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.
Category / NHS
Informed Consent training opportunities
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
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
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
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
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.
MHRA webinar regarding new regulations on Medical Devices – 6 Feb 2020
*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.
NIHR Podcast on Dementia Research
The NIHR have recently released another of their podcasts in their Health Research Futures series, this time from Professor Martin Rosser.
Professor Rosser founded Join Dementia Research, a national system for linking patients and public to research studies. He is also the Director of the NIHR Clinical Research Network for Dementia and Neurodegenerative diseases.
In this podcast he discusses dementia research and its importance in the clinical research landscape.
‘Research adrenaline junkie: how clinical research energised my career’
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)
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
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-
- Attending a REC meeting – this page gives you information on areas such as what happens at a REC meeting and attending a REC meeting by telephone;
- Guidance for Study Representatives attending a Full REC meeting– this page gives you guidance and advice as to the process of attending a REC meeting and to help you familiarise yourself with the procedure of ethical review.
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.
RKEDF – Overview of NIHR, CRNs and NIHR portfolio
On Tuesday 11th February, Research Development & Support are running a 2 hour workshop to give an overview of the National Institute for Health Research (NIHR), Clinical Research Networks and the NIHR ‘portfolio’.
This workshop is designed to raise awareness of the benefits of the NIHR’s portfolio of research studies to BU and NHS partners. It will also explore the role of the NIHR Clinical Research Networks (CRN), with an emphasis on the set-up and work of our local network, Wessex.
The workshop will cover the requirements to be eligible for the NIHR portfolio, how to apply so that your study may be considered for adoption, and how to access the support of the NIHR CRN.
By the end of this workshop you will have an understanding about:
- The work of the NIHR and layout of the CRNs
- How to apply for and the requirements for portfolio adoption
- The benefits of having a study on the NIHR portfolio
If you’re interested in attending then reserve your place via Organisational Development.
RKEDF – Good Clinical Practice ‘Lite’
On Tuesday 4th February, Research Development & Support are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.
This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.
The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.
By the end of this workshop you will have an understanding about:
- The importance of protecting the rights, safety and wellbeing of research participants
- The importance of ensuring that research data are reliable
- The roles and responsibilities of those involved in clinical research
- The different stages of the clinical research pathway
If you’re interested in attending then reserve your place via Organisational Development.
NIHR resources – Patient and Public Involvement and Social Media Toolkit
Two resources are now available on the NIHR Learn website for researchers –
- Patient and Public Involvement: Inspiring New Researchers – an online course developed by the Department of Health and NIHR. It is intended to help researchers to understand the benefits of good Patient and Public involvement into their research.
- Social Media Toolkit – a combination of practical resources on how to get started and real case studies from how colleagues across the NIHR Clinical Research Network are currently using social media to support their work.
To access the above resources you will need to have access to the NIHR Learn website. Once you have an account select the tab ‘Health Research Innovations’ and then click on ‘NIHR Endorsed Learning’. Both courses are free and do not require an enrolment key.
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.
CoPMRE Visiting Faculty bi-annual event
Yesterday CoPMRE welcomed 30 colleagues to our Visiting Faculty bi-annual event showcasing the exciting medical developments at BU from the new Bournemouth Gateway Building to the Institute of Medical Imaging and Visualisation. The key priorities to support delivery of BU2025 were presented by Dr Clare Wedderburn, Interim Head of Department of Medicine & Public Health presented. Juan Campos-Perez, Clinical Research Co-ordinator, BUCRU spoke about Biobanks which were highlighted in Professor Emma King’s research presentation on immunotherapy. Professor Jeffrey Wale, Lecturer in Law encouraged innovative medical cross faculty collaboration demonstrated by his recent research collaboration with Professor Sam Rowlands, Visiting Professor resulting in four co-authored papers. The main focus of the meeting centred around Visiting Faculty engagement in research and education to help us achieve our aims. The audience reported that they were ‘very excited’ about these new developments at BU and were keen to support this vision.
IRAS Central Booking Service closure
Please note that the Central Booking Service (CBS; used to book in for review of “IRAS Form” applications and applications only requiring ethical review) will close at 4.30pm on Wednesday 18 December 2019 and will re-open at 9am on Thursday 2 January 2020.
If you need to book in your project for NHS REC review please take note of this Christmas closure.
Any queries please email Research Ethics.
Talk/session with the Wessex Clinical Research Network Study Support Service
The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.
The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England. Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.
Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.
This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.
The session will take place next week on Tuesday 10th December at 2:30pm until 4:00pm on Lansdowne Campus.
To register your interest or if you have any queries, please get in touch with Research Ethics.
Checklist now available to support researchers undertaking clinical research
Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.
The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.
The document is also here on the Clinical Governance blog.
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 – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.
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