Category / Research Ethics

Meet members of the Research Ethics Panels

This morning we meet members from the Social Sciences & Humanities Research Ethics Panel (SSH REP).

Dr Parisa Gilani, Senior Lecturer in HR and OB, BUBS
I joined the Social Sciences and Humanities Ethics Panel in November 2019 as the departmental representative for People and Organisations (BUBS). As an Early Career Researcher I welcomed the opportunity to actively contribute towards the research community and meet and learn from knowledgeable colleagues across the university. I had also attended a number of SSH Ethics Panels as a researcher and found the experience to be a positive and rewarding one that enhanced the quality of research projects I had been involved in.

I joined the Panel at an interesting time – with the Pandemic hitting just a few short months after joining. I only had the pleasure of meeting my fellow Panel members in person once before we switched to virtual working. The current situation has also challenged our way of thinking about research in the current context. A lot of our recent discussions have focussed on researcher and participant safety and formulating suitable ethical protocols for online forms of data collection – particularly the use of Zoom and Microsoft Teams.

One of the things I have most enjoyed about being an SSH REP member is having the opportunity to learn about the exciting, innovative and important research that goes on across BU – outside of my own discipline. Every month I’m blown away by the innovative research projects that I have the pleasure of reading about. Many of these address current challenges such as the Covid Pandemic, well-being and links to the UN Sustainability goals.

Over the last few months we have changed the way we review Ethics documents that come to the Panel. Each research project is now assigned a lead reviewer and a secondary reviewer, which allows us the space and capacity to really delve into each project we are assigned to in-depth.

Working with fellow Panel members has also enhanced the quality of the Ethics documents I produce and enabled me to further support my own students as they embark on the Ethics process. Sometimes Ethics is seen as a tick box exercise, but if anything being a part of this Panel over the last year has reinforced to me the important role that Ethics plays in ensuring our physical and psychological safety, that of our participants and in strengthening the quality of research.

Finally, there is sometimes apprehension experienced over being asked to present research at Ethics Panels, however I can safely say that we are all a very supportive group of people, who strive to provide proportionate, consistent and high quality of research across the University. I have personally thoroughly enjoyed being part of the Panel. So if you are submitting your Ethics documentation – good luck and we hope to see you at a Panel soon!

Dr Osi Okwilagwe, Lecturer in Strategy, BUBS

A few years ago, whilst fresh out of my PhD journey and as a new member of staff, I joined the SSH REP. As an Early Career Researcher, I was indeed new to the world of research ethics and was especially pleased to be offered a place by Dr Sean Beer who was Panel chair at the time. In my four years on the role and currently working with a new Panel chaired by Prof Jonathan Parker, I have come to appreciate how large the industry of research is and how important it is for the members of the SSH REP to have a real interest in supporting Social Sciences & Humanities research at BU and in protecting potential participants’ interests – to give their opinion on whether the research methodology is ethical and fair. For me it has been an eye opener working with senior and more experienced colleagues reviewing each month an array of ethics checklists submitted by staff and postgraduate research students, all who conduct very interesting research.

I suppose when people think about ethical research, they think of rules for distinguishing between what is considered acceptable and unacceptable behaviour – right from wrong! Submitting ethics checklists for an ethics review or attending an interview with the Panel for a submission assessed as above minimal risk is really not daunting contrary to popular opinion. The SSH REP understands the sometimes complex issues involved in reaching ethical decisions; bear in mind that the Panel’s aim is to promote and facilitate research at BU. Staff and postgraduate research students who submit their ethics checklist should also not despair if the feedback from the Panel entails a long list of suggestions or amendments, as the role of the SSH REP is to ensure that all research carried out, is conducted to the highest possible ethical standards for research and to provides support to staff and students planning research projects. The mixed experiences and backgrounds of members that make up the Panel allow for wide perspectives as possible. Panel members take a robust approach to the consideration of risk and benefits of a research project. Each member brings their own valuable perspective, knowledge, and experience, as well as concern of the ethics checklist submitted for a particular research project to the Panel’s deliberations. Hence, the feedback given are usually suggestions for researchers to take on board to amend the ethics checklist or to improve the participant’s information sheet; invariably helping towards increasing the likelihood of participant recruitment and of generating quality and publishable research results.

The invaluable experience I have gained from reviewing submissions and working with the SSH REP, has allowed me to appreciate the diverse nature of research carried out by our colleagues at BU and has also ingrained in me that as researchers, a key duty is to promote ethical research.

Here are 3 top tips I like to share when considering making an ethics checklist submission:

1. If researchers are new to research, do ask for help, perhaps from a more experienced colleague/supervisor or send an email to the Research ethics team with any questions.

2. Complete the ethics checklist carefully and read the guidance on the documents to be submitted along with the checklist.

3. Spend a considerable amount of time on the Participant Information Sheet; the adequacy of consent is important. So do identify any contentious issues there may be in conducting the research.

Meet members of the Research Ethics Panels

On Monday we focussed on the work of the Research Ethics Panel and yesterday we heard from Dr Orlanda Harvey who visited the Social Sciences & Humanities Research Panel as part of her PhD journey.

Today you get to meet some of its members with the focus on the Science, Technology & Health Research Ethics Panel (STH REP).

 

Dr Liam Wignall (Psychology Department)

My research explores different aspects of sex and sexuality, looking at sexual identities and the experiences of non-heterosexuals; changing sexual practices, including during COVID-19kink activities and the changing role of the internet. Given my research interests on the often personal topic of sexuality, I am keenly aware of the need to consider the ethical implications of any research conducted. I have sat on numerous ethics panels and had fascinating discussions about my research and the ethical considerations. This has ranged from thinking about the wording of the questions and how participants may perceive them, to making sure I think of my own safety when collecting data in the field. These discussions forced me to think about how I conduct research and providing justifications for each step, ultimately improving my studies.

I became a member of the panel so that I could offer the same advice to others when they were conducting research, asking other researchers the same questions that I was once asked: “What precautions have you taken should things go wrong?”; “How are you protecting yourself when conducting research on a sensitive topic?”; “Do participants know what will happen to their data?” Often when conducting research, we can become so focused on one aspect of the project that it’s helpful for others to ask these questions – I see this as one of the jobs of the ethics panel.

The principal role of the STH REP is to ensure that all research is conducted in an ethical way, following principles and procedures set out by BU and associated bodies (e.g., British Psychological Society). I see my role on the panel as encouraging researchers to consider how they can follow these guidelines to conduct great research. Ethics is not about preventing research from being done, it’s thinking about how good research can be done in an ethical way.

On a personal note, it’s also amazing to see the range of research projects being conducted at Bournemouth University. Being on the panel allows me to chat with colleagues across the faculty and ask them about their research. As a panel, we have had ethical discussions relating to how technology can improve the lives of people with physical disabilities; the intricacies of how dating profiles are used; and how to explain research to children to ascertain consent. Three-hour meetings can just fly by…

Dr. Sofia Meacham (Senior Lecturer in Computing Department of Computing and Informatics)

“Why did I become a member?”

I became a member of the STH REP three years ago through my strong interest on the subject as part of my own research. Specifically, ethical considerations for Artificial Intelligence decision making and their acceptance from scientific and wider community was the matter that I came across first in my research. This raised an interest in how the two worlds: technical achievement and ethical considerations can be combined and the challenges arising from this combination can be overcome. Finding a community of like-minded academics from several fields was obviously the next step to progress this interest, get accustomed with BU’s processes on the matter and contribute through my previous knowledge on technical and ethical matters. Last but not least, ethics has been an integral part of my education from an early stage such as primary school through ancient Greek philosophy and family traditions.

“What do you like about being a member?”

After becoming a member and although the participation is voluntarily, I enjoyed every aspect of it. Without exaggeration, I have been given the option to reduce my workload by stepping down which I have rejected! Being a member, the panel discussions once a month provide a multi-disciplinary approach opening my personal horizons and patterns of thought. There is a democratic handling of all opinions and there is not a single meeting that was not beneficial and enjoyable. Although the panel meetings are taking place with a pleasant environment, the responsibility that the committee has to academia and the society is being taken very seriously.

Last but not least, I would like to emphasize that ethical considerations are of increasing importance in todays rapid technological and other developments. Academia should play integral role to ensure that research developments are performed in alignment with ethical considerations and STH REP is an excellent place within our BU academic community.

Thank you Liam and Sofia!

Tomorrow you get to meet members from the Social Sciences & Humanities Research Ethics Panel

What it’s like to attend a Research Ethics Panel …. A PGR’s account

Undertaking Research – Facing the BU Ethics Panel

By Orlanda Harvey

When you start your PhD journey, one of the first hurdles that you face is gaining Ethical Approval for your study. This can be a very daunting concept at the beginning, as it is often a complete unknown, or it was for me, as this was the first time I had to go through the process. Looking back now; from the very comfortable vantage point of having achieved my doctorate, it is easy to forget the anxiety and mystique surrounding this process. Questions such as: What happens if I do not get approval? dominated my thoughts. I was one of the lucky ones, for although I was seeking approval to investigate people’s experiences of using substances (In this case Anabolic Androgenic Steroids) which would mean I would have to face the BU panel, I did not need NHS ethical approval. Sitting in an office (the joy of life pre-Covid) alongside peers who were facing that experience made me very thankful, for small mercies, as although the BU process feels as if it takes a long time comparatively, with hindsight it is efficient. This, however, does not mean to say that I did not experience a few bumps in the road.

The key to success for me was advice from my Supervisory Team to ensure that I took time to get all my ducks in a row prior to submission and to take the time to prepare all my information sheets and paperwork. This was valuable as there were no changes required to my initial submission, and it went straight through to the panel. I had also looked at the panel meeting deadlines so that I could plan for my submission date and sought advice from the Research Development and Support (Governance) Team to clarify a few points. Going through the online documentation felt a little bureaucratic and at times repetitive but it was very straightforward and easy to use. It certainly made the write up of the ethics and methodology element chapters of the Thesis easier; as one of my supervisors is prone to say, no writing, when it relates to your study, is ever wasted (thank you Edwin).

The panel meeting itself was an interesting experience, for although my supervisor was there to support me (thank you Margarete) it was very clear that the focus was on me and my plans for the research, so all the questions were directed my way. At first, I was apprehensive but actually the experience turned out to be quite enjoyable. After all, at that point I was incredibly enthusiastic about my project and these people wanted me to talk about it! I later learnt to treasure such moments. The questions they asked came from a place of curiosity, and it was not long into the meeting before I realised that they were interested in supporting the research and were ensuring that I had considered key ethical points. If I am totally honest there was only one question that I found a little left field, but you are never going to agree with everything.

It was not all plain sailing, I did pass the panel but still had the email with, a few minor amendments needed. However, these were easily resolved, added clarity to the participant information sheets and could be covered by just replying with the amendments to the panel chair. Overall, the whole experience was beneficial to both my development as a researcher, and my understanding of the ethics challenges.  The positive comments from the panel also proved to be a bolster to my confidence at that early stage in my PhD Journey.

A final unexpected outcome was that, as a result of going through the checklist I had to consider if my population was vulnerable, as people who use illicit drugs are quite often are given this label as a de-facto result of their drug use. This was interesting as although they were using drugs that although not illegal, they do fall into a grey area of the law and was something that we discussed at Panel. This made me think more deeply about the population as a whole, and as a result ended up in me writing a short paper, which was published on the ethics of using AAS and the perceived vulnerability of this group: ‘Shades of Grey’: The Ethics of Social Work Practice in Relation to Un-prescribed Anabolic Androgenic Steroid Use,  which, brings me back to Edwin’s sage advice: nothing you write should ever be wasted 🙂

The role of the Research Ethics Panels at BU

Since 2014, the Social Sciences & Humanities (SSH) and Science, Technology & Health (STH) Research Ethics Panels have reviewed and continue to review ethics checklists submitted by staff and postgraduate research students (above minimal risk only). Their role is to review the ethical aspects of the study to facilitate high quality, safe research practice.  This may be involve a light-touch process if the research is deemed low risk, or it may include an interview with the Panel if it is assessed as above minimal risk.

When first established, the Panels were chaired by Dr Sean Beer (SSH REP) and the late Prof Holger Schutkowski (STH REP) who worked hard to establish the process we have today.  The current Panel Chairs are Profs Jonathan Parker (SSH REP) and Sam Porter (STH REP) who picked up the reins in February 2019 to continue and champion the work of the Panels and who work tirelessly to support our research community.

The Chairs are assisted by Deputy Chairs, Prof Richard Berger (SSH REP) and Dr Jayne Caudwell (STH REP) and academics colleagues from across BU and representatives from Professional Services and independent lay members.  Together, members have a wide range of experience and expertise.  This allows the Panel to provide well structured, consistent and balanced opinions when considering the ethical viability of projects submitted for review.

Support for the panels is provided Sarah Bell (SSH REP), who is the University’s Research Governance Advisor, and Suzy Wignall (STH REP), who is the Clinical Governance Advisor. They are happy to answer any queries that you may have.

Going through the process of an ethics review shouldn’t be a tick box exercise that is forgotten about once a favourable opinion is secured.  This isn’t what the process is about.  Ethical issues can occur at any time throughout the life cycle of a research project – when recruiting participants, in process of analysing data, in the reporting of research results.  Your ethics review is a living document that should be referred to and updated as and when appropriate.

Members are approachable should you have questions before you submit an ethics checklist and there is plenty of guidance available via the research governance & integrity website.  Never think you are alone in the process.  We are here to help and be a source of support throughout the life cycle of your research project.

NIHR issues final update on implementation of the Restart Framework

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.

Integrated Research Application System (IRAS) – survey open

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.

Department of Health and Social Care statement on prioritisation of research studies

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.

RKEDF: Research Training Events in November

 

The following events are coming up this month. These are all online events.

Wednesday 11th November 10:00 – 11:00

British Academy Newton International Fellowships – Information Session

This session provides support for preparing an application to the British Academy Newton International Fellowships. Potential BU mentors and international candidates are welcomed.

You will gain an understanding of the Newton International Fellowship Scheme, and it’s aims and objectives. Support will be provided for those considering applying, but this is also suitable for those who are not sure if this is the right fund to apply to.

Wednesday 11th November 15:00 – 16:00 – ECR Network Meeting

 Calling all ECRs, this is an opportunity to meet other Early Career Researchers and to get advice and support for any research-related queries and concerns. 

Monday 16th November 10:00 – 12:00

Enhancing research impact: understanding and navigating bibliometrics

 Bibliometric analysis uses data to measure the “output” of individuals, research teams, institutions etc., and it is increasingly being used to assess the “impact” of research in order to evaluate and quantify it. This session will cover how research impact is measured, how you can maximise it, and the role of social media in promoting research. 

Tuesday 17th November 10:00 – 12:00 – Navigating the Ethics Checklist

This workshop is designed to assist Researchers in the process of obtaining ethical approval.

The review and approval process will be discussed, including how risk is identified. What makes a good an application and how to create and submit an online ethics checklist.

Wednesday 18th November 10:30 – 15:00 – UK Research Office Update

 This event is comprised of a number of sessions:

·         UK Participation in Horizon 2020. An update on Horizon Europe developments

·         H2020 Evaluation process and proposal writing hints and tips – session for PIs involved in the Green Deal Call proposal submission

·         H2020 implementation matters – informal session with post-award team (based on questions submitted in advance)

·         1-1 sessions if time allows

For further information and to book, contact Ablaudums@bournemouth.ac.uk

Thursday 19th November 10:00 – 11:00 – Royal Society Overview

 This workshop will provide important information for potential applicants applying to the Royal Society, including tips on applying that will increase the likelihood of success.

Wednesday 25th November 10:00 – 11:00

Leverhulme Early Career Fellowships Information Session

This workshop will provide important information for potential applicants applying to this external funding call, including tips on applying that will increase the likelihood of success.

To book, please email OD@bournemouth.ac.uk with evidence of approval from your Head of Department or Deputy Head of Department.

You can see all the Organisational Development and Research Knowledge Development Framework (RKEDF) events in one place on the handy calendar of events.

If you have any queries, please get in touch!

HRA UPDATE: guidance on undergraduate and master’s research projects

At the beginning of August an update was released by the Health Research Authority with regard to the review of clinical research by undergraduate and master’s students.

The HRA have released a further update – please see below. If you have any queries or concerns please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.

Back in March the Health Research Authority and devolved administrations announced the decision to stop reviewing applications for individual undergraduate and master’s student projects until further notice while we prioritised the urgent review of COVID-19 studies. This was also due to the significant pressure on the NHS/HSC, limiting its ability to participate in research studies unrelated to COVID-19.

The pause on health and social care research projects for educational purposes has now been extended until September 2021. This decision is in line with national priorities for NHS/HSC to support COVID-19 studies and the restart of clinical trials and studies as well as the continuing pressure of the COVID-19 pandemic. This decision has been taken in collaboration with partners in the devolved administrations.

We are not reviewing applications for individual undergraduate and master’s student research projects until September 2021.

Any students with approved studies are reminded to check with the relevant NHS/HSC organisations locally about whether or not their projects may continue.

We have published information about other ways in which students can gain experience of health and social care research and have tips on our website.

We are committed to engaging our stakeholders as part of the development of ongoing guidelines for student research.

To receive updates about student research, please email communications@hra.nhs.uk to sign up.

HRA UPDATE: guidance on undergraduate and master’s research projects

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/

HRA launch new ‘Make It Public’ strategy

The Health Research Authority have launched a new strategy to ensure information about all health and social care research – including COVID-19 research – is made publicly available to benefit patients, researchers and policy makers. The new strategy aims to build on this good practice and make it easy for researchers to be transparent about their work.

You can read the announcement here.

For further information on the strategy itself you can take a look at the dedicated page on the HRA website.

 

Wessex reaches over 200,000 participants in clinical 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.

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 29th June, 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 blog.

HRA announcement – Amendment Tool now live

Please see below for a recent update from the Health Research Authority with regard to a new amendment tool and the online submission of amendments.

If you have any queries please email Suzy Wignall in Research Development & Support.


Online submission of amendments and a new amendment tool is now live across the UK, as of today Tuesday 2 June 2020.

These new processes for handling amendments are part of our ongoing Research Systems programme to improve services for applicants.

  • The amendment tool is designed to simplify the amendment process for applicants and
  • The ability to submit amendments online means that applicants can track the submission history of amendments.

From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms. Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date.

To help with these changes, we have now published:

For queries on how to complete the tool, questions on the results from the tool, once complete or how to submit your amendment online, please contact amendments@hra.nhs.uk

Amendment Tool

The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process, from 2 June. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)

The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to, based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.

The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.

The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS.

The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. SOPs, guidance documents and templates etc.). Organisations should do this in accordance with the new process in good time. Given the additional demands placed across the healthcare research systems at this time, the MHRA has confirmed that it will adopt a pragmatic approach during inspection.

Submitting amendments online

Once you have completed the amendment tool, you should follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online system.

For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.

Applicants will need to set up a new login and password for the new part of IRAS. We are sharing a login process with NIHR systems for the new parts of IRAS that provide online booking, the Combined Ways of Working (CWoW) pilot, and this new amendment system. If you already have a login for any NIHR system or one of these new parts of IRAS you can use the same details. If you do not already have a login for those systems, you will need to set up a new login and password as guided by the system.

Once you have logged in, applications will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a pdf of the tool itself. The system will issue an email to confirm the amendment has been submitted.

HRA announcement – Amendment Tool and Guidance now available

Please see below for a recent update from the Health Research Authority with regard to a new amendment tool and the online submission of amendments.

If you have any queries please email Suzy Wignall in Research Development & Support.


Online submission of amendments and a new amendment tool will go live across the UK on Tuesday 2 June 2020.

These new processes for handling amendments are part of our ongoing Research Systems programme to improve services for applicants.

  • The amendment tool is designed to simplify the amendment process for applicants and
  • The ability to submit amendments online means that applicants can track the submission history of amendments.

From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms. Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date.

To help with these changes, we have now published:

For queries on how to complete the tool, questions on the results from the tool, once complete or how to submit your amendment online, please contact amendments@hra.nhs.uk

Amendment Tool

The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process, from 2 June. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)

The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to, based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.

The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.

The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS.

The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. SOPs, guidance documents and templates etc.). Organisations should do this in accordance with the new process in good time. Given the additional demands placed across the healthcare research systems at this time, the MHRA has confirmed that it will adopt a pragmatic approach during inspection.

Submitting amendments online

Once you have completed the amendment tool, you should follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online system.

For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.

Applicants will need to set up a new login and password for the new part of IRAS. We are sharing a login process with NIHR systems for the new parts of IRAS that provide online booking, the Combined Ways of Working (CWoW) pilot, and this new amendment system. If you already have a login for any NIHR system or one of these new parts of IRAS you can use the same details. If you do not already have a login for those systems, you will need to set up a new login and password as guided by the system.

Once you have logged in, applications will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a pdf of the tool itself. The system will issue an email to confirm the amendment has been submitted.

New online booking service for IRAS – goes live Tuesday 19th May

Please see below for an update from the Health Research Authority with regard to the new system for booking in applications.

Any queries please get in touch with Suzy Wignall, Clinical Governance Advisor.


A new online booking service will be rolled out for IRAS studies on Tuesday 19 May – replacing the current Central Booking Service (CBS) telephone line. This is part of our ongoing Research Systems programme of work to improve our services for applicants.

Applicants submitting research projects through IRAS will no longer need to call the Central Booking Service to book a Research Ethics Committee, or to enable IRAS Form submission. Instead applicants will access the new online booking service via IRAS to book their application for review. The service is quick and easy to use and, unlike the current Central Booking Service, will be available 24 hours a day, seven days a week, making it easier for research applicants. If you need help and support with the new system you can call 0207 104 8008 between 8.30am and 4.30pm Monday to Friday.

In order to make use of this new functionality, applicants will be directed to a new part of IRAS which hosts the online booking service. A separate login will be required, but support will be provided. You will need to set up a new login and password for this area unless you already have a login for a NIHR system or as part of the Combined Ways of Working pilot (CWoW) pilot. In this case you can use your existing log in details.

Applicants will need to answer a series of questions online before being able to book a slot. This directs the applicant to the appropriate REC. The questions will be familiar to anyone who has used the CBS. Once you have completed your online REC booking, you will still need to electronically submit your application in IRAS using the normal process.

Applicants making contact about fast-track COVID-19 studies, should continue to follow our current guidance or email fast.track@hra.nhs.uk, DO NOT use the online booking service. 

The work to build the online booking service began before the current COVID-19 pandemic. It is being rolled out now so that the system can support research applicants with non-COVID-19 studies.

Training and guidance will be available via the IRAS website. You can also watch a short video to see how to use the online booking service.

 

Free online course! – Improving Healthcare Through Clinical Research

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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 now, via this link.

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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 blog.