Tagged / research

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

COVID-19 guidance for clinical researchers

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.

Employing Researchers at BU

Notice for those who currently employ or who need to employ researchers on projects.

There is a new Code of Practice for the Employment of Researchers available on the staff intranet.

This document provides guidance on the University’s expectations for the recruitment, support, management and development of research staff in line with the Concordat to Support the Career Development of Researchers.

If you have any queries, please contact RKEDF@bournemouth.ac.uk.

Pre-Call Announcement – GCRF Partnerships

GCRF ‘Conflict Intersections’ Global Partnership Development Awards: Prevention and Resilience at the Intersections between Conflict, Fragility and Wider Development Challenges and Risks

The Arts and Humanities Research Council (AHRC), working in collaboration with other Research Councils within UKRI, is planning to announce a new funding call in early 2020 for Partnership Development awards under the Global Challenges Research Fund’s Collective Programme. This call will support the development of equitable partnerships and an interdisciplinary community to explore the intersections between conflict and fragility (SDG 16: Peace, Justice and Strong Institutions & GCRF Conflict portfolio) and wider development challenges (and other SDGs and GCRF portfolios) such as health, environmental resilience, sustainable cities and food systems, as well as cross-cutting development issues such as gender, inequalities, poverty reduction and sustainable livelihoods.

The call will launch in early March 2020 with a closing date in late spring 2020 and projects expected to start from autumn 2020. Approximately 20 awards of varying sizes up to £200,000 (fEC) and between 12 and 24 months duration will be supported.

Further details can be found in this Pre-Call Announcement Document (PDF, 172KB)

Timescale

Call opens February/March 2020
Call Close May 2020
Panel July 2020
Expected grant start dates September/October 2020

If you require further information, please don’t hesitate to contact Alex Pekalski. She’s happy to have a chat with prospective applicants.

Early Career Conference Grants 2020 – applications are now open

Early Career Conference Grants fund emerging researchers who have not yet had the opportunity to travel internationally beyond their region to present at overseas conferences. Applications for the Early Career Conference Grants are now open. 25 grants of up to £2000 are available in 2020.

To apply, researchers must:

  • Be employed as a lecturer, research fellow/associate or post-doctoral researcher (or equivalent) at an ACU member university
  • Be within 7 years of the start of their academic career – applicants who have taken a career break and returned to work will also be considered
  • Not have previously travelled for work beyond their home region
  • Already have submitted a proposal to present at an overseas conference

How to apply

Full details and the application form can be found on the ACU website

Applicants are required to complete four short personal statements, upload their conference proposal, and attach a letter of reference from their line manager or head of department.

The closing date is 23:59 GMT on Wednesday 25 March.

If you have any queries, please contact RKEDF@Bournemouth.ac.uk

 

Latest NIHR-CRN podcast

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

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.

BRIAN Training

Nominating your outputs for the REF mock exercise

Thursday 27th February 14:00 -15:00 Talbot

BRIAN (Bournemouth Research Information And Networking) is BU’s publication management system.

BRIAN is also used to capture information regarding outputs to be submitted to the REF2021, and to the mock exercises related to REF2021.

This usage of BRIAN is the focus of this training session.

See here to book. Contact RKEDF@bournemouth.ac.uk if you have any queries.