Category / data management

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.

HE policy update for the w/e 17th December 2020

HE finances, a tidal wave of regulatory consultations and information from the OfS, and the Minister responds to student questions.  Wishing all our readers a lovely break and a happy new year!

Latest government COVID news and guidance

Of course we will have an update from Jim if there is local news that we need to know.  The latest guidance from the government on Christmas rules, from Wednesday, is here.

You will recall that despite the focus on infection rates, the original tiers were set on the basis of 5 tests:

  • case detection rate (in all age groups and, in particular, among the over 60s)
  • how quickly case rates are rising or falling
  • positivity in the general population
  • pressure on the NHS – including current and projected (3 to 4 weeks out) NHS capacity – including admissions, general/acute/ICU bed occupancy, staff absences
  • local context and exceptional circumstances such as a local but contained outbreak.

What next for 2021

We have updated our horizon scan as there has been a rush of OfS regulatory announcements and consultations and also quite a lot of other news over the last 6 weeks or so.  We don’t recommend reading it when you are meant to be relaxing but you might want to bookmark it for your return.

There may well be more next week as the OfS seem to be clearing their desks before the end of the year – but it is already clear that 2021 is going to be an important year in terms of tougher rules and interventions from the OfS drive by the government agenda.

Meanwhile, the government have announced that the budget will be on 3rd March.  Is that the date we will hear about the response to Augar and plans for the TEF?

And of course Brexit.  Who knows what is going to happen there.  MPs are starting their Christmas recess on Thursday – but they are likely to be recalled if a deal is achieved (from PoliticsHome).

The Institute for Government published a blog on the time needed to ratify a deal:

  • The UK government is planning to fast-track a new bill through parliament to ratify the deal. If the alternative was no deal on 1 January, it is unlikely either the Commons or the Lords would stand in the government’s way.
  • But this is likely to mean MPs and peers approving a deal which they have hardly had a chance to look at, and in doing so would risk storing up problem. When the government introduced the controversial clauses relating to implementation of the Northern Ireland protocol in the UK Internal Market Bill, it claimed these were necessary to address new concerns about what it had signed up to in the Withdrawal Agreement last year. Although this may have been disingenuous, the debate in the Commons suggested many MPs really didn’t know what they had agreed to in January when they rushed through the Withdrawal Agreement Bill.
  • …The process is more complicated on the EU side. First there would need to be a decision about who actually needs to be involved in ratification. Will the deal be a “mixed” agreement on which national parliaments have a vote, or can the process be limited to the Council and the European Parliament? And even if only the Council and European Parliament need to vote, there will be little time for the usual processes of consultations by member state governments with their own national parliaments and debates in the European Parliament.
  • Whether or not the deal is a mixed agreement, the Council does have the power to provisionally apply many aspects of it, including those dealing with tariffs. Legally speaking, it could even do so without the European Parliament voting on the deal until a later date. But this by-passing of MEPs could worsen tensions between the Council and the European Parliament at a time when member states need MEPs’ votes on a number of key issues. Michel Barnier has suggested that there may be a period of ‘no deal’ in January while the European Parliament considers a deal, but this would be deeply damaging for traders. However, it would be a mistake to assume MEPs will definitely acquiesce.

Constituencies review

The Parliamentary Constituencies Act has become law meaning the 650 individual constituencies across the UK will be redefined to have a more equal number of voters in each. The Government’s press release states: The updated constituencies will reflect significant changes in demographics, house building and migration – the current ones having been defined using outdated data from two decades ago.

Previously a 2018 review recommended reducing the number of MPs to 600; it was expected to have a big impact on our local constituencies (amongst other things, Mid-Dorset and North Poole was going to be radically changed and the separate constituency of Christchurch was expected to disappear). Instead a new review of the constituencies will commence in 2021, based on the number of registered voters at 1 December 2020.

Reviews of UK parliamentary constituencies are undertaken by four judge-led and independent bodies – the Boundary Commissions for England, Wales, Scotland and Northern Ireland. This review will have to be completed by the Boundary Commissions by 1 July 2023. The Government have also committed to ensuring reviews take place every eight years and the subsequent proposals are implemented automatically. This will stop any potential for political interference or further delays to updating constituencies, protecting fair representation of the British people for the future. There will be three periods of consultation on the proposed new electoral maps. The updated constituencies will reflect significant changes in demographics, house building and migration – the current ones having been defined using outdated data from two decades ago.

It is fair to say that the last process was very delayed and very political, so in theory these look like positive changes, but local issues will still make this very controversial in practice when changes happen.

OfS Christmas Bonus

It seems it’s not just us trying to clear the decks before Christmas. Happy Christmas HE, there’s nothing quite like a bit of regulatory shenanigans to look forward to in the New Year!

The Office for Students have issued three new consultations on reportable eventsinformation sharing, and a new take on the previously paused monetary penalties consultations.

At the time of publishing this week’s policy update The Office for Students has not yet released the updated National Student Survey results. You can look out for updates on this here and on Twitter.

They’ve also issued two sets of new guidance on regulatory monitoring and intervention and on third party notifications (i.e. what counts as a notification for regulatory reasons). Finally there is a student guide for students to report on the progress their university or college has made in delivering its 2019-20 access and participation plan. The OfS press release is here: Regulator sets out how students can register concerns. Wonkhe have a blog on it all here.

On 16th the OfS published lots of data on access and continuation by ethnicity, provider tariff group and subject group.  The report is only 10 pages and worth reading.  Their press release says:

The report finds that, between 2013-14 and 2018-19:

  • There was an increase in the proportion of black, Asian and minority ethnic students entering higher tariff universities (those with higher entrance requirements). This is consistent with data from the Department for Education, which shows that these students have higher rates of entry to higher education than white students.
  • There was a higher proportion of Asian, white and mixed ethnicity students at higher tariff universities compared with other providers, but only 5.3 per cent of entrants to these universities were black, compared with 12.0 per cent at other providers.
  • Whatever their ethnicity, students at higher tariff universities were the most likely to continue with their studies. In 2017-18, the continuation rate for white students at higher tariff providers was 96.1 per cent, 7.0 percentage points higher than for white students at other providers (89.1 per cent). For other groups, this difference was even larger:
    • 3 percentage points for black entrants (94.3 per cent per cent at higher tariff compared with 83.0 per cent at other providers)
    • 7 percentage points for mixed ethnicity entrants (95.8 per cent at higher tariff providers compared with 86.1 per cent at other providers)
    • 3 percentage points for students of other ethnicity (94.1 per cent at higher tariff providers compared with 85.8 per cent at other providers)
    • 2 percentage points for Asian entrants (95.7 per cent at higher tariff providers compared with 87.5 per cent at other providers).
  • Black entrants to non-higher tariff providers had the lowest continuation rates of any ethnic group in 2017-18 (83.0 per cent).
  • In non-STEM (Science, Technology, Engineering and Mathematics) subjects across all providers, white students had the highest continuation rates (91.3 per cent in 2017-18), while Asian students were most likely to continue in STEM subjects (90.8 per cent).
  • For both STEM and non-STEM entrants across all providers, in every academic year from 2013-14 to 2017-18, black students were least likely to continue into a second year of study.

HE Financial Health

The OfS have also published Higher Education financial sustainability – an update. It reports strong cash balances, increased but sustainable borrowing including through government-backed loans, and the fall in income from international students’ fees being less than feared, have combined to leave the sector in a reasonably stable financial position. Yet it recognises significant variation in the position of different providers across the sector.

  • The sector is expecting to report broadly similar levels of income of £35 billion across all three years, albeit with an expected decline in 2020/21 to below the levels achieved in 2018-19
  • Total HE course fees were reported at £18.5 billion in 2019/20, an increase of 7.2% compared with 2018-19 (£17.2 billion)
  • HE providers have forecast that fee income will fall by 1.7% in 2020/21, although this would still be above 2018/19 levels
  • Total Non-EU (overseas) tuition fee income was reported at £6bn in 2019/20, an increase of 16.4% compared with 2018/19 (£5.2 billion)
  • HE providers anticipate this to decrease by 10.4% in 2020/21 to £5.4bn, but this would also still be above 2018/19 levels
  • At the end of 2019/20, sector borrowing was £13.7bn (38.4% of income), a rise of £0.7bn compared to 2018/19
  • Forecasts show that the sector is projecting borrowing to continue to rise to £14.2bn by the end of 2020/21 (40.6% of income) – this is a slower increase in borrowing than in previous years

The analysis concludes that although there is currently a low chance of a significant number of unplanned closures of universities, colleges or other providers, there remain considerable uncertainties in the future.

Wonkhe: As the numbers start to come in we offer silent thanks that some of the worst-case scenarios about institutional collapse and sector-wide carnage have not come to pass. New analysis from the Office for Students offers the sector a decent bill of health, and throws light on the many adaptations and measures adopted by providers since the start of the pandemicagainst many expectations, the quality of the sector shone through; recruitment largely held up, planning was proportionate, and mitigations were well managed. In such a complex and chaotic environment, not every call the sector or providers made was right, but a lot of them were. On aggregate – HE is in a good place.

It’s good news, but, as we allude above, not for everyone – this Wonkhe blog speaks of the HE providers which are under closer monitoring due to a more precarious financial position, concluding: those providers under close monitoring will remain a worry – there’s a lot of variables but it seems as if structural weaknesses remain. This next year will be less tolerant of these than any other time in recent history.

Commenting on the OfS report, Nicola Dandridge, Chief Executive OfS, said:

  • There are many reasons for this relatively positive picture. Universities entered the pandemic in reasonably robust shape. England continues to be a popular destination for international students. And universities have been able to access significant support from the government, including via access to government-backed loans. All of this means that English higher education finds itself in reasonable financial shape, and the grave predictions of dozens of university closures have not materialised.
  • There are a number of uncertainties which will continue to affect finances both now and into the future, not least the fact that it is still not clear what the overall impact of the pandemic will be. Where universities have immediate concerns about their finances, they must let us know straight away. The OfS will work constructively with any university in financial difficulties, with our overarching priority being to protect the interests of students. At this point in time, though, we believe that the likelihood of significant numbers of universities or other higher education providers failing is low.

Assessments – Additional Considerations

The Office of the Independent Adjudicator (OIA) has published a new section within the Good Practice Framework: Requests for additional consideration. It sets out some good practice guidance on requests for additional consideration (i.e.  “mitigating”, “extenuating” or “special circumstances” procedures, or “factors affecting performance”). OIA state that a quarter of recent complaints relate to the handling of students’ requests for additional consideration when ill health or personal circumstances affected their exam/assessed performance.

The new guidance will apply from the 2021/22 academic year, however, providers are encouraged to consider the relevance it has to learning during Covid times. Providers are urged to consider flexibility and adaptations that they can implement in their approach (particularly evidence requests) for students requesting additional consideration now due to the pandemic.

Felicity Mitchell, Independent Adjudicator OIA, said: Students who need to submit a request for additional consideration may be experiencing significant difficulties and distress. It’s important that the process for considering such requests is fair and proportionate, and that students have a proper opportunity to show that they can reach the necessary academic standards.

Ofqual – online assessments

Ofqual have published the report of their review into the barriers to online and on-screen assessment for high stakes qualifications such as GSCEs and A Levels. IT provision, security and staffing issues are some of the barriers to the adoption of online and on-screen assessments in England. The review was, in part, a response to suggestions from some stakeholders that these assessment methods could be used to mitigate risks around disruption to summer 2021 exams. Dods have summarised the key points here.

Research

R&D Places Strategy: The transcript from the Science Minister’s speech on the Government’s ambition for research and innovation, and progress on developing the R&D Places Strategy is now available here.

Horizon Europe: Research Professional report: legislators have said financial contributions from non-European Union countries participating in Horizon Europe through association agreements will be channelled preferentially to the parts of the programme they won funding from, while EU negotiators have agreed a deal on Erasmus+, the bloc’s 2021-27 education and training mobility programme, which they say could broaden and even triple participation in it.

UKRI Ethnicity Data: Wonkhe report: UK Research and Innovation has published ethnicity data for all funding applicants and awardees, highlighting disparities between different ethnic groups. While the proportion of ethnic minority fellowship awardees has risen from 12 to 18 per cent between 2014-15 and 2018-19, large gaps still exist between ethnic groups, with fewer than one per cent of fellows being black. In addition, the proportion of ethnic minority principal investigators is still lower than the general proportion of ethnic minorities in teaching or research roles. The data is aggregated for UKRI’s seven research councils and is presented both by specific ethnicity and by broader ethnic group.

State of the Relationship: The National Centre for Universities and Business (NCUB) published their State of the Relationship report, which outlines the results of their Collaboration Progress Monitor, examining and tracking university-business collaboration over time.  The analysis uses 2017/18 data, compared to a five-year average.

Headline findings for Research and Innovation:

  • 85,218 interactions between universities and SMEs – a growth of 11.9% from the previous year
  • Almost 13,000 interactions between universities and businesses, increasing by 10.2% on the previous year
  • 27,645 interactions with large businesses – a growth of 5.5%
  • Investment by UK businesses in university R&D grew by 8.7%, taking total investment to £389m
  • 881 Innovate UK academic grants were awarded to universities – an increase of 41 and the highest number since the monitor began
  • Increase of 7.4% in foreign funds into HE, but growth is decelerating
  • £144m income from licencing, representing an increase of 39%
  • 44 spinout companies were still active for at least three years – an increase of 4.8%
  • Licences granted by universities decreased by 16.9% down to 7,075 – the first drop in six years
  • 1,770 patents were granted to UK universities, representing an increase of 27.7%

Headline findings for Skills and Talent collaboration:

  • Learner days delivered by universities to businesses was 1,313 days lower in 2017/18 than the five-year average of 25,027 days
  • 72 universities offered higher of degree apprenticeships in 2017/18, whereas five years prior this number was only four
  • 6,360 degree apprenticeships started, with 10,497 people participating in a higher of degree apprenticeship provided by a university
  • 7,605 HE leavers ran their own business in 2017/18
  • 69% of undergraduates and 78% of postgraduates were in full-time or part-time employment
  • Just over one quarter of undergraduates had enrolled on a sandwich course – an increase of 3.5% on 2014/15
  • 69% of undergraduates agreed or strongly agreed that they were using what they learnt during their studies
  • 80% of postgraduates agreed of strongly agreed that they were using what they learnt during their studies

Translational Research: UKRI and Zinc have launched a new programme researchers turn ideas into products and services that help people live longer, healthier lives. The programme is designed to support early career and other researchers with their applications for funding and will open with a series of workshops in January 2021. Researchers will be offered a nine-month package of support provided by Zinc including coaching and mentoring from an active network of experts and partner organisations and assistance in using design-led, impact-focused approaches to developing their ideas. It aims to help researchers with the most innovative ideas, who normally wouldn’t consider this kind of grant, to apply for up to £62,500 per project

Parliamentary Questions & Blogs

  • The £15 billion for R&D – will it replace EU funds?
  • Wonkhe have a new blog – Knowledge exchange and the arts: Evelyn Wilson introduces a new centre focused on capturing and recording the many benefits of knowledge exchanges between universities and the cultural sector.
  • Research Professional have a good blog from ex-Universities Minister Chris Skidmore which argues that postgraduate research policy needs attention and recalls why he abandoned postgraduate study. Excerpts:

Salaries over study

As to the value of a PhD and a career as a researcher, we champion its international appeal and encourage visa applications to improve access to global talent, rightly seeking to bring researchers to this country to establish themselves in our brilliant universities. Yet when it comes to domestic students, we create algorithms called LEO that deliver the harsh message that UK students should not think about any subject that might have a long-term and uncertain outcome—that risk factor we praise start-ups for encouraging—so why not chase a salary instead? It’s a message that makes postgraduate study a no-no. 

If we want to become a global science superpower, we need to value research—all of it

Qualification reform 

What would different look like? In an increasingly fast-paced economy and society, the idea of taking three to four years out of your life to research and write an 80,000-word thesis that 10 people might read seems a waste of a huge amount of potential and productivity. The Viva, too, belongs to an age that we might politely admit has passed. 

Much has already been done to expand the potential crossover between academia and industry, but the greatest barrier of qualification reform for postgraduate study remains. The question is, who in Whitehall understands this? It is an essential prerequisite for an R&D strategy that the level 8 qualification route is expanded and opened up

UCAS

UCAS have published their 2020 End of Cycle Report focusing on widening access and participation and student choice (data dashboard here). What happened to the COVID cohort? Lessons for levelling up in 2021 and beyond is the easy summary read of the end of cycle data.

Research Professional do a great job at interpreting the meaning behind the main points. Their (short) blog is well worth a read if this topic interests you.

Overall UCAS report progress on widening participation, although it remains slow meaning it would take 332 years to close the gap on the current trajectory. Highly selective universities were urged to admit 70 more disadvantaged students per year to close their admissions gap by 2030.

The recommendations are on page 4 and divide into short term 2021 recommendations, and medium-longer term 2022-2025. Here are just a few of interest:

Short Term

  • Maintain the uplift in capacity in HE places and improved support for employers to take on apprentices or offer T Level placements
  • Adopt UCAS’ MEM as the default mechanism for measuring participation, providing a true sense of progress
  • Promote sharing of information at the application stage, including that related to disability, learning difference and mental health, by building confidence in students to trust that UCAS and universities and colleges will use this information to arrange appropriate support and inform future improvements

Medium to long-term, 2022-25

  • Increase the number of HE places and apprenticeships to reflect the growing 18 year old population and ensure disadvantaged students do not miss out as a result of increased competition
  • Consider how a post-qualification admissions system might improve the application experience and outcomes for disadvantaged students. HE admissions reform should be used as an opportunity to explore how technical education and apprenticeships could be integrated into the UCAS application process
  • Explore the benefits of a UK shared apprenticeships admissions service to enable students to consider and connect to all post-secondary education options in a single location

Further insight into the 2020 cohort including the analysis of students’ choices and motivations is due to be published end January 2021.

Chris Millward, Director for Fair Access and Participation at OfS, said:

  • Through the access and participation plans they have agreed with the Office for Students, universities have committed to ambitious targets to improve access over the next five years. This UCAS data shows universities taking the first steps towards meeting these commitments… It is crucial that universities follow through on these commitments to reduce barriers for students from the most disadvantaged parts of the country, and we will closely monitor their progress.
  • Access is, though, only one part of the picture. It’s promising that a record number of applicants have been accepted from the most underrepresented groups, but these students also need good support once they get into university. That will be crucial for ensuring that they are able to continue with their studies, particularly through the disruption of the coronavirus pandemic, and have an equal opportunity to achieve the top grades. It will also equip them with the skills and knowledge they will need if they are to thrive in the industries and public services of the future.

Access & Participation

Ethnic Disparities: Wonkhe tell us: letter from the Commission on Race and Ethnic Disparities to equalities minister Kemi Badenoch seeking an extension to a reporting deadline highlights an approach to identifying disparities based on finer grained data. One section suggests that analysis has shown that white “working class” boys are the group least likely to go to university, and that many girls from a Bangladeshi background choose not to go to a university outside of London for family and cultural reasons.

Parliamentary Questions

Student Hardship funding: Following the announcement of £20 million to HE providers to contribute to student hardship for 2020-21 the DfE has begun distributing and monitoring the fund. Wonkhe: Michelle Donelan asks that funding split between full-time, part-time, and disabled student premiums is available to students as quickly as possible, and allocated by the end of the financial year. OfS will publish details of an allocation later this week.

During the APPG for students it was raised that £20m for hardship is approximately £13 per student. Minister Michelle Donelan Reiterates that this fund is not going to be accessed or required by every student, and it is there to support students who need support most.

International

Employment & Skills

The Lords Economic Affairs Committee published Employment and Covid-19: time for a new deal it includes:

  • Expand the number of social care workers by increasing funding in the sector with stipulations that funding should be used to raise wages and improve training and conditions;
  • Prioritise green projects that can be delivered at scale, quickly, and take place across the country
  • Government should introduce a new job, skills and training guarantee, available to every young person not in full-time education or employment for one year
  • The Government’s disparate skills and training policies, spread across many departments, should be joined up and be managed and coordinated at a regional local level
  • The Government should also consider incentives to help young people move towards jobs with opportunities to develop skills in digital and other growing sectors
  • The most significant barrier to hiring apprentices is cost – faced with falling numbers of apprenticeship starts and reduced recruitment, the Government should consider raising the level of hiring subsidies for apprentices
  • The DWP should include a greater emphasis on skills profiling in its employment support offer – it should examine successful examples of employment services in other countries, such as Sweden and Austria, which intervene early to support declining businesses and sectors and quickly transition and retrain workers into more viable employment

2020 Spending Review Priorities

Following the Chancellor’s 2020 Spending Review announcements the Treasury has published the provisional priority outcomes and metric document. We have a summary of the aspects related to education here.

APPG for Students

The All Party Parliamentary Group for Students met this week questioning Universities Minister Michelle Donelan on HE student issues. As an interest based parliamentary group the meetings aren’t recorded and transcribed like other parliamentary business. However, the APPG has done a fantastic job in capturing the Minister’s statements on their Twitter feed (you have to keep clicking ‘show replies’ to view the full range of topics the Minister responded to.

Most of Donelan’s responses are the standard Government HE policy stock, however a few stood out.

PQs

Inquiries and Consultations

Click here to view the updated inquiries and consultation tracker. Email us on policy@bournemouth.ac.uk if you’d like to contribute to any of the current consultations.

There are three new consultations from the Office for Students this week:

  • Monetary penalties
  • Reportable events
  • Publication of information about individual providers

Other News

Nursing: Care Minister Helen Whately has made an announcement on the record numbers of students accepted places to study nursing and midwifery in England this year based on the UCAS data released this week. The press release begins:

The final figures from this year’s admission cycle show there were 29,740 acceptances to nursing and midwifery courses in England, 6,110 more than last year and an increase of over a quarter (26%). This year, 23% (6,770) of acceptances were from students aged 35 years and older, a 43% increase on last year.

Net zero: The Government published the Energy white paper: Powering our net zero future this week.

Government Education Policy Commitments: In the traditional spirit of the end of year review Dods have published Boris Johnson: One Year On reviewing how the Government have fared in delivering their cornerstone policy commitments. There’s a short section on Education and Skills on page 9 which is worth a quick skim. The key reminder in relation to HE is: The promised assessment of student loan interest rates has yet to materialise – though some in Whitehall might argue that it’s a low priority on the list of problems facing the HE sector at the moment.

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Writing a Data Management Plan – Steps for a successful application

This is an image that displays an infographic of connected aspects of the research life cycle. The text that is part of the image reads as: Plan to make data work for you; Data Management Plans that meet institutional funder requirements.  DMPonline helps you to create, review, and share data management plans that meet institutional and funder requirements. It is provided by the Digital Curation Centre (DCC).

Image captured from the official website of DMP Online (Accessed 27 November 2020).

What is a Data Management Plan? 

Data Management Plans (DMPs) document how data generated during a research project will be managed and preserved for reuse. Funders are taking this increasingly seriously and are evaluating the strength of DMPs when assessing bids for research funding. 

Who does it apply to? 

Staff undertaking research and PGRs. 

What is DMP Online? 

DMP Online is a data management planning tool. Created by the Digital Curation Centre (DCC), it enables researchers to write DMPs using funder templates. It also benefits from: 

  • Integrated guidance 
  • Tools to enable collaboration with colleagues/supervisors/library support 

DMP Online is highly recommended, helping researchers to meet funder expectations. There is also a BU template for all other projects. 

Where to go for more information and support 

The Library has developed an extensive Research Data Management (RDM) guide, which includes guidance for DMPs. 

Email bordar@bournemouth.ac.uk for additional support. 

 

Image credit:

Digital Curation Centre, 2020. DMPonline [online]. Available at: https://dmponline.dcc.ac.uk/ [Accessed 27 November 2020].

COVID-19 affects research into other diseases

A systematic review published late last week assesses the impact of the COVID-19 pandemic on on-going and new clinical trials and research on a range of diseases [1]. The COVID-19 pandemic has resulted in a series of public health policies, including lock down, that have crippled the healthcare systems of many countries. These measures hugely impact on study participants, care providers, researchers, trial sponsors, and research organizations conducting clinical trials. This pandemic has a substantial impact on the trial sites as they experience difficulty in the continuation of trial activities which eventually hampers the progress of the trial and delays study timelines. Most sites are struggling due to delayed subject enrolment, shortfalls in monitoring, and risks of compromised data integrity, and this situation also has a negative impact on the start of future. Researchers are also concerned regarding the delay or cancellations of trials in the pandemic, which will have financial consequences for research organizations/human resources.

According to one survey, about two-thirds of the respondents have stopped or will soon halt subject enrolment in ongoing clinical trials, one-third halted randomization, and fifty percent of respondents are delaying or planning to delay the studies.  Adopting new approaches and understanding the key risk indicators will help managers support trial sites with flexibility and ingenuity. For instance, switching patient site visits to new-trial virtualization, and telemedicine to interact with patients will help manage current clinical trials also beneficial for the post-pandemic era.

 

Reference:

  1. Sathian B, Asim M,  Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, Borges do Nascimento IJ, Alhamad HK.  Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020;10(3); 878-887

 

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.

 

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.

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.

Upcoming webinars from the British Library

The British Library is planning a series of upcoming webinars which you may find useful and interesting –

How to access digital resources: a free webinar for researchers
Friday 1st May, 10.30-11.30am
Researchers working from home may find now, more than ever, that they cannot access all they need to do their research. This webinar will introduce the concept of open access, and the various tools and resources that enable access to the resources researchers need.
**This will be of particular interest to researchers, so it’d be great if you could circulate locally to your researchers. It will also serve as a general intro to OA for any colleagues wishing to learn about this area of research support.**
Details and sign-up here:https://attendee.gotowebinar.com/register/4784745156984703756

 

The British Library’s Shared Research Repository
Thursday 7th May, 2.30-3.30pm
Creative and cultural organisations require repositories that look good, are attractive to users and support a wide range of non-text research outputs. Join us to learn more about our shared repository for UK cultural heritage organisations.
Details and sign-up here: https://attendee.gotowebinar.com/register/5003834943448442636

 

Introduction to research data, data services and DataCite at the British Library (and beyond)
Thursday 14th May, 2.30-3.30pm
This webinar will provide an introduction to research data and how to use persistent identifiers such as DOIs to make research data and other digital outputs like theses and grey literature findable and citable online. This webinar will also provide an introduction to DataCite, an international non-profit organisation, which enables the ability to create DOIs for digital objects.
Details and sign-up here: https://attendee.gotowebinar.com/register/6958681955238901260

 

Introduction to EThOS: the British Library database of UK theses
Thursday 21st May, 2.30-3.30pm
The British Library service known as EThOS is effectively a shop window on the amazing doctoral research undertaken in UK universities. With half a million thesis titles listed, you can uncover unique research on every topic imaginable and often download the full thesis file to use immediately for your own research. This webinar will offer a guided walk through the features and content of EThOS, and the research potential for making use of EThOS as a dataset.
**This webinar will be of interest to doctoral students and researchers, so please do advertise locally. It will also be of interest to librarians wishing to learn more about how EThOS works**.
Details and sign-up here: https://attendee.gotowebinar.com/register/1072813692823727372

 

Project FREYA: How persistent identifiers can connect research together
Thursday 28th May, 2.30-3.30pm
This webinar will showcase the latest developments from the EC-funded FREYA project, including the PID Graph which provides a method to discover the relationships between different researchers and their organisations and find out the full impact of research outputs. It will also describe upcoming developments planned in the final year of the project such as a Common DOI Search.
Details and sign-up here:https://attendee.gotowebinar.com/register/6895938324199891724

 

Please join the British Library for as many of these as you can. They will all last approximately 25-30 minutes with time for questions.

External guides for managing remote research

Given current Government guidance on the pandemic response, a number of research projects will need to be conducted remotely. Below are a number of external help guides/guidance articles that aim to assist researchers with this new way of working.

The UK Data Service’s guidance on online data collection

Warwick University’s article on using Skype to collect data

Guidance on conducting telephone interviews –
Article one
Article two

The resource ‘Fieldwork during the pandemic’

The UK Research Integrity Office’s ‘Internet-mediated research’ guide

Research should remain within the ethics approval that has been granted – if you need to make any changes as a result of COVID 19 (for example moving from face-to-face to remote interviewing) please email researchethics@bournemouth.ac.uk if a member of staff or your supervisor if a student.

UK Data Service Webinars

We have received notification of the following external webinars:

UK Data Service webinars – April to June 2020

Take a look at our 2020 free online training programme of regular introductory webinars. To help you get the most from the UK Data Service, our series of webinars introduce different aspects of the Service. Join us for:

  • Introduction to the UK Data Service, 7 May
  • Finding and accessing data in the UK Data Service, 14 May
  • Key issues in reusing data, 21 May
  • Data management basics, 28 May
  • Guided walk through ReShare, 4 June

These webinars take place from 15.00 – 16.00.

We also provide more specialised webinars, including:

  • Web-scraping for Social Science Research: Websites as a Source of Data, 23 April, 15.00 – 16.00
  • Web-scraping for Social Science Research: APIs as a Source of Data, 30 April, 15.00 – 16.00
  • Being a Computational Social Scientist, 12 May, 13.00 – 14.00
  • Power Pivot and Dynamic Arrays in Excel, 19 May, 15.00 – 16.00

To book a place visit the UK Data Service events page.

Slides and recordings of UK Data Service webinars are made available on our past events pages and YouTube channel soon after the event has taken place.

This post is for information only. Bournemouth University is not responsible for the content or any other aspects of such external websites.

Research in the NHS during the COVID-19 pandemic – HRA update

You may have seen an earlier blog post with regard to a halt on the review and approval of undergraduate and master’s clinical research projects. The HRA have released another update with regard to all other research and the state of play due to COVID-19.

To recognise the significant pressures on the NHS at this time, the National Institute of Health Research (NIHR) announced that all new and existing studies supported through its Clinical Research Network would be paused to focus instead on COVID-19 research. You can read the full statement on the NIHR website.

The full HRA statement can be viewed here. If you have any queries mai in Research Development & Support.

Research Development & Support are also updating the following help page regularly for academics and researchers.

COVID-19 guidance for clinical researchers

The Health Research Authority have released guidance for clinical researchers, sponsors and sites with regard to COVID-19 (Coronavirus) – please read this guidance if you are currently conducting your project or are in the planning stages/set-up of the study (so you are aware of the current situation).

This guidance is subject to change and will be updated as and when required by the HRA.

You can read the guidance in the link provided above, but for convenience, these are the most likely situations BU clinical researchers may face. Please ensure that in planning amendments that these do not create additional burden to NHS staff or resources.

Amendments to existing studies impacted by wider COVID-19 response 

  • Example – Where changes to administrative arrangements are required to reduce burden or physical contact with sites – for example, changes to monitoring arrangements.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. Where the study involves the NHS, they will be marked by the sponsor as a category C amendment not requiring assessment, and sent directly to the sites. The site should implement the amendment on the date specified by the sponsor.

  • Example – Where changes are made to how or when patients are seen to avoid exposing patients or to reduce burden on clinical services – for example, changing site visits to phone calls or postal questionnaires.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. The same procedure as the first example should be followed.

  • Example – Where a temporary halt needs to be placed on some or all of the study, or the duration of the study needs to be extended.

How this should be handled – these are non-substantial amendments that do not require HRA/HCRW approval or NHS R&D agreement. The same procedure as above should be followed.

  • Example – studies that need to be closed.

How this should be handled – for studies not involving provision of treatment to participants, a notification to the REC or study-wide review (for non-REC studies) should be provided, and an end of study report should subsequently be provided.
For any studies involving provision of treatment to participants, careful consideration should be given to post-study care. If this cannot be in line with the information provided in the participant-information sheet, a substantial amendment should be submitted.

To support sites in implementing the amendments it is important that:

  • The changes and local implications are made clear
  • Any changes to documentation are provided in tracked changes
  • In England and Wales All correspondence to sites should be copied to R&D/I department and the PI and delivery teams
  • Where indicated above, the sponsor should include the category and confirm that no assessment is required.

There may be some instances in which the site may raise issues or changes that need to be made. If they do, please inform the Sponsor as soon as possible.

What to do next

If you think that you may need to implement any changes or amendments to your study due to COVID-19 please get in touch with us as soon as possible. If you have any concerns or queries then please also get in touch to discuss these.

Informed Consent training opportunities

Before agreeing to participate in your study, your participants should receive all the information they require in order to make an informed decision. Once they wish to participate, then an informed consent form should be completed and filed appropriately.
Although the process sounds complex, there are currently a great training opportunities to help familiarise yourself with the background to, and process of informed consent in clinical research.

The Wessex Clinical Research Network are hosting the following training sessions at University Hospital Southampton and at Wessex CRN’s office –

  • NIHR CRN Informed Consent training, Thursday 26th March, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN;
  • NIHR CRN Informed Consent training, Thursday 7th May, 8:30am – 12:30pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Thursday 7th May, 1:00pm – 5:00pm, University Hospital Southampton, Level C, West Wing, NIHR WTCRF, Southampton, SO16 6YD;
  • NIHR CRN Informed Consent training, Friday 26th June, 08:45am – 1:00pm, CRN Wessex, Unit 7, Berrywood Business Village, Hedge End, Southampton, SO30 2UN

If you’re interested in attending, get in touch with the Wessex CRN to book your place.

Introduction to Good Clinical Practice – Tuesday 17th March at Dorset County Hospital

Are you interested in running your own research project within the NHS or healthcare? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

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 wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Tuesday 17th March, at Dorset County Hospital, Dorchester – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact Research Ethics.

Remember that 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.