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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.

NHS research cost attribution and funding update – support on offer at BU

You may have seen an earlier post regarding recent developments, surrounding changes to the way that NHS research costs will be attributed and funded.

Acord specialists working within Local Clinical Research Networks (LCRN) are available to assist researchers in completing the SoECAT.
However, there is also further guidance and support on offer at BU. Email Research Ethics with any queries you may have, as well as requests for any guidance surrounding NHS research and associated procedures.

Changes to the way that NHS research costs will be attributed and funded

We have been informed by MRC of changes to the way that NHS research costs will be attributed and funded. You may already be aware but the Department of Health and NIHR have introduced a new attribution tool called the Schedule of Events Attribution Tool (SoECAT) which will now be mandatory for any researcher wishing to access resources within the NHS for their study. The Pilot stage for the project began on 1st October 2018 and there are three main changes;

1.  Any researcher applying to a funding call that opened from 1st October will be required to submit a SoECAT with their proposal or with their second stage proposal if applying to a 2-stage application process.

2.  All current research projects accessing resources within the NHS will be asked to migrate onto the new SoECAT system.

3.  A ‘high threshold’ is being introduced where the portion of NHS costs attributed to Excess Treatment Costs (ETC) will in future be reassessed for value to the NHS before these ETC are funded. This threshold is set at more than 1M per study or 20,000 per patient.

There are Acord specialists working within Local Clinical Research Networks (LCRN) who are available to assist researchers in completing the SoECAT. It is anticipated that these Acord specialists will be in high demand and while DH is training more Acord specialists they advise that researchers wishing to access this resource do so early during preparation of their proposals.

During this Pilot stage MRC are working with DH and NIHR to devise appropriate ways of working for MRC applicants and will be able to update their Guidance for Applicants in early 2019.

Next steps for researchers undertaking/planning to undertake clinical studies;

1.  Contact your Acord specialist within your LCRN for more information and to discuss completion of the SoECAT.

2.  While they are updating MRC guidance more information can be found here on the NIHR web-site.

If you have any questions, please contact your LCRN Acord specialist.

 

Good luck today to our DEALTS 2 finalists for the 9th National Dementia Care Awards!

The Dementia Education And Learning Through Simulation 2 (DEALTS 2) programme has been shortlisted for the 9th National Dementia Care Awards 2018 in the Best Dementia Training Initiative category, which recognises the vital role of effective training in dementia care. Today is the judging day and the award will be made to an individual or organisation that can demonstrate the value of a training initiative which has been successfully implemented.

“I was over the moon when I found out DEALTS 2 had been shortlisted, it is a real honour to be a finalist in the 2018 competition,” says Dr Michelle Heward, 1/4 of the DEALTS 2 research team. “We had been nominated by a colleague from another university who completed an application.”

The DEALTS 2 programme is a national simulation-based dementia education programme for hospital staff with regular contact with people with dementia. The programme is an innovative, low cost, high impact training toolkit which aims to facilitate staff to consider experiences from the point of view of a person living with dementia, enabling staff to see beyond the diagnosis and see the person.

These resources can be adapted to be relevant in different settings and have been designed using low key simulation scenarios, which will allow staff to make positive changes to how they care and support people with dementia. The training also integrates theory into practice introducing the Humanising Values Framework (HVF) a philosophical lens developed at BU that identifies potentially humanising and dehumanising care and support. The HVF enables trainers to support staff morals as well as improve the care of people with dementia.

“The team has worked hard to deliver 13 train-the-trainer sessions nationally across England in 2017 with 196 trainers attending. The toolkit has been developed iteratively to encapsulate feedback from dementia specialists, trainers and informal carers,” says Dr Heward.

Click here to find out more about the DEALTS 2 programme, or get in touch with Dr Michelle Heward here. The DEALTS team includes Professor Jane Murphy, Dr Michele Board and Ashley Spriggs.

Emotional Processing Therapy for Post Traumatic Stress Disorder Workshop – 26 October 2018

 

Our very own Professor Roger Baker is facilitating a one day workshop on Emotional Processing Therapy for PTSD in Leeds on 26th October 2018.

The workshop will explore what an emotional processing style is and how this is relevant to the development and presentation of PTSD, there will be a range of teaching, skills training, role play, discussion and exploring case studies.

Please see flyer here for more information or book online here.

Don’t forget, BUCRU can provide FREE methodological advice and support in designing your research project. We’re based on the 5th floor of Royal London House so feel free to pop in and see us, call us on 61939 or send us an email.