Tagged / collaborative research

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.

See your spine move in real-time motion at the AECC

innovation

The Centre for Biomechanics Research (CBR) of the AECC University College, Bournemouth are seeking volunteers for their latest research study, investigating spine biomechanics in near real time.

CBR are currently looking for volunteers to help us with our latest piece of research into understanding the back in motion. We need over 100 volunteers to come forward to take part to ensure the project is a success so we can establish a database of spine mechanics in healthy adults. This is the biggest study of its kind and those who volunteer for this research study will get the chance to see their spine move in real-time.

Currently we focusing our recruitment for a sub-study comparing a commonly used skin based marker system, for measuring the spine in motion, to the gold standard of bone tracking using low dose video x-rays. For this study 15 females volunteers are needed to take part.

To find out more about this study please visit the study web-page here.

Who are we looking for?

For this research study, we are looking for people who:

  • Are over 30 and under 70 years of age
  • Have not had low back pain that has prevented normal activity for at least 1 day in the past year
  • Have not had an abdominal/pelvic/lumbar spine surgery in the past 2 years
  • Have not had any medical radiation exposure in the past year or exposure in the past 2 years with a
    dose of greater than 8mSv (defined as CT scan of Chest, Abdomen or Pelvis or Interventional procedures under radiological control i.e. angiography).
  • Have a body mass index (BMI) of less than 30
  • Are not pregnant
  • Willing to participate and able to freely give informed consent.

Next steps

If you are interested in being involved in this project please visit the study web-page here or you can also learn more about this project through the participant information booklet here.
If you would like to register your interest please download the pre-study form here.
For any questions, or to send us your completed pre-study form, please contact us at cbrstudies@aecc.ac.uk

This study has received a favourable ethical opinion from HRA South West - Central Bristol Research Ethics Committee. 
REC reference: 10/H0106/65.

NERC standard grants (July 2020 deadline) – internal competition launched

Funding opportunities

NERC introduced demand management measures in 2012. These were revised in 2015 to reduce the number and size of applications from research organisations for NERC’s discovery science standard grant scheme. Full details can be found in the BU policy document for NERC demand management measures available here.

As at January 2020, BU has been capped at one application per standard grant round. The measures only apply to NERC standard grants (including new investigators). An application counts towards an organisation, where the organisation is applying as the grant holding organisation (of the lead or component grant). This will be the organisation of the Principal Investigator of the lead or component grant.

BU process

As a result, BU has introduced a process for determining which application will be submitted to each NERC Standard Grant round. This will take the form of an internal competition, which will include peer review. The next available standard grant round is July 2020. The deadline for internal Expressions of Interest (EoI) which will be used to determine which application will be submitted is 27th March 2020.  The EoI form, BU policy for NERC Demand Management Measures and process for selecting an application can be found here: I:\RDS\Public\NERC Demand Management 2020.

NERC have advised that where a research organisation submits more applications to any round than allowed under the cap, NERC will office-reject any excess applications, based purely on the time of submission through the Je-S system (last submitted = first rejected). However, as RDS submit applications through Je-S on behalf of applicants, RDS will not submit any applications that do not have prior agreement from the internal competition.

Following the internal competition, the Principal Investigator will have access to support from RDS, and will work closely with Research Facilitators and Funding Development Officers to develop the application. Access to external bid writers will also be available.

Appeals process

If an EoI is not selected to be submitted as an application, the Principal Investigator can appeal to Professor Tim McIntyre-Bhatty, Deputy Vice-Chancellor. Any appeals must be submitted within ten working days of the original decision. All appeals will be considered within ten working days of receipt.

RDS Contacts

Please contact Lisa Andrews, RDS Research Facilitator – andrewsl@bournemouth.ac.uk if you wish to submit an expression of interest.

 

New BU diabetes research

international, open access, Publishing, writing

Congratulations to Dr. Sarah Collard in the Department of Psychology, Dr. Pramod Regmi in the Department of Nursing Science and FHSS Visiting Professor Katherine Barnard-Kelly on their publication: ‘Exercising with an automated insulin delivery system: qualitative insight into the hopes and expectations of people with type 1 diabetes’  [1]. This paper in Practical Diabetes is a joint publication with several North American scholars.

The authors of this qualitative paper distilled three themes related to the benefits of automated insulin delivery systems: (a) more freedom and spontaneity in the individual’s ability to exercise; (b) relief
from worry of hypoglycaemia as a result of exercise; (c) removing the ‘guesswork’ of adjusting insulin for exercise, as well as two further themes relating to potential concerns with regard to safely exercising while wearing an automated insulin delivery system.

Well done!

Prof. Edwin van Teijlingen

CMMPH

 

Reference:

  1. Collard, S.S., Regmi, P.R., Hood, K.K., Laffel, L., Weissberg-Benchell, J., Naranjo, D., Barnard-Kelly, K. (2020) Exercising with an automated insulin delivery system: qualitative insight into the hopes and expectations of people with type 1 diabetes, Practical Diabetes 2020; 37(1): 19–23

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.

Leverhulme Doctoral Scholarships – internal expression of interest

Funding opportunities

The Leverhulme have launched their Doctoral Scholarships scheme offering UK universities funding of 15 Leverhulme Doctoral Scholarships in a priority research area for that institution. As a university we may submit one application only and therefore the university will be coordinating expressions of interest from Academic Staff.

By 11th February 2020, those who are interested in making an application to the Leverhulme Doctoral Scholarships are invited to submit the following expression of interest – Leverhulme Doctoral Scholarships EOI  to Alexandra Pekalski .

Further information about the scheme is available from the Leverhulme Trust. Applicants are advised to check the eligibility criteria very carefully.

Purpose of funding

The Leverhulme will fund 15 doctoral scholarships in a priority research area for that institution. Each award funds 15 Leverhulme Doctoral Scholarships at that institution, with 5 scholarships to be offered in each year of the first three years of the grant.

Each scholarship is for a fixed sum of £90,000 for each student for up to 48 months of full-time doctoral study. This covers:

  • maintenance (at research council levels)
  • tuition fees

Any remaining funds are to be used for the Leverhulme Scholar’s research and training expenses.

While the scholarships may be held by students of all nationalities, the Trust has a particular interest in supporting UK or EU students.

Process for selecting applications to be submitted

Should you be interested in applying, please note that your expression of interest application will be assessed by Doctoral Funding Panel. Further details of the assessment criteria can be found within the  Leverhulme Doctoral Scholarships EOI . Candidates can expect feedback by 25th February 2019.

Timetable

21-01-2020 RDS advertise Expression of Interest (EoI)competition for call
11-02-2020 EoI deadline (EoIs to be sent to RDS)
13-02-2020 Papers (applications) sent to Doctoral Funding panel (RDS to administer)
20-02-2020 Doctoral Funding panel meeting (virtual)
25-02-2020 Doctoral Funding panel decision and feedback disseminated to applicants
25-02-2020 RDS to contact Leverhulme to provide the Trust with the principal applicant’s name, departmental affiliation and email address. Access will then be granted to the Leverhulme Trust Grants Management System
March/April/May-2020 Applicants develop proposals with the support of RDS and Doctoral College
22-05-2020 Application finalised for APF financial sign-off by UET
05-06-2020 Leverhulme Doctoral Scholarships Deadline

If you have further questions or queries please contact Alexandra Pekalski (apekalski@bournemouth.ac.uk) and/or Lisa Andrews (andrewsl@bournemouth.ac.uk  ). For queries relating to Doctoral colleague support please contact Fiona Knight (fknight@bournemouth.ac.uk) and/or Julia Taylor (jtaylor@bournemouthac.uk).