New UK-wide student research eligibility come into force from 1 September.  To support the implementation of these changes a student research toolkit for use by students carrying out research in all UK nations. It has been designed to pull together all the resources a student will need to understand what approvals are required and whether they are eligible to carry out their research in the UK. It contains links to existing decision tools as well as some new ones developed especially for students. It uses a simple question and answer format to guide the student through to the outcome for them and the research they wish to carry out.

The toolkit provides access to five different decision trees providing answers to the following questions:

• is my study research?
• is my research taking place in the NHS and will need NHS approval?
• do I need NHS Research Ethics Committee (REC) review?
• what type of NHS ethics review do I need?
• can I carry out my research?

Completing the tool will provide students with an understanding what activities they can do and ensures that they do not waste time applying for approval for research that they are not able to carry out under the student eligibility criteria.

The commercial Organisation Information Document was initially introduced across the UK with the implementation of the UK Local Information Pack in June 2019. Following feedback from stakeholders, it has been agreed across the four nations that the commercial Organisation Information Document will not be used as part of study set up from Thursday 12 November 2020.  

Commercial studies use a commercial contract as the principal agreement between the sponsor and site, and feedback has indicated the commercial Organisation Information Document provides no additional information to support sites in study review and set up. To reduce unnecessary bureaucracy the commercial Organisation Information Document will be removed from the requirements.   

For new submissions the commercial Organisation Information Document will no longer be required as part of the application process through IRAS from Thursday 12 November 2020.  

For studies in site set up, if the commercial Organisation Information Document has been provided as part of the Local Information Pack, this can be processed and filed in accordance with local Standard Operating Procedures. 

Note: The non-commercial Organisation Information Document remains a required document for non-commercially sponsored studies.  

Our new online submission of amendments and amendment tool have today gone live across the UK (Tuesday 2 June 2020). These new processes for handling amendments are part of our ongoing programme to improve services for applicants. 

We are introducing this change now to help make implementing amendments more straightforward and clear – benefitting health researchers across the UK including those working on COVID-19 studies.

All applicants making an amendment to project-based research will now need to complete the amendment tool and submit their amendment online. The tool replaces the Substantial Amendment Notification Form, and Non-Substantial Amendment forms for non CTIMPs. For CTIMPs, the EudraCT Annex 2 amendment form will still be required and can be completed within the tool.

Guidance for amendments is now available on IRAS.

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.

There are two videos to help you through the new processes:

• amendment tool demonstration
• how to submit amendments online

Amendments to Research Tissue Banks (RTB) and Research Databases will also be submitted online from this date. These will continue to use the Notice of Substantial Amendment Form, the amendment tool should not be completed for RTB or Research Databases.

For queries on using the amendment tool or how to submit your amendment online, please contact:

For England and Wales led studies: amendments@hra.nhs.uk

For Scotland led studies: nhsg.nrspcc@nhs.net

For Northern Ireland led studies: Research.Amendments@hscni.net

You can provide feedback on your experience of the new online submission of amendments and the amendment tool by taking part in our survey.

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 programme to improve services for applicants.

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 Substantial Amendment Notification Form, and Non-Substantial Amendment forms for non CTIMPs. For CTIMPs, the EudraCT Annex 2 amendment form will still be required and can be completed within the tool.

Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date, but will not need the amendment tool.

To help with these changes, we have now published:

• The amendment tool and full guidance about the new process for handling amendments
• Training videos: amendment tool demonstration and how to complete online submission of amendments

For queries on using the amendment tool or how to submit your amendment online, please contact:

For England and Wales led studies: amendments@hra.nhs.uk

For Scotland led studies: nhsg.nrspcc@nhs.net

For Northern Ireland led studies: Research.Amendments@hscni.net

Mary Cubitt, Director of the Research Systems programme, said: ‘The online submission of amendments means that applicants can submit their documentation directly – via a new part of the IRAS website - without having to email them over. This will make it easier for applicants to track the submission history of their amendments.

‘We are also launching a new amendment tool. This categorises each amendment and provides tailored guidance on submission. It will identify any review bodies an amendment needs to be sent to, based on the changes that are being made to a study.

‘Together we hope this will make implementing amendments more straightforward and concise – benefitting health researchers across the UK including those working on COVID-19 studies.’

To read the guidance visit IRAS.

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:

• The amendment tool and full guidance about the new process for handling amendments
• Training videos: amendment tool demonstration and how to complete online submission of amendments

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:

For England and Wales led studies: amendments@hra.nhs.uk

For Scotland led studies: nhsg.nrspcc@nhs.net

For Northern Ireland led studies: Research.Amendments@hscni.net

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.

A new online booking service will be rolled out for IRAS studies on Tuesday 19 May – replacing the current Central Booking Service (CBS) telephone line. This is part of our ongoing Research Systems programme of work to improve our services for applicants.

Applicants submitting research projects through IRAS will no longer need to call the Central Booking Service to book a Research Ethics Committee, or to enable IRAS Form submission. Instead applicants will access the new online booking service via IRAS to book their application for review. The service is quick and easy to use and, unlike the current Central Booking Service, will be available 24 hours a day, seven days a week, making it easier for research applicants. If you need help and support with the new system you can call 0207 104 8008 between 8.30am and 4.30pm Monday to Friday.           

In order to make use of this new functionality, applicants will be directed to a new part of IRAS which hosts the online booking service. A separate login will be required, but support will be provided. You will need to set up a new login and password for this area unless you already have a login for a NIHR system or as part of the Combined Ways of Working (CWoW) pilot. In this case you can use your existing log in details.

Applicants will need to answer a series of questions online before being able to book a slot. This directs the applicant to the appropriate REC.  The questions will be familiar to anyone who has used the CBS.

Once you have completed your online REC booking, you will still need to electronically submit your application in IRAS using the normal process. 

Applicants making contact about fast-track COVID-19 studies, should continue to follow our current guidance or email fast.track@hra.nhs.uk, DO NOT use the online booking service. Similarly, in this first stage of release, CWoW applicants and phase I applicants, who currently make use of direct booking with a member of staff, should continue to use existing routes.

The work to build the online booking service began before the current COVID-19 pandemic. It is being rolled out now so that the system can support research applicants with non-COVID-19 studies.

Training and guidance will be available via the IRAS website.
You can also watch a short video to see how to use the online booking service.

The Four Nations NHS/HSC Compatibility Programme has confirmed that improvements to IRAS submissions and amendments will be introduced shortly as planned by the UK Policy Leads. This work started before the COVID-19 pandemic. We recognise that this is a challenging time for the research community, and we believe by rolling out these changes now it will make the amendments process more straightforward and allow greater flexibility when booking applications by making this accessible 24/7.

Online booking service for IRAS submissions

A new online booking service for IRAS submissions will be rolled out in late-May, replacing the current Central Booking Service telephone line.

Applicants submitting research projects through IRAS will access an online system via IRAS that will allow them to book in their submission and select the appropriate review. The online booking service is quick and easy to use and will be available 24 hours a day, seven days a week. Applicants will then be able to submit their application.

Telephone support to applicants, if they need help with the new system, will be available. Details will be given in the guidance once the service goes live.

Current process to fast-track COVID-19 studies will remain in operation see our current guidance.

Online submission of amendments and new Amendment Tool 

From June, applicants will be able to submit amendments for approved studies through IRAS without having to email documents. This will help speed up the processing of amendments.

We will also be rolling out a new amendment tool, which we have successfully piloted over the last six months, at the same time. The tool will simplify the amendment process by producing tailored guidance for the applicant on where to submit their amendment and what actions are needed. We also anticipate that it will make the process more efficient across the UK and increase UK compatibility. Guidance will be provided along with training videos and support.

We will send you further details about both new processes by email once the final testing is completed for you to cascade, and we will publicise it on IRAS.   

Organisation Information Document Revision

Following implementation of the UK Local Information Pack on 5 June 2019 the non-commercial Organisation Information Document and guidance has been updated to clarify the authorisation section, these are now available on IRAS Help.  The changes were made following feedback from stakeholders.

The questions relating to PI discharging responsibilities in line with UK Policy Framework and mitigation of any potential conflict of interest, and sponsor authorisation have been moved into the main body of the document. This is to clarify these questions are to be completed whether or not the document is to be used as the agreement.

There are no new questions.

We have also updated the guidance notes regarding version control and filing. A complete change history is provided in the guidance.

When initiating a new study always use the latest revision of the Organisation Information Document available on IRAS.

For studies already in progress when a revision is made to the Organisation Information Document template continue to use the outline Organisational Information Document originally submitted, there is no need to resubmit.

We value feedback from the research community to continue to streamline processes and make it easier for all researchers to do research across the UK.

Bite Sized Learning Modules

We have developed some bite sized learning modules to support research teams in completing the Organisation Information Document and Sharing the UK Local Information Pack. These are available on the 4 nations programme website.

Participant Identification Centres

Model Participant Identification Centre (PIC) agreements have now been published and are available on IRAS Help alongside guidance.

PICs are NHS/HSC organisations that identify potential research participants.  They are not research sites and should not be treated in the same way as research sites.

What contracting arrangements should be put in place with NHS/HSC PICs?

NHS/HSC PICs should be set up by through a sub-contracting arrangement with the participating NHS/HSC organisation that the PIC supports using the appropriate model agreement:

• Model Commercial PIC agreement (m-C-PICA)
• Model Non-Commercial PIC agreement (m-NC-PICA).

Non-commercial Organisation Information Document Revision

Following the implementation of the UK Local Information Pack on 5 June 2019 the non-commercial Organisation Information Document has been updated to correct internal clause referencing, this is now available on IRAS Help.

When initiating a new study always use the latest revision of the Organisation Information Document in IRAS.

For studies already in progress when a revision is made to the Organisation Information Document template you can continue to use the outline Organisational Information Document originally submitted, there is no need to resubmit.

Setting up NHS/HSC research in the UK: Implementation of the UK Local Information Pack

From today researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK. 

The UK Local Information Pack contains an Organisation Information Document which has replaced the Statement of Activities that was used in England and Wales and the Site Specific Information form, which was used in Northern Ireland and Scotland.  The Organisational Information Document is required as part of the UK Local Information Pack for commercial and non-commercial research.

Examples of completed Schedule of Events Cost Attribution Template and Organisation Information Document templates are also now available on the Four Nations NHS/HSC Compatibility website on the UK Local Information Pack: Questions and Answers page. 

For more information and guidance on the UK Local Information Pack please visit IRAS Help.

The UK Local Information Pack, including the Organisational Information Document, should not be used for Participant Identification Centres (PICs).  Model PIC Agreements, to be used as a subcontract between participating NHS/HSC host organisations and PICs, are being developed.  These will be released in the coming weeks.  In the interim, please continue to use the current process for recruitment and set up of PICs.

Setting up NHS/HSC research in the UK: Preparing for change on 5 June 2019

A UK Local Information Pack will be introduced on the 5 June 2019 to support the set-up of NHS / HSC research in the UK. Researchers working with NHS / HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across 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. More information is given in the Local Information Pack section of IRAS Help but there are some key features: 

• One new feature of the UK Local Information Pack is the Organisation Information Document, which will replace the current Statement of Activities used in England and Wales for non-commercial studies and the Site Specific Information Form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and NHS / HSC Site Specific Information Form will no longer be in use.

In outline format the Organisational Information Document will be a component of the IRAS Form submission and in a localised format will be required as part of the UK Local Information Pack for both commercial and non-commercial research. Organisation Information Document templates and associated guidance are available in IRAS Help.

For non-commercial, studies that are not clinical trials or clinical investigations, the Organisation Information Document should also be used as the agreement between sponsor and participating NHS / HSC organisation.

• Another feature of the 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.
• For non-commercial 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.

Guidance on the use of the 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 5 June 2019 please read the transition guidance so that you prepare the correct materials.

To support researchers and NHS / HSC organisations make the transition to using UK Local Information Packs, change management activities will be scheduled throughout April and May, with continuing support following implementation in June. Webinars have been scheduled to support the change (if you have not previously used the new HRA Learning Management System please register for an account via the link).

Guidance and information is provided in IRAS Help and some explanatory questions and answers are available on the Four Nations Compatibility project web page.

Setting up NHS/HSC research in the UK: Update on UK Local Information Pack

Implementation of the UK Local Information Pack is confirmed for 5 June 2019. It will be important to remember that from this date an Organisation Information Document will replace the current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland.  From this date the Statement of Activities and Site Specific Information form will no longer be in use.

The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK. 

Guidance and information is provided in IRAS Help and some explanatory questions and answers are available on the Four Nations Compatibility project web page.

Delegation Logs

Following feedback we have clarified the use and inclusion of the delegation log. Delegation Logs are required for all interventional studies requiring a local Principal Investigator. Sponsor will need to indicate if this is being provided with the UK Local Information Pack or if this is being provided at a later date i.e. following Site Initial Visit. The Q&As have been updated with regard to this. 

Further webinars will be held on 30 May at the following times 9.15am, 11.00am, 13.00pm and 14.30pm. To register sign on here.

Setting up NHS/HSC research in the UK: A UK Local Information Pack will be introduced on 5 June 2019

Following on from the previous communication in February, it is confirmed that a UK Local Information Pack will be introduced on the 5th June 2019. From this date an Organisation Information Document will replace the current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and Site Specific Information form will no longer be in use.

The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK. 

The Organisational Information Document template will be made available from end April 2019.  

Regular communications and updates will be available on the four nations NHS/HSC compatibility website. 

Setting up NHS/HSC research in the UK: Implementing a UK Local Information Pack

A UK Local Information Pack is being introduced in the summer of 2019.  Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.  A specific implementation date will be announced in March along with further guidance.

The current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland, will be replaced by an Organisation Information Document.

Regular communications and updates will be available on the four nations NHS/HSC compatibility website.