Category / Research Ethics

‘Health Research Futures course’ – starts today!

Health Research Futures is a four week, free online course that explores a range of topics in clinical research, offering continuing professional development (CPD).

The course includes twelve podcasts (three per week), a short weekly quiz and a live online discussion forum every week

You can sign up today, by creating an account on http://learn.nihr.ac.uk > select NIHR Learning > Future of Health E-Learning (Focus on new skills for new roles).

Enjoy!

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 – Lansdowne Campus, room 117 on Tuesday 6th November, at 13:00pm – 16:00pm.

There are 12 spaces available, so get in touch with Research Ethics if you would like to register your interest and book a place.

Valid Informed Consent for clinical research – training opportunity

Before agreeing to participate in your study, your participants should receive all the information they require in order to make an informed decision. Once they wish to participate, then an informed consent form should be completed and filed appropriately.
Although the process sounds complex, there is currently a great training opportunity to help familiarise yourself with the background to, and process of informed consent in clinical research.

The Wessex Clinical Research Network are hosting a training session at Poole Hospital on Wednesday 31st, 08:30am – 12:30pm.

If you’re interested in attending, get in touch with the Wessex CRN to book your place. Hurry as there are only 6 seats left!

Introduction to Good Clinical Practice – 10th October

Are you interested in running your own research project within the NHS? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 10th October, at Dorset County Hospital, Dorchester – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact Research Ethics.
Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Good Clinical Practice refresher on 2nd October 2018 – booking closes soon!

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 Royal Bournemouth Hospital on Tuesday 2nd October, 1pm – 4:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch as soon as possible with Research Ethics or the Wessex Clinical Research Network.

Good Clinical Practice refresher – 2nd October 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 Royal Bournemouth Hospital on Tuesday 2nd October, 1pm – 4:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics or the Wessex Clinical Research Network.

Introduction to Good Clinical Practice – 10th October

Are you interested in running your own research project within the NHS? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and well-being of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 10th October, at Dorset County Hospital, Dorchester – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact Research Ethics.
Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

NIHR and World Health Organisation joint statement – have your say!

There is an increasing emphasis on the need for researchers and sponsors to publish, and disseminate, the results of the clinical studies that they conduct. Timely disclosure of results is important ethically, morally, in the interests of research integrity and from a waste reduction perspective.
Dissemination of results, whether favourable or not, also achieves transparency – increasingly important from the perspective of the recent introduction of the GDPR.

The National Institute for Health Research (NIHR) have signed-up to the WHO’s joint statement on public disclosure of results from clinical trials. The policy sets out the expectations and support on offer in order for research communities to comply. The draft policy is available to read, with a quick survey open until 21st September, for you to have your say.

BU has access to the ClinicalTrials.gov system – get in touch for access and for the opportunity to register your study and results in the public domain.

Introduction to Good Clinical Practice – 10th October

Are you interested in running your own research project within the NHS? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 10th October, at Dorset County Hospital, Dorchester – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact Research Ethics.
Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Good Clinical Practice refresher – 2nd October 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 Royal Bournemouth Hospital on Tuesday 2nd October, 1pm – 4:30pm.

Spaces are still remaining and the closing date for bookings is the end of Monday 24th September. If you’d like to enrol, get in touch with Research Ethics or the Wessex Clinical Research Network.

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.