Cancer trials in Ireland-Clusters and Network 2021 - Frequently Asked Questions - V 1.0 - Health Research Board
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V 1.0 November 2020
Cancer trials in Ireland-
Clusters and Network 2021
Frequently Asked QuestionsV 1.0 November 2020 Application teams Cluster application: Applications must be made on behalf of a team which is made up of a selected Cancer Clinical Lead, CRF/C Director and Site Leads from each of the associated hospital sites, and submitted through a HRB Host Institution on behalf of a Hospital Group aligned to one of the seven below-named Clinical Research Facility/Centres (CRF/C’s) in Ireland. The seven named CRF/Cs and associated academic partners are; 1. Wellcome Trust-HRB-CRF at St. James Hospital in Dublin (hosted by Trinity College Dublin) 2. HRB-CRF Cork at the Mercy Hospital and Cork University Hospital (hosted by University College Cork) 3. HRB-CRF Galway at University College Hospital Galway (hosted by the National University of Ireland Galway) 4. University College Dublin CRCs at The Mater Misericordiae University Hospital and St Vincent’s University Hospital (hosted by University College Dublin) 5. Royal College of Surgeons in Ireland CRC at Beaumont Hospital (hosted by Royal College of Surgeons in Ireland) 6. The Health Research Institute Clinical Research Support Unit at Limerick University Hospital (hosted by University of Limerick) 7. Children’s Health Ireland (various hosting partners). The applicant team should consist of Co-Lead Applicants, a Cancer Clinical Lead and a CRF/C Director, and Co-Applicants (Site Leads) from each of the associated cluster partners, in addition to collaborators.
V 1.0 November 2020 Network Application: Applications will be accepted from established entities with a previous track record of providing services and supports for the conduct and delivery of high quality, safe and compliant cancer clinical trials. The application will be submitted in partnership with a recognised HRB Host Institution. The applicant team should consist of a Network Lead Applicant, Co-Applicants and Collaborators. Can a Cluster Clinical Lead applicant also be a site lead? Yes a Cluster clinical lead applicant may also act as site lead. This role should be outlined in their responsibilities. Is it expected that there is only one site lead per hospital site? Yes each hospital site will only have one site lead. The clinical lead applicant may also serve as a site lead, but we would expect that this would be outlined within their role details rather than they be added as another site lead. Scope of Application What is out of scope for this investment? HRBs investment through this specific instrument will not support; • funding for individual cancer clinical trials as it is expected that trials should come with competitive funding from sources with effective independent international peer review, such as the HRB Definitive Interventions and Feasibility Awards, other national/international funding sources, international collaborative groups and / or industry-funded studies
V 1.0 November 2020 • costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires • establishing new premises, including building work, or fit-out of buildings. Does the HRB support use of patient registries which might be used to identify patients for clinical trials? Including those supported by CRFs. As outlined above and in our guidance document, costs associated with patient registries would be out of scope for this award. Is coordination with other clinical trial infrastructures required? Yes. Cancer trials infrastructures are expected to work with other clinical trials infrastructures within the system to collectively improve patient access to clinical trials, integrate relevant best practices where necessary to support national performance for the benefit of the Irish clinical trials system. These include Clinical Research Facilities/Centres, Trials Methodology Research Network and the National Clinical Trials Coordination Programme. Funding What funding is available? Total HRB funding for this call will be up to a maximum of €4,175,000 per annum inclusive of overheads over five years. The overhead contribution is aligned to research activity per application and aligns with that paid to other HRB infrastructures; • 30% overhead contribution for Cluster applications (in line with CRFs), and
V 1.0 November 2020 • 25% overhead contribution for the National Cancer Clinical Trial Network application (in line with other CTNs). The funding split between the two calls is 65:35. With 65% of the overall funding going towards Cluster applications and 35% going towards the National Cancer Clinical Trial Network. Can all Clusters bid for the maximum amount? The investment is intended to align with the needs and capacity for clinical trials activity. Clusters with lower levels of trial activity (based on registered clinical trials between 1 Jan 2017 and 31 Dec 2020) will be expected to bid for lesser amounts, and build more activity over time. The cluster awards are expected to range from €150,000- €500,000 p.a. over 5 years. Where an application is forecasting a significantly increased level of activity post-2020, the HRB expect that that growth will be gradual and take into account factors such as time required to recruit staff to drive this level of increased activity. Funding management process Funding is awarded on a claims-made basis, annually in arrears, with funds claimed against actual expenditure on an annual basis. Budgets will be reforecast at Annual Report stage for the following year. Funds not claimed in any 1 year period are forfeit and are not transferrable to subsequent year budgets. We do provide some flexibility in this approach: The HRB are agreeable to allow 10% of the current year Budget to be requested by you to be adjusted into the next Budget year(s) where 10% of the Budget for the current year has either
V 1.0 November 2020 not been claimed, or over-claimed, and used for the Grant Funded Activities subject to the following: 1. The HI shall submit such claim to the HRB for approval with details of what aspects of the Budget are to be adjusted in the next Budget year(s) as part of the Annual Report. The proposed Budget for the next Budget year shall accompany such application. 2. The HI in submitting such application confirms that it will enter into a letter of variation to adopt the revised Budget, if approved, to the Grant. 3. At no time shall the total Budget exceed the original amount issued with the Grant, or most recent letter of variation, in total or cumulatively. Will this award provide funding for individual trials? No. Funding is not provided for individual trials (definitive interventions or feasibility studies). Trials and interventions are expected to be funded from other sources, e.g. industry- sponsored, charity funded or through competitive means, such as the HRB DIFA scheme. Regarding co-investment: can a trust or charity be recognised as a contributor to co-investment? The HRB are happy to accept this form of co-investment provided that it is verifiable in accounting terms meaning that it is a defined income source (such as FTE) that is consistent and measurable. How will the flow of funding be managed between the Host Institution (HI) and members of the cluster or network? The HRB will be contracting directly with the Host Institution (HI) for the purposes of this contract. The HI will be expected to manage the process of payments out to the appropriate sites for any staff agreed to be funded through the grant budget. This is a standard occurrence and many of the HIs will already have underpinning agreements in place with external sites such as the Clinical Research Facilities. It will be clear from budget negotiations where the payments are to be made to and the HI will manage that process for the duration of the grant.
V 1.0 November 2020 Can the co-funding by hospital groups/university or other stakeholders for specific trials support be counted as co-investment? E.g. Research Nurse roles where the nurse only works on that trial. No, HRB are not counting support for individual trials as co-investment in this round. Does the matched funding have to match HRB funding per calendar year? We expect the level of co-investment proposed to broadly match/exceed the requested HRB budget in any given calendar year, i.e. where €500,000 HRB budget is requested in Year 2, a similar level combined co-investment by (HI/Hospital/Associated charity) or more is expected in Year 2. Over the five-year period of the award the total confirmed co-investment must equal or exceed the requested HRB budget. Responsibility will lie with the Host Institution/Hospital to ensure the matching funding requirements are met. In all cases the Host Institution/Hospital contribution should be justified, measurable and verifiable. All documentation relating to matched funding provided to the HRB-CRF/C by the Host Institution/Hospital must be available for audit purposes if required. It is an eligibility requirement that the amount required and evidence for this matched funding is detailed at application stage. Failure to achieve matched funding will make an application ineligible for this call. Can resources/support be counted for multiple submissions: e.g. can host institution support be counted for both the Cancer Trials Ireland investment and CRF/C?
V 1.0 November 2020 No, allocating the same resource under both applications would be considered as double counting. Co-investment cannot be double counted across multiple bids. Resources to be counted as matched funding must be distinct and clearly identified for the infrastructure; i.e. resources counted for the Cancer Cluster should be available to support the operations of the cancer cluster. Similarly, resources counted as matched funding e.g. a CRF/C should be available to deliver for the CRF/C. It may be that part of a persons’ salary is counted towards a CTI bid, and part towards the CRF/C bid. This aspect will be reviewed by HRB Finance. Portfolio of the Cluster/Network: Registered Trial data A particular format is requested for capturing registered trial data - centres collect this currently in different ways. How should this be approached by applicants? We expect applicants to complete as much as possible– this is a key part of the application. For columns where the information is not currently collected and therefore remain blank, it will serve as an indicator of a gap in the current collect methods within the system. The international Panel will be assessing applications from multiple applicants’ groups and so templates are used to provide consistency in review. The application form also has a section for applicants to describe their approach to monitoring activity and performance, and this will likely be further discussed in the interview.
V 1.0 November 2020 Submission, Host Institution Signatory and the Review Process How do I apply for a Cancer trials in Ireland award? All applications must be made using the HRB online Grant E-Management System (GEMS). Applicants should carefully read the Guidance Notes prior to application. Submission process using GEMS Prior to final submission to the HRB, all applications must first be reviewed and approved within GEMS by the signatory approver at the research office (or equivalent) at the Host Institution. It is critical therefore that the Lead Applicant leaves sufficient time in the process for the Research Office (or equivalent) in their nominated Host Institution to review, seek clarifications and approve applications prior to the final submission date. This may involve being aware of and complying with any internal Host Institution deadlines for review and approval, distinct from the HRB deadline. What is the size limit for attachments in GEMS? The file size limit is 2MB. Are the templates for this application found only within GEMS or can they be downloaded via the HRB website? Yes, they are only available within GEMs. Anyone may create an account and access them for download, not just the lead applicant.
V 1.0 November 2020 How do we decide which is the most appropriate, an Infrastructure Agreement Form, a Collaborator Agreement Form or a Letter of Support? Where an infrastructure or organisation is to provide defined supports and services to a cluster or a network we recommend they complete an Infrastructure Agreement Form (linked for download in GEMS). There is an equivalent form for those named as collaborators, mostly individuals providing other input into an award (a Collaborator Agreement Form- again linked for download in GEMS). All others in support of the award but not directly participating as co- applicants or collaborators should submit a Letter of Support. The supports and services provided by the CRF partner should be detailed in the CRF Co-Lead section. Who has access to the application? Anyone added to the application including Co-lead applicants, Site Leads and Collaborators will all have access to the application. Can salary scales other than the IUA scale be used for staff appointments, for example HSE nursing scales? Yes, any appropriate scale can be used as long as you include the information on the scale used and the point at which the position in question sits. We used the IUA scale as the usual example as the majority of HRB contracts are for employment of researchers rather than medical staff. How will I know that my application has been successfully submitted? Once the HI endorses your application it will be sent automatically to the HRB to be considered for funding, a grant application number will be assigned to the application and you will receive a confirmation email.
V 1.0 November 2020 I have submitted my application but have just realised I have amendments to make; can I amend the application? No, once you have submitted your application, you cannot edit or retract it. What is the review process? Submitted applications will first be checked for eligibility by HRB staff against the minimum requirements for this scheme: that the application is in scope, eligibility of the team confirmed, and minimum requirements have been met. Eligible applications will undergo a Panel assessment process. Initial comments or questions from the international panel will be provided to the Applicant teams prior to interviews which will take place in late April 2021. It will be confirmed closer to the time whether interviews will take place virtually, or in person at the HRB Offices, in line with Covid-19 travel restrictions. What is the deadline for application submission? The award application deadline is Friday 15th January. Please be aware of any internal deadlines for Host Institution approval which may apply. When will awards commence? The earliest start date is January 2022. The duration of the awards will be 60 months with an interim review.
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