Category / Guidance

Checklist now available to support researchers undertaking clinical research

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

RKEDF – Clinical Research Documentation and Filing

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

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

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

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

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

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

Clinical Governance Standard Operation Procedures – now live

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

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

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

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

Happy reading!

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

Help shape and drive postgraduate researcher development at BU.

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

Some of the main responsibilities include:

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

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

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

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

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

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

Looking for your input…

Do you want to contribute to a University Steering Group?

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

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

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

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

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

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

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

Open Access Week – Fabulous Friday!!

Photo by Clay Banks on Unsplash

Lot’s of fabulous things have been going on across the sector to celebrate Open Access Week 2019. Here are a small selection…

 

 

The publishers have also been getting involved with numerous events, one of note is Royal Society Publishing who made all their content free to access this week. You can browse journals here.

Southampton University hosted a A Very Short Introduction to Open Access using Biscuits

Edge Hill University hosted as a webinar with Open Book Publishers. This non-profit organisation publishes academic books on an OA basis and doesn’t charge authors fees to use the service.

Open Access Week has been truly international with events across the globe:

To end, here is a lovely quote posted by University of Tennessee which reminds us why open access matters…

Royal Society Content for Free!!

For Open Access week, all of the The Royals Society’s content is free to access. Browse their journals: http://bit.ly/2W1pIac 

It’s INTERNATIONAL OPEN ACCESS WEEK!!

Yes it’s here again that joyful time of the year when we highlight and discuss all things open access. First up is a quick reminder…

 

What is Open Access?

Open access is about making the products of research freely accessible to all. It allows research to be disseminated quickly and widely, the research process to operate more efficiently, and increased use and understanding of research by business, government, charities and the wider public.

There are two complementary mechanisms for achieving open access to research.

The first mechanism is for authors to publish in open-access journals that do not receive income through reader subscriptions.

The second is for authors to deposit their refereed journal article in an open electronic archive.

These two mechanisms are often called the ‘gold’ and ‘green’ routes to open access:

  • Gold – This means publishing in a way that allows immediate access to everyone electronically and free of charge. Publishers can recoup their costs through a number of mechanisms, including through payments from authors called article processing charges (APCs), or through advertising, donations or other subsidies.
  • Green – This means depositing the final peer-reviewed research output in an electronic archive called a repository. Repositories can be run by the researcher’s institution, but shared or subject repositories are also commonly used. Access to the research output can be granted either immediately or after an agreed embargo period.

Article first published – http://www.hefce.ac.uk/rsrch/oa/whatis/

To encourage all academic communities to consider open access publishing, Authors Alliance has produced a comprehensive ‘Understanding Open Access‘ guide which addresses common open access related questions and concerns and provides real-life strategies and tools that authors can use to work with publishers, institutions, and funders to make their works more widely accessible to all.

To access and download the guide, please follow this link – http://authorsalliance.org/wp-content/uploads/Documents/Guides/Authors%20Alliance%20-%20Understanding%20Open%20Access.pdf

More information on Open Access Week and activities happening across the world can be found here – http://www.openaccessweek.org/ 

Re-Orientation Events for PGRs

These re-orientation events are your opportunity to receive Faculty and Doctoral College updates for the forthcoming academic year. You’ll also hear about the updates to the 2019-20 Researcher Development Programme and a reminder of support services available to you throughout BU. You’ll be asked to consider research ethics during and towards the end of your research degree and there will be a bite-size effective researcher session appropriate to each re-orientation stage.

Pre-Major Review Re-Orientation

Tuesday 8 October – 9.30 – 1pm – Lansdowne

This re-orientation will also include a preparation session for the Major Review.

Register here.

Post-Major Review (Transfer) Re-Orientation

Tuesday 15 October – 10.00 -1.30pm – Lansdowne

This re-orientation will also include a preparation session for the Viva Voce examination.

Register here.

I look forward to seeing you at one of these bespoke sessions.

Natalie
(Reasearch Skills & Development Officer)
pgrskillsdevelopment@bournemouth.ac.uk

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.

BU articles on academic writing & publishing

Last Friday ResearchGate informed us that ‘Writing an Abstract for a Scientific Conference’ [1] published by three Bournemouth University (BU) scholars (Prof. Vanora Hundley, Dr. Bibha Sinkhada and Prof. Edwin van Teijlingen and a BU Visiting Professor (Prof. Padam Simkhada) had reached 2,500 reads. This paper is one of a series of articles BU academics have published on several aspects of academic writing and scientific publishing.  The range of publications includes issue such as: predatory publishers, authors earning from copyright; finding the best title for your paper, and issues of authorship [2-13].  These are great resources for budding academic writers, especially as nearly are Open Access publications and hence freely available across the world.

Other useful BU resources include the work by Dr. Kip Jones, such as his blogs on Organising & Writing a PhD thesis or his advice on Writing Blogs.   Another great BU resource is the online publication by Dr. Miguel Moital, who wrote the e-book Writing Dissertations & Theses: What you should know but no one tells you, where he shares valuable practical information about the process of writing academic work, notably dissertations. The book starts with explaining the six criteria, expressed in the form of 6 ‘C’s, required to produce high quality dissertations: Confined, Corroborated, Critical, Coherent, Concise and Captivating. The e-book then goes on to share a range of ‘tips and tools’ which contribute to fulfilling the 6 Cs. 

Moreover, it is also worth pointing out that there are some great web resources on writing and publishing produced by BU Library staff, for example on plagiarism;  academic writing; or how to cite references.

 

Prof. Edwin van Teijlingen

Centre for Midwife

References

  1. Simkhada, P., van Teijlingen E., Hundley, V., Simkhada, BD. (2013) Writing an Abstract for a Scientific Conference, Kathmandu Univ Med J 11(3): 262-65. http://www.kumj.com.np/issue/43/262-265.pdf
  2. van Teijlingen, E, Hundley, V. (2002) Getting your paper to the right journal: a case study of an academic paper, J Advanced Nurs 37(6): 506-11.
  3. Pitchforth, E, Porter M, Teijlingen van E, Keenan Forrest, K. (2005) Writing up & presenting qualitative research in family planning & reproductive health care, J Fam Plann Reprod Health Care 31(2): 132-135.
  4. Kretschmer, M., Hardwick, P. (2007) Authors’ earnings from copyright and non-copyright sources: A survey of 25,000 British and German writers, Bournemouth: Bournemouth University,  Centre for Intellectual Property Policy & Management.
  5. van Teijlingen, E, Simkhada, PP, Rizyal A (2012) Submitting a paper to an academic peer-reviewed journal, where to start? (Guest Editorial) Health Renaissance 10(1): 1-4.
  6. van Teijlingen, E, Simkhada. PP, Simkhada, B, Ireland J. (2012) The long & winding road to publication, Nepal J Epidemiol 2(4): 213-215 http://nepjol.info/index.php/NJE/article/view/7093/6388
  7. Hundley, V, van Teijlingen, E, Simkhada, P (2013) Academic authorship: who, why and in what order? Health Renaissance 11(2):98-101 www.healthrenaissance.org.np/uploads/Download/vol-11-2/Page_99_101_Editorial.pdf
  8. Simkhada P, van Teijlingen E, Hundley V. (2013) Writing an academic paper for publication, Health Renaissance 11(1):1-5. www.healthrenaissance.org.np/uploads/Pp_1_5_Guest_Editorial.pdf
  9. van Teijlingen, E., Ireland, J., Hundley, V., Simkhada, P., Sathian, B. (2014) Finding the right title for your article: Advice for academic authors, Nepal J Epidemiol 4(1): 344-347.
  10. van Teijlingen E., Hundley, V., Bick, D. (2014) Who should be an author on your academic paper? Midwifery 30: 385-386.
  11. Hall, J., Hundley, V., van Teijlingen, E. (2015) The journal editor: friend or foe? Women & Birth 28(2): e26-e29.
  12. Sathian, B., Simkhada, P., van Teijlingen, E., Roy, B, Banerjee, I. (2016) Grant writing for innovative medical research: Time to rethink. Med Sci 4(3):332-33.
  13. Pradhan, AK, van Teijlingen, ER. (2017) Predatory publishing: a great concern for authors, Med Sci 5(4): 43.

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.

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.

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!

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.

British Academy Small Grant Call – To Open and Internal Deadlines

The call for the next round of BA/Leverhulme Small Research Grants will open on 4 September and close at 5.00 pm on 6 November 2019.

We welcome Intention to Bid (ITB) forms from Early Career Researchers and/or for bids that deliver pump priming / seed corn funding purposes.

Due to the volume of bids that are received by RDS in every round, the internal deadlines will be strictly applied to ensure that the pre-award team can provide all interested academics with optimal support in a timely manner.

Where ITB forms are received after 18 September 2019, they will be moved automatically to the next round.

The British Academy will be visiting BU on 10 September from 11.00 am to 2.00 pm – this has been organised in place of a workshop; it is highly recommended that you attend this to hear them and ask any questions.

The British Academy has provided guidance and FAQs.They have stipulated that all applicants must read the documentation carefully before starting their application.

Timeline

The call closes at 5.00 pm on 6 November 2019.

Date Action
4 September Call opens – start reading guidance and FAQs.
10 September British Academy’s visit to BU.
18 September Intention to Bid forms to be submitted to your Faculty Funding Development Officer.

 

At this date, advise your referee that you will be sending them your completed application on FlexiGrant and they will need to provide their supporting statement by 22 October.

 

25 September If you are Grade 8 or below and you wish to use the support of an External Application Reviewer (EAR), you must submit a first draft of the application to RDS by this date.

 

An EAR will not be allocated to you if you send a draft to RDS after this date.

 

21 October Latest date for you to fully complete your application on FlexiGrant, so it is ready for your referee to complete the supporting statement via FlexiGrant.

 

Note that the earlier you complete you application on FlexiGrant, the more time the referee will have to review your bid and provide the supporting statement by 22 October.

 

22 October Latest date for referee to complete the supporting statement via FlexiGrant.

 

23 October Click ‘submit’ and the form will be sent to BU’s account for RDS checks.

 

23 October – 5 November Institutional checking process – RDS will work with you to ensure compliance with all funder’s requirements.

 

6 November Submission deadline – latest date to formally submit on FlexiGrant.

 

 

If you have any queries, please contact your Research Facilitator or Funding Development Officer.