Tagged / clinical research

NIHR Grant Applications Seminar ONLINE – 7th July 2022

  

Dear colleagues

– Do you have a great idea for research in health, social care or public health?
– Are you planning to submit a grant application to NIHR?

Our popular seminar continues online and will take place on Thursday 7th July 2022 from 10.00am – 12.30pm.

The seminar provides an overview of NIHR funding opportunities and research programme remits, requirements and application processes. We will give you top tips for your application and answer specific questions with experienced RDS South West advisers.

We also have a limited number of 20-minute 1-to-1 appointments available after the seminar should you wish to discuss your proposed study with an RDS adviser.

Find out more and book a place.

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU)

We can help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

NIHR RDS SW Residential Research Retreat application drop-in sessions 4th April 1-3pm and 6th April 11am-1pm

 

 

 

The NIHR Research Design Service South West (RDS SW) is holding a Residential Research Retreat 13-15th September 2022 inclusive, at Dillington House in Somerset.

It offers a fantastic opportunity for research teams to develop high quality research proposals in health and social care suitable for submission to national peer-reviewed funding streams.  At the retreat there is advice on tap from a range of methodological advisers (statisticians, health economists, patient and public involvement experts, qualitative researchers etc.) and dedicated time to work on your proposal as a team.

FHSS is offering to cover the costs of  2-3 teams. Teams of up to 3 or 4 can attend the retreat, ideally with at least one member employed in an NHS, social care or public health organisation in the Southwest.  Multi-disciplinary teams with varied research experience will be considered favourably, and a mix of clinical and academic skills and experience is preferable. Teams may include service users or carers.

Places on the retreat are competitive and there is an application process. Fees may be waived for applicants from a public health or social care background, but applicants are advised to seek advice about this before submitting an application.

This is an excellent opportunity for academics who already have a proposal developed in health and social care research that is aligned with fusion and the strategic investment areas.

The deadline for applications is fast approaching: 20th April 2022.

What to do next?

You’ll need to book a slot with NIHR RDS SW Bournemouth site lead, Dr Sarah Thomas who is holding drop-in information and advice sessions to discuss potential applications.  After your slot you will be given an opportunity to apply for FHSS funding.

The sessions are from 1-3pm on Monday 4th April or 11am-1pm on Wednesday 6th April.  Please e-mail: wardl@bournemouth.ac.uk  to book your 15-minute slot.

Further details about the Residential Research Retreat, including the eligibility criteria and application process can be found here: Residential Research Retreat

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU)

The NIHR RDS can advise on all aspects of developing a grant application and can review application drafts as well as put them to a mock funding panel (run by NIHR RDS South West) known as the Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice.

Feel free to call Louise Ward on 01202 961939 or send an email bucru@bournemouth.ac.uk to make an appointment.

Equality Diversity and Inclusivity (EDI) toolkit – NIHR webinar

  

Dear colleagues

– Are you an NIHR funded researcher?
– Are you planning to submit a grant application to NIHR?

NIHR Research Design Service East Midlands are hosting a webinar introducing the new EDI (Equality, Diversity and Inclusivity) toolkit and is a valuable starting point for researchers seeking to develop more inclusive research proposals.

The NIHR Research Design Service (RDS) has developed an EDI toolkit to support researchers to consider and embed EDI at each stage of their research project, from inception through to dissemination, implementation and impact.

The 90 minute webinar is on 30th March 2022 at 13.30.

More information and link to book here.

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU)

We can help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

Medical Research Council – Better methods, better research

MRC are opening up a £2,000,000 fund on 6th May for improving the methods used by others in biomedical and health research.

Deadline: 15th June 2022

The full economic cost of your project can be up to £625,000. MRC and NIHR will fund 80% of the full economic cost.

This is an ongoing scheme. Application rounds open twice per year, closing in June and November

More details on the funding opportunity here.

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU)

We can help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

NIHR Grant Applications Seminar ONLINE – 31st March 2022

  

Dear colleagues

– Do you have a great idea for research in health, social care or public health?
– Are you planning to submit a grant application to NIHR?

Our popular seminar continues online and will take place on Thursday 31st March 2022 from 10.00am – 12.30pm.

The seminar provides an overview of NIHR funding opportunities and research programme remits, requirements and application processes. We will give you top tips for your application and answer specific questions with experienced RDS South West advisers.

We will also be joined by colleagues from the NIHR Health Technology Assessment (HTA) Programme. They will be talking about the HTA programme, the nature of the projects that it funds, tips for success and any upcoming changes.

We also have a limited number of 20-minute 1-to-1 appointments available after the seminar should you wish to discuss your proposed study with an RDS adviser.

Find out more and book a place.

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU)

We can help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

Request for feedback – MHRA clinical trials consultation

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Research Ethics in a Clinical setting

Author: Suzy Wignall, Clinical Governance Adviser

Clinical Research

Clinical Research

This week, we start our focus by looking at research ethics within Health and Clinical Research.

Research conducted within a healthcare setting in most cases will require additional approval to BU ethics. Ensuring that you have the correct approvals and oversight for your study is vital in assuring your participants that you are conducting the study in line with regulations and standards.

Under the UK Policy Framework for Health and Social Care Research, when a student or a member of staff is undertaking their own research within the NHS, then the organisation at which they study or work, should ideally take on the role of the research Sponsor. The Sponsor is defined as an individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research.

Under new guidance, undergraduate students are no longer permitted to make an application to conduct research in the NHS. In certain cases, Master’s students are also not permitted, but should check their eligibility via the Health Research Authority’s student research toolkit.

Approvals

Research involving the NHS or social care, including patients, carers, human tissue, or data may require ethics approval from an NHS Research Ethics Committee (REC) or Social Care REC.  Application for NHS REC is via the Integrated Research Application System (IRAS) and is coordinated by the Health Research Authority (HRA), so you only need to submit one application.

If you are unsure as to whether your research requires NHS REC approval, the HRA have provided a useful decision tool which determines whether NHS REC approval is required.

If NHS REC is not required, you may need other approvals such as HRA and HCRW Approval (Health and Care Research Wales) – for example if you are using NHS facilities, accessing anonymous patient data, or have NHS staff as participants. You may also in some cases need CAG Approval (access to identifiable data without patient consent).

What the University cannot approve

The storage of human tissue or other relevant materials for research, may require a licence from the Human Tissue Authority, which BU does not currently hold.  If you obtain NHS REC approval, this will allow you to collect and store relevant materials for the duration of the project, and for up to one year after the declaration of the end of the research, for the purposes of analysis and verification of research data.

Research where the research participants are adults (aged 16 and over) and are unable to make decisions for themselves i.e. they lack capacity[1].  An ‘Appropriate Body’ to review this type of Research are limited to flagged RECs (in England and Wales) and the Social Care REC.

The University’s research ethics panels are not recognised as Appropriate Bodies under the Act.

Who to contact for help and further information?

Your first point of contact with any queries should be –

Much of the health research at Bournemouth University involves collaborating with the NHS and therefore requires Trust approval.

The following documents have been compiled by Bournemouth University Clinical Research Unit (BUCRU) and Research Development & Support (RDS):

In contacting potential NHS sites, a full list of appropriate contacts can be found on the Research & Development Forum website. It is always worth contacting the Trust early in the process.

Useful documents and links

The clinical governance section on the Research Governance & Integrity website has a wealth of information and links to websites and templates that can be used to make the process easier and less tasking,

A good place to start is deciding whether your study is research. Sometimes what is deemed research at BU, is not classed as such within the NHS. The above tool can help decide for you, as well as the Defining Research table. If your study is not deemed research, then you can proceed with the university ethics route.

If you do need to apply through IRAS, then the Clinical Researcher Checklist (PDF and word formats) can be used to keep track of the tasks required throughout the process.

Further training

External
Good Clinical Practice (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 well-being of your research participants are protected, and that the data collected are reliable.

GCP training should be refreshed every 2 years in line with our training policy, which you can read here.

Please note that due to current advice as a result of COVID-19, courses are being provided online via Zoom. If you are interested in booking onto one of these courses, then please email Suzy Wignall who can put you in touch with the relevant contact.

You can undertake the training online by registering for an account here. On this website you can find full GCP e-learning, GCP refresher e-learning and also training surrounding areas such as informed consent in adults lacking capacity.

Internal
As part of the RKEDF Academics and Researchers can book onto the following sessions, either as a one-to-one meeting or a bespoke team session:

If you are a Postgraduate Research Student, there is also a Clinical Governance workshop as part of the Researcher Development Programme.

[1] The Mental Capacity Act 2005 (MCA)

Request for feedback – MHRA clinical trials consultation

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Updated HRA amendment tool now live

Please see below and note that from now any amendment made should be using version 1.6 of the document.

‘What: An updated amendment tool has been released for use when submitting amendments for health research studies

Who: All researchers and sponsors

When: Released 6 December

We’ve also made some other changes to the amendment tool to make it easier to use including:

  • improved guidance in the submission tab
  • changes to the radio selection buttons to make it clearer to complete and view once converted to a pdf
  • changes to help users avoid common mistakes

You can get all details on the changes we’ve made in the Change Record in General Guidance tab on the tool. Please start to use the new version (1.6) for all new amendments from 6 December 2021. We will continue to accept amendments using version 1.5 for two weeks. We will not accept amendments submitted on V1.5 after 20 December 2021.’

Please see this link for further information.

Wessex REACH Initiative – Peer support grant

The Wessex REACH Initiative was formally launched in the summer and their first newsletter can be found here.

Wessex REACH are offering a small amount of funding to groups of researchers who wish to create a space for thinking, connecting and problem solving with their peers.  By coming together in face-to-face peer group meetings, research ideas and local problems can be discussed, common challenges and possible solutions can be shared and learn from one another. Whether you want to meet for afternoon tea away from the office a few times a year or fund a grant writing away day or any other creative solution that suits your group, they are interested in receiving your applications.

Who is eligible?
Anyone currently working in healthcare, social care or in healthcare-related research in Wessex.

How much is available?
Each group can apply for up to £500 to be used over a 1 year period.  They are aiming to fund up to 4 groups in the first round.  All applications will be reviewed by the Wessex REACH Steering Group and successful applicants notified early in 2022.

How to apply?
Send a short summary (up to 500 words) to info@wessexreach.org.uk by 10 December 2021.  This summary should include the following information, which will be used in the shortlisting process:

  • Contact details for your group or an expression of interest in being part of a group in your area
  • Your reasons for applying and how the award will help to build research capacity in your group
  • Your planned event(s)/activity
  • What your group is hoping to achieve and how it aligns with building research capacity in the Wessex region
  • What facilitation support, if any, you would like from the Wessex REACH Exec Committee (https://www.wessexreach.org.uk/meet-the-team  )
  • Requested total budget

Questions
If you would like to discuss your eligibility or plans prior to applying please contact Beth Stuart (bls1@soton.ac.uk)

The future of mental health research in Wessex – online meeting

Date: 9 December 2021

Time: 12:30-14:00

Location: OnlineChaired by Professor Chris Kipps, in this meeting attendees will learn about the new mental health network in Wessex and explore opportunities to collaborate and discuss the mental health research landscape across Wessex. Register for a place here.

Paper published outlining good practice for receiving informed consent

A paper has been published by Hugh Davies (Chair, Oxford A NHS Research Ethics Committee) and the members of Oxford A Research Ethics Committee (REC) which includes a model for what the REC considers to be good practice in terms of consent for research participation. The paper proposes that there are four simple steps which consent processes should be built around:

  • Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.
  • Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.
  • Step 3: After a gap, if necessary, reviewing and checking understanding.
  • Step 4: Reaching agreement and recording consent.

The paper outlines common issues such as information provision to participants, inadequate public involvement, and lack of proportionality.

You can access the paper here.

Remember that RDS offers training in informed consent, as does the National Institute for Health Research. If you are interested in accessing this training, please email Research Ethics.

Template documents are also available via the Health Research Authority website.

RDS Funding Development Briefing this Wednesday – NIHR Research for Patient Benefit (RfPB).

Reminder: The RDS Funding Development Briefing will be Wednesday at 12 noon. The spotlight will be on the NIHR Research for Patient Benefit (RfPB).

We will cover:

  • Overview of the new schemes
  • How to apply
  • Q & A

For those unable to attend, the session will be recorded and shared on Brightspace here.

Invites for these sessions have been disseminated via your Heads of Department.

Research Fundamentals: In conversation with…the BU Clinical Research Unit

This week on the BU Research Blog we are considering bid quality and how to make a bid as good as it can possibly be. I set off on a quest to speak to members of the BU Clinical Research Unit to understand how they contribute to improving bid quality.

How can the Bournemouth University Clinical Research Unit (BUCRU) support researchers to enhance the quality of their external funding application?

BUCRU is here to support academics and clinicians to develop high quality health and social care research applications. BUCRU’s mission is to improve the quality, quantity, and efficiency of research across the university and National Health Service (NHS). We provide a research advice service to support funding applications and can continue providing support in funded research projects.

As a team, BUCRU has a range of expertise spanning intervention development, trial design, behaviour change, qualitative research, mixed methods, research governance, and patient and public involvement.   Our support is available to both BU staff and local clinicians in the NHS. There are no restrictions on project topic area or professional background of the researcher.

As we’re a hub of the National Institute for Health Research – Research Design Service South West (NIHR RDS SW)  (part of the national Research Design Service) we’re fortunate to have access to other methodological expertise (such as statistics and health economics) as well as popular NIHR SW events and services (for more detail about the NIHR RDS SW see below).

What type of support does BUCRU offer researchers?

We can provide advice on all aspects of preparing a grant application from the initial research idea, including:

  • identifying and refining the research question
  • designing a study
  • research methods (qualitative and quantitative)
  • identifying suitable sources of funding
  • involving patients and public in research design (the NIHR RDS SW has a public involvement fund to support public and patient involvement activities)
  • identifying potential academic, clinical, and public collaborators
  • medical statistics
  • health economics
  • impact and dissemination plans
  • grant writing skills
  • advice on common pitfalls
  • interpreting feedback from funding panels
  • support resubmissions

Which funders will BUCRU support applications to?

We’re keen to help researchers to develop applications for any national external funding bodies with an external peer review process. This includes many funders including NIHR funding schemes, research councils, charities, etc. If you’re applying for seed corn funding to do some initial work to help you to apply for larger scale funding then we can support you with this. If you’re unsure about whether we can help, please do get in touch with us.

If you’re interested in finding out more about NIHR funding and hearing top tips for getting funded, the NIHR RDS SW runs regular online Grant Applications Seminars. The next one of these popular events is on the 9th November 2021. You can find out about it here: http://www.rds-sw.nihr.ac.uk/research-funding-seminar.htm  and book a place here: https://www.eventbrite.co.uk/e/rds-south-west-nihr-grant-applications-seminar-tickets-177003420997

Can BUCRU support researchers in designing and implementing public and patient involvement (PPI) in bids?

Absolutely, Helen Allen is our PPI lead for the unit, with Louise Ward supporting and they work closely alongside the PPI team within NIHR RDS SW as well as BU PIER.

The recent development of VOICE@BU (a BU PIER and BUCRU initiative) has helped us work closely together in supporting researchers at the university.  We can help with plain English summaries, advise on recruiting and managing patient advisory/consultation groups, assistance with public involvement funding for national peer reviewed applications and advice with involving the public in all stages of the research cycle.  We can provide advice on engaging marginalised groups in research, collaborating with community organisations, developing participatory and user-led research, and delivering user-led public involvement training.  With PPI now such a core part of funding bids we strongly recommend that you sign up as a member to VOICE and look at how the platform can help involve the public in your research.  We have a previous blog here: https://blogs.bournemouth.ac.uk/research/2021/05/25/voicebu-2/ that explains VOICE including access to a recorded demonstration that we ran for researchers back in May.

How is the NIHR Research Design Service linked to BUCRU, and what advantages does this offer researchers?

The NIHR RDS-SW Research Design Service South West  is one of 10 regional services across England making up a national network of advisers. NIHR RDS advisers support health and social care professionals and academics in all aspects of developing a grant application (including research design, research methods, funding sources, involving patients and the public) to NIHR and other national peer-reviewed funding streams.

The Bournemouth hub of the NIHR Research Design Service South West sits within BUCRU and is one of four regional hubs (the others are Bristol, Exeter, Plymouth). Dr Sarah Thomas is lead for the Bournemouth hub and staff members include Helen Allen and Louise Ward.  We work regionally across the South West and this has the advantage that it gives us access to a wide variety of additional expertise (such as statistics, health economic, qualitative approaches etc.).  We work in accordance with the RDS charter.

We also offer a monthly NIHR RDS SW Project Review Committee. This offers researchers a fantastic opportunity to have their draft applications critically reviewed by a mock funding panel and detailed feedback provided. This brings the benefit of having an application looked at with ‘fresh eyes’ – the panel includes senior NIHR RDS advisers and public contributors. The committee replicates as far as possible the way a real funding committee will consider a funding application. The panel will also provide helpful feedback on an application that was submitted but not funded, to help you revise the application for a future submission. You can find out more about this service and the submission deadline dates here: http://www.rds-sw.nihr.ac.uk/project_review_committee.htm

How far in advance of a deadline should researchers make contact with BUCRU?

As early as you can!  It’s never too soon, even if you only have a vague idea of a research question. We suggest you contact us ideally at least 4-6 months ahead of a submission deadline. We generally need a minimum of 2-3 months to provide good input. Obviously, it depends on the stage of your application. If it is well-developed and you just require advice on a particular aspect then likely it would need less time. Please see our charter and get in touch with us if you are unsure or have any questions.

What is the best way to make contact with BUCRU?

 You can email us at bucru@bournemouth.ac.uk or wardl@bournemouth.ac.uk or call on 01202 961939.  We are based in BG117 (gradually returning).

Website: https://www.bournemouth.ac.uk/research/centres-institutes/bournemouth-university-clinical-research-unit

Our Twitter is: @BU_CRU

An enormous thank you to Louise Ward and Dr Samuel Nyman from BUCRU for their time to answer my questions. 

Health Research Authority – new final report requirements

Please see below for an update from the HRA –

Changes to the way you submit your final report

The Health Research Authority has implemented changes to final study reporting requirements. The changes apply to all studies across the UK which require ethics approval and which have not yet submitted a final report.

The Make It Public strategy set out our commitment to make transparency easy, make transparency the norm and make information public. We have now developed a standard dataset on research transparency which will be collected in the study final reports. Coupled with changes we have already made to help you plan at the start of a study how you will inform participants at the end, these changes are steps towards fulfilling that commitment.

In the future we will be able to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).

In standardising the information we request from you and the form for collecting this, we hope it will be easier for you to know what is expected.

If you have any questions, please email research.transparency@hra.nhs.uk