Category / Research Ethics

Good Clinical Practice refresher – Tuesday 8th October

BU research, Clinical Governance, data management, nhs, NHS, Research Ethics, research integrity, Research Training, Training

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 8th October, 8:30am – 11:30am.

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

Free online course! – Improving Healthcare Through Clinical Research

BU research, Clinical Governance, nhs, NHS, Research Ethics, research integrity, Research news, Research Training, Training

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and will be available from 7th October, via this link.

It is completely free and all online, lasting 4 weeks – registration now open!

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – 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.

RKEDF – Research Ethics @ BU workshop

BU research, Research Ethics, Research Integritiy, RKE development framework, Training

On Tuesday 8 October 2019, RDS are running a practical 2 hour workshop on the review and approval process at BU, so if you’re in the process of putting together an ethics application or you’d like a refresher, this workshop is for you.

The workshop is designed to assist Researchers (staff) in the process of obtaining ethical approval.

The review and approval process will be discussed, including how risk is identified. What makes a good an application and how to create and submit an online ethics checklist.

By the end of this workshop you will have an understanding about:

  • The process for gaining ethical approval
  • How to complete an online ethics checklist
  • What makes a good application

If you’re interested in attending then reserve your place via Organisational Development.

Introduction to Good Clinical Practice – Thursday 10th October

BU research, Clinical Governance, data management, nhs, NHS, Research Ethics, research integrity, Research Training, Training

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 Thursday 10th October, at Dorset County Hospital, Dorchester –9:00am – 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.

Update to HRA’s data transparency wording for Participant Information Sheets

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research communication, Research Ethics, Research news

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.

Training opportunity – completing and submitting your IRAS application

BU research, Clinical Governance, data management, Guidance, NHS, Research Ethics, research integrity, Research Training, Training

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, RDS)  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 103, Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

NIHR-CRN podcast – Research Ethics Committees

Clinical Governance, Guidance, NHS, Research communication, Research Ethics, research integrity, Research news

The latest podcast from the National Institute for Health Research is available and this time concentrates on Research Ethics Committees.

All research with human participants should have appropriate ethical reflection – the podcast this month contains the thoughts and guidance of Dr Hugh Davies who is an established Research Ethics Committee Chair and former Ethics Advisor for the Health Research Authority.

If you are interested in learning more about NHS Research Ethics Committees you can view the dedicated section on the HRA website here, and even register your interest to sit as an observer at a committee meeting.

Happy listening!

Training opportunity – completing and submitting your IRAS application

BU research, Clinical Governance, data management, NHS, Research Ethics, research integrity, Research Training, Training

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, RDS)  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 103 Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

New page on the Clinical Governance Blog – Public Involvement in Research

BU research, Clinical Governance, Guidance, NHS, Research Ethics, research integrity, Research news

Involving the public in your study is important, especially at the research design stage, this is known as ‘Public Involvement’ or ‘Patient & Public Involvement’ (PPI). This involvement can greatly improve the quality of your study design and documentation.

To better support researchers with this process (in particular for the purposes of clinical research), there is now a dedicated space for guidance, resources and wider reading, on the Clinical Governance blog space.

You can find the page here – as always if there are any specific queries, please get in touch with Research Ethics.

Good Clinical Practice refresher – Wednesday 14th August 2019

BU research, Clinical Governance, data management, NHS, Research Ethics, Research Training, Training

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 on Wednesday 14th August, 9am – 12:30pm.

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

Health Research Authority #MakeItPublic Campaign – internal survey

BU research, Clinical Governance, data management, NHS, open access, Research Ethics, research integrity, Research news

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.

Training opportunity – completing and submitting your IRAS application

BU research, Clinical Governance, data management, NHS, Research Ethics, Research Integritiy, Research Training, Training

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, RDS)  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 103 Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Good Clinical Practice refresher – Wednesday 14th August 2019

BU research, Clinical Governance, data management, NHS, Research Ethics, Research Training, Training

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 on Wednesday 14th August, 9am – 12:30pm.

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

Good Clinical Practice refresher – Wednesday 14th August 2019

BU research, Clinical Governance, data management, NHS, Research Ethics, Research Training, Training

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 on Wednesday 14th August, 9am – 12:30pm.

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

Reminder: Research Ethics Panel meetings in August

BU research, PG research, Research Ethics

A Reminder for Staff and Postgraduate Researchers

There are NO Research Ethics Panel (REP) meetings held during August, so if you’re hoping to start data collection activities over the summer and are in the process of completing your research ethics checklist, please keep this in mind when planning your research activities and submit your checklist in time for the final REP meetings to be held in July.  Checklists received during August which need to be reviewed by full Panel will be deferred until September (dates to be advised).

REPs review all staff projects and postgraduate research projects which have been identified as above minimal risk through the online ethics checklist.  Details on what constitutes high risk can be found on the research ethics blog.

There are two central REPs:

Science, Technology & Health
Social Sciences & Humanities
Staff/PGR ‘above minimal risk’ projects are reviewed by full REP and Researchers (including PGR Supervisors) are normally invited to Panel for discussions.

Staff Projects which are ‘low risk’

Reviews for low risk projects will continue as normal during August (via email), although turnaround may take longer than normal due to Reviewer availability during this month.

PGR Projects which are ‘low risk’

There are no changes to the review and approval process for low risk PGR projects and reviews will continues as normal throughout August, again subject to Reviewer (Ethics champions) availability.

More details about the review process and REP meeting dates can be found on the Research Ethics Blog.  Email enquiries should be sent to researchethics@bournemouth.ac.uk.

Reminder: Research Ethics Panel meetings in August

BU research, PG research, Research Ethics

A Reminder for Staff and Postgraduate Researchers

There are no Research Ethics Panel (REP) meetings held during August, so if you’re hoping to start data collection activities over the summer and are in the process of completing your research ethics checklist, please keep this in mind when planning your research activities and submit your checklist in time for the final REP meetings to be held in July.  Checklists received during August which need to be reviewed by full Panel will be deferred until September (dates to be advised).

REPs review all staff projects and postgraduate research projects which have been identified as above minimal risk through the online ethics checklist.  Details on what constitutes high risk can be found on the research ethics blog.

There are two central REPs:

  • Science, Technology & Health
  • Social Sciences & Humanities

Staff/PGR ‘above minimal risk’ projects are reviewed by full REP and Researchers (including PGR Supervisors) are normally invited to Panel for discussions.

Staff Projects which are ‘low risk’

Reviews for low risk projects will continue as normal during August (via email), although turnaround may take longer than normal due to Reviewer availability during this month.

PGR Projects which are ‘low risk’

There are no changes to the review and approval process for low risk PGR projects and reviews will continues as normal throughout August, again subject to Reviewer (Ethics champions) availability.

More details about the review process and REP meeting dates can be found on the Research Ethics Blog.  Email enquiries should be sent to researchethics@bournemouth.ac.uk.