Category / Clinical Governance

Introduction to Good Clinical Practice – 16th January 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 16th January, at Bournemouth University, Lansdowne Campus (Royal London 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.

UK hits milestone of sequencing 100,000 whole genomes in the NHS

Yesterday it was announced that the 100,000 Genomes Project, led by Genomics England in partnership with the NHS, has reached its goal of sequencing 100,000 whole genomes from NHS patients.

The project was launched in 2012 by former Prime Minister David Cameron. BU is on board with this project and has access to the data collected, providing great opportunities for research.

You can read the NIHR article here.

Free FutureLearn courses

The FutureLearn website has a whole host of different courses you can take advantage of whether for personal interest or educational needs, and for free.

Here are some courses that are specific to (clinical) research. Enjoy! –

*to be done in addition to the mandatory ethics modules.

#DataSavesLives – using patient data for research

Patient data underpins and leads to improvements in research and care.

The National Institute for Health Research (NIHR) has recently shared a resource surrounding the use of patient data in clinical research. The page contains a number of useful links to guidance such as the NHS pages on why patients’ data matters and also the Understanding Patient Data resource, which outlines a set of key principles that should be followed in using patient data for research purposes.

Acknowledging contribution

It’s important that if a researcher uses patient data, that they acknowledge it by using the following citation –

“This work uses data provided by patients and collected by the NHS as part of their care and support”

The above has been developed by use MY data, a movement of patients, carers and relatives, in place to ensure that the patient data used is protected by the appropriate safeguards, and is treated with the respect and confidentiality it deserves.

National data opt-out programme

The page likewise signposts the above programme which allows patients and the public to opt-out of their confidential patient information being used for planning and research purposes.

All health and care organisation will uphold these choices by March 2020.

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 – Lansdowne Campus, room 102 this Wednesday 5th December, at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

CQC inspection to include research in NHS Trusts

A partnership has been formed between the National Institute for Health Research (NIHR), the Health Research Authority (HRA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and the Care Quality Commission (CQC).

This partnership is looking to develop new assessment guidance and indicators as part of the CQC’s monitoring and inspection programme. This means that as part of inspection, an NHS Trust’s research activity will likewise be assessed. Research is recognised as a key factor in delivering quality patient care

Find out more here, including an article on the benefit of research for patients, that was published in the Royal College of Physicians member magazine, Commentary.

Suggest an idea for clinical research – NIHR opportunity

Do you feel there are any gaps in health and social care research? The NIHR are advertising the opportunity to submit your own idea, or ideas, for potential future research projects.

You can submit your idea here, and read example suggestions to help inspire you!

Once submitted, the NIHR will compare the suggestion with existing or ongoing research and will likewise seek advice from a number of stakeholders including patients and members of the public.

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.

Supporting Health and Social Care Research – NIHR resource

Supporting Health and Social Care Research

A range of resources and best practice success stories have been pulled together to make promoting research and its benefits to patient care more accessible to everyone.

The NIHR website now hosts a number of pages and resources, such as how the NIHR can help academic researchers to conduct and deliver research, and success stories from amongst the research community – access the following link to find out more.

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.

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 – Lansdowne Campus, room 102 on Wednesday 5th December, at 09:30am – 12:30pm.

Get in touch with Research Ethics 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 – Lansdowne Campus, room 102 on Wednesday 5th December, at 09:30am – 12:30pm.

Get in touch with Research Ethics 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 – Lansdowne Campus, room 102 on Wednesday 5th December, at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Dorset physio shares first experience as Principal Investigator on NIHR funded study

A recent article published on the Wessex Clinical Research Network website explores the experience of a local physiotherapist, based at Dorset County Hospital (DCH), who became the Principal Investigator for a clinical research study. Having undertaken the role for the first time, the article contains his experience of performing the duty and how this was balanced with his pre-existing clinical tasks and responsibilities.

The CORKA study investigates rehabilitation for patients that have undergone a knee arthoplasty and was the first collaborative study between DCH and Dorset Healthcare. To date the study has recruited over 300 participants.

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 – Monday 12th November

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 Poole Hospital on Monday 12th November, 9am – 12:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics or the Wessex Clinical Research Network.

Important update regarding human DNA from acellular materials

The revised Governance Arrangement for Research Ethics Committees document was released recently.

Amongst updates to incorporate legal, policy and operational developments, following a public consultation by the Human Tissue Authority, research involving human DNA extracted from acellular material is now included in the document, as requiring NHS Research Ethics Committee review.

If you are collecting ‘relevant materials‘ and rendering them acellular, then storage of the samples does not require a HTA license – however, a license is required for distribution of the samples, or if you are extracting DNA from these materials.

Please get in touch if you have any queries or wish to discuss the samples being collected/stored at BU.

Failing to publish data from clinical trials presents risk to human health

A recent inquiry into research integrity was made earlier this year by the Science and Technology Committee, which revealed that nearly half of clinical trials fail to publish their results.

This lack of publishing has been deemed a risk to human health and a contributory factor in research wastage.

The article gives examples of a number of studies that are yet to be published, and how this activity ‘threaten(s) research integrity, and in some cases, endanger(s) human life’. The full article can be found here.

The University has administrative access to the ClinicalTrials.gov system – get in touch with us  if you are conducting clinical research, to ensure that you have access.