Tagged / guidance

Trusted Research – information now live

Within the Research Environment pages on the BU website, there is now a section on the Trusted Research agenda.

The Trusted Research Agenda is a government initiative to secure the integrity of the system of international research collaboration and innovation.

Please visit the page to find out more, including key details and 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.

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.

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.

Checklist now available to support researchers undertaking clinical research

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

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  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

New UK Standards for Public Involvement

Involving the public in your study is important, especially at the research design stage. This is called ‘Public Involvement’ (also known as ‘PPI’ [Patient and Public Involvement]). Public involvement in research means research that is done ‘with’ or ‘by’ the public, not ‘to’, ‘about’ or ‘for’ them.

By seeking the opinions and recommendations of the public, it is a great way to ensure that your study is designed and set-up in a way that will be relevant to participants, and of good quality.
This can also help to avoid any setbacks once the project is underway.

The new UK Standards for Public Involvement have now been released and were developed over three years by a country-wide partnership between the National Institute for Health Research (NIHR), Chief Scientist Office (CSO) Scotland, Health
and Care Research Wales, and the Public Health Agency Northern Ireland

They describe what good public involvement looks like and encourage approaches and behaviours that are the hallmark of good public involvement such as flexibility, sharing and learning and respect for each other.

You can see the six UK standards and supporting materials, as well as further details about the partnership, project and the piloting of the new standards, here.

Further guidance is available via the Clinical Governance section of the Research blog and via the Health Research Authority and NIHR pages.

Checklist now available to support researchers undertaking clinical research

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

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  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

New HRA guidance launched for public co-applicants in research

‘Increasing numbers of public contributors are helping to shape and deliver health and social care research, and there has been a rise in the number of public co-applicants joining research teams.

Involving members of the public in research design and development has been shown to have a positive effect on projects by improving the quality and relevance of research. However, until now there has been no guidance, either for researchers or for people involved, about what it means to be a co-applicant.

Now new guidance co-developed by NIHR-INVOVLE, the NHS R&D Forum and the Health Research Authority, has been launched to help support members of the public who are co-applicants on research grants and ensure that their contribution is valuable and rewarding.’

See the HRA’s update here and remember that support is on offer at BU if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog.

BU Guide to Full Economic Costing

father tedLast year, RKEO revised and re-published the BU guide to full Economic Costing, know as fEC (which some people choose to pronounce in a ‘Father Jack’ style).  The full guide can be found on the BU intranet.

If you are applying for external funding for your research and knowledge exchange activities then you need to read the guide and understand what makes up the costs of a project.  The guide fully explains what fEC is, how it’s calculated, the difference between cost and price, estimating staff time, and explanation of the terminology, i.e. what is directly incurred, directly allocated, estates, indirect costs, and exceptional items.

For more information and assistance with costing your external research or knowledge exchange application, please contact your RKEO Funding Development Officer.

Changes to MRC funding policy

logo_mrcMRC have written to us outlining a recent update to its funding policy to allow the inclusion of a one-page ‘methodology and experimental design’ annex to the case for support.

MRC have stated “The methodological rigour of all applications to the MRC is scrutinised closely during the peer-review process. However, we are increasingly aware that applicants often focus on presenting a compelling scientific rationale at the expense of providing sufficient methodological detail to persuade reviewers that the study will deliver robust and convincing findings. To help address this deficit, and in response to feedback from the community, we are making an important change to our application process; with immediate effect, the MRC is introducing an optional one page annex to the case for support within all research proposals. This will allow applicants to specifically detail the methodology and experimental design aspects of their proposals, and to include figures, tables and/or diagrams relevant to this, where appropriate. Full details can be found in the MRC Guidance for applicants (Sections 2.4.3 and 4.1.4).”

You are strongly encouraged to use the new guidance.  Applications for funding will be rejected outright if they do not provide sufficient detail to convince MRC Research Boards and Panels that the proposed experiments will be carried out appropriately; i.e. in the context of a robust study design; with the necessary statistical power to answer the research question; and with an analysis plan that is fit for purpose.

If you are interested in applying to the MRC then please contact the RKEO Funding Development Team in the first instance.

Research Funders’ Guide is even better!

Imap of science previously posted about the new Research Funders’ Guide available on the Research Blog under the Research Toolkit.  This introduced the major funder pages, which include a wealth of information about their research strategies, what they fund, impact reports, funder guides and success rates.

These pages have now been expanded to include:

Don’t forget, we also have the Research Lifecycle on the blog where you can see how RKEO can support you with your research plans.

 

Research Funders’ Guide

The Research Funders’ Guide was launched last week on the Research Blogs ‘Research Toolkit’ (hover over the link to see what is available to assist you with your external application for funding).map of science

This has since been updated to include success rate data and past awards for the Research Councils.  These are a good indication of what the Research Councils are interested in and what they’re prepared to invest in.  If you’re interested in applying to a Research Council then do have a look around.

In addition, we’ve tidied up the charities so that the major funders are now shown at the top and also contain links to past awards and some have the quick guides that RKEO have produced to help internal applications understand the process at BU.

Do also have a look at the Research Lifecycle on the blog to see how RKEO can support you with your research plans.

Introductory Session: Marie Skłodowska-Curie Individual Fellowships 2015

Introductory Session: Marie Skłodowska-Curie Individual Fellowships 2015 – European (EF) and Global (GF)

WHAT: Two brief overview sessions (1 hour) introducing the fellowships,  the support being offered to staff applying and a mapping of the processes both internal and external.

 WHERE: Lansdowne (B407) : Tuesday 27th January 10.30am-11.30am , Talbot (P335): Wednesday 28th January 3.30pm-4.30pm (it’s the same session – one for each campus).

The 2015 call for these very popular fellowships is launching 12/03/15.  The scheme involves a Researcher, potentially from anywhere in the world, coming to BU for 1 or 2 years with generous funding for salary and other costs.

Come along and find out more!

Introducing the Fast Track Status – application process now open!

In an attempt to sharpen the response time of some of our knowledge exchange activities, a new process is to be introduced .  During the last 18 months feedback from academics engaged with BU’s knowledge exchange (KE) vehicles suggests that our RKE processes do not always provide the speed and flexibility to operate effectively within a commercial environment.  In light of this feedback and under the direction of Professor Bennett, the Research and Knowledge Exchange Office (RKEO) has worked with academics to review the current processes and, in collaboration with Legal Services, have drafted a series of recommendations.  These measures should enable those with a proven track record for KE activity to have greater autonomy and empower them to negotiate and close deals with clients in a more flexible manner, thereby providing a more responsive service.

The new process, ‘Fast Track status’, allows for expedited procedures to operate (within selected KE units) thereby enabling them to operate in a more entrepreneurial manner.  Fast Track status will be provided by application to KE units that request such status and subject to central audit by both RKE Operations and Legal Services to ensure that the processes are operating within agreed BU policies and the KE strategies of Schools.

Please refer to the Fast Track Status policy document for greater detail of the Fast Track status and guidance on completing the application form.

All applications will require authorisation by the Dean of School/Faculty.  If an application is successful, this signed form will act as the APF for all bids/projects from the individual/unit that meet the criteria agreed for Fast Track Status (e.g. individual KE projects under £25k (exclusions apply)).  The application will seek confirmation that it aligns to the Schools KE strategy and this will need to be confirmed by the Dean.    Recognising that the processes are there for good reason it is not appropriate to change them for all KE work.  Instead it is recommended that special status be applied to certain individuals/units to allow them to operate under licence outside of some of these processes enabling a more entrepreneurial approach.  To clarify, this status isn’t something that would be available to everyone and would only be awarded on the basis of set criteria against with units apply for such status (see the policy document for more information).

The timeline for implementation is shown below for information:

Time estimate Description Dates
Week 1 Fast Track Status call opens: RKE Ops advertise application process and notify interested parties. 13/1/14
Week 3 Application deadline. 31/1/14
Week 4 Collation and preparation of applications: RKE Ops collate applications and, together with Legal Services and Finance, provide input on the track record of applicants and ensure that BU’s charitable status is not impinged by such work (i.e. to ensure that the public benefit is clear) before forwarding documentation on to the PVC. 3/2/14 – 13/2/14
Week 6 Review of applications: PVC reviews applications and approves/ rejects; RKE Ops notify applicants of results. 13/2/14 – 21/2/14
Week 7 Drafting of standard contractual documentation and daily rates: Legal Services meet with successful applicants to agree contractual documentation required for activity; RKE Ops create competitive daily rates for each successful applicant. 24/2/14 – 14/3/14
Week 10 Fast Track Status operational 17/3/14

The application process is now open.  Please note that the closing date is 31 January 2014 and late submissions will not be accepted.  Applications must be submitted by the Dean of School/Faculty to jgarrad@bournemouth.ac.uk.

If you have any queries then please contact Jo Garrad at jgarrad@bournemouth.ac.uk.

How to create the perfect profile

BRIAN

The academic profile in BRIAN can hold a wide range of information about professional activities, publications and (shortly) grants.  As the information in BRIAN is used to populate the profile page which is available to anyone on the web, it is important that there is a minimum set of information that everyone maintains.  This minimum set of information will ensure that everyone’s academic profile contains entries for the same types of data, ensuring a consistent level of information across all profiles within the University.

The profile pages are displayed whenever anyone from inside or outside the University seeks information on a member of academic staff.  The external viewers include other academics who may be seeking collaboration partners, potential students, commercial enterprises investigating research or enterprise possibilities etc.  It is particularly important that those who are potentially being put forward for the REF have full external profiles.

To attain the minimum standard that has been defined for BRIAN, please ensure you have entries in the following areas.

  • Biography
  • Research theme
  • Keywords
  • Qualifications
  • Publications

In line with the new version of BRIAN, we have prepared a document ‘BRIAN – Minimum data requirements‘ containing examples of the information required.  This is especially relevant for the biography where recent examples of engaging biographies demonstrate what can be achieved.

Once the new version of BRIAN is deployed, we will add some more areas to the minimum standard.  These are:

  • Research
  • Grants
  • Photograph

In the new version of BRIAN, you will be able to maintain your photograph yourself.

Academic staff are encouraged to go beyond this minimum level and to record and maintain as much of their academic lives in BRIAN as possible.  We encourage you to use BRIAN as a living academic CV and to ensure that your research information and publications are always up to date.

There is no need to delay in adding and updating your information in BRIAN.  All the information you add to the current version of BRIAN will be carried across to the new version at the end of the month.