HRA Approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent Research Ethics Committee (REC) opinion provided through the UK Health Departments’ Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.
It does not mean that NHS organisations are required to participate in studies where they are named as potential sites, but it does mean that the decision to participate will be made on local consideration of capacity and capability to deliver the study alone. While HRA Approval is the single approval for research in the NHS in England, there is still the requirement for researchers to engage with sites and for sites to confirm that they have all the arrangements in place in order to participate in the study.
From 31 March 2016, HRA Approval is the process for applying for approvals for all project-based research in the NHS led from England. HRA Approval applies only to the NHS in England. Studies with sites in Northern Ireland, Scotland or Wales will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.
How to apply for HRA Approval
Applications for HRA Approval are made using IRAS, the Integrated Research Applications System, and are e-submitted directly to the HRA through IRAS. Study documents to sites will be provided directly from the sponsor for most study types.
The HRA website includes support on preparing study documentation as well as several e-Learning modules
As always, if you wish to undertake research at the East London NHS Foundation Trust, you should contact the team at noclor who will assist you.
Sponsors play a key role in the set up and delivery of studies – even when sometimes this is devolved to a Chief Investigator, a Clinical Trials Unit, a Contract Research Organisation, or study coordinator. The HRA expects applications for HRA Approval to be complete and of a high quality, and that the sponsor will work with participating organisations in a planned way to deliver the study.
Initial discussion with NHS organisation participating in research
Before finalising the IRAS form used to apply for HRA Approval, you are strongly advised to have preliminary discussions with potential participating organisations in order to understand if those organisations have the potential to participate. It is at this stage that potential participating organisations can assess their capacity and capability to participate in the study.
The minimum information that you should send to the potential participating organisation is the version of the protocol that will be submitted for HRA Approval. A list of R&D Contacts for all NHS organisations is available on the NHS R&D Forum website.
Only organisations that have agreed, by written confirmation (email) from the Research Office, that they might be able to participate in the study should be identified on Part C of the IRAS Form. It is sometimes the case that once a study has begun, additional participating organisations are identified and these can be added by amendment after HRA Approval.
Putting arrangements in place to deliver the study
Once an application for HRA Approval has been made and the HRA Initial Assessment letter (or HRA Approval Letter where no Initial Assessment letter needs to be issued) received, the Sponsor can work with participating NHS organisations to put the local arrangements in place to deliver the study.
The Sponsor/ CI/ Study Coordinator should supply the NHS organisation with the documentation submitted to (or approved by, depending on timing) the HRA, including the HRA Initial Assessment (or HRA Approval) Letter and the locally tailored draft agreement or statement of activities based on the template submitted to HRA, and proposed payments. These documents should be supplied electronically simultaneously to the local study delivery team and the research management function (at ELFT that’s noclor). In addition, if it is planned that researchers who are not employed by the participating organisation will deliver research activities locally, the applicant should work with the research office for the site to put HR arrangements in place in accordance with the HR Good Practice Resource Pack (Research Passport guidance).
Confirming that an NHS organisation will participate in a study
Once HRA Approval has been received, the Sponsor/CI/Study Coordinator submits the final unexecuted agreement ready for signature or finalised local statement of activities, based on the template submitted to the HRA to the participating NHS organisation.A person authorised by the participating NHS organisation (at ELFT confirmation must be issued via noclor) should provide confirmation as outlined in the HRA Approval letter that all the arrangements have been put in place to provide the capacity and capability to deliver a study. This will usually be by mutual agreement of the Statement of Activities or by signature of the template agreement – this will be made clear in the HRA Approval letter. The actual date at which the sponsor wishes to begin research activities at the site should have already been agreed and may be dependent on a site initiation visit or similar.
In limited exceptional cases, the HRA will be clear in the HRA Approval letter that some or all participating sites will not need to provide formal confirmation of the capacity and capability to deliver the study. However, it is still critical that you involve both the research office supporting each organisation and the local study team (where there is one), as the HRA expects the organisations’ research office to confirm by email to the CI and sponsor that the research may proceed. Remember, HRA Approval does not mean that NHS organisations will be required to participate in studies where they are named as potential sites.