Tagged / collaboration

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.

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

BU research, 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.

 

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.

NIHR Podcast on Dementia Research

BU research, Impact, Knowledge Exchange, nhs, NHS, Research communication, Research Ethics, research integrity, Research news

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’

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.

RKEDF – Overview of NIHR, CRNs and NIHR portfolio

BU research, Clinical Governance, Guidance, nhs, NHS, Research Training, RKE development framework, Training

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’

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

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.