This page explains how NHS organisations, which may be selected to participate in studies, are expected to work with sponsors/CIs in order to host research studies.
Sections on this page:
- HRA Approval
- HRA Approval: HRA’s review process
- Initial discussions with NHS organisations participating in research
- NHS organisations acting as host organisations for research delivery
- Putting arrangements in place to deliver the study
- Confirming that an NHS organisation will participate in a study
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 REC opinion provided through the UK research ethics service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England.
This allows these participating NHS organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study. Please refer to HRA Approval programme information for more details. 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. .
We have provided clarity on the HRA terminology on assessing, arranging and confirming capacity and capability at the local level [Internal link].
For details of our review process for HRA Approval, NHS organisations can refer to:
- HRA Approval: the new process for the NHS in England [Internal link]
- The HRA assessment criteria and standards document [Internal link]
Our guidance to applicants strongly advises preliminary discussions with potential participating NHS organisations before finalising the application for HRA Approval so that the organisations can assess their capacity and capability to participate in the study. The minimum information that the applicant is expected to send to the potential participating NHS organisation is the version of the protocol that will be submitted for HRA Approval.
Some sponsors may require a formal assessment phase and may undertake a site selection visit to determine if the organisation will be invited to participate in the study.
Organisations that have agreed that they might be able to participate in the study before the application for HRA Approval is submitted should be identified on Part C of the IRAS Form.
Where additional participating NHS organisations are identified once HRA Approval has been given then the applicant will add these through the appropriate notification of amendments process.
Sponsors/CIs of studies applying for HRA Approval and NHS organisations are expected to work collaboratively so that the participating NHS organisations can confirm that arrangements are in place, that they have the capacity and capability to deliver the study, and that they are ready to start the study.
In limited exceptional cases, the HRA will be clear in the HRA Approval letter that some or all participating NHS sites in England will not need to provide formal confirmation of the capacity and capability [internal link] to deliver the study, because the participating NHS organisation is expected to take part in the study, unless it specifically declares that it will not. In such circumstances, unless the participating organisation requests additional time, or opts out of the study, it will normally be assumed to have confirmed participation in the study within the timescale indicated in the HRA Initial Assessment letter or Approval letter. NHS organisations should adhere to the information provided in the HRA Initial Assessment or HRA Approval letter.
The sponsor/CI is responsible for providing study documents simultaneously to study delivery teams and research management functions supporting participating NHS organisations (and to the Local Clinical Research Network, where applicable), in order to facilitate study set-up and conduct. NHS organisations and Local Clinical Research Networks should ensure that contact details are kept up to date on the NHS R&D Forum website. [external link]
Once the applicant has made an application for HRA Approval and has received the HRA Initial Assessment letter (or HRA Approval Letter where no Initial Assessment letter needs to be issued), they can work with participating NHS organisations to put the local arrangements in place to deliver the study.
Some applicants may choose to set up sites after HRA Approval if that suits their study delivery plan better. It is for the sponsor/ chief investigator to determine the timetable and plan for setting up sites.
HRA Approval uses a new local information pack for NHS participating organisations in England.
NHS organisations in England should expect the applicant to send the following local document package simultaneously to the study delivery team and the research management team supporting them (and to the Local Clinical Research Network, where applicable) once they have received the HRA Initial Assessment letter (or HRA Approval Letter where no Initial Assessment letter is issued):
- Copy of IRAS Form (combined REC and R&D form) as submitted for HRA Approval
- Any amendments
- Participant information and consent documents
- Statement of Activity relevant to the participating NHS organisation (non-commercially sponsored only) or delegation log (commercially sponsored only)
- Relevant template contract/model agreement (if needed in addition to Statement of Activity)
- Costing template (commercially sponsored only) or Schedule of Events (non-commercially sponsored only)
- Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study
- Copy of HRA Initial Assessment letter (if one is issued) and (when issued) HRA Approval letter and final document versions
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 management function for the site to put HR arrangements in place in accordance with the HR Good Practice Resource Pack (Research Passport guidance) [external link].
The HRA Initial Assessment or HRA Approval Letter will provide information relevant to study set up. Any cost negotiations that are required can be finalised at this stage.
For English sites there is no requirement for an NHS SSI Form to be submitted to the R&D office for HRA Approval studies.
Once all the arrangements have been put in place to provide the capacity and capability to deliver a study and HRA Approval is in place, the participating NHS organisation can confirm this to the sponsor to begin the study. The actual date at which the sponsor wishes to start research activities at the site should have already been agreed and may be dependent on a site initiation visit or similar.
Participating NHS organisations in England should provide confirmation as outlined in the HRA Approval letter. 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 HRA has provided an example template of the email with which an organisation may wish to confirm capacity and capability with the sponsor. The HRA expect such emails to be short and to the point, use the IRAS number as the study identifier, and have attached the relevant confirmed agreement/Statement of Activities (as described in the HRA Approval Letter).
Support from regional Change Leads was available for NHS organisations during the implementation of HRA Approval. Now that HRA Approval has been implemented, we will continue to be in touch with NHS organisations through identified change contacts in each NHS R&D office. Please contact the HRA Approval Programme Team at firstname.lastname@example.org if you need more support for your organisation.
< HRA Approval: NHS organisation guidance; version 4.0, dated 14 April 2016 >