Grant application support

The HRB-TMRN is a national support Network, which currently has over 3,000 members, all with an interest in improving the conduct of randomised trials in healthcare. The Network operates across five university partners (National University of Ireland Galway, University College Cork, University College Dublin, University of Limerick and Trinity College Dublin); however, all supports are available to anyone in any institution, across both public and private sectors, on the Island of Ireland. The network operates across four central pillars of trials methodology activity, namely; (i) training and education, (ii) support (iii) research and innovation and (iv) Public Engagement. The supports provided by the HRB-TMRN range from providing advice, for example signposting, up to embedding large primary methodology research work packages within trials or standalone primary trials methodology research. The network has identified relevant expertise across a range of areas in trials methodology, and welcomes engagement from any individual, group or centre interested in advancing the methods used in trials.

Where relevant, HRB funding schemes support the conduct of trials methodology research within the context of proposed interventions and also support methodological studies within a trial (SWATs) to explore primary trial methodology questions. The HRB-TMRN can be involved in supporting an application, where an application includes at least one trials methodology research question, or uses an innovative* trial design.
(*An innovative design is considered non-standard and aims to address the challenges of new developments and emerging trends in health care).
The implementation of SWATs is one of the main objectives for research activity of the HRB-TMRN and we have considerable experience in the conduct of these studies.

The HRB-TMRN can assist with embedding methodology research questions on three levels:

1. Co-applicant
2. Collaborator
3. General infrastructure support

The following descriptions offer a guide as to the level of requirements and support available for each category. Applicants should discuss their needs with the HRB-TMRN Programme Manager.

HRB-TMRN as Co-applicant

As per the HRB guidance, a Co-applicant may receive funding for items such as running costs and personnel.

• A designated HRB-TMRN contact will be identified based on the needs of the study (clinical area will be considered where possible);

In a case where a methodological study within a trial (SWAT) is proposed:

• In consultation with the Principle Investigator, a suitable SWAT work package will be written and developed by the network member that addresses an important methodology question;
• Associated funding for the SWAT award will be managed by the HRB-TMRN SWAT lead, providing on-going assistance on the SWAT for the duration of the award and subsequent publication of findings.

Note: All the above act as a guide, and are subject to agreement between the trial team and nominated HRB-TMRN contact.

HRB-TMRN as Collaborator

The HRB-TMRN can provide a signed Collaboration Agreement Form for applicants who meet the following criteria:

1. The application includes at least one well-developed trial methodology question or uses an innovative trial design.
2. Where appropriate, a designated HRB-TMRN contact will be identified based on the needs of the study (clinical area will be considered where possible) to provide advice and assistance. This may incur a cost based on the nature of the agreement.
3. The applicant team agree to update the HRB-TMRN of the trials methodology study progress and to register any SWAT with the Northern Ireland Hub for Trials Methodology Research Repository.
4. The applicant team agree to share the published findings of the trials methodology study with network members, through delivery of an online webinar or present the study findings at a national HRB-TMRN educational event.

HRB-TMRN as an Infrastructure

The HRB-TMRN can also support applicants through an Infrastructure Agreement which sets out the full scope of service or collaboration agreed. Usually a funding allocation is not required for this level of engagement.

Contact the HRB-TMRN directly at hrb-tmrn@unoversityofgalway.ie to arrange a call with the Programme Manager (Dr Sandra Galvin) who will discuss the options available.

For applications which address embedded trial methodology research questions:

• An abstract of the feasibility study or host trial to include the primary clinical research question and design of the proposed host trial (relevant for pilot or definitive interventions).
  OR
• The primary clinical research question of the future host trial (if feasibility study).
  AND
• The trial methodology research question(s).

For applications which address methodology research questions only (i.e. no clinical question included in the research proposal):

• The primary methodology research question(s).

An additional €20,000 (inclusive of overheads) can be applied for if conducting a SWAT study within a HRB DIFA. Please note that individual proposed SWATs may cost more or less than €20,000; actual costs should be included. The additional budget allowance for SWATs is to encourage and support further SWATs within the HRB-funded portfolio.