CRN East Midlands Urgent Public Health Research Plan

Executive Summary

An urgent public health emergency, such as a new influenza pandemic could emerge at any time. Any pandemic could have the potential to cause widespread illness, large numbers of deaths and huge societal disruption, concentrated over a period of just a few weeks. 

This plan concentrates on the impact a public health emergency could have on the CRN East Midlands business, specifically the delivery of Portfolio research studies and the actions necessary to mitigate that impact.

As far as possible, the CRN East Midlands will focus on delivering ongoing research studies as normal, whilst also expediting urgent public health studies. It is likely that the number of people able and willing to participate in research will be severely reduced. Staffing numbers will also be reduced. Communication will be a key component throughout the emergency, both to internal and external stakeholders.

Introduction

This document covers the impact of a potential urgent public health emergency (such as a human pandemic) on the set-up and delivery of NIHR Portfolio research in the CRN East Midlands area. This plan is intended to complement each Partner Organisation’s (POs) policy and procedures for the management of a public health emergency. In the event of an urgent public health emergency, staff should follow guidance issued by the Department of Health and Social Care (DHSC) and  the UK Health Security Agency (UKHSA).

Definition of a pandemic

A pandemic is the worldwide spread of a disease, with outbreaks or epidemics occurring in many countries, and in most regions of the world. An influenza pandemic is likely to occur when the influenza virus undergoes a major change, and a new influenza virus emerges, which is markedly different to recently circulating strains, and to which people are not immune. A pandemic will occur if the new virus:

• infects people
• spreads from person to person
• causes illness in a high proportion of the people infected
• spreads widely

No-one knows when a pandemic will occur and once one arrives it is likely to spread throughout the country in a matter of weeks. It may come in two or more waves, several months apart. Each wave may last for two to three months.

There are currently no genetic markers that will predict the pathogenicity or spread in the human population. Until the virus emerges and has affected a large number of people, it is not possible to determine many of the features of the disease that will be important in assessing severity and impact. There is no known evidence of a link between transmissibility and severity. It is possible that a virus could be both highly transmissible and cause severe symptoms. 

Planning for a pandemic presents great challenges because it is impossible to predict its characteristics in advance, for example, whether it will be mild or severe, and whether it will have the most impact on the young, the elderly, or any other groups. Since the emergence of the SARS-CoV-2 virus and the subsequent pandemic, there have been some lessons learned and this updated plan reflects some of that learning.

Aims

The aims of this contingency plan are to:

• Provide accurate, timely and authoritative advice and information to staff
• Reduce the impact of an urgent public health emergency on CRN East Midlands 
• Minimise the disruption to the delivery of NIHR research studies across CRN East Midlands

• Expedite the approval of urgent public health studies through the Study Support Service process (commercial and non-commercial)
• Manage the impact of staff sickness and caring responsibilities during a pandemic

In the event of an urgent public health emergency (e.g. a pandemic) it will be imperative that the NIHR Clinical Research Networks are able to respond quickly to initiate, deliver and report on research studies related to the emergency. 

The Network has a nominated Urgent Public Health Champion, Dr Martin Wiselka, Consultant in Infectious Diseases, University Hospitals Leicester NHS Trust. Please see Appendix 1: Role Outline, Urgent Public Health Champion. 

The Clinical Research Network’s UPH Research Response will be activated at the request of the Department of Health and Social Care as outlined in the ‘NIHR CRN Urgent Public Health Research Response’ document (CSP091). Studies on the portfolio with a “suspended” status may be reopened in response to an urgent public health emergency. Following notification of reopening, these studies will pass through the UPH review processes as set out in CSP091. Studies already included in the portfolio may be repurposed to meet the research needs of urgent public health emergencies. 

Following notification by the UPH Review Group that a study will be re-purposed, a meeting should be established as soon as possible with the study team or company contact, Lead LCRN, and NIHR CRNCC Research Delivery team to discuss the changes to the existing study protocol. This guidance should be followed in line with the requirements of the study team or company contact. Such studies should be subject to the same oversight as all new UPH studies.

Urgent Public Health Advisory Team for CRN East Midlands

The Urgent Public Health Advisory Team is established to provide general advice from a  senior level and can be contacted for the escalation of any issues relating to an urgent public health emergency.

Urgent Public Health Operational Response Group for CRN East Midlands

In the event of an urgent public health emergency, a network operational group will be convened to coordinate CRN East Midlands’ response. The terms of reference for this group are attached at Appendix 3. Members of the group* may include: 

• Urgent Public Health Champion
• Public Health Specialty Lead 
• Division 6 Co-Clinical Research Leads 
• Clinical Director/Deputy Clinical Directors, CRN East Midlands 
• Chief Operating Officer/Deputy Chief Operating Officer, CRN East Midlands
• Research Delivery Managers 
• Communication and Engagement Lead, CRN East Midlands
• Representative, Primary Care (RDM/CRL and/or SL)
• SG lead of relevant SG if emergency/outbreak occurs 
• Representative from Study Support Service
• Administrator, CRN East Midlands 

*Possible suggestions

Staff Absence

The major risk to CRN East Midlands is significant and ongoing staff absence, both within the centrally based teams and across research delivery teams within NHS Trusts. Staff may be absent from work if:

• they are ill because of the pandemic/public health emergency or are required to self-isolate
• they need to care for children or other family members
• they have medical problems
• Host organisations are utilising staff in a clinical and/or service delivery capacity

In the event of a pandemic, staff absence is likely to follow the pandemic profile. In a widespread and severe pandemic, affecting 50% of the population, between 15-20% of staff, or more, may be absent on any given day. These levels would likely remain constant for quite some time, often weeks or months and then decline. Teams where staff work in close proximity are likely to suffer from higher absence rates. In a widespread and severe pandemic, 30-35% of staff, or more, in smaller teams may be absent on any given day. Additional staff absences will result from the other factors described above, particularly the need to care for family members. 

If staff are required to shield in line with national guidance, will work with their employing organisation to support appropriate working arrangements.

In a major pandemic, all services are likely to be affected. Fuel shortages may make it difficult for staff to travel to work, and public transport provision will also be reduced.

Expedited Procedures and Contingency Plans for the Rapid Set Up of Research

With respect to research set-up and delivery, the aim of the CRN East Midlands Central Team during an urgent public health emergency will be to:

• ensure rapid feasibility and set-up of urgent public health research studies
• provide cross-cover to maintain business as usual activities
• provide support and advice to research staff based across Partner Organisations

It may be appropriate to establish dedicated teams to coordinate the response to the urgent public health emergency. This could include a team to focus on urgent public health research studies and a team to maintain CRN business as usual activities and other non-UPH priorities.

CRN East Midlands will work with Partner Organisations and other stakeholders to ensure essential business processes can be maintained, including support with major staff absence. Please refer to CRN EM Business Continuity Plan to support this.

Specifically within primary care, this would mean working with independent contractors and potentially local authorities to understand and agree business continuity from a research delivery perspective, including but not limited to, impact of staff absences on research delivery at any given site, mobilisation of alternative staff, and depending on severity of the pandemic, availability of patient cohort within any given practices to recruit swiftly into studies. Consideration should be given to joint working with local health resilience forums and NHS England to consider alternative space where patients/community may be held, i.e. school halls, community leisure centres etc. which may provide a suitable and appropriate place for patient/participant recruitment to take place.

Study Support Service (SSS) Team

It is important to ensure continued provision of the Study Support Service during an urgent public health emergency. The key priority area will be ensuring that urgent public health studies are prioritised and set-up is expedited paying particular attention to capacity and facilities to deliver. 

If necessary, priority will be given to studies open to recruitment and those of an observational nature over new Site Initiation/Site Selection Visits with the exception of where the study is a new urgent public health study. 

It must be made clear to research teams that the priority is to ensure patients enrolled in CTIMPs with regular dosing or scanning visits are able to attend as usual or ensure alternative methods of completing study visits such as online appointments or home visits as necessary. This may mean delays in the set-up and recruitment for other studies and potentially studies being paused.

Providing continuity of service

CRN East Midlands works in partnership with our Partner organisations and stakeholders in the processing of setting up studies. 

Services can be extended from the CRN East Midlands network office during an urgent public health emergency if staffing within a particular Partner organisation is affected. The Study Support Service provides consistency in its application across all healthcare sectors, so it is possible to redeploy staff regardless of their employing organisation, ensuring that cross cover can be provided when necessary. This may be in the form of a physical presence or  virtual support.

Expediting Pandemic Studies

CRN East Midlands will prioritise the set up of any NIHR CRN urgent public health studies in all sites, for both commercial and non-commercial sponsors.  Where East Midlands is the Lead LCRN, there will be early discussions around potential new studies with Chief Investigators and study coordinators to ensure timely set-up and implementation.

In line with the national procedure, CRN East Midlands will prioritise supporting the set up of any pandemic-related study for which it is the network acting in the capacity of Lead Network supporting the Chief Investigator. The NIHR CRN Urgent Public Health Research Response document (CSP091) is available through the NIHR CRN Contract Support Pages website, which is published by the CRN Coordinating Centre.

SSS Team Delegation

There are no major changes from the standard feasibility and set-up processes for commercial studies, except that the turnaround time is much shorter. The CRN Coordinating Centre will lead an expedited process and advise on appropriate timelines for individual studies. 

The need for rapid turnaround will be clearly communicated to research teams and departments. Teams should be made aware of the need to carefully consider their capacity to take on pandemic studies at a time of greater clinical pressures.

Research Delivery Support

Direct Delivery Team (DDT)

Requests for support from the CRN East Midlands Direct DeliveryTeam for urgent public health studies should be made using this form. The request should include details of the requirements of support and where the study is being conducted to ensure a rapid response.

In the instance that this plan is triggered and specifically if DDT staff are asked to work in the case of an urgent public health emergency, an additional risk assessment step (in line with host policy) will be conducted to consider the importance/relevance of any given study at this time, any additional risks at particular sites, competing priorities (e.g. clinical redeployment by Host) and the DDT individual staff members circumstances, e.g. own health, caring responsibilities etc. Where there are competing priorities for a finite resource, a final decision will be made by CRN East Midlands Chief Operating Officer. Additionally, CRN East Midlands reserves the right to recall DDT staff from existing placements in order to support UPH research or other priority areas.

Redeployment of Trust-based research staff to clinical and other supporting areas

If an urgent public health emergency causes sufficient staff absence that there is a shortage of clinical staff to provide essential care for patients, all Trust staff, both clinical and non-clinical, may be required to provide a level of cover as required to maintain essential services, and commensurate with their skills and experience.

Decisions about the redeployment of Trust-based staff will be made in accordance with national guidance by their line managers and the R&D/I Department, in line with requirements of the clinical service. Provision must be made for those patients who are enrolled on research studies with regular dosing or scanning visits. 

Staff should be provided with appropriate training for the duties they are asked to undertake, and allowed to return to their research duties as soon as possible. 

Trusts will be required to provide regular updates to the CRN in the event that CRN-funded staff are diverted to non-research activity (over and above in response to a short incident, e.g. 1-2 days).

Cross cover across research teams

There should be sufficient flexibility within research support teams to provide cross cover for studies in the event of staff absence. The management of ongoing research studies should be a priority, particularly where research visits are time critical.

Redeployment of CRN East Midlands Central Team staff to clinical and supporting areas

If the urgent public health emergency reaches maximum severity, any suitably qualified member of staff, including the CRN East Midlands Central Team could be asked to provide support within clinical areas. An appropriate risk assessment would always take place prior to this change in support.

Workers at direct risk

Pregnant people and staff with compromised immune systems or staff who are required to shield should be considered for work duties away from direct patient care for the duration of the pandemic. This must be agreed by the line manager and staff member, with Occupational Health involvement as appropriate and in line with local policies and procedures including the undertaking of risk assessments as appropriate. 

A pandemic vaccine i.e. influenza, would likely be available four to six months after a pandemic emerges. Front-line health workers, which should include research nurses and other delivery staff, will be prioritised for vaccination.

Suspension of open studies

Recruitment to some open studies may need to be put on hold due to lack of PI, nursing or clinical support service staffing. Priority will be given to CTIMPs with time-critical dosing or scanning visits and new urgent public health studies. Decisions on the suspension of open studies must be taken by the Principal Investigator at the site in discussion with the Sponsor and the R&D Department.  The only variation to this, is if there is a central decision by the NIHR, Funders, Sponsors or DHSC; in which case the CRN will work within these parameters.

Decisions about the suspension of studies may be very difficult and must be taken in an open and transparent way. Study suspension must be quickly and clearly communicated to participants.

CRN East Midlands Central Teams

Sickness Absence

Staff should report sickness absence following UHL or the Employing Organisation’s policy, contacting their line manager by telephone. It should be clear to staff who they can contact if their line manager is also off sick, in broad terms it would be the next available manager. In the event the Urgent Public Health Research Delivery Plan is activated, each line manager (or if they are absent, the next available manager) will update the ‘Business Continuity Staff Dashboard’ in accordance with the process defined in CRN EM Business Continuity Plan, please refer to this plan for details.

Line managers should be flexible in managing ongoing workload around sickness absence. Regular Managers’ & Team Meetings should take place throughout the urgent public health emergency to manage the ongoing situation.

Office Closure

If there is significant sickness absence, a decision may be made to close one or both of the central offices located at the LRI and QMC, or other CRN office bases. Guidance on how this should be managed is set out in CRN East Midlands Business Continuity Plan.

CRN East Midlands managers and deputies

If line managers are off sick, staff should either refer to the most senior manager in their team or, if they are also unavailable, to any other manager.

Communications

During an urgent public health emergency, communication will be a key component, both to internal and external stakeholders.

The CRN network supported workforce will be notified of this strategy via appropriate management structures locally and plans established to enable staff to engage in supporting delivery of urgent public health studies if the need arises. It will be emphasised that there may be a need for cross partner organisational working. 

Regular communications (such as a weekly meeting and/or a bulletin) will be used to keep Partner Organisations updated on key issues pertaining to the urgent public health emergency and any actions needed. This may also include provision of out-of-hours contact details for CRN management staff in case urgent contact is needed.

It may also be appropriate to set up regular response meetings with CRN East Midlands Central Team to provide updates on the urgent public health emergency and any actions required.

A key contacts list (Appendix 2) will be agreed and maintained by the CRN East Midlands in collaboration with R&D departments. This will identify individuals within each Partner Organisation who have a working knowledge of urgent public health studies currently on the NIHR Portfolio and understand their role in the effective delivery of these studies locally.

Efforts will be made early to engage with public health directorates within local authorities and the regional UKHSA team to ensure the cross organisational working (contact details are provided in Appendix 2).

Collaboration and integration

The communication section outlines the lines of communication that will be implemented in an emergency – being led by the NHS response as a whole and determining what resource would be needed to support urgent work and adapting our resource in accordance with our priorities.

This emergency plan will be integrated into other local plans e.g. other Partner Organisations and with the higher level DHSC, NHS England and NIHR plans. Thus the plan is not set in stone, it may have to be adapted according to the scale and duration of the emergency. It will also need to be implemented in line with other different types of emergency plans.

Appendix 1: Role Outline - Urgent Public Health Champion

Background

The National Institute for Health and Care Research (NIHR) CRN is preparing systems for rapid set-up of research into, and investigation of, unexpected and severe infections that have the potential to cause disease widely amongst the UK population. The most likely occurrence is a severe acute respiratory infection (SARI) such as MERS (Middle East Respiratory Syndrome), but the Network can equally respond to other potentially severe outbreaks such as the recent epidemics of botulism amongst intravenous drug users. Contract support is available via the LCRN Contract Support documents, on urgent public health1. Each LCRN should ensure they have an active clinical investigator to be the network’s urgent public health champion.

The champion:

• should have experience of recruitment of patients to NIHR CRN Portfolio studies.
• must be willing and able to coordinate recruitment of patients from a range of medical settings to urgent public health studies.
• should ensure they link with other relevant Specialties within the Network including: Infection; Respiratory Disorders; Injuries and Emergencies; Critical Care; Primary Care and Children.

Responsibilities

1. The champion will:

• support the development and on-going review of the LCRN Urgent Public Health Plan by providing clinical leadership and oversight.
• support activities associated with the development of the LCRN Urgent Public Health Plan including training needs, discussions with local Trusts, raising awareness amongst local researchers.
• respond to national calls for sites to recruit patients to nationally coordinated urgent public health studies. Such studies will likely be organised rapidly in response to an emerging epidemic or pandemic. In the event that cases of the disease in question emerge amongst patients at all relevant local medical units under the umbrella of the LCRN, the champion will be required to work with the LCRN on feasibility and preparation of local capacity.
• act as a key link between the national CRN Coordinating Centre, LCRN, research teams and Specialty members feeding back challenges and developing solutions.

    2. In the event of an urgent public health emergency where there is an associated nationally coordinated research programme, the champion will familiarise him/herself with emerging investigational protocols coordinated through the LCRN and support activities associated with rapid set up and delivery.

Travel and reasonable expenses will be provided by the LCRN in which the champion is based.

1 See Contract support document: 'CSP091: NIHR CRN Urgent Public Health Research Response

Appendix 2: Contact list of key R&D personnel in Partner Organisations and other stakeholders

Key contacts list of CRN East Midlands staff

East Midlands Directors of Public Health

UKHSA East Midlands Health Protection team

This team covers:

• Derby City
• Derbyshire County
• Nottingham City
• Nottinghamshire County
• Leicester City
• Leicestershire County
• Lincoln
• Lincolnshire County
• Rutland

Contact:

East Midlands HPT

UK Health Security Agency

Seaton House, City Link

Nottingham

NG2 4LA

Telephone: 0344 2254 524 (option 1)

Out of hours advice: 0344 2254 524

Email: emhpt@ukhsa.gov.uk 

Email for personal identifiable information (PII): phe.emhpt@nhs.net

Appendix 3: Terms of Reference for Urgent Public Health Operational Response Group

Aim

This Group will be convened in the event CRN East Midlands Urgent Public Health Plan is activated. The aim of the group is to plan and coordinate CRN East Midlands’ response to an urgent public health emergency.

Remit

The group will:

• Review urgent public health studies, including current and new studies with discussion of any issues/concerns;
• Review study pipeline for information and any actions needed;
• Discuss reports of any regional impact on research as a result of the urgent public health emergency, including the process for notifying the CRN Coordinating Centre of local issues;
• Discuss impact on primary care and any actions needed;
• Discuss communications approach, including communication to/from the CRN Coordinating Centre, partners and staff; 
• Discuss and review any actions required as part of the Business Continuity Plan; 
• Be a route for resolving any queries, or further escalation as necessary;
• This group can also be used for the purpose of reviewing the urgent public health plan

Composition of the group

Members of the group* may include: 

• Urgent Public Health Champion 
• Division 6 Co-Clinical Research Leads
• Clinical Director/Deputy Clinical Directors, CRN East Midlands 
• Chief Operating Officer/Deputy Chief Operating Officer, CRN East Midlands
• Research Delivery Managers Division 3, 5 and 6 
• Communication and Engagement Lead, CRN East Midlands
• Representative, Primary Care (CRL and /or SL)
• SG lead of relevant SG if emergency/outbreak occurs 
• Representative from Study Support Service
• Administrator, CRN East Midlands

Chair

The chair will be nominated when this group is established and can be revised as needed. This would likely be the Clinical Director, Chief Operating Officer, Deputy Chief Operating Officer or Urgent Public Health Plan Lead, although could be other members of staff as appropriate.

Reporting

An agenda and a summary of agreed actions will be documented for each meeting.

Notes and documents pertaining to the group will be saved on the Urgent Public Health Team Drive on the NIHR Hub.

Meeting form and frequency

Meetings will likely take place regularly during an urgent public health emergency and frequency can be adapted as needed to manage the ongoing situation. Meetings can be conducted by video/teleconferencing where appropriate.

Review date

These terms of reference will be reviewed as and when required to ensure they are fit for purpose.