Tagged / clinical research

Could you help the Health Research Authority improve the research ethics review?

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS or social care – email the Clinical Research mailbox, and take a look at the Clinical Governance section of the website.

NIHR Research for Patient Benefit (RfPB) seminar – 1st September 12-2pm

Are you interested in finding out about the NIHR RfPB funding
programme? Join our online seminar on 1st September 2022 from
12.00pm – 2.00pm

About the seminar

The seminar will be hosted by the NIHR Research Design Service and will provide a great opportunity to hear from members of the RfPB programme team and funding panel, as well as from successful applicants. There will also be information about the RDS and the support available for people who are applying to the programme.

Who is the seminar for?

Researchers and health and social care professionals who want to learn more about the RfPB programme and the support available to them.

What will the seminar cover?
• An overview of the RfPB programme
• What the funding panel look for in an application
• Experience of previous successful applicant(s)
• Including Patient and Public Involvement (PPI) in your application
• Including Equality Diversity and Inclusion (EDI) in your application
• How the NIHR RDS can support applicants

How to book a place
Please register via this link.
The full programme and further details will be sent nearer to the date of the seminar.

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

We can help with grant applications to National peer reviewed funders. 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.

RKEDF Clinical Research Governance Sessions

As you will be aware, RDS offers something called the RKEDF, or Research & Knowledge Exchange Development Framework – as part of this there are a number of sessions available surrounding clinical research governance. These sessions can be booked as a 1:2:1 or in bespoke group sessions with Suzy Wignall, BU’s Clinical Governance Advisor.

As always, general chats/specific discussions can also be booked in too – please just email!

The RKEDF sessions available are as follows:

Please get in touch if you are interested in any of these sessions.

For general guidance, documents and further information surrounding processes, take a look at the Clinical Governance website.

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.