€¦  · web viewpgfar stage 2 standard application form. this word template of the pgfar...

56
*Standard Application Form* Form Template draft PGfAR STAGE 2 STANDARD APPLICATION FORM This Word template of the PGfAR application form can be used to assist applicants complete the online application form. Please note that this Word template cannot be submitted as an application. Only applications submitted online via the CCF RMS will be accepted, however information can be copied from the Word template into the online application form Section: Introduction Please note the following information and guidance is intended for applicants submitting a Stage 2 Programme Grants for Applied Research application to competition 22 ONLY. There are a number of online guidance prompts (marked as a ?) available to you throughout the online form to help you when completing an application. It is strongly advised that you also read the Guidance for Applicants document before completing your application as important changes have been made to the Programme. The rationale for this change is outlined in the Programme Director’s message and associated podcast . Briefly: Programme Grants will continue to support leading research groups able to demonstrate an excellent track record of achievement in applied health research and the potential to deliver research findings that will benefit patients and the NHS within the relatively near future. PGfAR awards will also still support a set of cohesive projects which tackle high priority health issues for the NHS, and we will continue to welcome applications proposing not only trials but also other robust methodological designs. However, the structure of funding and timing for Programme Grants will be made more flexible, as follows: There is now no fixed upper limit to Programme Grant funding, but it will be very unusual for funding of more than £2.5 million to be agreed. For full funding to be agreed for the development and trialling of a complex intervention, the normal expectation is for a substantial powered trial to be included in the proposal. A feasibility or pilot trial will normally have preceded the full trial, with a staging report to consider whether progression to a full trial is warranted Reference: Competition 22 Stage 2 Date updated: December 2016 Page 1 of 56

Upload: vuonghanh

Post on 04-Jun-2018

214 views

Category:

Documents


0 download

TRANSCRIPT

*Standard Application Form* Form Template draft

PGfAR STAGE 2 STANDARD APPLICATION FORMThis Word template of the PGfAR application form can be used to assist applicants complete the online application form. Please note that this Word template cannot be submitted as an application. Only applications submitted online via the CCF RMS will be accepted, however information can be copied from the Word template into the online application form

Section: Introduction

Please note the following information and guidance is intended for applicants submitting a Stage 2 Programme Grants for Applied Research application to competition 22 ONLY.

There are a number of online guidance prompts (marked as a ?)  available to you throughout the online form to help you when completing an application. It is strongly advised that you also read the Guidance for Applicants document before completing your application as important changes have been made to the Programme. The rationale for this change is outlined in the Programme Director’s message and associated podcast. Briefly:

Programme Grants will continue to support leading research groups able to demonstrate an excellent track record of achievement in applied health research and the potential to deliver research findings that will benefit patients and the NHS within the relatively near future. PGfAR awards will also still support a set of cohesive projects which tackle high priority health issues for the NHS, and we will continue to welcome applications proposing not only trials but also other robust methodological designs. However, the structure of funding and timing for Programme Grants will be made more flexible, as follows:

There is now no fixed upper limit to Programme Grant funding, but it will be very unusual for funding of more than £2.5 million to be agreed. For full funding to be agreed for the development and trialling of a complex intervention, the normal expectation is for a substantial powered trial to be included in the proposal. A feasibility or pilot trial will normally have preceded the full trial, with a staging report to consider whether progression to a full trial is warranted

The normal expectation for many complex interventions is that intervention development, feasibility or pilot trial, and the full trial (again, where a trial is the appropriate study design) can all be performed within the five year time frame. However, the development of some difficult complex interventions will mean that, in some instances, six years will be needed, but applicants will need to provide very clear justification for a longer time frame

Where a full trial is required, but is deemed to be a significant risk, and a feasibility or pilot trial is an appropriate end-point (perhaps, in particular, for more risky complex interventions), the normal expectation will be for a reduced funding limit (normally under £500,000 but up to £1 million for difficult complex interventions) and reduced duration (normally two years, but up to three years for difficult complex interventions).

Stage 2 applications should observe the maximum word limits as indicated throughout the form. Keep the use of acronyms to a minimum. Only use acronyms where a term is used frequently throughout the application. If you do choose to use an acronym, do not assume that the reader knows what it means, and be sure to define it when first used.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 1 of 43

*Standard Application Form* Form Template draft

You are strongly advised to structure the longer sections of the application form (particularly the Research Plan) in such a way that they can be read easily by reviewers. The use of long passages of dense, unstructured text should be avoided.

The deadline for this call is 1pm, 5 th April 2017

Any colleague(s) previously invited to participate in this bid will need to log into the system and access the application. Please ensure that all co-applicants invited to collaborate on this application have reviewed their involvement, contributed to and approved the application form content as appropriate before submission. Please note that all co-applicants must manually add their own relevant publications to the application form using the ‘Applicant Publication Details’ section of the application. Whilst confirming and approving an application can be done at any time during the submission of an application it is strongly encouraged that this is well in advance of the deadline.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 2 of 43

*Standard Application Form* Form Template draft

Section: Research details

Research TitlePlease provide the title for the research. This should be both concise and descriptive and should contain keywords relevant to the research.

Host organisation (which will administer any award)Please indicate which NHS body or other provider of NHS services1 would act as the contracting organisation should the application be successful.

Any award will only be administered through an NHS body or other provider of NHS services1.

1Under Schedule 4 paragraph 138(2)(c) of the Health and Social Care Act 2012, ‘NHS body’ means: (a) the Board; (b) a Clinical Commissioning Group; (c) a Special Health Authority; (d) an NHS trust; and (e) an NHS foundation trust. NOTE: If your organisation does not appear on this list, please contact the Central Commissioning Facility.

Research duration:Please indicate the expected length of the proposed research in months, ensuring that you include sufficient time to complete all aspects of the research including the final report.

NOTE: The normal expectation is that programmes, even those proposing the development, piloting and full trial of complex interventions, (where a trial is the appropriate study design) can be performed within the five year time frame. However, the development of some difficult complex interventions will mean that, in some instances, six years will be needed, but applicants will need to provide very clear justification for a longer time frame.

Where a full trial is required, but is deemed to be a significant risk, and a feasibility or pilot trial is an appropriate end-point (perhaps, in particular, for more risky complex interventions), the normal expectation will be for a reduced duration (normally two years, but up to three years for difficult complex interventions).

Proposed start date if awarded fundingCannot be before 18/05/2018 Please indicate the proposed date on which the research would start.   This can be an estimate, but please ensure that it allows sufficient time to obtain any necessary regulatory approvals and/or submit any appropriate documents to the PGfAR programme.  Given this, a ‘cannot start before’ date will be proposed online. NOTE: Successful applications will be expected to start within a reasonable time following confirmation of funding (typically six months).

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 3 of 43

*Standard Application Form* Form Template draft

Section: Lead Applicant detailsThe Lead Applicant may be an NHS or University employee; in the latter case, the individual would need to have an appropriate relationship with the NHS organisation to ensure proper governance and accountability. 

As a minimum, the Lead Applicant must have an honorary contract with the NHS body or other provider of NHS services submitting the application.

The Lead Applicant is also required to input their ORCID ID information into their online CV. This can be added by selecting 'Save and Close' at the top of this screen and accessing the Manage My Details section on the left hand menu toolbar.Further information about ORCID ID can be found at http://www.nihr.ac.uk/about-us/how-we-are-managed/our-structure/systems/research-information/orcid-id.htm and http://www.nihr.ac.uk/news-and-events/news/archive-news.htm?postid=3024.

NOTE: Some of your details will have been pre-populated based on the information provided in the CV; any remaining fields must be completed.

Some of the responses required in this section will have been pre-populated based on your CV details. To update your CV details, please visit the Manage My Details section by selecting 'Save and Close' at the top of this screen and accessing the left hand menu toolbar.

Forename(s) Auto populated from the ‘Manage my details’ section

Surname Auto populated from the ‘Manage my details’ section

Title:

Position held:

Specialty:

Institution:Department:

Address:City/Town:

County:

All information in this box is auto populated from the’Manage my details’ section within the Lead Applicant’s CCF RMS Portal account, which should be updated and edited prior to submission.

Post Code:

Country:

E-mail:

Tel/Ext/ Mobile No:

Please ensure that your role on this research and %FTE commitment information is detailed within the ‘Co-applicant Details’ section.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 4 of 43

*Standard Application Form* Form Template draft

Provide an approximate breakdown (%) of how your current appointment is divided between the following activities: NOTE: Please use this section to provide an approximate breakdown of how your current appointment is divided.

%Service/ClinicalResearch

Teaching

Other

If applicable, please specify what your 'other' research activity consists of.(20 words)

Administrative contact detailsPlease 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.

Administrative contact name:

Administrative contact job title:

Administrative contact telephone number:

Administrative contact email address:

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 5 of 43

*Standard Application Form* Form Template draft

Section: Applicant Publication Details

Please note that relevant publication details must be added by each individual applicant on this page.

Select and order what you consider to be your ten most relevant publications to date:

Applicants should update their list of publications in the Manage My Details section. Applicants should also add up to ten relevant publications to the application form using the green “+” icon.. Use the delete icon (the red and white button) to remove a publication from the list. Click and drag the arrow icon to change the sort order of each publication. The save button can be used to save the selections in their respective order.

________________________________________To update your publications, please visit the Manage My Details area by selecting 'Save and Close' at the top of this screen and accessing the left hand menu toolbar. Once in Manage My Details, the publications are available via the Update CV section of your account.

Add Publication...

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 6 of 43

*Standard Application Form* Form Template draft

Section: Joint Lead Applicant(s):

In exceptional circumstances, applications may be led by joint Lead Applicants. Justification should be given within the ‘Case for Support’ section, under 'relevant expertise and experience' to demonstrate why more than one person would be required to lead this research (and how this brings added value to the application).

Add Joint Lead Applicant: Please select if there is more than one Lead Applicant.

Please note that the joint lead applicant will be counted as one of the maximum number of permissible co-applicants (which is 15), i.e., if you have listed a joint lead co-applicant, then only a further 14 co-applicants will be allowed.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 7 of 43

*Standard Application Form* Form Template draft

Section: Co-applicant details:

Please note there is a maximum limit of 15 co-applicants which includes the joint lead applicant if listed.

All co-applicants are expected to make a substantive contribution to the management and delivery of the programme. To reflect this, all new co-applicants will need to confirm and approve their participation while existing ones invited from Stage 1, will still need to approve this application before the submission deadline.

Please note completed CVs for all co-applicants are a mandatory requirement for submission and will be ‘pulled through’ into the application. To update these details, a co-applicant should visit the ‘Manage My Details’ section by selecting 'Save and Close' at the top of this screen and accessing the left hand menu toolbar.

However, 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. A separate text box is provided for this purpose in the ‘Add applicant role and % FTE commitment...’ section below.

Add co-applicant: Please note, once a colleague has approved their participation, their CV details will populate the application. Please ensure these are completed before the submission deadline.

Please note, if you plan to involve more than 15 colleagues, these additional members of the team must be listed as collaborators and their contribution to the research must be detailed in the 'relevant expertise and experience' element within the Case for Support section.

NOTE: Please note that 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. A separate text box is provided for this purpose in the ‘Add applicant role and % FTE commitment...’ section.

Forename(s) Surname

Position:

Specialty:

Please specify if other:

Organisation:

Department:

Address 1:

Address 2:

Address 3:

Post Code:

Country:

E-mail:

Tel/Ext/ Mobile No:

Fax No:

The table below including the finance section must be completed for each applicant.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 8 of 43

*Standard Application Form* Form Template draft

Add applicant role and % FTE commitment...

Name of applicantPlease note once an applicant has been 'invited' their details will automatically appear in the field below.

Please indicate if this co-applicant is a member of the publicYes/NoIf yes:

Co-applicants who are patients, service users or carers are 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.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 organisationsLinks with any relevant groups, committees, networks or organisationsExperience of particular health conditions, treatments, use of services - or as a member of a particular communityKnowledge and experience of research including previous research undertakenKnowledge and experience of patient and public involvement including previous involvement activitiesSkills from any other roles that are transferableRelevant qualifications, training and learning

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

500 words Specify role in researchEach co-applicant should provide a brief overview of their role in the proposed research. You have the opportunity to elaborate upon this further in the 'relevant expertise and experience' element of the ‘Case for Support’ section.

%FTE commitmentEach applicant should include the percentage of time that they will devote to the research. NOTE: Full-Time Equivalency (FTE): percentage of full-time hours per week.(% value under 100)

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 9 of 43

*Standard Application Form* Form Template draft

Co- applicant CV details:

Degrees/professional qualifications (including details of subject, awarding body and date)

Auto populated from the co-applicants’ ‘Manage my details’ section

Present and Previous Positions Held (including from/to dates job title and employing organisation) or Experience of Service Users

Auto populated from the co-applicants’ ‘Manage my details’ section Selected Relevant Publication(s) (including list of authors,article title, publication name,volume reference)

Auto populated from the co-applicants’ ‘Manage my details’ section

Research Awards(s) Held

Title of Research Award Held:      

Role in this Research Award:

Total Award: (£’s)     

Source of Award (Organisation Name): All information in this box is auto populated from the co- applicants’’Manage my details’ section within the co-applicants’ CCF RMS Portal accounts, which should be updated and edited prior to submission.Reference number of application:

Duration: months

Start Date: dd/mm/yyyy

End Date: dd/mm/yyyy

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 10 of 43

*Standard Application Form* Form Template draft

Section: Research & Development office contact

Please not we will notify the R&D office of the outcome of this application, including any associated feedback.

Host institution (which will administer any award) This will be the host NHS organisation previously specified.

R&D contact namePlease 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: Please note this person does not need to be included as a co-applicant.

R&D contact job title

R&D contact telephone number

R&D contact email address:

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 11 of 43

*Standard Application Form* Form Template draft

Section: History of this Application

Has this application, or a similar application previously been submitted to this or any other funding body? Select 'Yes' if this application, or part of this application, has previously been submitted to another funding organisation or other NIHR or DH funding scheme.Yes/No

Title of previous applicationProvide the full research title for the application.

100 words

Name of Lead Applicant

Funding body to whom it was submittedIdentify the organisation to which it was submitted previously.

Funding scheme under which the application was submittedIdentify the funding scheme to which it was submitted previously.

Please indicate whether this was a Stage 1 (outline) or Stage 2 (full) application.

The reference number of the previous applicationProvide the reference number for the application.

Outcome Funded/Pending/Rejected

Please state the outcome date, if a decision is still pending. dd/mm/yyyy

If unsuccessful, please indicate why. NOTE: Please note that you can also upload a copy of the relevant funding organisation assessment of the application and/or any pertinent reviewer comments/reports as part of the Supporting Documentation section.

500 words

Where a previous, related application was made, please indicate how this research differs from the previous application.Please summarise the key changes made to the research in response to the feedback provided, if the related application was previously submitted to this funding scheme.

500 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 12 of 43

*Standard Application Form* Form Template draft

Section: Patient & Public involvement

In this section it is important that you describe, in as much detail as possible, how patients and the public have been involved in the development of the application as well as plans for involvement in the proposed research.

Were patients and the public actively involved in identifying the research topic/prioritising the research questions and/ or preparing this application?NIHR expects the active involvement of patients and the public in the research it supports. NIHR recognises that the nature and extent of active patient and public involvement (PPI) is likely to vary depending on the context of each study or award.

The Guidance for Applicants document provides more information on PPI in research.

In addition: a definition of patient and public involvement in research, further information and resources are available from INVOLVE; the NIHR Research Design Service provides advice on applications and the James Lind Alliance has a step-by-step guidebook on involvement in research identification and priority setting.

If yes, please tick the appropriate boxes below.

Yes NoInvolved in identifying the research topic/prioritising the research questions

Involved in preparing the application

Please further describe how patient and public involvement has informed and/or influenced the development of the application and how patients and the public have been involved. If you have selected either of the boxes above please further describe the aims of the involvement and the ways in which you have involved patients and the public.

Explain how patient and public involvement has informed and/or influenced the development of the research application including any of the following:

Identification and/or prioritisation of the research topic Identification and/or prioritisation of the research questions Development of the research design Preparation of the application.

350 words

If patients and the public were not actively involved please explain why patient and public involvement was not thought necessary.

200 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 13 of 43

*Standard Application Form* Form Template draft

Please indicate the ways in which the public will be actively involved in the proposed research, by ticking all the relevant boxes below.

Design of the research

Management of the research (e.g. steering/advisory group)

Developing participant information resources

Undertaking/analysing the research (e.g. member of the research team)

Contributing to the reporting of the study report

Dissemination of research findings

No plans for involvement

Other

Please give more details, including how patient and public involvement will benefit the research, the reasons for taking this approach and arrangements for training and support.For the boxes ticked above, please outline:

the aims of the patient and public involvement, The ways in which patients and the public will be involved (where appropriate, provide names of the

individuals and/or groups (with consent) and a description of any plans for training and/or support. 

Please note that a budget line for the costs of patient and public involvement is included in the finance section which applicants are expected to complete.

For further information you can access an involvement cost calculator and budgeting guide via INVOLVE's website.

350 words

Please explain how patients and the public have been actively involved in other ways.

100 words

If there are no plans for active involvement, please explain why it is not necessary.

300 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 14 of 43

*Standard Application Form* Form Template draft

Section: Case for Support – part 1

You may find it helpful to refer back to the aims and scope and criteria sections of this document. The key is that the reasoning underlying all stages of the research should be transparent. Whatever the nature, it is vital to add as much detail as possible on design and methodology, including justification of sample size, power calculations and sample selection and exclusion criteria where applicable.

Research titleThis is the full research title of your application as detailed within the initial 'Research Details' section. Please do not amend this unless you wish to amend the title of your application. NOTE: This is largely administrative and has been autopopulated based on your previous entry within the 'Research Details' section.

Auto-populated from the Research Details Section

Aims and objectivesDescribe the overarching aims of the research, outlining the research question which the work will address.This section should be used to indicate the main aims/objectives of the research, outlining the research question which the work will address and, where appropriate, the main hypothesis.

250 words

Plain English summaryProvide a statement, to explain to a lay reader the nature of the proposed research programme, the prospective outcomes and the expected benefits for health services provision, patients and the publicThe importance of a 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: those carrying out the review (reviewers and board and panel members) to have a better

understanding of your research proposal inform others about your research such as members of the public, health professionals, policy

makers and the media the research funders to publicise the research that they fund.

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

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

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

aim(s) of the research background to the research design and methods used patient and public involvement dissemination.

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.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 15 of 43

*Standard Application Form* Form Template draft

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.rds.nihr.ac.uk/

450 words

Scientific abstract of researchPlease provide a structured summary of the research.Please use the following ordered headings to provide a structured summary of the research:

Aims and Objectives, including the question(s) to be addressed Background and rationale Research plan, specifying, in as much detail as possible, the methodological approaches proposed

for each work stream/package (sample sizes, length of follow up, choice of analysis, techniques of data collection etc.)

Projected outputs & dissemination plans Benefits to patients and the NHS.

800 words

Background and rationale Describe the background and rationale to the research programme, addressing the following areas:

The problem being addressed 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

Work undertaken previously by the research team which has led to the proposed programme of research (e.g. describe any pilot or feasibility studies).

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

NOTE: 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.

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 review of the currently available and relevant evidence (using as appropriate a predetermined and described methodology that systematically identifies, critically appraises and then synthesises the available evidence) and then summarise this in their proposal. All applicants must also include reference to relevant on-going studies, e.g. from trial registries.

1000 words

Why is this research important in terms of improving the health of the public and/or patients and the NHS?Please describe:

The importance of the proposed research and its relevance to the priorities and needs of the NHS

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 16 of 43

*Standard Application Form* Form Template draft

(including a statement of the significance of the research area, e.g. burden of disease) The anticipated outputs, outcomes and impact of the proposed research on the health of patients

and/or the public, highlighting the innovation and/or development aspects and quantifying the potential benefits where possible

The anticipated timescale for the benefits to the NHS resulting from the proposed research to be realised.

NOTE: 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.

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 review of the currently available and relevant evidence (using as appropriate a predetermined and described methodology that systematically identifies, critically appraises and then synthesises the available evidence) and then summarise this in their proposal. All applicants must also include reference to relevant on-going studies, e.g. from trial registries.

1000 words

Research EnvironmentDescribe how the clinical or academic environment(s) in which the research will be undertaken will increase the chances of success. Explain how the research will benefit from facilities provided by the host institution.  Describe any clinical, academic, or organisational links needed to support the research, or to help translate it into practice.

350 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 17 of 43

*Standard Application Form* Form Template draft

Section: Case for Support – part 2

The attached file contains the feedback points from your Stage 1 (or Programme Development Grant) application.

File Name Description

Changes from Stage 1 or (Programme Development Grant)Please address both the main and methodological feedback (appended to this application) detailed about your Stage 1 application (or proposed future programme if you have undertaken a Programme Development Grant), and explain how your Stage 2 application has changed as a result of the feedback received.The feedback relating to your earlier submission has been provided as an appendix to this application.

Please detail your response to the main and methodological feedback provided about your Stage 1 (or the proposed future programme described in your Programme Development Grant) application.

NOTE: You will be asked to confirm that you have reviewed the attachment and responded to the best of your ability.

3300 words

I confirm that I have read the attached feedback received on the Stage 1 (or Programme Development Grant) application and have responded, as appropriate, to the fullest extent.

Please detail any additional alterations to the application.Summarise any changes to the proposed research which have occurred since the Stage 1 (or Programme Development Grant) application was submitted that are in addition to the alterations made in response to the feedback points contained above (e.g. changes in the light of new research findings and/or as a result of feedback from a previous Stage 1 or Stage 2 application).

400 words

Research PlanDescribe the proposed research plan, taking individual projects/workstreams/workpackages in turn using sub-headings and spacing as appropriate. In particular, specify the methodological approaches proposed with sufficient detail to allow them to be assessed.Describe the proposed research plan, providing descriptions of individual projects/workstreams/workpackages in turn using sub-headings and spacing as appropriate. In particular, specify the methodological approaches proposed with sufficient detail to allow them to be assessed, e.g.:

Justification for sample sizes Inclusion and exclusion criteria Choice of outcome measure and why Nature of follow up Techniques of data collection Choice of analysis and why.

Researchers may find the SPIRIT 2013 statement a useful resource when considering their protocol.

7500 words

Please upload the Gantt Chart

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 18 of 43

*Standard Application Form* Form Template draft

Please note that if uploaded in a file format other than .doc or .docx this will not appear in the body of the application and instead, will form part of the Supporting Documentation section at the end of the application.

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

When uploading, applicants must only use the filename description ’Appendix_Gantt Chart’.Attach

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 19 of 43

*Standard Application Form* Form Template draft

Section: Case for Support – part 3

Projected outputs and disseminationPlease describe your plans for disseminating the findings of this research.In addition to traditional publication routes, please indicate how any findings arising from the research will be disseminated so as to promote or facilitate take up by users in the NHS.

Describe also how you will engage with health care planners, practitioners and policy makers. NOTE: Please also provide information about plans for sharing the findings of the research with the research participants.

500 words

Expected Output of Research/ImpactPlease describe how the outcomes of this research could be translated into the NHS and wider healthcare community to provide improvements in service delivery, patient health and/or wellbeing.Describe the anticipated outputs, outcomes and impact of the proposed research on the health of patients and/or the public, and on the NHS, highlighting the innovation and/or development aspects.  Indicate the anticipated timescale for the benefits to patients, the public and the NHS resulting from this research to be realised and provide a quantitative estimate of the scale of potential benefits, population level, where possible.  NOTE: It is expected that as part of the long-term research and/or implementation strategy all research funded by DH or through the NIHR, should be able to demonstrate that it is capable of generating outcomes that are likely to contribute to the benefit of those who use the services of the NHS in England.

500 words

Relevant expertise and experienceSummarise the relevant expertise of the research team that will undertake the proposed programme of research and its track record in applied health research, in terms of skills and experience, previous publications, grant funding and impact on health service provision.Explain why the group is well qualified to do this research, describing the track record of the research team in applied health research.

Explain how the applicants work together (or propose to work together if they have not done so previously), and identify other major collaborations important for the research.

Describe the existing research support (e.g. funding from other sources) available to the research team, which is relevant to this application.  Clearly delineate the proposed programme from other related research, funded from another source.

NOTE: If the salary costs of members of the team are not being sought via this application, it should be clarified, within the Finances section, how their contribution will be supported.

450 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 20 of 43

*Standard Application Form* Form Template draft

Section: Management & Governance

Research timetablePlease provide an overview of the research plan which includes specific milestones and deliverables.Describe the progression of the research plan, including the timetable and key milestones and deliverables of each work package/work stream.

200 words

Research management arrangementsPlease explain the practical arrangements for managing the research and its constituent components.Explain the practical arrangements for managing the programme and its constituent components.  This should include specification of the roles and responsibilities of the individual team members who will undertake the proposed research, 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 research. NOTE: Programme grant awards are required to have a programme steering committee in place. Successful applicants will be requested to  provide the names of an independent Chair and three independent members of the committee (one of whom should represent the interests of patients and the public) once funding has been approved.

300 words

Has any work relevant to this application already commenced? Yes/No

If yes, please give details of any relevant work that has already commenced in the preparation of this research.

200 words

Success criteria and barriers to proposed work Please set out the measurements of success you intend to use and also the key risks to delivering this research and what contingencies you will put in place to deal with them.A risk is defined as any factor which may delay, disrupt or prevent the full achievement of a research objective. 

Please set out the measurements of success you intend to use and also the key risks to delivering this research and what contingencies you will put in place to deal with them. NOTE: This section should identify appropriate actions that would reduce or eliminate each risk or its impact. 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).

300 words

Does the proposed research raise ethical issues?

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 21 of 43

*Standard Application Form* Form Template draft

Please outline any ethical issues associated with this research and the arrangements for handling them.

Please also describe any research governance arrangements that would apply to the proposed research.

Researchers may find the SPIRIT 2013 statement a useful resource when considering their protocol.

NOTE: Research must adhere to the Research Governance Framework. Yes/No

If yes, discuss how these will be addressed.

200 words Please detail how and when you intend to get ethical review completed.

300 wordsIf no, please justify why you consider ethical review is/will not be required.

150 words

Have any appropriate regulatory bodies already granted a favourable opinion?Yes/No

If the letter indicating a favourable ethical opinion has already been received, please upload it here.If you select Yes, please ensure that the name of the committee and date of the approval letter is specified. NOTE: Please note that files MUST be submitted in Microsoft Word format only.

attach a file option

Involvement of Clinical Trials Units

Is Clinical Trials Authorisation required? Yes/No

Is a Clinical Trials Unit (CTU) involved with this research proposal? Yes/No

If yes, what is the name of the CTU?

Does the CTU hold a UKCRC registration number?Yes/No

If yes, please provide the CTU registration number.

Please describe how you have worked with the CTU in developing your application and what support they will provide if funding is approved.

Please explain the involvement of the CTU in all stages of your research, including design and follow up, should the research be funded.  Clinical Trials Units are regarded as an important component of any trial application and can advise and participate throughout the research process from initial idea development and design through to project delivery and reporting.  However they may not be essential for all types of research studies, and if you feel this is the case please justify the reasons in your application. NIHR CTU Support Funding (http://www.nets.nihr.ac.uk/programmes/ctu) provides information on units receiving funding from the NIHR to collaborate on research applications to NIHR programmes and funded projects. 

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 22 of 43

*Standard Application Form* Form Template draft

The UKCRC CTU Network (http://www.ukcrc-ctu.org.uk) provides a searchable information resource on all registered units in the UK, and lists key interest areas and contact information.

NOTE: Applications claiming CTU involvement must include a letter from the CTU Director confirming support as part of the submission, and enter the relevant CTU ID number (if a UKCRC registered unit) in the application form. A list of UKCRC CTU ID numbers can be accessed via http://www.ukcrc-ctu.org.uk/.

Please also note; if funded, all primary research studies need to be assigned an International Standard Randomised Controlled Trial Number (ISRCTN). You can view the ISRCTN website at: www.isrctn.org/.  The remit of this database has been widened to include all primary research projects, even those that are not randomised controlled trials.  There is no registration fee for NIHR funded trials.

200 words

If a CTU is not being used, please explain why and who/what will be involved instead.

200 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 23 of 43

*Standard Application Form* Form Template draft

Section: Intellectual Property & Innovation

The definition of Intellectual Property (IP) includes copyright (such as new software, checklists, scales, protocols, questionnaires, toolkits, guidelines or similar) and research tools (such as data analysis techniques, assays, cell lines, biomarkers, materials or equipment and devices) patents, trademarks and designs.

What relevant IP (patents, design right, copyright etc.) is held by the applicants and how does it relate to this application? Intellectual Property (IP) includes;

Copyright (such as new software, checklists, scales, protocols, questionnaires, toolkits, guidelines or similar)

Research tools (such as data analysis techniques, assays, cell lines, biomarkers, materials or equipment and devices)

Trademarks Designs Patents

NOTE: It is important for the NIHR to understand your starting IP position so that any IP generated during your research, and also with reference to third parties’ rights which may be found during due diligence searches, can be placed in context. This knowledge will delineate the “rights” and who might own them.

You or your institution may hold the relevant background IP. The term ‘background IP’ refers to the IP available at the start of your research project - which is being used in delivery of this project. Background IP may have been developed through earlier research projects which you may or may not have been involved; and may or may not have benefitted from NIHR funding. If the research you propose will use background IP you will need to ensure you have reached agreement to use the background IP. This may require licences, collaboration agreements and/or sub-contracts. If so, you will need to tell us about these arrangements in your application and provide a copy of these agreements if you are successful in obtaining funding for your proposed research.

An important part of this process is ensuring that any relevant background IP has been identified before the research starts. It may be that you or your institution holds the background IP or alternatively, it may be held by another individual, institution or company. Even if your institution owns it others may have rights. The ‘freedom to operate’ with background IP not just in the research but in how that research may translate into patient benefit is important.

300 words

Has a freedom to operate search been conducted and by whom?A ‘freedom to operate search’ is taken to mean undertaking a series of activities to determine if the background IP (including any interventions) you are proposing to use or develop as part of the research can be used/developed without infringing on valid intellectual property rights of others. Such activities may be undertaken by you or a third party on your behalf. In the context of research funding this is important as it could be that the intellectual property rights of others may either prevent your proposed work from going ahead, prevent you from maximising the benefits from your research, or prevent you from using any foreground IP generated by your study. It is worth noting that IP rights are specific to different countries or regions (jurisdictions), and any freedom to operate search and analysis needs to consider this aspect as many health interventions cross jurisdictional boundaries.

You need to tell us if you have, or have not, conducted a freedom to operate search in relation to this application. If you have already, or you plan to undertake a search, then please indicate briefly the procedure you have used/plan to use. If you have conducted a search you need to tell us and what you have found from your searches, even if you have found nothing. If you have not undertaken a search it is very likely that your study draws upon existing background IP and therefore a search would be helpful in preparing for your study.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 24 of 43

*Standard Application Form* Form Template draft

If you need further advice regarding this issue you should contact your Technology Transfer Office.Yes/No

If yes, please provide details of all relevant IP and how it relates to the application.All related IP not owned by any of the applicants should be listed, including details relating to third party licence requirements.

Please indicate briefly the procedure you used to search for existing IP. NOTE: You should indicate here what you have found from your searches, even if you have found nothing.

150 words

If no search has been conducted please set out the rationale.

150 words

Will any IP be produced or improved during the proposed research? Radio Yes/No button

If yes, please describe what IP will be produced and/or improved.Indicate where and when new or improved IP will arise. Link this back to any existing IP that you may have previously mentioned. Indicate why you think the new IP is novel over what is already known in the literature.

300 wordsPlease describe how any new IP generated through the proposed research will be recognised, captured, managed, and utilised, either through adoption in the healthcare service or through commercial exploitation. Please give details on who will lead on dissemination and / or exploitation.Please indicate the plans for benefit realisation (adoption and/or commercial exploitation) of IP or products of your research applications, and whether you have commercial partners in place or in view. Please further detail what is likely to be the ultimate impact on the health service. NOTE: It is important to demonstrate that you have plans and competent staff in place to manage any new (or existing) IP, as; 

NIHR funding requires benefit realisation from all resulting IP of value, this is not restricted to Patents and Devices, but includes Copyright and Knowhow, encapsulated in software, checklists, scales, protocols, questionnaires, toolkits, guidelines or similar that have a market within the healthcare service.

Adoption in the healthcare service can also be achieved through the application of commercial exploitation models.

300 wordsWhat are the key current and future barriers to utilising any new IP/innovation through dissemination and adoption in the healthcare service or through commercial exploitation e.g. potential regulatory hurdles?Please indicate where and when any regulatory hurdles will arise.

You should provide an indication of timing and any delays that may occur and whether this is something you or a commercial partner will have to deal with.

NOTE: You should also indicate whether you are aiming for UK/EU or US approval routes and state why.

300 words

Section: Involvement with NIHR Infrastructure

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 25 of 43

*Standard Application Form* Form Template draft

Network involvement Please describe links to NIHR networks, identifying, if appropriate, any benefits that have already accrued from working with networks.The programme expects, where appropriate, that the applicants will work with the relevant Local Clinical Research Network (LCRN). NOTE: Please indicate which LCRN (http://www.nihr.ac.uk/about-us/how-we-are-managed/managing-centres/crn/) you intend to work with and the extent to which any links have been established.

150 words

Research Design Services (RDS) InvolvementPlease indicate, if applicable, which organisations (e.g. NIHR Research Design Service) you have contacted in the course of preparing this application. NIHR Research Design Service (RDS) supports researchers to develop and design high quality research proposals for submission to NIHR and other national, peer-reviewed funding competitions for applied health or social care research. This includes giving advice on patient and public involvement in the development of applications.  Please find below the ten NIHR Research Design Services: 

East of England East Midlands London North East North West South Central South East Coast South West West Midlands Yorkshire and The Humber

East of England/East Midlands/London/North East/North West/South Central/South East Coast/South West/West Midlands/Yorkshire and The Humber/n/a

Please describe the RDS’s input.

Please give details of any advice you have received in preparing your application e.g. from a statistician or health economist. NOTE: It will be helpful to indicate whether this advice has been restricted to a single element of the design or has been more wide-ranging. 

150 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 26 of 43

*Standard Application Form* Form Template draft

Involvement with other partners

What, if any, other NIHR organisations will partner this research?

Biomedical Research Centre (BRC)/Biomedical Research Unit (BRU)/Clinical Research Facility (CRF)/Collaboration & Leadership Health Research Centre/Other (please specify)/n/a

Please specify what other NIHR organisations will partner this research.Please provide details of the other organisations involved (including international collaborations) and, if applicable, explain how any shared funding arrangements would work.

150 wordsDescribe the role, if any, these will have in the research.

150 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 27 of 43

*Standard Application Form* Form Template draft

Section: Finances

There is no fixed upper limit to PGfAR funding, the amount awarded will depend on the nature of the proposed work, in particular whether or not the proposal includes a substantial powered trial; however it will be very unusual for funding in excess of £2.5m to be agreed. Where the proposed programme has a feasibility or pilot trial as an end-point, the normal expectation will be for a reduced funding limit (normally under £500k, but up to £1m for difficult complex interventions).

This excludes any NHS Support and NHS Treatment Costs, which will not be met via any Programme Grant award. The selection panel will take into account the estimated NHS Support and NHS Treatment Costs when assessing the overall value for money provided by the proposed programme of research.

This Word document of the PGfAR application form does not calculate the the financial information entered; therefore, it is advised that financial information is directly inputted into the online application form.

Details of Post and SalariesPlease enter the FULL numeric value in £'s only.

NOTE: You should avoid the use of shorthand, inclusion of commas or decimal places.

The relevant Staff Details and Salary Costs options below should be completed, as appropriate, for all colleagues participating on the research bid (including for those individuals listed within the 'Co-applicant Details' section of the form).

If there are any applicants whose costs are not being claimed then, for each person, state their name and explain briefly why costs are not being claimed and what resources are being used to cover their contribution

300 words

Direct Costs

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

Salary Costs This section should specify 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 ‘% full time on this research’ and the ‘Year’ columns are independent and the % figure is not used to calculate the net staff costs.

It is important to double check that the %, 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 ensure that you check the column describing the 'Type of Cost' (employing organisation) for a member of staff as this impacts on the level of funding provided.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 28 of 43

*Standard Application Form* Form Template draft

NOTE: For PGfAR and PRP, staff employed by a Higher Education Institution (HEI) are funded at up to 100% of cost and staff employed by NHS, commercial or other partner organisation at up to 100% of cost.

Please further 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 staff costs.

Staff MemberStaff Type: Other/Lead applicant/Co-applicantName:Type of cost: NHS/HEI/Commercial/Other% Full-time on this research:Total Months on this research:

Name Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Total Annual Costs of Posts

Year 1 (£) Year 2 (£) Year 3 (£) Total (£)Total HEI

This table is calculated in the online application formTotal NHSTotal CommercialTotal Other

Travel, Subsistence and Conference Fees 

This section should include 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.

Please note that 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 but the programme does not usually fund first class travel.

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

CONFERENCE FEES;For research of up to 5 years, the programme will usually fund up to a maximum of two international conference attendances.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 29 of 43

*Standard Application Form* Form Template draft

NOTE: Where national or international conference fees 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.

Travel, Subsistence and Conference Fees...Type of Cost NHS/HEI/Commercial/Other

Description Journey Costs/Subsistence/Conference Fees

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

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 verses purchasing costs must be provided in the ‘Justification of Costs’ section below.

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 below for any purchase above this limit.

NOTE: Equipment must exclude VAT, but if your organisation is unable to reclaim/recover the VAT on a piece of equipment, you should tick the box ‘VAT cannot be reclaimed’.

If you check the ‘VAT cannot be reclaimed’ column, VAT at 20% will be calculated into the overall cost of that item.

You will need to seek expert advice from the organisation purchasing the equipment regarding its VAT status.

Equipment..Type of Cost NHS/HEI/Commercial/Other DescriptionPrice excluding VAT £Expected life time (Months)

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Consumables This section should include 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.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 30 of 43

*Standard Application Form* Form Template draft

Consumables...Type of Cost NHS/HEI/Commercial/Other Please describe fullyPrice excluding VAT £Expected life time (Months)

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Patient and Public Involvement Please itemise and describe fully all patient and public involvement costs. These are likely to include out of pocket expenses, payments for time and any relevant training and support costs.

For further information you can access an involvement cost calculator and budgeting guide via INVOLVE's website.

Patient and Public Involvement...Type of Cost NHS/HEI/Commercial/Other Please describe fully

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Other Direct Costs These are costs, not identified elsewhere, that are specifically attributed to the research. For example, external consultancy costs, specialist publications, open access publications, computer licensing, recruitment and advertising costs, and training specifically for the research team. 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.

Any costs associated with publication, presentation or dissemination of findings (except related travel and subsistence or consumables costs) should be itemised and included here. 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.

NOTE: 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

Other Direct CostsType of Cost NHS/HEI/Commercial/Other Please describe fully

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 31 of 43

*Standard Application Form* Form Template draft

Year 1 (£) Year 2 (£) Year 3 (£) Total (£)Total Direct Costs This table is calculated in the online application form

Indirect Costs

Commercial Indirect Costs Commercial organisations can claim indirect costs which are the costs of resources used by the research that are shared by other activities.Indirect costs will be charged in proportion to the amount of research staff effort requested on the research. Commercial organisations should calculate them, using their own cost rates.

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

NOTE: Please seek advice from your finance department about the appropriate cost for this section.

Commercial Indirect Costs...Name of Company / Organisation

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Other Partner Organisation Indirect Costs Other partner organisations can claim indirect costs which are the costs of resources used by the research that are shared by other activities.

Indirect costs will be charged in proportion to the amount of research staff effort requested on the research. Other partner organisations should calculate them, using their own cost rates.

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

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 32 of 43

*Standard Application Form* Form Template draft

Cost of capital employed

NOTE: Please seek advice from your finance department about the appropriate costs for this section

Other Partner Organisation Indirect costsName of Partner Organisation

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Year 1 (£) Year 2 (£) Year 3 (£) Total (£)Total Indirect Costs This table is calculated in the online application form

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 Clinical Research Network (LCRN) Senior Manager for advice on NHS Support Costs.

NOTE: Further details about LCRN contacts is available at http://www.crn.nihr.ac.uk/

NHS Support Costs...Cost per patient (£)Description of expected additional procedures/resource requirements

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Have you discussed and agreed these costs with the Lead Network?Yes/No

Please expand on your above response including justification either for the costs entered or if relevant, why no costs will be required. (300 words)

NHS Treatment CostsThese 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. Researchers should provide an estimate of the patient care costs associated with the research (if

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 33 of 43

*Standard Application Form* Form Template draft

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. For full details of cost attribution please refer to AcoRD https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research

NHS Treatment Costs...Cost per patient (£)Description of expected resources required or released

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

Have you discussed and agreed these costs with the Lead Trust?Yes/No

Please expand on your above response including justification either for the costs entered or if relevant, why no costs will be required. (300 words)

Is the patient care being provided different from the usual standard treatment for the condition ?If the patient care intervention is in addition to usual care there is no need to cost usual treatment.Yes/No

If yes, detail the costs of usual standard care below (200 words)

Usual Treatment Costs Please note if the 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.

Usual Treatment Costs...Cost per patient (£)Description of expected resources required or released

Cost Information Year 1 (£) Year 2 (£) Year 3 (£) Total (£)

NHS Support and Treatment Costs The panel will take NHS Support and Treatment Costs into account when considering the value for money

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 34 of 43

*Standard Application Form* Form Template draft

of the research.  It is important that you consider these costs and discuss them with the NHS bodies 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 Local Clinical Research Networks (LCRN).  NHS Treatment Costs, including any Excess Treatment Costs/Savings, will be met by the NHS through normal patient care commissioning arrangements. NOTE: A representative of the NHS body - incurring any NHS Support and Treatment Costs - must sign off the application. The ‘Declarations and Signatures’ 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.

Total (£)NHS Support Costs requested from networks This table is calculated in the online application

formNHS Treatment Costs requested from the NHSTotal NHS Support and Treatment Costs

Research Costs Requested From Funder NIHR programmes currently fund NHS bodies or other provider of NHS services at 100% and

commercial/other partner organisations at 100%. The PGfAR programme currently funds Higher Education Institutes at 100% If your organisation is claiming less than the maximum percentage allowed, please enter the

percentage you wish to claim in the appropriate column.

NOTE: Please note that whilst these percentages will be used to calculate the maximum amount payable, the programme reserves the right to award funding for less than this maximum where it is considered appropriate.

Direct costs Indirect costs/Overheads

Total cost % of costs paid by NIHR 1-80% or 100%

Amount requested

Total Higher Education Institution Costs

This table is calculated in the online application form

Total Commercial CostsTotal Other Partner Organisation CostsTotal NHS Research CostsTotal Research Costs Requested From Funder

Total Funding RequiredTotal (£)

Total Research Costs Requested from FunderThis table is calculated in the online application Total NHS (Support and Excess Treatment) Costs

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 35 of 43

*Standard Application Form* Form Template draft

formTotal Funding Required

Please explain how the research costs requested have been calculated and justify how they have been allocated. Please provide a breakdown of research costs, in as much detail as possible, associated with undertaking the research and provide justification for the resources requested. In this section you should provide a brief explanation as to why the following costs are necessary for the research and why these are attributable to research in accordance with AcoRD https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research 

staff costs, travel, subsistence and conference fees equipment (including lease versus purchase costs) consumables,  patient and public involvement  any other direct costs

750 words

Please explain how the NHS Support and Treatment costs requested have been calculated and justify how they have been allocated. Please provide a breakdown, in as much detail as possible, of the NHS Support or Excess Treatment costs associated with undertaking the research and provide justification for the resources required. If there are no NHS Support and/or Excess Treatment costs associated with the research you must explain why you think this is the case and you must relate your justification back to AcoRD. https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research

750 words

Please explain how the research provides value for money. You should describe how this research provides value for money taking into account the total cost of the research, including the NHS costs.

500 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 36 of 43

*Standard Application Form* Form Template draft

Section: DH Monitoring information

Department of Health Monitoring Information - Please use the drop-down menus and tick boxes to provide the information requested. This will be used by the Department of Health solely for accountability, audit and monitoring purposes.

Place of work of lead applicant:

Acute Trust/Community Trust/Consultancy/Higher Education Institute/Medical School/Mental Health Trust/CCG/Othwer/N/A

Lead Applicant’s Profession: Allied Health Professional/Clinical Acedemic/Consultant/Dentist/NHS Doctor/NHS Manager/NHS Scientist/Non-clinical Acedemic/Nurse/Patient/Other/N/A

Is the research multicentre? Yes/No

UKCRC Health Categories:Please select all appropriate categories from the UKCRC Health Categories list. NOTE: For guidance please see the UKCRC Health Research Analysis

Please select all classifications from the below list that are applicable.

Blood MusculoskeletalCancer Neurological

Cardiovascular Oral and GastrointestinalCongenital Disorders Renal and Urogenital

Ear Reproductive Health and ChildbirthEye Respiratory

Infection Skin Inflammatory and Immune

SystemStroke

Injuries and Accidents Generic Health RelevanceMental Health Other

Metabolic and Endocrine

Programme monitoring data

Research Team

Commercial IndependentAcademic (clinical) Nurse

Academic (non-clinical) MidwifeAllied health professional Patient/service user/carer

Care/service manager Social care/work professionalDentist Other – please specify

Doctor – GP Doctor – Hospital

Research Design

Case study Non-clinical trialClinical trial Pilot study

Cohort/panel study Systematic or retrospective review

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 37 of 43

*Standard Application Form* Form Template draft

Cross-sectional studyEpidemiological study

Other – please specify

Ethnographic studyFeasibility study

Meta Analysis Survey

Research Setting (in which research will take place)

Acute/emergency care Social careCommunity health care Specialist care

Population-basedPrimary Care

Interface (between any of the above)

Secondary care Other – please specifyLaboratory-based

Research Participants

Children and/or adolescents (under 18yrs)

Working age adults (18-65yrs)Older people (65 yrs plus)

People with mental health problems People with learning disabilities

People with physical and complex disabilities

Black and minority ethnic populations

Other - please specify

Research Purpose

ExplanatoryExploratoryEvaluative

Other – please specify

Research Team - If 'other' is selected please describe

Research Design - If 'other' is selected please describe

Research Setting (in which research will take place) - If 'other' is selected please describe

Research Participants - If 'other' is selected please describe

Research Purpose - If 'other' is selected please describe

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 38 of 43

*Standard Application Form* Form Template draft

Section: Research Design Service (RDS) Involvement

Did you contact the RDS? Research Design Services (RDS) support those developing application submissions.

If you have received advice from your local RDS, we would value your feedback on the services you received from your RDS in order to improve service. Your individual comments will not be attributed to you. NOTE: Responses to these questions will not constitute a part of the assessment of your application by the NIHR.

Yes/ No

Please indicate in which region:

East Midlands/East of Englnad/London/North East/North West/South Central/South East Coast/South West/West Midlands/ Yorkshire and The Humber

If not, was this because: (please tick all that apply) tick box

You felt your team already has sufficient methodological expertise?

You were unaware of RDS support available?

Other

N/A

Please specify:      

50 words

How satisfied overall were you with the input of the RDS?

Very satisfied/Satisfied/Neither satisfied or dissatisfied/Disatisfied/Very dissatisfied/N/A

To what extent do you feel the quality of your proposal improved as a result of RDS involvement

Very much/Quite a lot/A little/Somewhat/Not at all/N/A

Would you recommend the RDS to other people developing research proposal?

Definitely Yes/Probably yes/Not sure/Probably no/Definitely no

Please expand on your responses above, explaining the reasons for your choices, and including details about the extent and nature of the support provided by the RDS. Please also add any other comments about your experience of using the RDS.

150 words

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 39 of 43

*Standard Application Form* Form Template draft

Section: Supporting Documentation

Please note that all supporting documentation uploaded should be given concise and clear file name descriptions. These should be headed by a numbered ‘Appendix’ and a brief filename description that clearly describes the file (e.g. Appendix_References).

The following file is mandatory to submission, please attach: A list of references cited in the application.

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

Any further supporting documentation (diagrams, pictures, trial protocols, any letters of support etc.)

For those applying through the Programme Development Grant route, please clearly indicate (NIHR Programme Development Grant Report) and upload your report as part of this submission.

No more than 5 separate files are permitted. The total file size should not exceed 5Mb. Total file sizes larger than this may not be considered as part of this submission. We strongly recommend that only .doc or .pdf files are uploaded as some file types are not supported by the system (such as .xls and .zip file types which will not render out into the final version of the application form).  Should you wish to upload documents of other file types, we encourage you check that they appear in the PDF of the application form prior to submission as changes cannot be made after the deadline has passed.

File name Description

Upload of a new attachment

Please note that the attachments in an .xls or .zip file format will not render out into the final version of the application form. All other formats will show as appendices to the main application.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 40 of 43

*Standard Application Form* Form Template draft

Section: Declaration

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant personal, non-personal and commercial interest that could be perceived as a conflict of interest.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.

300 words

How did you hear about this call?Health Service Journal/The Guardian/Department of Health Website/NIHR Website/Nursing Times/the British Medical Journal/RD Info Website/Research Research/Research Design Service/By email/The Internet/Word of Mouth//Other

Please specify how you heard about this call.

I confirm that I have read the NIHR Carbon Reduction Guidelines and, where possible, taken steps to reduce the carbon emissions generated by this research. 

Please tick this box to confirm that you have read the NIHR Carbon Reduction Guidelines and, where possible, taken steps to reduce the carbon emissions generated by this research. NOTE: Researchers applying for NIHR funding are asked to consider the carbon footprint of their research and take steps to reduce carbon emissions where appropriate. Advice on how to do this can be obtained from the NIHR Carbon Reduction Guidelines

Lead ApplicantThe lead applicant for this application must complete the COI declaration below then assign the following contacts:

Administrative Authority or Finance Officer Senior Manager, Director of Research, Grants or Contracts Manager

On assigning these contacts an email will be sent to each by the system requesting they approve the application and confirm the content by checking the boxes below.Once these contacts have approved the application you will be able to proceed to submit.

In ticking this, you as Lead Applicant confirm that the information given on this form is complete and correct and that you will be actively engaged in this research and responsible for its overall management. Ticking this box constitutes an electronic signature of the supporting role with regard to this application

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 41 of 43

*Standard Application Form* Form Template draft

Director of Finance

The assigned finance Director must approve the application and check the access controlled box below before the application can be submitted.

Director of Finance signature against declarationIn ticking this, you as the Director of Finance for the host NHS body or other provider of NHS services confirm that you have checked the financial details of this of application and that the named institution is prepared to carry out this research at the stated costs and to administer the award if made. You also confirm that the staff grades and salaries quoted are correct and in accordance with the normal practice of this organisation.  Ticking this box constitutes an electronic signature of the supporting role with regard to this application.

Head of Department

The assigned head of department must approve the application and check the access conrolled box below before the application can be submitted.

Head of Department or Senior Manager signature against declarationIn ticking this, you as Senior Manager, Director of Research, Grants and Contracts Manager, Clinical Director or Chief Executive for the host NHS body or other provider of NHS services confirm that you have read this application and that, if funded, the work will be accommodated and administered in the named NHS body or other provider of NHS services and that the body or other provider of NHS services is capable of fulfilling the role of research sponsor as set out in the Research Governance Framework for Health and Care. You also confirm that the applicants for whom you are responsible may undertake this work. Ticking this box constitutes an electronic signature of the supporting role with regard to this application.

 

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 42 of 43

*Standard Application Form* Form Template draft

Section: Validation Summary

Top of (online) page

Please follow the next steps in order to complete your application submission process; 

Validate all mandatory/required fields listed below (that are required to be completed/amended) before submitting

Check all co-applicants have completed their CV details as appropriate and review the PDF final version for any formatting issues

Click 'Save and Close' Click the 'Submit' option (this must be completed by 1pm, 5th April 2017

You will receive an automated email containing the acknowledgment that we have received your application.Bottom of (online) page

If there are no validation requirements above you may be ready to submit the application. To do so 'Save and Close' the application.

Please note that your submission will not be considered complete until all applicants have both confirmed and approved the application and the 'Submit' button becomes available and is then used.

Reference: Competition 22 Stage 2 Date updated: December 2016 Page 43 of 43