HRA approval implementation

The two main points to be aware of are:

1. HRA approval will be the process for applying for all research projects in the NHS led from England

Research applications will still be done via the existing Integrated Research Application System (IRAS). Applicants should select the HRA approval option in the project filter using the IRAS Form that will automatically provide a combined application for HRA Assessment and NHS REC review (where REC review is required).

The HRA assessment verifies the information and documentation submitted by the sponsor and confirms these are of good quality. This means that the HRA will issue HRA Approval for the NHS organisations in England to provide assurance that the study is legally compliant.

The sponsorship review for studies at UCL and UCLH has therefore been adapted to ensure studies meet these requirements.

For studies submitted to the JRO, click here to access information and tools to help prepare your study.

If your study is managed via a UCL Clinical Trials Unit contact the unit for advice.

2: NHS permission is replaced with a confirmation of Capacity and Capability

Sponsors will no longer submit SSI forms. Instead core documents and schedules of funding and activity are provided.to sites. The site must assess if they have the capacity and capabilities to take part in the study (feasibility).

At UCLH, the JRO will work closely with Principal Investigators, relevant divisions and service departments to support this process. In some cases, approved feasibility units at UCLH will lead on feasibility assessments, supported by the JRO for costing and contracting.

Further information on the key submission documents to initiate these procedures can be found on the JRO website.

A local feasibility assessment conducted at UCLH will cover the following guidance from the HRA:

Assess: assessing whether or not the NHS organisation has the capacity and capability to participate in the study

Arrange: putting practical arrangements in place to provide the capacity and capability to deliver the study

Confirm: confirming that the NHS organisation has the capacity and capability in place to deliver the study and will deliver it. The confirmation is given through a formal agreement or a statement of activities.

UCLH will include the necessary requirements for Assess, Arrange and Confirm (feasibility) as outlined by the HRA in their guidance to host organisations and the CRN Principles Framework for Local Capacity and Capability.

Feasibility at UCLH will include the above points within a feasibility assessment alongside all other relevant, local criteria which is deemed to be required by the trust's divisions or directorate.

The JRO will provide the necessary SOPs, templates and guidance documents relevant to conducting a feasibility assessment at UCLH.

On completion on Feasibility the JRO will confirm the decision to deliver the study to the sponsor and research teams.

The JRO is running a number of drop-in sessions for investigators submitting studies via UCL/UCLH for sponsorship or via UCLH for host approval. R&D staff will be on hand during these sessions to talk through how each study should be managed.

Contact JRO.Communications@uclh.nhs.uk or 0203 447 2178 if you plan to attend one of the sessions below.

10.30am-12pm, Tuesday 5 April

10.30am-12pm, Tuesday 12 April

10am-12pm, Thursday 7 April

10am-12pm, Thursday 14 April

All at Maple House, Suite 1B, 149 Tottenham Court Road, London W1T 7DN