NHMRC Development Grants UQR&I Scheme Overview Taina Lloyd, Research Management Office

1. NHMRC Development Grants • UQR&I Scheme Overview • Taina Lloyd, Research Management Office • 30 November 2016Contact: nhmrc@research.uq.edu.au

2. Scheme Overview NHMRC Development Grants scheme overview, including Key changes from last year Compliance and Eligibility Issues Panel Review and Assessment Application process UQR&I internal review process

3. Important Dates

4. Scheme Overview Grants to accelerate research translation. Supports health and medical research at the proof-of-concept stage that specifically drives towards a commercial outcome within a foreseeable timeframe. Supports the commercial development of a product, process, procedure or service that, if applied, would result in improved health care, disease prevention, or provide health cost savings. Highly values research that aims to improve health and health care outcomes that target unmet or poorly met healthcare needs for Australians. Applicants must provide comprehensive evidence of their strategies to commercialise their product and bring it to market.

5. Key Changes ‘Proof-of-concept’ stage replaces ‘proof of principle or pre-seed’ stage ‘Foreseeable’ timeframe replaces ‘5 year’ timeframe Industry/commercial partner removed Business Case (4 page) replaces Commercial Potential (3 pages) section of Grant Proposal

6. Scheme Objectives Increase, facilitate and expedite the translation of health and medical research outcomes through to commercialisation, within a foreseeable timeframe. Support proof-of-concept research with a feasible commercialisation pathway and a high likelihood of resulting in protected Intellectual Property (IP). Provide a potential mechanism through which research outcomes can be progressed to a stage that makes them competitive to receive industry investment through other government scheme or from the private sector. Encourage collaboration between health research, the private sector and industry (domestic and international).

7. Scheme Overview Development Grants are distinct from Project Grants and other NHMRC Schemes “Whereas a Project Grant and other NHMRC schemes including those focused on research translation, may ultimately generate new knowledge that results in protectable IP with the potential to be commercialised at a future point in time, a Development Grant specifically drives towards a commercial outcome within a foreseeable timeframe.” Development Grants Scheme-Specific Funding Rules 1.3

8. Exclusion Criteria NHMRC will not assess or fund applications that meet exclusion criteria: Have a focus on the early stage or knowledge creation stages of research (e.g. research that is fundable through the NHMRC Project Grants scheme). Contain significant clinical trial component/s (these are relevant to the Project Grants scheme which has a Grant Review Panel specifically for clinical trials). Are, in the view of the NHMRC, the same or similar to any application submitted to any NHMRC funding scheme in the same funding year (excluding any re-submissions to Development Grants) or research grant currently being funded or completed. Are beyond the proof-of-concept stage, and therefore are more appropriate to receive support in the form of a grant from other government agencies, or support from the private sector to successfully achieve a commercial outcome. (Development Grants Scheme-Specific Funding Rules 5.2)

9. Eligibility Eligibility to be CIA (Lead Chief Investigator) CIA (first-named CI on the application) is expected to lead the project At the time of acceptance and for the duration of a grant, the CIA must be an Australian or New Zealand citizen, a permanent resident of Australia or have an appropriate work visa in place. Citizenship/Residency waiver no longer required. CIA must be based in Australia for at least 80% of the funding period – cannot be located overseas (no waiver possible). Researchers not meeting these requirements can be a CI on the application, but not CIA. The contribution of the CIA, both in time and intellectual input as outlined in the application, will be reviewed by the Peer Review Panel to determine if it is adequate for the research proposed.

10. Eligibility Eligibility to be a Chief Investigator (CI) Maximum allowable number of CIs is 10 (CIA to CIJ): All CIs must be able to demonstrate the role and contribution expected of a Chief Investigator. PhD students are eligible to be CIs: Under exceptional circumstances where the PhD student is critical for the successful completion of the proposed research. But UQ policy prevents PhD students from taking on the role of CIA. CIs may apply for and hold other NHMRC grants BUT you must demonstrate sufficient time commitment. CIs must have an eligible appointment for the term of the project. Some CIs can request salary support: Must be based in Australia for at least 80% of the project duration.

11. Assessment Criteria • Development Grants vs Project Grants

12. Panel Review and Assessment Eligibility check including exclusion criteria (NHMRC) Peer Review Process Phase 1 - Assessment by Expert Peer Reviewers (EPRs) Up to 8 assessors – 4 scientific assessors and 4 commercialisation assessors Scientific EPRs will assess only the Scientific Merit of the Proposal criterion Commercialisation EPRs will assess only the Record of Commercial Achievements and Commercial Potential criteria Not For Further Consideration (NFFC) applications removed from assessment process No rebuttal NHMRC 2017 Development Grants Category Descriptors

13. Panel Review and Assessment Peer Review Process Phase 2 – Assessment by Grant Review Panel Scientific panel members will score against the Scientific Merit of the Proposal criterion Commercialisation panel members will score against the Record of Commercial Achievements and Commercial Potential criteria Allocation of spokespersons (scientific and commercial) for budget scrutiny Preparation of ranked list and nomination of applications requiring full panel discussion Grant Review Panel Meeting Funding Recommendations/Funding Announcements Application Assessment Summary for all non-NFFC’d applications

14. Application Process Minimum Data Requirements General (Part A Properties - Home): Administering Institution Application Title Aboriginal/Torres Strait Islander Research Synopsis Plain English Summary A-RC: Research Classification (all sections) Placeholder text is not accepted by the NHMRC Applications that do not provide minimum data requirements by the deadline (4pm 18 January 2017) will not be accepted

15. Application Process Read the Funding Rules, and Advice and Instructions to Applicants. Each document is in two parts: scheme-specific rules/advice for Development Grants, and general rules and instructions applicable to all NHMRC schemes. All CIs must have an up-to-date Profile and CV in RGMS Please tick ‘yes’ to allow RAO access on RGMS application form (allows UQR&I to run snapshot reports) Internal review carried out by UQR&I Amendments/changes based on feedback from UQR&I review, Faculty/Institute readership schemes Certification/consent obtained from all CIs/AIs - use certification form available on UQR&I website (Participating Institutions without CI also need to certify) Submission - completed by UQR&I within RGMS once all parties are satisfied with the application

16. Application Process RGMS application consists of: CV sections of CI’s RGMS account RGMS application fields (Parts A and B) Grant Proposal Any other supporting documentation uploaded into RGMS No letters of support

17. Application Process – RGMS CV CV sections of CI’s RGMS account – populate into the Assessor Snapshot CV-RO: Relative to Opportunity (if applicable) CV-CD: Career Disruption (if applicable) CV-Pub: Publications CV-RF: NHMRC Research Funding CV-ORF: Other Research Funding Plus All mandatory sections of RGMS profiles for all CIs must be completed – indicated by a red asterisk in RGMS

18. Application Process – RGMS CV Relative to Opportunity vs Career Disruption All applications are assessed relative to opportunity. Circumstances to be considered under ‘relative to opportunity’ include: Amount of time spent as an active researcher Career disruption Available resources, including research in remote or isolated communities Building relationships of trust with Aboriginal and Torres Strait Islander communities over long periods Clinical, administrative or teaching workload Relocation (including research laboratory or clinical practice setting) Time spent employed in other sectors and restrictions on publication (eg. Industry, policy, government) For Aboriginal and Torres Strait Islander applicants, community obligations including ‘sorry business’ Typical performance of researchers in the field in question

19. Application Process – RGMS CV Career Disruption Prolonged interruption to an applicant’s capacity to work due to: Pregnancy Major illness/injury Carer responsibilities Interruptions must involve either a continuous absence from work for periods of 28 calendar days or more and/or a long-term partial return to work that has been formalised with the applicant’s employer NHMRC Funding Rules 2017 6.2.1

20. Application Process – RGMS Part A: Application Details generic to most NHMRC schemes General (A-PA: Properties - Home) A-Pinst: Institutions – Participating A-RC: Research Classification A-BoD: Burden of Disease A-RT: Research Team (including salary requests) A-EG: Ethics – General Part B: Application Details specific to Development Grants B-GP: Grant Proposal B-PBRF: Proposed Budget – Research Facilities (research services from third parties, e.g. Australian Twin Registry, Cell Bank Australia) B-PB: Proposed Budget – Direct Research Costs and Equipment B-NA: Non-assessor

21. Application Process – Budget Funding may be used for salaries for CIs and other support staff direct research costs per usual NHMRC guidelines. Grant Duration is from 1 to 3 years. No limit set on the amount of funding that can be requested in an application. Check funded amounts on NHMRC website - Outcomes of funding rounds 2017 Development Grants Average funded amount: $606,221 Largest funded amount: $1,010,214 Smallest funded amount: $189,692 50% of awards were between $400K-$599K

22. Application Process – Budget A-RT: Research Team (including salary requests) Only CIs and AIs should be named on the application. Any other salary requests are by role only. Salary requests must use the PSP levels provided by the NHMRC. Refer to the Budget Mechanism at http://www.nhmrc.gov.au/grants-funding/apply-funding/budget-mechanism-funding-commencing-2017. Completed in the Research Team section (A-RT) for each team member Each request to be justified (compelling argument why NHMRC should fund the position, how it strengthens the project, etc) CIs can request salary support (up to PSP 5): Must be based in Australia for at least 80% of the project duration Casual salaries are requested at Proposed Budget section (B-PB).

23. Application Process – Budget Part B-PB: Proposed Budget – DRC and Equipment Direct Research Costs Includes equipment items costing less than $10,000 Costs need to be described in detail and justified The justification should be aligned with the proposed aims of the project, and detailed on a yearly basis. No longer need to round items to the nearest $5000 – RGMS does this for the total DRCs in each year. The final rounded amount is available in the ‘Summary’ tab of the application. Equipment Total may not exceed $80,000 Only for equipment items costing $10,000 or more Quote required – provide to UQR&I Budget amounts should be GST-exclusive.

24. Application Process – Budget Part B-PB: Proposed Budget – DRC and Equipment Funding can be requested to support overseas research (but not overseas CIs salary) Must clearly demonstrate that the research activity is critical to the successful completion of the research aims and that the equipment/resources required for the research activity are not available in Australia.

25. Application Process – Grant Proposal Changes to Formatting Requirements Margins removed from the list of requirements Font size is recommended and must be readable – NHMRC recommends a minimum of 12 point Times New Roman font Note: If the assessor cannot read the application due to inconsistency with any of the formatting requirements, the assessor is not compelled to consider the improperly completed section in their assessment or complete the assessment of the application. When an assessor cannot complete an assessment because the formatting renders the grant proposal unreadable and therefore does not submit an assessment, the application will not be excused from the NFFC process because they do not meet the minimum assessment requirements. NHMRC Funding Rules 2017 10.3.3 Table 1

26. Application Process – Grant Proposal Do not include: Links to websites apart from references to journal articles, guidelines, government reports, datasets and other outputs that are only available online. Where links are provided, include the URL in full. Publication metrics such as Journal Impact Factors and the previous Excellence in Research for Australia (ERA) Ranked Journal List. NHMRC Funding Rules 2017 10.3

27. Application Process – Grant Proposal A. Research Proposal (9 pages), to include a detailed timeline with yearly research milestones B. References (2 pages) C. CI’s Research Achievements, including top 5 publications in the last 5 years (2 pages per CI) D. Commercialisation Business Case (4 pages) E. Record of Commercial Achievements (1 page per CI) F. Indigenous Research Excellence Criteria, if applicable (2 pages) Applicants must use the NHMRC’s Grant Proposal template Refer to Development Grants Scheme-Specific Advice and Instructions to Applicantsfor details of what is to be included in this section

28. Application Process – Grant Proposal A. Research Proposal (9 pages) This section should address the following assessment criteria: Scientific Merit of the Proposal (40% of overall score) – this includes the clarity of the hypotheses or research objectives, the strengths and weaknesses of the research plan, the experimental design, feasibility of the proposed research, and the record of scientific research achievements.

29. Application Process – Grant Proposal B. References (2 pages) References relating to the Research Proposal must: Provide a list of all references cited in the application in an appropriate standard journal format; NHMRC prefers the Author-date (also known as the Harvard system), Documentary-note and the Vancouver System List authors in the order in which they appear in PubMed Only include references to cited work Do not include links to websites in any part of the application Be written in English Additionally: Do not use the RGMS ID generated by CV-Pub to refer to publications in any part of the application

30. Application Process – Grant Proposal C. CI Research Achievements, including the Top 5 publications in the last 5 years (2 pages per CI) This section should address the following assessment criteria: Scientific Merit of the Proposal (40% of overall score) – this includes feasibility of the proposed research by the research team, and the record of scientific research achievements. This section has two components: Overall record of research achievements in the last 5 years The top 5 publications in the last 5 years (including the reasons why these publications have been selected) Please note: Do not use journal impact factors or ERA journal rankings – not allowed by NHMRC

31. Application Process – Grant Proposal D. Commercialisation Business Case (4 pages) – Advice and Instructions to Applicants This section should address the following assessment criteria: Commercial Potential (40% of overall score) – this includes submission of a detailed and feasible business case for the commercialisation of the research. At a minimum, detail the potential development pathway to move from proof-of-concept research to an outcome that can be successfully commercialised, including: The nature of the market The route to market The regulatory pathway Strategies for managing IP connected with the proposal The milestones, commercial barriers and risks of the venture Any additional information necessary to support the business case.

32. Application Process – Grant Proposal D. Commercialisation Business Case (4 pages) – Funding Rules Applicants must provide a business case for the commercialisation of their proposed research that includes at a minimum: A market analysis Management of IP Work plan including the relevant milestones Consultation with Technology Transfer Office or similar commercialisation support

33. Application Process – Grant Proposal Grant Proposal Template D. Commercialisation Business Case (4 pages): a. market analysis b. management of IP c. work plan for commercialisation including the regulatory pathway, route to market, contribution of the Technology Transfer Office or similar commercial support, key development milestones/review points, commercial barriers and risk mitigation strategies applicants may include any additional information relevant to the Business Case, with appropriate sub headings. Consult your Research Partnerships Manager (RPM)

34. Application Process – Grant Proposal E. Record of Commercial Achievements (1 page per CI) This section should address the following assessment criteria: Record of commercial achievements (relative to opportunity) (20% of overall score) – this includes any previous experience of the research team in the commercialisation of research. Provide evidence of the CI’s commercial achievements: inventorship on approved patents industry consulting involvement in sponsored research programs licensing of their intellectual property direct involvement in industry placements any other relevant information

35. Application Process – Grant Proposal F. Indigenous Research Excellence Criteria (2 pages if applicable) This section should address the Indigenous Research Excellence Criteria as set out in Section 6.3 of the NHMRC Funding Rules 2017. To qualify as Aboriginal and/or Torres Strait Islander health research, at least 20% of the research effort and/or capacity building must relate to Aboriginal and/or Torres Strait Islander health.

36. UQR&I Internal Review Process How to initiate internal review by UQR&I: Upload the Grant Proposal PDF and any other relevant PDFs to RGMS (e.g. APP1002303_Douglas_Grant Proposal.pdf) Request latest snapshots Complete a UQ-NHMRC Specific Application Coversheet, available on the UQR&I website at http://www.uq.edu.au/research/research-management/nhmrc-development-grants Must be signed by CIA and Head of School/Centre/Institute Please provide the name of a second contact – does not have to be a CI Email scan of signed coversheet to UQR&I (nhmrc@research.uq.edu.au) by the internal deadline. No hard copies are required. You do not need to email snapshots or any PDFs that are uploaded to RGMS Full draft applications are due to UQR&I for reviewby no later than Wednesday 18 January 2017 (same as minimum data requirements deadline)

37. UQR&I Internal Review Process Any application received by the NHMRC that does not fully comply with the Funding Rules or Advice and Instructions to Applicants may be deemed ineligible for funding. UQR&I must complete a review of your application prior to submission: NHMRC requires UQ to certify the application is both eligible and compliant UQR&I’s role is to help applicants and grant holders Why is internal submission by the UQR&I closing date important? Allow time for applicants to make changes after UQR&I review Technical issues with RGMS Experience – past years have taught us to make allowance for problems with some applications that may take weeks to resolve

38. UQR&I Internal Review Process UQR&I Review - Amendments/Changes UQR&I will complete a review of your application using the e-copy of your Grant Proposal and by checking details in RGMS and the Assessor Snapshot. Please avoid making changes to your Application while under review If you do make changes, let UQR&I know Feedback will be provided to CIA by email Second contact (from UQ Coversheet) will be cc’d on email Please advise our office if CIA will be uncontactable during application process Once feedback is received, you will be asked to make changes/corrections as soon as possible Feedback email/s from UQR&I will include detailed instructions for final submission

39. Resources Information and Documentation - NHMRC Funding Rules 2017 incorporating the Development Grants scheme for funding commencing in 2018: http://www.nhmrc.gov.au/book/nhmrc-funding-rules-2017 Advice and Instructions to Applicants 2017 incorporating the Development Grants scheme for funding commencing in 2018: http://www.nhmrc.gov.au/book/nhmrc-advice-and-instructions-applicants-2017 Peer Review Guidelines incorporating the Development Grants Scheme for funding commencing in 2018 The NHMRC provides information on user accounts, documentation, a video demonstration and who to contact for assistance with technical issues (http://www.nhmrc.gov.au/grants/rgms/index.htm) Links to relevant NHMRC documentation can also be accessed via the UQR&I website

40. Resources Information and Documentation – UQR&I Website Scheme-specific information and documentation for Development Grants (including the Funding Application Coversheet and Certification form are available from the UQR&I website (http://www.uq.edu.au/research/research-management/nhmrc-development-grants). UQR&I NHMRC Update mailer (http://www.uq.edu.au/research/forms/render.php?form=mailing-lists/subscribe) Subscribers will be advised of deadlines, changes, important notices and rulings Applicants should make sure they sign up for this mailer