HRA Approval cohort 4 confirmed

Last updated on 28 Jan 2016

Implementation of HRA Approval continues, with the third cohort of studies incorporating all study types which exclude the first four categories of IRAS from 30 November 2015. This extends HRA Approval to a broad range of studies other than clinical trials or clinical investigations taking place in secondary care in the NHS. Early studies for this cohort have included cross-border studies with the devolved administrations, managed through compatible arrangements between the nations.

The plans for cohort 4 (clinical trials and clinical investigations in secondary care) are confirmed and, by the end of March 2016, HRA Approval will be the route for submission and Approval in England, and CSP will be closed for all new applications. The continued commitments of the HRA and the Devolved Administrations to UK wide compatibility mean that, from the end of March 2016, the combined form on IRAS will be adopted UK wide and a new format for site information will be provided for the UK. For commercial studies, the local information will be significantly reduced and there will be no requirement to submit SSI forms. The HRA will continue to test suitable formats for site information for all study types.

All countries are keen to encourage applicants to use HRA Approval where the study is led in England, including studies with sites in the other countries. This includes cohort 4 type studies where applicants and sponsors are ready to move across to the new ways of working before the final switch over at the end March. It is particularly important that we are able to test the cross border processes fully now. All cohort 1, 2 and 3 types should already be using HRA Approval in England. We already have studies coming through with sites across the UK.

The HRA has been listening to feedback on the handling of non-commercial single site studies taking place in the NHS in England where that organisation is also the study sponsor, to ensure that we implement a proportionate approach for HRA Approval. We can now confirm that these studies (which we have called cohort 5) will be included in HRA Approval, but a reduced site information set will be used because we would expect the NHS organisation to be addressing its own requirements as a site while setting up the study. Where the sponsor decides to add an additional participating organisation, the full site information document set will be required alongside the amendment notification in order to support confirmation of capacity and capability at the additional participating organisation(s). These studies will be accepted for HRA Approval by the end of March, in line with the roll out of HRA Approval. We are continuing to collect views on appropriate ways of managing studies solely for educational purposes.

Provision of training for industry stakeholders is underway. Following input on the training package from the Association for the British Pharmaceutical Industry (ABPI) commercial Clinical Operations Group (cCOG), a workshop with the Ethical Medicines Industry Group (EMIG) has taken place, with further workshops scheduled in January and February with the ABPI, the Institute for Clinical Research (ICR) and the Contract Clinical Research Association (CCRA). Our regional change leads continue to support NHS organisations and their local partners, including universities, in implementing new systems so that they are able to support and advise researchers.

HRA closely monitors the progress of studies through HRA Approval, to ensure learning is incorporated at each stage. A total of 107 studies have been received (as of 11 January), with HRA Approval being issued to 62. At this stage, due to the definitions of the early cohorts, the majority of studies are those not requiring Research Ethics Committee (REC) review or those eligible for proportionate REC review, and the median time from application to approval (without any clock stop) is 16 calendar days. As more studies which require full REC review come under HRA Approval, this timeline is expected to extend, as HRA Approval will not be issued until the REC process is complete (including confirmation that any REC required conditions have been met).

Revisions have been made to processes and to the format of template documents in response to feedback during the cohorts. We continue to welcome feedback to

Guidance for applicants is provided in IRAS.

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