Tagged / clinical research

Free online course! – Improving Healthcare Through Clinical Research

BU research, nhs, NHS, Research Ethics, research integrity, Research news, Research Training, 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

BU research, COVID-19, Doctoral College, EPSRC, ESRC, Funding opportunities, innovation, NHS, pre-award

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

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research communication, Research Ethics, Research news

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

BU research, Clinical Governance, nhs, NHS, Research communication, Research Ethics, Research news, 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, pre-award

  

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

BU research, Clinical Governance, data management, nhs, NHS, Research communication, Research Ethics, Research news

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

BU research, Clinical Governance, Knowledge Exchange, nhs, NHS, Research Ethics, research integrity, Research news

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

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research Ethics, research integrity, Research Training, 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

BU research, Clinical Governance, data management, nhs, NHS, Research Ethics, research integrity, Research Training, 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

BU research, Clinical Governance, nhs, NHS, Research communication, Research Ethics, Research news

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

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research Ethics, research integrity, Research Training, 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

BU research, Coffee Morning, data management, Guidance, nhs, NHS, Research Ethics, research integrity, Research Training, 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

Uncategorized

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

BU research, 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’

BU research, Clinical Governance, nhs, 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!

The Schedule of Events Cost Attribution Tool (SoECAT)

BU research, Clinical Governance, Guidance, nhs, NHS, Research news

SoECAT stands for the ‘Schedule of Events Cost Attribution Tool’ – either a SoECAT or a Schedule of Events (SoE) is required whenever you are conducting clinical research in the NHS or Social Care. Further information and clarification is provided below.

What is the purpose of the SoECAT?

  • The SoECAT is a way of providing clarity to participating NHS  organisations on the cost attributions associated with a study.
  • The template is designed to support correct cost attribution at application for Research Cost funding, to ensure that full site level Research Costs are recovered.

When is a SoECAT required?

  • A SoECAT is required by National Institute for Health Research (NIHR) and NIHR non-commercial partner research funders where the call relates to studies that may involve participants under an NHS or Health and Social Care duty of care.
  • In some cases, your study may be funded by an NIHR infrastructure award which does not cover Excess Treatment Costs (ETCs) – in these cases, a SoECAT would be required in order to access the ETC process for England. Further information on ETCs can be found here.
  • In cases where your study is not funded by the NIHR or a NIHR non-commercial partner, but you wish to make an application to the NIHR CRN Portfolio, you will need to complete a SoECAT.

How do I complete one?

  • The NIHR have recently released new guidance on how to complete a SoECAT which can be found here.

When is it completed and where does the SoECAT go when it is completed?

  • The SoECAT should be completed at the funding application stage.
  • The form must be authorised by an AcoRD Specialist prior to submission for Research Cost funding.
  • It should be submitted alongside your other supporting documents when applying through the IRAS system for NHS Ethics approval and/or Health Research Authority approval*.
  • The SoECAT/SoE is then sent to your participating NHS/HSC organisations as part of the Local Information Pack at the site study set-up stage.

*Where there is no external funding attached to a project, the Schedule of Events should be used instead of a SoECAT.

Where can I get further support and guidance?

  • Your research funder should have guidance you can follow if you are unsure about whether your application requires a SoECAT at the Research Cost funding application stage.
  • Get in touch with Suzy Wignall, the Clinical Governance Advisor, or your Funding Development Officer.
  • Further information about the SoECAT can be found 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.

Guidance available to support researchers attending an NHS REC meeting

BU research, Clinical Governance, Guidance, nhs, NHS, Research communication, Research Ethics, research integrity

Two new links have been added to the Clinical Governance blog under the ‘Useful Links and Documents’ section which give further information and guidance as to attending an NHS Research Ethics Committee meeting for your project. The links are also provided below-

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.