Category / Clinical Governance

Could you help the Health Research Authority improve the research ethics review?

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS or social care – email the Clinical Research mailbox, and take a look at the Clinical Governance section of the website.

RKEDF Clinical Research Governance Sessions

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.

BU Integrity Week: 16th to the 20th May 2022

Unlock greater potential by maximising your awareness and understanding of Integrity! 

The ability to utilise integrity in research, writing and teaching is vital for academic success. However, continuing to retain your integrity is fundamental but this can only be achieved by maintaining an ability to keep up-to date with the rules constituting academic dishonesty. Not so unlike technology rules and guidelines are continually changing. How then do you develop and maximise your understanding of honesty and dishonesty and continue to retain Integrity?  BU’s Integrity Week will give you the skills and resources to do just that! 

The importance of Academic Integrity will be highlighted at Bournemouth University’s Integrity Week. 

Organised by cross faculty departments for students, staff and faculty, the week will comprise of a combination of interesting workshops, cross faculty and professional presentations where experts will share their knowledge on differing aspects of honesty and dishonesty. Panel discussions, open to all, will provide a lively forum for the sharing of experiences. 

Reasons to attend! 

  • Unlock and achieve greater success through integrity
  • Discover Integrity resources 
  • Acquire skills to utilise integrity in research, writing and teaching
  • Learn how to maintain integrity in an evolving world of change

This will be an unparalleled week of opportunity for students, staff and faculty to ensure that through awareness and understanding BU stays at the forefront of everything that Integrity represents.  

 

Check out the programme and book here

Request for feedback – MHRA clinical trials consultation

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.

Research Ethics in a Clinical setting

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

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.

Research Integrity – Clinical Research

by Suzy Wignall, Clinical Governance Adviser

All clinical research, whether a simple interview study or a clinical trial of a new medicine, must adhere to a set of standards called Good Clinical Practice, or in other words, ‘GCP’.

It is the international ethical, scientific and practical standard to which all clinical research is conducted and is in place to protect the rights, safety and wellbeing of research participants and to ensure the data collected through the research is credible and of a high quality.

GCP is a legal requirement in the UK, which stresses the importance of ensuring it is inherent throughout all research activities, regardless of the study type. Good data management and participant management guarantees the integrity of the research and the integrity of the researcher and their team.

Participants donate their time freely, and trust their sensitive data to the research team, therefore it is vital that said data is handled with care and their participation is valued.

A key component of GCP, is the feasibility process, or in other words, making sure those interested in conducting the research have the necessary facilities and measures in place to run the study safely and appropriately. This might be a hospital team, a GP practice, or even just an external colleague. Regardless, all involved must be appropriately trained and experienced, in turn again ensuring the integrity of the research and the research activities being conducted.

Research integrity and GCP go hand in hand and should be considered at every stage of the study, from design and planning, to receiving consent and data collection, right through to publication of the results.

Part of ensuring that research integrity is maintained, is by good documentation and filing. Under GCP, the ALCOAC general principles are key –

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete

If a total stranger was to review your study records, they should be able to re-create the study through the contents of the files. Indeed, clinical research is often monitored and audited, by both the organisations responsible for the study, and by regulatory bodies. Organisations can be prevented from conducting future studies if any critical findings arise from inspection, so integrity of the research and data is key from a reputational standpoint too.

Appropriate file-keeping and using the correct versions and dates of documents likewise ensures participant safety. When a participant is invited to a study, they should receive all the information they require and have the opportunity to ask questions or for additional documentation to allow them to make an informed decision. Not only does this then ensure you are receiving fully informed consent, but you are ensuring GCP standards are maintained.

Although this post has concerned integrity in clinical research, a lot of the good practice is transferable to non-clinical, particularly when studies involve human participants.

There are a number of documents available on the Research Governance & Integrity website (click explore Clinical Governance) such as a template file index, a new researcher checklist and template participant-facing documents. We advise that researchers at BU use these for all types of studies, to ensure the highest standards of research governance, ethics and integrity.

Updated HRA amendment tool now live

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.

The future of mental health research in Wessex – online meeting

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

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.

Health Research Authority – new final report requirements

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

NIHR Research Design Service – Starting Research Workshop

Please see below for the following training opportunity:

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

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

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

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

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

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

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

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

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

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

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

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

Health Research Authority Releases Question and Answers: Student Eligibility Criteria

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

You can find the Q&As here.

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

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

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

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.