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i4i PDA Stage 1 Frequently Asked Questions

 

Contents

i4i PDA Stage 1 Frequently Asked Questions

General

Q: Is there any weighting assigned to the assessment criteria listed in the i4i PDA supporting information?

A: The application is assessed in its entirety against the eight assessment criteria; there is no specific weighting allocated to each criterion.

Q: Where can I find the submission and outcome dates for i4i competitions?

A: Dates for i4i funding competitions can be found here. 

Q: What organisations can lead i4i PDA applications and is a second party required?

A: i4i PDAs can be led by Small and Medium sized Enterprises (SMEs), Higher Education Institutions (HEIs) or NHS Trusts. A minimum of two collaborating parties are required (i.e. the Lead Organisation plus one other).  

Q: Do i4i PDA applications require a specific referencing style

A: Please using Vancouver or Harvard style format.

Q: Can one organisation submit two different applications to the same i4i PDA funding call?

A: Yes, but you would have to clearly indicate the differences, and where applicable, potential synergies.

Q: Should potential applicants submit a pre-submission engagement form prior to the Stage 1 application and what are the time-scales for receiving a response?
A: Applicants are strongly encouraged to submit a pre-submission engagement form to ensure that their project is within scope of the award. Pre-submission enquiries are aimed to be responded to within seven days.

Q: The application form indicates that there is potential for Joint Lead Applicants. Please clarify the implications of this and under what circumstances it would be acceptable.
A: An application might include Joint Lead Applicants for a number of reasons and is project dependent. Common examples are (but not limited to): if the intended Lead does not have experience of leading large projects; or if there are two co-applicants equally involved in the project from two different organisations. Justification for Joint-Lead applicants must be given.

Q: Can an application to an i4i PDA be submitted whilst waiting for an outcome from another award (e.g. i4i Connect)?

A: Yes, but this must be explained in the application form. If the project is the same or very similar, applicants will not be awarded funding for both projects.

Q: What evidence is required to demonstrate commitment from a collaborating party at Stage 1 of an i4i PDA application?
A: Letters of support would be welcomed at Stage 1 but are not a requirement. 

Q: Please can you clarify what “researcher-led” means in this context?

A: Researcher-led means that applications are open to all research and development of medical technologies in all areas of unmet clinical need.

Q: Must Lead organisations and Collaborators be based in England or the UK?

A: The Lead organisation must be based in England, collaborating organisations can be based anywhere in the UK, or if suitably justified, overseas.

Q: Do Joint Lead Applicants need to be from different organisations?

A: Joint Lead Applicants can be from the same or different organisations.
Q: Are collaborators from outside of the UK eligible to be included in an i4i PDA?
A: UK collaborations are encouraged but non-UK collaborators are allowed in specific cases where good justification is given. This would be decided by the Committee on a case-by-case basis.

Q: Are i4i PDA Applications confidential?

A: i4i PDA applications are confidential, guidance can be found on the Research Management System. If funded, the Plain English Summary, Chief Investigator/Co Investigator(s) names, award amount, start date and end date will be published on the NIHR funding and awards page

Q: Where can applicants seek support with application writing?

A: Applicants can seek support with their application from their local Research Design Service.

Q: What is the current success rate for applications made to i4i PDAs?
A: The overall success rate for i4i PDAs is 14%, with 26% of applicants being invited to submit a Stage 2 application and 54% of Stage 2 applicants being awarded funding.

Project specific

Q: What is a typical balance between product development and evidence generation within an i4i PDA?

A: i4i PDAs will fund the majority of activities associated with product development and evidence generation (excluding animal studies). There is no typical balance of these two aspects as this will depend on the stage of product development. i4i will also fund commercial activities, a full list of funded activities can be found in the i4i PDA supporting information.

Q: What is acceptable as demonstrated ‘proof of principle’?

A: Proof of principle refers to there being enough evidence to convince an Assessment Committee that a technology/intervention has a high potential to be developed into a tangible product. This will differ depending on the type of technology/intervention and applicants are encouraged to submit a pre-submission engagement form with their project idea if they require clarification.

Q: Could an i4i PDA project consist of proving the concept for development of a technology?
A: To be eligible for an i4i PDA, the technology must have established proof of concept. NIHR i4i Connect awards, fund smaller projects (£150k, for up to 12 months) and are aimed at boosting SMEs to the next critical stage and could be used for proof of concept.

Q: If incorporating trials within an i4i PDA, what proof of ethical clearance is required at application stage?
A: Applicants are encouraged to discuss ethical approval requirements with their local Clinical Research Network and the Health Research Authority (HRA). All necessary approvals must be sought during the course of the project or before, and this should be stated and/or planned for within the application.

Q: If an application includes Joint Lead Applicants, is it possible for one Lead Applicant to lead commercial activities and not be involved in research and development?
A: It is acceptable for one Joint Applicant to be primarily involved in commercialisation activities if relevant to the project and justified.

Q: Is it possible for an application to change between Stage 1 and Stage 2, and if so, to what extent?
A: The overall aim of the project shouldn't change but it is possible to add or remove work packages if justified. In this situation, applicants would be advised to discuss the changes in advance of the submission of their Stage 2 application with their i4i Programme Manager.

Small and Medium sized Enterprise (SME) specific

Q: Can an SME be a Lead Applicant?
A: A Lead Applicant should be a person, the associated SME would be the Lead organisation.

Q: The application form asks for the publication history of the Lead applicant. Is it an issue if the Lead Applicant is from an SME and does not have an extensive academic record?

A: The NIHR uses a Standard Application Form for all of it is funding programmes. i4i applications will be assessed on the strength of the research team and their ability to successfully deliver the planned project, and not necessarily on the academic record of the Lead Applicant.

Q: What percentage of SMEs are currently involved in i4i funded projects?

A: 21% of i4i projects are currently led by SMEs and 35% have SMEs as a co-applicant.

Finance and Intellectual Property (IP)

Q: What level of finance detail is required at Stage 1 for an i4i PDA application?

A: The estimated research cost and estimated NHS support and treatment costs must be included within the application form at Stage 1. Stage 2 requires a detailed breakdown of these costs.

Q: Where can I find more information on what to include as NHS support and treatment costs? 

A: Local Clinical Research Networks are there to advise on NHS support and treatment costs. A summary of what these costs include can be found in the i4i finance guidance.

Q:  What is the usual funding amount awarded to i4i PDA projects?

A: Funding for i4i PDAs is uncapped. Typically, awards range between £0.6m-£1m but applications do not have to be within this range. Applicants should make sure that they justify their costs and that their project offers value for money.

Q: What is the total research cost deviation that is allowed between Stage 1 and Stage 2 of an i4i PDA?
A: It is acceptable for the total funding requested to deviate +/- 10%. Reasons for this must be outlined in the Stage 2 application. Deviations should be discussed with the i4i Secretariat ahead of submission of a Stage 2 application.  

Q: Can funds be used to pay subcontractors?
A: Funds can be used to pay subcontractors.

A: During the project, how are funds distributed to the Collaborators?

Q: The Lead Organisation will be paid in arrears and is responsible for distributing agreed monies to Collaborating parties.

Q: Can the cost of capital equipment be included in the grant application?
A: Capital equipment costing up to £5k can be included.

Q: Can rental of a piece of capital equipment be included?
A: Rental for a piece of capital equipment can be included within an i4i PDA application, but the need to do so must be justified.

Q: Can funds be used to pay for health economic studies as part of product development?
A: Funds can be used for health economics activities, and these activities are encouraged.  

Q: Is there a limit on subcontractor costs before they should be classed as a Collaborator?
A: There is no official limit on the proportion of funds distributed to sub-contractors. Applicants should carefully consider whether an organisation should be classed as a subcontractor or a collaborator. A sub-contractor will normally be an organisation that is providing a service and will not  contribute to the generation of any foreground IP.

Q: What happens with arising IP if it is an improvement to existing IP owned by an SME partner?
A: Non-severable IP will be identified during the contract negotiation process. Ownership of non-severable background IP normally remains with the original owner. 

Q: Will the funder own any IP produced during an i4i PDA?

A: IP ownership would normally lie with the Lead applicant, or in certain circumstances with a collaborating party. The funder will not own any IP created during a funded i4i PDA.