Category / Research Integritiy

HRA responds to paper outlining concerns over study set-up delays

Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.

Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.

Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.

  • Approx. 89 individuals were involved in the study approvals;
  • 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
  • 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
  • 491 exhanges took place with the 89 individuals, generating 193 pages of text.

Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.

You can read the HRA’s response here, which signposts the reader to further resources.

Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.

Good Clinical Practice Refresher – Monday 4th February

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 on Monday 4th February, 9am – 12:30pm.

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

Valid Informed Consent training – 15th January at Poole Hospital

There are still seats available for the above training session, taking place at Poole Hospital, Education Centre on Tuesday January 15th.

The VIC workshop has been designed to enable attendees to embed the core principles of valid informed consent into their practice. The materials, developed by a group of Lead Nurses throughout the Clinical Research Network (CRN) aim to provide a foundation upon which to build competence in the valid informed consent process in a research setting.

Locally delivered workshops take the form of a combination of presentations, discussions and group activities designed to bring the principles of valid informed consent into the workplace.

Get in touch with Research Ethics if you are interested in booking a place.

Free Health Research Authority webinars on 10th January

The HRA are hosting three webinars this Thursday 10th January, for those undertaking healthcare research or for those applying for approval. You can book onto them by following this link.

On offer are the following webinars –

  • Managing your approval, scheduled from 2:30pm – 3:30pm
  • Understanding GDPR in relation to health research in the UK, scheduled from 11am – noon
  • Applying for HRA Approval – ‘getting it right first time’, scheduled from 1pm – 2pm

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.

The NHS Long Term Plan – released today

The NHS Long Term Plan has been released today, having been developed in partnership with those who know the NHS best – frontline health and care staff, patients and their families and other experts.

You can download the document here.

The plan discusses research and innovation throughout – see page 75 onward for plans surrounding research and innovation to drive future outcomes improvement.

Good Clinical Practice Refresher – Monday 4th February

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 on Monday 4th February, 9am – 12:30pm.

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

Introduction to Good Clinical Practice – 17th 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 Thursday 17th January, at Bournemouth University, Lansdowne Campus (Executive Business Centre) – 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.

Transparency in research: Health Research Authority survey results

The HRA recently carried out a survey which aimed to establish some of the current obstacles to transparency, and to identify future opportunities to improve practices.
The survey was advertised to researchers, researcher managers, sponsors and funders in order to collate views surrounding research transparency.

You can see the results here on the HRA website.

It’s vital that research participants are informed about the results of research, and in the beginning they are told about the research and implications, in a transparent fashion.

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.
Despite the name, the system may be used for other clinical research projects.

2019 Good Clinical Practice training dates

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 local dates for the 2019 Good Clinical Practice full day and half day refresher training are now on the Clinical Governance blog!

Get in touch with Research Ethics to find out how to book.

Health Research Authority releases eLearning for student researchers

The HRA have improved the information provided on their website for student researchers and those who support them, in planning to conduct research within the NHS.

The organisation has provided three bite size eLearning modules with a focus on the following topics:

  • Sponsors’ and supervisors’ role in educational research
  • Applying for HRA and HCRW (Health and Care Research Wales) Approval
  • Setting up research sites in England and Wales.

You can see the update here, and access the modules here.

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.

Introduction to Good Clinical Practice – 17th 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 Thursday 17th January, at Bournemouth University, Lansdowne Campus (Executive Business Centre) – 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.

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.