Category / Clinical Governance

EDGE International Conference 2019 – CONNECTED

BU takes responsibility for a large number of NHS-based research projects, spanning a number of clinical areas. To better support BU’s position as Sponsor for these studies, last August the university adopted the EDGE system. This allows us to better collaborate with our NHS colleagues and to ensure our research data is held in a secure and central location. Currently the system is being piloted within the Faculty of Health and Social Sciences for a year.

Last week the EDGE International Conference took place at The Vox Conference Centre in Birmingham, hosted by Fergus Walsh, the BBC’s Medical Correspondent, and organised by the Clinical Informatics Research Unit at the University of Southampton.

Over the two days we heard from speakers from across various organisations during breakouts, workshops and meet & greet sessions. Topics ranged from how to get the best out of the system’s features, using EDGE to connect with colleagues, and use of the system to improve the recording of study data and procedures. Given our implementation of EDGE, and the rarity of use by Universities, BU’s Clinical Governance Advisor, Suzy Wignall was invited to present on how BU has integrated the system.

Across the two days we likewise had keynote sessions, including talks from colleagues in New Zealand and Belgium where the system has been implemented. We also heard from parents of children who have been given access to life-saving research projects, improving their quality of life and health conditions, substantially.

The full agenda can be found here, with EDGE’s twitter feed here, showing photos from the event, and numerous tweets by colleagues.

For any guidance regarding implementing your research in a healthcare setting, take a look at the Clinical Governance blog or get in touch with BU’s Research Ethics team with any queries.

Introduction to Good Clinical Practice – 15th May 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 15th May, at Bournemouth University, Lansdowne Campus (Bournemouth 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.

Health Research Authority public involvement guidance – third blog post

Involving patients and/or the public in your clinical research is a great way to ensure that your study is designed and set-up in a way that will be attractive to participants. By carrying out PPI (patient and public involvement) you can also ensure that your research will be of benefit, not only to individuals but also the wider population and healthcare in general.

In 2018 the Health Research Authority (HRA) released guidance to help applicants better identify where they have involved the public in their research applications, and the difference that it made to their studies.

In addition, in January of this year two HRA blog posts were advertised, following the journey of a Research Fellow at the University of Surrey, who conducted PPI for her research project. The first and second posts can be found on the HRA website alongside other news items.

The HRA have just released the third blog post in which they talk to one of the lay Research Ethics Committee (REC) members who sat on the panel that reviewed the fellow’s study. The post explores the Committee member’s views on how public involvement benefited the research application. You can find it here.

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

NHS R&D Forum response to Mental Capacity Act Code of Practice consultation

The NHS R&D Forum Research Management Working Group have released their thoughts on how they feel that the Mental Capacity Act Code of Practice can be refined and improved, to reflect current needs.

‘The Research Management Working Group is a group of members of the NHS R&D Forum with a wealth of experience
and expertise in both managing and delivering research activity within NHS organisations.’

You can read the group’s response here. The consultation is now closed, however the current Code of Practice can be found here.

If you are planning to conduct research with human participants that lack the capacity to consent or who may eventually lack capacity to consent, then the research application must go to an ethics committee that is flagged to review Social Care research.

BU ethics panels are not authorised to undertake this review or issue approval, and so an application via the IRAS system must be made. Further information can be gained via the HRA website and by emailing Research Ethics.

REMINDER – 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, 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, this 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.

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, 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.

Clinical Research Transparency – Responsibilities

Researchers, sponsors and funders have responsibilities – that may be legal requirements or ethical and moral expectations within an accepted governance framework of best practice and standards – to participants in research, patients and the wider public and research communities.’

The HRA have recently released a page of useful links and guidance that encompasses areas such as ‘top tips for transparency’, making your research results public, and also registering your study.
Related to this, hopefully you will have seen a recent blog post regarding the HRA’s commitment to ensuring research transparency. This has been a hot topic lately, and the subject of a recent House of Commons Science and Technology Committee report.

Take a look at the HRA guidance here.

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

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, 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 help guides – data and technology

An updated Code of Conduct for the application of data-driven technologies in the NHS was published on Tuesday of this week – the code ‘sets out what the NHS expects from companies who are developing new technologies for the health system, and what they can expect in return.

In order to assist applicants and researchers, the HRA have created new pages that set out the approvals process for data-driven technology research.

The section incorporates two pages of support –

The help pages will be added to the Clinical Governance section of the blog, for ease of access.

Research transparency – HRA response to the Science and Technology Committee

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

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

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

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

‘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

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

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.