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Urgent Public Health designation guidance notes

 

Contents

Urgent Public Health Designation

UPH Designation criteria

Your study will be assessed by the UPH Group and assessed against the following criteria:

  • 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 study of appropriate scope and scale for national priority status?
  • 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 relevant to this pandemic?

UPH Designation process

Complete and submit the application  form on the NIHR website and wait to hear if you have received UPH designation status (usually within 5 working days)

The Urgent Public Health portal no longer accepts part-funded or unfunded studies.  Only fully funded studies will be considered for Urgent Public Health designation.  Funding is required to be eligible for adoption onto the CRN Portfolio (see below). 

UPH application submission

The submission of your UPH application can be made by either a Chief Investigator or a commercial company. Please ensure that the study is only submitted once.

The questions that will be asked during the submission process are:

  • Chief Investigator / Principal Investigator contact details and alternative contact details
  • Project title
  • IRAS number (if known)
  • Project Type (Interventional, Observations, Other)
  • Project summary to be made publicly available
  • Protocol/project synopsis
  • Publicly available information (eg website)
  • Project Type (commercial, non-commercial, collaborative)
  • Name of sponsor
  • Has funding been obtained? Confirmation will be required
  • For non-commercial projects, please provide an estimate amount of the research costs for 20/21 (estimate only, non-binding value)
  • For non-commercial projects, please provide an estimate amount of research costs for 21/22 (estimate only, non-binding value)
  • Does the project / research require enrolment of patients with COVID-19?
  • If this project / research requires enrolment of patients with COVID-19, in what setting will this take place?
  • Which UK nations will be or are intended to be project locations?
  • Does your study include drug therapy? If yes, what is the name, dosage, number of doses and sample size?
  • Do you have the drug in stock? If yes, please indicate how many doses and who is your supplier?
  • Does your study require viral swabs?
  • Do you have viral swabs in stock? If yes, please indicate how many? Who is your supplier?
  • Does your study require kits?
  • Do you have the kits in stock, if yes, indicate how many? Who is your supplier?

UPH Designation scope

In Scope
The study must fall into one of the following categories:

  • Therapeutics
  • Vaccines
  • Diagnostics
  • Collection of samples and data from people undergoing treatment
  • Serious mental health problems such as suicide, self-harm and eating disorders

In addition, the study cannot happen without CRN resources eg:

  • Requires study-specific patient consent
  • Requires access to CRN services

Out of scope
The study does not fall into one of the categories listed above and/or can happen without CRN resources eg:

  • Pre-Clinical
  • Data Science using anonymised and pseudonymised data
  • Samples purchased from commercial organisations
  • Samples from diagnostic archives

UPH Designated study amendments

Studies that are already underway need to be assessed by the Urgent Public Health Group if they require support from NIHR CRN for the amended protocol.  Application for amendments can be submitted via the ‘short-form’ application process.  Please email covid19application@nihr.ac.uk for access to the form.

 

Eligibility

Eligibility for NIHR Clinical Research Network support

All studies, regardless of type, must:

  • Meet the definition of research (as outlined in the Department of Health and Social Care Eligibility Criteria) as follows:
    “Research can be defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This excludes: audit; needs assessments; quality improvement and other local service evaluations. It also excludes routine banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis.”
  • Have appropriate ethical approval; and Health Research Authority (HRA) approval where required
    • HRA Approval includes the provision of Schedule of Events Cost Attribution Tool (SoECAT) which has been authorised by the Lead CRN AcoRD Specialist
  • Have full research funding (i.e. funding to meet all Research Costs in compliance with the AcoRD guidance and outlined in a SoECAT completed with support from the Lead CRN AcoRD Specialist) from an eligible funding source

Please also refer to full details on Eligibility for NIHR Clinical Research Network Support