Welcome to the first edition of HRA Latest for 2016.

The past year was significant for the HRA as we gained new policy functions and remit after being established as a Non-Departmental Public Body (NDPB) and started the roll out of HRA Approval.

We have a big agenda for the year ahead as we keep building on our new functions and approaches to improve the environment for health research in the UK, including our consultation on a new UK policy framework for health and social care research. It is aimed at all those responsible for health and social care research in the UK so your feedback is important and we have created a number of opportunities for your input.

We remain dedicated to improving the quality and consistency of ethics review as a key independent component of HRA Approval, and we will continue to progress in 2016 the HRA Approval programme through to full implementation and benefit realisation.

Our stakeholders are vital to its success and we will continue to work closely together to support and facilitate high-

HRA Latest Volume 18


quality research that has the confidence of patients, researchers and the public.

Thank you to all who continue to support the work of the HRA, we look forward to a productive and collaborative year with you.

Janet Wisely
Chief Executive
Consultation on the UK Policy Framework for the conduct and management of Health and Social Care research

The HRA, together with the Devolved Administrations, are seeking your views on the new UK Policy Framework for Health and Social Care Research, which will replace the Research Governance Frameworks for England, Wales, Scotland and Northern Ireland.
These are the policy documents that set out principles, requirements and standards for research in health and social care. This framework will support good practice across the UK in the conduct and management of health and social care research.
The Policy Framework covers a wide range of principles, some of which will in due course be followed up with more detailed guidance.  It is therefore important that the underlying principles have broad support. 
For example, the Policy Framework suggests that students should not normally take the role of chief investigator at any level of study and that relevant supervisors (or course leaders, where different) should be encouraged to develop and lead research projects that individual students at Masters level and below can contribute to at different stages. In this way, undergraduate students would be encouraged to undertake research as part of a team and would not be required to seek ethical review as individual students.
It also proposes that proportionality should be applied to the provision of information to potential research participants and suggests that the closer the research is to standard practice, the less need there is to provide participants with lengthy information. Underpinning this principle, the HRA is working on guidance on proportionate consent including point of care trials (also known as pragmatic trials), where existing licensed treatments are tested comparatively. The same principle might also be applied to Phase 4 trials.
Patient involvement is considered a key principle, particularly in clinical trials.  The Policy Framework states that patients, service users and the public are involved, where appropriate, in the design, management and conduct of research. Similarly, it suggests that findings of interventional studies are shared with those who took part in them. 
We are holding a series of afternoon consultation events to discuss these principles and the impact of the Policy Framework on research and are inviting you to attend:
 Audience  Date  Location
 R&D directors and managers    23 Feb            Birmingham      
 Patients and service users  24 Feb  Birmingham 
 Researchers  1 March  Manchester 
 Commercial funders and sponsors  3 March  London
 Researchers and non-commercial funders and sponsors               8 March  London
 Patients and service users  9 March  London
 Regulators 10 March      London
We hope you will be interested to see the proposed new Policy Framework and will take the opportunity to comment, as well as attending one of our events.

Places are filling up quickly, so please email to reserve your place.

Please give us your comments on the new Policy Framework via the online survey here.

The consultation is open until Thursday 24 March 2016

Any queries, please email Bill Davidson:
HRA Approval Programme

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 and on the HRA website here.
Pilot of revised Proportionate Review process

A project is being undertaken to review whether there is benefit to a slightly longer Proportionate Review (PR) review process which puts greater focus on facilitating applications through the review process and working more closely with applicants to ensure better quality applications are prepared. This is due to a high number (23%) of PR applications being invalidated and rejected before reaching the REC for review.

The current PR process requires an opinion to be issued by the Committee within 14 calendar days, the revised process will allow up to 21 calendar days. There are 16 REC involved in the pilot UK wide.

The aim of the pilot is to assess whether a longer period of time for review is more effective and efficient by increasing the number of applications which go through the system on first submission: by decreasing the not valid rate and increasing the number of favourable opinion issued as the REC (including allowing more time for the REC to contact the applicants on valid applications regarding points of clarity). Additionally, we will be assessing satisfaction levels of REC staff, REC members and applicants to see whether the lengthened period of time is preferred. 

Upcoming changes to NIHR Performance Measurements

A joint communication from the NIHR Central Commissioning Facility (CCF), NIHR Clinical Research Network (CRN) and Health Research Authority (HRA).

Over the last few years, the NIHR has introduced a number of performance measurements to focus the priorities of organisations delivering research in NHS. In 2010, the CRN ‘High Level Objectives’ were introduced and have since generated a robust source of study level information, providing a national view of research delivery and a unique resource for encouraging new research. In 2011, the Government’s Plan for Growth announced the transformation of incentives at local level for efficiency in initiation and delivery of research with the introduction of the Performance in Initiating and Delivering Clinical Research (PID) exercise. The Performance in Initiating (70 day benchmark) and the Performance in Delivering (recruiting commercial trials to time and target) exercises were introduced from 2012 in a number of providers of NHS services with NIHR contracts, and expanded to the majority of providers of NHS services through the Local CRN contracts in 2014. This measurement provided a comprehensive understanding of set-up times at a site level, both for portfolio and non-portfolio studies.

Demonstrating delivery
The results show that the measurements have reinforced NHS organisations’ commitment to delivering research. The latest CRN Performance Report 14/15 shows a continued increase in the numbers of studies and participants to clinical research on the NIHR CRN portfolio. The most recent PID data from the CCF shows a continued trend in reducing the time taken to recruit the first patient in a site. The data provides a compelling case for the NHS in attracting new studies from around the world.

Maintaining focus
While the trend demonstrates a positive trajectory, NHS organisations and independent provider research sites, such as General Practices, care homes and community pharmacies, are encouraged to maintain efforts on the key elements of timely study set-up and predictable delivery. This continued focus will strengthen the position of the NHS in the global clinical trials marketplace and improve the production of research evidence for the NHS.

Process refinement
The implementation of HRA Approval further supports these key elements. In doing so, a number of data points within the study and site start-up and recruitment measurements are changing with the introduction of the combined IRAS form and the alignment of local activities to the HRA Approval process. This provides an opportunity to review and refine the start-up activities to better support consistent and efficient study delivery. A collaborative project involving CCF, CRN and HRA has developed a single ‘minimum data set’ that reflects the new HRA Approval processes and will simplify the reporting system. The revised data set proposed will provide greater flexibility for understanding performance at all points across the study life-cycle at both a site and study level, without competing or duplicating metrics.

Further information
Details regarding the revised data points, definitions and collection processes will be shared through the CCF, CRN and HRA communication channels in due course.  In the meantime, NHS organisations are advised to contact their Local CRN representatives to keep up to date with the latest information. 
Appointments to the Confidentiality Advisory Group

The Confidentiality Advisory Group (CAG) is looking to appoint new members.

The CAG provides the Health Research Authority and the Secretary of State for Health with independent expert advice on applicants who wish to access confidential patient information. The work of the group is challenging, but it is also immensely rewarding.

As one of the CAG’s voluntary members, you will robustly assess applications to advise whether the applicant’s activity is in the public interest, fulfills a medical purpose, and if consent can be obtained from those whose data has been requested.

We are keen to recruit a diverse set of members from a variety of backgrounds. You could be a member of the public, a patient representative, a member of a consumer group, a healthcare professional, or a member of a professional regulatory body or an academic/research institution.

To find out more about CAG please visit our website.

Member recruitment will begin shortly. If you are interested in applying for this voluntary role, please visit our website the week commencing Monday 8 February.  

Interviews will take place on Tuesday 15 and Friday 18 March 2016.
NHS R&D Forum Annual Conference in association with the HRA

This year’s NHS R&D Forum Annual Conference will take place on Monday 23 and Tuesday 24 May 2016 in Stratford-Upon-Avon. With over 400 delegates attending each year, this national event is one of the largest gatherings of R&D management professionals working in providers and commissioning organisations across the UK.
The HRA has worked with the R&D Forum to develop an integrated programme of updates, poster presentations and interactive sessions. At the event, key note speakers will aim to stimulate and challenge the audience while sessions will share best practice, debate and discuss hot topics as well provide training opportunities.
Networking is a key focus of the event and there will be a dinner attended by most delegates on the first evening. Bookings for the conference are now open – you can find out how to book your place, information about speakers and sessions on the conference website.
Please circulate this to your colleagues; you can subscribe to HRA communications here. 
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