Category / Guidance

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.

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.

REF2021: the importance of Open Access compliance

BRIAN, BU Challenges, BU research, Guidance, open access, policy, Publishing, Research assessment

      

Introduction

The four main HE funding bodies in the UK believe that ‘the outputs of publicly funded research should be freely accessible and widely available.’ The REF2021 Open Access Policy was introduced as a requirement for the next REF and it states that – all journal articles and conference contributions (with ISSN) accepted for publication from 1 April 2016 and published on or before 31 December 2020 must comply with the policy to be eligible for submission to the REF.

What does this mean?

Any non-compliant outputs that do not satisfy the policy requirements will NOT be eligible for the next REF.

What are the policy requirements?

  • The outputs must be available open access (via the gold or green open access routes), three months after their acceptance date;
  • The outputs must be discoverable through search engines on the internet, and free to download
  • The outputs must also be in a format where they allow anyone with internet access to search electronically within the texts, to read and to download them

What does this mean to you at BU?

Once you’ve received an official notification from your publisher that your manuscript has been accepted, you should take action right away!

First of all, you should ensure that the publication record is created in BRIAN – Bournemouth Research Information and Networking, clearly specifying the acceptance date. Once you’ve created a record, following instructions on the screen, click on the BURO deposit page as shown below –

To comply with the REF Open Access Policy, you only need to upload/deposit the final accepted peer-reviewed manuscript (and not the final published version). However, depending on individual publisher copyright and policies, this is not always the case. To verify the publisher copyright policies and to decide which version of your manuscript you should use, you can do so through the SHERPA RoMEO online resource, which is a reliable source of information recommended by Research England.

Some of these deposited manuscripts may also be subjected to a period of embargo before they can be made available. Again, this would depend on the publisher copyright policies, which you can also check out on SHERPA RoMEO.

On the ‘Deposit’ page in BRIAN, you will see this message –

BURO, which stands for Bournemouth University Research Online is the University’s Institutional Repository. All manuscripts uploaded on BRIAN will be deposited in BURO and are available to anyone in the world with internet access (subject to embargo).

BURO is supported by a team of colleagues from the Faculty Library Team. The BURO team is available to support and advise you through the open access compliance process and to ensure that you are compliant with all publisher copyright and policies.

Do remember, this process has to be done within three months of your publication acceptance date! Please see this video for more guidance.

What do embargo periods mean for compliance?

As mentioned above, use SHERPA RoMEO to find out more about deposit policies and embargo periods.  As long as your manuscript is deposited within 3 months of the acceptance date, the REF2021 Open Access Policy allows for an embargo period of up to 12 months for the REF Panels A & B and 24 months for the REF Panels C & D.

What if the output doesn’t meet the compliance requirements?

In some circumstances, some outputs cannot meet the open access policy requirements due to deposit, access, technical or other issues (for more information see here). If these circumstances fall under the permitted exceptions in accordance with the REF Open Access policy, these outputs may still be submitted to the REF. If you are unsure, please seek advice and guidance from ref@bournemouth.ac.uk as early as possible.

If you have questions regarding REF2021 or Open Access compliance, please feel free to contact ref@bournemouth.ac.uk or if you have questions specific to uploading of your manuscript, please contact BURO@bournemouth.ac.uk.

NIHR resources – Patient and Public Involvement and Social Media Toolkit

BU research, Clinical Governance, data management, Guidance, Knowledge Exchange, nhs, NHS, Research communication, Research Ethics, research integrity, Research news, Research Training, Training

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.

BU signs San Francisco Declaration of Research Assessment

BU research, BU2025, Guidance, Publishing, Research assessment, research integrity

We’re pleased to announce BU has signed up to the San Francisco Declaration on Research Assessment (DORA), which recognises the need to improve the ways in which the outputs of research are evaluated.

Vice-Chancellor Professor John Vinney recently signed DORA on behalf of BU and said:

“At BU we value research as an important part of Fusion, in which we bring together excellent education, research and engagement with industry and professional practice.

“Our signature of DORA supports our commitment in our BU2025 strategic plan to inclusivity, and to building a vibrant learning community. “

The declaration was developed in 2012 and by signing it, BU is committing to supporting and promoting the responsible use of metrics and quantitative indicators of research.

DORA’s ultimate aim is to promote real change in research assessment. One of the keys to this is the development of robust and time-efficient ways of evaluating research and researchers that don’t rely on journal impact factors. As a result, they look to share and promote examples of good practice in research assessment, including approaches to funding and fellowships, hiring and promotion and awarding prizes that emphasise the research itself and not where it’s published.

To find out more about the declaration, please head to the DORA website.

Checklist now available to support researchers undertaking clinical research

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

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.

New UK Standards for Public Involvement

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

Involving the public in your study is important, especially at the research design stage. This is called ‘Public Involvement’ (also known as ‘PPI’ [Patient and Public Involvement]). Public involvement in research means research that is done ‘with’ or ‘by’ the public, not ‘to’, ‘about’ or ‘for’ them.

By seeking the opinions and recommendations of the public, it is a great way to ensure that your study is designed and set-up in a way that will be relevant to participants, and of good quality.
This can also help to avoid any setbacks once the project is underway.

The new UK Standards for Public Involvement have now been released and were developed over three years by a country-wide partnership between the National Institute for Health Research (NIHR), Chief Scientist Office (CSO) Scotland, Health
and Care Research Wales, and the Public Health Agency Northern Ireland

They describe what good public involvement looks like and encourage approaches and behaviours that are the hallmark of good public involvement such as flexibility, sharing and learning and respect for each other.

You can see the six UK standards and supporting materials, as well as further details about the partnership, project and the piloting of the new standards, here.

Further guidance is available via the Clinical Governance section of the Research blog and via the Health Research Authority and NIHR pages.

Update on Leverhulme Trust Visit

BU research, Events, Funding opportunities, Guidance, Research news, Research Training, Training

On Weds 20th November, BU were delighted to welcome Dr Tracey Henshaw, Assistant Director of Leverhulme Trust to speak about the funding opportunities available from Leverhulme. Tracey provided an overview of who the Leverhulme Trust are, what they will (and won’t!) fund, their funding programmes, and what they are looking for in funding applications including useful hints and tips for their main programmes.

You can now view the slides via Brightspace here.

Checklist now available to support researchers undertaking clinical research

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

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.

RKEDF – Clinical Research Documentation and Filing

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

On Tuesday 5th November, Research Development & Support are running a 2 hour workshop on clinical research documentation and filing.

This workshop is designed to share best practice in ensuring that records are completed, stored and shared appropriately, in accordance with the ‘ALCOAC’ general principle, and Good Clinical Practice standards.

The workshop will cover the ‘essential documents’ to be kept during the research project, as well as what to do once the study has ended. Also covered will be how to ensure compliance when storing data on paper and electronically and requirements for source data.

By the end of this workshop you will have an understanding about:

  • The ‘ALCOAC’ general principle and how it applies to your research
  • What to keep in your study file
  • How to maintain good and compliant research records, throughout the life-cycle of the study
  • Requirements for once the study has ended

If you’re interested in attending then reserve your place via Organisational Development.

Clinical Governance Standard Operation Procedures – now live

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

The Standard Operating Procedures relating to Clinical Governance at BU are now live and can be found on SharePoint.

A full list of documents and links to each are provided in this table, with a link also present on the Clinical Governance blog.

If you have any queries surrounding the information present within the SOPs, or cannot access the links, please email Research Ethics.

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.

Happy reading!

Expressions of Interest Close TOMORROW – Postgraduate Researcher Development Steering Group – Call for Members (Academics, PGRs and ECRs)

BU research, BU2025, Doctoral College, ECR Network, Featured, Guidance, PG research, Research Concordat, Research news, research staff, Research Training, Student Engagement, student research, Training, Vitae

Help shape and drive postgraduate researcher development at BU.

Join the brand new Postgraduate Researcher Development Steering Group to provide direction to postgraduate researcher development at BU.

Some of the main responsibilities include:

  • Develop and enhance the strategic direction, nature, quality, development and delivery of the University’s provision of researcher development for postgraduate research students (PGRs) which reflect the needs of all PGRs.
  • Guide centrally and faculty provided researcher development provisions promoting complimentary support of both increasing the personalisation of support for PGRs.
  • Evaluate University-wide PGR researcher development provisions, to ensure all programme content is maintained at a high standard and aligns with the university strategic priorities under BU2025.
  • Promote the benefits of facilitation of researcher development to staff and the benefits of engaging with researcher development to PGRs.
  • Enhance the overall PGR student experience at BU.

See the full Terms of Reference for details on the Steering Group if you are interested in becoming a member. There will be 2 meetings per academic year.

Please submit your Expression of Interest, including a half-page as to why you are interested, the knowledge, skills and experience you can bring to the group, via email to Natalie at pgrskillsdevelopment@bournemouth.ac.uk by midday, Friday 1 November.

Membership available:
– PGR Student Champion: 1 per Faculty (open to all PGRs)
– Academic Champion: 1 per Faculty (ideally an active PGR supervisor)
– Early Career Researcher: 1 representative

Expressions of Interest will be assessed by the Chair and Deputy Chair of the Steering Group, we look forward to receiving them.

Postgraduate Researcher Development Steering Group – Call for Members (Academics, PGRs and ECRs)

BU research, BU2025, Doctoral College, ECR Network, Featured, Guidance, PG research, Research Concordat, research staff, Research Training, student research, Training, Vitae

Looking for your input…

Do you want to contribute to a University Steering Group?

Last month, approval was provided by the University’s Research Degree Committee for a brand new Postgraduate Researcher Development Steering Group to provide direction to postgraduate researcher development at BU, and I am recruiting members.

There will be 2 meetings per academic year and ad-hoc if required. Some of the main responsibilities include:

  • Develop and enhance the strategic direction, nature, quality, development and delivery of the University’s provision of researcher development for postgraduate research students (PGRs) which reflect the needs of all PGRs.
  • Guide centrally and faculty provided researcher development provisions promoting complimentary support of both increasing the personalisation of support for PGRs.
  • Evaluate University-wide PGR researcher development provisions, to ensure all programme content is maintained at a high standard and aligns with the university strategic priorities under BU2025.
  • Promote the benefits of facilitation of researcher development to staff and the benefits of engaging with researcher development to PGRs.
  • Enhance the overall PGR student experience at BU.

See the full Terms of Reference for details on the Steering Group if you are interested in becoming a member.

Please submit your Expression of Interest, including a half-page as to why you are interested, the knowledge, skills and experience you can bring to the group, via email to Natalie at pgrskillsdevelopment@bournemouth.ac.uk by midday, Friday 1 November.

Membership available:
– PGR Student Champion: 1 per Faculty (open to all PGRs)
– Academic Champion: 1 per Faculty (ideally an active PGR supervisor)
– Early Career Researcher: 1 representative

Expressions of Interest will be assessed by the Chair and Deputy Chair of the Steering Group, we look forward to receiving them.