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NIHR Urgent Public Health Group Terms of Reference

 

Contents

Purpose

The NIHR Clinical Research Network (CRN) is convening a group to provide clinical intelligence to the selection, prioritisation, set-up and delivery of studies relating to COVID-19.  This group will discuss strategic clinical issues and not operational delivery issues, which will be addressed through study specific meetings.

The primary purpose of this group will be to address the items listed below:

  1. Review studies submitted for an Urgent Public Health (UPH) label and provide a recommendation to the Department of Health and Social Care (DHSC).  Studies may be commercial or non-commercial, and may be funded or unfunded, unfunded studies will be forwarded to funders for consideration. Review to address:
    • Feasibility
    • Funding appropriateness 
    • Prioritisation 
    • Management plan to ensure studies do not overlap, and do co-enroll or share samples and data where appropriate
  2. Support ongoing UPH studies through providing clinical intelligence
  3. Provide a mechanism for specialty experts (including Specialty Leads) to link into UPH studies, including identification of a lead clinical contact for each study

Scope

The remit of this group will extend to all areas of the UK and as such membership from the devolved nations has been sought. 

Commercial and non-commercial studies will be evaluated, feedback for commercial studies will be provided by the Business Development and Marketing Team directly to the sponsor.

Funded studies that require access to CRN or additional NHS resources will be evaluated.  Studies without full funding will be forwarded to a Rapid Review Funding Panel prior to review by the Urgent Public Health Group.

Urgent Public Health remit is defined as: COVID-19-related research that requires access to CRN or NHS resources to facilitate the delivery of research during emergency phases of the pandemic. Impact is to be delivered in 12 months and includes:

  • Therapeutics
  • Vaccines
  • Prophylactics
  • Diagnostics
  • Collection of samples and data from patients and staff in hospitals and care settings
  • Mental Health where there is a life-threatening risk

Meeting arrangements

Meetings will be convened as often as needed from 5:30-7:00pm. Papers will be provided 24 hours in advance, although given the fast paced nature of the situation it may not always be possible to adhere to this requirement. Lead reviewers will be nominated and informed 48 hours in advance of the meeting.

Decision making

  • How compelling is the science underpinning the proposed study?
  • Is it feasible to deliver in the current environment of the NHS and social care?
  • Is the funding appropriate to deliver the proposed outcomes of the study?
  • Is there an appropriate management plan to avoid interference with recruitment to other Urgent Public Health studies?
  • Will results be known within 12 months of the start of the study?

Where decisions are to be taken in respect to recommendations to DHSC, a minimum quorum for this group will be representation from 50% of the represented specialties (currently 4 Specialty Leads), one member of the represented MedTech and In vitro Diagnostics Cooperatives (MICs), one member from each of the devolved nations and one member of the Research Delivery Directorate, deputies have been requested from these members and have authority to act on behalf of the person they are deputising for.  Should a vote be required for decision making, decisions will be made by a vote from the Specialty Lead, MIC, Clinical Trials Network and Devolved Nation representatives with the chair having the casting vote.

Feedback

Decisions will be forwarded to the Scientific, Research and Evidence (SRE) Group by the NIHR Urgent Public Health group secretariat. The expectation is that the SRE Group and Chief Medical Officers (CMO) office will respond to ratify decisions made within 2 working days. CIs will be notified of the decision following CMO confirmation of the UPH Group recommendations.

Clinical Link

The NIHR UPH Review Group (UPHG) will allocate a National Clinical Link (CL) to each study designated as Urgent Public Health (UPH). 

The Research Delivery Directorate will also have an allocated Research Delivery Link (RDL), this individual will provide the personal point of contact for the CL.

CLs will be the main clinical point of contact for the NIHR CRN Research Delivery Directorate (RDD) and Lead LCRN on a per study basis, and will be the CRN team’s first point of escalation for set up and delivery issues and challenges.  Likewise, the CL should ensure that they liaise with the RDD regarding any study queries or concerns that they become aware of.  To facilitate this collaborative approach to supporting the study, the RDD team will ensure that the clinical link is invited to key discussions and study-related meetings, and is kept up to date on progress with the study.

The role of the CL is to support activities throughout the lifecycle of the study by offering clinical expertise; specific support required will be based on the needs of the individual study.

Membership

A list of members is published. New members will be identified as needed.