Tagged / nhs

HRA help guides – data and technology

An updated Code of Conduct for the application of data-driven technologies in the NHS was published on Tuesday of this week – the code ‘sets out what the NHS expects from companies who are developing new technologies for the health system, and what they can expect in return.

In order to assist applicants and researchers, the HRA have created new pages that set out the approvals process for data-driven technology research.

The section incorporates two pages of support –

The help pages will be added to the Clinical Governance section of the blog, for ease of access.

Research transparency – HRA response to the Science and Technology Committee

The House of Commons Science and Technology Committee released a report last year on clinical trials transparency, as it was evident that a nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.

At the time the HRA issued a response but today have published a further statement which sets out their commitment to research transparency. This is especially pertinent given the article published simultaneously in BMJ Open, which details the numbers of clinical trials that are publicly registered, compared with those that have received favourable opinion (approval) from a UK NHS research ethics committee.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to register your study.
Despite the name, the system may be used for other clinical research projects.

NIHR – Making a difference: Improving treatment for advanced prostate cancer

The NIHR have recently published an article on the STAMPEDE trial which is helping to improve the prognosis and quality of life of those diagnosed with prostate cancer.

This is a research study that’s supported by the NIHR, and has been up and running since 2005, with more than 10,000 men having taken part. 125 UK sites are conducting the research, with local NHS Trusts amongst those 125.

The trial is multi-arm, so compares different treatments amongst the participant group – it is also ‘randomised’, so participants are allocated their treatment at random, reducing any bias in allocation.

The results to date from the trial have also influenced the NHS treatment for men with high risk, locally advanced metastatic prostate cancer. More STAMPEDE related news can be found on their website.

You can read the article here, which contains a testimony from a trial participant whose condition and quality of life have been vastly improved.

NIHR Programme Grants for Applied Research (PGfAR) Roadshow – 10th April 2019

NIHR Programme Grants for Applied Research (PGfAR) Roadshow

We are offering a number of events which offer an opportunity to gain a greater understanding of the NIHR Programme Grants for Applied Research (PGfAR) and Programme Development Grant (PDG) funding streams.

Registration to these events will be FREE and refreshments will be provided.

The next event taking place in the South is in Exeter, Devon. 10 April 2019.

Places are limited and will be allocated on a ‘first come, first served’ basis. In order to secure your place at our South West event in Exeter, please register using our online form by 1pm, 27 March 2019.

Researchers currently developing, or considering developing, a proposal for submission to PGfAR or PDG for funding are also invited to take advantage of a one to one session (subject to availability) with the NIHR Programme team and RDS staff to discuss their proposed study. To access this opportunity please complete the one to one booking form.

And don’t forget, your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) on the 5th floor of Royal London House. Feel free to pop in and see us, call us on 61939 or send us an email.

Training opportunity – completing and submitting your IRAS application

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

HRA responds to paper outlining concerns over study set-up delays

Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.

Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.

Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.

  • Approx. 89 individuals were involved in the study approvals;
  • 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
  • 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
  • 491 exhanges took place with the 89 individuals, generating 193 pages of text.

Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.

You can read the HRA’s response here, which signposts the reader to further resources.

Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.

Medical research: articles/blogs of interest

A medical ethicists explores the need to temper researchers’ enthusiasm when it comes to presenting the benefits of a treatment, and how important it is to distinguish research from a treatment.

Read the full article here.

Six project management tips for a PhD – Whatever kind of large research project you are doing, these tips from the private sector might be of some use.

Read the full article here.

#DataSavesLives—Patient participation ensures data are accurate and useful – In this blog, the author argues that we must not ignore the benefits that sharing patient data can have on quality in healthcare

Read the full blog post here.

New HRA guidance launched for public co-applicants in research

‘Increasing numbers of public contributors are helping to shape and deliver health and social care research, and there has been a rise in the number of public co-applicants joining research teams.

Involving members of the public in research design and development has been shown to have a positive effect on projects by improving the quality and relevance of research. However, until now there has been no guidance, either for researchers or for people involved, about what it means to be a co-applicant.

Now new guidance co-developed by NIHR-INVOVLE, the NHS R&D Forum and the Health Research Authority, has been launched to help support members of the public who are co-applicants on research grants and ensure that their contribution is valuable and rewarding.’

See the HRA’s update here and remember that support is on offer at BU if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog.

HRA Update – Travel insurance and participation in clinical trials

Please see below for a message from the NIHR Workforce Development team –

‘We are pleased to inform you that the Association of British Insurers (ABI) have confirmed to the Health Research Authority that participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.

ABI agree that taking part in a clinical trial should not affect insurance cover if the medical condition itself doesn’t. Please share the following message with your teams, organisations etc.

‘When individuals apply for travel insurance, insurers will typically ask questions about an individual’s health in order to make an accurate risk assessment. This risk assessment takes into consideration the health of the individual and the insurer will often ask questions about any pre-existing health conditions and medical treatments for those conditions. Travel insurers do not typically ask about clinical research trials. Where an insurer does ask an individual about their participation in clinical research trials, the insurer must ensure the question is clear and the individual should answer it accurately and honestly”.

If you are aware of instances when participation in a trial is given as a reason for not providing insurance or insurance being an obstacle to participation in clinical trials, please contact hrapublicinvolvement@nhs.net

NIHR CRN – Principal Investigator Workshop

The above course is designed for those working as a Principal Investigator (PI) on clinical research projects, or those wishing to become a PI. It is particularly suited to those who have been in working in this role for less than 6 months.

The course will focus on the role and responsibilities of the PI, developing a greater understanding of the regulatory landscape in research, leadership, oversight and communication skills and the importance of building working relationships with local NHS Research & Development and Research & Innovation departments.

For further details of the course please email Kelly.Adams@nihr.ac.uk and to request the course agenda please email Research Ethics.

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Southern Health Research and Development Conference 2019

‘Population Health: Can Research Improve Outcomes’

Southern Health Research & Development will be holding the above conference on Wednesday 30th January, at the Hilton, Ageas Bowl in Southampton.

The conference is free and will feature a range of guest speakers focusing on research’s impact on population health and how this can not only improve the health of the population but also reduce health inequalities across diverse population groups. The programme for the day can be found here.

This event is open to everyone within research, business, and voluntary sectors as well as to the public – you can find out more and register through the Eventbrite link here.

Free Health Research Authority webinars on 10th January

The HRA are hosting three webinars this Thursday 10th January, for those undertaking healthcare research or for those applying for approval. You can book onto them by following this link.

On offer are the following webinars –

  • Managing your approval, scheduled from 2:30pm – 3:30pm
  • Understanding GDPR in relation to health research in the UK, scheduled from 11am – noon
  • Applying for HRA Approval – ‘getting it right first time’, scheduled from 1pm – 2pm

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

CRN Wessex Awards – shortlist revealed

Huge congratulations to our colleagues at neighbouring NHS Trusts, who have been shortlisted for a CRN Wessex Award!

The Wessex Awards comprises seven categories which celebrate those who have made outstanding contributions to the delivery of NIHR CRN portfolio studies. The categories are:

– Rising star
– Excellence in the delivery of commercial research studies
– Outstanding research professional
– Excellence in patient & public involvement & engagement
– Outstanding collaborative working
– Outstanding clinical trial support
– Outstanding research leaders

You can see the shortlist here.

Great to see those we work with closely being appreciated for their hard work. Congratulations again!

The NHS Long Term Plan – released today

The NHS Long Term Plan has been released today, having been developed in partnership with those who know the NHS best – frontline health and care staff, patients and their families and other experts.

You can download the document here.

The plan discusses research and innovation throughout – see page 75 onward for plans surrounding research and innovation to drive future outcomes improvement.

NHS Research – Twitter pages to follow!

There is a huge amount of research being conducted across the county by our neighbouring NHS Trusts – you can follow them all on Twitter on the links below.

It’s a great way to keep up to date with developments, news and upcoming events. as well as interesting articles related to healthcare research:

Follow Dorset County Hospital Research & Innovation’s page here;
Follow Royal Bournemouth Hospital’s Research page here:
Follow Dorset HealthCare Research & Development’s page here;
Follow Poole Hospital’s page here.

Happy tweeting!

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

CHAIN – Contact, Help, Advice and Information Network

CHAIN is an online mutual support network for people working in health and social care. It gives people a simple and informal way of contacting each other to exchange ideas and share knowledge.

Members use CHAIN in all sorts of ways, from highly proactive networking to more passive ‘horizon-scanning’.
CHAIN also provides a simple mechanism for ideas which emerge in one context to be shared with fellow-members across boundaries of organisations, professions, and territories which makes the network unique.

Joining is free, and open to anyone working in these areas. You can see recent examples of feedback here, as well as a snapshot report here, of the network’s reach.

Follow CHAIN updates on Twitter; @CHAIN_Network ; Find them on Facebook; Connect with CHAIN on LinkedIn.