Tagged / Health

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.

Floods and PTSD in India

Cover of NJE Yesterday the Nepal Journal of Epidemiology published its latest issue which included the paper on ‘Post-Traumatic Stress Disorder among the Flood Affected Population in Indian Subcontinent’ [1].  This Short Communication is co-authored by Prof. Edwin van Teijlingen and two members of the Visiting Faculty in our Faculty of Health & Social Sciences, namely: Prof. Padam Simkhada and Dr. Brijesh Sathian.  The Nepal Journal of Epidemiology is an Open Access journal hence this paper is freely available for anybody with internet access to read.

  Reference:

  1. Asim, M., Mekkodathil, A., Sathian, B., Elayedath, R., N, R., Simkhada, P., & van Teijlingen, E. (2019). Post-Traumatic Stress Disorder among the Flood Affected Population in Indian Subcontinent. Nepal Journal of Epidemiology, 9(1), 755-758. https://doi.org/10.3126/nje.v9i1.24003

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.

Top ten cited paper in MIDWIFERY

Looking at the SCOPUS data for 5 May 2019 on the International Day of the Midwife showed that the theoretical paper ‘Risk, Theory, Social & Medical Models: critical analysis of the concept of risk in maternity care’ [1] is in the top ten mosted quoted articles in Midwifery.  Now in its 35th year, Midwifery is an international  journal published by Elsevier.  Since its inception in 1985 it has published 2,626 papers, and our paper ”Risk, Theory, Social & Medical Models’ has now been cited by 108 papers, making it the eight most cited article.

Professor Edwin van Teijlingen

Centre for Midwifery, Maternal & Perinatal Health (CMMPH)

 

Reference:

  1. MacKenzie Bryers H., van Teijlingen, E. (2010) Risk, Theory, Social & Medical Models: critical analysis of the concept of risk in maternity care, Midwifery 26(5): 488-496.

HRA Research Transparency Strategy Group minutes available

The Health Research Authority (HRA) has formed the Research Transparency Strategy Group in response to the House of Commons Science and Technology Committee Report on clinical trials transparency.

You can read more about the first meeting of the expert group, including the minutes by clicking here

In relation to this, the HRA’s Director of Policy, Juliet Tizzard has released a blog post entitled What’s the point of research transparency? You can read the post here.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. On ClinicalTrials.gov, it is free to do so.
Despite the name, the system may be used for other clinical research projects.

AXA Fellowship campaign

The AXA Research Fund announced new AXA Fellowship campaign. It will remain open until May 20, 2019 at 04:00 pm (Paris, France time).

The AXA Fellowship is a funding scheme aiming at supporting young promising researchers on a priority topic aligned with AXA and the Society – ‘Towards an Improved and Better Supported Mental Health’.

The campaign is dedicated to young Post-Doctoral Fellows – candidates should be maximum PhD+ 5 years with proven scientific excellence and high potential for innovation, transformation and dissemination. Selected projects will be supported for an amount of 125.000€ over 2 years (selection rate in 2018 was 20%). More details can be found on AXA website.

Each institution is eligible to submit maximum ONE expression of interest per call. To avoid more than one expressions of interest (what will lead to disqualification), submission process will be coordinated by RDS.

If you are interested to apply, please contact your research facilitator by 6 May 2019. In case of multiple expressions of interest internal competition will be organised.

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

 

Congratulations to Fairbairn, Tsofliou & Johnson

Congratulations to BU’s Paul Fairbairn, Fotini Tsofliou and Andrew Johnson who together with former BU academic Simon Dyall (now at the University of Roehampton) published their latest paper in the journal Prostaglandins, Leukotrienes and Essential Fatty Acids . This scientific paper is called: ‘Combining a high DHA multi-nutrient supplement with aerobic exercise: Protocol for a randomised controlled study assessing mobility and cognitive function in older women‘.

Well done.

Prof. Edwin van Teijlingen

CMMPH

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.