Category / Research communication

NIHR stands by Black Lives Matter

The National Institute for Health Research have recently published their statement in support of the Black Lives Matter movement.

The NIHR recognise the problem of racism and structural barriers to minority communities in the research system and have vowed to do more to change this, both in the research landscape and their own organisation.

You can read the statement here.

Conversation article: Sierra Leone faces coronavirus as rainy season hits – local disaster planning will be key

Sierra Leone faces coronavirus as rainy season hits – local disaster planning will be key

Local coroanvirus awareness raising in Funkia Market, Sierra Leone.
Trocaire/Flickr, CC BY

Lee Miles, Bournemouth University

The government of Sierra Leone called a state of emergency on March 25, seven days before the first case of COVID-19 was even confirmed. The virus has spread steadily since then, with 1,272 cases confirmed and 51 deaths as of June 19.

At the same time, the country has begun the rapid countdown to the full onset of the annual rainy season, which raises challenges of its own, especially for the flood-prone local communities in the capital, Freetown. In mid-2019, Freetown and other major Sierra Leonean cities were engulfed in major flooding. Before this, in 2017, more than 1,000 people died in major mudslides in the capital.

This year, there has been recognition that more forthright action is required. My colleagues and I are currently working with Sierra Leone’s Department of Disaster Management and Freetown City Council to create disaster preparedness guides for district councillors, disaster managers and local volunteers. The goal is to have several guides and handbooks available by July 2020 across four major cities of Sierra Leone to improve scenario planning if multiple disasters happen at once.

In recent years, there has been a strong focus among those who plan for disasters to build more robust forms of resilience in local communities. Not least in Sierra Leone, where – like most of Africa – disaster management relies heavily on local volunteers and traditional forms of community leadership.

Across Africa, there are many poverty-stricken slums and informal settlements. These are vulnerable to natural hazards such as flooding, suffer from overcrowding, and often lack running water and electricity.

As past experiences of Ebola in west Africa demonstrated, it’s also important to focus on the local communities. Poor handling of pandemics and other natural disasters by national governments and international institutions can lead to resistance, inertia and non-compliance among communities and influential community leaders. In the case of the 2014-16 Ebola outbreak, there were many instances where local communities did not trust or were slow to heed advice that ultimately delayed responses to the disease and ended up costing further lives.

Today, local communities in Sierra Leone could be confronted with a perfect storm when it comes to preparing for future disasters and events. Better disaster management is an imperative, particularly in the face of three inter-linked challenges.

Coronavirus transmission

First, there is the impact of COVID-19. Community transmission is becoming a stark reality. The situation in both Sierra Leone and elsewhere in Africa remains highly challenging given the fragile state of many African health services and the limitation of bringing external humanitarian assistance on the ground during the crisis. It’s possible that overcrowded urban communities in some parts of Africa will become sources of future COVID-19 outbreaks and even be an endemic source of reoccurring COVID-19 incidents in the future.

Current COVID-19 prevention tools, such as social distancing and the prevention of mass gatherings to reduce the spread of the disease, are highly challenging to administer in such areas. In many ways, the local communities in Sierra Leone – and Africa more widely – often do the best they can with what is available. Yet, the reality is that COVID-19 is likely to have an impact on the local communities.

Climate threat

Second, the practical, discernible impacts of climate change mean that many local communities are already facing worsening dry seasons with increased fires and droughts, followed by more unpredictable and erratic rainy seasons. Cities in west Africa, such as Accra in Ghana or Freetown in Sierra Leone, or central African cities such as Yaounde in Cameroon, now endure almost annual experiences of flash flooding and landslides that threaten to overwhelm poverty-stricken communities.

There is a growing paradox of frequency here. Local disaster managers and volunteers must meet public expectations to handle ever more frequent disaster. But they also recognise there is very little real time to build this local knowledge and review capacity before the onset of the next deluge, flood or fire.

Overlapping disasters

Third, local communities in Africa are increasingly aware that they also face multiple hazards that are very likely to overlap over the rest of 2020.

There will be major difficulties in delivering effective responses to flood and pandemics such as COVID-19 simultaneously. The standard response to flooding in Freetown is to move those affected to the safety of a large stadium or hall or school, placing them out of harm’s way in often large, robust locations. Yet this poses challenges for carrying out measures needed to contain COVID-19, such as avoiding large gatherings or social distancing.

Local communities need to think more deeply through how they plan for these combinations of possible disasters to save lives in the future. And yet, as my own research is finding, this raises a very serious challenge in that the local areas often lack even the most basic and accessible documentation, guidance and training in risk assessment and disaster management plans.

It’s often said that all disasters are local. The rest of 2020 is likely to prove this point more than ever for resource scarce, often poverty-stricken local communities in Africa. There is an urgent need here that must be addressed as quickly as possible.The Conversation

Lee Miles, Professor of Crisis & Disaster Management, Bournemouth University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

PGR Virtual Poster Showcase | Ismail Can Kurtuk

This week in our PGR Virtual Poster Showcase:

Ismail Can Kurtuk, PhD student in the Faculty of Management with this poster entitled:

‘The butterfly effect of decisions: Enhancement of teaching-decision making in project management within UK higher education.’

Click the poster below to enlarge.

This research is investigating how to improve the teaching in UK Higher Education of decision-making related to project management. Decision-making is a core element of effective project management, but practitioners have reported that without extensive experience of real-life project management, the decision making of newly qualified professionals is inadequate. As a result, projects are delayed, resources are used ineffectively, risks are increased and opportunities are overlooked. Using an inductive approach based upon interviews and focus groups, this research study will investigate the experience of project managers to develop a better understanding of what how decision-making can be taught more effectively, and from this new perspective, a decision-making teaching framework will be developed and validated for application across UK Higher Education.

 


If this research has inspired you and you’d like to explore applying for a research degree please visit the postgraduate research web pages or contact our dedicated admissions team.

Doctoral College Newsletter | June 2020

The Doctoral College Newsletter provides termly information and updates to all those involved with postgraduate research at BU. The latest edition is now available to download here. Click on the web-links provided to learn more about the news, events and opportunities that may interest you.

If you would like to make a contribution to future newsletters, please contact the Doctoral College.

Conversation article – Coronavirus: the future of women’s football is under threat

England’s Nikita Parris and US’s Crystal Dunn at the 2019 FIFA Women’s World Cup Semi Final match in France.
Jose Breton- Pics Action/Shutterstock

Beth Clarkson, University of Portsmouth; Alex Culvin, Durham University; Keith Parry, Bournemouth University, and Stacey Pope, Durham University

Women’s football has made great strides in recent years. Attendances at the women’s FA Cup final continue to set new records. One survey suggested that one-third of adults are interested in the women’s game and 69% of those believe it deserves the same profile as men’s football.

However, the coronavirus pandemic has left the game in a precarious position. Although the suspension of elite football in England was initially applied evenly to both men’s and women’s competitions, there will be deeper and more far-reaching consequences for the women’s game.

The Football Association’s (FA) 2017 Game Plan for Growth, which included doubling the number of women and girls taking part in football by 2020 and improving commercial prospects, has largely been left unfulfilled. Such promises of equality (football for all) by the FA are starting to sound hollow. The Women’s Super League (WSL) and Championship seasons have now been cancelled. In contrast, plans to resume the men’s Premier League and Championship advance at pace.




Read more:
There are plenty of female superstars in football, but very few women coaches – here’s why


In our recently published research – the first academic study on this topic – we have highlighted why the pandemic is impacting men’s and women’s football differently.

Significant challenges

Prior to the pandemic, elite women’s football was already facing poor pitches, lower wages and prize money and conditions far behind men’s clubs. The biggest challenge for women’s football is that elite women’s teams rely on sponsorship for income. For example, 80% of Manchester City Women’s turnover is from commercial activity, most of which is sponsorship.

Women’s sport is also underfunded when compared to men’s in terms of things like marketing and prize money – see the tweet below. COVID-19 is also likely to hit many businesses’ profits hard, leaving companies who previously wanted to invest in women’s football unable to. If this causes the pool of sponsors to shrink – a pool that is already small – the future of women’s football will be under financial threat.

At the same time, financial strain on men’s football means women’s football could be one of the casualties. The majority of elite women’s teams are secondary sides under the umbrella of the professional men’s club. There are numerous examples in recent history where relegation or financial hardship for the men’s club has resulted in cutting ties with the women’s team.

For example, when the men’s club withdrew their financial support in 2017, Notts County women’s club collapsed the day before the new season, leaving their players jobless and, in some cases, homeless. When men’s teams cut their ties like this, women’s teams can be left with no choice but to fold.

Finally, elite women’s football is partially funded by the FA. The association has put significant investment into the women’s sport since professionalisation occurred in 2018, but historically, women’s football has been undervalued by the FA. It banned women’s matches from the grounds of FA-affiliated clubs between 1921 and 1971. And during earlier periods of financial insecurity, clubs and the FA cut investment to the women’s game.

Worryingly, the governing body has predicted a loss in excess of £100 million as a consequence of COVID-19. Grassroots and women’s football are not areas likely to be axed, but at present, there is no clear message that women’s football will continue to be invested in.

Steps to save the game?

Women’s football has gone through tough times before. It is resilient. So, COVID-19 may not be a fatal blow. However, swift and decisive action is needed to protect the recent momentum and growth of women’s football in England. Our recommendations are:

1) Clubs must shift their perspective so that women’s football is viewed as a core business and not as a goodwill gesture to the community.

2) Clubs should be entrepreneurial and innovative in their approaches to generating revenue for the women’s game, such as crowdfunding.

3) Women footballers are often on short-term contracts and juggle other jobs and family responsibilities alongside football careers. Issues surrounding wellbeing might be felt more acutely in women’s football. Clubs must work to actively support players.

4) The 12-month delay to the Women’s European Championship, now due to be held in England in 2022, should be seen as an opportunity. Leveraging mainstream interest in the Men’s 2022 FIFA World Cup, a “festival of football” could be created to attract fan interest in the women’s game.

5) When the game restarts, women’s football supporters must remain faithful in their support of the game. Visible advocates will show the governing body and clubs that there is a sustained demand for women’s football.




Read more:
Sing when you’re women: why it’s time to take female sports fans seriously


If we are to continue advancing a “new age” of women’s football, it is important that the women’s game is part of the conversation about football’s return. Without a clearly communicated strategy for the women’s game, the future of clubs and players’ health and wellbeing remain at risk.The Conversation

Beth Clarkson, Senior Lecturer in Sports Management, University of Portsmouth; Alex Culvin, Postdoctoral Researcher in Professional Women’s Football, Durham University; Keith Parry, Deputy Head Of Department in Department of Sport & Events Management, Bournemouth University, and Stacey Pope, Associate Professor in the Sociology of Sport, Durham University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

PGR Virtual Poster Showcase | Varshini Nandakumar

Center stage this week in the PGR Virtual Poster Showcase:

Varshini Nandakumar, PhD student in the Faculty of Science & Technology with this poster entitled:

‘Design of a functional electrical stimulation device adaptive to walking.’

Click the poster below to enlarge.

Functional Electrical Stimulation (FES) is a neuro-rehabilitation technique commonly used to aid walking in individuals suffering from Drop Foot (DF), a condition that limits ankle dorsiflexion leading to drag the foot while walking. FES devices make use of small electrical pulses to generate functional muscle contraction, enabling dorsiflexion to overcome DF. Existing FES devices are aiding mobility significantly, but one limitation in them is the inefficacy to allow the user to walk confidently in different walking scenarios. As reported by users, this is caused due to the inability to lift their foot sufficiently to ambulate on different walking scenarios. Hence this project proposes to overcome this limitation using machine learning algorithms to develop a predictive model to identify steps, ramps, and kerbs. The output of this model will then be used to control the stimulation levels to provide sufficient stimulation to enable the user to overcome the obstacle.


If this research has inspired you and you’d like to explore applying for a research degree please visit the postgraduate research web pages or contact our dedicated admissions team.

PGR Virtual Poster Showcase | Chris Williams

Still plenty to share in this PGR Virtual Poster Showcase:

Chris Williams, PhD student in the Faculty of Management with this poster entitled:

‘Accreditation of higher education in the UK: The rise of PSRBs & potential influence.’

Click the poster below to enlarge.

This poster will provide a graphical illustration and analysis of data collected as part of my PhD. The data collected identifies when Professional, Statutory and Regulatory Bodies (PSRB’s) that accredit UK undergraduate degrees began their accreditation programmes. PSRB’s were identified from data held by the Higher Education Statistics Agency (HESA) and contacted individually to establish when they began accrediting, leading to the collation of a unique set of figures. HESA’s data is used as part of the Key Information Set (KIS) that HE institutions display on their web pages and other printed material. The information is also held by the Office for Students (OfS), the independent regulator of HE in the UK. Further, the poster identifies key events impacting the UK HE sector and provides a brief analysis of any correlation with the commencement of the accreditation schemes that responded.

 


If this research has inspired you and you’d like to explore applying for a research degree please visit the postgraduate research web pages or contact our dedicated admissions team.

How to support children with special educational needs as they return to school

Children and parents have struggled to adjust to homeschooling. Now, some have to cope with returning to schools which will seem very different to those they left at the beginning of lockdown. One group of children, though, are facing challenges beyond those experienced by the majority.

Children with special educational needs (SEN) make up around 15% of all pupils in mainstream education. Developmental dyslexia is the most common condition in this group, estimated to affect between 10%-16% of the UK population. Autism is much rarer, affecting about 1.1%.

Our research suggests that children with these conditions might find it especially difficult to adapt to changes in their education. We need to recognise the extra challenges homeschooling and online learning have posed for many children – and take this into account as schools reopen.

Extra challenges

Many people think of dyslexia as a language disorder, but it also affects the memory and people’s ability to verbalise ideas and to pay attention. Even in the best of learning environments, struggles in school are likely to lead to low self-esteem for dyslexic children.

Dyslexia can affect many aspects of a child’s life.
Bildagentur Zoonar GmbH

These difficulties are also experienced by autistic children, who may perceive the sensory world differently. Sounds can be magnified, for example, making it hard for a child working at the kitchen table to drag their attention away from the ticking of a clock or the dripping of a tap. Their experience of “not fitting in” also affects their self-esteem.

Another aspect of autism is concrete, black and white thinking. Some autistic children struggle with homework because they think school is for work and home is for play. Routine and predictability is crucial for these children. The move to home education has been another change for them in a sea of turmoil caused by the pandemic.

In school, autistic and dyslexic children would often have specialist support in place to help them with these problems. Without this kind of support, problems with attention and self-esteem may make learning at home very difficult.

It’s also important to recognise that dyslexia and autism are often inherited. Educational and emotional support at home may be limited, further disadvantaging the child and reinforcing the parent’s own potential sense of inadequacy. Children with SEN are also more likely to come from poorer families, an additional layer of inequality.

Positive impacts

Recent research has found that while many children with SEN (and their parents) are indeed more anxious and sad than usual, some families actually report minimal or even positive impacts of distance learning under lockdown. For some children, lockdown is a respite. For dyslexic children, it means they are not the child who is taken out of typical lessons to catch up on other work.

Some parents of children with SEN have reported positive outcomes from home learning.
MIA Studio

For autistic children, it may be an escape from the bullying which is tragically endemic in this group. Many autistic children, including those with a type of autism called pathological demand avoidance, are simply too anxious to attend school regularly.

Remote online education may offer children a greater opportunity for personalised learning at their own pace. For these reasons, many parents of SEN children choose to homeschool their children even under normal circumstances. They argue that home-schooling allows teaching to be built upon the child’s interests, while removing them from rigid standardised testing which is focused on the majority of learners and may set children with conditions like autism or dyslexia up to fail.

Back to school

As schools begin to reopen, advice is already emerging around how best to protect and support children. It’s important to make children feel safe and in control as we emerge from the coronavirus pandemic.

Experts suggest that emotional and social development should take precedence over school work. Some children may need special help with this. Autistic children, for instance, may need to be explicitly taught how to play appropriately, and may need adult assistance to make friends.

Learning in small groups may benefit children with SEN.
iofoto/Shutterstock

Before the coronavirus pandemic, teachers were advised to set up small circles of friends for vulnerable children. As such, the current advice, which recommends that children should stay in small groups, may be well suited to those with special educational needs. However, teachers will also need to actively adopt other strategies to foster social bonds between the child and their peers.

As always, it will be important for parents and teachers to collaborate closely to ensure as much consistency as possible. There are things that teachers and parents can do to help children deal with difficult emotions. Children might also be dealing with bereavement and new financial insecurity at home. The involvement of other child specialists, like psychologists and social workers, might therefore be beneficial.

To help build a sense of control, we need to do more to help children with special educational needs succeed in school, respecting their own pace and learning styles. As this situation evolves, we must be mindful of its impact on the already entrenched inequality that hampers these learners. However, the situation also forces us to come face-to-face with the cracks in our previous systems and come up with new ways of doing things which might, in the long term, reap surprising benefits.The Conversation

Julie Kirkby, Senior Lecturer in Psychology, Bournemouth University and Rachel Moseley, Senior Lecturer in Psychology, Bournemouth University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Managing References and Writing for Publication with EndNote Desktop

Monday 8th June 10:00 – 12:00

This workshop will introduce you to EndNote, software that saves you time when managing your references and writing for publication.

 

 

 

This session will cover:

  • The role of EndNote in the research workflow
  • Reference collation and management
  • Full text harvesting
  • Writing for publication; citation and reference creation​

Essential Preparation

You must have the correct software loaded onto your machine prior to attending.

  • If you are using a BU staff machine, EndNote desktop (X9) needs to have been installed by BU IT Services. This includes the toolbar for Word.
  • If you are using your own device running Windows 10, you can access it via AppsAnywhere from BU. However, please test it before the workshop to make sure that it can run EndNote desktop (X9) and that your version of Word has the EndNote toolbar installed.
  • If you are using your own Mac, you will need to contact BU IT Service and ask them to install EndNote desktop (X9).

You may find it beneficial (but not essential) to have dual monitors. This could allow you to watch the teaching and try things out at the same time.

See here to book.

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.

PGR Virtual Poster Showcase | Hina Tariq

Next up in the PGR Virtual Poster Showcase:

Hina Tariq, PhD student in the Faculty of Health & Social Sciences with this poster entitled:

‘Validation of contracture assessment screening tool.’

Click the poster below to enlarge.

Contractures are a debilitating consequence of prolonged immobility potentially leading to physical impairments, limited functional mobility, decreased independence with everyday activities, and reduced social participation. There is no standard assessment tool available to assess the risk of contracture development or progression. The Contracture Assessment Screening Tool (CAST) was developed by Dorset Health Care University NHS Foundation Trust to address this gap. This project aims to establish the 1) CAST validity and 2) CAST effectiveness in reducing contracture development and progression. Timely identification of those at risk of contracture development or progression may help facilitate contracture prevention and the associated negative sequelae.  To evaluate CAST, a mixed methods approach is being utilised including realist review and evaluation.  Merging different methodologies and a realist approach will provide a unique perspective on CAST validation and use. This project is ongoing and the poster will present the overall methodology and significance of the project.


If this research has inspired you and you’d like to explore applying for a research degree please visit the postgraduate research web pages or contact our dedicated admissions team.

PGR Virtual Poster Showcase | Juliette Hecquet

Taking us into the sixth week of the PGR Virtual Poster Showcase:

Juliette Hecquet, PhD student in the Faculty of Management with this poster entitled:

Exploring yoga as a flow experience: A phenomenological study of contemporary communities.’

Click the poster below to enlarge.

The definition of yoga remains fluid and controversial, creating an oxymoron between the philosophical roots of yoga and physical practice. The majority of published academic research is in medicalised fields; however researchers agree yoga has vast positive outcomes with the potential to be valuable in society.  A lack of clarity exists on what the yoga experience now is, with sparse evidence of, non-medical, qualitative research.  The flow experience and the practice of yoga continue to draws parallel’s from a philosophical standpoint.   Yoga can be regarded as one of the oldest and most systematic methods of producing flow experience but has yet to be researched as one. This interpretative phenomenological research aims to explore the lived yoga experience and the potential flow experience, across contemporary yoga communities.  Videos (vlogs) and in-depth semi-structured interviews will explore the research questions; how yoga participants explain their lived yoga experience and the potential flow experience.


If this research has inspired you and you’d like to explore applying for a research degree please visit the postgraduate research web pages or contact our dedicated admissions team.

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.