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Study authorisation and review update – important information for researchers

The Joint Research Office (JRO) are handling an unprecedented number of queries, applications and contracts. 

Capacity to support the numbers of requests is very stretched.

As a result, the speed of throughput and response to queries are being affected.

The key pressures:

  • High numbers of studies requesting authorisations to restart following the suspension of activities during the first wave of Covid-19 (sponsored and hosted studies)
  • High numbers of pipeline studies (that were ready to start but unable to do so due to the first Covid-19 wave) for which grant and other milestones require a rapid initiation 
  • Requirement for additional and detailed assessments of the viability of the study including infection control measures for Sponsors and each participating NHS site (the JRO acts both on behalf of UCL and UCLH sponsor and UCLH NHS site) 
  • Rapid approval of Urgent Public Health studies (UPH) 
  • Brexit planning and associated national GDPR and privacy shield rulings (high volume) 
  • Staff absence

To help manage priorities (for the JRO, clinical support, research staff) we request researchers:

  • only apply to restart or initiate studies where it is currently viable and safe to do so (sites are receiving applications, research staff are in place, participants are available and covid-19 measures have been considered)
  • refer to the JRO and HRA websites (rather than email) to resolve general queries or where  templates are required
  • approach the JRO in good time for grant authorisations - at least 8 weeks for clinical trials and 3 weeks for all other studies
  • approach the JRO in good time for Sponsor or UCLH authorisations and reviews 
  • provide as much information and completed documentation as possible when requesting a study review, costing, agreement or grant application 
  • unless the matter is urgent, avoid sending chaser emails - all emails will be addressed but it may take longer than usual to receive a response 

During periods of limited capacity, and where Covid measures require, there may be a need to implement a prioritisation framework for managing reviews within the JRO. 

Where it is required, priority will be applied in accordance with DHSC guidance:

Level 1: Essential studies providing evidence for pandemic management, i.e. nationally prioritised COVID-19 Urgent Public Health (UPH) Research studies.

Level 2: Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient.

Level 3: All other studies (including new COVID-19 studies not in Level 1).

The JRO will also continue to receive all other types of study but these will be treated as level 4 priority and therefore likely to be subject to delay in responses

This priorisation framework is currently in place for new Hosted Studies (studies approved to start at UCLH)  grants and sponsorship applications (December 2020) and will be reviewed at the end of February 2021.