Category / Clinical Governance

Research transparency – HRA response to the Science and Technology Committee

BU research, Clinical Governance, data management, Knowledge Exchange, NHS, Research communication, Research Ethics, research integrity, Research news

The House of Commons Science and Technology Committee released a report last year on clinical trials transparency, as it was evident that a nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.

At the time the HRA issued a response but today have published a further statement which sets out their commitment to research transparency. This is especially pertinent given the article published simultaneously in BMJ Open, which details the numbers of clinical trials that are publicly registered, compared with those that have received favourable opinion (approval) from a UK NHS research ethics committee.

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. It is free to register your study.
Despite the name, the system may be used for other clinical research projects.

Training opportunity – completing and submitting your IRAS application

BU research, Clinical Governance, data management, NHS, Research Ethics, Research Training, Training

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, RDS)  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 Thursday 28th March at 09:30am – 12:30pm.

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

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

Clinical Governance, data management, NHS, Research assessment, Research Ethics, Research Integritiy, Research news

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.

Medical research: articles/blogs of interest

BU research, Clinical Governance, data management, Knowledge Exchange, NHS, Research communication, Research Ethics, research integrity, Research news

A medical ethicists explores the need to temper researchers’ enthusiasm when it comes to presenting the benefits of a treatment, and how important it is to distinguish research from a treatment.

Read the full article here.

Six project management tips for a PhD – Whatever kind of large research project you are doing, these tips from the private sector might be of some use.

Read the full article here.

#DataSavesLives—Patient participation ensures data are accurate and useful – In this blog, the author argues that we must not ignore the benefits that sharing patient data can have on quality in healthcare

Read the full blog post here.

New HRA guidance launched for public co-applicants in research

BU research, Clinical Governance, Guidance, NHS, Research communication, Research news

‘Increasing numbers of public contributors are helping to shape and deliver health and social care research, and there has been a rise in the number of public co-applicants joining research teams.

Involving members of the public in research design and development has been shown to have a positive effect on projects by improving the quality and relevance of research. However, until now there has been no guidance, either for researchers or for people involved, about what it means to be a co-applicant.

Now new guidance co-developed by NIHR-INVOVLE, the NHS R&D Forum and the Health Research Authority, has been launched to help support members of the public who are co-applicants on research grants and ensure that their contribution is valuable and rewarding.’

See the HRA’s update here and remember that support is on offer at BU 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.

HRA Update – Travel insurance and participation in clinical trials

Clinical Governance, NHS, Research news

Please see below for a message from the NIHR Workforce Development team –

‘We are pleased to inform you that the Association of British Insurers (ABI) have confirmed to the Health Research Authority that participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.

ABI agree that taking part in a clinical trial should not affect insurance cover if the medical condition itself doesn’t. Please share the following message with your teams, organisations etc.

‘When individuals apply for travel insurance, insurers will typically ask questions about an individual’s health in order to make an accurate risk assessment. This risk assessment takes into consideration the health of the individual and the insurer will often ask questions about any pre-existing health conditions and medical treatments for those conditions. Travel insurers do not typically ask about clinical research trials. Where an insurer does ask an individual about their participation in clinical research trials, the insurer must ensure the question is clear and the individual should answer it accurately and honestly”.

If you are aware of instances when participation in a trial is given as a reason for not providing insurance or insurance being an obstacle to participation in clinical trials, please contact hrapublicinvolvement@nhs.net‘

Good Clinical Practice Refresher – Monday 4th February

BU research, Clinical Governance, data management, NHS, Research Ethics, Research Training, Training

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.

NIHR CRN – Principal Investigator Workshop

BU research, Clinical Governance, NHS, Research Ethics, Research Training, Training

The above course is designed for those working as a Principal Investigator (PI) on clinical research projects, or those wishing to become a PI. It is particularly suited to those who have been in working in this role for less than 6 months.

The course will focus on the role and responsibilities of the PI, developing a greater understanding of the regulatory landscape in research, leadership, oversight and communication skills and the importance of building working relationships with local NHS Research & Development and Research & Innovation departments.

For further details of the course please email Kelly.Adams@nihr.ac.uk and to request the course agenda please email 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 – Monday 4th February

BU research, Clinical Governance, NHS, Research Ethics, Research Integritiy, Research Training, Training

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.

Training opportunity – Next steps in delivering Clinical Research

Clinical Governance, NHS, Research Training, Training

The Wessex Clinical Research Network are accepting applications from research practitioners for the above training, taking place Wednesday 13th and Thursday 14th February 2019. The course will take place in Hedge End, Southampton.

The two day course is designed for research practitioners who are new to research posts, (in post for more than 6 months and as a refresher for all research practitioners). The NIHR GCP course is a prerequisite for this course.

The training will cover –

  1. Historical context of research
  2. The basics of clinical research methodology
  3. Human subjects protection, advocacy and the 6 C’s
  4. Patient information giving and Informed consent: process and principals
  5. Recruitment and retention of patients in clinical research
  6. Protocol review and feasibility
  7. Study management and documentation
  8. Roles and responsibilities of the research team
  9. Monitoring, audits and MHRA
  10. Drug and medical device development
  11. The national and international picture

Applications should be submitted by Friday 25th January for consideration, with more information found here.

Research Active Dorset – delivering research and Innovation in Dorset’s Integrated Care Systems

BU research, Clinical Governance, NHS, Research news

There are some exciting developments surrounding clinical research within Dorset, most recently with the formation of the Research Active Dorset (RAD) group. The group has a number of representatives from BU, and recently has launched their online platform, which you can find here.

Please see below for a message from the Chair of RAD, Dr Phil Richardson, NHS Dorset CCG:

‘Senior clinical and management research leads from all NHS and Local Authority partners in Dorset have agreed to work together to drive research and innovation to deliver better quality of health and care for the Dorset population. Members of Research Active Dorset also includes Bournemouth University, Southampton University, Academic Health Science Network, Applied Research Collaboration, the National Institute for Health Research and Clinical Research Network (Wessex).

Our aim is to provide research and innovation that leads to better health, employment, economic development, national and international collaboration. Please share the link with all those interested in research and innovation. In the coming months we will be setting up a community of interest.

I look forward to bringing you more news as RAD develops.’

Valid Informed Consent training – 15th January at Poole Hospital

Clinical Governance, NHS, Research Ethics, Research Integritiy, Research Training, Training

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

BU research, Clinical Governance, data management, NHS, Research Ethics, Research Integritiy, Research Training, Training

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

BU research, Clinical Governance, NHS, Research Ethics, Research Integritiy

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.

NHS Research – Twitter pages to follow!

Clinical Governance, NHS, Research communication, Research news

There is a huge amount of research being conducted across the county by our neighbouring NHS Trusts – you can follow them all on Twitter on the links below.

It’s a great way to keep up to date with developments, news and upcoming events. as well as interesting articles related to healthcare research:

Follow Dorset County Hospital Research & Innovation’s page here;
Follow Royal Bournemouth Hospital’s Research page here:
Follow Dorset HealthCare Research & Development’s page here;
Follow Poole Hospital’s page here.

Happy tweeting!

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 4th February

BU research, Clinical Governance, NHS, Research Ethics, Research Integritiy, Research Training, Training

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.