Category / Research Integritiy

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 103 Tuesday 20th August at 09:30am – 12:30pm.

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

An epidemic of invitations

Once you have submitted you manuscript to a scientific journal, the editor has a (quick) look at it and sends it out for review.  As I remind students and colleagues in training sessions on academic writing and publishing, the editor and the peer reviewers are academics like me and my colleagues who do both the editing and the reviewing, for free and over and above the day job.  Being an editor and a reviewer are part of being any academic’s so-called scholarly activity.  We are expected to do this as part of the wider scientific community for the benefit of our academic discipline(s).

When an academic receives an invitation to peer review, the journal will send you a copy of the paper’s abstract.  On reading this abstract you then decide whether you wish to do the review.  If the paper sounds interesting and it is in your field and you have the time you may volunteer to conduct a review.  Once you have agreed you will get the full paper (or more likely you are send a link to the publisher’s website).  The requirements of the review report varies between disciplines and often between journals. Some follow an informal structure, but others have a more formal approach, sometimes with scoring systems for sections of the paper.

Unfortunately, academics across the globe are experiencing an ‘epidemic’ of invitations to review for scientific journals.  And I am not talking about so-called predatory publishers, i.e. journals and publishers that are only in it for the monetary gain, no I am talking about legitimate journals sending out invitations to review for them.   Especially scholars with a few decent publications receive several emails a week from often high quality scientific journals.  The photo of my email inbox shows three invitations in a row I received in the space of two hours last week (10th July), two are even from different Associate Editors for the same journal!

I would like to stress that doing peer reviews is very important.  It is the backbone of academic publishing.  Reviewing is part of our overall scholarly responsibility so we all do it, although some more than others.  We all have are favourite journals to review for, perhaps because the journal is high quality, or we like to publish in it ourselves, because we know the editor, or our reviewing is recognised on websites like KUDOS.  I would like to urge colleagues who don’t manage to review at least once a month to step up and agree to review a wee bit more often.

Prof. Edwin van Teijlingen

Centre for Midwifery, Maternal & Perinatal Health

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.