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Writing a Scientific Research Project Proposal

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The importance of a well-written research proposal cannot be underestimated. Your research really is only as good as your proposal. A poorly written, or poorly conceived research proposal will doom even an otherwise worthy project. On the other hand, a well-written, high-quality proposal will increase your chances for success.

In this article, we’ll outline the basics of writing an effective scientific research proposal, including the differences between research proposals, grants and cover letters. We’ll also touch on common mistakes made when submitting research proposals, as well as a simple example or template that you can follow.

What is a scientific research proposal?

The main purpose of a scientific research proposal is to convince your audience that your project is worthwhile, and that you have the expertise and wherewithal to complete it. The elements of an effective research proposal mirror those of the research process itself, which we’ll outline below. Essentially, the research proposal should include enough information for the reader to determine if your proposed study is worth pursuing.

It is not an uncommon misunderstanding to think that a research proposal and a cover letter are the same things. However, they are different. The main difference between a research proposal vs cover letter content is distinct. Whereas the research proposal summarizes the proposal for future research, the cover letter connects you to the research, and how you are the right person to complete the proposed research.

There is also sometimes confusion around a research proposal vs grant application. Whereas a research proposal is a statement of intent, related to answering a research question, a grant application is a specific request for funding to complete the research proposed. Of course, there are elements of overlap between the two documents; it’s the purpose of the document that defines one or the other.

Scientific Research Proposal Format

Although there is no one way to write a scientific research proposal, there are specific guidelines. A lot depends on which journal you’re submitting your research proposal to, so you may need to follow their scientific research proposal template.

In general, however, there are fairly universal sections to every scientific research proposal. These include:

• Title: Make sure the title of your proposal is descriptive and concise. Make it catch and informative at the same time, avoiding dry phrases like, “An investigation…” Your title should pique the interest of the reader.
• Abstract: This is a brief (300-500 words) summary that includes the research question, your rationale for the study, and any applicable hypothesis. You should also include a brief description of your methodology, including procedures, samples, instruments, etc.
• Introduction: The opening paragraph of your research proposal is, perhaps, the most important. Here you want to introduce the research problem in a creative way, and demonstrate your understanding of the need for the research. You want the reader to think that your proposed research is current, important and relevant.
• Background: Include a brief history of the topic and link it to a contemporary context to show its relevance for today. Identify key researchers and institutions also looking at the problem
• Literature Review: This is the section that may take the longest amount of time to assemble. Here you want to synthesize prior research, and place your proposed research into the larger picture of what’s been studied in the past. You want to show your reader that your work is original, and adds to the current knowledge.
• Research Design and Methodology: This section should be very clearly and logically written and organized. You are letting your reader know that you know what you are going to do, and how. The reader should feel confident that you have the skills and knowledge needed to get the project done.
• Preliminary Implications: Here you’ll be outlining how you anticipate your research will extend current knowledge in your field. You might also want to discuss how your findings will impact future research needs.
• Conclusion: This section reinforces the significance and importance of your proposed research, and summarizes the entire proposal.
• References/Citations: Of course, you need to include a full and accurate list of any and all sources you used to write your research proposal.

Common Mistakes in Writing a Scientific Research Project Proposal

Remember, the best research proposal can be rejected if it’s not well written or is ill-conceived. The most common mistakes made include:

• Not providing the proper context for your research question or the problem
• Failing to reference landmark/key studies
• Losing focus of the research question or problem
• Not accurately presenting contributions by other researchers and institutions
• Incompletely developing a persuasive argument for the research that is being proposed
• Misplaced attention on minor points and/or not enough detail on major issues
• Sloppy, low-quality writing without effective logic and flow
• Incorrect or lapses in references and citations, and/or references not in proper format
• The proposal is too long – or too short

Scientific Research Proposal Example

There are countless examples that you can find for successful research proposals. In addition, you can also find examples of unsuccessful research proposals. Search for successful research proposals in your field, and even for your target journal, to get a good idea on what specifically your audience may be looking for.

While there’s no one example that will show you everything you need to know, looking at a few will give you a good idea of what you need to include in your own research proposal. Talk, also, to colleagues in your field, especially if you are a student or a new researcher. We can often learn from the mistakes of others. The more prepared and knowledgeable you are prior to writing your research proposal, the more likely you are to succeed.

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One of the top reasons scientific research proposals are rejected is due to poor logic and flow. Check out our Language Editing Services to ensure a great proposal , that’s clear and concise, and properly referenced. Check our video for more information, and get started today.

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• v.62(5); Sep-Oct 2017

Summary and Synthesis: How to Present a Research Proposal

Maninder singh setia.

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

Saumya Panda

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

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

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

Components of a Research Proposal

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

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

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

A complete clinical research protocol includes the following:

Study design

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

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

Project Summary

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

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

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

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

Background and Review of Literature

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

Provide a critical analysis of the literature

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

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

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

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

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

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

Discuss the limitations and lacunae of these studies

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

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

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

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

Justify the present proposal by review

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

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

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

Aims and Objectives

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

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

The specific objectives are:

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

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

For example, the methods should describe the following:

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

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

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

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

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

Study population, sampling strategy, and sample size

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

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

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

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

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

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

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

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

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

Types of study (Source: Panda, 2015)

Research questions vis-a-vis study designs

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

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

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

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

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

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

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

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

Variables of interest and collection of these variables

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

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

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

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

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

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

Statistical methods

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

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

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

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

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

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

Multivariate models

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

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

Clinical Record Forms

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

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

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

Concluding Remarks

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

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Conflicts of interest.

There are no conflicts of interest.

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Debra A. Schwinn , Elizabeth R. DeLong , Steven L. Shafer; Writing Successful Research Proposals for Medical Science   . Anesthesiology 1998; 88:1660–1666 doi: https://doi.org/10.1097/00000542-199806000-00031

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HIGH-QUALITY research proposals are required to obtain funds for the basic and clinical sciences. In this era of diminishing revenues, the ability to compete successfully for peer-reviewed research money is essential to create and maintain scientific programs. Ideally, the essentials of “grantsmanship” are learned through observation and participation in grant preparation, but the training environment experienced by most physicians typically focuses on clinical skills. Most physicians are never exposed to a research environment and therefore do not learn how to write grants. The result is that many clinical studies, even when designed by skilled clinicians and those that address important clinical questions, often do not compete successfully with proposals written by basic scientists. This creates a perception that clinical studies are not favorably viewed by research review committees. The opposite is probably closer to the truth; research review committees are very keen to fund excellent clinical research. Although greater numbers of researchers with Ph.D. degrees have applied for National Institutes of Health (NIH) grants compared with researchers with M.D. degrees over the last 10 yr, funding rates (percent applications funded) have remained approximately the same for these investigators ( Figure 1 ; 1995 success rates: all degrees, 6,759 [26.8%]; M.D. - Ph.D., 370 [23.1%]; M.D., 1,518 [28.1%]; Ph.D., 4,746 [26.8%]; other degree, 125 [23.1%]).[section]

Figure 1. Overall success rates for NIH funding of scientific applications, 1986 - 1995. No difference in funding rate is observed between applicants holding M.D. versus Ph.D. degrees. As the success rate for first-time applications was 11.3% in 1993, it is apparent that resubmission of a revised application significantly increases the overall chance of having research proposal ultimately funded.[section]

Capable medical researchers ultimately write research proposals for funding by the NIH. Standards of excellence for NIH grants are high (only the top [almost equal to] 20% of grants are funded). Research questions posed must be hypothesis driven; the investigator must be qualified to perform the study; and preliminary evidence should be presented demonstrating that the research is feasible and will answer the questions posed. The goal of this article is to review important elements of successful research proposals, with emphasis on funding sources available to the anesthesiology community. Two important anesthesia-specific organizations exist to support anesthesia research - The Foundation for Anesthesia Education and Research (FAER, an organization under the auspices of the American Society of Anesthesiologists) and the International Anesthesiology Research Society (IARS).

Successful applications for research support from FAER and IARS have many of the characteristics of grants funded by the NIH and other peer-reviewed funding sources. These characteristics include (1) a highly qualified investigator(s);(2) for junior investigators, a mentor with a successful track record in scientific investigation, peer-reviewed funding, and mentorship of fellows and faculty;(3) a supportive academic environment; and (4) a scientifically sound proposal. Each of these characteristics is discussed in the subsequent sections.

Training of the Investigator

One of the most important components of a successful research proposal is a well-trained investigator. Training in clinical anesthesia is not training in research methodology or scientific thinking; it does not prepare an individual for a career in investigation. Although obvious for basic science research, clinical research also requires commitment of a minimum of 1 yr of dedicated training with a good mentor, and more typically 2 - 3 yr in the field of the proposed research. The applicant also needs to demonstrate commitment to a career in investigation. Several years of scientific training is the first demonstration of such commitment. Research proposals must document institutional support for nonclinical time, and the investigator must provide evidence that this time has been used wisely and will continue to be dedicated to the proposed research.

The research proposal must document a track record of productivity by the investigator. This expectation increases as the training and career of the investigator progresses. Fellowship awards do not have an expectation of prior research training, so publications from prior research are not expected. At the fellowship level, outstanding letters of recommendation, undergraduate and medical school performance, and related accomplishments are most important. Because previous training is not required of the fellowship applicant, prior success of the mentor (publications and track record with previous trainees) weighs heavily in the fellowship review. For junior faculty, peer-reviewed publications are expected from the fellowship period. Young Investigator Annoucements (from FAER) and several new IARS awards require several years as a successful junior faculty member, so expectations of demonstrated research success are further increased. The investigator must demonstrate (1) rigorous training, (2) commitment to research, (3) an appropriate career path, and (4) a track record of productive work. None of these are trivial issues, and none can be easily accomplished without making a commitment to research early in the academic career.

The quality of the mentor is another important aspect of awards granted to fellows and junior faculty. Identification of a mentor is explicitly required for FAER and certain junior level NIH grant applications. First and foremost, the mentor must be a successful investigator. Criteria for this include a track record of publication in the area of the proposed research, continued peer-reviewed funding, and a history of successfully training young investigators. Although mentorship is not considered heavily in more senior grant applications, input from a more experienced investigator often remains beneficial throughout one's career (as we can personally attest to). In addition to the mentor, high-quality coinvestigators, collaborators, and consultants also play important roles in strengthening a research proposal.

Environment

Good research is best accomplished in a supportive, cooperative environment. Because of the changing climate of clinical medicine, researchers (both clinical and basic science) face increasing pressure to minimize research time. It is not possible to become a successful investigator in one's spare time. Documentation of adequate nonclinical time for research (not for committee meetings or other unrelated tasks) is essential. Receiving funding at a junior level often enables the department to match funds or to guarantee nonclinical time to the budding investigator. In general, the more non-clinical time available to an investigator, the more competitive the application.

Other important elements of the environment include people, space, and institutional resources. People include mentors, consultants who can help with specific methodologies, statistical support, helpful colleagues, experienced technicians, a clinical research team, and a dedicated chairperson. There must be adequate space for performing the proposed studies, office space for research personnel, and storage space for equipment and supplies. Institutional resources include related departmental and interdepartmental seminar series, a critical mass of investigators in a related area, instrument development and repair shops, and necessary laboratory space and common facilities.

Criteria for a sound research proposal are the same whether the proposal is submitted to NIH, FAER, IARS, or other funding sources. In crafting a proposal, it is essential to consider the perspective of the reviewer; therefore, items of interest to the reviewer are listed after general definition of the grant proposal.

Review committees receive dozens of grants. NIH study sections may review as many as 150 proposals during one session. Typically, only two or three reviewers are assigned to read each grant in detail, but everyone is expected to read each abstract. Hence, the abstract is often one of the most important parts of the research proposal. The abstract should address the significance of the question and the overall topic, state the hypothesis, and point out key preliminary data. Additionally, the abstract should provide a synopsis of methodologies planned. In the end, the reviewer must be convinced that the applicant is uniquely (or ideally) suited to undertake this important study by the end of this concise paragraph.

Body of the Grant

Specific Aims. The specific aims section is critically important in a scientific proposal. It is here that the investigator crystallizes the overall goal of the research and states specific hypotheses.

Beginning with the specific aims, the proposal must be well written and logically organized. A poorly organized grant application is difficult to review, even if the science is otherwise excellent. Typically, the specific aims begin with a short introduction (one paragraph), followed by a formally stated hypothesis. The hypothesis must be answerable by the research methods proposed. Generally, two or three specific aims are outlined with subheadings where appropriate. Organization of the specific aims is often temporal, starting with a proposed mechanism or the first set of studies in a clinical project. In general, the specific aims section should be no longer than one page.

Background and Significance. The background section provides an opportunity to bring reviewers up to date on current research in the area of the proposal. This section should summarize succinctly studies from the literature and related work published by the investigator. The most crucial aspect of the background is to build a case for significance of the proposed research regarding the ultimate clinical application or mechanistic understanding. Ideally, the background section should demonstrate that the current proposal is a logical extension of previous studies in the field and will provide new information and novel insights. In general, the background section should be about one fourth of the length of the grant proposal.

Preliminary Data. Preliminary data provide the opportunity for the investigator to demonstrate his or her ability to perform the proposed research. The goal in presenting preliminary data is to convince the reviewer that the investigator is capable of performing the proposed studies and that the mechanisms proposed are plausible. Good preliminary data support novel (or even unlikely) hypotheses. Each experimental method proposed should be accompanied by preliminary data demonstrating facility and expertise with related preparations. For example, if the investigator proposes using a specific electrophysiologic technique to study an ion channel, evidence demonstrating that this technique has been used by the investigator with other ion channels and a Figure showingresults from pilot experiments on the channel of interest would suffice. In clinical studies, demonstration of a working investigative team and the ability to enroll a given number of patients per week is helpful. Figures or tables help to convey the message in a succinct manner. They also conserve space in the proposal and create a more impressive effect. Although it is best if the applicant has generated his or her own preliminary data, for training awards, preliminary data from the mentor's laboratory is entirely appropriate. An effective way to organize preliminary data is to present it in the same order as the specific aims (e.g., C.1 preliminary data corresponds to A.1 specific aims, C.2 preliminary data corresponds to A.2 specific aims, etc.). Presentation of preliminary data usually takes about one fourth to one third of the length of the grant application.

Methods. The methods are the guts of the research proposal. Unfortunately, many investigators run out of steam by the time they reach the methods, leaving reviewers unconvinced by the proposed methodology. Ideally, the model being investigated should be broken down into simple, logical components, each accompanied by a description of specific experiments/interventions to be performed. The investigator should assume that at least one reviewer is an expert in each method presented. Therefore, enough detail should be provided to convince an expert that the experiment or technique is being performed properly. Methods presented as a list of recipes, requiring the reviewer to guess which method applies to each study, are recipes for disaster. Individual experimental techniques should be state of the art. In addition, approaching a problem from several angles is often helpful. “Lingo” of the field should be avoided; it is very annoying to reviewers to have to look up unexplained abbreviations or to have models alluded to rather than described. For training grants, methods should involve techniques currently being performed in the laboratory of the mentor. An effective way to organize the methods section is to follow the same order as the preliminary data and specific aims sections (e.g., D.1 methods corresponds to C.1 preliminary data and A.1 specific aims, etc.).

The methods sections should include a description of the design, conduct, and analysis of each study being proposed. Common errors in design include lack of specification of primary outcome, lack of randomization or blinding in clinical trials, inadequate justification of sample size, failure to adjust the total study number for expected dropouts/failed experiments or patient refusal, and use of single drug doses or concentrations rather than development of dose - response or concentration - response relations. Common errors in conducting research include lack of confirmation of drug concentrations, inadequate reproducibility of final results, lack of standardization of procedures, inadequate follow-up, incomplete data recording, and overall lack of organization.

Inadequate or inappropriate statistical methods can be a major weakness of a grant proposal. Many investigators feel confident with all aspects of their methods except the statistical section. Because statistical issues underlie the design and analysis strategy for every study, the input of a biostatistician is essential in planning the research and writing the grant application. Statistical considerations include specification of the primary end points that drive power calculations. Common statistical errors in research proposals include lack of sample size/power calculations, treating continuous variables as dichotomous, repeated t tests when a more comprehensive modeling approach should be taken, application of statistical tests that assume normality without verifying assumptions, failure to consider covariate effects, and failure to distinguish between interindividual and intraindividual variability. The investigator should be familiar with the concept of statistical power and be prepared to estimate some of the quantities needed to formulate an alternative hypothesis appropriately. The statistical analysis should be clearly outlined with specific methodology directed toward the hypotheses of the study. A statistical reviewer is unlikely to be convinced by a statement that “appropriate statistical methodology will be used” or by a barrage of nonspecific statistical jargon. At least one full paragraph (and sometimes an entire page) of the research proposal should be devoted to statistical analysis. Often several smaller statistics sections are appropriately included after each method is presented.

Even the best methods have potential problems and weaknesses. It is critical that the methods section discuss potential problems that may be encountered during the study and state how the investigator proposes to deal with these problems creatively. Reviewers tend to be impressed when the investigator presents potential problems that never occurred to them, because it suggests that the investigator is an expert in this area of research. A time line and organizational plan (who will be responsible for what) should also be included in the methods section so the reviewers can determine whether the investigator is being realistic in his or her approach. The methods section is typically one third to one half of the length of the entire grant proposal.

Introduction to Revised Application. Because so few grant applications are funded on their first submission (11.5% in 1993), the new investigator should not be unduly alarmed if his or her application is not funded. When a grant application has been unsuccessful, an investigator should revise the application and reapply, even if the original score was “noncompetitive”(meaning the grant was in the lower 50% of applications). Often the reviewers suggest key changes that will improve the application significantly. When submitting a revised application, an introduction (placed before the specific aims section) is used to discuss how criticisms of the original grant have been addressed in the revised proposal. Because the reviewer's comments are intended to be helpful, it is important to address each concern carefully in the revised proposal (changed text should be highlighted in the revised application by italic, bold, or identifying lines in the margin), with changes outlined in the introduction section. Angry responses to reviewers do not facilitate funding of the revised application. Remember that reviewers usually have a copy of the prior review, and they expect corrections or, when appropriate, an explanation of why you have chosen not to incorporate some suggestions from a prior review. Time taken to revise an application is well spent; as Figure 1 demonstrates, investigators who persist in revising and resubmitting their applications have an increased chance ([almost equal to] 20% with no previous NIH support, [almost equal to] 35% if previously funded) of ultimately being funded.[section]

In writing a research grant, it is helpful to consider the reviewer's perspective. Key features considered by reviewers include significance, approach, and feasibility. It is wise for the investigator to reread his or her application before submission with these features in mind. The NIH recently has published two documents on-line that discuss review criteria; examination of these documents before submission of a research proposal may prove helpful. These include the Report of the Committee on Rating Grant Applications[double vertical bar] and Review Criteria for Rating Unsolicited Research Grants.#

Significance

First and foremost, is the investigator asking an important question? There are two general ways research studies can be significant. The first is to demonstrate clinical significance. The litmus test for clinical significance is whether the proposed research will improve patient care. The second is elucidation of fundamental mechanisms underlying disease or biologic processes. The ideal research question succeeds in being significant in both areas.

The reviewer assesses whether the research plan can support or refute the stated hypothesis. In addition, the reviewer assesses whether the methodologies used provide adequate or, better yet, elegant approaches to the problem. Recently, the NIH has mandated an increasing emphasis on innovation in research. [1] **

Review committees generally are composed of individuals with expertise in many scientific areas. Additionally, study sections often retain outside reviewers with expertise in the proposed research area. The investigator should assume that his or her methods will be critiqued by at least one expert. Therefore, the investigator should not propose a method that would strike the world's expert in the field as being simplistic, inappropriate, or nonsensical, because the world's expert just might be one of the reviewers. Conversely, some reviewers do not have expertise in the proposed area of research. To ensure that the nonexpert is convinced of the validity and importance of proposed methodologies, the overall proposal should be written with a logical flow of ideas that build from basic to sophisticated concepts. Beginning each portion of the methods section with a short introduction for the nonexpert, followed by a more detailed description of the proposed methods, is an effective strategy to address the needs of both expert and nonexpert reviewers.

Feasibility

The investigator must convince reviewers that the chosen approach is feasible. Preliminary data provide the best demonstration of feasibility. Feasibility is often demonstrated by a track record of publications or peer-reviewed grant support for the applicant or mentor using the proposed experimental approach. Feasibility also can be demonstrated by appropriate statistical analysis of the proposal. For example, a power analysis and corresponding data on the number of patients with the required characteristics at the investigator's institution helps convince reviewers that a clinical study is feasible.

Anesthesiology Funding Sources

Funding for research performed by anesthesiologists is available from many sources. Because the discipline of anesthesiology overlaps many other fields, anesthesiologists have the opportunity to apply for research funds from agencies as diverse as the American Academy of Pediatrics, American Cancer Society, American Heart Association (national and local), American Thoracic Society, American Society for Regional Anesthesiology, critical care societies, Department of Veterans Affairs, National Science Foundation, Shriners, Society for Cardiovascular Anesthesiology, Society for Obstetrics and Perinatology, National Aeronautics and Space Aviation, NIH, and many other private foundations. Grants from FAER and IARS are available specifically to the anesthesiology community.

It is important that anesthesiologists continue to apply for NIH grants. For fiscal year 1996, the NIH awarded 149 research grants (including career development grants, R29, R01, and program project grants) to departments of anesthesiology, totaling $21 million in direct costs ([almost equal to]$31 million in total costs). Because of the diversity of research projects in anesthesiology, these grants were awarded by 14 different institutes, centers, and divisions within the NIH. In analyzing data for three recent review sessions (June 1996, October 1996, and February 1997) from the surgery, anesthesiology, and trauma study section, 26% of anesthesiology applications scored in the top 20th percentile, and 31% scored in the top 25th percentile; clearly no bias exists against anesthesiology in this predominantly surgical study section, at least in this limited sample (Alison Cole, anesthesiology representative for the National Institute of General Medicine Science at the NIH, personal communication, December, 1997). Table 1  

Table 1. Number of Recipients of NIH Research Project Annoucements  

A brief list of funding opportunities available to anesthesiologists early in their career is shown in Table 2 . Several sites are available on the World Wide Web ( Table 3 ) to facilitate access to grant/training resources for anesthesiologists. We have created an additional website ( http://pkpd.icon.palo-alto.med.va.gov/grants/grants.htm ), which provides access to more comprehensive lists of funding agencies and direct links to funding sources. This website also contains example grants designed to illustrate the grant writing principles discussed in this article.

Table 2. Potential Funding Sources  

Table 3. Grant/Training Resources on the WWW  

Successful grant applications require a well-trained investigator who carefully outlines a hypothesis-driven research proposal. Unique to FAER and IARS research committees is that the reviewers are mostly investigators and practicing anesthesiologists. These reviewers fully appreciate the importance of clinical research and enthusiastically support high-quality clinical studies. Although descriptive clinical studies are interesting to practicing clinicians, from a scientific perspective, clinical research must be driven by testable hypotheses. Without a testable hypothesis, clinical research cannot pass the test of adequate significance required for funding.

It is our hope that by demystifying the grant writing and review process that more anesthesiologists will be encouraged to submit proposals for research funding. As part of this effort, we strongly encourage residents and fellows interested in research careers to obtain adequate research training and to apply for appropriate fellowship/junior faculty awards early in their careers.

[section] NIH Extramural Data and Trends, Fiscal Years 1986 - 1995. Bethesda, Office of Reports and Analysis (component of the Office of Extramural Research), National Institutes of Health. (Published on-line and periodically updated. http://www.nih.gov/grants/award/award.htm ).

[double vertical bar] Report of the Committee on Rating Grant Applications. Revised 5/17/96. Bethesda, National Institutes of Health. (Published on-line. http://www.nih.gov/grants/peer/rga.pdf ).

# Review Criteria for Rating Unsolicited Research Grants. NIH Guide, Vol. 26, No. 22, 6/27/97. Bethesda, National Institutes of Health. (Published on-line. http://www.nih.gov/grants/guide/1997/97.06.27/notice-review-criter9.html ).

** Brown KS: A winning strategy for grant application: Focus on impact. The Scientist 1997; April 8:13–4

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

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

Table of Contents

How To Write a Research Proposal

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

1. Title and Abstract

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

2. Introduction:

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

3. Research Objectives

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

4. Literature Review:

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

5. Methodology:

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

6. Timeline:

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

7. Resources:

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

8. Ethical Considerations:

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

9. Expected Outcomes and Significance:

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

10. References:

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

11. Appendices:

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

Research Proposal Format

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

1. Title Page:

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

2. Abstract:

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

3. Introduction:

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

5. Research Objectives:

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

6. Methodology:

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

7. Timeline:

8. Resources:

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

9. Ethical Considerations:

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

10. Expected Outcomes and Significance:

11. References:

12. Appendices:

Research Proposal Template

Here’s a template for a research proposal:

1. Introduction:

2. Literature Review:

3. Research Objectives:

4. Methodology:

5. Timeline:

6. Resources:

7. Ethical Considerations:

8. Expected Outcomes and Significance:

9. References:

10. Appendices:

Research Proposal Sample

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

1. Introduction

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

2. Objectives

The main objectives of this research are as follows:

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

3. Methodology

3.1 Study Design

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

3.2 Participants

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

3.3 Data Collection

The research will employ the following data collection methods:

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

3.4 Data Analysis

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

4. Ethical Considerations

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

5. Significance and Expected Outcomes

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

6. Timeline

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

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

8. Conclusion

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

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Affiliation.

• 1 Department of Anaesthesiology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India.
• PMID: 27729688
• PMCID: PMC5037942
• DOI: 10.4103/0019-5049.190617

Writing the proposal of a research work in the present era is a challenging task due to the constantly evolving trends in the qualitative research design and the need to incorporate medical advances into the methodology. The proposal is a detailed plan or 'blueprint' for the intended study, and once it is completed, the research project should flow smoothly. Even today, many of the proposals at post-graduate evaluation committees and application proposals for funding are substandard. A search was conducted with keywords such as research proposal, writing proposal and qualitative using search engines, namely, PubMed and Google Scholar, and an attempt has been made to provide broad guidelines for writing a scientifically appropriate research proposal.

Keywords: Guidelines; proposal; qualitative; research.

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Medical Research Proposal Sample & Guide

Table of Contents

A medical research proposal sample is a great way to understand what your proposal should look like. It can give you the structure and guidance needed to create a successful proposal.  Well-written medical research proposals help researchers stand out from other applicants and boost their chances of being selected or funded. Read on to find out what a medical research proposal entails and how to write yours with our easy sample.

What Is a Medical Research Proposal?

A medical research proposal is a document that outlines the purpose and methodology of a proposed research project . It includes information about what the researcher intends to study, how they plan to conduct their research and measurement for success or failure.  The proposal also explains why the research is essential, what ethical considerations need to be considered, and the potential risks associated with it. 

Why Is a Medical Research Proposal Necessary?

A medical research proposal is essential because it outlines the critical information and details necessary to complete a project successfully.  This document ensures that everyone understands their position and how they will contribute resources, time, and effort to make the project successful. It also helps researchers to secure funding from sponsors and provide transparency for potential participants in the study. 

What to Include in a Medical Research Proposal?

A medical research proposal should include the following:

• A brief description of the project, outlining the purpose and goals. 
• An explanation of how you plan to collect data; through surveys or interviews with participants?
• List any ethical considerations involved, including who will have access to the collected information and how it will be stored securely. 
• Budget required for the research and any timeline associated with the completion of the study. 
• Samples from past researchers, so you can learn more about what makes a successful medical research proposal. 

Steps on How to Write a Medical Research Proposal

It is important to remember that all proposals, no matter the topic, should follow specific steps to make them effective and organized. Here are a few steps to guide you:

Brainstorm and Outline the Problem

The first step is to brainstorm the project you are proposing, making sure that it has relevance in medicine. Determine what issue you are trying to address through your research and explain it clearly as a problem statement. 

Describe Your Project

Provide detailed information on your project, the aims, the expected outcomes, and any methods used to achieve them. 

Break It Into Small Sections

Once you have a clear vision of what you want to accomplish, break it down into small sections to effectively convey your thoughts. 

Set Your Objectives

Set specific objectives for your project and explain how you plan to achieve them. 

Outline Your Methodology

 Describe the processes used to collect data, analyze results, and draw conclusions from the research. 

Discuss Ethical Considerations

Explain any ethical considerations relevant to your proposed project, such as privacy and consent.

Write a Budget

Outline the cost of the project, including any equipment or materials needed.

Proofread the Proposal

Make sure to read through your proposal carefully before submitting it and ask someone else to do so, if possible. 

Medical Research Proposal Sample

To help you get started with your medical research proposal, here is an example: Project Aims:  This project aims to study air pollution’s effects on public health in a particular city.  Objectives:  To investigate how air pollution impacts public health in the target city and how to mitigate it. Methodology:  Data will be collected through surveys, interviews with residents, and environmental air quality sampling.  Ethical Considerations:  All participants in the project must be informed of the risks involved and consent to its use for research purposes. Personal information will be kept confidential and only used for research purposes.  Budget:  The budget allocated for this project is $5000. 

Developing a medical research proposal requires careful consideration and organization. Consequently, a medical research proposal sample might serve as an excellent starting point when writing your own project .

Abir Ghenaiet

Abir is a data analyst and researcher. Among her interests are artificial intelligence, machine learning, and natural language processing. As a humanitarian and educator, she actively supports women in tech and promotes diversity.

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6+ SAMPLE Medical Research Proposal in PDF | MS Word

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To create a medical research proposal, you need to find valuable information and create a complicated document. The proposal is mainly devised for investors, academic heads, or other people who would value the legitimacy of your project proposal and assess the merit. For successful research proposals, you need to follow certain guidelines for efficiency. We have all sorts of medical research proposal templates for users with specific needs. Whether it’s for a clinical Ph.D. research on public health issues or an undergraduate letter over pharmacology, we got them all right here. Or if you are wondering, you can use proposal templates that bring ready-made documents for your benefit!

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IC² Institute, Dell Medical School Seeking Research Proposals to Advance the Use of AI in Health Care

The IC² Institute, in collaboration with Dell Medical School, announces a research funding opportunity aimed at UT Austin faculty and researchers on the theme of “Designing Artificial Intelligence (AI) to Mitigate Health Disparities.”

Through this 2024 call for proposals, the IC² Institute and Dell Med are offering one-year awards up to $75,000 for selected projects with a single principal investigator (PI) or up to $150,000 for collaborative projects including two or more PIs. Collaborative, multi-PI projects must include a Dell Med researcher. The deadline for concept paper submission is May 24, 2024.

Multi-disciplinary research in AI offers the potential to generate technologies producing impactful solutions to diverse and pressing problems. IC² has partnered with Dell Med to grow UT’s expertise and impact in the rapidly evolving area of Health AI — a domain that involves the development and deployment of intelligent systems capable of processing vast amounts of health data, offering diagnostic support, identifying patterns in individual or population health and assisting healthcare professionals in decision-making.

Since adopting its current mission of “innovating well-being” in 2022, the IC² Institute has been actively engaging in research and stakeholder engagement efforts that seek to improve the delivery of health care.  Executive Director S. Craig Watkins explains that engaging UT research experts on this issue holds great promise: “UT has such a strong commitment to cutting-edge research and clinical innovation. By teaming up with Dell Med to stimulate new research from our talented faculty, we can really push our knowledge about the equitable and effective use of AI in health care.” Dell Med Dean Claudia Lucchinetti, M.D., commented further:

“Innovation in technology and AI holds the potential to transform treatment and the delivery of health care.  However, ensuring that their development and application are designed with active input from stakeholders and protecting against bias are key to realizing that potential. By using a collaborative approach to the research in this space, UT is not only shaping the future of care but also making sure that patients and their families realize benefit from this innovation.”

Despite the considerable attention devoted to Health AI, some populations are overlooked in its development and potential benefits. For example, research suggests that the implicit biases in health-based data sets often influence the design of algorithmic models that can lead to disparate and negative impacts on underserved populations. Similarly, AI-informed medical devices may perform poorly when used to treat patients from under-tested populations.

To address these sorts of challenges, the IC² Institute and Dell Med seek research that falls into two broad categories:

• Relating to the use of Health AI in safety-net contexts, research that seeks to deploy AI to better understand disparate health outcomes with greater computational nuance and precision
• Believing that the design of future Health AI will benefit from diverse voices and expertise, research that demonstrates innovative and effective ways to engage community stakeholders in the design and deployment of Health AI.

The IC² Institute and Dell Med are open to research projects that explore health and well-being disparities in relation to geography (i.e., rural or urban); gender/sexuality; race and ethnicity; socio-economic status; and chronic diseases.

As the first part of a two-step review process, the deadline for concept paper submission is May 24, 2024. Select applicants will then be invited to participate in an interactive workshop in June and asked to submit final proposals in July. Additional details and application instructions can be found here .

Learn more about UT’s “Year of AI” initiative and other AI news and campus events at yearofai.utexas.edu .

Tags: TexasAI, Health & Well Being, IC2 Institute, Dell Medical School, Research, Technology

April 2, 2024

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US unveils proposal to ease restrictions on marijuana

By Sarah N. Lynch

WASHINGTON (Reuters) - The U.S. Justice Department on Thursday unveiled a historic proposal to ease restrictions on marijuana, a rule that if enacted would also enable more research on its medicinal benefits.

The proposal, first announced in April, would reclassify cannabis from a so-called schedule one drug to a schedule three. Schedule one drugs, such as heroin, are considered highly addictive with no medical benefits, while schedule three drugs are considered to have a moderate to low potential for physical and psychological dependence.

The U.S. Food and Drug Administration said it found "some credible scientific support for the use of marijuana in the treatment of chronic pain, anorexia related to a medical condition, and nausea and vomiting."

"Additionally, no safety concerns were identified in the FDA’s review that would indicate that medical use of marijuana poses unacceptably high safety risks," the proposal says.

President Joe Biden, a Democrat who is running for reelection in November, initiated a review of the drug's classification in 2022, fulfilling a campaign promise that was important to left-leaning members of his political base.

Currently, the drug falls under the Drug Enforcement Administration's (DEA) class that includes heroin and LSD. It would be moved to a group that contains ketamine and Tylenol with codeine.

Reclassifying marijuana represents a first step toward narrowing the chasm between state and federal cannabis laws. The drug is legal in some form in nearly 40 states.

While rescheduling the drug does not make it legal, it would open up the doors to more research and medical use, help lead to potentially lighter criminal penalties and increase investment in the cannabis sector.

In a new legal opinion made public on Thursday, the Justice Department's Office of Legal Counsel criticized the DEA's long-held approach for how it determines whether a drug has an acceptable medical use, calling it "impermissibly narrow."

The opinion also found that the DEA should "accord significant deference" to the U.S. Department of Health and Human Services' (HHS) scientific and medical determinations.

According to the proposal, HHS's assistant secretary for health recommended that the DEA should place marijuana into schedule three back in August 2023.

The DEA, however, has yet to make its own determination.

If marijuana's classification were to ease at the federal level, cannabis companies could reap significant benefits, such as being eligible for listing on major stock exchanges and more generous tax deductions.

Moreover, they could face fewer restrictions from banks. With marijuana illegal federally, most U.S. banks do not lend to or serve cannabis companies, prompting many to rely on cash transactions.

The public will get 60 days to submit comments on the Justice Department's proposal.

A public hearing on the proposal can also be requested.

(Reporting by Sarah N. Lynch; Editing by Bill Berkrot)

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Clinical Research in Primary Care

Research opportunity announcement: integrating clinical research into primary care settings through network research hubs – a pilot (ot2).

Research Opportunity Announcement Overview

Purpose and Scope

Phased Approach

Definitions

Eligibility

Application Responsiveness

Application Requirements

Objective Review

Special Award Terms

Research Opportunity Announcement Overview #announcementoverview

ROA Number: OTA-24-016

• ROA Posting: May 6, 2024
• Technical Webinar 1: 12pm EDT on May 14, 2024
• Technical Webinar 2: 12pm EDT on May 22, 2024
• Submission Deadline: Complete applications must be submitted under OTA-24-016 via NIH eRA Commons ASSIST no later than 5:00pm EDT on June 14, 2024. Late applications submitted to this ROA will not be accepted.

Brief Overview of the Research Opportunity: The purpose of this limited competition research opportunity announcement (ROA) is to invite applications by organizations currently affiliated with and participating in specific existing clinical research networks --to serve as “Network Research Hubs” and establish the infrastructure to conduct clinical research in primary care settings. This opportunity is limited to organizations that focus on serving rural communities and are part of or funded by: NIH Institutional Development Award Clinical and Translational Research (IDeA-CTR) awards, the NIH Clinical and Translational Science Award (CTSA) Program, and/or the Patient-Centered Outcomes Research Institute’s (PCORI) Patient-Centered Clinical Research Network (PCORnet).

Award Mechanism: This funding opportunity will use the Other Transactions Authority (OTA) governed by 42 U.S. Code § 282 (n)(1)(b) to issue Other Transaction (OT) awards. OT awards are not grants, cooperative agreements, or contracts and use an OTA, provided by law. Policies and terms for individual OTs may vary between awards. Each award is therefore issued with a specific agreement which is negotiated with the recipient, and which may be expanded, modified, partnered, not supported, or later discontinued based on program needs, changing research landscape, performance and or availability of funds.

Anticipated Awards and Budget: NIH anticipates 2-5 awards will be issued through this ROA in FY24. NIH intends to allocate a total of approximately $5M in FY24 and approximately $20M in FY25 to fund Network Research Hubs during the two-year pilot phase, contingent on programmatic objectives, performance and availability of funds. After the two-year pilot phase, individual awards may be terminated, extended, or curtailed based on programmatic objectives, performance, and availability of funds.

Contact Information: [email protected]    

Background #background

In recent years, the U.S. has experienced trending declines in health that are disproportionately occurring in medically underserved and disadvantaged populations. Many of these sectors are also often underrepresented in clinical research. When study demographics don’t match the demographics of those impacted by the illness or condition under investigation, the results may have limited generalizability, leading to evidence gaps and further compounding health disparities. A major barrier to participating in clinical research is lack of access to or availability of clinical studies. In addition, the majority of Americans have never talked to their doctor about participating in research. There is a critical need to extend research participation opportunities to communities often underrepresented in clinical research, and to integrate those opportunities into settings where people seek care.

Therefore, the National Institutes of Health (NIH) is planning to establish a coordinated infrastructure that integrates innovative research into routine clinical care in primary care settings. Through this effort, NIH will:

• Pilot and implement infrastructure to support primary care-based clinical research in mission areas across all NIH Institutes and Centers (ICs) spanning prevention and treatment and with a focus on health equity and whole person health;
• Establish a foundation for sustained engagement with communities underrepresented in clinical research (e.g., individuals who live in rural environments, racial and ethnic minority groups, older adults, persons experiencing challenging social determinants of health and related experiences);
• Implement innovative study designs that address common health issues, including disease prevention; and  
• Utilize a full range of clinical research designs as appropriate, including dissemination and implementation research, to inform clinical practice 

NIH envisions this infrastructure will facilitate and accelerate research advances for adoption and implementation into everyday clinical care, improving health outcomes, and advancing health equity for all Americans.

The infrastructure NIH will pilot and implement is anticipated to include the following components:

• Providing oversight of the studies/protocols and site and study selection 
• Providing statistical and data management support  
• Developing innovative clinical study designs and implementation strategies to minimize burden on participants and providers in primary care settings  
• Operations Center – conducting site feasibility assessments, site agreements/contracting, and coordination of study operations (protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; communications; training; auditing; quality assurance; and data monitoring)  
• Independent Review and Monitoring Boards - including Data and Safety Monitoring Board (DSMB), Observational Study Monitoring Board (OSMB), and the Central Institutional Review Board (IRB)  
• Network Research Hubs – leveraging existing research networks and partnerships with Clinical Sites to conduct clinical research in primary care settings   
• Community Engagement – providing support, advice, and resources, in part through partnerships with existing entities, to facilitate sustained participant and community engagement, community-driven research, and integration of studies in primary and community care settings 
• Industry Partnerships – engaging for-profit partners for collaborative knowledge sharing and potential participation in/use of the infrastructure

Purpose and Scope #purposeandscope

The purpose of this research opportunity announcement (ROA) is to invite applications by existing clinical research networks – as well organizations currently affiliated with and participating in specific existing clinical research networks – to serve as “Network Research Hubs” as part of a larger infrastructure (comprising the components described above) supporting research in primary care settings. These Network Research Hubs must be actively part of (i.e., active funding/award) one or more of the following: NIH Institutional Development Award Clinical and Translational Research (IDeA-CTR) awards, the NIH Clinical and Translational Science Award (CTSA) Program, and/or the Patient-Centered Outcomes Research Institute’s (PCORI) Patient-Centered Clinical Research Network (PCORnet). The Network Research Hubs will serve to expand accrual efforts of select existing NIH-funded studies and develop and conduct new studies with a focus on engaging underrepresented populations, particularly those in rural or underserved areas, and enhancing study inclusivity. Bringing clinical research studies to individuals in their own communities, informed by those communities, and improving clinical research inclusivity will facilitate the generation of a more broadly applicable evidence base that contributes to improved patient outcomes and health equity for all Americans. 

Objectives #objectives

Network Research Hubs will be responsible for:

• Provide clinical research leadership and oversight for clinical studies at all sites supported by and/or partnering with the Network Research Hub, including Clinical Sites.  
• Participate in select existing studies/trials conducted by NIH-funded investigators. Identify and recruit primary care-providing organizations to serve as Clinical Sites for study accrual, supporting the particular needs of each site (e.g., assembling and/or mentoring local research team(s), training providers and clinical staff, assuring protocol adherence, ensuring adequacy of human subjects protections) in collaboration with the Operations Center.
• Accurately identify, screen, recruit and enroll eligible participants for clinical research studies, meeting or exceeding demographic representation and study inclusivity targets as agreed upon with the Scientific and Medical Director and/or the Scientific Committee.
• Implement strategies for culturally appropriate and inclusive study participation, including ensuring study interventions and measures are clinically meaningful and adapted for different populations, as appropriate.
• Provide complete, accurate, and timely collection and entry of high-quality data and biosamples into data management system and repositories as required by the protocol, Scientific Medical Director, and/or Scientific Committee.
• Track and report trial and performance data (e.g., recruitment, retention, adverse events) by site on a regular and frequent basis as required by the clinical studies, the Scientific and Medical Director, Scientific Committee, and/or data and safety monitoring plans.
• If successful with enhancing accrual of an existing NIH-funded study, develop new study ideas (interventional or observational) for consideration by the Scientific and Medical Director, Scientific Committee, and Operations Center that reflect the clinical needs and priorities of the applicant’s community base. These ideas for new studies will require external funding sources to cover study costs not supported by the components of the coordinated infrastructure.
• Respond to information requests for study feasibility assessments (e.g., accessible study population, enrollment estimates, resources available) during research planning and protocol development.
• Identify health disparities and care disparities and needs of the local population of clinical sites for research planning and prioritization.
• Participate in data analysis, development of results, and dissemination efforts as appropriate.
• Ensure that aggregate research results and/or final study findings are shared with study participants through effective communications.
• Work collaboratively with and through individuals and communities on a continuum of practices from outreach to shared decision making to build trust, foster meaningful bi-directional relationships, and identify and address the health needs and priorities of those individuals and communities. 
• Increase and sustain the involvement of research participants, patients, patient advocates, and community organizations as partners in research, including research planning and prioritization.
• Operationalize and sustain engagement from the onset of research activities and through various culturally appropriate approaches to create awareness, provide education, develop and perform targeted recruitment and enrollment activities, and mobilize knowledge of the benefits of the research.
• Leverage existing resources and expand community partnerships (e.g., safety-net health systems, other health systems, grassroots organizations, public health departments, community and faith-based organizations, schools or childcare settings, Tribal organizations and agencies) to increase access to clinical studies.
• Manage unintended consequences and/or breaks in community relationships.
• Evaluate engagement efforts for continuous improvement and sustainability.
• Share approaches and strategies for effective community engagement and build a community of practice.
• In coordination with the Scientific Committee and Scientific and Medical Director, apply and execute innovations across the landscape of clinical research to minimize burden of research on participants and clinical staff. Innovations may include activities such as: leveraging electronic health records for recruitment, randomization, and data collection; leveraging digital health technologies to reduce research burden and facilitate incorporation of diverse precision measurements into participant monitoring and clinical outcomes assessments; aligning clinical care and research workflows; implementing point-of-care trial, pragmatic, and decentralized approaches in study designs.
• Optimize study designs to increase research equity and accessibility in real world health care settings while maintaining scientific rigor.
• Through alignment of research and clinical workflows, facilitate clinical sites movement towards a learning healthcare system, accelerating the adoption and implementation of evidence into clinical practice.
• Accept and implement policies and procedures established and/or approved by the Scientific and Medical Director, Scientific Committee, Operations Director, and/or additional governance structures established as the infrastructure is further developed.
• Contribute to the development of policies and procedures by participating in Working Groups or Sub-Committees of the Scientific Committee and other governing bodies established as the infrastructure is further developed.
• Actively participate and cooperate with quality assurance, study oversight, and study monitoring efforts.
• Interact and collaborate with other federal and non-federal primary care and clinical research networks and entities (e.g., the NIH Community Engagement Alliance (CEAL), Federally Qualified Healthcare Centers (FQHCs), the NIH Collaboratory, IDeA-CTRs, CTSAs, PCORnet), to leverage existing resources and partnerships, as appropriate.
• Work collaboratively with all other components of the coordinated infrastructure.
• Participate in cross-site and cross-component/cross-effort meetings to foster relationship building and enhance partnerships. 
• Identify, track, and consolidate challenges and successes and share best/promising practices to integrating research in primary care settings for scalability and sustainability.

Phased Approach to Launching Studies and Building the Infrastructure #phasedapproach

NIH is planning to launch this effort as a two-year pilot. The first year of the pilot will involve selecting and funding Network Research Hubs through this ROA to support participation in select existing NIH-funded studies that are agreed upon between the applicant and NIH (in coordination with NIH-funded investigators as needed) during negotiations of a potential award. These initial studies may be interventional or observational and are expected to be reasonably suitable for primary care settings. It is expected that the select existing NIH-funded studies will have infrastructure to support operational aspects (e.g., central IRB, data management) for new sites, but resources available and needed will be negotiated prior to award.

If the Network Research Hub is successful in enhancing participant accrual into an existing study, they may potentially expand in year two with new research in coordination with the other components of the infrastructure. In order to leverage the coordinated research infrastructure described above, these new research concepts will require approval by the Scientific and Medical Director, and Operations Director and funding from external sources for all study aspects not covered by the coordinated infrastructure described above (e.g., specific interventions, additional clinical research staff). Before ramping up to an implementation phase in year three, NIH will conduct an evaluation of the program to assess which approaches and efforts are working. NIH may expand, pivot, and/or sunset awards and/or components based on the results.

Definitions #definitions

This announcement follows the definitions for Clinical Trial-Related Terms below in addition to those in the NIH glossary for clinical trial-related terms: https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm.

Additional key terms are defined below:

Central Institutional Review Board (Central IRB) : A centralized approach to human subject protection through a process that streamlines IRB review of selected NIH-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards.

Clinical Research Network : Collaborative groups of researchers and/or clinicians and that come together in partnership with healthcare systems to identify important clinical questions and design clinical studies to answer them, with coordinated support to manage regulatory, financial, scientific, and/or operational aspects of the research.

Clinical Site : A primary care practice, community health center, hospital, or other health services institution where participants are identified, screened, recruited, and/or enrolled in research conducted by the Network Research Hub.

Federally Qualified Health Centers (FQHC) : As defined by the Health Resources and Services Administration (HRSA), public and private non-profit health care organizations that meet certain criteria under the Medicare and Medicaid Programs. FQHCs include:

• Nonprofit entities that receive a grant, or funding from a grant, under section 330 of the Public Health Service Act to provide primary health services and other related services to a population that is medically underserved;
• FQHC “Look-Alikes” – nonprofit entities certified by the Secretary of the U.S. Department of Health and Human Services as meeting the requirements for receiving a grant under section 330 of the Public Health Service Act but are not grantees; and
• Outpatient health programs or facilities operated by a Tribe or Tribal organization under the Indian Self-Determination Act or by an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act.

Medically Underserved Area/Population (MUA/P) : As defined by HRSA, MUAs may be a whole county or a group of contiguous counties, a group of county or civil divisions or a group of urban census tracts in which residents have a shortage of personal health services; MUPs may include groups of persons who face economic, cultural or linguistic barriers to health care.

Milestones : Objective, measurable events that are indicative of project progress occurring as proposed in the application.

Network Research Hub : An institution/organization with an established organizational structure and scientific and statistical leadership for developing, implementing, and analyzing multi-institutional clinical studies/trials.

Other Transactions Authority (OTA) : A unique type of authority that allows an agency to enter into a legal agreement with a recipient organization that is not a contract, grant, or cooperative agreement (Learn more about OTAs on the NIH website) .

Partnership : An association of two or more individuals or entities with a commitment to an ongoing relationship to work toward common goals as established.

Primary Care: As defined by HRSA, the provision of integrated, accessible health services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.

Primary Care Setting : As defined by HRSA, a setting with integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. These don’t meet the criteria:

• Emergency departments
• Inpatient hospital settings
• Ambulatory surgical centers
• Independent diagnostic testing facilities
• Skilled nursing facilities
• Inpatient rehabilitation facilities

Research Opportunity Announcement (ROA) : Used to solicit applications for programs using Other Transactions Authority.

Rural: For the purposes of this ROA, rural areas are defined according to the Office of Management and Budget and Federal Office of Rural Health Policy (FORHP) definitions, where primary Rural-Urban Commuting Area (RUCA) codes between 4 and 10 correspond to rural areas and primary RUCA codes 1-3 correspond to urban areas.

Rural Health Clinic: An entity certified by the Centers for Medicare & Medicaid Services. A rural health clinic provides outpatient services to a non-urban area with an insufficient number of health care practitioners.

Social Determinants of Health (SDOH) : As defined by the CDC, SDOH are the nonmedical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live and age, and the wider set of forces and systems (e.g., economic policies and systems, development agendas, social norms, social policies, racism, climate change, and political systems) shaping the conditions of daily life.

Eligibility #eligibility

Eligible applicants are limited to organizations that are lead or funded partner organizations of one or more of the following clinical research networks: the NIH IDeA-CTRs, NIH CTSA, and/or PCORI PCORnet. For the purposes of this ROA, organizations with IDeA-CTR and CTSA awards or sub-awards in no-cost-extensions are eligible to apply. In addition, applicant organizations must be located in a state/jurisdiction where at least 25% of its census tracts are defined as rural using the Revised 2010 RUCA Codes.

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 not allowed.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-Serving Institutions (HSIs)
• 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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• American Indian/Native American Tribal Governments (Federally Recognized)
• American Indian/Native American Tribal Governments (Other than Federally Recognized)
• Independent School Districts
• Public Housing Authorities/American Indian Housing Authorities
• Native American Tribal Organizations (Other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Application Responsiveness #responsiveness

Applications will undergo a responsiveness screening conducted by NIH program staff. Applications that are deemed nonresponsive will be withdrawn and will no longer be in consideration for funding. Examples of projects that will be considered unresponsive to this announcement include the following:

• Applications that do not meet the “Eligibility” requirements specified above.
• Applications from organizations that are not actively participating as lead or a funded partner in one or more of the following clinical research networks: IDeA-CTRs, CTSA, and/or PCORnet in the United States,
• Applications proposing partnerships only with Clinical Sites that do not meet the definition of primary care settings.
• Applications proposing support for routine patient care unrelated to human subjects research.
• Applications proposing animal or in vitro research.

Application Requirements #applicationrequirements

All application components should be uploaded in eRA Commons in searchable PDF format with a font size of 11 or 12 point and font type of Calibri, Aptos, Arial, or Times New Roman. Margins must be 1-inch wide (top, bottom, left, and right). The components of the application should be loaded as separate attachments and should be titled as specified in each section below (title included in parentheses following each section). Guidance for OT application submission can be found on the NIH website.

Cover ( “Cover.pdf”, 2 page maximum )

• Number and title of this Research Opportunity Announcement
• Application Title 
• Principal Investigator(s) (PI) first and last name, title, organization, mailing address, email address and phone number. If multiple PIs are named, the Contact PI is clearly identified. 
• Name and address of the partnering Clinical Sites with a contact for each (full name, email address)
• Recipient Business Official/Signing Official first and last name, title, organization, mailing address, email address and phone number 
• First and last name of other key personnel, their title, institutional affiliation, and email address

Abstract ( “Abstract.pdf”, no more than 250 words )

A brief summary of the application.

Specific Aims ( “Specific Aims.pdf”, 1 page maximum )

Provide a cogent overview, at a high level, of the capabilities and proposed plans to carry out the objectives of a Network Research Hub as part of a coordinated infrastructure supporting clinical research in primary care settings. Include how the work of the Network Research Hub will increase the accessibility of clinical research and improve health equity.

Project Plan ( “Project Plan.pdf”, 16 pages maximum )

Applications must include a Project Plan that clearly and fully demonstrates the applicant’s capabilities, understanding, and experience to accomplish the objectives of the Network Research Hubs.

Technical Approach ( 6 pages maximum )

Section A: Overview and Organization

• Outline the overall organization of the Network Research Hub and partnering Clinical Sites, and briefly describe the collective strengths of the team. Include how the Network Research Hub is actively participating in and/ or affiliated with one of the following clinical research networks: NIH IDeA-CTRs, NIH CTSA, PCORI’s PCORnet. 
• Provide a diagram (and/or map) showing the geographical relationships between all entities included in the application. The rural participant catchment area is not limited to the applicant organization’s state. 
• List the underrepresented populations that could be served by the Network Research Hub. Define the community or communities the Network Research Hub will serve.
• Describe plans to collaborate with NIH-funded investigators, other Network Research Hubs, and the other components of the coordinated infrastructure. Share how the Network Research Hub plans to contribute to the development of policies and procedures and abide by them as they are established.

Subsection B. Developing and Implementing Studies and Use of Innovative Designs

• Identify areas of research that the Network Research Hub would like to pursue if successful with implementing expansion of an initial, existing NIH-funded study. Include a description of the criteria to be used and process by which studies will be identified that are priorities of and/or co-developed by their community.
• Explain how the Network Research Hub’s research interests and/or proposed research agenda will improve scientific knowledge, develop a more broadly applicable clinical evidence base, and improve clinical practice.
• Describe innovative/novel solutions to address challenges with integrating research into primary care settings and to minimize the burden of research on participants and clinical staff. Share the team’s expertise and experience with operationalizing these solutions. 
• Briefly describe processes the applicant will use to ensure compliance with regulations for research involving human subjects, and that study teams obtain and maintain sufficient proficiency level regarding the conduct of clinical research in coordination with the Operations Center.

Subsection C. Participant and Community Engagement

• Illustrate the team’s expertise in implementing related plans through recent examples and experiences.
• Clearly describe how the Network Research Hub will solicit and understand the challenges and health needs of their community.
• Highlight flexibilities in study designs, features, and engagement plans that can be adapted to meet the needs of a variety of participant groups and community partners, including those that are underrepresented in research.
• Describe how the Network Research Hub will contribute to the development of a community of practice in community engagement.

Primary Care Research Experience (6 pages maximum)

• Study title, type/design, research question(s) addressed, and target and actual total enrollment over time
• Partnerships with organizations providing care in primary care settings.
• Total enrollment by site
• Demographic breakdown of enrolled participants by race/ethnicity, sex, age, rural vs non-rural, and at least one other measure of social determinants of health (SDOH)
• How the data and/or results were shared and disseminated (including if shared with research participants)
• List additional previous relationships and/or partnerships with the proposed Clinical Sites to provide evidence supporting the likelihood of successful collaborations on future research.

Environment and Resources (3 pages maximum) 

List and describe the salient features of the facilities and other resources available for use by the proposed Network Research Hub. 

• Describe the resources available to facilitate carrying out the objectives of a Network Research Hub.
• Characterize the proposed Clinical Sites: describe the collective catchment area of the potential research participants through geographic boundaries, quantify the proportion of the catchment area as being rural vs urban in alignment with primary RUCA codes between 1-3 as defining urban areas and 4-10 as defining rural areas, and share any unique features to facilitate accrual of populations underrepresented in research.

Leadership Plan (1 pages maximum)

A brief leadership plan should be presented which identifies and describes the governance of the Research and Clinical Sites, chain of responsibility for decision making, and process for conflict resolution. The plan should describe how the leadership will contribute to the success of and collaboration within the infrastructure and the implementation of clinical studies with a focus on underrepresented populations. A succession plan with identification of a substitute/back-up lead investigator candidate should be included, if possible, to assure programmatic continuity.

Budget ( “Budget.pdf”, no page limitations )

The Budget must demonstrate estimated baseline costs of adding a select and limited number of primary care Clinical Sites to existing studies conducting clinical research in primary care settings, where the operational aspects of the study are supported by other NIH awards. Budgets are expected to be negotiated as the initial study is selected in coordination with NIH before an award is issued. Cost sharing is allowable.

Applicants shall assume a budget period of 12 months initially, and an additional 12-month option period during the 2-year pilot of this infrastructure for research in primary care settings. Funding for core support will be reimbursable, but costs per participant is expected to be funded based on study accrual milestones. Towards the end of the initial budget period, NIH will conduct an evaluation of the program to assess which approaches and efforts are working; NIH may continue, expand, pivot, and/or sunset awards and/or award components based on the results, infrastructure needs and/or congressional appropriations.

Study budgets should include funds for the community partners to be fully engaged and successfully participate in research prioritization, design and implementation.

Provide the overall expected cost for expanding research enrollment in primary care settings including but not limited to each of the following categories: 

• Personnel 
• Equipment 
• Travel 
• Subawards/subcontracts/consultants 
• Other direct costs 
• Total cost (with indirect costs included) 
• Proposed Cost Share contribution (if applicable)

Applicants must provide a budget justification for all budget items. Subrecipients/subaward budgets must include a breakdown of costs and a budget justification. Applicants should provide one budget and budget justification per institution or organization in the application.

Additional information to include in the submission

List of Key Personnel (“Key Personnel.pdf”, 1 page maximum)

Provide a list of key personnel that will significantly contribute to the objectives of the Network Research Hub. Provide their first name, last name, title, institutional affiliation, and email address.

Biosketches of Key Personnel (“Biosketch.pdf”, 3 page maximum per individual)

Provide a biosketch of each named key individual appearing in the Key Personnel List. The information in the biosketch should include the name and position title, education/training (including institution, degree, date (or expected date) of degree, and field; list of positions and employment in chronological order (including dates); list of relevant publications, proposed level of effort and a personal statement that briefly describes the individual’s role in the project and why they are well-suited for this role. Providing successful examples from past work on similar infrastructure building projects as appropriate to illustrate the relevant experience is desired. The format used for an NIH grant application is acceptable: https://grants.nih.gov/grants/forms/biosketch.htm .  

Letters of Interest/Support (1 page maximum per institution or organization)

A letter from the applicant's current affiliated clinical research network(s) (e.g., the director of the network coordinating center, administrative core, other authorized representative) should provide assurance that the proposed Network Research Hub is active and in good standing with the affiliated clinical research network. In addition, letters of interest and support should be provided from an authorized official from each of the proposed Clinical Sites and should include references to or direct evidence of prior research partnership or relationship with the Network Research Hub.

Appendix of Data Characterizing the Research and Clinical Sites’ Catchment Area (no page limit)

Data used to characterize the catchment area as rural or non-rural may be included to verify the catchment area descriptions in the Project Plan.

Objective Review #objectivereview

The intent of the objective review is to evaluate the strengths and the weaknesses of the proposed Network Research Hub and how well they would meet the objectives of a Network Research Hub. Applications will not be evaluated against each other during the review process but rather on their own individual merit.

Objective review will involve the submission of written critiques by subject matter experts documenting the strengths and weaknesses of responsive applications against the Review Criteria described below and interactive individual discussions between those experts and NIH program staff. The subject matter experts will include NIH staff and/or other federal staff.

Applications may be triaged for review based on the proposed catchment area of potential research participants, with applications with catchment areas characterized by >50% of the population being from rural areas, as defined by primary RUCA codes between 4-10 , receiving priority for review.

NIH will NOT provide feedback on applications, except as a part of follow-up on an as-needed basis as time permits. NIH will not accept an appeal of the objective review or funding decision outcomes.

Review Criteria:

Potential Contribution to the Coordinated Infrastructure for Supporting Research in Primary Care Settings

The approach of proposed Research Site has a high likelihood of meeting the objectives of a Network Research Hub. The applicant has described adequate plans for collaboration with other components of the coordinated infrastructure. The proposed activities involve engagement following a comprehensive framework, facilitating early and sustained engagement with a diverse group of individuals and communities, especially those that are underrepresented in research. Plans to engage the community they serve will successfully support a community-driven research agenda. Leadership plans, support from existing clinical research networks, and support from Clinical Site partners demonstrate a high commitment to the success of the proposed Network Research Hub.

Capabilities and Experience

The applicant has a demonstrated track record of successfully implementing research in primary care settings in the recent past. Prior experience showcases the ability to access and partner with underrepresented individuals in clinical research. Evidence of prior partnerships or relationships with proposed Clinical Sites has been provided. Key personnel have sufficient and relevant expertise to support the activities of the Network Research Hub.

Resources and Environment

The Network Research Hub is currently participating in and affiliated with one or more clinical research networks (NIH IDeA-CTRs, NIH CTSA, and/or PCORI PCORnet), that will increase site readiness to rapidly launch as a new site for existing NIH-funded studies. The catchment area of the Network Research Hub and its Clinical Sites will provide a high likelihood of facilitating engagement and study accrual of populations underrepresented in research (with a priority on individuals in rural communities).

Award Negotiation and Selection Information

Based on the identified strengths and weaknesses, NIH will determine whether an application will be selected for negotiation and/or award. NIH may select up to six viable applications to move forward in negotiations for a potential award, based on the objective review. Negotiations will involve identification of the initial study already funded by NIH to which the Network Research Hub will serve as an additional enrollment site. Coordination with the NIH-funded investigators and/or NIH program staff overseeing those studies will be required in order to understand the needs and existing support for the studies and to develop a final budget and milestone plan for the Network Research Hub. Final award selection will involve assessment of applications with successful negotiations and review and approval by NIH leadership and development of objective milestones as agreed upon by NIH and the applicant.

The level of funding for any award(s) made will depend on the negotiated studies and milestones and availability of funds.

Special Award Terms #Special Award Terms  

The complete terms and conditions of each OT award issued under this ROA are subject to negotiation and will be contained in the Agreement entered between NIH and award recipient. This Special Award Terms section is provided for informational purposes only in order to provide prospective applicants with an understanding of key expectations and terms that may differ from traditional NIH award mechanisms. All terms and conditions of award will flow down to any partners (e.g., subrecipients, collaborators) participating in the OT award.  

Lower Tier Agreements  

Award recipients will be expected to issue sub-awards to entities identified in their applications and approved by NIH under this ROA. Any changes to sub-awards must be in consultation with NIH prior to adding or removing partners.

Milestone-Based Workplan 

A milestone-based workplan will be requested and negotiated prior to award for inclusion in the OT Agreement. The workplan should include a description of operational milestones, completion criteria, and expected start and completion dates.

Enhancing Diversity, Equity, Inclusivity, and Accessibility in the Research Community

Award recipients will be encouraged to diversify their staff populations to facilitate engagement with diverse research partners and to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as those defined in Notice of NIH’s Interest in Diversity ( https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html ).

Program Governance   The Network Research Hubs will be part of a program consisting of a coordinated infrastructure involving the following governance and components:   

• establishing the vision, mission, strategic objectives, and goals of the coordinated infrastructure to be carried out by a Scientific and Medical Director (SMD) and Operations Director.
• ensuring the supported work appropriately and equitably supports and prioritizes the needs of all NIH ICs. 
• monitoring and evaluating the progress of the infrastructure, its efficiency and effectiveness, and that its outputs align with the vision and mission.
• providing oversight of the studies/protocols and site and study selection, 
• managing/coordinating the Central Institutional Review Board (IRB), 
• providing statistical and data management support, 
• collaborating with sites to develop innovations on clinical study design and implementation to minimize burden on participants and providers in primary care settings, 
• facilitating sustained engagement with key partners through a community advisory board, and
• other functions as the governance and structure of the Clinical Science Center is further developed.
• conducting site feasibility assessments
• facilitating Clinical Site agreements/contracting,
• coordination of study operations (protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements,
• quality assurance, and 
• data monitoring.

OT Agreement Governance 

Other Transactions (OT) are a special type of legal instrument other than contracts, grants or cooperative agreements. Generally, these awarding instruments are not subject to the Federal Acquisition Regulation (FAR ), nor to grant regulations unless otherwise noted for certain provisions in the terms and conditions of award. They are, however, subject to the OT authorities that govern the initiative and/or programs as well as applicable legislative mandates. NIH and its components, including the Office of Strategic Coordination (OSC), have been authorized by Congress to use them. They provide considerable flexibility to the government to establish policies for the awards, so the policies and terms for individual OT awards may vary between awards. Each award is therefore issued with a specific Agreement, which is negotiated with the recipient and details terms and conditions for that specific award. Program and administrative policies and the terms and conditions of individual awards are intended to supplement, rather than substitute for, governing statutory and regulatory requirements. Awards or a specified subset of awards also may be subject to additional requirements, such as those included in executive orders and appropriations acts (including the other transaction legislation cited in the Agreement), as well as all terms and conditions cited in the Agreement and its attachments, conditions on activities and expenditure of funds in other statutory or regulatory requirements, including any revisions in effect as of the beginning date of the next funding segment. The terms and conditions of the resulting OT awards are intended to be compliant with governing statutes.

For the awards funded under this ROA, NIH will engage in negotiations and all agreed upon terms and conditions will be incorporated into the Agreement. Either a bilateral agreement or a Notice of Award (NoA) will be used as the official Agreement. The signature of the Signing Official in the application certifies that the organization complies, or intends to comply, with all applicable terms and conditions, policies, certifications, and assurances referenced (and, in some cases, included) in the application instructions.

Award Administration Roles and Responsibilities

Other Transactions Agreements Officer (OTAO) 

• is responsible for legally committing funds on behalf of the Federal government and that OT actions taken are in the best interest of the government
• administers, manages, and closes out awards
• oversees the management of award records
• receives and acts on requests for NIH approval; the only NIH official authorized to change the funding, duration, or other terms and conditions of award

Other Transactions Agreements Specialist (OTAS) 

• serves as the first line contact for OT correspondence with applicants/recipients for administrative and financial aspects of the award

Other Transactions Program Official (OTPO) 

• provides the day-to-day programmatic oversight of individual awards 
• seeks guidance and advice as appropriate from subject matter experts for various disease areas and/or clinical trial oversight (e.g., medical monitoring)
• documents programmatic decisions related to an OT
• upholds government regulations on the appropriate use of federal funds
• conducts timely review of reports, inspection of deliverables, and other mechanisms to monitor and evaluate performance of the OT recipients
• serves on the OT Team, which includes developing ROAs and contributing to the development of OT award terms and conditions
• maintains certifications to serve as OTPO
• coordinates with other NIH Program Officers when partnering on other NIH-funded projects

Subject Matter Experts

• assist the OTPO in scientific and technical discussions with awardees
• review reports and discuss progress towards milestones and deliverables
• provide recommendations to the OTPO based on progress reviews
• attend face-to-face awardee meetings, as necessary
• attend site visits, as necessary

The terms and conditions of each award will address this criterion as appropriate based upon the final negotiated terms and agreed upon budget.

Human Subjects Research

All applications for work that will involve engagement in Human Subjects Research (as defined in 45 CFR § 46)( https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 ) must provide documentation of one or more current Assurance of Compliance with federal regulations for human subject protection, including at least a Department of Health and Human Services (HHS), Office of Human Research Protection (OHRP), Federal Wide Assurance ( https://www.hhs.gov/ohrp/index.html ). All research involving Human Subjects must be reviewed and approved by an Institutional Review Board (IRB), as applicable under 45 CFR § 46 ( https://www.ecfr.gov/current/title-45/subtitleA/subchapter-A/part-46 ) and/or 21 CFR § 56 ( https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56 ).

The entity’s Human Subjects Research protocol must include a detailed description of the research plan, study population, risks and benefits of study participation, recruitment and consent process, data collection, and data analysis. Award recipients must comply with all applicable laws, regulations, and policies for NIH-funded work. This includes, but is not limited to, laws, regulations, and policies regarding the conduct of Human Subjects research, such as the U.S. federal regulations protecting human subjects in research (e.g., 45 CFR § 46, 21 CFR § 50, § 56, § 312, § 812) and any other equivalent requirements of the applicable jurisdiction.

The informed consent document utilized in human subject research funded by NIH must comply with all applicable laws, regulations, and policies, including but not limited to U.S. federal regulations protecting human subjects in research (45 CFR§ 46 ( https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 ) and, as applicable, 21 CFR § 50 ( https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50 ). The protocol package submitted to the IRB must contain evidence of completion of appropriate Human Subject Research training by all investigators and key personnel who will be involved in the design or conduct of NIH funded human subject research. Funding cannot be used toward human subject research until all approvals are granted.

Intellectual Property

Specific terms with respect to intellectual property will be negotiated at the time of award; however, any negotiation will consider other laws (as relevant) that affect the government’s issue and handling of intellectual property, such as the Bayh-Dole Act (35.U.S.C. 200-212); the Trade Secrets Act (18U.S.C. 1905) the Freedom of Information Act (5 U.S.C. 552); 10 U.S.C. 130; 28 U.S.C. 1498; 35 U.S.C. 205 and 207-209; and the Lanham Act, partially codified at 15 U.S.C.1114 and 1122.

Payment  

The OT award will use the Payment Management System (PMS) operated by the DHHS Program Support Center. Payments by PMS are made on a reimbursement basis unless otherwise specified in the terms of the Agreement.

Management Systems and Procedures 

Recipient organizations are expected to have systems, policies, and procedures in place by which they manage funds and activities. Recipients may use their existing systems to manage OT award funds and activities as long as they are consistently applied regardless of the source of funds and across their business functions. To ensure that an organization is committed to compliance, recipient organizations are expected to have in use clearly delineated roles and responsibilities for their organization’s staff, both programmatic and administrative; written policies and procedures; training; management controls and other internal controls; performance assessment; administrative simplifications; and information sharing.

Financial Management System Standards 

Recipients must have in place accounting and internal control systems that provide for appropriate monitoring of other transaction accounts to ensure that obligations and expenditures are congruent with programmatic needs and are reasonable, allocable, and allowable. A list of unallowable costs will be included in the terms and conditions of the award. In addition, the systems must be able to identify unobligated balances, accelerated expenditures, inappropriate cost transfers, and other inappropriate obligation and expenditure of funds, and recipients must notify NIH when problems are identified. A recipient’s failure to establish adequate control systems constitutes a material violation of the terms of the award.

Property Management System Standards 

Recipients may use their own property management policies and procedures for property purchased, constructed, or fabricated as a direct cost using NIH OT award funds. The terms and conditions of award will address this criterion as appropriate based upon the final negotiated and agreed upon budget. Procurement System Standards and Requirements Recipients may acquire a variety of goods or services in connection with an OT award-supported project, ranging from those that are routinely purchased goods or services to those that involve substantive programmatic work. Recipients must acquire goods and services under OT awards in compliance with the organizations established policies and procedures. The terms and conditions of each award will address this criterion as appropriate based on the final negotiated and agreed upon budget.

Organizational Conflicts of Interest (OCIs)  

Applicants are required to identify and disclose all facts relevant to potential OCIs involving subrecipients, consultants, etc. Under this section, the proposer is responsible for providing this disclosure with each Detailed Plan. The disclosure must include the PI/Collaborators’, and as applicable, proposed members’ OCI mitigation plan. The OCI mitigation plan must include a description of the actions the proposer has taken, or intends to take, to prevent the existence of conflicting roles that might bias the proposer’s judgment and to prevent the proposer from having an unfair competitive advantage. The government will evaluate OCI mitigation plans to avoid, neutralize, or mitigate potential OCI issues before award issuance and to determine whether it is in the government’s interest to grant a waiver.

The government will only evaluate OCI mitigation plans for proposals that are determined selectable. The government may require applicants to provide additional information to assist the government in evaluating the proposer’s OCI mitigation plan. If the government determines that a proposer failed to fully disclose an OCI or failed to reasonably provide additional information requested by the government to assist in evaluating the proposer’s OCI mitigation plan, the government may reject the Detailed Plan and withdraw it from consideration for award.

Monitoring 

Recipients are responsible for managing the day-to-day operations of OT award-supported activities using their established controls and policies. However, to fulfill their role in regard to the stewardship of federal funds, the program team will monitor their OT awards to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence, audit reports, site visits and other information, which may be requested of the recipient. The names and contact information of the individuals responsible for monitoring the programmatic and business management aspects of awards will be provided to the recipient at the time of award.

Monitoring of a project or activity will continue for as long as NIH retains a financial interest in the project or activity as a result of property accountability, audit, and other requirements that may continue for a period of time after the OT award is administratively closed out and NIH is no longer providing active OT award support.

Audit 

NIH OT recipients for the Program are subject to the audit requirements of OMB 2 CFR 200, Subpart F- Audit Requirements, as implemented by DHHS 45 CFR Subpart F. In general, 45 CFR 75, Subpart F-Audit Requirements requires a state government, local government, or non-profit organization (including institutions of higher education).  

For-profit organizations have two options regarding the type of audit that will satisfy the audit requirements. The recipient either may have (1) a financial-related audit (as defined in, and in accordance with, the Government Auditing Standards (commonly known as the “Yellow Book”), GPO stock 020-000-00-265-4, of a particular award in accordance with Government Auditing Standards, in those cases where the recipient receives awards under only one DHHS program, or (2) an audit that meets the requirements of 45 CFR 75, Subpart F-Audit Requirements.

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