Tagged / Update

Setting up clinical research – the ‘Organisation Information Document’

If you are currently conducting research within the NHS or Health & Social Care (HSC), then please bear in mind the following update if you wish/plan to add new NHS/HSC research sites to your study.

As of 5th June, the set-up procedure for clinical research projects involving NHS or HSC organisations changed (see blog post) –

  • If you applying for HRA/NHS REC approval you will be required to follow the new procedure using the Organisation Information Document (OID), as referenced in the above post;
  • If you are already conducting a study with HRA/NHS REC approval, in NHS/HSC organisations, and wish to involve new sites, then please be aware that the OID should be used, even if existing sites were set-up using the previous document, the Statement of Activities.

Further help and guidance

Guidance on the use of the new UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants with the change.

If you have any queries regarding any of the information provided above, information in the referenced blog post, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.

You can also take a look at the Clinical Governance blog for documents, links and training opportunities.

Setting up NHS / HSC research in the UK– changes from TODAY

The new ‘UK Local Information Pack‘  has been introduced today, 5th June to support the set-up of NHS / HSC research in the UK.

The ‘UK Local Information Pack’ is the set of documents that NHS / HSC organisations use to formally start preparing to deliver the study. You can find more information here, including what comprises the pack. All researchers wishing to set-up their study at an NHS/HSC site from today, 5th June, need to be aware of this change.

The Organisation Information Document

Researchers and research teams may be aware of a document called the ‘Statement of Activities’ – this is essentially a document that allows the sponsor to make clear to the research site, what activities will be undertaken locally. The document can also act as the agreement between the sponsor and site.

From today the Statement of Activities has been replaced by a document called the ‘Organisation Information Document‘. For non-commercially sponsored studies, that are not clinical trials or clinical investigations, the ‘Organisation Information Document’ should be used as the agreement between sponsor and participating NHS / HSC organisation.

A new delegation log template

Another feature of the new UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / HSC organisations. This will allow NHS/HSC organisations to locally record who will be working on the study and who is authorised to undertake study tasks. The delegation log can be found here and should be used for studies submitted for approvals from today.

Schedule of Events or Schedule and Events Cost Attribution Tool (SoECAT)

For non-commercially sponsored studies studies an IRAS Schedule of Events or a SoECAT will be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / HSC organisations on the cost attributions associated with a study.

Further help and guidance

Guidance on the use of the new UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants get ready for the change.

If you are making an IRAS Form submission or planning to set up research in an NHS / HSC organisation from today, 5th June 2019 please read the transition guidance so that you prepare the correct materials.

If you have any queries regarding any of the information provided above, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.

You can also take a look at the Clinical Governance blog for documents, links and training opportunities.

Knowledge Exchange and Impact Team Summer Sucesses

Over the past month or two the Knowledge Exchange and Impact Team (KEIT) have had quite a few successes we’re #BUProud of so we thought we’d share them.

Firstly we’re delighted that HEIF5+1 has been extended to HEIF5+1+1 and that there will be a further 12 projects funded until August 2017  – to find out more take a look at Jayne’s post about it here

In case you haven’t spotted it Rachel has also been working hard with the PR team to do some comms around our Olympic themed research. This content was shared internally, externally & on social media and had some good engagement which led to Bryce Dyer and Osman Ahmed being interviewed on Wave 105 & Tim Rees being featured in the Independent.

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She’s also been working with Alex Wardrop to have her research on how to improve access to higher education featured in Times Higher.

Thanks to Charlene’s hard work the Student Project Bank is almost up and running! We will be launching to students in October and are planning a pilot event for September/October – more information to follow soon!

I’ve also been working hard with Genna to finish the wash up report for Festival of Learning and we’re pleased to say that event with less events we still had over 4,500 visits over the course of 5 days compared to 5,000 over a week with an additional 50 activities in 2015.  We’re already planning madly for next year when we’ll be running FoL from 8-12th July, mark the date in your diary and start thinking of your event ideas!

We’re also hugely proud to announce we’ve launched our impact toolkit aiming at supporting the academic community to develop and record impactful research.  This is available here on the blog and contains helpful tips and examples of case studies.  There is also a handy mini-guide available in a printed format floating around the campus or available from anyone in the team.

Finally we’re very pleased to greet our two newest members of the team, Joanna Pawlik and Hannah Jones who will be working as the Event Coordinator/ Student Engagement Coordinator (respectively) for the next 12 months.