Funding Proposals & Budgets

A Plain English Summary (PES) is usually the first section of a funding application, and sometimes academic papers (though it should be noted that a PES is not the same as an abstract).

The purpose of a PES is to, in a short format, communicate the nature and purpose of a research project or study, in plain language, devoid of jargon or complex terms.

A good PES should accurately and concisely describe the project, but should be easily understood by any reader, including a lay person. It should also be able to stand alone and should be both understandable and complete without further information or reading.

The Value of Plain English Summaries

When communicating information about your project to potential participants, you will usually be speaking with lay persons, who don’t necessarily work in science, medicine or research, but who will still need to understand the project, and what it involves, just as well as the study team. A big part of this is that prospective participants must fully understand what their participation will involve, what the risks are, and what will happen to their data and any donated tissues or samples.

You can write a PES to accompany your Participant Information Sheets (PIS) and for your Informed Consent Forms (ICF).

What to include in a Plain English Summary

In your summary, consider including:

• Background:
  • What question or problem does your project look at?
  • What impact does this problem have on people/patients and services like the NHS?
• Aims:
  • What question does your project aim to answer?
  • Specific objectives
• Research Plan:
  • How do you plan to answer the question?
  • What methods will you be using?
  • What is the general structure of the project?

• Community Outreach:
  • How has your project been shaped and influenced by people with lived experience from the community you plan to study?
  • How will these groups continue to influence and have input on the project?
• Dissemination:
  • How, where, and when will the work be published?

The introduction or background section of a proposal should include the existing literature on the topic of study being proposed, and the scientific grounding for the proposal.

Where there is little existing literature, for example for projects involving novel technologies, you must be able to demonstrate proof of concept, and should ideally be able to demonstrate where the novel technology or intervention fits into the current landscape i.e. what niche does this innovation fulfil?

You should clearly describe the planned intervention e.g. testing the use of a new medical device, and how you intend to use the intervention within the study.

You should clearly state the aims of the project, and what research question the project aims to answer. You will usually format this as a bullet point list.

This may include a statement of what knowledge gap this project aims to address.

This is where you should state the study specific information such as:

• Study type
• Study duration
• Methodology type
• Sample size, and any relevant demographic information

If you are unsure of what study type your project is, the downloadable PDF of this resource includes a brief list of the most common study types.

The size of your sample will be dictated by the power calculation conducted by your study statistician or data analyst. This calculation will give you the minimum number of participants required to observe a significant correlation between the variables. The term “power” or “statistical power” specifically refers to the probability of correctly rejecting the null hypothesis.

When deciding sample size, it is important to consider how the sample size may change across the course of the trial. Participants may drop out, or may be withdrawn for other reasons, leading to a smaller than planned sample size. To circumvent this issue, it is recommended define the endpoint of recruitment i.e. when recruitment closes, as the number of participants who reach a specific point in the study.

For example, in a study of 100 participants recovering from kidney transplants where each participant attends five appointments, and the primary hypothesis assesses participant outcomes at visit three (with a secondary hypothesis assessing outcomes at visit five), instead of ending recruitment when 100 participants have been screened for enrolment, it would be sensible to end recruitment when 100 participants have attended their third visit. This ensures that the minimum sample size for statistical power has been achieved, and any additional participants over that number will only strengthen the data set.

It should be noted that, this method can incur significant additional financial burdens on your budget (as you will be screening and enrolling a higher number of participants).

In terms of demographic distribution of participants, you should ideally not restrict the sample to certain demographic factors, unless they are relevant to the research question.

For example, a study that aims to assess maternity outcomes in ethnic minority patients would be limited to female participants overall and then may be ethnically split into two groups: one group of patients from ethnic minority groups, and a control group of patients from majority ethnicities. However, if the study was assessing how patients at high risk of strokes respond to treatment using warfarin, there would be no need to stratify the groups by demographic factors as they are not relevant to the hypotheses.

You may still observe some demographic biases depending on the field of study however.

For example, studies of type 2 diabetes may naturally have a higher average participant age (in years) due to the national average age at which type 2 diabetes is diagnosed. When drafting your proposal’s sample outline, it can be useful to acknowledge any expected biases.

When writing your proposal, you should include a succinct statement that describes your planned sample, and contains the sample information in as much detail as possible, for example:

“This study will recruit (number) participants. Group A will include (number) participants with (characteristic), and Group B will include (number) participants with no history of (characteristic) as a control.”

OR

“This study will recruit (number) participants from (demographic group / background). Group A will include (number) participants with (characteristic), and Group B will include (number) participants with no history of (characteristic) as a control.”

etc.

It is also important to include some information on how you plan to allocate participants to groups, specifically detailing if there will be any blinding, and any randomisation of participants to groups, how those processes will be achieved, and how researcher bias will be mitigated.

N.B. Your study documents, specifically the Standard Operating Procedures (SOP) / Manual of Procedures (MOP), will include more detailed information about inclusion and exclusion criteria. Detailed criteria are not usually required for proposals.

This section will vary depending on the type of study or trial being conducted, as the type of data and the methods of collection will differ between studies.

Include details on how, from whom, and in what format you intend to collect your data. For example, a physical examination may be conducted by a qualified Nurse, who will record the participant’s height, weight, blood pressure, and demographic data in a standardised case report form. The case report form may be digitised by the Nurse and validated by another member of the project team. Tailor this section to your specific project and provide enough detail that readers can easily understand your planned methodology.

You should also include some information on how data will be stored, and how it will be collated for analysis, you should also provide some information on how data will be validated (i.e. confirmed to be accurate), and any information on how data will be securely transferred between parties (e.g. from the site to your statistician etc). This will demonstrate to anyone reviewing your proposal that you understand data protection and data integrity, and that you understand both why you need the data you are collecting, how to utilise the data properly in a research context.

At the proposal stage of planning a study / clinical trial, it is unlikely that you will have officially secured the research site, as this would likely be dependent on funding. You can indicate the proposed sites, but state that these will be confirmed later in the process.

You should, at this point, include a small amount of information regarding why you would choose the proposed site e.g. the site is geographically appropriate, perhaps there is a specific clinic there that will be part of the recruitment process, maybe your team has an established relationship with a clinic there, or perhaps there are specific laboratories there that will be needed for sample processing etc.

Alternatively, you may be able omit this section if you do not have a proposed site – Check any funder specific guidance that is available.

This section can include site specific details where it is possible to do so, for example, you could state that the site has in-house secure data or sample storage facilities that you would be able to use as part of the study.

Where you do not yet have any site-specific information, you should include details of the proposed plans for sample or data storage, and demonstrate how you plan to meet data protection, security, and participant confidentiality requirements.

Where you have study specific procedures such as phlebotomy, or any intervention specific procedures (e.g. administration of an IMP) etc. you should detail them here.

This will be drawn up in close collaboration with your study statistician, or equivalent. This will lay out the plan for how the data generated by the study will be analysed and may dictate how data will be presented to answer the research questions.

If there are any ethical considerations at all, including on the choice to use, for example, human participants, you should detail how the study is ethically sound, and how any ethical concerns will be managed or mitigated in practice. Proposals that raise significant ethical concerns, or where there is no clear plan to mitigate ethical concerns, will not be considered by funding bodies, and would not pass a research ethics committee assessment.

You should fully consider any ethical issues that risk occurring as part of the study, and should demonstrate your understanding of these risks, and most importantly how they will be prevented or mitigated in practice.

It should be noted that some ethical concerns are never acceptable and cannot be sufficiently mitigated. The main items that may reach this threshold relate to participant safety and the safety of any proposed intervention, up to and including risk to life. In these instances, the project should go through other trial pathways such as cadaveric studies or animal studies before a proposing a clinical trial involving human participants.

See below for a non-exhaustive list of potential ethical concerns to consider:

When including information on a proposed budget within a research or funding proposal, you should first take note of any provided guidance on how to present this information and what to include.

The budget items to include will vary between funding bodies, as will the items a funding body can / will cover as part of an award. For example, some funding bodies can cover all costs associated with a trial, whereas other funding bodies may only cover study consumables and site costs but not staffing costs. Another useful item to note is the overall award amount, and how many projects the funding body intends to fund out of that amount. If your proposed budget exceeds the total award amount or would account for a large portion of an award designed to fund multiple projects, you will be less likely to be successful.

How to present the information will also vary. Some funding bodies have pre-set / predefined forms to complete, whereas others prefer you submit a budget sheet as an additional document. Check the guidance for any specifics about table formats, fonts, and other presentation methods.

It is also recommended to calculate “per participant / patient costs” and “per appointment costs” as part of your budget. This means calculating how much it will cost to have each participant move through the study e.g. staff hours cost per participant, consumables used, time spent at the site (rent, staff costs etc.), and calculating how much it will cost per study appointment respectively. These should be separate breakdowns and should be separate from the overall master budget calculations (though should still be kept within the same document). It is a good idea to keep a Budget Master File that includes the full prospective budget, and all breakdowns and itemised lists. You can then easily pull out and collate information relevant to specific funding calls or submissions.

This section should aim to answer the question: “Who cares?” Impact statements are your chance to comment on why your project is important.

This section will help the reviewers understand the value of the proposed project. This should include a discussion on how answering the research question will benefit the wider human population or the field of study and should demonstrate an understanding of how to maximise the impact of the project’s results.

• Check the funder or ethics guidelines and guidance for any restrictions or requirements for how references should be presented, for example if you are expected to reference in a particular style.
• On average, you should usually be using one reference per 100 words, though this may vary depending on the statement you are making or the section you are working in. Most of your references will be contained within the introduction / background / literature section of your proposal, but you may have some references in sections dedicated to methodology and statistical analysis.
• References should primarily come from academic journals and peer reviewed literature. Occasionally there may be necessity to use other sources for reference material, for example reference books or tools (such as the British National Formulary (BNF)), websites, media outlets or specific media reports, or legislation. When referencing sources that are not journals / articles, make sure you follow any referencing style guidance that may apply, for example, if the proposal must use APA referencing style, make sure all of your sources are referenced in this style.
• It is good practice to use superscript numbers in the text to indicate a reference, and to make sure that the number in the text (e.g. “journal quote” 1 ) corresponds to the list number of that reference (so in this example, the reference would be number 1 in the references list). Additionally, references should be organised in the order they first appear / are referenced in the text.

N. B. Some funders / ethics guidelines will require the reference to be named within the text. In these cases, you should use the “Name (Date)” format of in-text referencing, and the references list should be organised in the order each reference first appears in the text. Refer to any specific guidance provided, as needed.