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HRA Latest
March 2019
NHS
Contents
The latest guidance on the implications of a no-deal Brexit

Announcing the Research Transparency Strategy Group

The Combined Ways of Working pilot: one year on

Pharmacy Assurance roll-out: next steps

Become a Pharmacy Assurance registered reviewer

Setting up NHS/HSC research in the UK: A UK Local Information Pack

Our new public involvement guidance: a Research Ethics Committee member’s perspective

Expectations for public involvement in research applications

What is Dynamic Consent?

NIHR Research on Research survey:  decision-making processes for grant fund allocation in health research

Indemnity scheme for primary care to include research activities




















 
Introduction from Teresa Allen, HRA Chief Executive
Hello and welcome to the March 2019 edition of HRA Latest. As you will be aware, this month has had a Brexit focus and although the EU exit date has been delayed, the possibility of leaving without a deal remains.

To plan and prepare for every Brexit eventuality, we have been working with our partners to ensure the research community has as much guidance and support as possible, to respond to a changing landscape. Our advice is still to follow our latest guidance on the implications of a no-deal Brexit and to keep checking our website for updates.

I recently presented at the Westminster Health Forum about how we can ensure the UK remains an attractive place to do research. The HRA has an important role to play in this and our second strategic ambition sets out how we are making it easier to conduct high quality research in the UK.

One way that we’ve been working towards this goal is through our Combined Ways of Working pilot, which has now been running for 12 months. You can read about some of the achievements of the pilot to date in the news story below.


This month I am also delighted to introduce you to the members of our Research Transparency Strategy Group. This group has the important task of directing the development of our new strategy to increase the registration of clinical trials. The strategy will then go out to public consultation this summer. Watch our website for more information.

I’m also pleased to share an update with you on the phased implementation of our technical assurance process as we announce the second phase of our Pharmacy Assurance roll-out in England and Wales. You can read more about this below.

Another way we’ve been striving to enable world-leading research in the UK is by working collaboratively with our partners to deliver Local Information packs to researchers working with NHS or HSC organisations across the four nations. I’m looking forward to seeing the positive impact the Local Information packs will have on study set-up across the UK.

Supporting researchers through their applications is a central part of what we do. This month we have the final instalment of our blog series, providing the Research Ethics Committee (REC) member perspective on one researcher's application as she uses our public involvement guidance on the Integrated Research Application System (IRAS), to build public involvement into her research.

We’re also developing a set of expectations for public involvement in research applications. The expectations aim to help researchers involve patients and the public as effectively as possible, and to design high quality studies that will make a difference to the health and wellbeing of patients, carers, the public and service users.
 
Increasingly, technological developments are featuring in research projects and we anticipate that they will play a major part in making the UK a great place to do research. Last year we released a joint statement with the MHRA to outline the ethical and legal requirements for using electronic consent (eConsent) in research. This month we hear from Dr Harriet Teare about technology that’s making the consent process more dynamic and flexible, giving patients more control over their consent. I find it very exciting that we are using technology in this way, to help put patients at the heart of research.

Finally, we have news from our partners. The NIHR are conducting a short online survey about decision-making of health research funding allocation and we encourage people to take part. We also have confirmation that the new state-backed indemnity scheme for primary care will include delivery of research activities involving NHS patients from the start of April.

I hope you enjoy reading this month’s HRA Latest. As always, we are keen to determine if the way we provide information to our stakeholders is helpful, or if there are any areas in which you think we could improve. Please direct any feedback or queries to communications@hra.nhs.uk
The latest guidance on the implications of a no-deal Brexit
 
We highlight updates and additional guidance published recently to help organisations prepare for a no-deal EU Exit, as well as our own guidance on aspects of planning which are within our regulatory remit.

Our website has information on everything from handling amendments to transferring data between countries.

 
  READ MORE    
Announcing the Research Transparency Strategy Group
The HRA has formed The Research Transparency Strategy Group in response to the House of Commons Science and Technology Committee Report on clinical trials transparency, part of its inquiry on research integrity.

Meet the group, announced today for the first time, who will help the HRA create a draft strategy that can be put out to consultation.
READ MORE
The Combined Ways of Working pilot: one year on
 
The HRA and MHRA, in partnership with the Devolved Administrations, have been piloting a streamlined process for the submission and review of applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK.

This Combined Ways of Working pilot has now been running for 12 months. In this blog we give an update on how the pilot has developed, and set out our plans for the upcoming months.
READ MORE
Pharmacy Assurance roll-out: next steps
 
Technical Assurance is the coordinated review process for studies that involve pharmacy and/or ionising radiation.

We are pleased to announce that we are now accepting phase III oncology CTIMPs for review through Pharmacy Assurance in England and Wales.

During this next phase of Pharmacy Assurance roll-out, we are still accepting oncology phase I, I/II, II and II/III CTIMPs.

An overview of the benefits and the Pharmacy Assurance process can be found on our Pharmacy Assurance webpage. Detailed submission guidance can be found on IRAS.

 
READ MORE
Become a Pharmacy Assurance registered reviewer
 
If you would like to become a Pharmacy Assurance registered reviewer we have information on how to apply available on our website.

We’re particularly interested to hear from radiopharmacists or radiopharmaceutical scientists.

 
READ MORE
Setting up NHS/HSC research in the UK: A UK Local Information Pack
 
In last month’s HRA Latest we featured the news that a UK Local Information Pack was coming soon. We can now confirm that this will be introduced on the 5 June 2019.

Researchers working with NHS or HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.
 
Regular updates will be available on the
four nations NHS/HSC website.

 
READ MORE
Our new public involvement guidance: a Research Ethics Committee member’s perspective
 
Read the third and final blog in our series about the HRA’s public involvement guidance on IRAS. The guidance helps researchers to build public involvement into research ethics applications, to make approval easier.

We’ve been following Dr Marianne Coleman’s story. In the first blog we heard her perspective on the practicalities of using the guidance. The second blog featured Vandra and Brian, a patient and carer involved in Marianne’s research. In this final edition we speak to Dr Alison Ledward, a lay member of the REC that approved Marianne’s research application.

 
READ MORE

Expectations for public involvement in research applications
 
The HRA is developing a set of expectations for public involvement in applications for Approvals, to help applicants benefit from the contribution patients and the public can make to their research.  
 
These expectations will describe the key elements of how good public involvement can improve the design of studies that the HRA reviews. It will set out how the HRA expects applicants to work collaboratively, to involve relevant patients and/or the public in designing and conducting high quality studies that are relevant and important to patients. These research studies should as a result, be approved and recruit participants more easily.

 
READ MORE
What is Dynamic Consent?
 

Last year the HRA and MHRA released a joint statement setting out the ethical and legal requirements for using electronic consent (eConsent) in research.
 

Dr Harriet Teare is part of a team that developed an eConsent system that puts patients at the heart of decision making, with a dynamic element that allows a unique flexibility to the consent process. Harriet has blogged for us about Dynamic Consent to explain how it works and why eConsent is becoming more commonplace.

READ MORE
NIHR Research on Research survey:  decision-making processes for grant fund allocation in health research
 
Funders are responsible for fair and transparent allocation of funding for health research.  To do this, decisions are made about which research applications merit funding.
 
The NIHR Research on Research (RoR) team are collecting information about the different approaches to decision-making that health research funders are currently using, have used in the past or may consider using in the future, and their opinions of these approaches.
 
If you would like to take part in the survey it will take about 20 minutes to complete and can be accessed by clicking the button below.


The close date of the survey is 17 April 2019.
 
READ MORE
Indemnity scheme for primary care to include research activities
 
From 1 April 2019 the new indemnity scheme for primary care will include delivery of research activities involving NHS patients.
 
The Clinical Negligence Scheme for General Practice (CNSGP) was administered by NHS Resolution on behalf of the Secretary of State for Health and Social Care, and covers clinical negligence liabilities for general practice in England that arise as a result of an incident that occurs on or after 1 April.
 
Guidance about the scheme can be found by clicking the button below.
READ MORE
                                       






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