Tagged / BU research

Setting up NHS / HSC research in the UK– upcoming changes

The UK Local Information Pack

A ‘UK Local Information Pack‘ will be introduced on the 5 June 2019 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 5 June, will 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. Researchers setting up their study before 5 June should continue to use this document.

From 5 June the Statement of Activities will be 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 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.

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 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 5 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.

Article published in Physiological Reports

 

The article titled “The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study” has been published by Physiological Reports.

 

It is the first research to describe the effects of inspiratory muscle training (i.e. breathing exercises that improve the strength of inspiratory muscles) on static and dynamic balance (measured with the clinical tool mini-BEST) and functional mobility (such as Timed Up and Go and 5 sit to stand tasks) with community dwellers older adults (aged 65+).

The research is part of Francesco Ferraro PhD journey. Journey guided with the supervision of Professor Alison McConnell, Dr James Gavin and Tom Wainwright

The article is now fully available as open access here

https://doi.org/10.14814/phy2.14076

Abstract

To examine the effects of 8‐week unsupervised, home‐based inspiratory muscle training (IMT) on the balance and physical performance of healthy older adults. Fifty‐nine participants (74 ± 6 years) were assigned randomly in a double‐blinded fashion to either IMT or sham‐IMT, using a pressure threshold loading device. The IMT group performed 30‐breath twice daily at ~50% of maximal inspiratory pressure (MIP). The sham‐IMT group performed 60‐breaths once daily at ~15% MIP; training was home‐based and unsupervised, with adherence self‐reported through training diaries. Respiratory outcomes were assessed pre‐ and postintervention, including forced vital capacity, forced expiratory volume, peak inspiratory flow rate (PIFR), MIP, and inspiratory peak power. Balance and physical performance outcomes were measured using the shortened version of the Balance Evaluation System test (mini‐BEST), Biodex® postural stability test, timed up and go, five sit‐to‐stand, isometric “sit‐up” and Biering–Sørensen tests. Between‐group effects were examined using two‐way repeated measures ANOVA, with Bonferroni correction. After 8‐week, the IMT group demonstrated greater improvements (P ≤ 0.05) in: PIFR (IMT = 0.9 ± 0.3 L sec−1; sham‐IMT = 0.3 L sec−1); mini‐BEST (IMT = 3.7 ± 1.3; sham‐IMT = 0.5 ± 0.9) and Biering–Sørensen (IMT = 62.9 ± 6.4 sec; sham‐IMT = 24.3 ± 1.4 sec) tests. The authors concluded that twice daily unsupervised, home‐based IMT is feasible and enhances inspiratory muscle function and balance for community‐dwelling older adults.

Paper in top 30 most cited Journal Advanced Nursing articles

BU’s Dr. Bibha Simkhada’s paper ‘Factors affecting the utilisation of antenatal care in developing countries: a systematic review of the literature’ [1] is currently the 27th most cited paper in the Journal of Advanced Nursing.  This is great achievement considering that the journal has published nearly ten thousand articles since its inception (to be precise 9,847).  The Journal of Advanced Nursing (published by Wiley) is one of the prestigious journals in the nursing field.  This extremely well-cited paper was part of Bibha’s Ph.D. study at the University of Aberdeen.  Dr. Bibha Simkhada is Lecturer in Adult Nursing in the  Department of Nursing and Clinical Sciences.  One of her co-authors also works at BU, Prof. Edwin van Teijlingen and a second co-author, Prof. Padam Simkhada from Liverpool John Moores University is Visiting Professor in the Faculty of Health & Social Sciences.  The third co-author Dr. Maureen Porter retired a few years ago.

 

 

Reference:

  1. Simkhada, B., van Teijlingen E., Porter, M., Simkhada, P. (2008) Factors affecting the utilisation of antenatal care in developing countries: a systematic review of the literature, Journal of Advanced Nursing 61(3): 244-260.

Future frameworks for international collaboration on research and innovation – Call for evidence

Overview

The Secretary of State for Business, Energy and Industrial Strategy and the Minister of State for Universities, Science, Research and Innovation have commissioned Professor Sir Adrian Smith to provide independent advice on the design of future UK funding schemes for international collaboration, innovation and curiosity-driven blue-skies research. There is a written call for evidence to inform this advice, and BU is preparing an institutional response to this call.

 

Further information can be found in the call for evidence document, and associated Terms of Reference.

 

How to contribute

If you would like your feedback to be included in the institutional response, please complete the feedback form and send to Lisa Andrews, RDS Research Facilitator by Wednesday 15th May.

Introduction to Good Clinical Practice – 15th May 2019

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 15th May, at Bournemouth University, Lansdowne Campus (Bournemouth House) – 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.

Setting up NHS / HSC research in the UK– upcoming changes

The UK Local Information Pack

A ‘UK Local Information Pack‘ will be introduced on the 5 June 2019 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 5 June, will 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. Researchers setting up their study before 5 June should continue to use this document.

From 5 June the Statement of Activities will be 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 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.

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 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 5 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.

Excellent scientific paper by Dr. Alison Taylor

Congratulations to Dr. Alison Taylor and her Ph.D. supervisors on the acceptance of the paper ‘’Scrutinised, judged and sabotaged’: A qualitative video diary study of first-time breastfeeding mothers’ by Midwifery (published by Elsevier) [1].  This is the second paper from Alison’s extremely interesting Ph.D. research, the first one was accepted late last year.  The first article ‘The therapeutic role of video diaries: A qualitative study involving breastfeeding mothers’ was accepted by the international journal Women & Birth  [2].  Alison is Senior Lecturer in Midwifery in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH) and Infant Feeding Lead in the Faculty of Health & Social Sciences.  Her co-authors are Professor Emerita Jo Alexander, Prof. Edwin van Teijlingen (in CMMPH) and Prof. Kath Ryan based at the University of Reading.

 

 

 

Reference:

  1. Taylor, A.M., van Teijlingen, E., Ryan, K., Alexander, J.,  2019, Scrutinised, judged and sabotaged’: A qualitative video diary study of first-time breastfeeding mothers. Midwifery, 75: 16-23.
  2. Taylor, A.M., van Teijlingen, E., Alexander, J., Ryan, K., 2018, The therapeutic role of video diaries: A qualitative study involving breastfeeding mothers, Women and Birth, (online first) DOI. 10.1016/j.wombi.2018.08.160

 

Research in the NHS – HR Good Practice Resource Pack updated

Researchers from BU wishing to conduct their research within NHS premises will require the appropriate documentation. There is plenty of guidance available to guide researchers through these processes.

The Human Resources (HR) Good Practice Resource Pack has been reviewed and updated in light of the Data Protection Act 2018 (DPA 2018) and the General Data Protection Regulation (GDPR) which came into force in the UK on 25 May 2018.

The HR Good Practice Resource Pack describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS.

Changes to the document include:

  1. Inclusion of a transparency notice, which informs and clarifies to the applicant the purpose of collecting their personal data, their rights relating to data processing, as well as fulfilling other GDPR transparency requirements.
  2. The data requested in the Research Passport application form has been minimised following discussion with Data Protection and Information Governance Officers and Human Resource experts.
  3. All references to the Data Protection Act 1998 have been updated to DPA 2018.

You can find all the updated documents here along with the RDS workflow here surrounding staffing and delegation.

Remember that there is guidance available at BU with regard to implementing your research in a healthcare setting. Take a look at the Clinical Governance blog for documents, links and training opportunities. You can also get in touch with BU’s Research Ethics team with any queries.

British Academy Small Grant Call – Now Open

The call for the next round of BA/Leverhulme Small Research Grants will open 10th April 2019 and close 5pm on Wednesday 5th June 2019 and is aimed at Early Career Researcher and/or pump priming purposes.

If you can’t attend this session, then we ask you to submit your intention to bid form to your Funding Development Officer by 17th April 2019, after this date applications will be moved to the Autumn round.

The British Academy have provided updated guidance on the small grants – BA scheme notes for applicants and BA FAQs . They have asked that all applicants read the documentation carefully before starting their application.

Timeline

The call closes at 5pm on Wednesday 5th June 2019.

20th March 2019

 

RDS British Academy Guidance session

 

10th April 2019 Call Opens – start reading guidance
17th April 2019 Intention to bid forms to be submitted to your faculty Funding

Development Officer.

27th May 2019 Nominated referee supporting statement to be completed via FlexiGrant
28th May 2019 Your final application must be submitted on FlexiGrant  by this date at the latest.
28th May -5th  June 2019 Institutional checks to take place by RDS

Any queries please contact Alexandra Pekalski