NIHR Development and Skills Enhancement - Round 9 Guidance Notes

Introduction

The NIHR Academy is launching the Development and Skills Enhancement (DSE) award as part of the NIHR Fellowship Programme, funded by the Department of Health and Social Care.

The DSE award is a post-doctoral level award aimed at supporting NIHR Academy members to gain specific skills and experience to support the next phase of their research career. Whilst not ineligible, we wouldn’t expect professorial level applicants to require this award. For applicants at a more senior academic level, i.e Chair or Pre-Chair, there must be a clear justification why the training in your application is required. There should also be a clear explanation of why the support for such training is not available through your host organisation.

The DSE award supports a mixture of applications in areas of strategic importance and researcher led applications. This will include NIHR Academy members requiring support for career continuity in advance of applying for further NIHR academic career development funding, who haven’t been able to source support from elsewhere e.g. from Research Capability Funding. In all cases applicants will be required to demonstrate the new skills and experience they hope to gain through the award and how it will benefit their future career in research.

Awards will be 1 year maximum (in terms of NIHR funding) and may be taken up on a part time basis of between 50 and 100% whole time equivalent (WTE), however the maximum duration that NIHR will fund will still be 1 year regardless of WTE. There is an expectation that host organisations will match the level of support provided by NIHR. If this is not the case then host support will be assessed as part of the application review process.

Applicants should have been awarded their PhD by the time of starting the award and should be applying within 12 months of their previous NIHR award finishing. The 12 month window is from when the round opens and not the closing date of the competition call, for example individuals applying to Round 9 should have held an NIHR award that finished no later than 10 January 2021. The award should not be used to develop an application for the next stage in the applicant’s career but rather be used to gain skills and experience which would benefit future applications and longer term career plans.

NIHR is particularly keen to see applications from people wishing to develop skills and experience in the following areas:

• Clinical trials
• Health data science
• Entrepreneurship and working with industry

Further details of the expectations in terms of outcomes from the award for these 3 areas are given below. Applicants should note that although these 3 areas are being highlighted, applications are welcome from people looking to further develop skills and experience in any area which will benefit their development as a researcher within NIHR’s remit.

NIHR Remit

Whilst these awards are not designed to fund large scale research projects it is still important to be aware of the remit of NIHR in terms of the type of research it will fund and tailor the training programme accordingly.

All research funded by the NIHR as part of a training award managed by the NIHR Academy must fall within the following remit:

1. The overall remit of the NIHR is early translational (experimental medicine), clinical and applied health research, and social care research

2. For personal doctoral-level awards the proposal:

• must be for clinical and applied health research, or social care research
• must have clear potential for directly benefiting patients/service users, carers and the public (but recognising the training element of the research)
• can involve: patients/service users and/or carers; samples or data from these groups; other people who are not patients/service users and/or carers; populations; health technology assessment; or health or care services research

At doctoral-level, early translational (experimental medicine) research is funded through the NIHR Infrastructure, particularly the NIHR Biomedical Research Centre (BRC) training programmes.

3. For Advanced Fellowships, early translational (experimental medicine) research will be within remit. A clear and plausible path to patient /service user, carer or public benefit must, however, be demonstrable.

4. NIHR does not support basic research or work involving animals or their tissue

5. If the work involves biomarkers:

• research that tests whether application of new knowledge can improve treatment or patient outcomes, and has obvious direct potential benefit, is within remit; this might include application of known biomarkers, or other prognostic factors, to refine and test novel therapeutic strategies
• research that aims only to elucidate mechanisms underpinning disease, or identify risk factors for disease or prognosis (including search for biomarkers) is out of remit.

6. The NIHR is also prepared to support high quality research into 'medical education' (defined broadly as education for healthcare providers) and methodological research. It is expected that the research will have the potential to have practical application and the potential impact on patients/service users, carers and the public must be made clear.

Eligibility Criteria

• Current or previous member of the NIHR Academy (see Annex C for definition).
• For clinical academic applications: completion of relevant pre-registration training.
• Proposed host is an English HEI, NHS body, or other provider of health and/or care services.
• Applicants must hold a relevant PhD or MD, or have submitted their thesis for examination at the time of application. Applicants must have been awarded their PhD or MD by the time they start.
• Not submitted a DSE application in the previous round.

Start dates

Awards must start on the first of the month and for this round, awards will be available to start between 01 August 2022 and 01 November 2022.

Applicants looking to start their Award later than 01 November 2022 should apply to the next round of the competition, launching in May 2022.

Assessment Criteria

Applicants will be expected to demonstrate a continued commitment to a research career in an area of relevance to NIHR and a clearly articulated plan for how the award will support an application for future funding, including the skills and experience they hope to gain by undertaking the award. The level of host organisation support will also be assessed. The specific criteria are outlined below:

• On a trajectory to become a future health or social care research leader.
• Continued commitment of the applicant to a career as a researcher within NIHR’s remit.
• Clear articulated plan for how the award will support an application for future funding for research within NIHR’s remit.
• Quality and relevance of the academic training proposed
• The provision of a strong academic environment.
• Appropriateness of the proposed academic supervision and mentorship
• Demonstrable track record of the host department in training and supporting people who have gone on to develop successful academic careers.
• Level of matched funding provided by the Host Organisation.
• Evidence of the host organisation(s) commitment to creating and maintaining an inclusive and supportive research culture, including evidence of commitment to the principles of equality, diversity and inclusion and research integrity.

Assessment Process – Narrative CV

As part of a wider programme of work to consider the use of a narrative CV in NIHR application and funding activities we are piloting the use of a narrative CV in this funding round.  

Find out more information on NIHR's commitment to exploring a shared approach towards a narrative.

Find out more information on narrative CVs.

Award Length and Part-time Options

Applicants are able to select the Whole Time Equivalent (WTE) they wish to hold the award at between 50% and 100%. Awards will be 1 year maximum (in terms of NIHR support) and may be undertaken on a part time basis of between 50% and 100% WTE. The maximum NIHR support is 1 year regardless of WTE.

When deciding the length of the award please consider the training needed to get to the next stage in your career. However the award is being utilised, any of the options can be used provided this is justified and fits with the expected outcomes from the award.

NIHR Support

NIHR will cover the salary of the applicant for the duration of the award, training and development costs up to £5,000, conference costs up to £1,000 and mentorship costs up to £1,000. Full Economic Costings (FEC) are not covered by this award.

Matched Funding

There is an expectation that host organisations will match the level of support provided by NIHR. If this is not the case then the level of host support will be assessed as part of the application review process.

In terms of NIHR funding the maximum award duration is 1 year therefore matched funding can be used in two ways:

1. Cover 50% of costs over 1 year.
2. Extend the award beyond the time funded by NIHR. For example Year 1 costs covered by NIHR and Year 2 by Host organisation.

Please note that collaborating partners, such as an industry partner or Clinical Trials Unit, is not expected to provide match funding, this is an expectation of the host organisation.

Strategic Themes

We have a number of strategic areas which we are keen to develop expertise in, although applicants do not necessarily need to target these areas. If you are proposing training which fits within one or more of the following themes you should indicate this on the application form.

Health Data Science

Health Data Science (HDS) is a recently established inter-disciplinary field whose importance to all aspects of health research will continue to grow. The three pillars of HDS are: statistics; computation; domain knowledge. The first two of these are underpinning methodologies, the third is context-specific, ranging from molecular to whole-population studies. For further information see Annex D.

Applicants who would like training in HDS may use the award to fund MSc level modules or full courses in HDS. This award can be used to support existing NIHR Academy members who wish to develop their skills in data science as applied in clinical, biomedical or population health settings. NIHR Academy members of all professional and research backgrounds are encouraged to use the DSE Award to develop their skills in HDS.

Clinical Trials

The award can be used to support existing NIHR Academy members with an interest in, and experience of, working with clinical trials as part of their previous NIHR award who would benefit from further training within the setting of a Clinical Trials Unit (CTU). The collaboration should expose the Academy member to all aspects/stages of trials and should not limit individuals to one study. A list of potential UKCRC registered CTUs that you could link with can be found at UKCRC Registered Clinical Trials Units Network. For further information see Annex E.

Entrepreneurship and industry

NIHR aim to increase the number of researchers and clinical academics equipped with the skills to work at the interface of academia, the NHS and industry, and therefore able to contribute to the translation of ideas into new treatments and products from which patients can benefit.  By utilising a DSE award to increase skills and training in entrepreneurship combined with the experience of working with industry partners.

It is hoped successful applicants will contribute to this aim and go on to become research leaders able to confidentially engage and collaborate with the life sciences and med-tech industries throughout their career.  Also, to develop skills, experience and make useful networks which would allow them to develop their research ideas and outcomes into business opportunities. If applicable, a letter of support from collaborators should be included in the application. For further information on the core elements your training could include see Annex F.

Industry Partner Opportunities

Videregen Limited

Videregen Limited, along with the Royal Papworth Hospital and the Cell and Gene Therapy Catapult are leading a pioneering project aiming for a paradigm change in functional organ reconstruction and as part of this there is an opportunity to be involved with an airway repair and regeneration research project. The awardee would gain invaluable experience in multi-centre collaborations, data gathering and analysis, understanding the viewpoint of industry in the development of new treatments and how they interact with patients and the NHS systems; in addition to working with high profile national thoracic centres, experts in the field of health economics and market access to understand the drivers behind new technology adoption and funding from the perspective of the NHS, NICE and industry

Sonosine

Our vision is to create a new imaging technology which delivers a relatively low cost diagnostic electromagnetic imaging capability to a wider community than currently achieved. We aim to give those communities access to high quality innovative medical diagnostic capabilities, high quality imaging and tissue characterisation at an economic cost.

We are at a very interesting point in the development because we are about to develop the commercial product and we would ideally like to onboard a doctorate or postdoc clinician, likely in the broad radiology or MSK specializations but would consider other backgrounds, that could, in collaboration with clinics and hospitals, initially setup and carry out a clinical investigation / trial focused on soft tissue MSK injuries and ideally on rotator cuff injury assessment using EMA technology.

This opportunity will provide the applicant with an opportunity to develop skills in the areas of product testing, medical imaging assessment and trials, commercial product development and regulatory process management.

More information regarding the projects and partnerships can be found in Annex G. If you are interested in these opportunities we request that you contact NIHR Academy before applying.

Scope of Funding

1. Applicants need to identify an eligible Host Organisation which will act as their employer for the duration of the award. Any organisation wishing to host an NIHR Fellowship must be able to provide the applicant with a contract of employment for the duration of the award and be capable of fulfilling the role of research sponsor as set out in the Research Governance Framework for Health & Care. Further guidance on the roles and responsibilities of a research sponsor can be found on the Health Research Authority’s (HRA) website. Host Organisations can either be a recognised Higher Education Institute (HEI) or any other organisation which provides health or social care services and is based in England and in receipt of public funding (for example, social enterprises or local authorities). Applicants with a non-HEI Host Organisation should include details of a partner HEI(s) in the proposed training and development programme question of the application form.
2. An NIHR Fellowship award requires that the award holder has a contract of employment with the Host Organisation for the duration of the Fellowship. The Department of Health and Social Care (DHSC) will enter into a Fellowship contract with the host organisation. Government procurement transparency regulations require the publication of all contracts made with the DHSC to be made available on the DHSC website. Confidential information including research proposals, detailed finance information, bank details, and departmental staff names (other than the award holder’s name) will be removed from the published versions.
3. NIHR Fellowships are individual training awards which will offer funding to cover the salary costs of the individual, and the training and development programme.
4. All Fellowships will be funded at 100% and Full Economic Costs will not be covered.
5. There is an expectation that host organisations will match the level of support provided by NIHR at a level of 50% of the total Fellowship costs. If the host is not able to match the level of support for the award host support will be assessed as part of the application review process.

Application Procedure and Selection Process 

• NIHR Academy uses an adapted version of the NIHR Standard Application Form (SAF), which is a 1 stage process.
• NIHR Academy can advise on eligibility and remit enquiries, and answer queries you may have when completing the application form.
• All applications will undergo an initial screen for eligibility. Following this, applications are reviewed by the Selection Committee in advance of a funding recommendation meeting where decisions on which applications to recommend for funding are made.
• Details of Selection Committee membership are available on request.
• The Selection Committee will make recommendations for funding that will be considered by the Chief Scientific Adviser and the Director for the Department of Health and Social Care (DHCS) Science, Research and Evidence (SRE) Directorate. Once confirmed, the funding decisions will then be communicated to applicants.
• Applicants will be informed of the outcome of their application by email when all required processes are complete.
• The selection process and subsequent management of the Awards will be managed by NIHR Academy.
• All documents must be submitted in English.
• Awards cannot be deferred, without the consent of the NIHR.
• If applicants are successful in being awarded a Fellowship while simultaneously being involved in another NIHR research training award competition, they will be asked to decide which programme they would like to continue with and will be withdrawn from the other.

Application Deadlines

Your application must have been submitted by 1pm 31 March 2022 and any signatories must have approved your application by this time using the Academy Research Awards Management Information System (ARAMIS) online application system.

All components of your application must be submitted by the deadline. No additional supporting documents will be accepted after the deadline.

Please give yourself sufficient time to obtain your signatory’s approval before the deadline. No exceptions will be made.

Registering, Completing and Submitting the Application

Registering 

All fellowship applications must be completed and submitted via the online application system. 

Before you can start an application you will be required to register on the system. You will be asked to supply a valid email address and to complete some basic information. Once this has been submitted you will receive an email confirming your registration and a temporary password. You should follow the instructions in the email to log onto the system.

Once signed into the system you will be able to update various details including your CV (in ‘manage my details’) and apply for any open applications. To start an application you will need to go to ‘My Applications’ and select ‘New Application’.

You should then select Development and Skills Enhancement Award from the list provided.

After answering all the eligibility questions you will be able to start completing the online form. Please make sure you read all available guidance text including this document as well as any online instructions thoroughly whilst you are completing the form. You can at any stage download a PDF version of the application which can be useful for sharing applications with others.

Completing and submitting the form 

Please see Annex B for flow diagrams of the application submission process.

Applicant:

You will need to complete all of the mandatory sections of the form and enter under the ‘Participants and Signatories’ section the names and contact details of participants and signatories (see below). Once all other parties have made their contribution, you will be required to ‘Submit’ the application to the signatories for final sign off before the closing date. Please note that you will need to read and be aware of the roles of participants and signatories as described in these guidance notes.

You will only be able to press the ‘Submit’ button, which will send the application for final sign off by the signatories when:

• all mandatory sections of the application form are complete;
• all participants have agreed to be part of your application;
• the signatory has agreed to their role;
• the Head of Department has completed the ‘Host Organisation Support Statement’.

Please note; when completing the application form, you are advised to validate your application as you go. You will find a Validation Summary button in the left hand menu. This section will detail any points within your application that are either incomplete or incorrect. Failing to validate your answers may result in you being unable to submit your application by the required deadline.

Participants

You are required to supply the names and email addresses (if not already registered on the ARAMIS application system) of the individuals who will be undertaking ‘participant’ roles as part of your application. Everyone named in this section will be acting as a ‘participant’ to your application and will need to agree to be part of this application. Participants are required to review the declaration for the role before confirming participation as part of the one-click ‘confirm’ process.

By confirming participation, participants are acknowledging their involvement and input into this application and agree to be involved in it before it is submitted. You must ensure all participants are happy for your application to be submitted before submitting it on the online system. Details of the individuals who will be required to approve your application after submission (signatories) should be entered in the ‘Participants & Signatories' section. Please note it is often the case that one or more of the participants named in this section are also named in the "Participants and Signatories" section of the form.

Required Participants (if applicable):

Research Support: The individual(s) providing Research Support (mentorship) must confirm that they have read the application and the guidance notes and are willing to act as your mentor for career development and agree to abide by the conditions under which an award may be granted. If you have included external collaboration in your application for example with a CTU, Industry or Health data science they must confirm their participation in this section of the application.

PhD Primary Supervisor: If you have submitted your thesis but have not yet been awarded the degree, your primary supervisor needs to be included in the application to confirm this. (Signatory on ARAMIS is Post-Doctoral Primary Supervisor)

Research Contract Officer: A Research Contract Officer at the host organisation must confirm that they have read the guidance notes for the relevant NIHR programme and the standard NIHR contract, and confirm that the host organisation would be willing to accept an award according to the published terms and conditions of the NIHR standard contract.

Participants must confirm their participation on your application before you will be able to press the submit button. They will have no further action to take in the submission process once you have submitted.

Signatories:

You are required to supply the names and email addresses (if not already registered on the ARAMIS application system) of the individuals who will be ‘signing off’ your application. Once their contact details have been entered, the signatories will be invited to log into the system and confirm their participation. Details of what is required and expected of each of the roles can be found below.

Signatories will be required to agree to the role being asked of them in the application before the application is submitted by the applicant, and then approve the final version of the application after it has been submitted via the online system, i.e. all signatories must have agreed to participate and complete their sections before the applicant is able to press the SUBMIT button and send the application for signatory approvals. Signatories must approve the application after the applicant has selected the SUBMIT option but BEFORE the application submission deadline. Please see the 'Application Submission Process Flow Diagram’ (Annex B) for further information. The final signatory approval will result in the application being fully submitted to the NIHR. All parties (applicant, participants and signatories) will be notified of this via an automated system generated email.

NIHR will not accept any applications unless fully approved by your signatories prior to the 1pm deadline, no exceptions will be made.

Required Signatories:

Head of Department or Senior Manager: You will be required to include the Head of Department from your host organisation. The Head of Department from the host organisation (in which this award will be based) must confirm that they support this application and that, if funded, the research and training will be supported and administered in the named organisation and that the applicant for whom they are responsible will undertake this work. As such, the Head of Department will be required to complete questions in the ‘Training & Development and Research Support’ section of the Application Form.

Host Organisation Administrative Authority or Finance Officer: The Administrative Authority or Finance Officer for the employing host must confirm that they will ensure the accuracy of the financial details of the application and that the host organisation is prepared to host and administer the award, at the stated costs, if made.

Once the application is ready (see list of required steps under the ‘applicant’ heading above), you will be able to ‘Submit’ the application for final sign off by the signatories.

At this point, the signatories will be prompted to log back into the system and approve the finalised application. The application will not be submitted to the NIHR for consideration until all the required signatories have approved the final version. When the last signatory presses the approve button, the application will be submitted to NIHR.

Please note that all of the steps described here need to take place before the deadline of 1:00 pm on the day the round closes as stated on the website, no exceptions will be made.

Should you require assistance in completing the online form, please contact the NIHR Academy at 0113 532 8410 or by emailing academy-awards@nihr.ac.uk.

Stage 1 Guidance

1. Application Summary Information

Host Organisation

Please give details of the organisation who will be the contractor if the award is funded.

Please note that we expect the applicant’s proposed host organisation (substantive employer) to act as the contractor.

Please also bear in mind that:

• The contractor is expected to respond to annual financial reconciliation exercises, provide the final financial reconciliation statement for the project and to provide ad hoc requests for financial information during the lifetime of the project.
• In the same way, the contractor is expected to respond to any queries relating to Intellectual Property, commercialisation and benefit realisation.

If the name of your host organisation does not appear in the pre-populated list please email academy-awards@nihr.ac.uk.

Application Type

Please indicate the type of award you are applying for using the drop down lists available. Please ensure you have read the relevant guidance above before selecting your responses to these questions.

Proposed Start Date

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

WTE of Award

Awards can only be undertaken with the WTE options given. 

2. Applicant CV

Please note some of the responses to these questions are automatically pulled through from information you have entered in the ’Manage My Details’ page.

The ‘Publication Record’ section of the form is automatically populated from publications added into the “My Research Outputs” page of your ARAMIS account.

Degrees and Professional Qualifications

Please give the full details of any key qualifications completed and, where relevant, the full details of any key qualifications you are currently undertaking. 

This information can be edited in the ‘Manage My Details’ page of your ARAMIS account.

Present and previous positions

Please give the full details of any relevant present and previous positions. This information can be edited in the ‘Manage My Details’ page of your ARAMIS account.

When entering details of your current and previous positions please indicate at what percentage (WTE) in each post you were undertaking research. For example, if you were a Clinical Lecturer and undertook research for 2.5 days a week and clinical work for 2.5 days per week; please enter 50% for that position. If you have worked part time at 60%, and undertook research for half of that time, please enter 30% for that position.

Research grants held

Please give the details of all relevant grants obtained in the last five years, including personal research training awards or fellowships, plus any additional previous grants relevant to this application. Please indicate clearly any co-applicants and provide brief details of the nature and full extent of your involvement (e.g. project design, project management, day to day running, data collection, data analysis, writing papers for publication, etc.).

Please also include in the ‘Role in Research Grant’ box for each entry: registration number and name of registry and the DOI of the main related publication. Where the study is still ongoing or final results have not yet been published, please provide an estimated publication date. This is in line with the NIHR policy on clinical trial registration and disclosure of results.

Please note that your research grant record must be completed within the application form and not via the CV section on ARAMIS.

Publication Record

The publication record is automatically populated from the information added to the “Research Outputs” section of your ARAMIS account. To update, please “save and close” your application, return to the “home” screen and select “Research Outputs” from the left-hand menu.

When publications have been added, the Lead Applicant name can be edited to show in bold within application forms via the “Assign Grant Contacts” option.

To ensure publications display correctly, with all of the required information, applicants are strongly advised to use the “import” function and import their publications from Europe PMC.

Do not include abstracts, conference proceedings or articles in preparation. If relevant, details of these may be included in the ‘Applicant Research Background’ section.

Details of articles which are in press and have been accepted as final by the publisher may be included. Depending on professional background and expertise, applicants are not necessarily expected to have an extensive list of publications.

Only publications relevant to your application should be included.

Relevant Prizes, Awards and other Academic Distinctions

Please provide details of any awards or distinctions that are relevant to your application including details of what the award was for. For example, travel bursaries for a conference, presentation prizes etc.

ORCiD

The NIHR is an ORCID member and encourages all researchers to obtain this persistent digital identifier that distinguishes you from every other researcher. You must include an ORCID iD in your application. Without it, your application will not be validated and you will not be able to submit. For more information and to register please see the ORCiD website.

3. Applicant Research Background

Professional background

Select the one option which best describes your professional group. This will determine the options that appear below for your professional background.

Please describe your research career to date

Please use this question to provide a narrative describing your relevant research experience and career to date and how this makes you suitable for this award. All applicants should describe contributions across the four sections below.

Contribution to knowledge 

Explain how you have contributed to the generation of new ideas and hypotheses, and which key skills you have used and how you have communicated on your ideas. to develop ideas and test hypotheses. You can highlight contributions and skills acquired from previous roles and research projects, funding you have won, awards received, and a small selection of key outputs explaining why they are of particular relevance and why they are considered in the context of knowledge generation. Where outputs have a DOI please only include this.

Contribution to the development of others

You might include experiences from project management, supervision, mentoring or line management contributions to the success of a team or team members, establishment of collaborations, or where you exerted strategic leadership in shaping the direction of a team, organisation, company or institution. Highlight expertise you provided which was critical to the success of a team or team members e.g., project management, strategic leadership, teaching activities, mentoring, establishment of collaborations.

Contribution to the wider research community

Highlight activities where you have engaged in to progress the research community e.g., commitments such as committee memberships, editing and reviewing and contributions to the evaluation of researchers and research projects. You can also highlight contributions to increasing research integrity and improving research culture (gender equality, diversity, mobility of researchers, reward, and recognition of researchers' various activities).

Contribution to broader society

Provide examples of where you have been involved in societal engagement and knowledge exchange i.e., engagement with patients and the public, industry, across private sector,and public sectors, clients and with the broader public. Describe where you have contributed to policy development or public understanding, and other impacts across research, policy, practice and business, and other examples of and how you have ensured research reaches and influences relevant audiences.

Impact of Award

Please describe the impact this award will have on your future career, including details of why you are looking to undertake this award and where you see your career going as result of doing so. Specifically, how will the proposed training and development enhance your chances of achieving your career goals.

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

Select ‘Yes’ or ‘No’ to indicate whether this or a similar application has previously been submitted to this or any other funding body. This must include any previous submissions for an NIHR research training award, even if the proposed training programme has changed. Please detail the title of any previous submission(s), the funding body and scheme, the outcome and the date this is due if a decision is pending. If the application was unsuccessful please indicate why and detail how this application differs from previous submission(s) and how any feedback received has been used to inform this application.

Current and previous NIHR awards

In order to help track the progression of NIHR academy members and to check the applicants eligibility please indicate whether you have previously held or currently hold another NIHR research training award. Please indicate in this section if you are applying as part of the NIHR Infrastructure; for example BRCs, ARCs etc.

Mitigating factors

Please use this question to detail any mitigating factors you wish to make the Selection Committee aware of. NIHR wants to know about any circumstances so that they may take them into consideration during the assessment of your application. Mitigating factors may include:

• Career breaks due to parental leave, or periods of illness.
• Reduced time spent undertaking research due to a disability or caring responsibilities. This could include any physical or mental difficulty that may have impacted your research career. These are situations that have a significant impact on your ability to undertake research
• Reduced opportunities to career support e.g. mentorship, and limited opportunities to undertake prior research and training.

Please also use this section to detail any other factors that may have impacted your research career not listed in the examples provided. The impact on your career to date will be specific to your particular circumstances but could include such impacts as limited opportunities to obtain grant funding, or fewer publications. In general terms, mitigating factors should be significant, and relevant.

NIHR acknowledges that you may be reluctant, or uncomfortable disclosing relevant information that is sensitive. However, you should bear in mind that we are unable to take into account factors that you do not disclose. Please be assured that information provided by you is sensitive and will be treated confidentially and in line with General Data and Protection Regulations (GDPR).

Please also use this section to indicate any specific impact of the COVID-19 pandemic on your application.

4. Training and Development and Research Support

Proposed training and development programme

Please use this section to detail the training and development you will undertake as part of the award. This should cover both the training you may need to undertake any future research plans but also training designed to support your development as a future health and/or social care research leader. Training may include, but is not limited to; formal courses, training in specialist skills and research methodologies, placements with other research groups or centres, leadership skills, conference attendance and overseas research visits. All of which should support the individual in applying for further post-doctoral level fellowship funding to progress their research career within NIHR’s remit.

Any training that you include as part of your award should detail how this will add to development and enhancement and must be justified.

Whilst not ineligible, we wouldn’t expect professorial level applicants to require this award. For applicants at a more senior academic level, i.e Chair or Pre-Chair, there must be a clear justification why the training in your application is required. There should also be a clear explanation of why the support for such training is not available through your host organisation. If applying for this award at this level it should be viewed as a training award rather than bridging between awards. 

Please ensure that you include detailed information regarding any research visits that you plan during your award. For example ensure that you include length of time of the visit and what you will do/achieve during that time and why this particular training element is required.

Research support

The individuals you list here must also be added in the ‘Participants and Signatories’ section of the application form. Although we acknowledge that formal supervision may not be appropriate for applicants, we believe that the applicant will benefit from research support or mentorship. The individuals who provide research support may or may not be based in your host organisation. They should, however, have a clear understanding of the research process, the demands your chosen area of training and development are likely to place on you, and your particular strengths and weaknesses.

Research support is referred to in the literature as ‘mentorship’ and there are numerous models to be found that could be employed. Clearly describe how the proposed arrangements will support your overall development and provide an initial assessment of the time that will be allocated to the research support process.

Collaborations

Explain what collaborations you intend to establish to support your training and development programme. Collaborations should complement and enhance the skills and experience you are looking to gain through this award and can include (but not limited to) individuals, research groups, CTU’s, organisations and industry partners.

The NIHR is particularly keen to enhance the cadre of researchers equipped to work at the university/NHS/industry interface, translating ideas into new treatments and products from which patients can benefit. Therefore, where appropriate, you should consider any industry collaborations you may wish to establish during the course of your award. You should include; the training and development the collaboration will provide; the facilities and expertise you will have access to; and how the collaboration will strengthen links between academia, industry and the NHS.

Host Organisation support statement

The statement is completed by the Head of Department and should detail how the host organisation is going to support the applicant to successfully complete their training and development programme as detailed in this application. This statement should be tailored specifically to the applicant, their training needs, and include how the organisation intends to support the applicant to develop their research career in the long-term.

NIHR see the responsibility for training the next generation of research leaders as a joint enterprise with host organisations. Therefore information should also be provided on the organisation’s track record of supporting early career researchers, such as evidence of bridging or other support provided to fellows upon completion of an award.

In addition, the statement should also describe the host organisation’s approach to creating and maintaining an inclusive and supportive research culture for all.  The statement should provide evidence of how the organisation values and supports equality, diversity and inclusion as well as acknowledging the organisation’s responsibilities with respect to research integrity.  Statements may wish to refer to the principles and best practice outlined within relevant Charters and Concordats in these areas, such as the Researcher Development Concordat and Advance HE’s Equality Charters.  It should be noted that being a signatory to Concordats or holding bronze/silver status from the Equality Charters isn’t a requirement of funding and evidence can be provided through other means.

Host Organisations are expected to comply with the relevant Principles and Obligations for clinical academic training and it is recommended Host Organisations read these documents, where relevant, before completing the statement of support.

Read about the Principles and Obligations for medics and dentists.

Read about the Principles and Obligations for other professions.

NIHR expects that all commitments made to the applicant within this statement will be honoured for the lifetime of the award.

The host organisation should state here the level of matched funding being committed to this award. Where this is less than 50% of the total cost of the award the host organisation should provide a rationale and justification for this.

5. Detailed Budget

Justification of costs

This section should be completed in conjunction with your host organisation’s finance office. You should only include the funding requested from NIHR, any matched funding from your host organisation should be detailed in the support statement.

Please provide a breakdown of costs associated with undertaking the award and provide justification for the resources requested. This award provides:

1. Salary for the applicant for up to 1 year.
2. Up to £5,000 towards training.
3. Up to £1,000 towards conference/meeting related travel expenses.
4. Up to £1,000 towards the costs of mentorship

NIHR Fellowships are not project or programme grants; therefore, extensions to the duration of awards to allow for completion of training and development are not permitted. This doesn't affect suspensions of awards to allow for periods of maternity, paternity, adoption or sickness leave.

Detailed Budget Breakdown

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

GENERAL INFORMATION

• The information entered in this section should provide an analysis of the total funds requested to undertake the fellowship proposed and should be based on current prices. These costs will be used to assess value for money.
• It is in the best interest to undertake a thorough, realistic and accurate costing. You must provide a clear and full justification for all costs.
• Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by DHSC. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded.
• Years should be calculated starting from the anticipated start date of the proposed fellowship. For example, if your fellowship is expected to start on 01 June 2020 then its second year starts 01 June 2021.
• Further itemisation of costs and methods of calculation may be requested to support the application at a later date.Payments will be made to the contracted organisation only and the contracted organisation will be responsible for passing on any money due to their partner organisation(s).
• Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
• All applications are expected to have appropriate NHS, HEI, commercial and other partner organisation input into the finance section of the application form.
• There is no need to individually itemise costs where the total is below £1,000.

INFORMATION ON DIFFERENT TYPES OF ORGANISATIONS

This award does not cover Full Economics Costs therefore all prices should be entered at, and will be paid at, 100% regardless of the type of organisation (NHS, HEI or Other).

If the Employing host organisation is a Higher Education Institution, please select the “other” option when entering the “Type of Cost” to prevent costs being submitted at 80%.

DIRECT COSTS

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

I) Details of posts and salaries.

This section presents an overview of salary costs for the applicant, including normal salary increments broken down individually.

Applicant

Please state the proposed salary point and scale at the start of the fellowship. Please note immediate promotion to a higher grade as a result of securing a fellowship will not be funded.

The Apprenticeship Levy can be included in the salary costs from 1st April 2017 where relevant.

II) Salary costs

This section specifies the annual costs of the applicant. You should now allocate the individual staff member costs to each year of the fellowship, 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 fellowship is underway.

Please note the salary figures need to be calculated using the current annual costs, %WTE and number of months.

It is important to double check that the %WTE, 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 % WTE etc, whereas the yearly costs in ‘Salary Costs’ depend on % WTE etc).

III) Travel, Subsistence and Dissemination costs

This section includes journey costs, subsistence and dissemination costs, including conference fees. Where applicable, you will need to include the travel and subsistence costs relating to meetings with supervisors.

If a cost relates to travel, subsistence or fees for a conference please select ‘conference’. Conference costs don’t need to be individually itemised for each conference. The justification box should detail the conferences the costs will cover.

Journey Costs

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

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

Subsistence

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

Conference Fees

There is a £1,000 limit on the amount that can be spent on conference related costs (including all related travel and subsistence as well as conference fees).

IV) Training and Development

Please itemise and describe fully the costs associated with training and development. Please provide estimates if exact costs are not available at the time of application. Any travel and subsistence associated with training and development should not be included here and should be included in the travel section of the form.

Details of mentorship/supervision costs up to £1,000 should be included here under ‘other’.

6. Uploads

To support your research plan you are able to upload the following documents in the ‘uploads’ section of the form:

• Personal Statement: you may provide a personal statement that reflects on your overarching goals and motivation for the activities in which you have been involved.
• Collaborators letter of support: where you are working with a CTU or industry please include a supporting letter.
• It would be helpful to include a Gantt chart of your planned award to aid the selection committee members in understanding the timeline of your training and development programme.

7. Participants and Signatories

A number of participants and signatories are required to be added to your application and, where applicable, to complete sections of it.  Details of the required individuals are provided on the online application form along with details of how they should added.  The flow diagram in Annex B goes through the actions required of participants, signatories and the applicant.

8. Acknowledge, review and submit

Conflict checks

Please declare any conflicts or potential conflicts of interest that you may have in undertaking this research, including any relevant, non-personal & commercial interest that could be perceived as a conflict of interest.  Please check with your supervisor if unsure.

Agreement to terms and conditions

Please click the check box to confirm you agree to the Terms and Conditions of submission as detailed on the application form.

Additional Supporting Information

Plagiarism in NIHR funding applications

NIHR expects all content within applications for funding to be original material of the applicant's own work, with the exception of sections that other participants are required to complete. Whilst we anticipate and expect that applicants will get help and advice from various sources when putting together an application, including on occasion input from those previously awarded funding, care must be taken to ensure this does not lead to plagiarism of either published work or other previous applications. If an allegation of plagiarism is raised against an application this will be investigated in accordance with the NIHR Academy’s policy on plagiarism, a copy of which is available on request from academy-awards@nihr.ac.uk.

NIHR Privacy Policy

Our purpose for collecting information is to communicate with you about your application and have the necessary information to evaluate you for a fellowship. The data we collect here is collected in the public interest. Information provided here may be subject to Freedom of Information requests.

The NIHR Academy is part of the Department for Health and Social Care (DHSC), NIHR. The contracting agent for the NIHR Academy is the Leeds Teaching Hospital Trust (LTHT). The DHSC is the Data Controller and LTHT is the Data Processor under the General Data Protection Regulation (GDPR) EC 2016/679. DHSC NIHR respects the privacy of individuals who share their data and processes it in a manner that meets the requirements of GDPR. The DHSC Data Protection Officer can be contacted by email at data_protection@dhsc.gov.uk).

The NIHR privacy policy includes further information including ways we may use your data, our contact details and details on your individual rights regarding how your data is used. Your data may be shared across the NIHR, including with other coordinating centres, to allow the application to be managed and for statistical analysis, and with external grant reviewers as part of the process for managing the allocation of a grant. Information collected from you will not be shared outside the EEA without your consent.

This notice is under constant review and will be updated and / or revised based on that review as appropriate.

Equality and Diversity Monitoring Information

NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide Equality and Diversity Monitoring Information (age, sex, ethnicity and race, and disability).  By answering these Equality and Diversity Monitoring Information questions, you will help us to better understand the different groups of people that we fund and their experiences of being funded – particularly the groups protected by UK equality legislation.  Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response.  However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.

Requirements for systematic reviews to be registered with PROSPERO 

Applicants undertaking systematic reviews should note the commitment of NIHR to publication in the database. PROSPERO was developed by the NIHR’s Centre for Reviews and Dissemination (CRD), and is the first online facility to register systematic reviews for research about health and social care from all around the world. Access is completely free and open to the public. PROSPERO registration is a condition of NIHR funding for eligible systematic reviews.

UK Biobank 

UK Biobank is a major national health resource, and a registered charity in its own right, with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the country to take part in this project. They have undergone measures, provided blood, urine and saliva samples for future analysis as well as detailed information about themselves. The health of members of this large cohort will be followed over the coming years and the participants have consented to be approached about health research. 

Applicants are encouraged to consider whether Biobank may be able to provide suitable data for their study. We do not want to discourage establishment of new collections of participants and their data where this is necessary to address the research questions under consideration, our aim is to avoid applications for funding to set up Biobank-like cohorts where the use of Biobank would prevent wasteful duplication of Biobank-like activities.

NIHR Carbon Reduction Guidelines

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. 

Transparency Agenda

In line with the government’s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information on the transparency agenda is in the Procurement and contracting transparency requirements: guidance. 

Ethics / Regulatory Approvals

Guidance on the application process for ethical and other approvals can be found on the HRA website. Please note that if your study is led from England and involves the NHS in England you should apply for HRA approval.

If you are using patient information from an existing database, you should check whether the patients have given their consent for their data to be included in that database for research purposes, or if not whether the database is exempt under Section 251 of the NHS Act 2006. Where exemptions are not already in place, approval to use confidential patient information without consent must be requested from the HRA who make decisions with advice from the Confidentiality Advisory Group (CAG).

NOTE: NIHR is interested in taking advantage of the growing utility of routine data (such as HES, GP records etc.), and would like investigators, where appropriate, to ask study participants to consent to long term follow up (e.g. beyond the outcomes to be collected in the funded trial) using routinely collected data, and appropriate linkage to allow this data to be best used.

Contractual Arrangements

Financial support under an NIHR Fellowship is subject to a contract between the Department of Health and Social Care (DHSC) and the host organisation.

Once funding for a Fellowship has been discussed and agreed, NIHR will confirm the financial arrangements with the host organisation. NIHR will provide the host organisation with a contract setting out the details of these arrangements.

The host organisation will be expected to issue the individual with an employment contract commensurate with their experience and seniority.

Government procurement transparency regulations require publication of details of all contracts made with the DHSC on their Website. Confidential information including research proposals (Plain English Summaries will be published), detailed finance information, bank details, and departmental staff names (other than the award holder’s name) will be removed from the published versions.

Freedom of Information Act

The NIHR Academy manages the NIHR Fellowship Programme on behalf of the DHSC. As such the findings of researchers funded by the programme are incorporated in to the Department of Health and Social Care Freedom of Information Publication Scheme.

Equal Opportunities and Diversity

NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide Equality and Diversity Monitoring Information (age, sex, ethnicity and race, and disability). By answering these Equality and Diversity Monitoring Information questions, you will help us to better understand the different groups of people that apply to us for funding and their experiences of the funding process – particularly the groups protected by UK equality legislation.  Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response. However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.

Guidance and Advice

Please read these Guidance Notes carefully.

If you require any further information, advice or guidance please contact the Personal Awards team by calling 0113 532 8410 or email academy-awards@nihr.ac.uk.

Annex A: NIHR Remit frequently asked questions (FAQs)

The following FAQs are designed to help applicants decide whether the research they are proposing as part of a Fellowship or other research training application falls within the remit of the NIHR. Please bear in mind that in these applications, the research project proposal does not stand alone, but is part of a package of elements expected to provide an excellent training experience that will allow the successful applicant to take his/her skills and experiences to a still higher level. Therefore, along with the research proposal, NIHR panels will assess the abilities, academic trajectory, existing experience, commitment to a career in health and/or social care research, ambition and aspirations of the applicant, the standards in the research training environment, and the plans for explicit training in research methods. The research proposal provides a framework for research experience so has to be of high quality, but a good research proposal will not be supported if other elements are weak.

If you are proposing a programme of work as part of an application (particularly relevant for more senior awards) it maybe that certain elements of the programme would be outside the remit of NIHR if considered in isolation. If this is the case it is important that you make clear in your application that the research overall fits within the remit of NIHR and also why any elements which could be considered out of remit are necessary to include. It is also important to note that any elements of the research which are considered out of remit will not be funded by NIHR should your application be successful. This includes any work involving animals or their tissue, which NIHR does not fund under any circumstances. Applications which include a programme of work where the majority of the work is out of remit but with a small study within NIHR remit added on, will not be considered.

If you have queries over whether the research you are proposing as part of a research training application falls within the NIHR remit you are strongly advised to speak to a Senior Programme Manager for the award you applying for before submitting an application.

Do you fund the evaluation of education and/or training schemes?

Yes. Proposed studies should be within the overall remit of the NIHR and outcomes measured should be health/social care related, or there should be good evidence for a link between the outcome measured and a health/social care outcome.

Do you fund the development and/or evaluation of decision aids for patients?

The development or updating of a decision aid will be considered as part of a larger project or programme.

Do you fund the development of interventions, devices, technologies or services?

The development or adaptation of interventions can be considered as part of a larger project or programme of work. We will not fund standalone developmental studies.

Do you fund the development and/or evaluation of outcome measures, questionnaires or surveys (e.g. Patient Reported Experience/Outcome Measures)?

The development, adaptation or updating of outcome measures questionnaires or surveys can be considered as part of a larger project or programme of work.

Do you fund the development, evaluation and/or validation of models (e.g. risk factor models, health economic models etc)?

Yes – we will consider funding the development of models where there is a case for service need or patient/public benefit. There should also be an evaluation or validation aspect to the study.

Do you fund research requiring observational/applied epidemiological methods?

We fund research according to the potential for patient/public benefit rather than according to specific methodologies. We therefore fund research using a wide range of study designs including observational and applied epidemiological methods. Any study that uses observational and applied epidemiological methods should be an evaluation of an intervention itself, or have a clear, credible and articulated trajectory to further research within NIHR remits. An applied epidemiological component can also be considered as part of a larger project or programme of work.

Do you fund research into workforce?

Yes. Proposed studies should be within the overall remit of the NIHR and should concern the impact on health and well-being, whether of patients, the public, or of the workforce itself.

Do you fund research into patient and public involvement in research?

Yes. Proposed studies would need to demonstrate the potential for practical application and make clear the potential impact on patients and/or the public.

How does NIHR define the early translational (experimental medicine) research that it is interested in funding?

NIHR is interested in funding translational research which involves investigation undertaken in humans which can show a trajectory to benefiting patients.

Proposals must show a clear link to improving disease outcomes and/or improvements in health. This could include proof of concept studies in humans and phase 1 clinical trials. Research which is aimed only at furthering understanding of the underlying biology and physiology of disease, including research into disease mechanisms is not within remit.

Annex B: Submission Flow Diagram

Outlined are the steps for submitting an application. The applicant starts the application and adds participant and signatory details. The participants and signatories can then log in and confirm their participation and signatories can complete the sections of the form as directed. The applicant can continue entering data and completes all relevant sections of the form (step 3). The applicant then presses the ‘Submit’ button. Once the applicant submits, signatories will receive automated emails to approve the application. However, automated ‘out of office’ replies to these emails will not be relayed to the applicant. Once all signatories have approved the application, it is automatically submitted to NIHR for consideration. Rejection of the application by any individual at this stage will return the application to step 3.

Annex C: Eligible Academy Members

To be eligible for the DSE award applicants must be a current or previous member of the NIHR Academy.

Academy membership is reliant on holding a current NIHR Academy award or an award that ended no longer than 12 months from when the competition call opened. The 12 month period does not include any periods detailed in section 3 of the application form which have been identified as mitigating.

Eligible awards grouped by NIHR Academy Programmes are as follows:

NIHR Fellowships

• Doctoral Fellowship
• Advanced Fellowship/ Associated support posts

Research Professors

• Associated support posts

HEE-NIHR Integrated Clinical Academic (ICA)

• Clinical Doctoral Research Fellowship
• Clinical and Senior Clinical Lectureship

Integrated Academic Training

• Academic Clinical Fellowship
• Clinical Lectureship (including NIHR badged locally funded)

NIHR Infrastructure and NIHR Schools

An NIHR Academy member based within NIHR Infrastructure or Schools should satisfy all three of the bullets points below:

1. Be undertaking a formal training/career development award, which should meet all of the following criteria: be competitive, include a training plan and have a defined end point (such as an application for further funding).
2. Receive at least 25% funding from the NIHR (for ARCs and HPRUs funding can be from NIHR or from an official co-funding partner) for salary/stipend over the lifetime of the individual’s award.
3. Be hosted in a setting with a remit for research capacity development (this includes: NIHR BRCs, PSTRCs, ARCs, HPRUs, SPCR, SPHR, SSCR)

Annex D: Health Data Science

This award can be used to support existing NIHR Academy members who wish to develop their skills in data science as applied in clinical, biomedical or population health settings. Health Data Science (HDS) is a recently established inter-disciplinary field whose importance to all aspects of health research will continue to grow. The three pillars of HDS are: statistics; computation; domain knowledge. The first two of these are underpinning methodologies, the third is context-specific, ranging from molecular to whole-population studies. It is rare to find this combination of expertise in a single individual. Hence, HDS is best approached as a team science endeavour in which each member of the team is an expert in one of the three pillars but conversant in all three. NIHR Academy is interested in applications from individuals from all types of professional and research background who are seeking to develop skills in HDS.

Below is a list of key skills that are relevant to HDS. The list is broader than could be covered in any single award. Applicants should propose a training programme that balances breadth and depth in a way that reflects their current skill-set and their future career development goals. The double listing of machine learning is deliberate. A key characteristic of data science is that many of its methodological underpinnings bridge the traditionally separate disciplines of statistics and computer science.

Statistics

• Study design principles: formulating the research question, validity, efficiency, controlling for extraneous variation
• Choosing a study design: observational, interventional or randomised trial
• Probability: quantifying uncertainty in data, and in conclusions drawn from data
• Inference: turning data into evidence - testing, estimation or prediction?
• Critical appraisal of research evidence
• Machine learning

Computing

• Data collection, processing and management
• Programming
• Machine learning
• Reproducibility of data-driven research
• User-interfaces

Domain knowledge

• Biology
• Epidemiology
• Public health
• Health services

Generic

• Multidisciplinary team science: leadership, networking, collaboration
• Communication: within and beyond the research team
• Governance, including regulatory requirements and research ethics
• Patient and public involvement

Annex E: Clinical Trials

This award can be used to support existing NIHR Academy members with an interest in, and/or experience of, working with clinical trials as part of their previous NIHR award who would benefit from further training within the setting of a CTU. The award should expose the Academy Member to all aspects/stages of trials and should not limit individuals to one study. A list of potential UKCRC registered CTU’s that you could collaborate with can be found at UKCRC Registered Clinical Trials Units Network. 

NIHR does not dictate what the training within an award should be or how it is delivered as it should be bespoke to an individual’s needs and requirements. However it is very important that the trainee experiences all elements of clinical trials from idea to dissemination. It is particularly important for example to ensure training in patient and public involvement and health economics (where needed) is included early in the lifecycle of a training award to ensure these elements can be utilised right from the inception of the study.

Below is a list of key skills that applicants should consider when putting together an application focussed around clinical trials. The list is intended to cover all aspects of clinical trials that future health research leaders competent in clinical trials should be knowledgeable in and it may not be necessary for a training award to encompass all these elements depending on the skills and experience the applicant already has.

• Evidence based medicine and critical appraisal of clinical trials
• Systematic reviews
• Basic statistics for clinical trials including power calculations
• Clinical trial design and protocol design
• Complex interventions and intervention development
• Randomisation
• Blinding
• Governance including; GCP, regulatory requirements, ethics.
• Recruitment
• Data collection, processing and management
• Data analysis
• Trial reporting, dissemination and impact
• Patient and public involvement
• Outcome measurement
• Health economics
• Priority setting and question development
• How to reduce bias and research wastage
• Funding for pilot and feasibility work
• Multidisciplinary working encompassing leadership, networking, and collaborating
• Ideas generation

In order to experience all the elements of a clinical trial as described above it may also be beneficial to gain exposure to the following:

• Trial development groups
• Trial management groups
• Data monitoring and ethics committees
• Trial steering groups
• Dissemination meetings

For more details see our Clinical Trials Guide. 

Annex F: Entrepreneurship and working with industry

This award can be used to support existing NIHR Academy members with an interest in, and/or experience of entrepreneurship and working in industry. NIHR does not dictate what the training should be or how it is delivered as it should be bespoke to an individual’s needs and requirements. However it is important that the awardee experiences enough aspects of entrepreneurship and working in industry which would allow them to work successfully in this area in the future.

Some of these core elements should involve:

• People and Leadership - HR framework, policies, goals, team dynamics, role of the board and business pitch.
• Clinical Need - health economics, patient benefit, product definition and competitive advantage.
• Market analysis and strategy -market structure, routes to market, quantifying patient benefits, commercial potential and value proposition.
• IP/Route to market - IP strategy and overview, protection, contracts, product roadmap, technical risks, project plan and product adoption.
• Manufacturing - Scalability of process, process development, project plan and contracts and licences.
• Regulatory - Compliance framework, milestones and approvals, risk assessment and management, pre-clinical development and clinical development
• Funding and Finance - Finance basics, financial models, valuation, sources of funds, funding strategy and elevator pitch.
• Business plans - Purpose, content and presentation.

It is expected that applicants who are using the DSE to gain skills in entrepreneurship and working in industry will collaborate with an SME or an industrial partner. Below is a list of organisations who could facilitate finding an appropriate business to collaborate with, if you would like specific contact information please get in touch with the NIHR Academy-

• Association of the British Pharmaceutical Industry (ABPI) - Represent innovative research based biopharmaceutical companies, large, medium and small, leading an exciting new era of bioscience in the UK.
• Association of British HealthTech Industries (ABHI) - is the UK's leading industry association for health technology (HealthTech). ABHI supports the HealthTech community to save and enhance lives.
• The British In Vitro Diagnostic Association (BIVDA) - is the national industry association for the manufacturers and distributors of in vitro diagnostic products in the UK.
• NIHR Office for Clinical Research Infrastructure (NOCRI) - NOCRI is a unique resource for the global life sciences industry - improving the quality, efficiency and success of translational research.
• NIHR Medtech and In vitro diagnostics Co-operatives (MICs) - build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially-supplied in vitro diagnostic tests. 
• Knowledge Transfer Network (KTN) - Innovate UK’s network partner and also provides innovation networking for other funders in line with its mission to drive UK growth
• Academic Health Science Network (AHSN) - As the only bodies that connect NHS and academic organisations, local authorities, the third sector and industry, we are catalysts that create the right conditions to facilitate change across whole health and social care economies, with a clear focus on improving outcomes for patients.

NHS Clinical Entrepreneur Programme

Alongside placements with industry partners it is possible to take advantage of already established training programmes, such as the NHS Clinical Entrepreneur Programme. The programme is the biggest entrepreneurial workforce development programme of its kind. Open to both clinical and non-clinical NHS staff, the programme aims to provide the commercial skills, knowledge and experience needed to successfully develop and spread innovative solutions to the challenges facing the NHS. 

The curriculum covers all aspects of setting up and running a small business, including attracting investors, applying for funding, and ensuring appropriate corporate governance. A dedicated programme in how to build a start-up – and how to operate in this highly-charged environment – is delivered as a series of educational events attended by industry mentors. The programme aims to allow entrepreneurs to pursue their innovation without having to leave the health service,providing  a wider benefit to economic growth through inward investment in the health, social care and life science sectors.

As such, the programme currently offers mentoring, networking, bespoke commercial education, customer matching, resources and development tools to over 500 individuals including Doctors, Dentists, Healthcare Scientists, Nurses and Midwives, Allied Health Professionals and Pharmacists. More information can be found at the Clinical Entrepreneur training programme webpage. 

Annex G: Industry Opportunities

Videregen

Airway repair and regeneration research

Videregen Limited, along with the Royal Papworth Hospital and the Cell and Gene Therapy Catapult are leading a pioneering project aiming for a paradigm change in functional organ reconstruction. In a UK government funded (Innovate UK) collaborative project, bio-engineered tissue is currently in development and intended for clinical evaluation as a novel treatment for bronchopleural fistula. This new translational project will seek to extend these current research findings and use innovative tissue bio-engineering principles for the design of future therapeutic constructs for airway reconstruction.

Rare diseases pose significant clinical problems with regards development of standard of care treatment. Additionally, due to their rare nature, there is often a scarcity of published information with regards the clinical pathway the patients follow, including their medical history pre-diagnosis and clinical treatment pathways post-diagnosis. This makes clinical research in the patient population problematic, impacting development and execution of clinical trials to evaluate potential new treatments. The knowledge gap also impacts the quality of Health Technology Assessment/Appraisal data available for NICE evaluation.

The proposed research project will involve:

1. Establishment of a comprehensive multi-centre historic database of bronchopleural fistula cases which may be used to form a prospective registry
2. Completion of a national survey which will investigate the clinical pathway and the impact of bronchopleural fistula as well the social and economic burden arising

The principle activities would involve collaborating with national thoracic centres to identify current and historic patients, gather data to populate a database, analyse the data to identify trends and common practice leading to publications in peer review journals.

Working closely with the Royal Papworth Hospital, Videregen and expert health economics advisors, the candidate will develop a detailed picture of the existing clinical pathway for treatment of bronchopleural fistula and how new technology interventions could disrupt and improve patient outcomes, experience, quality of life and economic advantages for the NHS.

The successful candidate would gain invaluable experience in multi-center collaborations, data gathering and analysis, understanding the viewpoint of industry in the development of new treatments and how they interact with patients and the NHS systems; in addition to working with high profile national thoracic centres, experts in the field of health economics and market access to understand the drivers behind new technology adoption and funding from the perspective of the NHS, NICE and industry.

Ideally the role in this project is suited to a medically qualified individual, such as an aspiring thoracic surgeon, motivated to gain research experience and exposure to industry. The position would be for a minimum of a year.

Sonosine

Sonosine's vision is to create a new imaging technology which delivers a relatively low cost diagnostic electromagnetic imaging capability to a wider community than currently achieved. We aim to give those communities access to high quality innovative medical diagnostic capabilities, high quality imaging and tissue characterisation at an economic cost.

• The general focus is diagnostics of soft tissue associated conditions in limbs and joints in general and that includes tendons as well
• We also have a handful of potential ultrasound manufacturing partners identified already and we are in conversations with one of them that has an OEM program in place so that we can have a white branded ultrasound scanner system on which to integrate our EMA technology (which is a straightforward process)
• We have already integrated EMA with two different commercially available scanner systems and a system is available to carry out commercial development oriented research

We are at a very interesting point in the development because we are about to develop the commercial product and we would ideally like to onboard a doctorate or post doc clinician, likely in the broad radiology or MSK specializations but would consider other backgrounds, that could, in collaboration with clinics and hospitals, initially setup and carry out a clinical investigation / trial focused on soft tissue MSK injuries and ideally on rotator cuff injury assessment using EMA technology.

The precise scope, methodology and carrying-out of the trials will be defined by the applicant in collaboration with our regulatory affairs advisor and the output and learning from the trials and the clinical usage of the technology will provide further input and guide the commercial EMA product development and regulatory approval process in USA, UK and EU.
     
This opportunity will provide the applicant with an opportunity to develop skills in the areas of product testing, medical imaging assessment and trials, commercial product development and regulatory process management.