep in mind when preparing the application, which include strengthening the research environment of eligible institutions and engaging students from eligible institutions in pain research. it is expected that the project, and two-thirds of the total project budget, will be directed by the pd(s)/pi(s) at r15-eligible institution(s). a letter of support from each collaborator is required verifying the research collaboration at the time of application submission according to the eligibility criteria indicated above. the letter(s) should detail how the proposed research partnership will help to accomplish the proposed pain research project, enhance the r15-eligible institutions research program, and promote synergy from an integrated, interdisciplinary research partnership(s) among the multiple proposed institutions. see the application instructions for other attachments on the sf424(r&r) other project information form in section iv.2 instructions for application submission. foreign organizations non-domestic (non-u.s.) entities (foreign organizations) are not eligible to apply. non-domestic (non-u.s.) components of u.s. organizations are not eligible to apply. foreign components, as defined in the nih grants policy statement , are allowed. required registrations applicant organizations applicant organizations must complete and maintain the following registrations as described in the how to apply - application guide to be eligible to apply for or receive an award. all registrations must be completed prior to the application being submitted. registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference nih grants policy statement section 2.3.9.2 electronically submitted applications for additional information system for award management (sam) – applicants must complete and maintain an active registration, which requires renewal at least annually . the renewal process may require as much time as the initial registration. sam registration includes the assignment of a commercial and government entity (cage) code for domestic organizations which have not already been assigned a cage code. nato commercial and government entity (ncage) code – foreign organizations must obtain an ncage code (in lieu of a cage code) in order to register in sam. unique entity identifier (uei) - a uei is issued as part of the sam.gov registration process. the same uei must be used for all registrations, as well as on the grant application. era commons - once the unique organization identifier is established, organizations can register with era commons in tandem with completing their grants.gov registrations; all registrations must be in place by time of submission. era commons requires organizations to identify at least one signing official (so) and at least one program director/principal investigator (pd/pi) account in order to submit an application. grants.gov – applicants must have an active sam registration in order to complete the grants.gov registration. program directors/principal investigators (pd(s)/pi(s)) all pd(s)/pi(s) must have an era commons account. pd(s)/pi(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in era commons. if the pd/pi is also the organizational signing official, they must have two distinct era commons accounts, one for each role. obtaining an era commons account can take up to 2 weeks. eligible individuals (program director/principal investigator) any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director(s)/principal investigator(s) (pd(s)/pi(s)) is invited to work with their organization to develop an application for support. individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for nih support. see, reminder: notice of nih's encouragement of applications supporting individuals from underrepresented ethnic and racial groups as well as individuals with disabilities , not-od-22-019 . for institutions/organizations proposing multiple pds/pis, visit the multiple program director/principal investigator policy and submission details in the senior/key person profile (expanded) component of the how to apply - application guide . to be eligible for support under a prep grant, the pd(s)/pi(s) must meet the following additional criteria: each pd/pi must have a primary appointment at either an r15-eligible institution, including professional or graduate schools, undergraduate-focused organizations, or a college within the applicant institution, as defined in eligible organizations, above. if proposing multiple pd(s)/pi(s), each pd/pi must be at an r15-eligible institution. each pd/pi may not be the pd/pi of an active nih research grant, including another r15 grant, at the time of award of a prep grant, although they may be one of the key personnel for an active nih grant held by another pd/pi. each pd/pi may not be awarded support under more than one r15 grant at a time, although he or she may have support under successive new or renewal grants. 2. cost sharing.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:
1. requesting an application package.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Jessica McKlveen, PhD National Center for Complementary & Integrative Health (NCCIH) Telephone: 301-594-8018 Email: [email protected]
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
Sf424(r&r) other project information.
Facilities & Other Resources (Required):
Applications without a Facilities & Other Resources document will be withdrawn.
Other Attachments:
Applications that fail to include the following three required ‘other attachments will be considered incomplete and will be withdrawn.
1.Team Management Plan (Required three pages maximum):
A key goal of this program is to establish new research partnerships among R15-eligible investigators and other domestic research centers, programs, or institutions with complementary research expertise and/or resources. To ensure that prospective research teams fit the goals of the PREP, a team management plan is required. Applications with team management plans that exceed the three-page limit will be withdrawn.
As an Other Attachment entitled Team-Management-Plan.pdf, applications should describe how the research collaborators will function to accomplish program objectives. Team management approaches raised in the subsections listed below should be described in the plan. Note that a Multiple PD/PI Leadership Plan may also be submitted as a separate attachment, and if it is included the information in that plan should not be duplicated here. Whereas the Multiple PD/PI Leadership Plan focuses on leadership by and interactions across the PD/PIs, the Team Management Plan focuses on management of the whole team/key personnel. Applicants are encouraged to consult resources to aid in developing effective team-based programs (see e.g., the NCI Collaboration and Team Science Field Guide ).
Organizational structure and team composition: The Team Management Plan should clearly show the organizational structure and composition of the proposed project team. Two-thirds of the proposed research project team should be health professional students trainees or graduate students or undergraduate from the primary R15-eligible institution. The plan should describe a management structure based on project objectives that effectively promote the proposed research. The structure should account for team composition, institutional resources, and policies that conform with PREP objectives outlined in Section I.
Shared leadership, contributions, and distributed responsibility for decision-making: The Team Management Plan should include a description of how the proposed collaborators will work together to direct the overall scientific team to leverage the diverse perspectives, expertise, and skills of the team members to successfully accomplish the goals of the project. One key consideration is that teams employing multidisciplinary approaches and having diverse areas of intellectual and technical expertise are more productive if the process for making decisions incorporates different points of view. The Team Management Plan should describe how major decisions will be made or how conflicts will be resolved.
Resource sharing and allocation across the team: Applications should describe management and decision-making processes that promote collective input for allocation of program resources with flexibility when resources may need to be dynamically reallocated to achieve programmatic goals. A plan for how intra-team, institutional, and regional resources that are integral to the team goals will be shared and made accessible to team members should also be included.
Credit assignment: A plan for how credit and IP will be shared, especially with the R15 institutions students, should be included. Methods for attributing contributions to publications should be described to enable individual professional assessment in joint projects.
Coordination and communication plans: Practical aspects should be described, including frequency and logistics of real-time communication across all key personnel, consultants, scholars, early-stage investigators etc., and other significant contributors regardless of effort level.
An important and meaningful impact of team science may come from shaping the next generation of pain scientists. Because of the interdisciplinary expertise of the research groups, students are exposed to and can learn a variety of scientific approaches and methodologies, resulting in multifaceted early-stage investigators. Plans for how students trainees will be immersed in and benefit from different approaches taken by the collective team program should be described. This could include shared mentorship, inter-laboratory meetings, all-hands tutorials, shared meeting and document space, inter-laboratory visits, and student presentations.
2. Provost Letter(s) of Support: The application must include a PDF-formatted letter named ProvostLetter.pdf (without quotation marks). For MPI applications a signed provost letter is required from each involved institution. The letter must be signed by the provost or similar official with institution-wide responsibility attesting to the following information:
For Undergraduate Focused Institutions:
For Health Professional and Graduate Schools:
3. Collaborator Letter(s) of Support: Applications must include additional PDF-formatted letter(s) from collaborating subaward holder(s) named CollaboratorLetter_ Initials .pdf (without quotation marks). For multiple collaborators, a signed letter is required from each involved collaborator. Note that collaborators do not need to meet the R15-eligibility criteria outlined above. The letter should demonstrate the collaborator's willingness to collaborate with the study lead as well as briefly outline their contributions to the project that will result in a well-integrated, interdisciplinary research approach to the understanding of pain. If the proposed collaboration is a new research partnership among investigators, this information should also be included.
Plan for Enhancing Diverse Perspectives (PEDP)
Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:
Examples of items that are not appropriate in a PEDP include, but are not limited to:
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials .
R&r or modular budget.
Budget Justification:
Personnel Justification: Since a primary objective of the PREP is to expose and incorporate students into multidisciplinary pain research, PD(s)/PI(s) must include health professional or undergraduate and/or graduate students from the applicant institution/applicant component in the proposed research. Students from the R15-eligible institution should compose the majority of the research team (two thirds or more). Indicate aspects of the proposed research in which students will participate. If participating students have not yet been identified, the number and academic level of those to be involved should be provided. Collaborators or consultants for the project should provide additional budget information, including their names, their organizational affiliations, and the services they will perform.
PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.
Phs 398 cover page supplement, phs 398 research plan.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Research Strategy:
The research strategy must address how the proposed project intends to accomplish all three objectives of this program, including: 1) Supporting the efforts by R15-eligible principal investigators (PIs) at undergraduate-focused institutions OR health professional schools and graduate schools to conduct small-scale basic and mechanistic pain research; (2) promoting integrated, interdisciplinary research partnerships between R15-eligible PIs and additional investigators from U.S. domestic institutions; and (3) enhancing the pain research environment at the R15-eligible institution for health professional students or undergraduate and/or graduate students by actively engaging them in the proposed pain research projects.
Applications should include a detailed description of a research approach that will produce rigorous data that can be disseminated and advance our basic and mechanistic understanding of pain. Additionally, the research strategy should detail how the proposed research partnership includes sufficient integrative pain expertise and related resources and/or institutional infrastructure that increase the likelihood of success. The application should detail how the proposed scientific research and proposed program and research partnership will have a substantial effect on strengthening the research environment at the proposed applicants institution.
Applications should provide details on how the research project will be directed by the R15-eligible PI and how two-thirds of the research project will be conducted at the R15-eligible institution. The research strategy should detail how the research team will recruit additional prospective investigators, including students, from a range of backgrounds, skills, and expertise for the broad pool of researchers who may apply to participate and contribute to the project. Applications should include details about how the investigators will cooperate and coordinate their activities with other HEAL investigators at PD/PI meetings, including (but not limited to) other investigators in the R15 program, the HEAL Annual Scientific and PURPOSE meetings.Proposed PD/PI(s) should include evidence of experience supervising students in previous research efforts, as well as describing any innovative approaches to engage students in the proposed pain research project. Applications should provide additional details outlining student involvement in the research project by addressing the following questions:
Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
The NIH HEAL Initiative has additional requirements that must be addressed in the Data Management and Sharing Plan. All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEALs compliance guidance ( https://heal.nih.gov/data/complying-heal-data-sharing-policy ). Specifically, HEAL applicants must include:
The NIH HEAL Initiative has developed additional details and resources to fulfill these requirements ( https://www.healdatafair.org/resources/road-map ). Budgeting guidance for data sharing can be found in NOT-OD-21-015 and the NIH Scientific Data Sharing site .
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
Section 2 - Study Population Characteristics
2.5 Recruitment and Retention Plan
Describe the following:
2.7 Study Timeline
Include a table or graph of the overall study timeline. This is expected to be a visual representation (such as a Gantt chart) of recruitment milestones and key project management activities. A narrative is not expected in this section.
The study timeline should include recruitment milestones that need to be met throughout the life cycle of the clinical trial to ensure its success, and the subtasks that will be used to reach the recruitment milestones. In the timeline, the study duration is expected to be displayed in months. The timeline should include, but is not limited to, the following:
(a) When the study opens to enrollment (b) When recruitment milestones (see below) are met (c) What subtasks are needed to reach of the recruitment milestones (d) When final transfer of the data will occur (e) When analysis of the study data will occur (f) When the primary study manuscript will be submitted for publication
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.
3. unique entity identifier and system for award management (sam).
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIHs electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide .
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide . Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide .
See more tips for avoiding common errors.
Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO and title, PD/PI name, and title of the application.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35 .
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] .
Applicants are required to follow the instructions for post-submission materials, as described in the policy
The following post-submission materials will be accepted: Team Management Plan (e.g., due to the hiring, replacement, or loss of an investigator).
1. criteria.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular NOFO, note the following:
The purpose of this HEAL Initiative program is to (1) support the efforts by R15-eligible principal investigators (PIs) at primarily undergraduate-focused serving institutions or health professional schools and graduate schools to conduct small-scale basic and mechanistic pain research projects ; (2) promote integrated, interdisciplinary research partnerships between R15-eligible PIs and investigators from U.S. domestic institutions; and (3) enhance the pain research environment at the R15-eligible institution for health professional students or undergraduate and/or graduate students by actively engaging them in the proposed pain research projects.
Applications in response to this notice of funding opportunity (NOFO) should include plans to accomplish these goals. Specifically, applications should include a rigorous plan for conducting basic and mechanistic pain research projects in the Research Strategy section of the application . In addition, a research partnership between the PIs institution and at least one investigator from a separate U.S. domestic institution that provides resources and/or expertise that will enhance the proposed pain research program must be included in a separate Team Management Plan. The proposed partnership will be a sub-award agreement(s) with at least one partnering institution, which does not need to be R15-eligible. The budget of all sub-awards must not exceed one third of the total budget. Furthermore, applications must include a Facilities & Other Resources document that demonstrates active involvement of health professional students or undergraduate and/or graduate students from the R15-eligible institution(s) in the proposed pain research projects.
Although preliminary data are not required for an R15 application, they may be included if available. The scientific foundation for the proposed research should be based on published research and/or any available preliminary data.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).As part of the overall impact score, reviewers should consider and indicate how the Plan for Enhancing Diverse Perspectives affects the scientific merit of the project.
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific to this NOFO:
Taking into consideration the type of R15-eligible institution the application has been submitted from, if funded, will this grant have a substantial effect on strengthening the research environment at the applicant institution and exposing students to research ?
Does the project adequately describe how the research partnership will advance our understanding of pain conditions?
If the aims of the project are achieved, will the project yield rigorous data that can be disseminated and is likely to be important to the field?
Will the proposed collaboration appropriately improve the R15 institutional environment in a manner to support more students to engage in pain research at that institution?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application provide details about how the research project will be directed by the R15-eligible PI and how two-thirds of the research project will be conducted at the R15-eligible institution?
Is it clear how the applicant intends to recruit additional prospective investigators, including students, from a range of backgrounds, skills, and expertise for the pool of researchers who may apply to address the proposed scientific problem?
Will the combined scientific expertise (of the proposed collaborative research team) likely result in a well-integrated, interdisciplinary research approach to the understanding of pain?
Does the team of investigators include sufficient integrative pain expertise for the proposed research?
How appropriate is the PD/PI's experience in supervising and engaging students in research?
Does the application include details about how the investigators will cooperate and coordinate their activities with other HEAL investigators at PD/PI meetings, including (but not limited to) other investigators in the R15 program, the HEAL Annual Scientific and PURPOSE meetings?
Team Management Plan (Attachment):
How fair and adequate are the governance processes for decision making, conflict resolution, and resource allocation outlined in the plan?
How effective is the plan for team leadership and management with sufficient examples of distributed responsibility?
How well would the program leadership create a sustainable environment for maintaining cohesiveness, productivity, and shared vision?
How adequate are the management plans for shared professional credit?
If shared research resources will be utilized, how adequate are the plans for resource sharing and allocation to ensure that all team members will have the access they require?
How well does the plan include examples of team coordination and communication?
How clearly does the plan include details about which personnel are available at the R15-eligible institution(s), including health professional students or graduate students or undergraduate students, that would compose a two-thirds majority of the project team and how they would contribute to the research project?
How well does the management plan outline how the collaborative partnership will supervise and engage students?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Does the proposed research include innovative interdisciplinary pain research topics?
Is the proposed research partnership a new collaboration between investigators?
Are innovative approaches for engaging health professional or undergraduate and/or graduate students in research proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Taking into consideration the type of R15-eligible institution the application has been submitted from, how suitable are the plans for ensuring that students are well integrated into the research program?
How will this project provide students with a high-quality research experience focused on the execution, analysis, and reporting of the study?
Would students have adequate opportunities to present at national or local meetings, publish research findings, and/or participate in other collaborative activities?
Would the proposed research project provide adequate opportunities for students to improve their research capabilities and support their progress toward a biomedical research career?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Does the "Facilities & Other Resources" attachment describe strong and innovative approaches to how students or trainees will participate in the research project?
Does the application demonstrate appropriate plans to recruit health professional or undergraduate and/or graduate students from diverse backgrounds to participate in the research project?
Does the application provide a plan to aid students at the R15-eligible institution/academic component to pursue careers in the biomedical sciences?
Do(es) the PD/PI(s) have sufficient time and institutional support to conduct the proposed project?
Is there synergy to be gained from the integrated, interdisciplinary research partnership(s) among the multiple proposed institutions?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Specific to this NOFO: Are the clinical trial recruitment milestones feasible given the proposed study timeline?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not applicable.
Not applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms ) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .
1. award notices.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipients business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions . Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website ( https://register.clinicaltrials.gov ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support .
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
HEAL Data Sharing Requirements
NIH intends to maximize the impact of NIH HEAL Initiative-supported projects through broad and rapid data sharing. All NIH HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy. NIH HEAL Initiative award recipients must follow all requirements and timelines developed through the HEAL Initiative Data Ecosystem ( https://heal.nih.gov/about/heal-data-ecosystem ), as described in the initiatives compliance guidance (See Already Funded section: https://heal.nih.gov/data/complying-heal-data-sharing-policy ):
1. Select a HEAL-compliant data repository ( https://www.healdatafair.org/resources/guidance/selection )
2. Within one year of award, register your study with the HEAL platform ( https://heal.github.io/platform-documentation/study-registration/ )
3. Within one year of award, submit HEAL-specific study-level metadata.
4. Submit data and metadata (and code, if applicable) to HEAL-compliant repository
6. Additional Requirements for NIH HEAL Initiative studies conducting clinical research or research involving human subjects.
These studies must meet the following additional requirements:
Additional details, resources, and tools to assist with data-related activities can be found at https://www.healdatafair.org . Budgeting guidance for data sharing can be found in NOT-OD-21-015 and the NIH Scientific Data Sharing site .
All data collected as part of the NIH HEAL Initiative are collected under a Certificate of Confidentiality and entitled to the protections thereof. Institutions who receive data and/or materials from this award for performance of activities under this award are required to use the data and/or materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and Federal laws and regulations, including any informed consent requirements and the terms of the institutions NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d). Failure to adhere to this criterion may result in enforcement actions.
Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm
( To follow the next section ):
Report and ensure immediate public access to HEAL-funded publications
Publications resulting from NIH HEAL Initiative-funded studies must be immediately publicly available upon publication.
Prior to publication, the NIH HEAL Initiative expects investigators to alert their program officers of upcoming manuscripts to ensure coordination of communication and outreach efforts.
Award recipients and their collaborators are required to acknowledge NIH HEAL Initiative support by referencing in the acknowledgment sections of any relevant publication:
This research was supported by the National Institutes of Health through the NIH HEAL Initiative ( https://heal.nih.gov ) under award number [include specific grant/contract/award number; with NIH grant number(s) in this format: R01GM987654].
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email: [email protected] (preferred method of contact) Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email: [email protected]
Alex Tuttle, Ph.D. National Center for Complementary and Integrative Health (NCCIH) Phone: 301-814-6115 Email: [email protected]
Mark Egli, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phone: 301-594-6382 E-mail: [email protected]
Rebecca N Lenzi, Ph.D. NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) Phone: (301) 402-2446 E-mail: [email protected]
Rene Etcheberrigaray, M.D. National Institute on Aging (NIA) Phone: 301-451-9798 Email: [email protected]
Susan Marden, PhD, RN Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-435-6838 Email: [email protected]
Elizabeth Sypek, PhD National Institute of Neurological Disorders and Stroke (NINDS) Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears 2 weeks after the submission due date).
Debbie Chen National Center for Complementary and Integrative Health (NCCIH) Phone: 301-594-3788 Email: [email protected]
Judy Fox National Institute on Alcohol Abuse and Alcoholism (NIAAA) Telephone: 301-443-4704 Email: [email protected]
Erik Edgerton NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) Phone: 301-594-7760 E-mail: [email protected]
Ryan Blakeney National Institute on Aging (NIA) Phone: 301-451-9802 Email: [email protected]
Margaret Young Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-642-4552 Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
IMAGES
VIDEO
COMMENTS
Formulating research objectives has the following five steps, which could help researchers develop a clear objective: 8. Identify the research problem. Review past studies on subjects similar to your problem statement, that is, studies that use similar methods, variables, etc.
Example: Research objectives. To assess the relationship between sedentary habits and muscle atrophy among the participants. To determine the impact of dietary factors, particularly protein consumption, on the muscular health of the participants. To determine the effect of physical activity on the participants' muscular health.
Research questions, hypotheses and objectives. There is an increasing familiarity with the principles of evidence-based medicine in the surgical community. As surgeons become more aware of the hierarchy of evidence, grades of recommendations and the principles of critical appraisal, they develop an increasing familiarity with research design.
The research aims, objectives and research questions (collectively called the "golden thread") are arguably the most important thing you need to get right when you're crafting a research proposal, dissertation or thesis.We receive questions almost every day about this "holy trinity" of research and there's certainly a lot of confusion out there, so we've crafted this post to help ...
3. Simple hypothesis. A simple hypothesis is a statement made to reflect the relation between exactly two variables. One independent and one dependent. Consider the example, "Smoking is a prominent cause of lung cancer." The dependent variable, lung cancer, is dependent on the independent variable, smoking. 4.
INTRODUCTION. Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses.1,2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results.3,4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the ...
and hypotheses, and sometimes objectives, to shape and specifically focus the purpose of the study. Quantitative research questionsinquire about the relationships among variables that the investigator seeks to know. They are used frequently in social science research and especially in survey studies. Quantitative hypotheses, on the other hand ...
2-sided hypotheses are generally preferred unless there's a strong justification for a 1-sided hypothesis. A solid research hypothesis, informed by a good research question, influences the research design and paves the way for defining clear research objectives. Types of Research Hypothesis. Y- and X-Centered Research Designs
The specific group being studied. The predicted outcome of the experiment or analysis. 5. Phrase your hypothesis in three ways. To identify the variables, you can write a simple prediction in if…then form. The first part of the sentence states the independent variable and the second part states the dependent variable.
A research objective is defined as a clear and concise statement of the specific goals and aims of a research study. It outlines what the researcher intends to accomplish and what they hope to learn or discover through their research. Research objectives are crucial for guiding the research process and ensuring that the study stays focused and ...
Research Objectives. Research objectives refer to the specific goals or aims of a research study. They provide a clear and concise description of what the researcher hopes to achieve by conducting the research.The objectives are typically based on the research questions and hypotheses formulated at the beginning of the study and are used to guide the research process.
The number of hypotheses should be determined based on the research objectives, research questions, and the complexity of the research topic. It is important to ensure that the hypotheses are focused, testable, and directly related to the research aims. 9. Can research hypotheses be used in qualitative research?
The first question asks for a ready-made solution, and is not focused or researchable. The second question is a clearer comparative question, but note that it may not be practically feasible. For a smaller research project or thesis, it could be narrowed down further to focus on the effectiveness of drunk driving laws in just one or two countries.
Additionally, research objectives are integral components of the research framework, establishing a clear direction that aligns with the overall research questions and hypotheses. This alignment helps to ensure that the study remains focused and relevant, facilitating the systematic collection, analysis, and interpretation of data.
Examples of research hypotheses can guide researchers in writing effective ones. In this blog, we'll learn what a research hypothesis is, why it's important in research, and the different types used in science. ... Choose research methods that align with your study objectives, such as experiments, surveys, or observational studies. The ...
A research hypothesis (or scientific hypothesis) is a statement about an expected relationship between variables, or explanation of an occurrence, that is clear, specific and testable. So, when you write up hypotheses for your dissertation or thesis, make sure that they meet all these criteria. If you do, you'll not only have rock-solid ...
Summary. One of the most important aspects of a thesis, dissertation or research paper is the correct formulation of the aims and objectives. This is because your aims and objectives will establish the scope, depth and direction that your research will ultimately take. An effective set of aims and objectives will give your research focus and ...
HYPOTHESES & RESEARCH QUESTIONS Nature of Hypothesis The hypothesis is a clear statement of what is intended to be investigated. It should be specified before research is conducted and openly stated in reporting the results. This allows to: Identify the research objectives Identify the key abstract concepts involved in the research
uestion, hypothesis and study objectives:Study: Warden SJ, Metcalf BR, Kiss ZS, et al. Low intensity pulsed ultrasound for chronic patellar tendinopathy: a randomi. d, double blind, placebo cont. olled trial. Rheumatology 2008;47:467-71.Research question: How does low intensity pulsed ultrasound (LIPUS) compare with a placebo device in ...
A good research question is essential to guide your research paper, dissertation, or thesis. All research questions should be: Focused on a single problem or issue. Researchable using primary and/or secondary sources. Feasible to answer within the timeframe and practical constraints. Specific enough to answer thoroughly.
The primary objective of a study is paired with the hypothesis of the study, and should be clearly stated in the introduction of the research protocol. Objectives usually state exactly the outcome measures that are going to be used within their statements. Strong verbs like determine, measure, assess, evaluate, identify, examine, investigate ...
The steps to write a research hypothesis are: 1. Stating the problem: Ensure that the hypothesis defines the research problem. 2. Writing a hypothesis as an 'if-then' statement: Include the action and the expected outcome of your study by following a 'if-then' structure.
In every research, the terms 'research aim', 'research objectives', 'research questions' and 'research hypotheses' tend to have precise meaning, therefore defining the core objectives is the ...
Objective 1: Develop Small-Scale Basic and Mechanistic Pain Research Projects. Proposed research projects should be hypothesis driven and use a rigorous scientific design to generate research data/evidence and advance scientific knowledge. Applications should include objectives that are attainable within the 3-year grant period.