The Health Research Authority (HRA) has launched new Quality Standards to improve information given to people who are invited to take part in research. The Quality Standards have been launched alongside Design and Review Principles, which show researchers and Research Ethics Committees (REC) what the important ethical considerations are for participant information.
- The new HRA Participant Information Quality Standards will help research organisations to understand what good participant information looks like, and will make clear to researchers what the Research Ethics Committees will consider as part of the ethics review, including the review of participant information. The REC will support researchers to create information that meets the Quality Standards.
- The aim of the Quality Standards and Design and Review Principles is to make participant information better, and to make the way that RECs review that information more consistent. The documents set out the basic criteria that all participant information must meet, and covers language, accessibility, and mandatory content.
The Quality Standards and Design and Review Principles will be phased in from autumn 2023. As study materials are prepared in advance, REC reviews of participant information will initially be presented to research organisations as recommendations as opposed to actions required for approval.
From December 2023, the Quality Standards and Design and Review principles will become mandatory and will be applied to all research applications submitted for review.
Changes to participant information are currently the most likely reason for ethics committees to give a provisional opinion. Using this guidance will increase the possibility of receiving a favourable opinion.
Remember that BU has Participant Information Sheet templates that provide much of the required wording to ensure your participants are making a fully informed decision before agreeing to participate.
It is vital that when compiling your information sheets that you remember to include the HRA GDPR transparency wording.
Questions or concerns?
If you have any questions regarding these new standards or about clinical research in general, please email Suzy Wignall, Clinical Governance Advisor – firstname.lastname@example.org or email@example.com
As you will be aware, RDS offers something called the RKEDF, or Research & Knowledge Exchange Development Framework – as part of this there are a number of sessions available surrounding clinical research governance. These sessions can be booked as a 1:2:1 or in bespoke group sessions with Suzy Wignall, BU’s Clinical Governance Advisor.
As always, general chats/specific discussions can also be booked in too – please just email!
The RKEDF sessions available are as follows:
Please get in touch if you are interested in any of these sessions.
For general guidance, documents and further information surrounding processes, take a look at the Clinical Governance website.
The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.
The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.
There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.
If you wish to attend the meeting, please get in touch to be added to the invitation.
If you are unable to make the above time but wish to offer your thoughts, please email firstname.lastname@example.org to ensure your feedback is included.
Please see below and note that from now any amendment made should be using version 1.6 of the document.
‘What: An updated amendment tool has been released for use when submitting amendments for health research studies
Who: All researchers and sponsors
When: Released 6 December
We’ve also made some other changes to the amendment tool to make it easier to use including:
- improved guidance in the submission tab
- changes to the radio selection buttons to make it clearer to complete and view once converted to a pdf
- changes to help users avoid common mistakes
You can get all details on the changes we’ve made in the Change Record in General Guidance tab on the tool. Please start to use the new version (1.6) for all new amendments from 6 December 2021. We will continue to accept amendments using version 1.5 for two weeks. We will not accept amendments submitted on V1.5 after 20 December 2021.’
Please see this link for further information.
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.
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 email@example.com.
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.
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 firstname.lastname@example.org.
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.
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/‘
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.