Developing your proposal
Patient and Public Involvement
Does the lead applicant need an NHS contract? And if so, does it need to be in place when an application is submitted?
Any award will be administered by an NHS organisation and the lead applicant must therefore have an appropriate relationship with the NHS organisation submitting the application to ensure proper governance and accountability. This will mean that the lead applicant (if they are not already employed by the host NHS organisation) will need to arrange, at a minimum, an honorary contract with that NHS organisation. However, it is not necessary for the honorary contract to be in place at the time the application is submitted provided the NHS organisation is able to confirm that it intends to provide an honorary contract if the application is successful.
Can more than one NHS Trust collaborate in a joint application?
Yes. Applications involving multiple sites are welcome. The Trust which offers the most appropriate setting in which to undertake the programme (nearly always that of the PI) will need to take the role of host institution. Evidence of multi-site academic collaboration would also strengthen the bid.
How can I find out whether my research idea would fall within the scope of the programme?
Please refer in the first instance to the guidance for applicants document which is available here. You may also find it helpful to read the Director's Messages which are available here. Details of previously funded programmes are available here. If you are still unsure, please contact us at firstname.lastname@example.org.
Is basic science in scope for funding?
Programme Grants will not fund programmes that are solely basic science. It is also unlikely that an 'upstream' or basic science component of a programme will be supported unless it can be clearly demonstrated that the work will be rapidly 'drawn down' into an applied phase that will be of benefit to patients and the NHS during the course of the programme, for example, the validation and then investigation of the clinical utility of a biomarker would be acceptable but endeavours to simply indentify and then validate a biomarker would not.
Is there a limit on the number of proposals an individual can submit in the same competition?
No, but it is probably not a wise approach to submit multiple applications with overlapping co-applicants. Due to the amount of work involved in preparing applications, it is unlikely each co-applicant could devote a sufficient amount of time to produce multiple applications of the high quality required.
Can an organisation outside of England submit an application?
No, we cannot consider an application from an NHS organisation outside of England. NIHR funding schemes are devoted to supporting proposals from research teams based in England.
An application from an NHS organisation in England can include a partner organisation from outside of England provided a strong case is made that they are best placed to provide the academic input to the planned research.
Can I include co-applicants who are based outside of England?
Yes, but a strong case needs to be made for why this person is best placed to lead/carry out the proposed research.
If my application is unsuccessful, can I resubmit?
We very rarely request resubmissions and if so, this is made explicit in the feedback. If you feel that your application can be amended to address comments from either the peer reviewers or the feedback from the sub-panel then you may submit a new application.
It is important to realise that it will be treated as a new application so please note that there is no guarantee that it will be sent to the same peer reviewers who assessed the original submission (it may be sent to the previous reviewers or to new ones) and that it will be assessed by a new sub-panel (although the sub-panel may comprise members who reviewed the original proposal). Addressing the feedback points is, of course, recommended, but there can be no guarantee that this will result in funding and it will not necessarily advance your case if you choose to point out that you have done so.
Do Programme Grants fund animal research?
Programme Grants does not itself fund basic research or work involving animals and/or animal tissue. The NIHR recognises that the carefully regulated use of animals in research is important in understanding disease and in developing safe and effective ways of preventing or treating illness. The NIHR also recognises the need for robust application of the 3Rs – that animals are replaced with non-animal alternatives wherever possible, that the number of animals used is reduced to the minimum needed to achieve the results sought, and that, for those animals which must be used, procedures are refined as much as possible to minimise their suffering. The NIHR therefore supports the Government’s policies on research using animals set out in Working to reduce the use of animals in scientific research NIHR works in close partnership with the Medical Research Council which funds animal research in carefully defined circumstances. NIHR funding is focused on clinical and applied health and care research.
Developing your proposal
When developing my proposal, should I be working with NIHR Networks?
Applicants should establish links with the appropriate NIHR Clinical Research Network as early as possible. This is because Networks are responsible for funding support costs arising from research programmes and it is important to be confident that these funds will be made available should the application be successful. Additionally, networks play a key role in helping with recruitment of participants to the studies that they adopt. Further information regarding the support that the NIHR CRN can offer to researchers is available at http://www.crncc.nihr.ac.uk/researchers.
Can the programme be led by joint Principal Investigators (PIs)?
Yes. Applications may be led by two joint Lead Applicants in exceptional circumstances. Justification should be given within the body of the research plan under 'relevant expertise and experience' within the Case for Support section of the application form, to demonstrate why more than one person would be required to lead this research (and how this brings added value to the application).
How expert does the team need to be, particularly the PI, and what sort of track record would be expected?
Lead applicants should have a strong track record of achievement in applied health research. This would be expected to be demonstrated through:
- Publications in an area relevant to the subject of the application.
- Experience of managing large research grants (while it is not possible to put absolute figures on this – see comment below - previous awards would be expected to be in excess of £250k and likely to be more than £500k).
- Evidence of impact on NHS service provision.
We do view the experience of the lead applicant in the context of the team. If a lead applicant is not as strong as they could be in one of the areas listed above then we take into account leadership that would be provided by other applicants. If a researcher is seeking to build a track record in applied health research then applications to other smaller NIHR schemes, like Research for Patient Benefit, should be considered.
Teams should include co-applicants with expertise in all disciplines required to carry out the programme of applied health research that is being proposed. In addition to content expertise and general applied health research methodology, this would often (but not always) include a combination of a statistician, health economist, health psychologist/behavioural expert and qualitative methods expert. It should be noted that all second stage applications are systematically commented on from these perspectives when considered by sub-panels. We look for both breadth and depth in the team. Breadth in the sense that they have all the disciplinary skills needed to deliver the proposed programme; depth in the sense that they also have the necessary expertise and experience. Co-applicants should therefore be selected carefully to ensure they have the relevant specific expertise for the work planned e.g. if a cost effectiveness analysis is proposed then a health economist with expertise and experience in cost effectiveness analysis should be included in the team. It is not necessarily expected that the co-applicants would have such an extensive track record as the lead applicant. It is acceptable for less senior researchers to be included as co-applicants to carry out the work provided that they are under the supervision of more experienced co-applicants (with a smaller % time commitment to the programme) or if it can be demonstrated that they have particularly relevant expertise in the specific topic area of the research proposed.
Who is an appropriate NHS Manager to include as a co-applicant and what if there is more than one site involved? Do they have to be based at the lead Trust?
One of the applicants should be an NHS service manager. He/she should be in a position to ensure that any interventions or new services developed would be carried forward and embedded into the NHS. This should be a full-time manager, with responsibility for the provision of clinical service, rather than a part-time clinical director or a Research and Development manager.
The manager does not necessarily need to be based in the lead NHS trust if multiple sites are involved in the research – the research team should select the person who would be most closely involved in implementing any outputs delivered by the research. More than one service manager can be included in the team if this is considered appropriate and beneficial for the programme.
How much change is acceptable from Stage 1 to Stage 2 (allowing for responding to reviewers comments)?
Most Programme Grant applications include some changes between Stage 1 and Stage 2 (and the Stage 2 form has sections to describe these). However, the original programme should still be recognisable at Stage 2 and the research plans clearly related to the Stage 1 application that was shortlisted.
Are all programmes expected to include an RCT at the end?
It is widely accepted that randomisation is usually the best way to avoid selection bias in a comparative study. Nevertheless, it is recognised that it may not be possible to deliver a definitive trial within the timescale and funding envelope of a Programme Grant. It is therefore acceptable for a programme to have as one of its deliverables ‘positioning’, such as through a feasibility study for a later definitive trial funded from another source, provided there are other outputs that will clearly benefit patients and/or the NHS within 3-5 years of the end of the programme.
Can you clarify what is expected in respect of the programme delivering benefit to patients and the NHS?
A key assessment criterion of a Programme Grant is benefit to patients and/or the NHS within 3-5 years of the end of the programme. Programmes are also expected to deliver interim benefits within a shorter timescale, e.g. within the duration of the programme. Nevertheless, despite the importance put on short and medium term benefits, it is recognised that some of the deliverables from a programme may only have benefits that are indirect or beyond 3-5 years of the programme’s end.
Programme Grant applications seem to have many different structures; can you recommend an ideal model to help support the development of an application?
Programmes can be structured in many different ways therefore it is not possible to provide a standard model. The means by which programmes are divided into work packages should depend on the nature of the work planned. For example, for some programmes, it may be appropriate to have only two but with multiple components within each work package; for others up to eight, less complex, work packages may be more appropriate.
How related do the work packages have to be?
A programme should include a number of sub-projects that, when carried out in programme format, deliver benefits that are greater than would be delivered should the projects be carried out in isolation i.e. the value of the whole is greater than the sum of its component parts. Therefore, the work packages should be clearly related to each other and findings from some are likely to inform others. It is not acceptable to propose a series of disparate studies that have no clear relation to each other, apart from the theme (such as a clinical topic) being studied, as this is unlikely to satisfy the need for the programme structure to add value.
Is it possible to give an indication of the level of linearity that is acceptable within a programme’s work package structure?
When assessing an application the panel takes into consideration the level of risk associated with a study being able to deliver its planned outputs. Therefore, a programme judged to have an overly linear structure would be seen as potentially high risk: each later component would be dependent on the outcome of a preceding work package, leading to a “domino effect” should an early package fail. It is preferable, if possible, that some work packages are carried out in parallel, So, while it is appropriate for some later elements of a programme to depend on the outcome of earlier ones, many funded programmes have components that are carried out alongside each other.
What additional information would be appropriate to included within the supporting documentation?
This can form a key component of the application and so it is important to target information that will support and enhance the content within the main application form, for example, letters of support, important research papers in press/draft that provide further background to the research plans, diagrams to clarify a complicated trial protocol etc. It should not be used to provide details that should have been included in the research plans (or any other part of the form) or as a means to submit all documents loosely related to the programme of research in the hope that this will strengthen the bid.
Do you pay Full Economic Costs (FEC)?
The scheme does not pay FEC.
Do I need to account for inflation when costing the programme?
Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by the Department of Health. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded.
My programme is experiencing delays; can I obtain an extension to the contracted end date?
Our expectation is that award holders will take all measures to ensure that the programme of research progresses to the specified Gantt chart but we do understand that delays can occur. If it appears that more time will be needed to ensure that the programme can be delivered to the required standard, applicants can request a variation to the contract (VTC) to obtain an extension.
VTC requests are considered by the Programme Director and the appropriate sub-panel chair on a case by case basis and if sufficiently justified, a formal VTC will be granted to the programme.
We wish to add/replace a co-applicant/institution in our programme; do we need to inform the CCF of this change?
Yes. The CCF must be notified of any significant changes (e.g. change of Principal Investigator, a need to change the Trust hosting the award, major changes to the research plans, etc.) throughout the lifespan of the programme. Any changes must be suitably justified as approval of them is usually sought from the Programme Director.
How often do we need to submit progress reports to the CCF?
Applicants are expected to submit annual reports from the start of the programme followed by a final report. Additional progress reports are sometimes requested, for example, where lengthy time extensions have been applied for. Site visits are occasionally made to award holders when problems are identified with a programme’s progress. A financial statement is also expected at the end of each financial year.
Please note that early awards (up to and including competition 8) will remain on an 18 month reporting frequency.
My programme is likely to overspend from the contracted amount. Can I request additional funding?
Our expectation is that award holders will take all measures to ensure that the programme of research is completed to the budget specified. If it appears that further resource will be required to ensure that the programme can be delivered to the required standard, a request for additional funds can be made by completing a variation to contract (VTC) request form. In instances where the additional funding requested is large, the request will be sent for peer review and then for assessment by panel. In all other cases, the decision to grant additional funds will be made by the Programme Director, appropriate sub-panel chair and additional counsel if deemed necessary.
A member of the research team funded by the award needs to take maternity/paternity/long-term sick leave; how should the associated costs of this leave be covered?
Where the member of the research team is employed by an NHS organisation, Research Capability Funding (RCF) should be used to cover the additional costs incurred (for example to employ a temporary replacement during the period of leave). Where the member of the research team is employed by a Higher Education Institution, then the host NHS organisation may choose to use RCF to contribute to the additional costs incurred, but only where there is no other source of funding (such as quality-related (QR) funding) available. In both cases, the proportion of the award dedicated to the individual on leave should be used to cover their salary costs.
My application involves evidence synthesis, what should I be aware of?
Applicants undertaking systematic reviews should note the commitment of NIHR to registration in the PROSPERO database. PROSPERO was developed by the NIHR’s Centre for Reviews and Dissemination (CRD), and is the first international online facility to prospectively register systematic reviews for research about health and social care. Access is free of charge and open to the public.
PROSPERO registration is a condition of NIHR funding for systematic reviews. It is accepted that not all systematic reviews commissioned by the NIHR programmes will fall in to the scope of the CRD register. The immediate focus is on reviews of the effects of interventions and strategies to prevent, diagnose, treat, and monitor health conditions for which there is a health related outcome. A review should also only be registered once it is in receipt of confirmed funding, and not before.
The timing of registration should be at the point when the protocol is complete/ stable but before screening studies for eligibility has begun. It is at this point where intentional, or inadvertent, bias could come in to play i.e. manipulating the inclusion criteria to capture those studies that show a particular desired result.
Researchers are required, once registered on PROSPERO, to keep their protocol up to date, this includes mirroring any major protocol amendments, updating status when completed (or abandoned) and adding publication details when published.
Registration should take place on the PROSPERO website, and can be accessed at http://www.crd.york.ac.uk/prospero/.
Patient and Public Involvement
What is considered to be appropriate Patient and Public involvement (PPI) in a Programme Grant application?
There is no standard model for appropriate PPI as Programme Grant applications vary immensely. Things to consider when thinking about public involvement in your programme can be found on our PPI pages. You can also visit the INVOLVE website where there is a set of FAQs especially for researchers wanting to find out why and how they might involve the public in research. INVOLVE has also published guidance to applicants about public involvement in research and a guide to payments for PPI.
How can I find out what research has been funded by the NIHR as Programme Grants and Development Grants?
A list of funded Programme Grant awards may be found under the Funded research section of this website. A list of awarded Programme Development Grant awards may be found under the Funded Development Grants section. All funded programmes may also be found via the "Grant Lookup" tool on the UKPMC website (http://ukpmc.ac.uk).
How does NIHR support researchers in developing their proposals?
The NIHR provides specific support to help researchers develop and design high quality research proposals through its Research Design Service and through the involvement of Clinical Trials Units in your research. To find contact details for your local RDS, please click here.