Category / Guidance

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.

NIHR Learn – Resources to support you through the Covid-19 pandemic

The NIHR Learn platform now contains a number of resources to offer guidance and support to help researchers during the pandemic.

There are resources in the following areas:

  • Understanding the science of Covid-19
  • Leading in uncertain times
  • Conveying Difficult Information to patients and relatives
  • Personal resilience
  • Wellbeing
  • Remote working
  • Online Webinars and Events

To access these you will need to create an account on the system* – if you run into any issues with creating an account  phone the helpdesk on 0207 333 5894 or email them.

Once you are on the system, click on ‘Bite-sized Learning’ from the options and then select ‘Resources to support you through the Covid-19 pandemic’.

*If you have used the system to access Good Clinical Practice training or dates you will already have an account.

Doctoral Supervisors – Free UKCGE Webinar – Friday 1 May, 2pm

Effective Practices in Supervising Doctoral Candidates at a Distance

Online— 2pm Friday 1st May 2020.


As we continue working remotely, UKCGE thought you may appreciate the opportunity to hear from, and put your questions to, experienced research supervisors and an academic developer sharing effective practices in research supervision at a distance.

To that end, they have set up a free-of-charge, 1-hour webinar taking place at 2pm on Friday 1st May 2020.


Register for the Webinar
The webinar will take place online via Zoom. Places are strictly limited – Register your free place here:

https://us02web.zoom.us/webinar/register/


Send them your Questions
If you have any specific questions you would like answering during the webinar, please email them.


If you can’t make it at on the 1st, you can watch the recording of the webinar on YouTube or the UKCGE website.

 

Jisc, UK institutions and Wiley agree ground-breaking open access deal

Bournemouth University authors can now publish Open Access in more than 2,000 Wiley journals at no extra cost!

Jisc and Wiley, a global leader in research and education, have struck a four-year “read and publish” agreement that offers researchers at UK universities open access (OA) publishing in all Wiley journals at no cost to them.

As part of the new agreement, the proportion of OA articles published by UK researchers will increase from 27% to an estimated 85% in year one, with the potential to reach 100% by 2022. The agreement will also enable institutions and their users to access all of Wiley’s journals.

This ground-breaking agreement will enable institutions to control the costs of access and OA publishing. It will also support a simplified process for authors and their institutions, enabling compliance with funder mandates and Plan S.

The agreement begins in March 2020, and all participating Jisc member institutions and affiliated researchers are eligible. The contract has been made publicly available on 31 March 2020.

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.

PGRs Library & Learning Support

Message from Tim Calvert (Doctoral College Librarian Contact & Faculty of Health & Social Sciences Librarian)

——————————–

I hope you are finding everything you need from the library, and know where to go for any extra support or guidance in your research. We just wanted to draw your attention to some of the help offered to researchers, and let you know who to get in touch with if you have any questions – we’re always happy to help, especially if it saves you time and energy later on when you want to submit your thesis and move on to the next thing.

  • Copyright: This can be an issue for students writing a thesis which is going to be published on the university’s repository (BURO), especially if you are using any images from journal articles, books, websites etc. If you are using images you may need permission to use them if they are not made available on a Creative Commons licence, as theses are published online. You can read the library’s guidance here, or book a session with your specific Faculty Library team (see contact details below).
  • Referencing: It’s important to deal with any issues here before you come to submitting your work to the library so that you don’t experience any delays. Using EndNote can speed things up for you (check out our guide here), but the references it produces do still need to be checked, and it can produce incorrect references.
  • Researcher Guides: We have guides to help you with the research process. The Guide for Postgraduate Researchers has lots of useful information and is a good starting point for many queries.
  • Research Data: It’s becoming more and more important for the data supporting research findings to be made openly available to verify results and to encourage the discovery of new knowledge. Many funders and publishers, to promote the integrity and value of the research they fund or publish, have made this a requirement. The library supports researchers to adopt best practice data management (which ultimately saves you time and energy!) and looks after BORDaR, our research data repository. All Postgraduate Research Students are required by BU to produce a Data Management Plan (DMP) and to deposit their research data in the repository. You can access the library’s guide for more information.
  • Getting in touch. You can contact your Faculty Library team to make a one-to-one appointment if you want to discuss any of the areas raised above, or you’d like support with another area such as finding literature or using databases.
  1. Faculty of Management Library Team
  2. Faculty of Media & Communication Library Team
  3. Faculty of Science & Technology Library Team
  4. Faculty of Health & Social Sciences Library Team

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.

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.

Safeguarding Researchers: Preparing & Supporting PGR Fieldwork

GOOD-PRACTICE SHARING

Safeguarding Researchers: Preparing & Supporting PGR Fieldwork

Discover effective practices and contribute to a sector-wide standard for support and guidance in safeguarding postgraduate researchers undertaking fieldwork.

8th March 2020. University of Glasgow

This workshop will explore effective practices in, and opportunities to enhance, the support for researchers undertaking fieldwork, during the preparation phase, whilst they are away and on their return.

What to Expect
This workshop will consider:

  • Pre-departure training, including personal safety, travel health, first aid, data security and special considerations for working in conflict zones
  • Mental health support and training
  • Peer networks
  • Strategies and technology to keep in touch and provide support and connection to researchers in the field
  • Post-fieldwork debrief and support.

Date & Venue                                        Cost
18th March 2020.                                  UKCGE Member: £195
University of Glasgow.                          Non-member: £295

Find Out More >

 

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.

Good Clinical Practice Refresher – Dorset County Hospital, Tuesday 18th February

Are you currently undertaking research within the NHS, and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Dorset County Hospital, Dorchester on Tuesday 18th February, 9:00am – 12:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics.

The Schedule of Events Cost Attribution Tool (SoECAT)

SoECAT stands for the ‘Schedule of Events Cost Attribution Tool’ – either a SoECAT or a Schedule of Events (SoE) is required whenever you are conducting clinical research in the NHS or Social Care. Further information and clarification is provided below.

What is the purpose of the SoECAT?

  • The SoECAT is a way of providing clarity to participating NHS  organisations on the cost attributions associated with a study.
  • The template is designed to support correct cost attribution at application for Research Cost funding, to ensure that full site level Research Costs are recovered.

When is a SoECAT required?

  • A SoECAT is required by National Institute for Health Research (NIHR) and NIHR non-commercial partner research funders where the call relates to studies that may involve participants under an NHS or Health and Social Care duty of care.
  • In some cases, your study may be funded by an NIHR infrastructure award which does not cover Excess Treatment Costs (ETCs) – in these cases, a SoECAT would be required in order to access the ETC process for England. Further information on ETCs can be found here.
  • In cases where your study is not funded by the NIHR or a NIHR non-commercial partner, but you wish to make an application to the NIHR CRN Portfolio, you will need to complete a SoECAT.

How do I complete one?

  • The NIHR have recently released new guidance on how to complete a SoECAT which can be found here.

When is it completed and where does the SoECAT go when it is completed?

  • The SoECAT should be completed at the funding application stage.
  • The form must be authorised by an AcoRD Specialist prior to submission for Research Cost funding.
  • It should be submitted alongside your other supporting documents when applying through the IRAS system for NHS Ethics approval and/or Health Research Authority approval*.
  • The SoECAT/SoE is then sent to your participating NHS/HSC organisations as part of the Local Information Pack at the site study set-up stage.

*Where there is no external funding attached to a project, the Schedule of Events should be used instead of a SoECAT.

Where can I get further support and guidance?

  • Your research funder should have guidance you can follow if you are unsure about whether your application requires a SoECAT at the Research Cost funding application stage.
  • Get in touch with Suzy Wignall, the Clinical Governance Advisor, or your Funding Development Officer.
  • Further information about the SoECAT can be found here.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

Guidance available to support researchers attending an NHS REC meeting

Two new links have been added to the Clinical Governance blog under the ‘Useful Links and Documents’ section which give further information and guidance as to attending an NHS Research Ethics Committee meeting for your project. The links are also provided below-

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

RKEDF – Overview of NIHR, CRNs and NIHR portfolio

On Tuesday 11th February, Research Development & Support are running a 2 hour workshop to give an overview of the National Institute for Health Research (NIHR), Clinical Research Networks and the NIHR ‘portfolio’.

This workshop is designed to raise awareness of the benefits of the NIHR’s portfolio of research studies to BU and NHS partners.  It will also explore the role of the NIHR Clinical Research Networks (CRN), with an emphasis on the set-up and work of our local network, Wessex.

The workshop will cover the requirements to be eligible for the NIHR portfolio, how to apply so that your study may be considered for adoption, and how to access the support of the NIHR CRN.

By the end of this workshop you will have an understanding about:

  • The work of the NIHR and layout of the CRNs
  • How to apply for and the requirements for portfolio adoption
  • The benefits of having a study on the NIHR portfolio

If you’re interested in attending then reserve your place via Organisational Development.

REF2021: the importance of Open Access compliance

      

Introduction

The four main HE funding bodies in the UK believe that ‘the outputs of publicly funded research should be freely accessible and widely available.’ The REF2021 Open Access Policy was introduced as a requirement for the next REF and it states that – all journal articles and conference contributions (with ISSN) accepted for publication from 1 April 2016 and published on or before 31 December 2020 must comply with the policy to be eligible for submission to the REF.

What does this mean?

Any non-compliant outputs that do not satisfy the policy requirements will NOT be eligible for the next REF.

What are the policy requirements?

  • The outputs must be available open access (via the gold or green open access routes), three months after their acceptance date;
  • The outputs must be discoverable through search engines on the internet, and free to download
  • The outputs must also be in a format where they allow anyone with internet access to search electronically within the texts, to read and to download them

What does this mean to you at BU?

Once you’ve received an official notification from your publisher that your manuscript has been accepted, you should take action right away!

First of all, you should ensure that the publication record is created in BRIAN – Bournemouth Research Information and Networking, clearly specifying the acceptance date. Once you’ve created a record, following instructions on the screen, click on the BURO deposit page as shown below –

To comply with the REF Open Access Policy, you only need to upload/deposit the final accepted peer-reviewed manuscript (and not the final published version). However, depending on individual publisher copyright and policies, this is not always the case. To verify the publisher copyright policies and to decide which version of your manuscript you should use, you can do so through the SHERPA RoMEO online resource, which is a reliable source of information recommended by Research England.

Some of these deposited manuscripts may also be subjected to a period of embargo before they can be made available. Again, this would depend on the publisher copyright policies, which you can also check out on SHERPA RoMEO.

On the ‘Deposit’ page in BRIAN, you will see this message –

BURO, which stands for Bournemouth University Research Online is the University’s Institutional Repository. All manuscripts uploaded on BRIAN will be deposited in BURO and are available to anyone in the world with internet access (subject to embargo).

BURO is supported by a team of colleagues from the Faculty Library Team. The BURO team is available to support and advise you through the open access compliance process and to ensure that you are compliant with all publisher copyright and policies.

Do remember, this process has to be done within three months of your publication acceptance date! Please see this video for more guidance.

What do embargo periods mean for compliance?

As mentioned above, use SHERPA RoMEO to find out more about deposit policies and embargo periods.  As long as your manuscript is deposited within 3 months of the acceptance date, the REF2021 Open Access Policy allows for an embargo period of up to 12 months for the REF Panels A & B and 24 months for the REF Panels C & D.

What if the output doesn’t meet the compliance requirements?

In some circumstances, some outputs cannot meet the open access policy requirements due to deposit, access, technical or other issues (for more information see here). If these circumstances fall under the permitted exceptions in accordance with the REF Open Access policy, these outputs may still be submitted to the REF. If you are unsure, please seek advice and guidance from ref@bournemouth.ac.uk as early as possible.

If you have questions regarding REF2021 or Open Access compliance, please feel free to contact ref@bournemouth.ac.uk or if you have questions specific to uploading of your manuscript, please contact BURO@bournemouth.ac.uk.