Tagged / clinical research

New online booking service for IRAS – goes live Tuesday 19th May

NHS, Research Ethics

Please see below for an update from the Health Research Authority with regard to the new system for booking in applications.

Any queries please get in touch with Suzy Wignall, Clinical Governance Advisor.

A new online booking service will be rolled out for IRAS studies on Tuesday 19 May – replacing the current Central Booking Service (CBS) telephone line. This is part of our ongoing Research Systems programme of work to improve our services for applicants.

Applicants submitting research projects through IRAS will no longer need to call the Central Booking Service to book a Research Ethics Committee, or to enable IRAS Form submission. Instead applicants will access the new online booking service via IRAS to book their application for review. The service is quick and easy to use and, unlike the current Central Booking Service, will be available 24 hours a day, seven days a week, making it easier for research applicants. If you need help and support with the new system you can call 0207 104 8008 between 8.30am and 4.30pm Monday to Friday.

In order to make use of this new functionality, applicants will be directed to a new part of IRAS which hosts the online booking service. A separate login will be required, but support will be provided. You will need to set up a new login and password for this area unless you already have a login for a NIHR system or as part of the Combined Ways of Working pilot (CWoW) pilot. In this case you can use your existing log in details.

Applicants will need to answer a series of questions online before being able to book a slot. This directs the applicant to the appropriate REC. The questions will be familiar to anyone who has used the CBS. Once you have completed your online REC booking, you will still need to electronically submit your application in IRAS using the normal process.

Applicants making contact about fast-track COVID-19 studies, should continue to follow our current guidance or email fast.track@hra.nhs.uk, DO NOT use the online booking service. 

The work to build the online booking service began before the current COVID-19 pandemic. It is being rolled out now so that the system can support research applicants with non-COVID-19 studies.

Training and guidance will be available via the IRAS website. You can also watch a short video to see how to use the online booking service.

 

BU academics at Virtual International Day of the Midwife

conferences, international, PG research, Publishing, writing

Five FHSS academics have presentations and/or posters at this year’s Virtual International Day of the Midwife (IVDM) conference.  Dr. Luisa Cescutti-Butler  (Senior Midwifery Lecturer in  the Centre for Midwifery, Maternal & Perinatal Health (CMMPH) and Dr. Humaira  Hussain have an online presentation ‘on the topic of Making discoveries through research: midwifery student’s perceptions of their role when caring for pregnant women who misuse substances: neonatal simulators as creative pedagogy’.

BU Midwifery Lecturer Denyse King also in CMMPH has been interviewed by the VIDM her poster on her PhD research around Virtual Reality Learning Environments (VRLE), which can be offered as a computer-generated virtual simulation of a clinical workspace.

Whilst Dr. Luisa Cescutti-Butler,  Dr. Jacqui Hewitt-Taylor and Prof. Ann Hemingway have a poster  ‘Powerless responsibility: A feminist study of women’s experiences of caring for their late preterm babies’ based on Luisa’s PhD research.  Last, but not least, FHSS Visiting Faculty and holder of a BU Honorary  Doctorate Sheena Byrom is key note speaker at the week’s IVDM conference!

Congratulations!

Prof. Edwin van Teijlingen

CMMPH

Free online course! – Improving Healthcare Through Clinical Research

NHS, Research Ethics, Training

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and is be available now, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – 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.

COVID-19 funding and research

Funding opportunities, innovation, NHS

To support the response to COVID-19 the Research Design Service South West (RDS SW) has put together a useful resource page to help researchers. This includes relevant funding calls as well as more general information about the pandemic.

Don’t forget, your local branch of the NIHR RDS is based within the BU Clinical Research Unit (BUCRU)

The BUCRU/RDS office is currently closed due to Coronavirus.  Staff are still working and able to offer research advice remotely, call us on 01202 961939 or send us an email.

Research in the NHS during the COVID-19 pandemic – HRA update

Guidance, NHS, Research Ethics

You may have seen an earlier blog post with regard to a halt on the review and approval of undergraduate and master’s clinical research projects. The HRA have released another update with regard to all other research and the state of play due to COVID-19.

To recognise the significant pressures on the NHS at this time, the National Institute of Health Research (NIHR) announced that all new and existing studies supported through its Clinical Research Network would be paused to focus instead on COVID-19 research. You can read the full statement on the NIHR website.

The full HRA statement can be viewed here. If you have any queries mai in Research Development & Support.

Research Development & Support are also updating the following help page regularly for academics and researchers.

COVID-19: health and social care research projects for educational purposes

NHS, Research Ethics, student research

The HRA have therefore decided stop reviewing applications for individual undergraduate and master’s student projects from now until further notice.

Please see this new guidance which relates to health and social care research projects conducted by undergraduate and master’s students: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/

BUCRU & RDS SW

NHS

  

Please note that Bournemouth University Clinical Research Unit (BUCRU) and NIHR RDS SW (Research Design Service South West) offices are currently closed due to Coronavirus.  Staff are still working and able to offer research advice remotely,

Please contact bucru@bournemouth.ac.uk in the first instance.

We are looking forward to working with you all face to face when this is over.

COVID-19 guidance for clinical researchers

NHS, Research Ethics

The Health Research Authority have released guidance for clinical researchers, sponsors and sites with regard to COVID-19 (Coronavirus) – please read this guidance if you are currently conducting your project or are in the planning stages/set-up of the study (so you are aware of the current situation).

This guidance is subject to change and will be updated as and when required by the HRA.

You can read the guidance in the link provided above, but for convenience, these are the most likely situations BU clinical researchers may face. Please ensure that in planning amendments that these do not create additional burden to NHS staff or resources.

Amendments to existing studies impacted by wider COVID-19 response 

  • Example – Where changes to administrative arrangements are required to reduce burden or physical contact with sites – for example, changes to monitoring arrangements.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. Where the study involves the NHS, they will be marked by the sponsor as a category C amendment not requiring assessment, and sent directly to the sites. The site should implement the amendment on the date specified by the sponsor.

  • Example – Where changes are made to how or when patients are seen to avoid exposing patients or to reduce burden on clinical services – for example, changing site visits to phone calls or postal questionnaires.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. The same procedure as the first example should be followed.

  • Example – Where a temporary halt needs to be placed on some or all of the study, or the duration of the study needs to be extended.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. The same procedure as above should be followed.

  • Example – studies that need to be closed.

How this should be handled – for studies not involving provision of treatment to participants, a notification to the REC or study-wide review (for non-REC studies) should be provided, and an end of study report should subsequently be provided.
For any studies involving provision of treatment to participants, careful consideration should be given to post-study care. If this cannot be in line with the information provided in the participant-information sheet, a substantial amendment should be submitted.

To support sites in implementing the amendments it is important that:

  • The changes and local implications are made clear
  • Any changes to documentation are provided in tracked changes
  • In England and Wales All correspondence to sites should be copied to R&D/I department and the PI and delivery teams
  • Where indicated above, the sponsor should include the category and confirm that no assessment is required.

There may be some instances in which the site may raise issues or changes that need to be made. If they do, please inform the Sponsor as soon as possible.

What to do next

If you think that you may need to implement any changes or amendments to your study due to COVID-19 please get in touch with us as soon as possible. If you have any concerns or queries then please also get in touch to discuss these.

Latest NIHR-CRN podcast

Knowledge Exchange, NHS, Research Ethics

The latest podcast in the Health Research Futures series comes from Professor Julie Lovegrove. Professor Lovegrove is from the University of Reading and talks about the challenges of conducting nutritional research and overcoming them.

 

Informed Consent training opportunities

Guidance, NHS, Research Ethics, Training

Before agreeing to participate in your study, your participants should receive all the information they require in order to make an informed decision. Once they wish to participate, then an informed consent form should be completed and filed appropriately.
Although the process sounds complex, there are currently a great training opportunities to help familiarise yourself with the background to, and process of informed consent in clinical research.

The Wessex Clinical Research Network are hosting the following training sessions at University Hospital Southampton and at Wessex CRN’s office –

  • NIHR CRN Informed Consent training, Thursday 26th March, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN;
  • NIHR CRN Informed Consent training, Thursday 7th May, 8:30am – 12:30pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Thursday 7th May, 1:00pm – 5:00pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Friday 26th June, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN

If you’re interested in attending, get in touch with the Wessex CRN to book your place.

Introduction to Good Clinical Practice – Tuesday 17th March at Dorset County Hospital

NHS, Research Ethics, Training

Are you interested in running your own research project within the NHS or healthcare? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Tuesday 17th March, at Dorset County Hospital, Dorchester – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact 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.

Health Research Authority email addresses are changing

NHS, Research Ethics

All email addresses at the HRA are changing in the coming weeks and this change will be complete by March 2020.

HRA staff email addresses will be standardised as firstname.lastname@hra.nhs.uk. A full list of contact email addresses for the Research Ethics Committees is now available here.

If you use the HRA staff member’s @nhs.net email address to contact them after they have moved to their new email address, you will receive a response containing their new details but your email won’t be automatically forwarded.

If you are unsure which contact information to use for the individual or service you require, please contact the HRA mainline on 020 797 22545 or use their contact form.

Make sure to check your junk mail if you are expecting emails from the HRA or an NHS REC as they often are sent there instead. Please add them to your safe senders list if this is the case to make sure you don’t miss any important study emails!

Introduction to Good Clinical Practice – Tuesday 17th March at Dorset County Hospital

Guidance, NHS, Research Ethics, Training

Are you interested in running your own research project within the NHS or healthcare? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Tuesday 17th March, at Dorset County Hospital, Dorchester – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact 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.

Good Clinical Practice Refresher – Dorset County Hospital, Tuesday 18th February

Coffee Morning, Guidance, NHS, Research Ethics, Training

Are you currently undertaking research within the NHS, and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Dorset County Hospital, Dorchester on Tuesday 18th February, 9:00am – 12:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics.

New BU paper published on Plos One

Congratulation to Dr Francesco Ferraro, who published his latest paper on Plos One. 

The paper “Comparison of balance changes after inspiratory muscle or Otago exercise training” comes from Dr Ferraro`s PhD where, under the supervision of Professor McConnell, Dr Gavin and Associate Professor Wainwright, he looked at the effects of inspiratory muscle training on balance and physical performance with older adults.

This latest paper looks at the potential benefit of inspiratory muscle training as an alternative to standard balance training intervention.  The findings of this pragmatic parallel study support the hypothesis that 8 weeks of unsupervised, individual, home-based inspiratory muscle training, improves balance ability to a similar extent to supervised, group-based balance training in healthy older adults.

The article is now fully available as open access here

https://doi.org/10.1371/journal.pone.0227379

 

–

Dr Ferraro.

fferraro@bournemouth.ac.uk

www.ferrarotrainer.com

 

MHRA webinar regarding new regulations on Medical Devices – 6 Feb 2020

Industry collaboration, NHS

*Unfortunately this webinar is being postponed

On 6 Feb MHRA are running a webinar about changes to the UK law for medical devices which will affect the NHS/University.

The changes will apply from 26th May 2020 and introduce a number of changes for Healthcare Institutions, including for clinical trials for medical devices, reprocessing single use devices and storing device identifier information.

If you are involved in developing a clinical trial for a device, manufacture, reprocess or regularly use medical devices, they encourage you to attend the webinar.

This is your opportunity to see what changes are being made and better understand how it will impact on you.

The meeting will be held on: Feb 6, 2020 12:00 PM

You will need to register in advance for this meeting at the following link: https://mhra.zoom.us/meeting/register/v5wqc-ChrDkrj8YZBNePipahj_S_yXcWng Instructions on how to register can be found here.

After registering, you will receive a confirmation email containing information about joining the meeting.

If you have any further questions about this webinar please reply to Devices.Consultation@MHRA.gov.uk

 

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 in person, call us on 61939 or send us an email.

‘Research adrenaline junkie: how clinical research energised my career’

NHS

The Royal College of Physicians have recently published a set of articles that reflect the crucial role clinical research plays in the NHS.

This article comes from a Consultant Gastroenterologist at the Royal Wolverhampton NHS Trust in which he talks about the transformational effect that clinical research had on his career.

You can see the article here.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

Happy reading!