Category / nhs

RKEDF Clinical Research Governance Sessions

As you will be aware, RDS offers something called the RKEDF, or Research & Knowledge Exchange Development Framework – as part of this there are a number of sessions available surrounding clinical research governance. These sessions can be booked as a 1:2:1 or in bespoke group sessions with Suzy Wignall, BU’s Clinical Governance Advisor.

As always, general chats/specific discussions can also be booked in too – please just email!

The RKEDF sessions available are as follows:

Please get in touch if you are interested in any of these sessions.

For general guidance, documents and further information surrounding processes, take a look at the Clinical Governance website.

Congratulations to Dr. Rachel Arnold on her latest paper

Congratulations to Dr. Rachel Arnold in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH) on the publication today of her  paper ‘Why use Appreciative Inquiry? Lessons learned during COVID-19 in a UK maternity service‘ [1].  This methodological paper is co-authored with Dr. Clare Gordon who holds a has joint clinical academic post at UCLan and Lancashire Teaching Hospitals NHS Trust, with a focus on developing clinically focused stroke research, education and improvement. Clare is also a former BU Ph.D. student.  Further co-authors from CMMPH are Professors Sue Way and Edwin van Teijlingen.  The final co-author, Dr. Preeti Mahato, finished her post in CMMPH two days ago to start her Lectureship in Global Health at Royal Holloway (part of the University of London).

The paper highlights that selecting the most appropriate research method is an important decision in any study. It affects the type of study questions that can be answered. In addition, the research method will have an impact on the participants – how much of their time it takes, whether the questions seem important to them and whether there is any benefit in taking part. This is especially important when conducting research with staff in health services. This article is a reflection on the process of using Appreciative Inquiry (AI) in a study that explored staff well-being in a UK maternity unit. The authors  discuss our experience of using AI,the strengths and limitations of this approach, and conclude with points to consider if you are thinking about using AI. Although a study team was actively involved in decisions, this paper is largely based on reflections by dr. Arnold, the researcher conducting the field work in the maternity services.

 

Reference:

Arnold, R., Gordon, C., van Teijlingen, E., Way, S., Mahato, P. (2022). Why use Appreciative Inquiry? Lessons learned during COVID-19 in a UK maternity service. European Journal of Midwifery, 6(May), 1-7. https://doi.org/10.18332/ejm/147444

Request for feedback – MHRA clinical trials consultation

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Request for feedback – MHRA clinical trials consultation

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Updated HRA amendment tool now live

Please see below and note that from now any amendment made should be using version 1.6 of the document.

‘What: An updated amendment tool has been released for use when submitting amendments for health research studies

Who: All researchers and sponsors

When: Released 6 December

We’ve also made some other changes to the amendment tool to make it easier to use including:

  • improved guidance in the submission tab
  • changes to the radio selection buttons to make it clearer to complete and view once converted to a pdf
  • changes to help users avoid common mistakes

You can get all details on the changes we’ve made in the Change Record in General Guidance tab on the tool. Please start to use the new version (1.6) for all new amendments from 6 December 2021. We will continue to accept amendments using version 1.5 for two weeks. We will not accept amendments submitted on V1.5 after 20 December 2021.’

Please see this link for further information.

The future of mental health research in Wessex – online meeting

Date: 9 December 2021

Time: 12:30-14:00

Location: OnlineChaired by Professor Chris Kipps, in this meeting attendees will learn about the new mental health network in Wessex and explore opportunities to collaborate and discuss the mental health research landscape across Wessex. Register for a place here.

Paper published outlining good practice for receiving informed consent

A paper has been published by Hugh Davies (Chair, Oxford A NHS Research Ethics Committee) and the members of Oxford A Research Ethics Committee (REC) which includes a model for what the REC considers to be good practice in terms of consent for research participation. The paper proposes that there are four simple steps which consent processes should be built around:

  • Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.
  • Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.
  • Step 3: After a gap, if necessary, reviewing and checking understanding.
  • Step 4: Reaching agreement and recording consent.

The paper outlines common issues such as information provision to participants, inadequate public involvement, and lack of proportionality.

You can access the paper here.

Remember that RDS offers training in informed consent, as does the National Institute for Health Research. If you are interested in accessing this training, please email Research Ethics.

Template documents are also available via the Health Research Authority website.

Health Research Authority – new final report requirements

Please see below for an update from the HRA –

Changes to the way you submit your final report

The Health Research Authority has implemented changes to final study reporting requirements. The changes apply to all studies across the UK which require ethics approval and which have not yet submitted a final report.

The Make It Public strategy set out our commitment to make transparency easy, make transparency the norm and make information public. We have now developed a standard dataset on research transparency which will be collected in the study final reports. Coupled with changes we have already made to help you plan at the start of a study how you will inform participants at the end, these changes are steps towards fulfilling that commitment.

In the future we will be able to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).

In standardising the information we request from you and the form for collecting this, we hope it will be easier for you to know what is expected.

If you have any questions, please email research.transparency@hra.nhs.uk

NIHR Research Design Service – Starting Research Workshop

Please see below for the following training opportunity:

Date: 15 September 2021
Time: 09:15-13:30
Location: Online

Funded and hosted by the NIHR Research Design Service (RDS) South Central, discover how to move from thinking about doing research to taking your first steps in the getting support, dedicated time and funding to actually do it. Sign up to the workshop on Eventbrite.

Health Research Authority’s new student research eligibility criteria – live from today

New eligibility criteria for standalone student research go live today (1 September 2021). These changes are designed to ensure that students’ experience of research reflects how modern health and social care research is conducted.

This new criteria encourages innovative approaches to student research like group research, mock Research Ethics Committees (REC) or shadowing a range of people in an existing project.

The changes mean some master’s students will now be eligible to apply for approval to carry out their research.

To help students plan their research we have created a new student research toolkit. The toolkit has been designed to pull together the resources a student will need to understand what approvals are required and whether they are eligible to carry out their research in the UK.  It contains links to existing decision tools as well as some new ones developed especially for students. It uses a simple question and answer format and will provide answers to the following questions:

  • Is my study research?
  • Is my research taking place in the NHS and will it need NHS approval?
  • Do I need NHS REC review?
  • What type of NHS ethics review do I need?
  • Can I carry out my research?

Completing the tool will provide students with an understanding of what activities they can do and ensures that they do not waste time applying for approval for research that they are not able to carry out under the new student eligibility criteria. Through completion of the toolkit, students can access supplementary declarations that need to be completed by their academic supervisor, confirming that they meet the criteria for the type of approvals they need for their research. There are three separate declarations depending on the approvals needed – the toolkit guides the student to the right one based on their responses.

Please share this update and new resource with colleagues and students who might benefit. Further details about the new eligibility criteria can be found on the HRA website.

Please see our question and answer section for further information. If you have any other queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Please contact Suzy Wignall, Clinical Governance Advisor in RDS if you have any queries or concerns.

Health Research Authority Releases Question and Answers: Student Eligibility Criteria

The Health Research Authority have published some questions and answers in relation to student research – this is in relation to the recent update regarding the upcoming changes to eligibility criteria.

You can find the Q&As here.

If you have any queries please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.

Dorset Integrated Care System (ICS) Innovation Hub: Open call for priority support

Dorset Integrated Care System (ICS) Innovation Hub: Open call for priority support

Dorset ICS Innovation Hub

To help improve health and social care outcomes, equity and accessibility across Dorset, University Hospitals Dorset NHS Foundation Trust is implementing a Dorset Innovation Hub. It will seek to address the unique challenges of caring for the population of Dorset, and the need to innovate and transform care.

The Hub will support adoption of proven innovations across the Dorset ICS. It will coordinate horizon scanning approaches and prioritise which innovations to bring to Dorset for rapid adaptation and adoption, at scale. A core project team of innovation multidisciplinary professionals will be assisted by a wider well-established network of subject matter experts.

Details of the Call

The Innovation Hub recognises that there is a plethora of improvement, transformation and innovative workstreams being undertaken and it has therefore been agreed that an open call would be made to partner organisations such as Bournemouth University so that each could made one request for priority support.

Priority Support Available

The Innovation Hub is seeking to support a range of local priorities across health and social care in the process towards implementation and adoption via the following ways:

  • Project management and oversight
  • Horizon scanning
  • Implementation
  • Training and education
  • Benefits realisation including evaluation
  • Finance, commission, and procurement advice
  • Quality and risk advice
  • Patient, public engagement advice

Therefore, if you have a health or social care related project that supports these local priorities and which would benefit from additional priority support to speed its implementation and adoption, you are strongly encouraged to submit your project for nomination.

 

 

Eligibility

Bournemouth University will nominate one project to go forward for priority support consideration by the Innovation Hub core project team.

Nomination assessment criteria

All projects submitted before the deadline will be evaluated using the following scoring criteria:

  • The project provides a solution to a problem in one of the following areas: Health inequalities/Population health management/Place based interventions/Workforce/Winter planning/Implementing clinical services review/Digital/COVID recovery
  • Novelty (Score 1-5): Projects should be novel and highly innovative in their support of local health or social care priorities.
  • Alignment with SIAs (Score 1-5): Projects that are nomination worthy will demonstrate alignment to the scope of one or more of the SIAs.
  • Interdisciplinarity (Score 1-5): Projects that are nomination worthy will demonstrate how they will secure interdisciplinary working that will achieve stronger outcomes than disciplines working in silos.
  • The potential for medium/long-term development and impact across Dorset (Score 1-5): Projects that are nomination worthy will demonstrate potential to secure societal impact with extensive reach and/or significance.

Application Process and Timescales

To apply, please complete and submit the application form to Lesley Hutchins (Research Commercialisation Manager) at innovate@bournemouth.ac.uk by 17:00 Friday 20 August 2021. Applications submitted after this time will not be considered.

Completed applications describing eligible projects will be reviewed by BU members of the Dorset Innovation Hub and the DDPPRs after the application deadline.

The nominated project will be informed and announced on the BU Research and Faculty blogsBU’s nomination will be submitted to the Dorset ICS Hub for consideration on or before Tuesday 31 August 2021. 

The Dorset Innovation Hub core project team will then approve which projects will be taken forward in their Tuesday 28 September 2021 meeting. If selected by the Innovation Hub, the BU nominated project’s Principal Investigators will be notified shortly thereafter.

Important: The Dorset ICS Open call for priority support may be promoted elsewhere. Please do not submit your application to any of these other portals as it will not be eligible for nomination. BU applications should only be submitted to innovate@bournemouth.ac.uk

Find out more

If you have any questions, please email Lesley Hutchins (Research Commercialisation Manager) at innovate@bournemouth.ac.uk

Health Research Authority UPDATE: undergraduate and master’s research projects

New eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.

The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 the HRA paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, they are introducing new eligibility criteria for standalone student research.

The new criteria mean that some master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged. Full details are in table one – permitted student research table. They have also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator.

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of the HRA event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read the HRA website for further information and ideas https://www.hra.nhs.uk/student-research/.

The HRA are giving notice now so that course leaders and students have time to prepare for the new arrangements, including ensuring that any changes to institutional policies and procedures are made.

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk or swignall@bournemouth.ac.uk

Congratulations to Sara Stride

Congratulations to Sara Stride and her PhD supervisors on the publication of ‘Identifying the factors that influence midwives’ perineal practice at the time of birth in the United Kingdom’ in the international journal Midwifery [1].  The Obstetric Anal Sphincter Injuries (OASI) Care Bundle is designed to reduce the incidence of obstetric anal sphincter injuries. However, introducing behavioural change requires an understanding of current practice. This national study aims to establish midwives practice at the time of birth, and the factors that influence this.  The paper concludes that there has been a growth in the number of midwives using “hands on” at the time of birth but midwives feel that they require additional training in regards to identifying an OASI. The study should be repeated following the roll out of the OASI care bundle, to identify its impact on midwives’ perineal practice.  This nation-wide study identified the need for improvements in the recognition of OASI by midwives, and in future repeating the study would identify whether the OASI care bundle has influenced midwives’ practice.

Well done!

Prof. Edwin van Teijlingen

CMMPH

 

Reference

  1. Stride, S.L., Hundley, V.A., Way, S., Sheppard, Z.A. (2021) Identifying the factors that influence midwives’ perineal practice at the time of birth in the United Kingdom, Midwifery, 103077

Free online course – Improving Healthcare Through Clinical Research

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and is be available from Monday 24th May, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

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 website.