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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.

Doctoral and Advanced NIHR Fellowship Awards are now open for applications

The Doctoral and Advanced NIHR Fellowship Awards are now open to support individuals to undertake exciting and impactful research on their trajectory to becoming future leaders.

Now with increased flexibility and options to include clinical time, they support people at various points of their development from initial pre-doctoral training to senior post-doctoral research.

The NIHR has also partnered with seven charities to offer jointly-funded Partnership Fellowships at Doctoral and Advanced (post-doctoral) levels to utilise the strengths and expertise of both partners.

What do the Doctoral and Advanced Fellowships offer?

Round 3 Doctoral Fellowship – application deadline 1pm, 17 December 2019

The NIHR Doctoral Fellowship is a three year full-time award that supports individuals from all professional backgrounds to undertake a PhD in an area of NIHR research. This Fellowship may be taken up on a part-time basis between 50-100% whole time equivalent (WTE).

Clinical applicants can include up to 20% clinical time as part of the Fellowship.

Need help with your application? Find out tips from Professor Gary Frost, Chair of the NIHR Doctoral Fellowship Selection Committee.

Find out more

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Round 3 Advanced Fellowship – application deadline 1pm, 3 December 2019

The NIHR Advanced Fellowship is for those at post-doctoral level and aimed at several specific points of a researcher’s career development. It is between 2 and 5 years and can be completed on a full or part-time basis (between 50-100% WTE).

They are also available with a ‘clinical academic’ option where clinical applicants can request up to 40% of their time be dedicated to clinical service/development, which would be covered by the award.

Find out what makes an excellent Advanced Fellowship application from Professor Jayne Parry, Chair of the NIHR Advanced Fellowship Selection Committee.

Find out more

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NIHR-Charity Partnership Fellowships

Last year the NIHR Academy announced it would partner with leading UK medical research charities for the first-time, to offer jointly funded NIHR-Charity Partnership Fellowships at both Doctoral and Advanced (post-doctoral) level.

The aim, as part of the newly restructured NIHR Fellowships programme is to harness the strengths and expertise of both partners by adding value and quality in order to make the greatest impact.

Jointly funded NIHR Charity Partnership Fellowships enable researchers to:

  • Be part of an active and supportive research community; maintaining and building a relationship with both the NIHR and charity partner.
  • Engage with and receive valuable input from patient groups, making the most of the patient engagement/involvement opportunities available.
  • Gain greater research exposure through a variety of media and communication channels.
  • Potential events/conferences/networking opportunities available from the NIHR Academy and charity partner.

Please note that Doctoral and Advanced Fellowships now have two rounds per annum that open in April and October.

 

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.

RKEDF – Overview of NIHR, CRNs and NIHR portfolio

On Tuesday 24th October, RDS are running a 2 hour workshop to give an overview of the National Institute for Health Research (NIHR), Clinical Research Networks and the NIHR ‘portfolio’.

This workshop is designed to raise awareness of the benefits of the NIHR’s portfolio of research studies to BU and NHS partners.  It will also explore the role of the NIHR Clinical Research Networks (CRN), with an emphasis on the set-up and work of our local network, Wessex.

The workshop will cover the requirements to be eligible for the NIHR portfolio, how to apply so that your study may be considered for adoption, and how to access the support of the NIHR CRN.

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

  • The work of the NIHR and layout of the CRNs
  • How to apply for and the requirements for portfolio adoption
  • The benefits of having a study on the NIHR portfolio

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

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 15th October, RDS are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

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

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

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

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 15th October, RDS are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

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

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

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

RKEDF – Overview of NIHR, CRNs and NIHR portfolio

On Tuesday 24th October, RDS 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.

Successful Introduction to Research Day at BU

Yesterday Dorset Healthcare University NHS Foundation Trust held an away day for its clinical staff to learn more about health research.  The event was hosted by the Faculty of Health & Social Sciences on its Lansdowne Campus.  The organiser, Dr. Ciarán Newell, a Consultant Nurse Eating Disorders as well as Dorset Healthcare’s Facilitator for Research and Development organised the event to increase research collaborations between Dorset Healthcare and Bournemouth University. 

Our guests were offered a very varied programme with many FHSS staff (as well as one of our Psychology colleagues) presenting their own research or research-related services available at the university.  We hope this event will lead to further fruitful collaborations between the NHS and the university in the near future.

TIME SESSION FACILITATOR
9.30am Welcome Dr. Ciarán Newell
9.40am What research means to me: Patient Research Ambassador (PRA) Anna Glanville-Hearson
10.10am Health & Social Care Research at BU: overview

·        Strategic Investment Areas

·        Departments / Research Centres

Prof. Edwin van Teijlingen
10.30am Research at Dorset HealthCare University NHS Trust: an overview Dr Paul Walters   Clinical Lead, R&D
10.50am Research Design Service & BU Research Support Prof. Peter Thomas
11.00am COFFEE BREAK
11.15am Mixed-methods & qualitative research Prof. Edwin van Teijlingen
11.30am What Bournemouth University Library can offer Caspian Dugdale
11.50am Postgraduate Studies at BU Dr. Sharon Docherty
12.20am Research into health of BAME communities Dr. Bibha Simkhada
12.30pm LUNCH
1.30pm Trust Research & Development team: how can we help you with your research? Dr. Ciarán Newell, Facilitator, R&D

Irene Bishton, Lead Research Nurse

2.15pm

2.25pm

2.35pm

Research into: Nutrition/Dementia/Ageing

Pain research

Smoking cessation & baby dolls

Prof. Jane Murphy

Dr. Carol Clark

Dr. Humaira Hussain

2.45pm TEA BREAK
3.00pm Clinical Academic Support (links to Wessex) Prof Vanora Hundley
3.15pm Academic Writing & Publishing Prof Edwin van Teijlingen
4.15pm Psychology: Mental health research Dr. Andy Mayers
4.30pm Close – Questions & Answers Prof. Edwin van Teijlingen / All

 

Prof. Edwin van Teijlingen

Centre for Midwifery, Maternal & Perinatal Health (CMMPH)

Introduction to Good Clinical Practice – Thursday 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 Thursday 10th October, at Dorset County Hospital, Dorchester9:00am – 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.

Update to HRA’s data transparency wording for Participant Information Sheets

Following the implementation of GDPR in May of this year, the Health Research Authority released transparency wording for use in Participant Information Sheets.

The recommended wording for data transparency has been updated following consultation with various stakeholders and public involvement and feedback on the initial published wording to provide a clearer more layered approach.

The user group developed a short summary text for the Participant Information Sheet which is supplemented by a generic leaflet. The text for both is now live on the HRA website.

What information should be used in my PI Sheet?

The HRA website section is here. Click on ‘Transparency wording for all sponsors’ – this will take you to this page which contains the information to be used.

To access the text to be used in preparing the leaflet to accompany your PI Sheet, click here. If you are on the HRA website section, the text appears once you click the heading ‘Template wording for generic information document’.

What does the revision in text mean for me?

  • If you have already updated your information sheets with the previous wording, you do not need to do anything.
  • The revised wording can be uses for new studies, but the HRA will accept the previous wording if you have already submitted your application or prepared your information sheet for submission.
  • If you do wish to change your wording to the new text, please email Research Ethics so that your participating sites can be contacted.

 

If you have any queries or concerns please email Research Ethics.

NIHR RDS Grant Applications – seminar & support event, Truro, Cornwall – 8th October 2019

Are you planning to submit a grant application to NIHR?

We are holding a one-day event at the Knowledge Spa, Truro, Cornwall on Tuesday 8 October that is aimed at helping you to improve your chances of success..

The morning seminar session is open to anyone to come and hear RDS advisers give presentations on what makes a good grant proposal. Topics covered will include:

  • what does the NIHR look for?
  • the application as a marketing document: selling the topic, selling the method, and selling the team
  • the team
  • clarity of description and explanation
  • feasibility issues
  • identifying and avoiding potential pitfalls.

The afternoon support session of one-to-one appointments is for those who would like to discuss their own proposal with an RDS adviser.

This event is FREE and refreshments and lunch will be provided. Places are limited and will be allocated on a ‘first come, first served’ basis. In order to secure your place please register using our online form by 1pm, 25 September 2019Find out more.

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.

RDS Residential Research Retreat 26-28 November 2019 – Deadline Friday 16th August

Do you have a great idea for a research project?

Are you planning to apply for research funding?

Do you need a dedicated period of quality time with support to develop your research project?

Dillington House, Somerset

26 – 28 November 2019

Deadline for Applications: FRIDAY 16 AUGUST

The Residential Research Retreat provides protected time with expert coaching and support for you to develop your research proposal to the standard required to be competitive in seeking high quality research funding.

Please apply by 16th August here

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.

NIHR-CRN podcast – Research Ethics Committees

The latest podcast from the National Institute for Health Research is available and this time concentrates on Research Ethics Committees.

All research with human participants should have appropriate ethical reflection – the podcast this month contains the thoughts and guidance of Dr Hugh Davies who is an established Research Ethics Committee Chair and former Ethics Advisor for the Health Research Authority.

If you are interested in learning more about NHS Research Ethics Committees you can view the dedicated section on the HRA website here, and even register your interest to sit as an observer at a committee meeting.

Happy listening!

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, RDS)  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 – Lansdowne Campus, room 103 Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

New page on the Clinical Governance Blog – Public Involvement in Research

Involving the public in your study is important, especially at the research design stage, this is known as ‘Public Involvement’ or ‘Patient & Public Involvement’ (PPI). This involvement can greatly improve the quality of your study design and documentation.

To better support researchers with this process (in particular for the purposes of clinical research), there is now a dedicated space for guidance, resources and wider reading, on the Clinical Governance blog space.

You can find the page here – as always if there are any specific queries, please get in touch with Research Ethics.

Good Clinical Practice refresher – Wednesday 14th August 2019

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 Wednesday 14th August, 9am – 12:30pm.

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

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, RDS)  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 – Lansdowne Campus, room 103 Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Setting up NHS / HSC research in the UK– changes from TODAY

The new ‘UK Local Information Pack‘  has been introduced today, 5th June to support the set-up of NHS / HSC research in the UK.

The ‘UK Local Information Pack’ is the set of documents that NHS / HSC organisations use to formally start preparing to deliver the study. You can find more information here, including what comprises the pack. All researchers wishing to set-up their study at an NHS/HSC site from today, 5th June, need to be aware of this change.

The Organisation Information Document

Researchers and research teams may be aware of a document called the ‘Statement of Activities’ – this is essentially a document that allows the sponsor to make clear to the research site, what activities will be undertaken locally. The document can also act as the agreement between the sponsor and site.

From today the Statement of Activities has been replaced by a document called the ‘Organisation Information Document‘. For non-commercially sponsored studies, that are not clinical trials or clinical investigations, the ‘Organisation Information Document’ should be used as the agreement between sponsor and participating NHS / HSC organisation.

A new delegation log template

Another feature of the new UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / HSC organisations. This will allow NHS/HSC organisations to locally record who will be working on the study and who is authorised to undertake study tasks. The delegation log can be found here and should be used for studies submitted for approvals from today.

Schedule of Events or Schedule and Events Cost Attribution Tool (SoECAT)

For non-commercially sponsored studies studies an IRAS Schedule of Events or a SoECAT will be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / HSC organisations on the cost attributions associated with a study.

Further help and guidance

Guidance on the use of the new UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants get ready for the change.

If you are making an IRAS Form submission or planning to set up research in an NHS / HSC organisation from today, 5th June 2019 please read the transition guidance so that you prepare the correct materials.

If you have any queries regarding any of the information provided above, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.

You can also take a look at the Clinical Governance blog for documents, links and training opportunities.

NIHR RDS Residential Research Retreat 26-28 November 2019 – Applications open NOW

Do you have a great idea for a research project?

Are you planning to apply for research funding?

Do you need a dedicated period of quality time with support to develop your research project?

Dillington House, Somerset. 26 – 28 November 2019.

Applications NOW OPEN

The Residential Research Retreat provides protected time with expert coaching and support for you to develop your research proposal to the standard required to be competitive in seeking high quality research funding.

Register your interest with us by filling in the form here

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.