Category / Research Ethics

Guidance available to support researchers attending an NHS REC meeting

Two new links have been added to the Clinical Governance blog under the ‘Useful Links and Documents’ section which give further information and guidance as to attending an NHS Research Ethics Committee meeting for your project. The links are also provided below-

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.

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 4th February, Research Development & Support are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

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

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

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

NIHR resources – Patient and Public Involvement and Social Media Toolkit

Two resources are now available on the NIHR Learn website for researchers –

  • Patient and Public Involvement: Inspiring New Researchers – an online course developed by the Department of Health and NIHR. It is intended to help researchers to understand the benefits of good Patient and Public involvement into their research.
  • Social Media Toolkit – a combination of practical resources on how to get started and real case studies from how colleagues across the NIHR Clinical Research Network are currently using social media to support their work.

To access the above resources you will need to have access to the NIHR Learn website. Once you have an account select the tab ‘Health Research Innovations’ and then click on ‘NIHR Endorsed Learning’. Both courses are free and do not require an enrolment key.

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.

IRAS Central Booking Service closure

Please note that the Central Booking Service (CBS; used to book in for review of “IRAS Form” applications and applications only requiring ethical review) will close at 4.30pm on Wednesday 18 December 2019 and will re-open at 9am on Thursday 2 January 2020.

If you need to book in your project for NHS REC review please take note of this Christmas closure.

Any queries please email Research Ethics.

Talk/session with the Wessex Clinical Research Network Study Support Service

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place next week on Tuesday 10th December at 2:30pm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

Checklist now available to support researchers undertaking clinical research

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

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  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

New UK Standards for Public Involvement

Involving the public in your study is important, especially at the research design stage. This is called ‘Public Involvement’ (also known as ‘PPI’ [Patient and Public Involvement]). Public involvement in research means research that is done ‘with’ or ‘by’ the public, not ‘to’, ‘about’ or ‘for’ them.

By seeking the opinions and recommendations of the public, it is a great way to ensure that your study is designed and set-up in a way that will be relevant to participants, and of good quality.
This can also help to avoid any setbacks once the project is underway.

The new UK Standards for Public Involvement have now been released and were developed over three years by a country-wide partnership between the National Institute for Health Research (NIHR), Chief Scientist Office (CSO) Scotland, Health
and Care Research Wales, and the Public Health Agency Northern Ireland

They describe what good public involvement looks like and encourage approaches and behaviours that are the hallmark of good public involvement such as flexibility, sharing and learning and respect for each other.

You can see the six UK standards and supporting materials, as well as further details about the partnership, project and the piloting of the new standards, here.

Further guidance is available via the Clinical Governance section of the Research blog and via the Health Research Authority and NIHR pages.

Introduction to Good Clinical Practice – Wednesday 15th January

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 15th January at Bournemouth University 08:45am – 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.

Checklist now available to support researchers undertaking clinical research

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

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  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

Good Clinical Practice Refresher – Wednesday 4th December

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 Poole Hospital on Wednesday 4th December, 9:00am – 12:30pm.

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

Talk/session with the Wessex Clinical Research Network Study Support Service

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place on Tuesday 10th December at 2:3opm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

Clinical Governance Standard Operation Procedures – now live

The Standard Operating Procedures relating to Clinical Governance at BU are now live and can be found on SharePoint.

A full list of documents and links to each are provided in this table, with a link also present on the Clinical Governance blog.

If you have any queries surrounding the information present within the SOPs, or cannot access the links, please email Research Ethics.

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.

Happy reading!

Talk/session with the Wessex Clinical Research Network Study Support Service

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place on Tuesday 10th December at 2:3opm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

Talk/session with the Wessex Clinical Research Network Study Support Service

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place on Tuesday 10th December at 2:3opm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 15th October, RDS are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

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

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

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

RKEDF – Research Ethics @ BU workshop

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.

Research Ethics – Resources

When involving research participants in your activities, it’s important to provide them with all the information they require to make an informed decision on whether or not they wish to participate.  We’ve recently updated the Participant Information Sheet, so please download the latest version of the template available from the research ethics blog.

We’ve also added  ‘Research Ethics FAQs‘ as a new resource, which we hope you’ll find useful!