Tagged / nhs

Free online course! – Improving Healthcare Through Clinical Research

BU research, Clinical Governance, 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 from Monday 29th June, 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.

HRA announcement – Amendment Tool now live

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

Please see below for a recent update from the Health Research Authority with regard to a new amendment tool and the online submission of amendments.

If you have any queries please email Suzy Wignall in Research Development & Support.

Online submission of amendments and a new amendment tool is now live across the UK, as of today Tuesday 2 June 2020.

These new processes for handling amendments are part of our ongoing Research Systems programme to improve services for applicants.

  • The amendment tool is designed to simplify the amendment process for applicants and
  • The ability to submit amendments online means that applicants can track the submission history of amendments.

From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms. Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date.

To help with these changes, we have now published:

For queries on how to complete the tool, questions on the results from the tool, once complete or how to submit your amendment online, please contact amendments@hra.nhs.uk

Amendment Tool

The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process, from 2 June. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)

The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to, based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.

The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.

The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS.

The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. SOPs, guidance documents and templates etc.). Organisations should do this in accordance with the new process in good time. Given the additional demands placed across the healthcare research systems at this time, the MHRA has confirmed that it will adopt a pragmatic approach during inspection.

Submitting amendments online

Once you have completed the amendment tool, you should follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online system.

For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.

Applicants will need to set up a new login and password for the new part of IRAS. We are sharing a login process with NIHR systems for the new parts of IRAS that provide online booking, the Combined Ways of Working (CWoW) pilot, and this new amendment system. If you already have a login for any NIHR system or one of these new parts of IRAS you can use the same details. If you do not already have a login for those systems, you will need to set up a new login and password as guided by the system.

Once you have logged in, applications will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a pdf of the tool itself. The system will issue an email to confirm the amendment has been submitted.

HRA announcement – Amendment Tool and Guidance now available

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

Please see below for a recent update from the Health Research Authority with regard to a new amendment tool and the online submission of amendments.

If you have any queries please email Suzy Wignall in Research Development & Support.

Online submission of amendments and a new amendment tool will go live across the UK on Tuesday 2 June 2020.

These new processes for handling amendments are part of our ongoing Research Systems programme to improve services for applicants.

  • The amendment tool is designed to simplify the amendment process for applicants and
  • The ability to submit amendments online means that applicants can track the submission history of amendments.

From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms. Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date.

To help with these changes, we have now published:

For queries on how to complete the tool, questions on the results from the tool, once complete or how to submit your amendment online, please contact amendments@hra.nhs.uk

Amendment Tool

The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process, from 2 June. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)

The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to, based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.

The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.

The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS.

The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. SOPs, guidance documents and templates etc.). Organisations should do this in accordance with the new process in good time. Given the additional demands placed across the healthcare research systems at this time, the MHRA has confirmed that it will adopt a pragmatic approach during inspection.

Submitting amendments online

Once you have completed the amendment tool, you should follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online system.

For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.

Applicants will need to set up a new login and password for the new part of IRAS. We are sharing a login process with NIHR systems for the new parts of IRAS that provide online booking, the Combined Ways of Working (CWoW) pilot, and this new amendment system. If you already have a login for any NIHR system or one of these new parts of IRAS you can use the same details. If you do not already have a login for those systems, you will need to set up a new login and password as guided by the system.

Once you have logged in, applications will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a pdf of the tool itself. The system will issue an email to confirm the amendment has been submitted.

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

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

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.

 

New BU breastfeeding research paper

BU research, Featured academics, international, NHS, Publishing, Research news, writing

Congratulations to Dr. Alison Taylor  in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH) the publication two days ago of her paper ‘Commercialisation and commodification of breastfeeding: video diaries by first-time mothers’ in the International Breastfeeding Journal [1].   Alison is Deputy Head of Department Midwifery and Health Sciences as well as Infant Feeding Lead.   This paper is the third paper from her excellent PhD study It’s a relief to talk…”: Mothers’ experiences of breastfeeding recorded in video diaries.  The first and second paper we published in 2019 also with Alison supervisors Professors Jo Alexander, Kath Ryan and Edwin van Teijlingen [2-3].  This third paper focuses on how many of aspects of our lives became increasingly commercialised. Although breastfeeding is perhaps a late comer to this process in recent years, it too has seen significant commercialisation facilitated by social media and our obsession with celebrity culture. This paper explores how the commercialisation and commodification of breastfeeding impacts mothers’ experiences of breastfeeding.

This qualitative research is based on five new mothers in the United Kingdom recorded their real-time breastfeeding experiences in video diaries. The purposive sample of five participants recorded 294 video entries lasting 43 h and 51 min, thus providing abundance of rich data. using a multi-modal method of analysis, incorporating both visual and audio data, a thematic approach was applied.  The study found that women preparing for breastfeeding are exposed to increasing commercialisation. When things do not go to plan, women are even more exposed to commercial solutions. Under the influence of online marketing strategies the need for paraphernalia grew.  Women’s dependence on such items became important aspects of their parenting and breastfeeding experiences.  Alison and her co-authors conclude that the audio-visual data demonstrated the extent to which “essential” paraphernalia was used.  The paper offers new insights into how advertising influenced mothers’ need for specialist equipment and services. Observing mothers in their video diaries, provided valuable insights into their parenting styles and how this affected their breastfeeding experience.

References:

  1. Taylor, A.M., van Teijlingen, E., Alexander, J., Ryan, K. (2020) Commercialisation and commodification of breastfeeding: video diaries by first-time mothers, International Breastfeeding Journal 15:33   https://doi.org/10.1186/s13006-020-00264-1
  2. Taylor A, van Teijlingen, E.,Ryan K, Alexander J (2019) ‘Scrutinised, judged & sabotaged’: A qualitative video diary study of first-time breastfeeding mothers, Midwifery 75: 16-23.
  3. Taylor, A.M., van Teijlingen, E., Alexander, J., Ryan, K. (2019) The therapeutic role of video diaries: A qualitative study involving breastfeeding mothers, Women & Birth 32(3):276-83. https://www.sciencedirect.com/science/article/pii/S1871519218300064

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.

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.