Dissemination note

Meeting: / Champions for Research Support – 22nd April 2014
Issuedate: / 16th June 2014
Meetingobjectives: / National updates
Plans for Health Research Authority (HRA) approval
Support for providers reporting research performance

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National updates

Department of Health(DH)

Working with industry: The working group, convened at the last meeting to develop material on providing an excellent service to industry, has been seeking to identify relevant resources that are already available, e.g. from the National Institute for Health Research (NIHR) Clinical Research Network (CRN) and NIHR Office for Clinical Research Infrastructure (NORCI), before developing main themes for a ‘top tips’ document, on which NHS research managers’ feedback will be sought via Champions in due course. To inform the document, Champions toletknow of any other (e.g. local) effective tools, advice or guidance on working successfully with industry.

Performance in initiating and delivering research: All NIHR contracts since autumn 2011 require providers to report their performance in recruiting the first participant to clinical trials at the site(against a benchmark of 70 days from receipt of a valid research application to recruitment of the first patient) and in recruiting the rest of the participants to the agreed time and number targets. Contracts underpinning the new NIHR Local Clinical Research Networks from 1st April 2014 include these requirements. DH has sought feedback on how best to achieve the intended outcomes of these requirements, without creating disincentives or perverse behaviours, and has received responses from providers, the Association of the British Pharmaceutical Industry (ABPI) and the Association of UK University Hospitals (AUKUH). As a result: the NIHR Clinical Research Network (CRN) has changed performance management and local metrics to avoid confusion between the 70-day benchmarkand the metrics for CRN’s high-level objectives; reasons for delay, ‘valid research application’ and other definitions will be clarified; the data submitted will be subject to audit; and NIHR is considering using Research Capability Funding (rather than the value of a provider’s individual NIHR contract(s) that contain the performance requirements) to address the NIHR funding implications of a provider’s performance.

Health Research Authority (HRA)

The Health Research Authority has received funding in full for its business plan for 2014-15, including the plans for HRA Assessment and Approval. Janet Messer presented slides on the plans that were being developed for implementation, and invited the group to cascade the slides locally. Key points were that the award of funding meant that staff could now be taken on by the HRA to develop the detailed operational arrangements for HRA Approval, working with the CRN and with stakeholders to plan the timetable. More details about the plans will therefore emerge over time, and will be shared with the Champions group. The first round of adverts was due out shortly with further rounds to follow. Group discussion focussed on considering the implications for NHS R&D staff. The purpose of HRA Approval is to simplify the approvals process, allowing R&D offices to focus on supporting research teams in getting studies set up and managing the delivery of studies. It is important for R&D staff to make use of the opportunity of the new CRN structures to work with colleagues to identify current variations in practice and harmonise local processes to provide a consistent baseline for implementation of HRA Approval. The discussion also highlighted that local policies often still drove local processes, and the review of consistency across neighbouring organisations provided an opportunity to identify which local policies were not in line with national guidance and standards. Feedback is invited to on the accompanying slides.

NHS England(NHSE)

NHSE Research Development Strategy:Following consultation on the draft strategy, NHSE is now working with partners to develop the next version. A key theme to emerge from the consultation was that NHSE is in a unique position and should be clear about what it, and only it, can do.

NHS Commissioning Assembly research working group:The Assembly, a forum for all clinical commissioning groups (CCGs), is establishing a working group to promote research, encourage evidence-based decision-making in service system redesign and support the aim of research being offered to patients as part of their treatment options.

Excess treatment costs: A ‘task and finish’ group has been convened to develop an overarching framework for standard operating procedures and guidance to researchers and to revise the existing interim guidance.

Honorary research contracts: The NIHR HR Good Practice Resource Pack (‘the Research Passport guidance’) is being revised in light of a pilot of new arrangements for honorary research contracts for primary care researchers. This will address difficulties encountered by researchers since the abolition of primary care trusts (PCTs) in obtaining the necessary access agreements for primary care sites that are not their substantive employer. The new arrangements, expected to be rolled out this summer, will mean primary care researchers can get, and only need, one honorary research contract, with NHSE, in order to carry out their research at primary care sites anywhere in England.

National Institute for Health Research (NIHR) Clinical Research Network (CRN)

NIHR CRN was not represented but has supplied a written update. See annex.

Group discussion: research initiation and delivery

Rebecca Smith presented a draft of the pilot training session on Performance in Initiating and Delivering Research (PID) that had been prepared in conjunction with Michaela King, Alison Steel and Nicola Williams.

The accompanying training slides explain the key points of the new PID metrics as well as specifics about data collection, submission and performance improvement.The slides also provide some worked examples to test learning. The slides were very well received and feedback was requested to enable a final version to be prepared. Feedback was also to be invited from AUKUH and NIHR CCF CTP.

Suggestions around dissemination were also taken. It was agreed the main dissemination route should be via a presentation given by a NHS provider experienced in submitting PID data. Champions were asked to disseminate slides once finalised. The NHS R&D Forum was also suggested as a dissemination route.See accompanying slides – revised and finalised since meeting.

Next meeting

The group proposed that the next meeting on 15th July 2014 might cover:

  • the future role of Champions for Research Support, where they fit in the system and what can they develop to support HRA plans
  • respective roles of HRA Assessors and people locally, what this means for local R&D offices and communications around this
  • guidance on tools for working with industry
  • update on definitionsused in performance reporting

Subsequent meetings will be held on 17th October 2014 and 27th January 2015.

Annex: Update from National Institute for Health Research (NIHR) Clinical Research Network (CRN)

Engagement with Industry

  • Dedicated business development role to support new and repeat business through targeting and pipeline review.
  • Creating CRN advocates and knowledge sources in the Life Sciences Industry via ‘Network Expert’ group and dedicated training.

Study Delivery

  • Refining RAG reports and central data use to support effective performance management.
  • Defining network ‘feasibility’ service offering and provision of ‘how to’ resources such as the Feasibility Assessment Tool, Patient Predictor and guidance for feasibility form completion, linked to the CRN Study Support Service development.

Working Smarter

  • Expansion of theNIHR App Centrefor one click access to key resources for Industry and CRN Industry teams.
  • Key messages and information delivery through audio presentation on theCRN BrightTalk channelfor wider access.
  • Defined requirements for clinical support departments’ involvement in research, especially around set-up.

Customer Service

  • Revision of the Industry website and promotional literature to reflect the professional service the Life-Sciences Industry expect from the CRN.
  • Development of a contact management system for use across the CRN Industry staff with around 400 different companies listed.
  • Acting on feedback from service users.

Adviceand support:Anumberof small workinggroupshave been held to scope further streamlining within network research delivery and to provide information for further review of the CRN Study Support Service.

  • Sub Group 1: Mapping the Clinical Pathways– facilitate improvements in study set up and governance of research studies
  • Sub Group 2: Defining the roles & responsibilitiesand approvals/authorisations/permissions required for different types of sites involved in a research study
  • Sub Group 3: Guidance for researchers– advice and support that aligns the CRN service offerings with the researchers needs at different stages of their research study

Attributing the costs of health and social care Research & Development (AcoRD):In early 2014 the CRN began to pilot the CRN processes (i.e. pre application support, the Activity Capture and Attribution Template (ACAT) and ACAT Review) and tools (including training resources) that will support the implementation of the AcoRD guidance.The AcoRD Pilot will run for a period of around 11 months for a selection of AMRC funders (large and small charities) and NIHR funding streams that fund programme grants.

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