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.
Please see below for an update from the HRA –
Changes to the way you submit your final report
The Health Research Authority has implemented changes to final study reporting requirements. The changes apply to all studies across the UK which require ethics approval and which have not yet submitted a final report.
The Make It Public strategy set out our commitment to make transparency easy, make transparency the norm and make information public. We have now developed a standard dataset on research transparency which will be collected in the study final reports. Coupled with changes we have already made to help you plan at the start of a study how you will inform participants at the end, these changes are steps towards fulfilling that commitment.
In the future we will be able to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).
In standardising the information we request from you and the form for collecting this, we hope it will be easier for you to know what is expected.
Please see below for the following training opportunity:
Date: 15 September 2021
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.
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 firstname.lastname@example.org.
Please contact Suzy Wignall, Clinical Governance Advisor in RDS if you have any queries or concerns.
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.
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.
The National Institute for Health Research (NIHR) has re-launched key resources and guidance that support patient and public involvement in health and social care research. The resources help patients and the public learn more about the benefits of involvement and how to get involved, and also provide advice for researchers and professionals on involving patients and the public in their research projects.
The resources were originally produced by INVOLVE and have been brought up-to-date, made accessible and rehomed. As the INVOLVE website is due to be retired, this means everyone can have continued access to key guidance on involvement.
All of the updated resources can be found on Learning for Involvement. In addition, many of the resources have also been embedded in the NIHR website to provide essential guidance to people applying for funding, managing projects or looking to get involved with research.
You can read more here.
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
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:
- 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.
- 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.
- 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.
- 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.
- 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.
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.
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/.
If you have any queries about the eligibility criteria, please contact email@example.com.
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.
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.
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.
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.
At the beginning of August an update was released by the Health Research Authority with regard to the review of clinical research by undergraduate and master’s students.
The HRA have released a further update – please see below. If you have any queries or concerns please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.
‘Back in March the Health Research Authority and devolved administrations announced the decision to stop reviewing applications for individual undergraduate and master’s student projects until further notice while we prioritised the urgent review of COVID-19 studies. This was also due to the significant pressure on the NHS/HSC, limiting its ability to participate in research studies unrelated to COVID-19.
The pause on health and social care research projects for educational purposes has now been extended until September 2021. This decision is in line with national priorities for NHS/HSC to support COVID-19 studies and the restart of clinical trials and studies as well as the continuing pressure of the COVID-19 pandemic. This decision has been taken in collaboration with partners in the devolved administrations.
We are not reviewing applications for individual undergraduate and master’s student research projects until September 2021.
Any students with approved studies are reminded to check with the relevant NHS/HSC organisations locally about whether or not their projects may continue.
We have published information about other ways in which students can gain experience of health and social care research and have tips on our website.
We are committed to engaging our stakeholders as part of the development of ongoing guidelines for student research.
To receive updates about student research, please email firstname.lastname@example.org to sign up.‘
Please see below for an update from the Health Research Authority surrounding the review of undergraduate and master’s research projects.
‘Back in March the HRA and devolved administrations announced we had decided to stop reviewing applications for individual undergraduate and master’s student projects until further notice while we prioritised the urgent review of COVID-19 studies. This was also due to the significant pressure on the NHS/HSC, limiting its ability to participate in research studies unrelated to COVID-19.
As the lockdown eases, we wanted to update students, supervisors and HEIs on our current position in relation to student research and ethics review. For now, our existing position of not reviewing applications for individual undergraduate and master’s student projects will remain in place. This means that any student project requiring approvals will not be able to proceed. Any students with approved studies are reminded to check with the relevant NHS/HSC organisations locally about whether or not their projects may continue.
In the autumn we will publish our proposed new guidelines for student research for consultation in use. Students, research supervisors and HEIs will be invited to share their opinions and help shape our framework.
You can find more information on our current position on our website: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/‘