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HRA Approval now fully operational
HRA Approval is now the route for approval of all NHS based research projects in England. This means that amendments and requests to open sites for existing studies now use HRA Approval processes. In this edition we provide some top tips for working with the new arrangements.

As set out in a statement posted to our website on 10 May, we have received a larger than expected surge in amendments and requests relating to existing studies. We are aware of the difficulties this may be causing and we are sorry for any delay.

We would ask those whose applications have been affected to bear with us as we put in  place measures, including additional resources, to progress your applications.


We are working hard to resolve this issue and through our investigations, have also identified some actions that could further help alleviate the situation.

 

HRA Latest Volume 20


Contents


HRA Approval:

Please read the “Studies processed through pre-Approval systems” and “Amendments” articles for suggestions that we feel may be helpful.

We apologise again and thank you for your patience.





 
HRA Approval: Applications being received
 
HRA Approval is now fully operational and is the route for approval of all project-based research in the NHS in England. We now have a range of associated resources including training materials and e-learning modules which are available on the HRA website.
                     
               

Number of studies issued HRA Approval to April 2016

Thank you to those who have in any way contributed with feedback and ideas in developing HRA Approval. Now we are in full implementation we continue to welcome feedback from all stakeholders to hra.approvalprogramme@nhs.net

It is only by hearing how a range of stakeholders are experiencing HRA Approval that we can further refine and improve the process. HRA Approval does not apply for establishing Research Tissue Banks, Research Databases, research taking place outside NHS organisations in England and research taking place solely in a social care setting.


Types of studies submitted as applications for HRA Approval at April 2016

 
HRA Approval: Top Tips for applicants

While HRA Approval was available for most types of studies from late January it was only during March and April that the number of applications has increased significantly. The following information addresses the most frequently asked questions:
  • For HRA Approval applications, an initial assessment letter will not be issued until enough information is in place to support set up in the NHS parallel to REC review and full assessment. Applicants are asked to be timely in responding to requests for information from the HRA Assessment team.
  • Where relevant, the REC review process follows the same procedure as previously and letters will be issued in the usual way. The HRA Approval letter will only be issued once all relevant approvals are in place and all additional conditions have been met. It will list all the final approved document versions.
  • When working with sites please copy the local information package and all correspondence to the R&D office, the local study team and, where applicable, the LCRN. This ensures that all parties have the same information at the same time. Contact details for R&D offices and LCRNs are available from www.rdforum.nhs.uk.
  • NHS organisations will only confirm capacity and capability to take part in the study after HRA Approval has been issued. Please ensure that you work with your participating NHS organisations early so that arrangements can be put in place in a timely manner.
We have lots of guidance on the HRA website, IRAS and our Q&A document.
Please feedback if it is difficult to find the information you need.


From receipt of application (valid for REC review) to issue of HRA Approval in calendar days with no clock stop as at April 2016

We are measuring the time taken from application to HRA Approval for different study types. This measures the total elapsed time, including time taken for applicants to respond to any queries and for the REC review process (where applicable) to complete. We are also tracking the time from completion of the REC process to issuing HRA Approval to demonstrate the benefits of the parallel reviews within HRA Approval.


From final confirmation of REC decision, including conditions met, to issue of HRA Approval in calendar days with no clock stop as at April 2016 (not applicable to studies not requiring REC review).
HRA Approval: Studies processed through pre-HRA Approval systems

Please note: within the large number of amendments and applications for Approval on pre-Approval studies, we are identifying large volumes that did not need a request for HRA Approval. You do not need to request HRA Approval to continue an existing study or to submit amendments that are not adding a new site. We apologise for any confusion if this has not been clear. You should only request HRA Approval for an existing study if you want to set up new sites.

Setting up new sites where no is amendment needed
If you want to set up a new site for a study that was originally processed through pre-HRA Approval systems, you should make a request for HRA Approval. You do not need to submit an amendment if you have previously provided the site name in your original application or a subsequent amendment – but you should still make a request for HRA Approval.

To make a request for HRA Approval for a study originally processed by pre-HRA Approval systems please email hra.approval@nhs.net and include the current versions of the documents that have been approved by regulators and R&D/CSP along with a list of the document names and version numbers.

Documents superseded by amendments should not be included. Non-commercial studies should include Statement of Activities and Schedule of Events templates. A template which can be used to list current documents is available on the HRA website.

Setting up new sites where an amendment is needed
If you need to submit a substantial or non-substantial amendment for your new site, please send the amendment request as below:
  • Substantial amendments that need to go to REC should only be submitted to the REC by email. Do not send them to the Assessment team as well.
  • All other amendments should be sent by email to hra.amendments@nhs.net.
Please do not send a separate request for HRA Approval as well as the amendment, because we will follow up with you about HRA Approval.

If you have submitted duplicate or unnecessary requests please withdraw your request by emailing elizabethbottomley@nhs.net with the study reference number you quoted in your initial request.

Sponsors of pre-HRA Approval studies led from a devolved administration who are setting up new NHS sites in England can contact hra.approval@nhs.net for assistance.


Breakdown of requests for HRA Approval for existing studies to add new sites as at 14 May 2016



From receipt of request to issue of HRA Approval for existing studies in calendar days with no clock stop as at April 2016

The HRA acknowledges that the current volume of amendments and requests regarding pre-Approval studies will have impacted timelines for studies in the system at the moment.

Any concerns about requests for HRA Approval to set up new sites should be sent to hra.approval@nhs.net using the word ‘escalate’ in the subject heading.
HRA Approval: Amendments 

The HRA is initially receiving a far higher number of amendments than we anticipated. The categorisation and requirement for amendments has not been changed with the implementation of HRA Approval. Our investigations suggest that there is a variety of reasons for this unexpected number of amendments, but we apologise for any delay this has caused. We have put in place additional resources to manage the workload, but please note the following top tips:
  • Substantial amendments that need to go to REC should only be submitted to the REC by email. Do not send them to the Assessment team as well.
  • All other amendments should be sent by email to hra.amendments@nhs.net.
  • There is no need to request HRA Approval if you are only submitting an amendment.
  • If the amendment is to add new sites to the study, i.e. to add sites that were not listed on the original application or by previous amendment, please email your amendment as above. We will follow up with you about the arrangements for HRA Approval.
  • Amendments for studies where the lead NHS R&D office is based in Northern Ireland, Scotland or Wales are processed by appropriate bodies in those countries. If there are sites in England the amendment will be shared with the HRA.

From receipt of valid amendment to issue of categorisation in calendar days with no clock stop as at April 2016

For an interim period, while we have a temporary high volume, please only send in amendments that are pressing. In addition we would like to encourage you to send amendments to a study in batches instead of sending a series of separate amendments over a period of a few weeks. We are aware that some applicants have sent amendments that have already been sent to R&D or for sites that have already been listed in an application: this is not necessary.

Applicants concerned with any HRA delay such that it is materially affecting the conduct of the study should raise this with the assessment team. If they do not get a response please contact the HRA REC manager who will be able to escalate and help prioritise with the assessment team. Thank you for your patience – we are sorry for any inconvenience caused.
New EU Clinical Trials Regulation

New EU legislation is expected to take effect in the UK at the end of 2018, replacing the current EU Clinical Trials Directive and the UK legislation that implemented it.

The new EU Regulation is being designed to more effectively harmonise the individual Member States' regulation of drugs trials. It will apply directly in each Member State whereas the current directive was implemented by domestic legislation which left scope for national variations to be introduced.

The new EU Regulation also aims to improve 'risk stratification' that requires different regulatory pathways - proportionate to the risks presented by different trial designs. In particular site-level regulatory approvals will no longer be required and 'low-intervention' trials will allow proportionate regulation of research such as real-world evidence collections, which are neither purely observational nor part of the routine phase I-IV model.

The HRA has been working with the Medicines and Healthcare products Regulatory Agency and the Devolved Administrations to explore and plan for the UK's readiness for the new EU Regulation. This work has included helping to shape the domestic legislation relating to Research Ethics Committee (REC) review of drugs trials and communications to support stakeholders' awareness and preparation. We will begin to roll this out in the coming months.

The timetable for the new law to take effect across the EU is dependent on the European Medicines Agency's development of requisite information systems. This timetable has already been substantially revised. Application of the new regulation also depends on the outcome of the UK referendum on EU membership on 23 June.

If you would like further information please contact Bill Davidson, HRA Joint Head of Policy.
New Learning Resources from the HRA

The HRA is increasing its online learning presence to provide open access to eLearning courses and training opportunities for stakeholders, researchers and REC members. Over the coming months we will be developing our Learning Management System (LMS) and the training section of our website as well as moving more courses that have previously been offered face-to-face to online or to blended learning formats.

New eLearning courses are now available on the HRA’s Learning Management System. These include two complementary courses outlining the HRA Approval processes for commercial and non-commercial sponsors. They cover applying for HRA Approval and setting up studies in the NHS in England including details of new HRA Approval arrangements for amendments and new sites.

Another new course ‘Reviewing the Research Design of Clinical Trials’ provides an overview of the different types of clinical design and techniques used in ethical review of the research design of clinical trials.
Further courses will become available on the Learning Management System over the next few weeks. These modules are available with open access as a ‘guest user’ here: http://elearning.hra.nhs.uk and we encourage you to access the courses.

Please contact the HRA Training team if you would like more information.
Updated IRAS e-learning module
 
An updated version of the IRAS e-learning module has been published on the IRAS website. This version, which replaces the original module that was published in 2009, has a revised layout and updates and expands the content in response to common queries from IRAS users.

The module continues to provide an online guide to IRAS and the functionality that the system offers. Users can still choose whether to work through the whole module or just specific sections of interest and it remains free to use with no need to register prior to using. We strongly recommend that IRAS users refer to the module before using IRAS.

It is available from the top menu bar anywhere in IRAS or by following this link: www.myresearchproject.org.uk/elearning.   
HRA Year in Review
 
Each year we publish a Year in Review in July which highlights the successes of the past year and looks at the projects coming up in the months ahead.

As the HRA will have its five year anniversary in December 2016 we have decided to publish the 2015-16 Year in Review later this year with a particular focus on collaboration, efficiency and streamlining governance.    

The 2015-16 Year in Review will be available from our website and will feature in HRA Latest in November.
Please circulate this to your colleagues; you can subscribe to HRA communications here. 
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