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Full implementation of HRA Approval

HRA Approval is now implemented for all study types and from 31 March will be the route for the approval of all NHS based research projects in England.

This newsletter provides information and updates on how this affects your study and the support that is available to NHS organisations as part of the changes.

As always we value your feedback and encourage you to get in touch with any questions or comments.

 
 

HRA Latest Volume 19


Contents


 
 UK Policy Framework consultation - closing soon!
 
There’s only a week to go until the public consultation on the new UK Policy Framework for Health and Social Care research closes. The deadline for responses is Thursday 24 March.

The policy framework sets out principles of good practice in the management and conduct of health and social care research. When finalised, it will replace the Research Governance Frameworks currently issued by the four UK health departments.

Anyone can respond to the consultation and we look forward to receiving your comments. Please also remind your colleagues and organisational partners about the opportunity to feed in their views.

The consultation document and details of how to respond are all on the HRA website and are also accessible through our website homepage.

 
HRA Approval: application process for new studies 

From 31 March 2016, HRA Approval will be the process for applying for approvals for all research projects in the NHS led from England. Applicants should select the option in the project filter for applying to HRA Approval using the combined IRAS Form that will automatically provide a combined application for HRA Assessment and NHS REC review (where REC review is required), instead of separate REC and R&D application forms.

Existing systems for applying to the NIHR Coordinated System for gaining NHS Permission (CSP) will close before the end of March.

Applicants are recommended to review the guidance on the HRA website and check the updates to IRAS. If the study has sites in Northern Ireland, Scotland or Wales, the HRA will share information with the relevant national coordinating functions to retain existing compatibility arrangements.

If you have already started preparing applications in IRAS but not yet submitted, you can easily convert your separate forms to a combined IRAS form. Check the guidance in IRAS for details.

Any studies led from Northern Ireland, Scotland or Wales continue to apply using the existing systems in each nation. If there are English sites in the study, the national R&D coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.

The ethical review of all studies will continue to be undertaken in accordance with the UK Standard Operating procedures.
HRA Approval: new NHS sites in England for all studies

From 31 March, all studies that have started or completed existing approvals processes but want to set up new NHS sites in England will need to complete the set-up through HRA Approval systems.

This does not mean that the study has to start again and apply for HRA Approval: actions already completed in existing systems will be accepted. Moving all new and existing studies to the same system from 31 March means that there will be a single system for setting up NHS sites in England.

Any applications (R&D or SSI) that have already been submitted to the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) before the closure of applications, or submitted individually to NHS R&D in England (for non-portfolio studies) will complete their review and the outcome notified in accordance with the previous system. The review does not need to be completed before the end of March. Applicants should note the dates for last submissions as below:
  • The last date for submission of R&D applications to the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) is 23 March, and for SSI applications is 29 March 2016. The review of these applications may continue beyond the end of March in CSP. These dates have been agreed between the NIHR CRN, the HRA and the devolved administrations.
  • Non-portfolio studies may make applications to sites up until 30 March 2016 and NHS organisations should continue to process them using their pre-HRA Approval system for non-portfolio studies.
After 31 March, if an application for an NHS participating organisation in England has not yet been submitted for review under previous systems, it will be set up in accordance with the HRA Approval site level processes. This means that the HRA will issue HRA Approval for the NHS organisations in England to provide assurance that the study is legally compliant, and the NHS organisation can then assess, arrange and confirm its capacity and capability to take part in the study.

Applicants should provide the HRA with the current document set for the study, including any template agreements/ contracts and costing information. For non-commercial studies this includes the Statement of Activities and Schedule of Events. Where the study already has NHS permission or has applied for CSP study-wide review, the HRA will bring the study under HRA Approval and list the approved versions of documents for the sites in its approval letter. For studies that have already made an application to REC but not yet made any R&D application, the HRA will complete a full HRA assessment.

For all studies brought under HRA Approval, sponsors should provide the HRA Approval local package to English NHS sites (ie the local research team, the R&D office (and the LCRN, where appropriate)).

Applicants are recommended to review the guidance on the HRA website.
HRA Approval: amendments for the NHS in England for all studies

From 31 March, amendments for all English-led studies taking place in the NHS will be categorised on behalf of the NHS by the HRA in line with the UK Process for Handling UK Study Amendments. Amendments should no longer be submitted to NIHR CSP. The UK NHS categorisation process provides information to NHS sites about whether the amendment may require consideration prior to implementation, and is in addition to the definition of substantial or non-substantial for regulatory purposes. For studies led in England:
  • Applicants only need to submit substantial amendments to the relevant NHS REC (where REC review is required for the study type). They will also be accessed by the HRA Assessment Team for categorisation and the category communicated to the applicant.
  • Other amendments which do not need to be submitted to an NHS REC should be sent to hra.amendments@nhs.net. They will be categorised by the HRA Assessment Team and the category communicated to the applicant.
 It is the applicant’s responsibility to communicate the categorisation and the amendment to English sites (ie the local research team, the R&D office (and the LCRN, where appropriate).

There is no change to the R&D handling of amendments for studies led from Northern Ireland, Scotland and Wales. These should continue to be submitted to the relevant permissions coordinating function to be categorised and will then be shared with other participating nations.

The amendments section of the applicant guidance on the HRA website and in IRAS will be updated when the change comes into force.
HRA Approval: Radiation and Pharmacy Technical Assurances

Plans for technical assurance roll out will be published in due course, once the arrangements for reviewers across the NHS are in place.

HRA Approval studies should continue to use existing arrangements for radiation authorisations and existing local pharmacy set-up arrangements until technical assurances are available to a wider range of studies. Studies using the Experimental Cancer Medicine Centres will continue to use the technical assurances.
HRA Approval: Support for change across NHS organisations
 
Regional HRA Approval Change Leads have been working with NHS organisations since October 2014 to support and prepare for the changes to local processes that HRA Approval introduces. We would like to thank all the Change Leads who have worked on our behalf in supporting their NHS R&D management colleagues and others to think about and plan for a new way of working, as they now return to their other roles.

We recognise that we are now moving from preparing for change to embedding the change across NHS organisations and will support this activity in the following ways:
  • Continuing to use the HRA Approval change contacts in individual NHS organisations in England as a key point for communication
  • Supporting regional events, where invited, to embed change and listen to feedback
  • Providing support to HEI and NHS sponsors with regional training sessions
  • Publishing e-learning on HRA Approval in early April 2016
  • Making leaflets and other training materials available on the HRA website so that NHS R&D management staff can support researchers in their own and partner HEI organisations.
We continue to encourage feedback to hra.approvalprogramme@nhs.net
NHS R&D Forum Annual Conference in association with the HRA
 
The NHS R&D Forum Annual Conference will bring together more than 400 R&D management professionals for one of the largest national gatherings of its kind.

This is the third year that the conference will be delivered in association with the HRA – taking place on Monday 23 and Tuesday 24 May 2016 in Stratford-Upon-Avon.

The HRA will be sharing updates on key developments in our work in specifically designed sessions including:
  • Progress on the HRA UK Policy Framework for the conduct and management of health and social care research
  • Information on HRA Approval – operational updates, early experiences and lessons learnt so far.
  • Update on the HRA and information governance
Visit the conference website to find out more about the event and book your place. For all event enquires please call 0845 519 4230 or email.
HRA Annual Website Survey
 
We are committed to listening to the feedback and experiences of those who use our services so that we can continue to respond and improve.

Over the coming weeks and months, we will be seeking a range of views on our digital services, including the HRA website beginning with our Annual Website Survey.

It only takes about five minutes to fill out and can be accessed through this link.

Expressions of interest for future website research
We are also seeking expressions of interest from anyone who would like to take part in future research on our website, including user workshops and testing sessions. We are keen to have feedback and involvement so that future development activity reflects the needs of you as our users.

If you would like to know more and be invited to be involved, please email the communications team at hra.comms@nhs.net.
When should placebo surgery as a control in clinical trials be carried out?
 
A discussion paper ‘When should placebo surgery as a control in clinical trials be carried out?’ has been published by contributors to a workshop held jointly by the Health Research Authority and the Nuffield Council on Bioethics last year.

The workshop brought together surgeons, patient representatives, regulators and research ethics committees to discuss issues surrounding the use of placebo surgery.

The paper presents a number of research scenarios along with the associated ethical considerations and highlights existing guidance on the use of placebo controls in surgical research. The authors conclude that placebo interventions should be used more often to control surgical studies as this will often produce the best research evidence.

The full paper is published in the Royal College of Surgeons bulletin. The Royal College of Surgeons also provided a position statement on this piece of work.

N.B. This publication is a consequence of the joint HRA/Nuffield Council on Bioethics meeting but does not necessarily represent the opinion of the Health Research Authority, the Nuffield Council on Bioethics or the employers or participants at the workshop.
Citizens' Jury

As part of its research into questions around the control of access to patient records, The University of Manchester held a three day-day “citizens’ jury” with members of the public in January.

The event was facilitated by Kyle Bozentko from the Jefferson Center in the USA and Amanda Hunn from the Health Research Authority, who asked the “citizens” to tackle a public policy question on the extent that patients should control access to patient records.

Over three days, the citizens heard from and asked questions of expert witnesses and carried out group exercises to explore the issue. They reached conclusions together and were polled on their individual views at the start and end of the jury. A week later a different cross-section of 18 citizens went through the same process. 

Read more about the event and what the jury decided here.
Please circulate this to your colleagues; you can subscribe to HRA communications here. 
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