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Emergency Response and Preparedness Call - Stage 2 - PDG Guidance for Applicants

 

Contents

Emergency Response and Preparedness

Programme Development Grants

Guidance for applications

 

Introduction:

 Please read this guidance in conjunction with the Emergency Response and Preparedness Call Specification.

Please note several changes were made to NIHR Programme Development Grants in October 2019 and only the guidance for development work prior to programme grant is applicable to the Emergency Response and Preparedness call.

 

Programme Development Grants have changed

NIHR Programme Development Grants (PDG) are available to carry out preparatory work to develop a future Programme Grants for Applied Research (PGfAR) application. They can now also be obtained to further develop an existing/ongoing programme of research.

 

Scope

Following a review, the scope of the NIHR Programme Development Grants (PDG) scheme has changed although the link with PGfAR is retained:

  • They remain available to undertake preparatory work to develop a future programme of research but broader ranging development work is permitted, and less detail is required about the future programme
  • The scope has expanded so that they are now also available to further develop an existing/ongoing programme of research. Applications for such development grants are only available to applicants on or within 12 months before or 18 months after the programme grant contract end date
  • Funding and duration have increased; up to £150,000 is now available over 12 – 24 months
  • If seeking a PDG to develop a future programme of research, applicants can choose whether to enter directly into Stage 1 or Stage 2 of a future PGfAR call for proposals

For further information, please visit the Programme Development Grants web page.

 

 

Section 1: Application Summary Information

Host organisation

Provide details of the organisation who will be the contractor if the project is funded.

If you have any queries, please contact programme.grants@nihr.ac.uk before submitting your application.

 

Development work title

The project title should state clearly and concisely the proposed research. Any abbreviations should be spelled out in full.

 

Research type

Select the appropriate research type. If your proposed programme includes any element of primary research, please select ‘Primary Research’. If you are carrying out new analysis of existing data, select ‘Secondary Research’. If you are not sure which category to select, choose the closest match to your project as this can be adjusted later. If the majority of the development work will be devoted to conveying the research findings to practitioners, policy-makers, commissioners and providers of NHS and social care services, select 'Knowledge mobilisation.’

 

Proposed start date

Note this should be from 1st of the month regardless of whether this is a working day or not. Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project.

 

End date

This field will automatically populate once you have entered the start date and research duration information.

 

Total development work costs

This will be automatically pulled through from the budget section.

NOTE: Funding is available up to £150,000 for a development grant application

 

Development work duration (months)

Please select an option from the drop down below to confirm whether your application is

  • for development work prior to programme grant submission or
  • to further develop, analyse or disseminate your programme grant or its outcomes.

NOTE: Development grant applications can be for up to 24 months

 

Estimated date of submission of future programme grant application

Please indicate the anticipated date of submission in a DD/MM/YYYY format.

Please indicate the anticipated submission date of your Programme Grant for Applied Research Stage 1 application, once the preparatory work funded via any Programme Development Grant award has been completed (future Programme Grants for Applied Research competition dates are available at: http://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/funding-programmes/programme-grants-for-applied-research/).

 

NIHR reference number of current programme grant award

If applying to further develop your current programme grant award, please provide the NIHR reference number of the current grant award that this proposal relates to.

NOTE: only one PDG application pre current PGfAR award is permitted.

 

Programme grant end date

If applying to further develop your current programme grant award, please specify the current contractually agreed end date of the programme grant award that this application relates to.

NOTE: you may only apply for fir further development work on or within 12 months before or 18 months after the programme grant contract end date.

 

 

Section 2: CV - Lead and Co-applicants

Complete your name, contact details and other requested information.

Co-applicants who are patients, service users or carers are not obliged to complete a standard CV but are required to provide a summary of any knowledge, skills and experience relevant to their role in the application in a separate text box. This appears when ‘yes’ is selected to indicate if co-applicants are a member of the public.

We recognise and value the varied perspectives that patients / service users and carers bring to a project as applicants. In this section, please provide a summary of any relevant knowledge, skills and experience that you will draw upon to contribute to this project.

This could include information about:

  • Previous or present work (paid or unpaid) with any relevant organisations
  • Links with any relevant groups, committees, networks or organisations
  • Experience of particular health conditions, treatments, use of services - or as a member of a particular community
  • Knowledge and experience of research including previous research undertaken
  • Knowledge and experience of patient and public involvement including previous involvement activities
  • Skills from any other roles that are transferable
  • Relevant qualifications, training and learning.

The bullet point list above is not exhaustive. Please include anything else that is relevant to the application.

 

 

Section 3: Research Background - Lead and Co-applicants

Publication record

Provide details of a MAXIMUM of 6 of your most recent / relevant publications (in the last 10 years) relevant to this application (using Vancouver or Harvard citation format). Please use DOI reference numbers if needed.

 

Research grants held

Please select research grants held (as a named applicant) CURRENTLY or IN THE LAST 5 YEARS – as well as any additional previous grants, relevant to this application, stating who the grant is with and the amount of each grant. For more information about resubmission of a research/trainee funding application, or joint funding please contact the appropriate NIHR research funding programme.

 

Has this application been previously submitted to this or any other funding body?

To be completed by the lead applicant only.

Select ‘Yes’ or ‘No’ from the drop down box to indicate whether this or a similar application has previously been submitted to this or any other funding body.

 

Applications Submitted to other NIHR programmes

Where this application or a similar one has been submitted to this or another NIHR programme or elsewhere please complete the necessary information.

We are keen to know if the application has been submitted elsewhere and you must be as open about this as possible. This includes, but is not limited to, any facts that, should they come to light at a future date, would embarrass either the programme or the individual who withheld the fact (e.g. if a member of the team holds a patent or has a financial interest within the research area). 

Failure to disclose accurately or fully will be considered by the programme as academic misconduct and treated accordingly. You should also include in this section information on whether this or a similar application has been submitted to any programme previously, or to any other funder including other NIHR programmes. You should name, and provide dates and outcomes of these. Please indicate whether you hold or have ever held an NIHR programme contract which has been terminated prior to completion, extended in time or in terms of funding.

 

 

Section 4: The Development Work Team

Specify your (lead applicant) role in the PDG development work

Explain in addition to your role as Lead Applicant, the role that you will be undertaking in the research, e.g. co-ordination, communication planning, stakeholder engagement, project management, analysis, methodological input etc.

 

%FTE commitment on the PDG development work

Commitment: This refers to the percentage of your time that you will commit to this project.

 

Joint Lead Applicant

Where appropriate and justified it is acceptable for the application to be led by joint Lead Applicants. Where this applies, please complete your name, contact details and other requested information.

 

Justification for Joint Lead Applicant

Justification should be given to demonstrate why more than one person would be required to lead this research and how this brings added value to the application.

 

Relevant expertise and experience of Joint Lead Applicant

Please summarise the proposed Joint Lead Applicant’s relevant expertise and track record in applied health research, in terms of skills and experience, previous publications, influencing key stakeholders, grant funding and impact on health service and social care provision.

 

Specify your (joint lead applicant) role in the PDG development work

Explain in addition to your role as Lead Applicant, the role that you will be undertaking in the research, e.g. co-ordination, communication planning, stakeholder engagement, project management, analysis, methodological input etc.

 

%FTE commitment on PDG development work

Commitment: This refers to the percentage of your time that you will commit to this project.

NOTE: For application/contracting purposes, the joint lead applicant will be counted as a co-applicant.

 

 

Co-Applicants

Add details of all co-applicants and their specific role in the development work. Do not include collaborators, who should be mentioned (if necessary) in the Detailed Research Plan section of the form.

Co-applicants are those individuals with responsibility for the day to day management and delivery of the project. Co-applicants are considered part of the project team and are expected to share responsibility for its successful delivery. Collaborators normally provide specific expertise on particular aspects of the project but who do not share in the responsibility for the delivery of the project. If submitting with a joint lead applicant, please indicate which co-applicant will assume this role.

Allow sufficient time for your co-applicants to complete their sections of the online form before the application deadline.

 

 

Section 5: Other supporting roles – signatories (electronic)

Other supporting roles

The following supporting roles from the host organisation must be added to the application:

  1. Finance Director of host organisation or relevant delegated authority
  2. Head of Department or Senior Manager

 

Electronic signatures

On assigning these contacts an email will be sent to each of them by the system. They will be required to tick a check box indicating that they have read and understood the terms on which they have been nominated for this proposal and accept this role. Ticking this box constitutes an electronic signature of the supporting role for the full application.

At the time of adding the necessary supporting roles required to approve your application you are advised to inform the Trust R&D office of the site most likely to be the lead site for your proposed research. The aim is to help speed up the permissions process should your application be successful. Please note this will not apply to all proposals.

The Lead Applicant will also be required to tick a checkbox to indicate that they have read and understood the terms on which he/she has been nominated as Chief Investigator for this proposal and accept this role (see page 16/17).

Once everyone has approved the application you will be able to proceed to submit.

No original signatures or ‘wet ink’ signatures are required for this application.

 

 

Section 6: Scientific Abstract

The scientific abstract should be a clear and concise scientific summary of the Detailed Development Work Plan / Methods.

The following is a list of potential elements / headings that might be included depending on the design of the proposed research, the setting and programme being applied to, and whether it is for primary research or evidence synthesis. It will be for researchers to decide the appropriate elements to be included in the scientific abstract and could include elements outside this list. Applicants may find the guidance on the EQUATOR Network website (www.equator-network.org) useful.

Development work question

Background

Aims and objectives

Development work plan

Timelines for delivery

Anticipated impact and dissemination

 

 

Section 7: Plain English Summary

A plain English summary is a clear explanation of your research.

Many reviewers use this summary to inform their review of your funding application. They include clinicians and researchers who do not have specialist knowledge of your field as well as members of the public. If your application for funding is successful, the summary will be used on National Institute for Health Research (NIHR) and other websites.

A good quality plain English summary providing an easy to read overview of your whole study will help:

  1. those carrying out the review (reviewers and board and panel members) to have a better understanding of your research proposal
  2. inform others about your research such as members of the public, health professionals, policy makers and the media
  3. the research funders to publicise the research that they fund.

If it is felt that your plain English summary is not clear and of a good quality then you may be required to amend it prior to final funding approval.

It is helpful to involve patients / carers / members of the public in developing a plain English summary.

 

Content

When writing your summary consider including the following information where appropriate:

  1. aim(s) of the development work
  2. background to the development work, including for follow on projects, how this links to the current PGfAR award
  3. development work plan
  4. patient and public involvement
  5. dissemination and anticipated outcomes

 

The plain English summary is not the same as a scientific abstract - please do not cut and paste this or other sections of your application form to create the plain English summary.

Further guidance on writing in plain English is available online at NIHR Make it clear http://www.invo.org.uk/makeitclear/.

For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable). http://www.nihr.ac.uk/about-us/how-we-are-managed/our-structure/research/research-design-service/

 

 

Section 8: Detailed Development Work Plan 

Using all of the headings (in the order presented) and guidance below, clearly explain the development work needed prior to submission of a programme grant application OR

Schematics, tables, illustrations, graphs, and other types of graphics can be embedded to clarify the development work plan but they should not clutter the central narrative. Images do not count towards the overall word count but inclusion of them to overcome word limits is not permitted. Images may only be included within the 'Development Work Plan.' Images included in other sections will be removed from the application and not seen by reviewers.

As this is the main part of your application which will be considered by the reviewing committee you should ensure that the information is accurate, succinct, clearly laid out and provides adequate methodological detail.

Applicants should therefore aim to reserve a significant proportion of the word limit for the development work plan to ensure its appropriateness and rigour can be judged. (Limit: 6,000 words)

 

  1. Background and Rationale

Briefly describe the background and rationale of the development work and future programme, providing a clear explanation of:

  • the health problem to be addressed, and how this research would fill a demonstrable evidence gap, addressing patient needs and DHSC priorities (at national or local levels)
  • the importance of the proposed research and its relevance to the priorities and needs of the NHS (including a statement of the significance of the research area, e.g. burden of disease)
  • need for research in this area, drawing particularly from systematic reviews (including NHS context and relevant literature), and the rationale for the particular lines of research you plan to pursue
  • past and current research that justifies the proposed research and shows that it will add distinct value to what is already known, or in progress
  • the barriers to undertaking the proposed future programme that will be addressed through the development work that would be supported by the PDG

References should be provided as part of the ‘Supporting Documentation’ section of the application.

Please indicate under this question if you are responding to either the NIHR themed calls 2019 on ‘Frailty’ or ‘Chronic Pain’, or the highlight notice on ‘Brain Tumours’.

 

NOTE 1: Applicants are reminded that NIHR strategy encourages research which follows patient need. Researchers should clearly articulate how their research meets this objective, and how this contributes to the scientific rigour of their programme. Programmes should recruit participants from geographical areas where patient need is greatest including for example the rural and semi-rural areas where many older people live, and represent areas of diverse socioeconomic and ethnic diversity. Equality, inclusion and diversity should also be properly considered when planning and describing the research, and evidenced in the application.

NOTE 2: We will only fund primary research where the proposed research is informed by a review of the existing evidence.

Applicants should be aware of ongoing research in this area and comment on any other research which might be deemed to overlap with the contents of the proposal. In particular, applicants are advised to use both PubMed Central and Europe PubMed Central for recent material on the topic area they are applying for. All applicants must also include reference to relevant on-going studies, e.g. from trial registries.

Any applications that include primary research should include reference to the existing evidence and explain how this evidence has informed the proposed research. Where a systematic review already exists that summarises the available evidence this should be referenced, as well as including reference to any relevant literature published subsequent to that systematic review. Where no such systematic review exists, it is expected that the applicants will undertake an appropriate scoping review of the currently available and relevant evidence and then summarise this in their proposal. The application may then include a more detailed review in early work packages.

Further information can be found at:

https://www.nihr.ac.uk/about-us/our-purpose/principles/adding-value-in-research.htm

 

  1. Aims and objectives

Please indicate the overarching aims/objectives of the development work, outlining how it will inform the future programme and, where appropriate, any main hypothesis.

 

  1. Programme Development Grant work plan

Development work for a future PGfAR application

Give details of the development work to be undertaken. In particular, specify the key deliverables to be generated by the development work and how these outcomes will help develop and inform the future application to the PGfAR funding scheme.

List clear objectives and provide brief descriptions, including the methodological approaches proposed.

Researchers may find the SPIRIT 2013 (http://www.spirit-statement.org/) statement a useful resource when preparing their protocol.

 

  1. Future work plans

Briefly outline the proposed future programme, including:

  • the aims and objectives
  • a description of the individual studies comprising the programme and anticipated methodological approaches
  • an explanation of how the studies comprising the programme link together/inform one another
  • the anticipated patient benefits and impacts arising from the component studies and the programme as a whole

 

  1. Project/Research timetable

Describe the progression of the development work plan, including the timetable, key milestones and deliverables.

 

  1. Project management

Explain the practical arrangements for managing the development work. This should include specification of the roles and responsibilities of the individual team members who will undertake the development work, the management structure (i.e., reporting lines), the programme manager, frequency of meetings, financial management etc., and highlight the role of any Advisory or Reference Groups associated with the development work.

 

  1. Ethics / Regulatory Approvals

Outline any potential ethical issues associated with this development work and the arrangements for handling them. If there are no plans to obtain ethical review, this must be clearly justified.

 

NOTE: the work outlined in your application/protocol must adhere to the UK Framework for Health and Social Care Research (https://www.hra.nhs.uk/documents/1068/uk-policy-framework-health-social-care-research.pdf)

 

 

  1. Project / Research expertise

Explain why the group is well qualified to undertake the development work – describing the track record of the research team in applied health research (including innovation and, where appropriate, evidence synthesis and assembly for dissemination at national level), including publication outputs, grant income and impact on health service practice and policy.

Explain how the applicant's work together (or propose to work together if they have not done so previously), and identify other major collaborations important for the development work. State clearly the particular contribution that each of the applicants will make towards the development work and the particular contribution that any collaborators intend to make.

Where the PDG funding will be used to strengthen or formulate a team and build collaborations, describe the explain how this will be achieved. Clearly describe if and how the PDG funding, and/or the proposed programme, will contribute to capacity building/career development of applicants and of researchers employed on the grant.

(If, for any reason, salary costs of members of the team are not going to be sought via this application, it should be made clear how their contribution will be supported in the ‘Detailed Budget Finances’ section).

 

  1. Success criteria and barriers to proposed work

Please set out the measurements of success you intend to use and the key risks to delivering the development work. Also describe what contingencies you will put in place to reduce or eliminate each risk or its impact.

NOTE: A risk is defined as any factor which may delay, disrupt or prevent the full achievement of a research objective. Typical areas of risk for a research application might include staffing, resource constraints, technical constraints, data access, timing, management and operational issues (please note that this list is not exhaustive).

 

Upload a Gantt chart

It is mandatory to attach a Gantt chart indicating a schedule for the completion of work, including the timing of key milestones and deliverables.

 

 

Section 9: Patient and Public Involvement

Please describe how patients and the public have been involved in developing this proposal.

You should describe who has been involved and why this is appropriate, what role(s) they have they played and what influence or change has happened as result of their involvement

 

Please describe the ways in which patients and the public will be actively involved in the proposed research, including any training and support provided.

INVOLVE has developed guidance both on how patients and public can be involved http://www.invo.org.uk/posttypepublication/involve-briefing-notes-for-researchers/

and the processes, procedures and values necessary to support this involvement www.invo.org.uk.

Patients and public can be involved in every stage of a research project, from developing a proposal through to dissemination and evaluation.

In your description, you will need to say who will be involved and why.

Explain why your approach to public and patient involvement is appropriate for this proposal. Describe how you will support and enable patient and public involvement in your research (e.g.: payments, training)

In rare cases where proposals do NOT involve patients and the public, clear justification must be provided.

Complete/justify as necessary.

 

 

Section 10: Detailed Budget

NOTE: For applications involving the recruitment, consenting and/or treatment of patient participants, you are now required to submit a Schedule of Events Cost Attribution Template (SoECAT) with your PDG application.

You are not required to add costs on this form under the NHS Support Costs or NHS Treatment Costs sections as these are now entered on the SoECAT form. Please do complete all other questions on the budget form. The SoECAT must be signed off by an AcoRD specialist.

It is not necessary to submit a SoECAT if the development work does not involve the recruitment, consenting and/or treatment of patient participants.

 

Provide a breakdown of costs associated with undertaking the development work and provide justification for the resources requested, including the following:

i) staff costs,

ii) travel, subsistence and conference fees

iii) dissemination costs

iv) equipment (including lease versus purchase costs)

v) consumables,

vi) patient and public involvement

vii) any other direct costs

For help with estimating PPI costs please see the INVOLVE cost calculator available at http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/involvement-cost-calculator/

When justifying staff costs you should also provide the % amount of time input of each member of staff and link this to the specific area/work package of the proposed study where this input will be taking place.

You should indicate here how this research will potentially benefit the NHS and/ or public health. For example, where appropriate, describe the likely cost savings or benefits in terms of numbers of patients treated, treatment times etc.

You should describe the value for money of the conduct of the proposed research.

Also provide a breakdown of the NHS costs associated with undertaking the research and provide justification for the resources required. If there are no NHS Support or Excess Treatment Costs associated with the research you must explain why you think this is the case.

Provide a breakdown of any non-NHS intervention costs and provide justification for the resources required.  Non-NHS intervention costs should include costs incurred in delivering the intervention which would continue to be incurred after the trial, should the intervention become standard care.

 

Detailed Budget Breakdown

The finance section should provide a breakdown of costs associated with undertaking the research as described in the proposal.

 

Programme specific information

Programme Development Grants does not pay FEC. Therefore, indirect costs cannot be claimed for HEIs. However, Programme Grants and Programme Development Grants will fund 100% of HEI staff costs.

Awards can be for up to £150k over 12 – 24 months. The amount of funding awarded, however, is determined by the scale and nature of the research activity to be conducted.

NOTE: Letters of support from the NHS body or other provider of NHS services and appropriate Network should be provided as evidence to demonstrate that the NHS Costs requested will be met should the application be supported.

 

General information

The information entered in this section should provide an analysis of the total funds requested to undertake the research proposed and should be based on current prices. These costs will be used to assess value for money.

It is in your best interest to undertake a thorough, realistic and accurate costing. Where an outline/stage 1 application has been produced and this is the full stage (2) application, the committee/panel will pay close attention to any material increase in costs. You must provide a clear and full justification for all costs including NHS costs. You must also ensure that you include all costs including those required to secure good research management. 

  • 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.
  • Years should be calculated starting from the anticipated start date of the proposed research. For example, if your research is expected to start on 01 June 2020 then its second year starts 01 June 2021.
  • Further itemisation of costs and methods of calculation may be requested to support the application at a later date.
  • Payments will be made to the contracted organisation only and the contracted organisation will be responsible for passing on any money due to their partner organisation(s).
  • Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
  • NHS support costs are funded via Clinical Research Networks. Researchers should contact their local NHS R&D department initially and, if they are unable to help directly or if there is no local NHS R&D department, contact the Local Comprehensive Research Network (LCRN) senior manager for advice on NHS support costs. Further details about LCRN contacts are available at https://www.nihr.ac.uk/nihr-in-your-area/local-clinical-research-networks.htm.
  • All applications are expected to have appropriate NHS, HEI, commercial and other partner organisation input into the finance section of the application form.

Please note that whilst the applicable percentages will be used to calculate the maximum grant payable, the programme reserves the right to award a grant for less than this maximum where it is considered appropriate.

 

Information on different types of organisations

Higher Education Institutions (HEIs)

Please see the Programme Specific Information above. Programme Development Grants does not pay FEC. Therefore, indirect costs cannot be claimed for HEIs. However, it will fund 100% of HEI staff costs.

NHS bodies and other providers of NHS services in England

For applications where the contractor is an NHS body or provider of NHS services in England, up to 100% of direct costs will be paid.

Commercial/other partner organisations

If you are a commercial organisation/consultancy, please fill in direct costs and commercial indirect costs.  Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.

If you are another partner organisation (e.g. charity or NGO), please fill in direct costs and other partner organisations indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form.  Up to 100% of costs will be paid.

 

Direct costs

These are costs that are specific to the research, which will be charged as the amount actually spent and can be supported by an audit record. They should comprise:

Details of posts and salaries (posts and salaries summary)

This section presents an overview of salary and associated on-costs for the applicant(s) contributing to the research, including normal salary increments broken down individually. 

  • Please include all members of staff working on the research by clicking ‘Add Staff Details’ or editing a current one.
  • If there are any applicant(s) whose costs are not being claimed you should still include their details within this section, but don’t include any actual costs.
  • Where applicants are already in receipt of NIHR funding for any part of their salaries (e.g. NIHR Fellowships), these should not be additionally charged to the project.
  • Where applicants are already receiving salaries funded by NIHR, these should be declared in the application.
  • The Apprenticeship Levy can be included in the salary costs from 1 April 2017 where relevant.

Salary costs (apply to years)

This section specifies the annual costs of each applicant contributing to the research. You should now allocate the individual staff member costs to each year of the research, allowing for increments. Use current rates of pay, and build in any known annual increments (again at current rates). You will not be able to claim for pay awards retrospectively, once your research is underway.

  • Please note the ‘Total’ and ‘Overall’ column figures need to be calculated using the current annual costs, %FTE and number of months. If the research lasts for several years and an individual’s involvement varies over the course, it may be necessary to explain fully in the justification of costs section the % FTE and months per year for an individual staff member.
  • It is important to double check that the % FTE, total months and yearly costs information are consistent with the information presented in ‘Details of Posts and Salaries’ (‘Details of Posts and Salaries’ should show the full current staff costs independent of % FTE etc., whereas the yearly costs in ‘Annual Costs of Posts’ depend on % FTE etc.)

Please note that this section also includes ‘Shared Staff Costs’ which is located under directly allocated costs in some other funders’ applications. These are costs of an institution’s research resources which can be charged to the research on the basis of estimated use, rather than actual costs. These may include: IT technicians, laboratory staff, and costs of pooled staff efforts. HEI indirect costs cannot be claimed on these shared costs.

Please note, as this programme does not fund HEI indirect and estate costs, HEI shared staff costs charge out rates should exclude HEI indirect costs and estate costs when being calculated.

 

Travel, subsistence and conference dissemination costs.

This section includes journey costs, subsistence and conference fees. Where applicable, you will need to include the travel and subsistence costs of your project advisory group, steering committee and/or data monitoring & ethics committee. Travel and subsistence costs relating to dissemination should also be included here, as should costs relating to overseas travel.

Journey costs

Enter the total cost of transport for all journeys for destination/purpose. If travel is by car, apply your institution’s mileage rates (however this should not exceed HMRC approved mileage allowance payments, which is 45p per mile for the first 10,000 miles and 25p thereafter).

Travel by the most economic means possible is encouraged. NIHR programmes do not usually fund first class travel.

Subsistence

Subsistence covers accommodation (if necessary) and meals associated with the travel, excluding any alcoholic beverages.

Conferences

Where national or international conference costs are included, a statement naming the conference or purpose of travel and the benefit to the research must also be made; failure to adequately justify your attendance at a conference will mean the programme will not fund this cost.

For research of up to five years, the programme will usually fund up to a maximum of two international conference attendances. For research beyond five years, the programme will usually fund up to a maximum of two international conference attendances per five year or part of five year research period.

 

Equipment

Essential items of equipment plus maintenance and related costs not included as part of estates should be input in this section. These can be lease or purchase costs. 

  • The purchase cost of pieces of equipment, valued up to £5,000 excluding VAT, will be considered.
  • Pieces of equipment costing more than £5,000 to purchase will usually need to be leased. Where applicants are leasing equipment with a purchase price of more than £5,000, a comparison of leasing versus purchasing costs must be provided in the ‘Justification of Costs’ section.
  • Items of equipment valued at £250 or more must be itemised separately; however grouping same type equipment is permitted.
  • Costs of computers are normally restricted to a maximum of £650 each excluding VAT and a statement of justification must be included, in the relevant ‘Justification of Costs’ section for any purchase above this limit.
  • Equipment must exclude VAT, but if your organisation is unable to reclaim/recover the VAT on a piece of equipment, you should check the box ‘VAT cannot be reclaimed’.
  • You will need to seek expert advice from the organisation purchasing the equipment regarding its VAT status. If you check the ‘VAT cannot be reclaimed’ column, VAT at 20% will automatically be calculated into the overall cost of that item.

 

Consumables

This section includes non-reusable items specific to the research. Please itemise and describe the requirements fully (e.g. postage, stationery, photocopying). These items should be research specific, not just general office costs which should be covered by indirect costs.

Patient and public involvement

Please itemise and describe fully the costs associated with patient and public involvement. These are likely to include out of pocket expenses, payment for time and any relevant training and support costs. 

INVOLVE have produced a number of useful payment-related resources, including the ‘Budgeting for Involvement’ guide and the INVOLVE cost calculator, which can be found at the following link:

http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/

 

Other direct costs

These are costs, not identified elsewhere, that are specifically attributed to the research. For example, open access costs, other dissemination costs, costs associated with the use of research facilities, external consultancy costs, computer licensing, recruitment and advertising costs.

Please note that for organisations claiming indirect/overhead costs, costs such as recruitment of staff, and general training (e.g. in common IT packages) are costs that should be covered by the indirect costs element of the award being sought and should not appear in this section.

If external consultancy costs are included in this section they must be fully justified in the ‘Justification of Costs’ section. Please specify the hourly rate and the number of hours and note that consultants must not be people who are already employed by the applicant’s institution. If they are, any costs should be entered as direct costs in the ‘Details of Posts and Salaries’ and ‘Annual Costs of Posts’ sections.

Open access costs

During the course of your project and throughout the review and publishing phase, you may choose to submit an article based on your research to an open access publication. Depending on the publication, you may be subject to an Article Processing Charge (APC). APC rates vary but are usually within the range of £300 and £3000. Open access publications usually list their APC rates on their websites.

Where possible, you should include an estimate for any APC in your funding application, since NIHR expects that APCs will be covered by the funding award. https://www.nihr.ac.uk/about-us/our-purpose/principles/nihr-open-access-policy.htm

Other dissemination costs

Any large costs should be further detailed with a breakdown of constituent parts or a timescale profile of the costs. Meetings to share best practice, training events and events to disseminate research findings must be run at the lowest possible cost with minimal catering. ‘Conferences’ which are described as such are not eligible for funding.

Indirect costs/overheads

Indirect costs will be charged in proportion to the amount of research staff effort requested on the award.

They comprise:

  • General office and basic laboratory consumables
  • Premises costs
  • Library services/learning resources
  • Typing/secretarial
  • Finance, personnel, public relations and departmental services
  • Usage costs of major research facilities
  • Central and distributed computing
  • Charge out rates for shared equipment
  • Cost of capital employed

NHS bodies or other providers of NHS services indirect costs

NHS indirect costs cannot be claimed through NIHR/DHSC programme funding. NHS bodies or other providers of NHS services have been allocated NIHR Research Capability Funding (RCF) to contribute to the cost of hosting NIHR/DHSC-supported research. For more information please click on the link below:

https://www.nihr.ac.uk/research-and-impact/nhs-research-performance/research-capability-funding.htm

HEI indirect costs

Please see the Programme Specific Information above. Programme Development Grants does not pay FEC. Therefore, indirect costs cannot be claimed for HEIs.

Commercial/other partner organisation indirect costs

Commercial/other partner organisations can claim indirect costs which are the costs of resources used by the research that are shared by other activities. Please seek advice from your finance department about the appropriate cost for this section.

Total Commercial/other partner organisation indirect costs must be fully justified.

 

 

NHS support and treatment costs (incl. excess treatment costs/savings)

The finance section includes a section that asks researchers to provide an estimate of the patient care costs associated with the research (if applicable). An explanation of why these costs are being incurred and the basis on which the estimations have been made should be fully detailed under the relevant ‘Justification of Costs’ section.

The committee/panel will take NHS support and treatment costs into account when considering the value for money of the research. It is important that you consider these costs and discuss them with the NHS bodies or providers of NHS services involved in order to avoid any delay in commencing the research.   

Please be aware that the research award does NOT include NHS support and/or treatment costs. NHS support costs will be funded via the Comprehensive Research Networks. NHS Excess Treatment costs, can be accessed via the Lead LCRN managing the process on behalf of the local sites.

A representative of the NHS body or provider of NHS services - incurring any NHS support and treatment costs - must sign off the application. The ‘Other supporting roles – signatories (electronic)’ page is intended to ensure that the aforementioned organisation is satisfied that all NHS support and treatment costs in the application are correct and is prepared to meet these costs.

Upload a Schedule of Events Cost Attribution Template (SoECAT) form

NOTE: A Schedule of Events Cost Attribution Template (SoECAT) form is not required if the development work does not involve the recruitment, consenting and/or treatment of patient participants.

Please note that as part of the work to address the issues surrounding the way in which Excess Treatment Costs are funded, new arrangements are now being implemented as part of a pilot. To underpin the new arrangements, a cost attribution tool has been created by the Health Research Authority (HRA) in partnership with charity funders and research sponsors. This tool provides a standardised approach across England, ensuring that the attribution of study activities complies with the Department of Health and Social Care Guidance on Attributing the Costs of Health and Social Care Research and Development (AcoRD). As part of their funding applications, researchers are required to complete this new tool, known as a Schedule of Events Cost Attribution Tool (SoECAT) for clinical research, which has been developed from the current HRA Schedule of Events. This tool is designed to capture the different costs associated with clinical research and attribute them accordingly. The totals for excess treatment costs and NHS support costs are calculated by using the SoECAT. Therefore you are not required to add costs to the online application form under the ‘NHS Support Costs’ or ‘NHS Treatment Costs’ sections. However please still complete the question over whether the costs have been discussed and agreed with the Lead Network’

Researchers and/ or their study teams and Research Sponsor/ Lead NHS Provider (e.g. R&D office/ Clinical Trial Unit) are supported by AcoRD Specialists in the Local CRN to verify the accuracy of the SoECAT. For more information please see the NIHR CRN Routemap available at

https://www.nihr.ac.uk/funding-and-support/documents/study-support-service/researcher-routemap.pdf

Under the new arrangements, sign off via the LCRN AcoRD Specialist is required to confirm the study attribution complies with the Department of Health and Social Care AcoRD guidance. This early attribution support will underpin the excess treatment cost management process by providing formal sign off, supporting the role of the research sponsor and lead R&D office or Clinical Trial Unit. Completion of the Schedule of Events Cost Attribution Template will be required for studies eligible for the NIHR portfolio and the support this provides, which will include access to excess treatment cost payments under the new arrangements. This ETC value, alongside recruitment activity in the NIHR Central Portfolio Management System, will then be utilised to inform the payments to NHS providers.

When considered necessary by the LCRN AcoRD specialist, a completed Schedule of Events Cost Attribution Tool (SoECAT) is now required to be uploaded and submitted as part of the application submission for all applications.  If not considered necessary then it is not required/non-mandatory.

The SoECAT form and more information can be found here

https://www.nihr.ac.uk/funding-and-support/study-support-service/resources/excess-treatment-costs.htm

Guidance for completing the Schedule of Events Cost Attribution Template (SoECAT):

https://www.nihr.ac.uk/funding-and-support/documents/study-support-service/soecat-guidance.pdf

NHS support costs

These are the additional patient care costs associated with the research, which would end once the R&D activity in question has stopped, even if the patient care service involved continues to be provided. These might cover items such as extra patient tests, extra in-patient days and extra nursing attention. Researchers should contact their local NHS R&D department initially and, if they are unable to help directly or if there is no local NHS R&D department, contact the Local Comprehensive Research Network (LCRN) senior manager for advice on NHS support costs. Further details about LCRN contacts are available at

https://www.nihr.ac.uk/nihr-in-your-area/local-clinical-research-networks.htm

*Please note: you are not required to add NHS Support Costs on the online form as these are now part of the new SoECAT form. However please still complete the question over whether the costs have been discussed and agreed with the Lead Network’*

NHS treatment costs

Please read the following guidance on the funding of excess treatment costs prior to completing your application https://www.england.nhs.uk/ourwork/research/etc/.

These are the patient care costs that would continue to be incurred if the patient care service in question continued to be provided after the R&D activity has stopped. In determining NHS treatment costs you must assume that the patient care service being assessed will continue even though there may be no plans for it to do so. Where patient care is being provided which differs from the normal, standard, treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given), the difference between the total treatment costs and the costs of the “usual standard care" (if any) constitutes excess treatment cost/saving, but is nonetheless part of the treatment cost, not an NHS support or research cost. These costs should be determined in conjunction with your NHS body or provider of NHS services and their commissioners.

Please note if the patient care intervention under investigation is in addition to usual care there is no need to complete the ‘Usual Treatment Costs’ section however this will need to be justified in the relevant ‘Justification of Costs’ section. If the patient care intervention under investigation either wholly or partially replaces usual care, the ‘Usual Treatment Costs’ section must be completed.

*NOTE: you are not required to add NHS Treatment Costs on the online form as these are now part of the new SoECAT form. However please still complete the question over whether the costs have been discussed and agreed with the Lead Network’*

NOTE: In the Usual Treatment Costs part of the detailed Budget section, if no usual treatment are applicable, then £0 should be added to ensure that the application can be submitted.

For further information, please see:

Attributing the costs of health and social care research and development (AcoRD)

https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research

 

 

Section 11: Management and Governance

Is Clinical Trials Authorisation required?

Yes / No

 

Does your project require ethics approval?

Yes / No

 

If yes, has ethics approval already been obtained?

Yes / No

 

 

Section 12: Uploads

Mandatory:

A list of references cited in the application.

 

If claiming CTU support:

CTU letter of support.

 

The following file(s) are considered non-mandatory to submission; please number your files and attach:

Supporting documentation, including logic models, flow diagrams, pictures, charts, letters of support (including letters to confirm support for funding NHS Support and Treatment costs), papers in press etc. No more than five separate files are permitted. The total file size of all uploads should not exceed 6Mb (this includes the SoECAT form and Gantt Chart uploaded earlier in the form). Total files sizes larger than this may not be considered as part of the submission. All supporting documentation must be uploaded with a clear and concise filename description, preceded by a numbered ‘Appendix’ reference.

 

 

Section 13: Administrative contact details

Please provide the details of an administrative lead as a secondary point of contact for any queries relating to the application, should it be supported.

NOTE: This person does not need to be a co-applicant.

 

 

Section 14: Research and Development office contact details

Please provide the contact details and job title of a person in the R&D office so that we are able to notify them of the outcome of this application including any associated feedback.

NOTE: This person does not need to be included as a co-applicant.

 

 

Section 15: Acknowledge, review and submit

Conflict checks

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have, including any facts that, should they come to light at a future date, could lead to a perception of bias. Include any relevant personal, non-personal & commercial interest that could be perceived as a conflict of interest. Examples include (this list is not all encompassing) secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In a case of commercial sector involvement with the application or the study, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups.

Agreement to terms and conditions

As lead applicant, please tick the box to confirm that the information given on this form is correct and that you will be actively engaged in this research and responsible for its overall management.  In addition, you will accept responsibility for ensuring that the host institution and interested parties are kept informed.

 

Ticking this box constitutes an electronic signature of the lead applicant with regard to this application

Checklist of information to include when submitting a NIHR PDG research application

Applicants should click the checkboxes to indicate that they have included the necessary information prior to submitting their application.

 

Appropriate and relevant involvement of patients and the public http://www.invo.org.uk/

 

A good quality plain English summary www.involve.nihr.ac.uk/makeitclear

 

A clear description of team member roles and contribution

 

A clear scientific abstract

 

A clear description of the changes from first stage

 

A flow diagram illustrating the study design / flow of participants (document upload), if appropriate

 

A full and accurate detailed budget breakdown

 

A clear justification of costs / value for money

 

References (document upload)

 

A clear Detailed Research Plan outlining the study design, methods, dissemination etc.

 

A CTU letter of support if required (document upload)

 

The support and agreement from the necessary supporting roles / signatories

 

Completed Schedule of Events Cost Attribution Tool (SoECAT)