Category / research integrity

Paper published outlining good practice for receiving informed consent

A paper has been published by Hugh Davies (Chair, Oxford A NHS Research Ethics Committee) and the members of Oxford A Research Ethics Committee (REC) which includes a model for what the REC considers to be good practice in terms of consent for research participation. The paper proposes that there are four simple steps which consent processes should be built around:

  • Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.
  • Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.
  • Step 3: After a gap, if necessary, reviewing and checking understanding.
  • Step 4: Reaching agreement and recording consent.

The paper outlines common issues such as information provision to participants, inadequate public involvement, and lack of proportionality.

You can access the paper here.

Remember that RDS offers training in informed consent, as does the National Institute for Health Research. If you are interested in accessing this training, please email Research Ethics.

Template documents are also available via the Health Research Authority website.

NIHR Research Design Service – Starting Research Workshop

Please see below for the following training opportunity:

Date: 15 September 2021
Time: 09:15-13:30
Location: Online

Funded and hosted by the NIHR Research Design Service (RDS) South Central, discover how to move from thinking about doing research to taking your first steps in the getting support, dedicated time and funding to actually do it. Sign up to the workshop on Eventbrite.

Health Research Authority’s new student research eligibility criteria – live from today

New eligibility criteria for standalone student research go live today (1 September 2021). These changes are designed to ensure that students’ experience of research reflects how modern health and social care research is conducted.

This new criteria encourages innovative approaches to student research like group research, mock Research Ethics Committees (REC) or shadowing a range of people in an existing project.

The changes mean some master’s students will now be eligible to apply for approval to carry out their research.

To help students plan their research we have created a new student research toolkit. The toolkit has been designed to pull together the resources a student will need to understand what approvals are required and whether they are eligible to carry out their research in the UK.  It contains links to existing decision tools as well as some new ones developed especially for students. It uses a simple question and answer format and will provide answers to the following questions:

  • Is my study research?
  • Is my research taking place in the NHS and will it need NHS approval?
  • Do I need NHS REC review?
  • What type of NHS ethics review do I need?
  • Can I carry out my research?

Completing the tool will provide students with an understanding of what activities they can do and ensures that they do not waste time applying for approval for research that they are not able to carry out under the new student eligibility criteria. Through completion of the toolkit, students can access supplementary declarations that need to be completed by their academic supervisor, confirming that they meet the criteria for the type of approvals they need for their research. There are three separate declarations depending on the approvals needed – the toolkit guides the student to the right one based on their responses.

Please share this update and new resource with colleagues and students who might benefit. Further details about the new eligibility criteria can be found on the HRA website.

Please see our question and answer section for further information. If you have any other queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Please contact Suzy Wignall, Clinical Governance Advisor in RDS if you have any queries or concerns.

Health Research Authority Releases Question and Answers: Student Eligibility Criteria

The Health Research Authority have published some questions and answers in relation to student research – this is in relation to the recent update regarding the upcoming changes to eligibility criteria.

You can find the Q&As here.

If you have any queries please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.

Free online course – Improving Healthcare Through Clinical Research

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 24th May, 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 website.

NIHR welcomes new vision for the Future of UK Clinical Research Delivery

The National Institute of Health Research (NIHR) and partner organisations across the health research ecosystem have welcomed the publication of a bold and ambitious vision for the future of clinical research delivery in the UK.

This UK-wide vision sets out the ambition to create a patient-centred, pro-innovation and data-enabled clinical research environment, which empowers everyone across the health service to participate in delivering research and enables people across the country to take part in research that is of relevance to them.

The vision has been developed through the cross-sector Recovery, Resilience and Growth programme, with NIHR working alongside the NHS, regulators, medical research charities, life sciences industry, the UK government and devolved administrations.

You can read more here.

NIHR virtual event – Equality, diversity and inclusion in applied health and social care research

The NIHR Research Design Service South East is hosting an event to discuss and explore what is meant by equality, diversity and inclusion in research and the importance of thinking about it when planning your health or social care research project.

Professor Kamlesh Khunti, Director of the NIHR Applied Research Collaborations East Midlands and Centre for BME Health, will talk about his recent research on COVID-19 in ethnic minority populations. Dr Esther Mukuka will talk about her new role as the Head of Equality, Diversity and Inclusion at the NIHR, and the increasing emphasis being put on those that apply for any NIHR funding to demonstrate their commitment to equality, diversity and inclusion and a healthy research culture more generally.

The presentations will be followed by informal workshops to look at different case studies demonstrating the application of equality, diversity and inclusion principles in research.

The event is open to anyone with an interest in applied health and social care research.

Sign up online

https://www.nihr.ac.uk/events/equality-diversity-and-inclusion-in-applied-health-and-social-care-research/27216?utm_source=newsletter-fs&utm_medium=email&utm_campaign=fs-2021-04

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

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

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

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

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

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

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

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.