Category / research integrity

UK government sets out bold vision for the future of clinical research delivery

BU research, Clinical Governance, innovation, nhs, NHS, parliament, policy, Research communication, Research Ethics, research integrity, Research news

Patients, clinicians and researchers across the whole of the UK are set to benefit from the ambitious vision for the future of clinical research delivery according to this press release from the UK Government.

The plan includes:

  • Strengthening the UK’s renowned research expertise as a world-leader in designing and delivering research
  • An ambitious vision to unlock the true potential of research putting patients and NHS at its heart
  • Using the lessons from COVID-19 to build back better, the government will create a patient-centred, pro-innovation and digitally-enabled research environment.

Saving and improving lives: the future of UK clinical research delivery, published on March 23rd was developed by the UK government and devolved administrations. The policy paper sets out how they will deliver faster, more efficient and more innovative research – from the streamlining of costing, contracting and approvals processes to the Health Research Authority’s rapid ethics review pilot, which aims to halve the time to provide a final opinion for research applications.

Using best practice, it is hoped that participating in research will become more accessible, increasing diversity and allowing more people across the whole of the UK to take part. They will work with Centres of Excellence, such as the Centre for BME Health in Leicester, and there will be more support for research in more diverse and under-served communities and innovative approaches.

The NHS will be encouraged to put delivery of research at the heart of everything they do, making it an essential and rewarding part of effective patient care. This included building a culture across the NHS and all health and care settings that is positive about research, where all staff feel empowered and supported to take part in clinical research delivery as part of their job.

The vision is built around 5 key themes:

  1. Clinical research embedded in the NHS: to create a research-positive culture in which all health and care staff feel empowered to support and participate in clinical research as part of their job.
  2. Patient-centred research: to make access and participation in research as easy as possible for everyone across the UK, including rural, diverse and under-served populations.
  3. Streamlined, efficient and innovative research: so the UK is seen as the best place in the world to conduct fast, efficient and cutting-edge clinical research.
  4. Research enabled by data and digital tools: to ensure the UK has the most advanced and data-enabled clinical research environment in the world, building on our unique data assets to improve health and care.
  5. A sustainable and supported research workforce: which offers rewarding opportunities and exciting careers for all healthcare and research staff of all professional backgrounds – across both commercial and non-commercial research.

The vision reflects the ambition of all 4 UK governments and has been developed through a broad cross-sector approach involving NHS, medical research charities, life sciences industry and academia. Continued collaboration across sectors and organisations will ensure the key action areas will be delivered.

Remember – 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 Research Governance and Integrity website.

Some thoughts about PhD supervision in Public Health

BU research, Doctoral College, Featured academics, international, PG research, Publishing, research integrity, Training, Uncategorized

Recently, Health Prospect: Journal of Public Health published our article on ‘PhD supervision in Public Health’ [1].  The lead author is Dr. Pramod Regmi, with co-authors Prof. Padam Simkhada (FHSS Visiting Faculty) from the University of Huddersfield and Dr. Amudha Poobalan from the University of Aberdeen.  The paper has a strong Aberdeen connection, the fifth oldest university in the UK.  Three of us (Poobalan, van Teijlingen & Simkhada) use to work in the Department of Public Health at the University of Aberdeen (one still does), and three of us (Poobalan, Regmi & van Teijlingen) have a PhD from Aberdeen.

Reference:

  1. Regmi, P., Poobalan, A., Simkhada, P., van Teijlingen, E. (2021) PhD supervision in Public Health, Health Prospect: Journal of Public Health 20(1):1-4. https://www.nepjol.info/index.php/HPROSPECT/article/view/32735/28111

Health Research Authority UPDATE: undergraduate and master’s research projects

BU research, Clinical Governance, COVID-19, data management, nhs, NHS, Research communication, Research Ethics, research integrity, Research news, student research

Please see below for a further update from the HRA on Master’s and undergraduate research. Any queries or concerns please email Suzy Wignall, Clinical Governance Advisor.

Update on student research – new eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.
The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 we paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, we are introducing new eligibility criteria for standalone student research.

New critera

The new criteria mean that some Master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged.

Full details are in table one – permitted student research table. We’ve also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator?

Alternative ways of learning about health and social care research

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of our event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read our website for further information and ideas: https://www.hra.nhs.uk/student-research/.

Queries

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Clinical Governance RKEDF sessions

BU research, Clinical Governance, data management, nhs, NHS, Postgraduate Research, Research Ethics, research integrity, Research Training, Training

As part of the RKEDF Academics and Researchers can book onto the following sessions, either as a one-to-one meeting or a bespoke team session:

Please contact Suzy Wignall, Clinical Governance Advisor if you are interested in any of these sessions.

Meet members of the Research Ethics Panels

BU research, Research Ethics, research integrity

This morning we meet members from the Social Sciences & Humanities Research Ethics Panel (SSH REP).

Dr Parisa Gilani, Senior Lecturer in HR and OB, BUBS
I joined the Social Sciences and Humanities Ethics Panel in November 2019 as the departmental representative for People and Organisations (BUBS). As an Early Career Researcher I welcomed the opportunity to actively contribute towards the research community and meet and learn from knowledgeable colleagues across the university. I had also attended a number of SSH Ethics Panels as a researcher and found the experience to be a positive and rewarding one that enhanced the quality of research projects I had been involved in.

I joined the Panel at an interesting time – with the Pandemic hitting just a few short months after joining. I only had the pleasure of meeting my fellow Panel members in person once before we switched to virtual working. The current situation has also challenged our way of thinking about research in the current context. A lot of our recent discussions have focussed on researcher and participant safety and formulating suitable ethical protocols for online forms of data collection – particularly the use of Zoom and Microsoft Teams.

One of the things I have most enjoyed about being an SSH REP member is having the opportunity to learn about the exciting, innovative and important research that goes on across BU – outside of my own discipline. Every month I’m blown away by the innovative research projects that I have the pleasure of reading about. Many of these address current challenges such as the Covid Pandemic, well-being and links to the UN Sustainability goals.

Over the last few months we have changed the way we review Ethics documents that come to the Panel. Each research project is now assigned a lead reviewer and a secondary reviewer, which allows us the space and capacity to really delve into each project we are assigned to in-depth.

Working with fellow Panel members has also enhanced the quality of the Ethics documents I produce and enabled me to further support my own students as they embark on the Ethics process. Sometimes Ethics is seen as a tick box exercise, but if anything being a part of this Panel over the last year has reinforced to me the important role that Ethics plays in ensuring our physical and psychological safety, that of our participants and in strengthening the quality of research.

Finally, there is sometimes apprehension experienced over being asked to present research at Ethics Panels, however I can safely say that we are all a very supportive group of people, who strive to provide proportionate, consistent and high quality of research across the University. I have personally thoroughly enjoyed being part of the Panel. So if you are submitting your Ethics documentation – good luck and we hope to see you at a Panel soon!

Dr Osi Okwilagwe, Lecturer in Strategy, BUBS

A few years ago, whilst fresh out of my PhD journey and as a new member of staff, I joined the SSH REP. As an Early Career Researcher, I was indeed new to the world of research ethics and was especially pleased to be offered a place by Dr Sean Beer who was Panel chair at the time. In my four years on the role and currently working with a new Panel chaired by Prof Jonathan Parker, I have come to appreciate how large the industry of research is and how important it is for the members of the SSH REP to have a real interest in supporting Social Sciences & Humanities research at BU and in protecting potential participants’ interests – to give their opinion on whether the research methodology is ethical and fair. For me it has been an eye opener working with senior and more experienced colleagues reviewing each month an array of ethics checklists submitted by staff and postgraduate research students, all who conduct very interesting research.

I suppose when people think about ethical research, they think of rules for distinguishing between what is considered acceptable and unacceptable behaviour – right from wrong! Submitting ethics checklists for an ethics review or attending an interview with the Panel for a submission assessed as above minimal risk is really not daunting contrary to popular opinion. The SSH REP understands the sometimes complex issues involved in reaching ethical decisions; bear in mind that the Panel’s aim is to promote and facilitate research at BU. Staff and postgraduate research students who submit their ethics checklist should also not despair if the feedback from the Panel entails a long list of suggestions or amendments, as the role of the SSH REP is to ensure that all research carried out, is conducted to the highest possible ethical standards for research and to provides support to staff and students planning research projects. The mixed experiences and backgrounds of members that make up the Panel allow for wide perspectives as possible. Panel members take a robust approach to the consideration of risk and benefits of a research project. Each member brings their own valuable perspective, knowledge, and experience, as well as concern of the ethics checklist submitted for a particular research project to the Panel’s deliberations. Hence, the feedback given are usually suggestions for researchers to take on board to amend the ethics checklist or to improve the participant’s information sheet; invariably helping towards increasing the likelihood of participant recruitment and of generating quality and publishable research results.

The invaluable experience I have gained from reviewing submissions and working with the SSH REP, has allowed me to appreciate the diverse nature of research carried out by our colleagues at BU and has also ingrained in me that as researchers, a key duty is to promote ethical research.

Here are 3 top tips I like to share when considering making an ethics checklist submission:

1. If researchers are new to research, do ask for help, perhaps from a more experienced colleague/supervisor or send an email to the Research ethics team with any questions.

2. Complete the ethics checklist carefully and read the guidance on the documents to be submitted along with the checklist.

3. Spend a considerable amount of time on the Participant Information Sheet; the adequacy of consent is important. So do identify any contentious issues there may be in conducting the research.

NIHR issues final update on implementation of the Restart Framework

BU research, Clinical Governance, COVID-19, data management, Guidance, nhs, NHS, Research communication, Research Ethics, research integrity, Research news

The NIHR published a Framework on 21 May 2020 – when the NHS started to restore routine clinical services – to support the restarting of research paused due to COVID-19. Developed in partnership with multiple stakeholders and the devolved nations, the Framework provides a flexible structure for local decision-making.

You can read the latest and final update here.

Integrated Research Application System (IRAS) – survey open

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

IRAS, the Integrated Research Application System, is changing.

The Health Research Authority wants to hear from people who’ve used the system about how it should look in the future.

A short anonymous survey https://www.surveymonkey.co.uk/r/5B5X95H is available until 24th February 2021.

Department of Health and Social Care statement on prioritisation of research studies

BU research, Clinical Governance, COVID-19, data management, nhs, NHS, Research communication, Research Ethics, research integrity, Research news

Please find below a statement from the Department of Health & Social Care. Please bear this in mind when in correspondence with NHS Trusts and if planning a clinical research study.
If you have any queries, please contact Suzy Wignall, Clinical Governance Advisor, in the first instance.

Statement from DHSC 

We recognise that at the current time those working in many NHS sites are under huge pressure as the number of COVID-19 cases and admissions to hospitals continue to rise and frontline clinical staff are unable to work due to sickness.

While we have a small number of proven treatments and vaccines for COVID-19, more are needed to reduce transmission, reduce the number of patients that require hospitalisation and to improve outcomes for those that do. It is therefore critical that at this challenging time we continue to recruit participants to our urgent public health (UPH) studies. As such I am writing to confirm that the current levels of prioritisation for research studies, set out within the Restart Framework still apply, as follows:

  • Level 1a (Top Priority) – COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force and agreed by Jonathan Van-Tam, deputy CMO) and platform therapeutics trials (currently RECOVERY/RECOVERY +; PRINCIPLE; REMAP CAP).
  • Level 1b – Other COVID-19 UPH studies
  • Level 2 – Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient.
  • Level 3 – All other studies (including COVID-19 studies not in Level 1a or 1b).

I would also like to take this opportunity to remind you of the NIHR guidance for a second wave of covid 19 activity (https://www.nihr.ac.uk/documents/nihr-guidance-for-a-second-wave-of-covid-19-activity/25837).This guidance still applies and, as outlined, states that the deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR Clinical Research Network (CRN) to front line duties should only occur in exceptional circumstances.

The deployment of clinical academic staff should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical  Deans of the UK. Where NHS Trusts consider they need to redeploy staff to support the frontline this should only be done to support clinical activity during the emergency phase of the pandemic and we would expect them to return to their R&D roles as soon as possible, once the pressures on the system reduce.

As indicated by the Restart Framework, at the current time, we need to continue prioritise our support for the most urgent COVID-19 research as part of the response to tackle the pandemic. At the same time we need to ensure we continue to try and maintain support to deliver non-COVID studies currently open on the portfolio, particularly those within Level 2. A system-wide Recovery, Resilience and Growth programme has been established which brings together the key partners across the clinical research ecosystem to ensure the UK is well-positioned to take a coordinated national approach to achieving the recovery of the UK’s clinical research delivery and restore a full, diverse and active research portfolio as soon as practicable.

HRA launch new ‘Make It Public’ strategy

BU research, Clinical Governance, data management, Guidance, nhs, NHS, open access, Publishing, Research communication, Research Ethics, research integrity, Research news

The Health Research Authority have launched a new strategy to ensure information about all health and social care research – including COVID-19 research – is made publicly available to benefit patients, researchers and policy makers. The new strategy aims to build on this good practice and make it easy for researchers to be transparent about their work.

You can read the announcement here.

For further information on the strategy itself you can take a look at the dedicated page on the HRA website.

 

Wessex reaches over 200,000 participants in clinical research

BU research, Clinical Governance, nhs, NHS, Research communication, Research Ethics, research integrity, Research news

Over 200,000 participants have joined research studies supported by the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Wessex in the last five years, according to latest figures published by the NIHR CRN.

The NIHR CRN’s 2019/20 annual statistics show that 37,067 participants took part in NIHR CRN Wessex supported research studies in the last financial year, taking the CRN Wessex participant total for the last five years to 222,042.

Patients from 100% of NHS trusts across the Wessex region, which covers Hampshire, Dorset, south Wiltshire and the Isle of Wight, took part in research, demonstrating the opportunities for people to participate, wherever they live and work.

You can read the full article here.

A number of BU-sponsored clinical studies have contributed to this figure, so if you have your own research idea and wish to branch out into the NHS, please get in touch.

NIHR stands by Black Lives Matter

nhs, NHS, Research communication, research integrity, Research news

The National Institute for Health Research have recently published their statement in support of the Black Lives Matter movement.

The NIHR recognise the problem of racism and structural barriers to minority communities in the research system and have vowed to do more to change this, both in the research landscape and their own organisation.

You can read the statement here.

Free online course! – Improving Healthcare Through Clinical Research

BU research, Clinical Governance, nhs, NHS, Research Ethics, research integrity, Research news, Research Training, Training

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and is be available from Monday 29th June, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – 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.

Free online course! – Improving Healthcare Through Clinical Research

BU research, nhs, NHS, Research Ethics, research integrity, Research news, Research Training, Training

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and is be available now, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – 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.

External guides for managing remote research

BU research, COVID-19, data management, Guidance, Research Ethics, research integrity

Given current Government guidance on the pandemic response, a number of research projects will need to be conducted remotely. Below are a number of external help guides/guidance articles that aim to assist researchers with this new way of working.

The UK Data Service’s guidance on online data collection

Warwick University’s article on using Skype to collect data

Guidance on conducting telephone interviews –
Article one
Article two

The resource ‘Fieldwork during the pandemic’

The UK Research Integrity Office’s ‘Internet-mediated research’ guide

Research should remain within the ethics approval that has been granted – if you need to make any changes as a result of COVID 19 (for example moving from face-to-face to remote interviewing) please email researchethics@bournemouth.ac.uk if a member of staff or your supervisor if a student.

Latest NIHR-CRN podcast

BU research, Clinical Governance, Knowledge Exchange, nhs, NHS, Research Ethics, research integrity, Research news

The latest podcast in the Health Research Futures series comes from Professor Julie Lovegrove. Professor Lovegrove is from the University of Reading and talks about the challenges of conducting nutritional research and overcoming them.

 

Informed Consent training opportunities

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research Ethics, research integrity, Research Training, Training

Before agreeing to participate in your study, your participants should receive all the information they require in order to make an informed decision. Once they wish to participate, then an informed consent form should be completed and filed appropriately.
Although the process sounds complex, there are currently a great training opportunities to help familiarise yourself with the background to, and process of informed consent in clinical research.

The Wessex Clinical Research Network are hosting the following training sessions at University Hospital Southampton and at Wessex CRN’s office –

  • NIHR CRN Informed Consent training, Thursday 26th March, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN;
  • NIHR CRN Informed Consent training, Thursday 7th May, 8:30am – 12:30pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Thursday 7th May, 1:00pm – 5:00pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Friday 26th June, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN

If you’re interested in attending, get in touch with the Wessex CRN to book your place.

Introduction to Good Clinical Practice – Tuesday 17th March at Dorset County Hospital

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

Are you interested in running your own research project within the NHS or healthcare? 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 Tuesday 17th March, at Dorset County Hospital, Dorchester – 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.