Guidelines GA214F Guidelines. June Application Guidelines Project EOI and Full. GA219S and GA219F.

Transcription

1 Guidelines GA214F 2019 Guidelines June Project EOI and Full Application Guidelines GA219S and GA219F

2 Table of Contents Part A: What is a Project? Project Introduction Research Investment Streams Previous Funding Round Success Rate Rules Regarding Named Investigators on Programme and Project Contracts Important Note... 4 Part B: What is an Expression of Interest (EOI)?... 5 Part C: General rules for Submitting a Project application (EOI or Full) Use of GA219S Form Format (EOI and Full) Copies of Applications Required (EOI and Full) Closing Dates for EOI Closing Dates for Full Application Privacy Provisions Mailing Address Enquiries... 9 Part D: Submitting an EOI Completion of the GA219S Form Use of GA219S Form Module 1: General Information Module 2: Proposed Research Module 3: NZ Standard CV Part E: Submitting a Full Application Completion of the GA219F Form Use of GA219F Form Module 1: General Information Module 2: Proposal Module 3: References Module 4: Contract Information and Budget Module 5: NZ Standard CV template Module 6: Research Classification Appendix 1: Improving the Rigour and Completeness of Clinical Trial Proposals Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 2

3 Part A: What is a Project? 1. Project Introduction HRC Projects should address well-defined research questions with the aim of making significant improvements in, or developing knowledge contributing to, health outcomes. The HRC will offer contracts worth $0.4 M per year to a maximum value of $1.2 M for a three to five year term or pro rata for a shorter contract. For example, a two-year project may have a budget of up to $0.8 M or a five-year project may have a budget of up to $1.2M, but most projects have a term of three years with a budget of $1.2 M. Applicants who submit randomised controlled trial project applications are able to request an increase in budget cap to a maximum of no more than 20%, if required. At the Expression of Interest (EOI) stage applicants must include a comment in their application that they anticipate seeking an increase in budget cap (should the EOI be successful) but no specific budget details are required at this stage. At the Full Application stage applicants must provide full budget details and justification for an increase in budget cap in their application; this will only be considered if an initial notification was received at the EOI stage. Final approved budgets will be subjected to full assessment processes. The HRC reserves the right to allocate funds from the contestable funding pool to Programmes and Projects in an appropriate strategic mix. This may occur, for example, should the Research Committees recommend that more new research Programmes be established than was otherwise available. The HRC also reserves the right to transfer funds between the Programme and Project funding pools. 2. Research Investment Streams The HRC has established four Research Investment Streams (RIS) for the annual funding round: Health and Wellbeing in New Zealand: Keeping populations healthy and independent throughout life Improving Outcomes for Acute and Chronic Conditions in New Zealand: Improving outcomes for people with illness or injury New Zealand Health Delivery: Improving health and disability service delivery outcomes over the short-to-medium term Rangahau Hauora Māori: Supporting Māori health research that upholds rangatiratanga and utilises and advances Māori knowledge, resources, and people. Applicants must select one RIS. Assessing committees will score an application towards the bottom of the scale for Research Impact (HRC Peer Review Manual) if the application is out of scope of the chosen RIS as it will not advance the goals of the RIS although it may have wider impact. This applies to applications that are clearly out of scope, not those that could be considered relevant to more than one RIS. The HRC does provide advice on choice of RIS, as that decision is best made by the investigator. Applicants may change their final choice of RIS by creating duplicate applications and making a decision for the most appropriate RIS before the closing date for registration or submission. For Project applications, the RIS cannot be changed between the EOI and Full stages. 3. Previous Funding Round Success Rate Success rates for the 2018 funding round in each RIS are presented below: RIS EOI Full Funded Health and Wellbeing in NZ Improving Outcomes for Acute and Chronic Conditions in NZ New Zealand Health Delivery Rangahau Hauora Māori Total Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 3

4 4. Rules Regarding Named Investigators on Programme and Project Contracts A Named Investigator (NI) may lead only one HRC research Programme at a time but may collaborate and be funded as a NI on other HRC research contracts. 5. Important Note Use these guidelines and forms (GA219S for EOI, GA219F for Full) when submitting a Project EOI or Full Application for a RIS other than Rangahau Hauora Māori. Use the separate guidelines and forms (RHM219S for EOI, RHM219F for Full) when submitting a Project EOI or Full Application for the Rangahau Hauora Māori RIS. Use the separate guidelines and forms (PacificGA219S for EOI, PacificGA219F for Full) when submitting a Project EOI or Full Application for a Pacific Project Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 4

5 Part B: What is an Expression of Interest (EOI)? The EOI provides an overview of intended research and is the first stage of a two-stage application process for HRC Projects. EOI will be assessed and top-ranked applicants will be invited to submit a Full Application for the second stage of the process. The proposed research in the EOI must be substantially the same as that in the Full Application. Failure to do so will result in the disqualification of the Full Application. There are 3 modules in an EOI application form. All modules, except Module 2, are completed on the HRC Gateway. All investigators must have an HRC Gateway ( account and profile so that they can be included on an application. Module 2 is on a separate document (GA219S) that is completed offline and then uploaded using the HRC Gateway. The table outlines the process for submitting an EOI and Full Application. Applicants must allow time for host Research Office approval and processing of applications prior to final submission to HRC. Event Description Date Funding round documents released EOI Opens EOI round opens in Gateway Opens 11 June 2018 Registration Closes Registration deadline in Gateway Closes 11 July 2018 EOI Closes Complete online sections & upload GA219S Form Closes 18 July 2018 Submit hard copies of complete EOI Due 20 July 2018 EOI Assessment Review by HRC Assessing Committee During September 2018 EOI results 2 October 2018 Full Stage Opens Invitation to submit 2 October 2018 Full Stage Closes Complete online sections & upload GA219F Form Closes 14 November 2018 Submit hard copies of complete Full Application Due 16 November 2018 Assessment Peer review Dec 2018 to Feb 2019 Rebuttal Early March 2019 Review by HRC Assessing Committee During April 2019 Council approval End of May 2019 Results Outcome 31 May Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 5

6 Part C: General rules for Submitting a Project application (EOI or Full) 1. Use of GA219S Form When to Use GA219S Form The GA219S form must be used when submitting a Project Expression of Interest for all investment streams except Rangahau Hauora Māori (use the RHM219S form). Use the PacificGA219S form for Pacific Project applications. When to use GA219F Form The GA219F form must be used when submitting a Full Project application for all investment streams except the Rangahau Hauora Māori Research Investment Stream (use the RHM219F form). Use the PacificGA219F form for Pacific Project applications. Prior to Submission The HRC only accepts applications online (HRC Gateway) ( Prior to any submission, Named Investigators must have a current Gateway account, that must be updated annually. Key opening and due dates are in the section below. Before submitting this application form, applicants should read: This document for eligibility and specific instructions Research Investment Stream details The appropriate Peer Review Manual to understand application assessment Guidelines on Ethics in Health Research Guidelines for Researchers on Health Research Involving Māori Guidelines for Pacific Health Research. The regularly updated reference documents and forms are on the HRC website (). New Host Organisation New host organisations (e.g. Independent Hosts), that have not previously been funded by the HRC, will be required to provide due diligence information before a contract can be offered and preferably before an application is submitted to avoid unnecessary work. Please contact the HRC for further information. 2. Format (EOI and Full) General Formatting Proposals must be written in a clear, concise manner with sufficient detail to enable the reviewers to understand the scope and implications of the proposal. Applications must be in English or te reo Māori; if in te reo Māori a translation in English must also be provided (any translation will not be included in the page limit). Use the correct HRC form as it contains special features. Applicants must: Use Arial 10-point type font or larger Use default margins Use single line spacing Not exceed any page limits. Compliance The HRC will not process any application that does not comply with stated page limits and font sizes/styles. Additional Documents No other documents are to be included Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 6

7 3. Copies of Applications Required (EOI and Full) Paper Copy Applications must be submitted on the HRC Gateway and two printed copies sent to the HRC. The two complete printed applications must be double-sided and stapled. Electronic Copy Submit the form as a pdf file. Ensure that the pdf version meets page limits and that graphics and tables are converted correctly from the Word version. Submit the budget information file in both xlsx and pdf formats. Use the HRC file as it contains special features used for HRC processes. The HRC Gateway will allocate file names. Important The application is submitted to the host Research Office when the applicant uploads the files through the HRC Gateway. The application will be forwarded to the HRC after host Research Office approval. Always allow sufficient time before the HRC closing date for this approval step. Do not Send Files Do not send digital files directly to the HRC. Independent researchers and research providers requiring assistance with using HRC Gateway should contact the HRC in the first instance. Returned Applications No part or parts of an application can be returned to the applicant. 4. Closing Dates for EOI Submission of EOI Application Online Upload the GA219S file using the HRC Gateway. Submit the form as a.pdf file created by using the pdf function in MSWord or other pdf generator. Ensure that the pdf version meets page limits and that graphics and tables are satisfactorily presented. HRC Gateway will allocate file names. The EOI application is submitted in two parts. The first part involves submitting a registration via HRC Gateway by 1pm on 11 July The closing date for online submission of the EOI to the HRC is 1 pm on 18 July The EOI is released to the HRC only after approval by the Research Office. It must be submitted to the HRC online by closing date and time. Submission of Paper Copies The online system creates a single PDF document of the complete application by merging the uploaded application form with the online registration details for processing and printing. Send two copies of the system-generated version to the HRC by 5pm on 20 July Incomplete Applications Incomplete applications will be deleted from the HRC Gateway. 5. Closing Dates for Full Application Submission of Full Application Online Upload the GA219F file using the HRC Gateway. Submit the form as a.pdf file created by using the pdf function in MSWord or other pdf generator. Ensure that the pdf version meets page limits and that graphics and tables are satisfactorily presented. HRC Gateway will allocate file names Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 7

8 The closing date for invited Full Applications to be submitted online to HRC is 1pm 14 November Full Applications are released to the HRC only after approval by the applicant host Research Office or equivalent, which will require access to the Full Application several days before the HRC closing date. Submission of Paper Copies The online system creates a single PDF document of the complete application by merging the uploaded application form with the online registration details for processing and printing. Send two copies of the system-generated version to the HRC by 5pm on 16 November Incomplete Applications Incomplete applications will be deleted from the HRC Gateway. Significant Changes between EOI and Full Application Applicants may not make significant changes in the research team and research plans submitted in the EOI. Significant changes may result in the Full Application being disqualified. Please note that the HRC allows some changes of FTE between EOI and Full Application; however, these should be within the following limits: A change of up to 50 per cent in the Full Application, if the FTE of a named investigator is less than 0.1FTE in the EOI application A change of up to 30 per cent in the Full Application, if the FTE of a named investigator is greater than 0.1FTE in the EOI application Please note that the HRC will still need to be notified of these changes in order to make the changes in our system. If the change of FTE is greater than the above, then a form will need to be submitted to the HRC requesting these changes. Please notify the HRC at least two weeks prior to the full application submission deadline to justify the change. A form, to request a change of FTE greater than stated above, is available from your research office. As a general rule, no additional NIs can be added to the team at the full stage, with the following exceptions: for statistical expertise in clinical trials; for applications submitted to the RHM, Pacific or New Zealand Health Delivery streams; if specifically recommended by an EOI assessing committee; or to replace an existing member due to unforeseen circumstances In the Full Application, if the replacement of a named investigator, or an addition of a named investigator is required, please notify the HRC at least two weeks prior to the full application submission deadline to justify the change. A form, to request an additional named investigator or a replacement investigator, is available from your research office. The EOI Lay Summary can be slightly modified in the Full Application Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 8

9 6. Privacy Provisions Statistical Purposes The information provided in an application will be used for assessing that application and, in a nonidentifiable form, some information will be used for HRC statistical and reporting purposes. The HRC undertakes to store all applications in a secure place, which may include storing the information in the National Research Information System (NRIS) curated by MBIE with details provided by funders of the science sector. Personal Information Personal information contained in the application will available to members of the HRC Committees relevant to the review of the application. Media Release The HRC publishes details of research contracts including First Named Investigators', host institution, contact details (work phone or ), research title, lay summaries and funding awarded for public interest purposes and to meet the statutory requirements of the Health Research Council Act Official Information Act Official Information Act requests for information about an application or research contract will be discussed with the host institution and investigator before responding to the request. Where appropriate, the request may be transferred to the host institution. 7. Mailing Address Paper copies of applications should be sent to the HRC office address: Mailing Address: Research Investments & Contracts Health Research Council of New Zealand P O Box 5541 Wellesley Street, AUCKLAND 1141 Physical/ Courier Address: Research Investments & Contracts Health Research Council of New Zealand 3 rd Floor, ProCare Building 110 Stanley Street, AUCKLAND 1010 The HRC Gateway will show the status of any proposal. Do not contact the HRC for application status. 8. Enquiries All enquiries related to HRC applications should be directed in the first instance to the Research Office of the applicant s host institution. Where the Research Office cannot assist, or for technical enquiries relating to applications, contact the HRC: Vernon Choy Telephone: (09) vchoy@hrc.govt.nz Melanie Duncan Telephone: (09) mduncan@hrc.govt.nz Luke Garland Telephone: (09) lgarland@hrc.govt.nz Miguel Jo-Avila Telephone: (09) mjo-avila@hrc.govt.nz Tolotea Lanumata Telephone: (09) tlanumata@hrc.govt.nz Lucy Pomeroy Telephone: (09) lpomeroy@hrc.govt.nz Stacey Pene Telephone: (09) spene@hrc.govt.nz 2019 Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 9

10 Part D: Submitting an EOI Completion of the GA219S Form Modules 1 and 3 of the EOI application must be completed on the HRC Gateway. The GA219S Form contains a coversheet and Module 2 of the EOI application. The form can be downloaded and completed before being uploaded to the HRC Gateway as a pdf file. The completed application (Modules 1-3) will be compiled by the HRC Gateway; it can then be accessed for downloading and printing. Note: an applicant checklist has been added to the start of application form. Every point must be checked off to acknowledge compliance with application guidelines. Completion of the checklist by applicants indicates that the submitted application complies with all requirements as the HRC will no longer undertake this compliance check. 1. Use of GA219S Form Please use the original GA219S form as it contains special features: Complete all sections following the instructions on the form and described in this Guideline. Enter the HRC Ref ID and NI Surname on coversheet. HRC Gateway will remove the coversheet from the final system-generated pdf. 2. Module 1: General Information This Module must be entered in the HRC Gateway. 1st Step The applicant will first be required to enter a research title, select a research investment stream and select a host organisation (there will also be options to select a specific research office and research office contact if applicable). Research Title The research title should be succinct and clearly describe the proposed project. The title must not exceed 80 characters, including spaces and punctuation (e.g. growth factors contains 14 characters). Do not use all uppercase type. Host organisation The host organisation is the institution or organisation that will be responsible for administering any contract awarded. For example, for those applicants at Wellington School of Medicine, Dunedin School of Medicine or Christchurch School of Medicine, the host institution is the University of Otago Select the relevant Host organisation from the drop-down list (this shows host organisations currently recognised by the HRC). If applicable, a specific research office and research office contact will be able to be selected. Please note: If your host organisation does not appear in the drop-down list, please tick the check box My host organisation is not in the list. A field Host organisation details will appear in the next section and the name of the host organisation should be entered here. Research Investment Stream Create a new application by selecting the round Name, then the Proposal Type from the selection list, e.g., Project Health & Wellbeing. The HRC cannot re-assign applications that are entered into the wrong stream. If you wish to change streams while applying you need to create a new registration on Gateway. Assessing committees may score an application that is out of scope towards the bottom of the Research Impact scale as such applications will not advance the goals or priorities of the RIS although it may have wider impact. This applies to applications that are clearly out of scope, not those that could be considered 2019 Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 10

11 to fall within a grey area (are relevant to more than one investment stream). Consideration should be given to clinical trial outcomes, which may meet the 5-year time-frame requirements of the NZHD RIS. 2nd Step First Named Investigator Some of this information will be automatically populated from the First Named Investigator s profile in Gateway (e.g., Organisation and department). Please note that the FTE of the First NI will default to 1 this will need to be updated. If the profile is not current details will need to be updated. The details listed on the application will be automatically refreshed after the profile is updated. Click on the Update button to enter and update the information requested. The First NI will be considered the first point of contact during the application and assessment process, and will be understood to be acting for, and in concurrence with, the other NIs. All correspondence for the application will be addressed to this person and the host. Only the First NI will be cited by the HRC in its press release on successful applications. Once an application is created, the first named investigator cannot be changed. 3rd Step Click on the Update button to enter details for the following fields. Note: if a field does not need to be completed until the full application stage, there will be a blank space next to that field information will only be able to be entered at the full application stage. Named Investigators All NIs must be registered users of the HRC Gateway before they can be added to the application. User profiles must be updated before starting an application so that the current details are in the application. Click on the Update button to enter information as requested. Role in project should include brief information on what the investigator will undertake in the project (1-2 sentences max). Information on ethnicity, gender and whether the researcher is a clinician (and is practicing) is used for HRC information purposes only. Please note ethnicity, iwi, clinician, or practising clinician are not required to be entered as these details will automatically populate from the individual person profiles. Each named investigator will need to sign-in to HRC Gateway and check and update their details before EOI applications are submitted. FTE for each NI is also required, as the assessing committee needs to know the level of commitment or responsibility of each team member. It is particularly important to identify more junior investigators who may undertake key components for the proposed research. A clinician is defined as a health professional involved in the clinical practice of medicine, psychology, dentistry, physiotherapy/occupational therapy or pharmacy. This includes all qualified doctors, nurses, midwives, dentists, pharmacists, physiotherapists, occupational therapists, dieticians and psychologists. Dieticians and psychologists are only considered clinicians if they have been involved in clinical practice (evidence of this must be provided in the CV). Dental nurses and physiotherapy assistants are not considered to be clinicians. A practising clinician is an individual who is contractually obligated to treat patients or clients, and does not engage with patients only for the purposes of research. You may wish to designate a hapū, iwi or Māori organisation conducting the research that needs to be acknowledged in their own right as investigators on the application. It is still essential to list supporting NIs. Research Location(s) This is the specific department(s) and organisation where the majority of research or data analysis will be undertaken Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 11

12 Discipline Select from the drop-down box. Duration Enter the proposed term of the research (months). Type of Research Choose from the dropdown list what you consider the most appropriate term for broadly describing the research proposal for assessment purposes. The HRC reserves the right to assign applications to the most appropriate Science Assessing Committee. Commencement Date Enter the proposed commencement date. Please note that contracts cannot be activated until 1 July 2019 at the earliest. Recipients are required to begin within three months of contract offer. Lay Summary Provide a summary of the research (150-word limit). Include research objectives, principal methodologies (especially for randomised controlled trials and population interventions) and potential health outcomes or impact. This may be modified slightly for the full stage application. 3. Module 2: Proposed Research The page limit for this Section is three pages. The section headings provided should be used. The assessing committee membership is broadly discipline-based, matched to the range of applications assigned to that committee, so not all members will have working knowledge of every research topic. Write the proposal for scientists with a general understanding of the research area. The use of graphics and tables is an efficient use of space. Ensure that the format of non-text content is compatible with pdf conversion software. Rationale for Research Provide the research rationale with a robust demonstration of the research gap and a statement of purpose or research aims for scientific enquiry, hypothesis, new knowledge, technical advance and innovation. Demonstrate that you have adequately reviewed what is already known in the area and that there is a clear case for further research. For example, refer to systematic reviews or an otherwise robust demonstration of a research gap. Include information that is essential for the reader to better appreciate or understand why your proposed research should be undertaken. What is the significant/important gap in knowledge, policy, practice or service delivery that your research will address? How does your proposed research build on existing knowledge and evidence, and how will it contribute to, or align with, research currently being undertaken either nationally or internationally? For example, is it unique to New Zealand? What is the significance of the health issue for New Zealand health and society? Has responsiveness to Māori been considered? Is this an extension of current ongoing research, e.g., additional tests or sampling? Preliminary or published data? Research Design and Methods Provide sufficient details for technical assessment of scientific protocol, feasibility and validity of data. Include sufficient detail of study design and methods such that an assessment can be made of its appropriateness, robustness and/or innovativeness. This might include a description of subject recruitment and characteristics (including number, gender and ethnicity where relevant), study methodology, and proposed methods of data collection and analysis. Clinical trial applications are to include a description of data and safety monitoring arrangements. Where appropriate, provide an estimate of the likely effect size and the sample size required to detect this (power analysis). Indication of timelines for the research should be included. Consultation with specialists such as 2019 Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 12

13 methodologists, statisticians, health economists and Māori (if appropriate) before finalising your research design is recommended. The Science Assessing Committees need this information to judge and appropriately score this criterion, so ensure that the practicalities are clearly stated, i.e. what will be done, how, by whom, where and when. Science Assessing Committees are also reassured when methodologies have been used/trialled before. Research Impact For Health and Wellbeing in NZ and Improving Outcomes for Acute and Chronic Conditions in NZ: Note: applicants for IOACC and HW are no longer required to link their impact section to the Goals of the relevant investment signal. This is to encourage applicants to consider all potential ways in which their proposal can add value for NZ, and what actions within their influence can help achieve this potential. Assessment of Impact for these streams has been restructured to include two components: 1) a description of how your research might be used and the anticipated benefits for NZ, and 2) the action plan to maximise the use and benefits of the research. See the HRC s Impact Webinar for additional guidance on completing this section. 1 What types of benefits are expected to arise from your research, and who will benefit? This section should provide a realistic description of how research findings could contribute to improved health or other societal benefits over time (a potential line of sight or pathway to impact). Importantly, it should also identify the more immediate users and beneficiaries of the research, who will form a focal point for your Action Plan (below). The balance between describing short-term and longer-term considerations will be dependent on the specific research context, including the length and complexity of the pathway to impact and where the research sits along this pathway. The HRC s Impact Webinar includes discussion of elements that should be covered in this section, including the types of benefits and beneficiaries, and the geographical distribution of benefits (such as how contribution to international research effort will benefit NZ). Researchrelated benefits, such as capacity and capability gains for NZ, and influence on future research agenda-setting, may be included where relevant. What specific activities will you undertake, throughout the life of the research project, to maximise the use and benefits of your research? Describe what targeted actions will be taken 2 to improve the likelihood of research uptake and impact, and to ensure that the next users or beneficiaries (identified in the previous section) can meaningfully contribute to, and/or benefit from, the research. Describe other planned dissemination activities that are designed to reach broader audiences. Who can enable, or block, the uptake of your research, and how have they been considered in the research plan? Identify uncertainties to uptake by actors outside academia, or systematic/institutional barriers, and your mitigation strategies (where relevant). What elements of the team s track record of knowledge transfer provide confidence in the likelihood of research uptake? For example: existing links, relationships, or networks with relevant research next-users or end-users; demonstrable examples of knowledge mobilisation or transfer; or changes in health outcomes or societal impact generated from similar research. This component is considered relative to opportunity. For NZ Health Delivery: 1 Consult the HRC s Impact Webinar for further discussion on the types of benefits that can arise from health research, and where these benefits might be expected to occur along a pathway to impact. 2 Consult HRC Guidelines and funding rules for information on support of knowledge transfer activities and include these activities in objectives/milestones where appropriate. Progress against implementing the action plan will form part of the milestones HRC monitors with respect to contractual compliance and delivery Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 13

14 Include the anticipated outcomes of the research, and how they will advance the New Zealand Health Delivery goal. Comment on knowledge transfer. How will the expected outcomes of your proposed research lead to direct improvements in the NZ health and disability sector in the short-to-medium term? Describe realistically how this will be achieved within the specified five years of the contract commencing. Describe how the outcomes will make a difference - will they change policy, inform clinical decision-making, or improve productivity, for example. How widely applicable will the findings be? Comment on end-user engagement, and other plans and processes that will be used to support the uptake of research findings. The last point tends to be the weakness and most common reason for poor scores in applications to this stream. Responsiveness to Māori Sufficient details relative to this stage of planning. Indication of consideration is useful, but a formulaic response is less so. It is expected that research providers at the earliest planning stage indicate the quality and extent of their relationship with Māori in their research proposals. For example, would Māori be involved, should the application proceed to the Full application stage and beyond? How does the research address inequalities? We recommend that you obtain advice or collaboration to ensure that Māori involvement is appropriate. Expertise and Track Record of the Research Team Evidence that the team has the experience, qualifications and infrastructure to deliver the research. The role of each team member is required. Include a brief description of the team s track record, related to the proposal area, to demonstrate the ability to deliver proposed study outcomes. Highlight important skills and/or expertise in the team that would support delivery of the proposed research. Declare any career disruptions that may be relevant to your career history. A career disruption is defined as a prolonged interruption to an applicant s capacity to work due to pregnancy, major illness/injury and/or carer responsibilities. Clearly define the role, expertise and track record of each member of the team giving particular weight to those with high FTE commitments to the project. Team members unique identifiers on publication databases such as Scopus or Google Scholar may be provided in relation to their FTE. Justification for staff roles should be provided. The role and FTE of each team member is required. Please state if you have previously collaborated with the team assembled for this proposal. Note that changes in the research team between the EOI and the Full application require HRC s prior approval. In addition, state how you have utilised previous funding resources and your productivity. Applicants to NZ Health Delivery MUST provide information on the capability of the research team with regard to research outcomes AND research uptake (a weakness of most applications in this RIS). What is the dissemination pathway to changes in health delivery and who will be responsible for this? The HRC recognises that applicants with experience in sectors other than public sector research may have gained valuable expertise or produced outputs (e.g. patents) relevant to research translation, and this may have limited the applicant s opportunity to produce more traditional research outputs. References (one page) Put references in this part of the form after the 3 pages describing the proposed research. Do not extend the research description onto the references page. Details must include a full list of all author(s), title of article, journal, year, volume and page numbers. Asterisks are to be placed beside applicant's publications. If references are multi-authored, there is discretion to limit the author list to a more convenient number to fit any space limitations. Reference to Māori terms in the application with brief interpretation should be included here Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 14

15 4. Module 3: NZ Standard CV Note: TWO CVs can be provided at this stage. Upload the CV of First Named Investigator, who has overall responsibility for the Project, and another Named Investigator, who may be most involved in the day-to-day research activity of the Project, on the HRC Gateway. The NZ Standard CV template is downloadable from the HRC website. Take care to use the original CV formatting including the default font and page limits. The HRC will not accept any other form of CV. The information provided in the CV must be the same as that provided in Module 1. For example, title and contact details may need updating in the CV before submission Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 15

16 Part E: Submitting a Full Application Completion of the GA219F Form Applicants should confirm that they have been invited to submit a Project Full Application. Module 1 is now completed entirely via the HRC Gateway and is no longer part of the form. All or most information will have been completed at the EOI stage. Some fields may be editable or updated from EOI stage. The GA219F form contains a Coversheet, Modules 2, Module 3 and Module 4 (Sections 4A-4D) of Module 4. Module 4E is the Milestones and Objectives and is entered in HRC Gateway. The contract information and/or budget file for Module 4F-4I must be uploaded separately (HRC219budget.xlsx). Module 5 contains NI CVs that are uploaded separately. Module 6 is the research classification of the research that must be completed on the HRC Gateway. This form must be downloaded and completed by applicants before being uploaded to the HRC Gateway as a pdf file. The complete application with all Modules will be generated by the HRC Gateway for downloading and printing. Note: an applicant checklist has been added to the start of application form. Every point must be checked off to acknowledge compliance with application guidelines. Completion of the checklist by applicants indicates that the submitted application complies with all requirements as the HRC will no longer undertake this compliance check. 1. Use of GA219F Form Use the original form and contract information file as these contain special features. The form is compatible with Windows PC and MAC computers. The form has default formatting that conforms to HRC requirements. Figures and tables are best pasted in from a draft document instead of created directly in the form. Remember: a) Enter information only at the indicated form fields. b) Do not reformat Module and Section headings. c) Do not delete spreadsheet columns/shaded rows, but you may insert more unshaded rows. d) Use the original HRC document templates. Do not copy and paste into a new document as this can drastically change fonts and remove other features required for HRC processes. e) Input HRC Ref ID# and NI surname on the coversheet. 2. Module 1: General Information Module 1 is now completed entirely online and is no longer part of the form. All or most information will have been completed at the EOI stage. Some fields will not be able to be edited or updated from EOI stage. Please refer to the Part D: Submitting an EOI Completion of the GA219S Form section of these guidelines for further information. Additional information required for the full application is outlined below. Research Costs Enter in the relevant totals for Staff Costs, Overhead, Working Expenses and Total Cost of Research (from the excel budget spreadsheet) Note that this field is not required to be completed at the EOI stage (only required at the full application stage). Named Investigators (NI) All NI must be registered users of the HRC Gateway with a current profile, that must be updated annually. Please note that the HRC allows some changes of FTE between EOI and Full Application; however, these should be within the limits described in section 5.4. As a general rule, no additional NIs can be added to the team, with the following exceptions: 2019 Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 16

17 for statistical expertise in clinical trials; for applications submitted to the RHM, Pacific or New Zealand Health Delivery streams; if specifically recommended by an EOI assessing committee; or due to the replacement of an existing member due to unforeseen circumstances At the full application stage, for any replacement of a named investigator, or an addition of a named investigator, please notify the HRC at least two weeks prior to the full application submission deadline to justify the change. A form, to request an additional named investigator or a replacement investigator, is available from your research office. 3. Module 2: Proposal Section 2A Summary of Research (one page only) This section should clearly summarise the research proposal. The content should not be significantly different from the EOI. The summary should be a maximum of one page. A clear and succinct summary including all the important points of the application can help reviewers get an overview of the proposal and is useful as a quick reference for Science Assessing Committee members. Use the suggested headings and add subheadings if required. Section 2B references) Description of Proposed Research Project (10-page limit, excluding The section headings provided should be used. The assessing committee membership is broadly discipline-based, matched to the range of applications assigned to that committee, so not all members will have working knowledge of every research topic. Write the proposal for scientists with a general understanding of the research area. The use of graphics and tables is an efficient use of space (please ensure font type and size are easily legible). Ensure that the format of non-text content is compatible with pdf conversion software. Rationale for Research Demonstrate that you have adequately reviewed what is already known in the area and that there is a clear case for further research. For example, refer to systematic reviews or an otherwise robust demonstration of a research gap. Include information that you feel is essential for the reader to better appreciate or understand why you feel your proposed research should be undertaken. What is the significant/important gap in knowledge or what is the potential to advance knowledge in the field or health issue, policy, practice or service delivery that your research will address? How does your research contribute to, or align with, research currently being undertaken either nationally or internationally? Where does your proposed research fit relative to the world-wide perspective? For example, is it unique to New Zealand? Do your hypotheses build on existing knowledge? How original is the approach? What is the significance of the health issue for New Zealand health and society? Has responsiveness to Māori been considered? Research Design and Methods Include sufficient detail of study design and methods such that an assessment can be made of its appropriateness, robustness and/or innovativeness. This might include a description of sample recruitment and characteristics (including number, gender and ethnicity where relevant), study methodology, and proposed methods of data collection and analysis. Where appropriate, it is essential to provide power calculations and an estimate of the likely effect size and the sample size required to detect this (power analysis), after consultation/involvement with a statistician. Clinical trial applications (see Appendix 1) are to include a description of statistical guidelines for early termination and a description of data and safety monitoring arrangements, where appropriate. Basic science applications are encouraged to provide control data to aid with committee assessment. In addition, applicants should provide evidence that mouse models have been generated (even if not in house) and viable if transgenic/knock out mice. When research is patent protected applicants are encouraged to provide the patent number and a summary of information available (if no technical information can be provided) Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 17

18 The HRC Data Monitoring Committee provides an independent DMC with appropriate trial specific expertise that follows best international practice, if required. For more information on trial monitoring in general and the HRC DMC in particular see ( Indication of timelines for the research should be included. Consultation with specialists such as methodologists, statisticians and health economists before finalising research design is recommended. Where possible, detail the validity of the proposed analyses, and the feasibility of attaining the statistical power sought (if appropriate). The Science Assessing Committees need this information to judge and appropriately score this criterion, so ensure that the practicalities are clearly stated, i.e. what will be done, how, by whom, where and when. Science Assessing Committees are also reassured when methodologies have been used/trialled before. Research Impact Research Impact For Health and Wellbeing in NZ and Improving Outcomes for Acute and Chronic Conditions in NZ: Note: applicants for IOACC and HW are no longer required to link their impact section to the Goals of the relevant investment signal. This is to encourage applicants to consider all potential ways in which their proposal can add value for NZ, and what actions within their influence can help achieve this potential. Assessment of Impact for these streams has been restructured to include two components: 1) a description of how your research might be used and the anticipated benefits for NZ, and 2) the action plan to maximise the use and benefits of the research. See the HRC s Impact Webinar for additional guidance on completing this section. 3 What types of benefits are expected to arise from your research, and who will benefit? This section should provide a realistic description of how research findings could contribute to improved health or other societal benefits over time (a potential line of sight or pathway to impact). Importantly, it should also identify the more immediate users and beneficiaries of the research, who will form a focal point for your Action Plan (below). The balance between describing short-term and longer-term considerations will be dependent on the specific research context, including the length and complexity of the pathway to impact and where the research sits along this pathway. The HRC s Impact Webinar includes discussion of elements that should be covered in this section, including the types of benefits and beneficiaries, and the geographical distribution of benefits (such as how contribution to international research effort will benefit NZ). Researchrelated benefits, such as capacity and capability gains for NZ, and influence on future research agenda-setting, may be included where relevant. What specific activities will you undertake, throughout the life of the research project, to maximise the use and benefits of your research? Describe what targeted actions will be taken 4 to improve the likelihood of research uptake and impact, and to ensure that the next users or beneficiaries (identified in the previous section) can meaningfully contribute to, and/or benefit from, the research. Describe other planned dissemination activities that are designed to reach broader audiences. Who can enable, or block, the uptake of your research, and how have they been considered in the research plan? Identify uncertainties to uptake by actors outside academia, or systematic/institutional barriers, and your mitigation strategies (where relevant). 3 Consult the HRC s Impact Webinar for further discussion on the types of benefits that can arise from health research, and where these benefits might be expected to occur along a pathway to impact. 4 Consult HRC Guidelines and funding rules for information on support of knowledge transfer activities and include these activities in objectives/milestones where appropriate. Progress against implementing the action plan will form part of the milestones HRC monitors with respect to contractual compliance and delivery Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 18

19 What elements of the team s track record of knowledge transfer provide confidence in the likelihood of research uptake? For example: existing links, relationships, or networks with relevant research next-users or end-users; demonstrable examples of knowledge mobilisation or transfer; or changes in health outcomes or societal impact generated from similar research. This component is considered relative to opportunity. For NZ Health Delivery: Include the anticipated outcomes of the research, and how they will advance the New Zealand Health Delivery goal. Comment on knowledge transfer. How will the expected outcomes of your proposed research lead to direct improvements in the NZ health and disability sector in the short-to-medium term? Describe realistically how this will be achieved within the specified five years of the contract commencing. Describe how the outcomes will make a difference - will they change policy, inform clinical decision-making, or improve productivity, for example. How widely applicable will the findings be? Comment on end-user engagement, and other plans and processes that will be used to support the uptake of research findings. The last point tends to be the weakness and most common reason for poor scores in applications to this stream. Dissemination of Results and Knowledge Transfer Describe how the research results will be shared with professional colleagues, the general public, health service funders and providers, study participants, iwi and other important groups. As well as peer reviewed publications; examples include patient leaflets, participant newsletters, clinical guidelines, hui and public meetings and mass media items as appropriate for the research and the findings. Describe how knowledge transfer activities have been integrated in to the research plan. Specify who is responsible for any key knowledge transfer activities. Expenses associated with certain dissemination activities may be included in your budget (see section 4F) but must be included in the budget justification section. Responsiveness to Māori How might your research contribute to the health needs of Māori? What is the health significance and context of this research to Māori? Discuss the incidence or prevalence in Māori, or indicate if not known to be significantly different from the general population. Have you sought advice for the study from a Māori researcher/representative? Expertise and track record of the research team Provide evidence that the team has the qualifications, experience and knowledge in the proposed research area; right mix of expertise, and appropriate networks and collaborations; history of productivity and delivery; and the right research environment/infrastructure to deliver the research and disseminate results. Declare any career disruptions that may be relevant to your career history. A career disruption is defined as a prolonged interruption to an applicant s capacity to work due to pregnancy, major illness/injury and/or carer responsibilities. The expertise and track record of each member of the team, (i.e., NIs), must be described. Committees consider the FTE of senior investigators on each proposal and weight their scoring on the expertise and track record of the research team accordingly, i.e., high scores should not be allocated on the basis of a senior NI who has a small percentage FTE involvement in the research. Include a brief description of the team s track record related to the proposal area, to demonstrate the ability to deliver proposed study outcomes. Highlight important skills, expertise and previous collaborations in the team that would support delivery of the proposed research. Justification for staff roles should be provided. Applicants to NZ Health Delivery MUST provide information on the capability of the research team with regard to research outcomes AND research uptake (a weakness of most applications in this RIS) Project application guidelines 2018 Health Research Council of New Zealand. All rights reserved. Page 19