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Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS or social care – email the Clinical Research mailbox, and take a look at the Clinical Governance section of the website.
Tagged / Health Research Authority (HRA)
Health Research Authority – new final report requirements
Please see below for an update from the HRA –
Changes to the way you submit your final report
The Health Research Authority has implemented changes to final study reporting requirements. The changes apply to all studies across the UK which require ethics approval and which have not yet submitted a final report.
The Make It Public strategy set out our commitment to make transparency easy, make transparency the norm and make information public. We have now developed a standard dataset on research transparency which will be collected in the study final reports. Coupled with changes we have already made to help you plan at the start of a study how you will inform participants at the end, these changes are steps towards fulfilling that commitment.
In the future we will be able to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).
In standardising the information we request from you and the form for collecting this, we hope it will be easier for you to know what is expected.
If you have any questions, please email research.transparency@hra.nhs.uk
Health Research Authority’s new student research eligibility criteria – live from today
New eligibility criteria for standalone student research go live today (1 September 2021). These changes are designed to ensure that students’ experience of research reflects how modern health and social care research is conducted.This new criteria encourages innovative approaches to student research like group research, mock Research Ethics Committees (REC) or shadowing a range of people in an existing project. The changes mean some master’s students will now be eligible to apply for approval to carry out their research. To help students plan their research we have created a new student research toolkit. The toolkit has been designed to pull together 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 and will provide answers to the following questions:
Completing the tool will provide students with an understanding of 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 new student eligibility criteria. Through completion of the toolkit, students can access supplementary declarations that need to be completed by their academic supervisor, confirming that they meet the criteria for the type of approvals they need for their research. There are three separate declarations depending on the approvals needed – the toolkit guides the student to the right one based on their responses. Please share this update and new resource with colleagues and students who might benefit. Further details about the new eligibility criteria can be found on the HRA website. Please see our question and answer section for further information. If you have any other queries about the eligibility criteria, please contact queries@hra.nhs.uk. |
Please contact Suzy Wignall, Clinical Governance Advisor in RDS if you have any queries or concerns.
Health Research Authority Releases Question and Answers: Student Eligibility Criteria
The Health Research Authority have published some questions and answers in relation to student research – this is in relation to the recent update regarding the upcoming changes to eligibility criteria.
You can find the Q&As here.
If you have any queries please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.
Health Research Authority UPDATE: undergraduate and master’s research projects
New eligibility criteria from 1 September 2021
The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.
The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.
In March 2020 the HRA paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, they are introducing new eligibility criteria for standalone student research.
The new criteria mean that some master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged. Full details are in table one – permitted student research table. They have also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator.
It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of the HRA event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read the HRA website for further information and ideas https://www.hra.nhs.uk/student-research/.
The HRA are giving notice now so that course leaders and students have time to prepare for the new arrangements, including ensuring that any changes to institutional policies and procedures are made.
If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk or swignall@bournemouth.ac.uk
HRA UPDATE: guidance on undergraduate and master’s research projects
At the beginning of August an update was released by the Health Research Authority with regard to the review of clinical research by undergraduate and master’s students.
The HRA have released a further update – please see below. If you have any queries or concerns please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.
‘Back in March the Health Research Authority and devolved administrations announced the decision to stop reviewing applications for individual undergraduate and master’s student projects until further notice while we prioritised the urgent review of COVID-19 studies. This was also due to the significant pressure on the NHS/HSC, limiting its ability to participate in research studies unrelated to COVID-19.
The pause on health and social care research projects for educational purposes has now been extended until September 2021. This decision is in line with national priorities for NHS/HSC to support COVID-19 studies and the restart of clinical trials and studies as well as the continuing pressure of the COVID-19 pandemic. This decision has been taken in collaboration with partners in the devolved administrations.
We are not reviewing applications for individual undergraduate and master’s student research projects until September 2021.
Any students with approved studies are reminded to check with the relevant NHS/HSC organisations locally about whether or not their projects may continue.
We are committed to engaging our stakeholders as part of the development of ongoing guidelines for student research.
To receive updates about student research, please email communications@hra.nhs.uk to sign up.‘
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:
- 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 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:
- 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 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.
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: health and social care research projects for educational purposes
The HRA have therefore decided stop reviewing applications for individual undergraduate and master’s student projects from now until further notice.
Please see this new guidance which relates to health and social care research projects conducted by undergraduate and master’s students: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/
Health Research Authority email addresses are changing
All email addresses at the HRA are changing in the coming weeks and this change will be complete by March 2020.
HRA staff email addresses will be standardised as firstname.lastname@hra.nhs.uk. A full list of contact email addresses for the Research Ethics Committees is now available here.
If you use the HRA staff member’s @nhs.net email address to contact them after they have moved to their new email address, you will receive a response containing their new details but your email won’t be automatically forwarded.
If you are unsure which contact information to use for the individual or service you require, please contact the HRA mainline on 020 797 22545 or use their contact form.
Make sure to check your junk mail if you are expecting emails from the HRA or an NHS REC as they often are sent there instead. Please add them to your safe senders list if this is the case to make sure you don’t miss any important study emails!
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.
Update to HRA’s data transparency wording for Participant Information Sheets
Following the implementation of GDPR in May of this year, the Health Research Authority released transparency wording for use in Participant Information Sheets.
The recommended wording for data transparency has been updated following consultation with various stakeholders and public involvement and feedback on the initial published wording to provide a clearer more layered approach.
The user group developed a short summary text for the Participant Information Sheet which is supplemented by a generic leaflet. The text for both is now live on the HRA website.
What information should be used in my PI Sheet?
The HRA website section is here. Click on ‘Transparency wording for all sponsors’ – this will take you to this page which contains the information to be used.
To access the text to be used in preparing the leaflet to accompany your PI Sheet, click here. If you are on the HRA website section, the text appears once you click the heading ‘Template wording for generic information document’.
What does the revision in text mean for me?
- If you have already updated your information sheets with the previous wording, you do not need to do anything.
- The revised wording can be uses for new studies, but the HRA will accept the previous wording if you have already submitted your application or prepared your information sheet for submission.
- If you do wish to change your wording to the new text, please email Research Ethics so that your participating sites can be contacted.
If you have any queries or concerns please email Research Ethics.
Health Research Authority #MakeItPublic Campaign – internal survey
You will hopefully have seen numerous blog posts regarding the Health Research Authority’s (HRA) commitment to research transparency. This was prompted in response to the House of Commons Science and Technology Committee report last year on clinical trials transparency, which showed that nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.
The HRA have recently launched a consultation on their new draft strategy for research transparency – #MakeItPublic. You can find out more about the campaign here on their website where there are also pages outlining their plans and visions for this area of improvement.
If you would like to have your say and be a part of the consultation, BU has an internal survey you can complete. The survey will close on Friday 16th August and replies will be combined to create an institutional response.
Health Research Authority #MakeItPublic Campaign
You will hopefully have seen numerous blog posts regarding the Health Research Authority’s (HRA) commitment to research transparency. This was prompted in response to the House of Commons Science and Technology Committee report last year on clinical trials transparency, which showed that nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.
The HRA have recently launched a consultation on their new draft strategy for research transparency – #MakeItPublic. You can find out more about the campaign here on their website where there are also pages outlining their plans and visions for this area of improvement.
If you would like to have your say and be a part of the consultation, you can book onto one of their face-to-face workshops, or via their online survey.
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.
Setting up NHS / HSC research in the UK– upcoming changes
The UK Local Information Pack
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.
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 5 June, will 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. Researchers setting up their study before 5 June should continue to use this document.
From 5 June the Statement of Activities will be 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 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.
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 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.
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.
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