Category / Post-award

UKRO Visit (and Brexit)

As usual, RDS will host an annual UK Research Office visit to BU in 2019. This year’s event has been scheduled for November; the reason is obvious – Brexit!

 

All academic staff interested in EU funding are invited to attend the event:

Monday 18th November Fusion Building – FG06 from 11:00 – 14:30. Lunch will be included.

Dr Andreas Kontogeorgos, European Advisor of the UK Research Office will be discussing with us the impact of Brexit on EU funding opportunities. Academics are welcome to submit any other EU funding related topics for discussion to Ainar Blaudums by the end of October.

UKRO delivers subscription-based advisory service for research organisations and provides MSCA and ERC National Contact Point services in the UK. As part of UKRO services, BU members of staff may sign up to receive personalised email alerts and get early access to EU funding related publications on UKRO portal.

Please contact Organisational Development to book a place.

BUCRU (Bournemouth University Clinical Research Unit) – Newsletter

Please see the latest newsletter from the Bournemouth University Clinical Research Unit (BUCRU). We hope you find it interesting.  This is our ‘last’ newsletter and covers content from last year, we are shortly introducing new quarterly ‘BUCRU Bulletins’ with more recent content to be disseminated digitally.

BUCRU supports researchers to improve the quality, quantity, and efficiency of research locally by supporting grant applications and providing on-going support in funded projects, as well as developing our own programme of research.  2018 was an exciting year for BUCRU including being awarded a further 5 years of funding from National Institute for Health Research (NIHR) to continue our work as the RDS (Research Design Service) South West.  We’ve also submitted 14 grant applications, have 23 peer-reviewed publications and over £800,000 in grant involvement.

You can find out more within the newsletter, including news from our colleagues in the Centre of Postgraduate Medical Research and Education or visit: www.bournemouth.ac.uk/bucru

And don’t forget, your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) on the 5th floor of Royal London House. Feel free to pop in and see us, call us on 61939 or send us an email.

Update on Brexit preparations

The UK Government has produced a number of technical notices and provided details of the governmental Departments responsible for specific sectors and EU programmes. This has been done as part of no-deal Brexit preparations.

A number of Departments have drafted documents detailing plans to support UK researchers, universities and businesses who benefit from EU funding schemes, if the UK leaves the EU without a deal. Where applicable, the notices also set out how the Underwrite Guarantee, and the Post-EU Exit Guarantee Extension will operate if there is no deal.

More details are available on the ‘The Government’s Guarantee for EU-funded Programmes if the UK Leaves the EU Without a Withdrawal Agreement (No Deal)’ website. Website provides links to individual technical notices related to such programmes as Horizon 2020, Erasmus+, European Social Fund, European Regional Development Fund, Creative Europe, Europe for Citizens and some others. These are in addition to a wide range of other technical notices and announcements for specific sectors, which are available on the GOV.UK website.

Several submission portals have been developed by the UK Government to collect data of EU-funded projects. For example, UK Research and Innovation (UKRI) launched a portal to collect basic information from UK beneficiaries of on-going Horizon 2020/FP7 projects (the RDS have populated this on behalf of all awarded projects to BU); the UK Cabinet Office has set up a portal for recipients of funds under such programmes as Health for Growth, Rights, Equality and Citizenship Programme, Erasmus+, Competitiveness of Small and Medium-Sized Enterprises, Europe for Citizens and Creative Europe; the Department for Digital, Culture, Media & Sport has a dedicated portal for recipients of funds under Creative Europe and Europe for Citizens.

With regards to applying for new Horizon 2020 grants, in a no deal scenario the UK will automatically be assigned a third country status. With calls open to the third country participation, those will also be open to the UK applicants to participate and even coordinate collaborative projects. However, this may not be a case for European Research Council (ERC) and Marie Skłodowska-Curie actions (MSCA) applications – there are restrictions for third country participation in these actions, for example, as regards ERC grants, the PI has to be hosted by an institution in a Member State/Associated Country (MS/AC) and 50% of their total working time has to be spent in MS/AC.

If a no-deal scenario takes place shortly after a call deadline, the approach that the European Commission will follow regarding eligibility and evaluation of ERC and MSCA proposals is currently unknown. The Government and involved institutions are aware of potential issues that could arise and are working closely in seeking a solution.

BU academics having concerns regarding their research funding after Brexit or questions before applying for a new EU grant are welcome to contact Ainar Blaudums, International Research Facilitator, Research Development & Support directly, or ask your Research Facilitator/Funding Development Officer for advice.

Good Clinical Practice refresher – 2nd October 2018

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 Royal Bournemouth Hospital on Tuesday 2nd October, 1pm – 4:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics or the Wessex Clinical Research Network.

Introduction to Good Clinical Practice – 10th October

Are you interested in running your own research project within the NHS? 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 well-being of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 10th October, 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.

NIHR and World Health Organisation joint statement – have your say!

There is an increasing emphasis on the need for researchers and sponsors to publish, and disseminate, the results of the clinical studies that they conduct. Timely disclosure of results is important ethically, morally, in the interests of research integrity and from a waste reduction perspective.
Dissemination of results, whether favourable or not, also achieves transparency – increasingly important from the perspective of the recent introduction of the GDPR.

The National Institute for Health Research (NIHR) have signed-up to the WHO’s joint statement on public disclosure of results from clinical trials. The policy sets out the expectations and support on offer in order for research communities to comply. The draft policy is available to read, with a quick survey open until 21st September, for you to have your say.

BU has access to the ClinicalTrials.gov system – get in touch for access and for the opportunity to register your study and results in the public domain.

Introduction to Good Clinical Practice – 10th October

Are you interested in running your own research project within the NHS? 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 Wednesday 10th October, 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 – 2nd October 2018

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 Royal Bournemouth Hospital on Tuesday 2nd October, 1pm – 4:30pm.

Spaces are still remaining and the closing date for bookings is the end of Monday 24th September. If you’d like to enrol, get in touch with Research Ethics or the Wessex Clinical Research Network.

Updated HRA and HCRW Statement of Activities and Schedule of Events published

What is the significance of the Statement of Activities and Schedule of Events?

When the Health Research Authority (HRA) approval process was introduced in March 2016, the Statement of Activities (SoA) and Schedule of Events (SoE) documents were made mandatory for non-commercial studies – those initiated and managed by non-commercial organisations such as Universities, NHS Trusts, charities etc.
The two documents must be submitted alongside your study documents when seeking NHS Research Ethics Committee approval, and the approval of the HRA, as the ‘umbrella organisation’.

With the introduction of the new General Data Protection Regulations, the HRA and HCRW have amended the two documents. They may be found here.

Who is ‘HCRW’?

HCRW stands for Health and Care Research Wales, and they have recently aligned its processes and paperwork with the HRA’s, so as to streamline and make consistent the research application process within England and Wales. Until recently the HRA was the umbrella organisation in England only, and a separate process was required if you wished to include research sites in Wales, Scotland, and Ireland*.

*If you wish to include sites from Scotland and Ireland, then the ‘old process’ is still to be followed. Contact Research Ethics for guidance.

What do I need to do?

If you are currently awaiting your approvals from the REC and HRA/HCRW, you do not need to do anything unless otherwise instructed by the HRA/HCRW. If you are concerned please get in touch with your HRA assessor, or their queries line.

If you are simply thinking of introducing your research into the NHS, are at your beginning stages, or you are currently compiling your study documents, then please remember to use the new versions of the SoA and SoE.
Please get in touch with Research Ethics for guidance on any aspects of clinical research, guidance, and if not already obtained, to request sponsorship of your study. Guidance and useful documents may also be found on the Clinical Governance blog.

Updated HRA and HCRW Statement of Activities and Schedule of Events published

What is the significance of the Statement of Activities and Schedule of Events?

When the Health Research Authority (HRA) approval process was introduced in March 2016, the Statement of Activities (SoA) and Schedule of Events (SoE) documents were made mandatory for non-commercial studies – those initiated and managed by non-commercial organisations such as Universities, NHS Trusts, charities etc.
The two documents must be submitted alongside your study documents when seeking NHS Research Ethics Committee approval, and the approval of the HRA, as the ‘umbrella organisation’.

With the introduction of the new General Data Protection Regulations, the HRA and HCRW have amended the two documents. They may be found here.

Who is ‘HCRW’?

HCRW stands for Health and Care Research Wales, and they have recently aligned its processes and paperwork with the HRA’s, so as to streamline and make consistent the research application process within England and Wales. Until recently the HRA was the umbrella organisation in England only, and a separate process was required if you wished to include research sites in Wales, Scotland, and Ireland*.

*If you wish to include sites from Scotland and Ireland, then the ‘old process’ is still to be followed. Contact Research Ethics for guidance.

What do I need to do?

If you are currently awaiting your approvals from the REC and HRA/HCRW, you do not need to do anything unless otherwise instructed by the HRA/HCRW. If you are concerned please get in touch with your HRA assessor, or their queries line.

If you are simply thinking of introducing your research into the NHS, are at your beginning stages, or you are currently compiling your study documents, then please remember to use the new versions of the SoA and SoE.
Please get in touch with Research Ethics for guidance on any aspects of clinical research, guidance, and if not already obtained, to request sponsorship of your study. Guidance and useful documents may also be found on the Clinical Governance blog.

 

Training opportunity – completing and submitting your IRAS application

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, R&KEO)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House, room 103 on Thursday 23rd August, at 13:00pm – 16:00pm.

Get in touch with researchethics@bournemouth.ac.uk if you would like to register your interest and book a place.

Useful resources for those involved in clinical research

If you are involved in, or wish to be involved in clinical research, then take a look at this link, where you will find useful resources to support colleagues in getting involved with research, to find out more for yourself, and to help you to encourage more patients to take part too.

If your study will recruit NHS patients or staff, then BU must ‘sponsor’ your project, so remember to involve the Research Ethics team within R&KEO on researchethics@bournemouth.ac.uk as early as possible in your study planning.

‘Clinical Research is Everyone’s Future’

If you are interested in clinical research, or interested in working within this field, either on your own project, or as a future career, then take a look at the National Institute for Health Research’s short video about what clinical research is, and how to support it.

Watch the video to find out:

  • Why clinical research is at the core of the NHS
  • How to respond to patient questions about clinical research
  • How to help patients get involved in clinical research

Remember that the Research Ethics mailbox (researchethics@bournemouth.ac.uk) is available if you have any queries about your own plans to embark on clinical research within the NHS.