Category / Research Ethics

Updated HRA and HCRW Statement of Activities and Schedule of Events published

What is the significance of the Statement of Activities and Schedule of Events?

When the Health Research Authority (HRA) approval process was introduced in March 2016, the Statement of Activities (SoA) and Schedule of Events (SoE) documents were made mandatory for non-commercial studies – those initiated and managed by non-commercial organisations such as Universities, NHS Trusts, charities etc.
The two documents must be submitted alongside your study documents when seeking NHS Research Ethics Committee approval, and the approval of the HRA, as the ‘umbrella organisation’.

With the introduction of the new General Data Protection Regulations, the HRA and HCRW have amended the two documents. They may be found here.

Who is ‘HCRW’?

HCRW stands for Health and Care Research Wales, and they have recently aligned its processes and paperwork with the HRA’s, so as to streamline and make consistent the research application process within England and Wales. Until recently the HRA was the umbrella organisation in England only, and a separate process was required if you wished to include research sites in Wales, Scotland, and Ireland*.

*If you wish to include sites from Scotland and Ireland, then the ‘old process’ is still to be followed. Contact Research Ethics for guidance.

What do I need to do?

If you are currently awaiting your approvals from the REC and HRA/HCRW, you do not need to do anything unless otherwise instructed by the HRA/HCRW. If you are concerned please get in touch with your HRA assessor, or their queries line.

If you are simply thinking of introducing your research into the NHS, are at your beginning stages, or you are currently compiling your study documents, then please remember to use the new versions of the SoA and SoE.
Please get in touch with Research Ethics for guidance on any aspects of clinical research, guidance, and if not already obtained, to request sponsorship of your study. Guidance and useful documents may also be found on the Clinical Governance blog.

Updated HRA and HCRW Statement of Activities and Schedule of Events published

What is the significance of the Statement of Activities and Schedule of Events?

When the Health Research Authority (HRA) approval process was introduced in March 2016, the Statement of Activities (SoA) and Schedule of Events (SoE) documents were made mandatory for non-commercial studies – those initiated and managed by non-commercial organisations such as Universities, NHS Trusts, charities etc.
The two documents must be submitted alongside your study documents when seeking NHS Research Ethics Committee approval, and the approval of the HRA, as the ‘umbrella organisation’.

With the introduction of the new General Data Protection Regulations, the HRA and HCRW have amended the two documents. They may be found here.

Who is ‘HCRW’?

HCRW stands for Health and Care Research Wales, and they have recently aligned its processes and paperwork with the HRA’s, so as to streamline and make consistent the research application process within England and Wales. Until recently the HRA was the umbrella organisation in England only, and a separate process was required if you wished to include research sites in Wales, Scotland, and Ireland*.

*If you wish to include sites from Scotland and Ireland, then the ‘old process’ is still to be followed. Contact Research Ethics for guidance.

What do I need to do?

If you are currently awaiting your approvals from the REC and HRA/HCRW, you do not need to do anything unless otherwise instructed by the HRA/HCRW. If you are concerned please get in touch with your HRA assessor, or their queries line.

If you are simply thinking of introducing your research into the NHS, are at your beginning stages, or you are currently compiling your study documents, then please remember to use the new versions of the SoA and SoE.
Please get in touch with Research Ethics for guidance on any aspects of clinical research, guidance, and if not already obtained, to request sponsorship of your study. Guidance and useful documents may also be found on the Clinical Governance blog.

 

‘Research changed my life’ – NIHR stories

The National Institute for Health Research have gathered some inspiring stories from people across England, whose lives have been transformed by clinical research. The stories cover a wide range of health conditions.

You can read them here.

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email Research Ethics and take a look at the Clinical Governance blog.

Online Ethics Checklist is NOW OFFLINE

REMINDER that the online ethics checklist is now offline and won’t be available until Monday 3rd September.  During this time students/staff will not be able to apply for ethical approval.  This is to allow for data migration.

The new online checklist will be available from Monday 3rd September 2018.

If you have any questions, please email researchethics@bournemouth.ac.uk.

Online Ethics Checklist is NOW OFFLINE

REMINDER that the online ethics checklist is now offline and won’t be available until Monday 3rd September.  During this time students/staff will not be able to apply for ethical approval.  This is to allow for data migration.

The new online checklist will be available from Monday 3rd September 2018.

If you have any questions, please email researchethics@bournemouth.ac.uk.

Online Ethics Checklist – goes offline tomorrow!

REMINDER that the online ethics checklist will not be available from tomorrow, Friday 24th August 2018 until Monday 3rd September.  During this time students/staff will not be able to apply for ethical approval.  This is to allow for data migration.

The new online checklist will be available from Monday 3rd September 2018.

If you currently have an ethics checklist in the system and you are in the process of seeking ethical approval you will need to make sure it’s approved today or you may find you’ll have additional questions to answers when the new checklist comes online!

If you have any questions, please email researchethics@bournemouth.ac.uk.

 

Online Ethics Checklist – going offline this Friday 24th

REMINDER that the online ethics checklist will not be available from Friday 24th August 2018 until Monday 3rd September.  During this time students/staff will not be able to apply for ethical approval.  This is to allow for data migration.

The new online checklist will be available from Monday 3rd September 2018.

If you currently have an ethics checklist in the system and you are in the process of seeking ethical approval you will need to make sure it’s approved today/23 August or you may find you’ll have additional questions to answers when the new checklist comes online!

If you have any questions, please email researchethics@bournemouth.ac.uk.

 

*Spaces still available* – Training opportunity: completing and submitting your IRAS application

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, R&KEO)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House, room 103 on Thursday 23rd August, at 13:00pm – 16:00pm.

Get in touch with researchethics@bournemouth.ac.uk if you would like to register your interest and book a place.

Online Ethics Checklist

REMINDER that the online ethics checklist will not be available from Friday 24th August 2018 until Monday 3rd September.  During this time students/staff will not be able to apply for ethical approval.  This is to allow for data migration.

The new online checklist will be available from Monday 3rd September 2018.

If you have any questions, please email researchethics@bournemouth.ac.uk.

 

Training opportunity – completing and submitting your IRAS application

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, R&KEO)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House, room 103 on Thursday 23rd August, at 13:00pm – 16:00pm.

Get in touch with researchethics@bournemouth.ac.uk if you would like to register your interest and book a place.

Health Research Authority eLearning modules

The Health Research Authority’s website hosts a number of eLearning modules, in place to support staff and researchers with various aspects of conducting research within an NHS setting.

The modules encompass a wide range of topics, such as the HRA Approval process, and research involving human tissue.

You can register for free here!
Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email Research Ethics and take a look at the Clinical Governance blog.

Good Clinical Practice refresher – 15th August 2018 – booking closes end of tomorrow!

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, Wednesday 15th August, 9am – 12:30pm.

Spaces are still remaining and the closing date for bookings is the end of tomorrow 7th August – so if you’d like to enrol, get in touch with researchethics@bournemouth.ac.uk

Training opportunity – completing and submitting your IRAS application

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, R&KEO)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House, room 103 on Thursday 23rd August, at 13:00pm – 16:00pm.

Get in touch with researchethics@bournemouth.ac.uk if you would like to register your interest and book a place.

Research waste and ensuring transparency, HRA blog

The HRA have recently released a blog post, written by their Director of Policy, Juliet Tizzard surrounding Research waste and ensuring transparency. The blog goes into the importance of ensuring that research results, even if unfavourable, are published and disseminated appropriately.

You can read the blog here.

If you are running your own clinical research then get in touch with Research Ethics to discuss registering your study and for assistance with this task.

Good Clinical Practice refresher – 15th August 2018

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, Wednesday 15th August, 9am – 12:30pm.

Spaces are still remaining and the closing date for bookings is 8th August – so if you’d like to enrol, get in touch with researchethics@bournemouth.ac.uk

Good Clinical Practice refresher – 15th August 2018

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, Wednesday 15th August, 9am – 12:30pm.

Spaces are still remaining and the closing date for bookings will be 8th August – so if you’d like to enrol, get in touch with researchethics@bournemouth.ac.uk