Category / Clinical Governance

Introduction to Patient and Public Involvement

BU research, Clinical Governance, Guidance, nhs, NHS, Research communication, Research Ethics, research governance, research integrity, research methods, Research news, research opportunities, Research Training, Training

This half day course is an introduction to PPI and will:
1. Define PPI and why it matters
2. Explore the links between PPI and health equity
3. Explain how to deliver PPI and support those involved

It will be an interactive session, including input from someone with lived experience, talking about their involvement in research.

It will be delivered by Sue Bickler from the Involving People team at Help and Care, an organisation that ‘helps people and communities live the lives they choose’.

Sue has worked in the voluntary sector, local authorities, and health, and has substantial experience engaging with people and communities to ensure that services meet their needs.  Her current role brings together the four Healthwatch in Hampshire and the Isle of Wight (HIOW), ensuring that patient voice is central to decision making in the HIOW Integrated Care System and that people are equipped to support effective Patient and Public Involvement (PPI).

The session is funded by Clinical Research Network Wessex and is open to all health and care researchers working in Wessex including public contributors and community organisations.

Book your place here.  A link to the online training will then be sent to you.

Improving information for people taking part in clinical research

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research Ethics, research governance, research integrity, Research news

The Health Research Authority (HRA) has launched new Quality Standards to improve information given to people who are invited to take part in research. The Quality Standards have been launched alongside Design and Review Principles, which show researchers and Research Ethics Committees (REC) what the important ethical considerations are for participant information.

  • The new HRA Participant Information Quality Standards will help research organisations to understand what good participant information looks like, and will make clear to researchers what the Research Ethics Committees will consider as part of the ethics review, including the review of participant information. The REC will support researchers to create information that meets the Quality Standards.
  • The aim of the Quality Standards and Design and Review Principles is to make participant information better, and to make the way that RECs review that information more consistent. The documents set out the basic criteria that all participant information must meet, and covers language, accessibility, and mandatory content.

Next steps

The Quality Standards and Design and Review Principles will be phased in from autumn 2023. As study materials are prepared in advance, REC reviews of participant information will initially be presented to research organisations as recommendations as opposed to actions required for approval.

From December 2023, the Quality Standards and Design and Review principles will become mandatory and will be applied to all research applications submitted for review.

Changes to participant information are currently the most likely reason for ethics committees to give a provisional opinion. Using this guidance will increase the possibility of receiving a favourable opinion.

Available templates

Remember that BU has Participant Information Sheet templates that provide much of the required wording to ensure your participants are making a fully informed decision before agreeing to participate.

It is vital that when compiling your information sheets that you remember to include the HRA GDPR transparency wording.

Questions or concerns?

If you have any questions regarding these new standards or about clinical research in general, please email Suzy Wignall, Clinical Governance Advisor – swignall@bournemouth.ac.uk or clinicalresearch@bournemouth.ac.uk

NIHR Be Part of Research platform

BU research, Clinical Governance, Guidance, nhs, NHS, Research communication, Research Ethics, research governance, research integrity, research methods, Research news, research opportunities, research staff

The NIHR Be Part of Research platform is an online service that makes it easy for research participants to find and take part in health and social care research. Participants may search for trials and studies taking place looking at certain health conditions and in locations accessible to them.

Clinical researchers may also make use of the service to extend their recruitment and widen their recruitment methods, as the platform has been designed to make it easier for researchers and potential study participants to find each other.

Using Be Part of Research to recruit participants

To use the service for your recruitment, the study must meet the following requirements:

  • Be funded or supported by the NIHR. This includes studies on the NIHR Clinical Research Network Portfolio.
  • Have Research Ethics Committee approval to use the service as a recruitment tool.
  • Have a dedicated point of contact such as a pre-screener or website for interested volunteers to engage with your research team.

Getting your study onto the Be Part of Research platform

Once your study has been registered on either ISRCTN, ClinicalTrials.gov, or on the NIHR Clinical Research Network (CRN) Central Portfolio Management System (CPMS), your project will then appear on Be Part of Research. Given those visiting the site are mostly patients and members of the public, medical and scientific terminology should be omitted when writing your study summary, with plain English used to ensure the information is accessible to a broad audience. In order to do this, you should:
  • Keep it short – but don’t oversimplify it. The reader must understand what the study is trying to achieve.
  • Imagine you are talking to the reader.
  • Take out any jargon.
  • Make sure you cover the what, why, when, where and how so they have the basics of your study.

Additionally, to make sure that participants contact the appropriate person, the contact details provided on ISRCTN or ClinicalTrials.gov should be up to date and accurate. In general, the registry record should be monitored continuously so that any changes are reflected on Be Part of Research as soon as possible.

Further support/contact

If you have any questions regarding the platform or regarding clinical research in general, please email Suzy Wignall, Clinical Governance Advisor: swignall@bournemouth.ac.uk or clinicalresearch@bournemouth.ac.uk

Fitness to Practise paper published

BU research, Clinical Governance, NHS, Publishing, Research news, Uncategorized, writing

Congratulations to Megan Jadzinski, Sara White, Sue Way and Dominique Mylod on the acceptance of their paper ‘How are Fitness to Practise processes applied in UK Higher Education Institutions? – A systematic review’ by the international journal Nurse Education in Practice.  All authors are based in the Faculty of Health and Social Science, or were as Prof. Sue Way retired recently.

Well done,

Prof. Edwin van Teijlingen

Centre for Midwifery & Women’s Health

#StepForward and become an NHS Research Ethics Committee member

BU research, Clinical Governance, nhs, NHS, Research communication, Research Ethics, research integrity, Research news, research opportunities, Research Training

The Health Research Authority are inviting people to #StepForward and become a Research Ethics Committee (REC) member.

REC members meet virtually to review exciting new research studies for some of the biggest challenges in health and social care, including cancer, dementia and COVID-19.

It’s important that committees have insight from different perspectives so that we can all trust their decisions. The HRA are particularly looking for people with no healthcare or research experience.

You’ll be provided with regular training and support and it’s a great opportunity to work with people from a range of backgrounds and learn new skills.

You can find out more here. Alternatively, if you have any questions about being on a REC, please get in touch with Suzy Wignall, Clinical Governance Advisor, and Alternate Vice Chair of the West Midlands – Black Country Research Ethics Committee.

Researcher Roadshow – Exploring Health Data Science

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research Ethics, research integrity, research methods, Research Training, Training

Researcher Roadshow
Exploring Health Data Science

March 1st, 2023. 10:00 – 12:00

The NIHR Research Design Service, Health Data Research UK (HDR UK), the MRC Regulatory Support Centre and NHS Digital are pleased to offer the opportunity to attend the sixth in a series of virtual researcher roadshows.

This free to attend event is aimed at researchers and others working with health and social care datasets who would like to increase their understanding of roles of health data scientists and value of health data science.

The event will bring together health data scientists from the NHS, academia, and industry and provide insights and perspectives on the important work they do.

This event will include presentations on different roles and careers in health data science and different methods and approaches used by health data scientists.

Speakers will be confirmed in the New Year. 

Provisional registration is at: https://ukri.zoom.us/webinar/register/WN_GntzbzTITLmw0ghBRadQKQ

Recordings of previous Researcher Roadshows can be viewed here – Research Advisory Group (RAG) researcher roadshows – NHS Digital

Queries: If you have any questions about this event, please contact: rsc@mrc.ukri.org

Introduction to Patient and Public Involvement (PPI) for Researchers – free event

BU research, Clinical Governance, data management, Guidance, nhs, NHS, research integrity, research methods, Research news, Research Training

Introduction to Patient and Public Involvement (PPI) for Researchers

Date: Tuesday 10 January 2023
Time: 10:30 – 12:30

This event is aimed at people who are new to PPI or setting up their first PPI project, and is free for students and staff from the NIHR, NHS, UK universities, public sector institutions and registered charities based in the UK.

It will help them to discover the support available to plan, deliver and build PPI into their research, and highlight how PPI improves research for patients, services users and carers.

Free online course – Improving Healthcare Through Clinical Research

BU research, Clinical Governance, data management, nhs, NHS, Research communication, Research Ethics, research integrity, Research Training, Training

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 now, 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  Clinical Research mailbox, and take a look at the Clinical Governance website.

Could you help the Health Research Authority improve the research ethics review?

BU research, Clinical Governance, data management, Guidance, nhs, NHS, PG research, Postgraduate Research, Research communication, Research Ethics, research integrity, Research news

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

RKEDF Clinical Research Governance Sessions

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research communication, Research Ethics, research integrity, Research Training, RKE development framework

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.

BU Integrity Week: 16th to the 20th May 2022

BU research, BU2025, Clinical Governance, data management, Doctoral College, ECR Network, Events, PG research, Research Ethics, Research Integritiy

Unlock greater potential by maximising your awareness and understanding of Integrity! 

The ability to utilise integrity in research, writing and teaching is vital for academic success. However, continuing to retain your integrity is fundamental but this can only be achieved by maintaining an ability to keep up-to date with the rules constituting academic dishonesty. Not so unlike technology rules and guidelines are continually changing. How then do you develop and maximise your understanding of honesty and dishonesty and continue to retain Integrity?  BU’s Integrity Week will give you the skills and resources to do just that! 

The importance of Academic Integrity will be highlighted at Bournemouth University’s Integrity Week. 

Organised by cross faculty departments for students, staff and faculty, the week will comprise of a combination of interesting workshops, cross faculty and professional presentations where experts will share their knowledge on differing aspects of honesty and dishonesty. Panel discussions, open to all, will provide a lively forum for the sharing of experiences. 

Reasons to attend! 

  • Unlock and achieve greater success through integrity
  • Discover Integrity resources 
  • Acquire skills to utilise integrity in research, writing and teaching
  • Learn how to maintain integrity in an evolving world of change

This will be an unparalleled week of opportunity for students, staff and faculty to ensure that through awareness and understanding BU stays at the forefront of everything that Integrity represents.  

 

Check out the programme and book here

Request for feedback – MHRA clinical trials consultation

BU research, Clinical Governance, nhs, NHS, Research communication, Research Ethics, research integrity, Research news

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.

Research Ethics in a Clinical setting

BU research, Clinical Governance, Postgraduate Research, Research Ethics

Author: Suzy Wignall, Clinical Governance Adviser

Clinical Research

Clinical Research

This week, we start our focus by looking at research ethics within Health and Clinical Research.

Research conducted within a healthcare setting in most cases will require additional approval to BU ethics. Ensuring that you have the correct approvals and oversight for your study is vital in assuring your participants that you are conducting the study in line with regulations and standards.

Under the UK Policy Framework for Health and Social Care Research, when a student or a member of staff is undertaking their own research within the NHS, then the organisation at which they study or work, should ideally take on the role of the research Sponsor. The Sponsor is defined as an individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research.

Under new guidance, undergraduate students are no longer permitted to make an application to conduct research in the NHS. In certain cases, Master’s students are also not permitted, but should check their eligibility via the Health Research Authority’s student research toolkit.

Approvals

Research involving the NHS or social care, including patients, carers, human tissue, or data may require ethics approval from an NHS Research Ethics Committee (REC) or Social Care REC.  Application for NHS REC is via the Integrated Research Application System (IRAS) and is coordinated by the Health Research Authority (HRA), so you only need to submit one application.

If you are unsure as to whether your research requires NHS REC approval, the HRA have provided a useful decision tool which determines whether NHS REC approval is required.

If NHS REC is not required, you may need other approvals such as HRA and HCRW Approval (Health and Care Research Wales) – for example if you are using NHS facilities, accessing anonymous patient data, or have NHS staff as participants. You may also in some cases need CAG Approval (access to identifiable data without patient consent).

What the University cannot approve

The storage of human tissue or other relevant materials for research, may require a licence from the Human Tissue Authority, which BU does not currently hold.  If you obtain NHS REC approval, this will allow you to collect and store relevant materials for the duration of the project, and for up to one year after the declaration of the end of the research, for the purposes of analysis and verification of research data.

Research where the research participants are adults (aged 16 and over) and are unable to make decisions for themselves i.e. they lack capacity[1].  An ‘Appropriate Body’ to review this type of Research are limited to flagged RECs (in England and Wales) and the Social Care REC.

The University’s research ethics panels are not recognised as Appropriate Bodies under the Act.

Who to contact for help and further information?

Your first point of contact with any queries should be –

Much of the health research at Bournemouth University involves collaborating with the NHS and therefore requires Trust approval.

The following documents have been compiled by Bournemouth University Clinical Research Unit (BUCRU) and Research Development & Support (RDS):

In contacting potential NHS sites, a full list of appropriate contacts can be found on the Research & Development Forum website. It is always worth contacting the Trust early in the process.

Useful documents and links

The clinical governance section on the Research Governance & Integrity website has a wealth of information and links to websites and templates that can be used to make the process easier and less tasking,

A good place to start is deciding whether your study is research. Sometimes what is deemed research at BU, is not classed as such within the NHS. The above tool can help decide for you, as well as the Defining Research table. If your study is not deemed research, then you can proceed with the university ethics route.

If you do need to apply through IRAS, then the Clinical Researcher Checklist (PDF and word formats) can be used to keep track of the tasks required throughout the process.

Further training

External
Good Clinical Practice (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 well-being of your research participants are protected, and that the data collected are reliable.

GCP training should be refreshed every 2 years in line with our training policy, which you can read here.

Please note that due to current advice as a result of COVID-19, courses are being provided online via Zoom. If you are interested in booking onto one of these courses, then please email Suzy Wignall who can put you in touch with the relevant contact.

You can undertake the training online by registering for an account here. On this website you can find full GCP e-learning, GCP refresher e-learning and also training surrounding areas such as informed consent in adults lacking capacity.

Internal
As part of the RKEDF Academics and Researchers can book onto the following sessions, either as a one-to-one meeting or a bespoke team session:

If you are a Postgraduate Research Student, there is also a Clinical Governance workshop as part of the Researcher Development Programme.

[1] The Mental Capacity Act 2005 (MCA)

Request for feedback – MHRA clinical trials consultation

BU research, Clinical Governance, data management, nhs, NHS, Research communication, Research Ethics, research integrity

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.

Research Integrity – Clinical Research

BU research, Clinical Governance, Postgraduate Research, research integrity

by Suzy Wignall, Clinical Governance Adviser

All clinical research, whether a simple interview study or a clinical trial of a new medicine, must adhere to a set of standards called Good Clinical Practice, or in other words, ‘GCP’.

It is the international ethical, scientific and practical standard to which all clinical research is conducted and is in place to protect the rights, safety and wellbeing of research participants and to ensure the data collected through the research is credible and of a high quality.

GCP is a legal requirement in the UK, which stresses the importance of ensuring it is inherent throughout all research activities, regardless of the study type. Good data management and participant management guarantees the integrity of the research and the integrity of the researcher and their team.

Participants donate their time freely, and trust their sensitive data to the research team, therefore it is vital that said data is handled with care and their participation is valued.

A key component of GCP, is the feasibility process, or in other words, making sure those interested in conducting the research have the necessary facilities and measures in place to run the study safely and appropriately. This might be a hospital team, a GP practice, or even just an external colleague. Regardless, all involved must be appropriately trained and experienced, in turn again ensuring the integrity of the research and the research activities being conducted.

Research integrity and GCP go hand in hand and should be considered at every stage of the study, from design and planning, to receiving consent and data collection, right through to publication of the results.

Part of ensuring that research integrity is maintained, is by good documentation and filing. Under GCP, the ALCOAC general principles are key –

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete

If a total stranger was to review your study records, they should be able to re-create the study through the contents of the files. Indeed, clinical research is often monitored and audited, by both the organisations responsible for the study, and by regulatory bodies. Organisations can be prevented from conducting future studies if any critical findings arise from inspection, so integrity of the research and data is key from a reputational standpoint too.

Appropriate file-keeping and using the correct versions and dates of documents likewise ensures participant safety. When a participant is invited to a study, they should receive all the information they require and have the opportunity to ask questions or for additional documentation to allow them to make an informed decision. Not only does this then ensure you are receiving fully informed consent, but you are ensuring GCP standards are maintained.

Although this post has concerned integrity in clinical research, a lot of the good practice is transferable to non-clinical, particularly when studies involve human participants.

There are a number of documents available on the Research Governance & Integrity website (click explore Clinical Governance) such as a template file index, a new researcher checklist and template participant-facing documents. We advise that researchers at BU use these for all types of studies, to ensure the highest standards of research governance, ethics and integrity.

Updated HRA amendment tool now live

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research communication, Research Ethics, Research news

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

BU research, Clinical Governance, Events, nhs, NHS, Research communication, Research news

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.