Category / Clinical Governance

Introduction to Good Clinical Practice – 10th October

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 10th October, at Dorset County Hospital, Dorchester – 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.

Good Clinical Practice refresher – 2nd October 2018

Are you currently undertaking research within the NHS and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Royal Bournemouth Hospital on Tuesday 2nd October, 1pm – 4:30pm.

Spaces are still remaining and the closing date for bookings is the end of Monday 24th September. If you’d like to enrol, get in touch with Research Ethics or the Wessex Clinical Research Network.

Updated HRA and HCRW Statement of Activities and Schedule of Events published

What is the significance of the Statement of Activities and Schedule of Events?

When the Health Research Authority (HRA) approval process was introduced in March 2016, the Statement of Activities (SoA) and Schedule of Events (SoE) documents were made mandatory for non-commercial studies – those initiated and managed by non-commercial organisations such as Universities, NHS Trusts, charities etc.
The two documents must be submitted alongside your study documents when seeking NHS Research Ethics Committee approval, and the approval of the HRA, as the ‘umbrella organisation’.

With the introduction of the new General Data Protection Regulations, the HRA and HCRW have amended the two documents. They may be found here.

Who is ‘HCRW’?

HCRW stands for Health and Care Research Wales, and they have recently aligned its processes and paperwork with the HRA’s, so as to streamline and make consistent the research application process within England and Wales. Until recently the HRA was the umbrella organisation in England only, and a separate process was required if you wished to include research sites in Wales, Scotland, and Ireland*.

*If you wish to include sites from Scotland and Ireland, then the ‘old process’ is still to be followed. Contact Research Ethics for guidance.

What do I need to do?

If you are currently awaiting your approvals from the REC and HRA/HCRW, you do not need to do anything unless otherwise instructed by the HRA/HCRW. If you are concerned please get in touch with your HRA assessor, or their queries line.

If you are simply thinking of introducing your research into the NHS, are at your beginning stages, or you are currently compiling your study documents, then please remember to use the new versions of the SoA and SoE.
Please get in touch with Research Ethics for guidance on any aspects of clinical research, guidance, and if not already obtained, to request sponsorship of your study. Guidance and useful documents may also be found on the Clinical Governance blog.

NIHR call for peer reviewers

The National Institute for Health Research are in urgent need of psychiatrists and psychologists to peer review funding applications.

See the original tweet here advertising this opportunity, and how to apply here*.

*The link takes you to how to apply as a professional peer reviewer, from any clinical speciality. You can review for the NIHR for professional development (amongst other initiatives), and they need a wide range of expertise:

  • Academics
  • Clinicians
  • Health service managers and clinicians
  • Practitioners
  • Public health and related professionals
  • Social care sector workers
  • Patients and the Public
  • Anyone whose work has a potential impact on health.

 

Updated HRA and HCRW Statement of Activities and Schedule of Events published

What is the significance of the Statement of Activities and Schedule of Events?

When the Health Research Authority (HRA) approval process was introduced in March 2016, the Statement of Activities (SoA) and Schedule of Events (SoE) documents were made mandatory for non-commercial studies – those initiated and managed by non-commercial organisations such as Universities, NHS Trusts, charities etc.
The two documents must be submitted alongside your study documents when seeking NHS Research Ethics Committee approval, and the approval of the HRA, as the ‘umbrella organisation’.

With the introduction of the new General Data Protection Regulations, the HRA and HCRW have amended the two documents. They may be found here.

Who is ‘HCRW’?

HCRW stands for Health and Care Research Wales, and they have recently aligned its processes and paperwork with the HRA’s, so as to streamline and make consistent the research application process within England and Wales. Until recently the HRA was the umbrella organisation in England only, and a separate process was required if you wished to include research sites in Wales, Scotland, and Ireland*.

*If you wish to include sites from Scotland and Ireland, then the ‘old process’ is still to be followed. Contact Research Ethics for guidance.

What do I need to do?

If you are currently awaiting your approvals from the REC and HRA/HCRW, you do not need to do anything unless otherwise instructed by the HRA/HCRW. If you are concerned please get in touch with your HRA assessor, or their queries line.

If you are simply thinking of introducing your research into the NHS, are at your beginning stages, or you are currently compiling your study documents, then please remember to use the new versions of the SoA and SoE.
Please get in touch with Research Ethics for guidance on any aspects of clinical research, guidance, and if not already obtained, to request sponsorship of your study. Guidance and useful documents may also be found on the Clinical Governance blog.

 

‘Research changed my life’ – NIHR stories

The National Institute for Health Research have gathered some inspiring stories from people across England, whose lives have been transformed by clinical research. The stories cover a wide range of health conditions.

You can read them here.

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

*Spaces still available* – 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, R&KEO)  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, room 103 on Thursday 23rd August, at 13:00pm – 16:00pm.

Get in touch with researchethics@bournemouth.ac.uk if you would like to register your interest and book a place.

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, R&KEO)  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, room 103 on Thursday 23rd August, at 13:00pm – 16:00pm.

Get in touch with researchethics@bournemouth.ac.uk if you would like to register your interest and book a place.

Health Research Authority eLearning modules

The Health Research Authority’s website hosts a number of eLearning modules, in place to support staff and researchers with various aspects of conducting research within an NHS setting.

The modules encompass a wide range of topics, such as the HRA Approval process, and research involving human tissue.

You can register for free here!
Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email Research Ethics and take a look at the Clinical Governance blog.

Good Clinical Practice refresher – 15th August 2018 – booking closes end of tomorrow!

Are you currently undertaking research within the NHS and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Dorset County Hospital, Dorchester, Wednesday 15th August, 9am – 12:30pm.

Spaces are still remaining and the closing date for bookings is the end of tomorrow 7th August – so if you’d like to enrol, get in touch with researchethics@bournemouth.ac.uk

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, R&KEO)  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, room 103 on Thursday 23rd August, at 13:00pm – 16:00pm.

Get in touch with researchethics@bournemouth.ac.uk if you would like to register your interest and book a place.

Research waste and ensuring transparency, HRA blog

The HRA have recently released a blog post, written by their Director of Policy, Juliet Tizzard surrounding Research waste and ensuring transparency. The blog goes into the importance of ensuring that research results, even if unfavourable, are published and disseminated appropriately.

You can read the blog here.

If you are running your own clinical research then get in touch with Research Ethics to discuss registering your study and for assistance with this task.

Good Clinical Practice refresher – 15th August 2018

Are you currently undertaking research within the NHS and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Dorset County Hospital, Dorchester, Wednesday 15th August, 9am – 12:30pm.

Spaces are still remaining and the closing date for bookings is 8th August – so if you’d like to enrol, get in touch with researchethics@bournemouth.ac.uk

Dorset trust increases research participants by more than 200%

The NIHR’s Research Activity league Table has been released recently, showing that Dorset HealthCare University NHS Foundation Trust (DHUFT) has more than doubled its recruitment over the last year, compared with the previous. Over 1,200 participants were recruited to clinical research studies, showing a 217% increase.

The article, available here includes thoughts from Dr Ciarán Newell, an Eating Disorders Consultant Nurse and a Facilitator of Research and Development for Dorset HealthCare and Dr Jonathan Sheffield OBE, Chief Executive Officer of the NIHR Clinical Research Network (CRN). As a research Sponsor, we work closely with DHUFT and our colleagues at the Wessex CRN, and hope to contribute even further to the fantastic recruitment taking place throughout the country.

As always, if you’re interesting in running your own research in the NHS, get in touch with Research Ethics.

Weymouth patient praises care from research staff at Dorset hospital


Related to the increase in participants recruited to clinical research, the variety of studies and opportunity to participate have likewise increased.

Dorset County Hospital appeared in the media recently due to the praise received by one of their trial participants. You can read the article here on Wessexfm’s website.

Our local Clinical Research Network (CRN) likewise published the good news, and signpost the Research Activity League Table, where you can see how much clinical research is happening, where, in what types of trusts, and involving how many patients.

Within the CRN’s article, Dr Zoe Sheppard, Head of Research at DCH, and Rebecca McKay, Chief Operating Officer of the Wessex CRN signpost the fantastic recruitment achieved by DCH over the last year, and the growing opportunity for people to participate in research, in turn improving care and treatments.

As always, if you’re interesting in running your own research in the NHS, get in touch with Research Ethics.

NIHR figures and good news

The NIHR have recently released some staggering figures, revealing that 725,333 participants were recruited into clinical research last year! This is the highest number since records began, showing an 8.8% yearly increase.

Related to this, the NIHR supported 5,486 research studies last year, with the aid of 11,000+ support staff in the NHS. You can read the latest blog from the NIHR’s Director of Nursing, Dr Susan Hamer.

Follow the NIHR’s Twitter account for news, updates and training opportunities, and as always, if you’re interesting in running your own research in the NHS, get in touch with Research Ethics.