Tagged / clinical research

Research Ethics in a Clinical setting

Research Ethics

Author: Suzy Wignall, Clinical Governance Adviser

Clinical Research

Clinical Research

This week, we start our focus by looking at research ethics within Health and Clinical Research.

Research conducted within a healthcare setting in most cases will require additional approval to BU ethics. Ensuring that you have the correct approvals and oversight for your study is vital in assuring your participants that you are conducting the study in line with regulations and standards.

Under the UK Policy Framework for Health and Social Care Research, when a student or a member of staff is undertaking their own research within the NHS, then the organisation at which they study or work, should ideally take on the role of the research Sponsor. The Sponsor is defined as an individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research.

Under new guidance, undergraduate students are no longer permitted to make an application to conduct research in the NHS. In certain cases, Master’s students are also not permitted, but should check their eligibility via the Health Research Authority’s student research toolkit.

Approvals

Research involving the NHS or social care, including patients, carers, human tissue, or data may require ethics approval from an NHS Research Ethics Committee (REC) or Social Care REC.  Application for NHS REC is via the Integrated Research Application System (IRAS) and is coordinated by the Health Research Authority (HRA), so you only need to submit one application.

If you are unsure as to whether your research requires NHS REC approval, the HRA have provided a useful decision tool which determines whether NHS REC approval is required.

If NHS REC is not required, you may need other approvals such as HRA and HCRW Approval (Health and Care Research Wales) – for example if you are using NHS facilities, accessing anonymous patient data, or have NHS staff as participants. You may also in some cases need CAG Approval (access to identifiable data without patient consent).

What the University cannot approve

The storage of human tissue or other relevant materials for research, may require a licence from the Human Tissue Authority, which BU does not currently hold.  If you obtain NHS REC approval, this will allow you to collect and store relevant materials for the duration of the project, and for up to one year after the declaration of the end of the research, for the purposes of analysis and verification of research data.

Research where the research participants are adults (aged 16 and over) and are unable to make decisions for themselves i.e. they lack capacity[1].  An ‘Appropriate Body’ to review this type of Research are limited to flagged RECs (in England and Wales) and the Social Care REC.

The University’s research ethics panels are not recognised as Appropriate Bodies under the Act.

Who to contact for help and further information?

Your first point of contact with any queries should be –

Much of the health research at Bournemouth University involves collaborating with the NHS and therefore requires Trust approval.

The following documents have been compiled by Bournemouth University Clinical Research Unit (BUCRU) and Research Development & Support (RDS):

In contacting potential NHS sites, a full list of appropriate contacts can be found on the Research & Development Forum website. It is always worth contacting the Trust early in the process.

Useful documents and links

The clinical governance section on the Research Governance & Integrity website has a wealth of information and links to websites and templates that can be used to make the process easier and less tasking,

A good place to start is deciding whether your study is research. Sometimes what is deemed research at BU, is not classed as such within the NHS. The above tool can help decide for you, as well as the Defining Research table. If your study is not deemed research, then you can proceed with the university ethics route.

If you do need to apply through IRAS, then the Clinical Researcher Checklist (PDF and word formats) can be used to keep track of the tasks required throughout the process.

Further training

External
Good Clinical Practice (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 well-being of your research participants are protected, and that the data collected are reliable.

GCP training should be refreshed every 2 years in line with our training policy, which you can read here.

Please note that due to current advice as a result of COVID-19, courses are being provided online via Zoom. If you are interested in booking onto one of these courses, then please email Suzy Wignall who can put you in touch with the relevant contact.

You can undertake the training online by registering for an account here. On this website you can find full GCP e-learning, GCP refresher e-learning and also training surrounding areas such as informed consent in adults lacking capacity.

Internal
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:

If you are a Postgraduate Research Student, there is also a Clinical Governance workshop as part of the Researcher Development Programme.

[1] The Mental Capacity Act 2005 (MCA)

Request for feedback – MHRA clinical trials consultation

NHS, Research Ethics

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 clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Updated HRA amendment tool now live

Guidance, NHS, Research Ethics

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.

Wessex REACH Initiative – Peer support grant

Funding opportunities, NHS

The Wessex REACH Initiative was formally launched in the summer and their first newsletter can be found here.

Wessex REACH are offering a small amount of funding to groups of researchers who wish to create a space for thinking, connecting and problem solving with their peers.  By coming together in face-to-face peer group meetings, research ideas and local problems can be discussed, common challenges and possible solutions can be shared and learn from one another. Whether you want to meet for afternoon tea away from the office a few times a year or fund a grant writing away day or any other creative solution that suits your group, they are interested in receiving your applications.

Who is eligible?
Anyone currently working in healthcare, social care or in healthcare-related research in Wessex.

How much is available?
Each group can apply for up to £500 to be used over a 1 year period.  They are aiming to fund up to 4 groups in the first round.  All applications will be reviewed by the Wessex REACH Steering Group and successful applicants notified early in 2022.

How to apply?
Send a short summary (up to 500 words) to info@wessexreach.org.uk by 10 December 2021.  This summary should include the following information, which will be used in the shortlisting process:

  • Contact details for your group or an expression of interest in being part of a group in your area
  • Your reasons for applying and how the award will help to build research capacity in your group
  • Your planned event(s)/activity
  • What your group is hoping to achieve and how it aligns with building research capacity in the Wessex region
  • What facilitation support, if any, you would like from the Wessex REACH Exec Committee (https://www.wessexreach.org.uk/meet-the-team  )
  • Requested total budget

Questions
If you would like to discuss your eligibility or plans prior to applying please contact Beth Stuart (bls1@soton.ac.uk)

The future of mental health research in Wessex – online meeting

NHS

Date: 9 December 2021

Time: 12:30-14:00

Location: OnlineChaired by Professor Chris Kipps, in this meeting attendees will learn about the new mental health network in Wessex and explore opportunities to collaborate and discuss the mental health research landscape across Wessex. Register for a place here.

Paper published outlining good practice for receiving informed consent

NHS, Publishing, Research Ethics, Training

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.

RDS Funding Development Briefing this Wednesday – NIHR Research for Patient Benefit (RfPB).

Funding opportunities

Reminder: The RDS Funding Development Briefing will be Wednesday at 12 noon. The spotlight will be on the NIHR Research for Patient Benefit (RfPB).

We will cover:

  • Overview of the new schemes
  • How to apply
  • Q & A

For those unable to attend, the session will be recorded and shared on Brightspace here.

Invites for these sessions have been disseminated via your Heads of Department.

Research Fundamentals: In conversation with…the BU Clinical Research Unit

This week on the BU Research Blog we are considering bid quality and how to make a bid as good as it can possibly be. I set off on a quest to speak to members of the BU Clinical Research Unit to understand how they contribute to improving bid quality.

How can the Bournemouth University Clinical Research Unit (BUCRU) support researchers to enhance the quality of their external funding application?

BUCRU is here to support academics and clinicians to develop high quality health and social care research applications. BUCRU’s mission is to improve the quality, quantity, and efficiency of research across the university and National Health Service (NHS). We provide a research advice service to support funding applications and can continue providing support in funded research projects.

As a team, BUCRU has a range of expertise spanning intervention development, trial design, behaviour change, qualitative research, mixed methods, research governance, and patient and public involvement.   Our support is available to both BU staff and local clinicians in the NHS. There are no restrictions on project topic area or professional background of the researcher.

As we’re a hub of the National Institute for Health Research – Research Design Service South West (NIHR RDS SW)  (part of the national Research Design Service) we’re fortunate to have access to other methodological expertise (such as statistics and health economics) as well as popular NIHR SW events and services (for more detail about the NIHR RDS SW see below).

What type of support does BUCRU offer researchers?

We can provide advice on all aspects of preparing a grant application from the initial research idea, including:

  • identifying and refining the research question
  • designing a study
  • research methods (qualitative and quantitative)
  • identifying suitable sources of funding
  • involving patients and public in research design (the NIHR RDS SW has a public involvement fund to support public and patient involvement activities)
  • identifying potential academic, clinical, and public collaborators
  • medical statistics
  • health economics
  • impact and dissemination plans
  • grant writing skills
  • advice on common pitfalls
  • interpreting feedback from funding panels
  • support resubmissions

Which funders will BUCRU support applications to?

We’re keen to help researchers to develop applications for any national external funding bodies with an external peer review process. This includes many funders including NIHR funding schemes, research councils, charities, etc. If you’re applying for seed corn funding to do some initial work to help you to apply for larger scale funding then we can support you with this. If you’re unsure about whether we can help, please do get in touch with us.

If you’re interested in finding out more about NIHR funding and hearing top tips for getting funded, the NIHR RDS SW runs regular online Grant Applications Seminars. The next one of these popular events is on the 9th November 2021. You can find out about it here: http://www.rds-sw.nihr.ac.uk/research-funding-seminar.htm  and book a place here: https://www.eventbrite.co.uk/e/rds-south-west-nihr-grant-applications-seminar-tickets-177003420997

Can BUCRU support researchers in designing and implementing public and patient involvement (PPI) in bids?

Absolutely, Helen Allen is our PPI lead for the unit, with Louise Ward supporting and they work closely alongside the PPI team within NIHR RDS SW as well as BU PIER.

The recent development of VOICE@BU (a BU PIER and BUCRU initiative) has helped us work closely together in supporting researchers at the university.  We can help with plain English summaries, advise on recruiting and managing patient advisory/consultation groups, assistance with public involvement funding for national peer reviewed applications and advice with involving the public in all stages of the research cycle.  We can provide advice on engaging marginalised groups in research, collaborating with community organisations, developing participatory and user-led research, and delivering user-led public involvement training.  With PPI now such a core part of funding bids we strongly recommend that you sign up as a member to VOICE and look at how the platform can help involve the public in your research.  We have a previous blog here: https://blogs.bournemouth.ac.uk/research/2021/05/25/voicebu-2/ that explains VOICE including access to a recorded demonstration that we ran for researchers back in May.

How is the NIHR Research Design Service linked to BUCRU, and what advantages does this offer researchers?

The NIHR RDS-SW Research Design Service South West  is one of 10 regional services across England making up a national network of advisers. NIHR RDS advisers support health and social care professionals and academics in all aspects of developing a grant application (including research design, research methods, funding sources, involving patients and the public) to NIHR and other national peer-reviewed funding streams.

The Bournemouth hub of the NIHR Research Design Service South West sits within BUCRU and is one of four regional hubs (the others are Bristol, Exeter, Plymouth). Dr Sarah Thomas is lead for the Bournemouth hub and staff members include Helen Allen and Louise Ward.  We work regionally across the South West and this has the advantage that it gives us access to a wide variety of additional expertise (such as statistics, health economic, qualitative approaches etc.).  We work in accordance with the RDS charter.

We also offer a monthly NIHR RDS SW Project Review Committee. This offers researchers a fantastic opportunity to have their draft applications critically reviewed by a mock funding panel and detailed feedback provided. This brings the benefit of having an application looked at with ‘fresh eyes’ – the panel includes senior NIHR RDS advisers and public contributors. The committee replicates as far as possible the way a real funding committee will consider a funding application. The panel will also provide helpful feedback on an application that was submitted but not funded, to help you revise the application for a future submission. You can find out more about this service and the submission deadline dates here: http://www.rds-sw.nihr.ac.uk/project_review_committee.htm

How far in advance of a deadline should researchers make contact with BUCRU?

As early as you can!  It’s never too soon, even if you only have a vague idea of a research question. We suggest you contact us ideally at least 4-6 months ahead of a submission deadline. We generally need a minimum of 2-3 months to provide good input. Obviously, it depends on the stage of your application. If it is well-developed and you just require advice on a particular aspect then likely it would need less time. Please see our charter and get in touch with us if you are unsure or have any questions.

What is the best way to make contact with BUCRU?

 You can email us at bucru@bournemouth.ac.uk or wardl@bournemouth.ac.uk or call on 01202 961939.  We are based in BG117 (gradually returning).

Website: https://www.bournemouth.ac.uk/research/centres-institutes/bournemouth-university-clinical-research-unit

Our Twitter is: @BU_CRU

An enormous thank you to Louise Ward and Dr Samuel Nyman from BUCRU for their time to answer my questions. 

Health Research Authority – new final report requirements

Guidance, NHS, Research Ethics

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

Funding opportunities, NHS

RDS NEWS

From the RDS desk – navigating the innovation pathway 
The RDS blog this month provides a few tips on putting together an i4i application Read the blog here

NIHR News

NIHR awards £12 million to artificial intelligence research to help understand multiple long-term conditions

Major new funding opportunity for local government based public health research collaborations

eBulletins and Newsletters

NIHR Funding and support news: September 2021

NHS England and NHS Improvement: In Touch

Events

HEE SW NIHR Integrated Clinical Academic Awards Showcase Event
Online – MS Teams: Monday 20th September 2021 1.30pm – 2.30pm.

The event is open to everyone interested in finding out more about the awards. It will include:

  • an introduction to the HEE-NIHR Integrated Clinical Academic programme and South West region awards from the HEE SW NIHR Programme Delivery Team
  • presentations from previous awardees including an intern, pre-doctoral and postdoctoral awardees in the region.
  • a Q&A session

Join on your computer or mobile app: Click here to join the meeting

Funding Opportunities

Latest NIHR funding calls
Transforming care and health at home and enabling independence

Public Health Research (PHR) Programme
NIHR Health Determinants Research Collaborations (HDRC)

Health Technology Assessment (HTA) Programme
21/554 Health Technology Assessment Programme Researcher-led (primary research)
21/555 Health Technology Assessment Programme Researcher-led (evidence synthesis)
21/556 NIHR NICE Rolling Call – (HTA Programme)

 

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) should you need help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

NIHR Research Design Service – Starting Research Workshop

Guidance, NHS, Training

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

Guidance, NHS, Research Ethics, student research

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.

NIHR Bulletin

Funding opportunities, innovation, NHS

RDS NEWS

From the RDS (Research Design Service) desk – raising the public involvement standards in the RDS.
Patient and public involvement has been an essential element of research funding applications for many years, and the RDS has been making it an essential element in how we work. Our blog this month shows how we’ve integrated our public contributor teams to our advice-giving service, and the resulting benefits. Read the blog here.

NIHR News

Good Clinical Trials Collaborative launches new guidance consultation

Professor Lucy Chappell begins role as NIHR Chief Executive

eBulletins and Newsletters

NIHR Funding and support round-up: August 2021

NIHR ARCs – August Newsletter

Funding Opportunities

Latest NIHR funding calls

Evidence Synthesis Programme
Incentive Awards Scheme 2021

Programme Development Grants
Competition 31

 

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) should you need help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

Health Research Authority Releases Question and Answers: Student Eligibility Criteria

Guidance, NHS, Research Ethics, student research

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.

NIHR Bulletin

Funding opportunities, NHS

NIHR News

UK government’s innovation strategy: Intellectual property

eBulletins and Newsletters

RDS Blog

NIHR News and Research July 2021

NHS England and NHS Improvement – In Touch

South West AHSN – July 2021

Funding Opportunities

Latest NIHR funding calls

Evidence Synthesis Programme
Incentive Awards Scheme 2021

Programme Development Grants
Competition 31

 

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) should you need help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

NIHR Bulletin

Funding opportunities, NHS

NIHR News

The legacy of the CLAHRCs 2014-19 – 5 years of NIHR-funded applied health research

 

eBulletins and Newsletters

News from NIHR School for Social Care Research: Research findings, public involvement and webinars

Funding Opportunities

Latest NIHR funding calls

21/61 UK-wide antiviral clinical trial platform in non-hospitalised patients

Health Technology Assessment (HTA) Programme
21/532 Intensive Interaction for children and young people with profound and multiple learning disabilities
21/534 Surgical management of successfully reduced incarcerated inguinal hernia in children
21/535 Follow-up strategy after radical treatment for prostate cancer
21/536 Sodium bicarbonate in neonatal care
21/537 Neuroendoscopic lavage for preterm babies with post-haemorrhagic ventricular dilatation
21/538 Benefits and harms of reduced dose oral isotretinoin in the management of acne vulgaris
21/539 Benefits and harms of maintenance therapy for refractory acne vulgaris or previous relapses by reduced dose isotretinoin regimens
21/540 Pharmacological treatments for low back pain or sciatica
21/541 Medication support interventions and strategies for people with learning disabilities
21/542 Medication to manage sexual preoccupation in sex offenders

Policy Research Programme
Liaison and diversion services for children and young people
Access assessments for admission to adult medium and low secure services

Research for Patient Benefit (RfPB) Programme
Competition 46

Research for Social Care
Research for Social Care dementia call
Research for Social Care call for mental health research in Northern England

 

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) should you need help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.