Category / Research Ethics

Updated HRA amendment tool now live

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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.

Paper published outlining good practice for receiving informed consent

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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.

PGR Member Required – University Research Ethics Committee

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A fantastic opportunity has arisen for a new PGR member of the Research Ethics Committee (REC).

REC is responsible on behalf of Senate to promote best ethical practice in relation to research and research-related activities. Additionally, REC is responsible for the over-arching university-wide research ethics policies and procedures. REC considers ethical issues related to research and research-related activities brought to its attention by the Research Ethics Panels, researchers and the wider university community. REC is also responsible for constructing and maintaining the Research Ethics Code of Practice which informs local practices and procedures across the University, you can also view the REC Terms of Reference.

We are looking for someone to bring the student voice to this committee. The member must have a substantive understanding of research ethics, a keen interest and able to feed into the conversation of the committee. The committee meets 3 times per year of which it is expected that all members are present.

Next meeting dates: Wednesday 10 November, 2 March & 6 July; 2 pm – 3.30 pm and currently online.

If this is something you would like to be part of please email Natalie Stewart at pgrskillsdevelopment@bournemouth.ac.uk a short (~100 words) expression of interest (EoI) by Friday 15 October. If I receive more than 1 EoI we will go to a student vote where your EoI will be shared.

If you have any further questions about the committee please contact Sarah Bell or Suzy Wignall at researchethics@bournemouth.ac.uk.

Health Research Authority – new final report requirements

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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.

If you have any questions, please email research.transparency@hra.nhs.uk

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

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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

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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.

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

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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 the HRA paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, they 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. They have 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.

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 the HRA 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 the HRA website for further information and ideas https://www.hra.nhs.uk/student-research/.

The HRA are giving notice now so that course leaders and students have time to prepare for the new arrangements, including ensuring that any changes to institutional policies and procedures are made.

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

Free online course – Improving Healthcare Through Clinical Research

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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

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

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

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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

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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.

National Institute for Health Research publishes latest annual report

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The NIHR has published its latest Annual Report highlighting it’s achievements during 2019/2020. You can read more below.

The report celebrates how NIHR funding and support continues to have a lasting impact on our health and social care system. It details our world-class and ground-breaking research that is delivered by the talents and expertise within NIHR and the collaborations and partnerships we have forged. In addition to showcasing the breadth of areas NIHR provides funding and support, over 100 of our major research achievements are featured in the report, organised under the NIHR’s six core workstreams. The report also gives an insight into the shifting focus to COVID-19 research as we came to the end of 2019/20.

You can also access a HTML version of the NIHR Annual Report 2019/2020.

Highlights in this year’s report include:

1. Funding, supporting and delivering high-quality research

At the core of NIHR is a commitment to fund high quality research that benefits the NHS, public health and social care. Our research funding schemes – programmes, units and schools – deliver a coherent programme of response mode and commissioned research. We awarded over £250 million of funding to 310 new projects. Our first-ever dedicated social-care funding call awarded £2.5 million to 12 new projects focused on adult social care.

2. Investing in world-class infrastructure and a skilled delivery workforce

The NIHR’s sustained investment in people, facilities and technology has transformed the health and care system’s ability to translate discoveries into improved treatments and services. This infrastructure supports research funded by NIHR and by our partners. 5,405 research nurses were employed in the CRN, with 43,568 people participating in Good Clinical Practice.

3. Attracting, training and supporting the best researchers

We funded 525 new personal training awards to develop and support the next generation of researchers and leaders. More than 2,300 people were supported by NIHR-funded training awards to develop the skills they need to meet the nation’s health and care needs.

4. Partnering with other public funders, charities and industry

Working successfully with partners in the UK’s world-leading life sciences sector, our Clinical Research Network supported 1,580 industry and commercial studies and 1,738 charity funded studies.

5. Funding applied global health research and training

We supported 8 Research and Innovation for Global Health Transformation (RIGHT) awards, focused on epilepsy, severe and stigmatising skin diseases, and infection related cancers. 13 RIGHT Proposal and Partnership Development Awards (PPDA) on mental health, 17 Global Health Policy and Systems Research (HPSR) programme development awards and 61 Training Leads attended the first NIHR Global Health Research Training Forum.

6. Engaging and involving patients, carers and the public

More than 732,000 participants were recruited by the NIHR Clinical Research Network into health and social care studies. 398 members of the public reviewed 841 funding proposals, and 124 members of the public served on our funding committees and advisory boards.

Read more information about our contribution to research and access previous annual reports.

https://www.nihr.ac.uk/news/nihr-publishes-latest-annual-report/27175 

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

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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

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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.