Category / Research Ethics

Introduction to Good Clinical Practice – 15th May 2019

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 15th May, at Bournemouth University, Lansdowne Campus (Bournemouth House) – 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.

Health Research Authority public involvement guidance – third blog post

Involving patients and/or the public in your clinical research is a great way to ensure that your study is designed and set-up in a way that will be attractive to participants. By carrying out PPI (patient and public involvement) you can also ensure that your research will be of benefit, not only to individuals but also the wider population and healthcare in general.

In 2018 the Health Research Authority (HRA) released guidance to help applicants better identify where they have involved the public in their research applications, and the difference that it made to their studies.

In addition, in January of this year two HRA blog posts were advertised, following the journey of a Research Fellow at the University of Surrey, who conducted PPI for her research project. The first and second posts can be found on the HRA website alongside other news items.

The HRA have just released the third blog post in which they talk to one of the lay Research Ethics Committee (REC) members who sat on the panel that reviewed the fellow’s study. The post explores the Committee member’s views on how public involvement benefited the research application. You can find it here.

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

NHS R&D Forum response to Mental Capacity Act Code of Practice consultation

The NHS R&D Forum Research Management Working Group have released their thoughts on how they feel that the Mental Capacity Act Code of Practice can be refined and improved, to reflect current needs.

‘The Research Management Working Group is a group of members of the NHS R&D Forum with a wealth of experience
and expertise in both managing and delivering research activity within NHS organisations.’

You can read the group’s response here. The consultation is now closed, however the current Code of Practice can be found here.

If you are planning to conduct research with human participants that lack the capacity to consent or who may eventually lack capacity to consent, then the research application must go to an ethics committee that is flagged to review Social Care research.

BU ethics panels are not authorised to undertake this review or issue approval, and so an application via the IRAS system must be made. Further information can be gained via the HRA website and by emailing Research Ethics.

REMINDER – 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, 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 102, this Thursday 28th March at 09:30am – 12:30pm.

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

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, 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 102 Thursday 28th March at 09:30am – 12:30pm.

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

Clinical Research Transparency – Responsibilities

Researchers, sponsors and funders have responsibilities – that may be legal requirements or ethical and moral expectations within an accepted governance framework of best practice and standards – to participants in research, patients and the wider public and research communities.’

The HRA have recently released a page of useful links and guidance that encompasses areas such as ‘top tips for transparency’, making your research results public, and also registering your study.
Related to this, hopefully you will have seen a recent blog post regarding the HRA’s commitment to ensuring research transparency. This has been a hot topic lately, and the subject of a recent House of Commons Science and Technology Committee report.

Take a look at the HRA guidance here.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to use.
Despite the name, the system may be used for other clinical research projects.

Informed consent training – sessions available

When conducting research with human participants, it is essential that participants are fully informed as to the details of the study and what is expected of them by participating.

Participants’ informed consent is imperative, and should be in place prior to any data collection activities.

Sarah Bell (Research Governance Advisor) and Suzy Wignall (Clinical Governance Advisor) will be running sessions on informed consent procedure, scheduled for Tuesday 26th March. These sessions are open to staff and postgraduate researchers conducting research/hoping to conduct research with human participants.

We will be running two sessions on this day –

Talbot Campus (P425, Poole House) – 09:30am – 11:00am
Lansdowne Campus (B242, Bournemouth House) – 2:00pm – 3:30pm

If you are interested in attending one of the above sessions, please email Research Ethics.

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, 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 102 Thursday 28th March at 09:30am – 12:30pm.

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

Informed consent training – sessions available

When conducting research with human participants, it is essential that participants are fully informed as to the details of the study and what is expected of them by participating.

Participants’ informed consent is imperative, and should be in place prior to any data collection activities.

Sarah Bell (Research Governance Advisor) and Suzy Wignall (Clinical Governance Advisor) will be running sessions on informed consent procedure, scheduled for Tuesday 26th March. These sessions are open to staff and postgraduate researchers conducting research/hoping to conduct research with human participants.

We will be running two sessions on this day –

Talbot Campus (P425, Poole House) – 09:30am – 11:00am
Lansdowne Campus (B242, Bournemouth House) – 2:00pm – 3:30pm

If you are interested in attending one of the above sessions, please email Research Ethics.

HRA help guides – data and technology

An updated Code of Conduct for the application of data-driven technologies in the NHS was published on Tuesday of this week – the code ‘sets out what the NHS expects from companies who are developing new technologies for the health system, and what they can expect in return.

In order to assist applicants and researchers, the HRA have created new pages that set out the approvals process for data-driven technology research.

The section incorporates two pages of support –

The help pages will be added to the Clinical Governance section of the blog, for ease of access.

Research transparency – HRA response to the Science and Technology Committee

The House of Commons Science and Technology Committee released a report last year on clinical trials transparency, as it was evident that a 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.

At the time the HRA issued a response but today have published a further statement which sets out their commitment to research transparency. This is especially pertinent given the article published simultaneously in BMJ Open, which details the numbers of clinical trials that are publicly registered, compared with those that have received favourable opinion (approval) from a UK NHS research ethics committee.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to register your study.
Despite the name, the system may be used for other clinical research projects.

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, 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 102 Thursday 28th March at 09:30am – 12:30pm.

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

HRA responds to paper outlining concerns over study set-up delays

Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.

Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.

Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.

  • Approx. 89 individuals were involved in the study approvals;
  • 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
  • 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
  • 491 exhanges took place with the 89 individuals, generating 193 pages of text.

Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.

You can read the HRA’s response here, which signposts the reader to further resources.

Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.

Medical research: articles/blogs of interest

A medical ethicists explores the need to temper researchers’ enthusiasm when it comes to presenting the benefits of a treatment, and how important it is to distinguish research from a treatment.

Read the full article here.

Six project management tips for a PhD – Whatever kind of large research project you are doing, these tips from the private sector might be of some use.

Read the full article here.

#DataSavesLives—Patient participation ensures data are accurate and useful – In this blog, the author argues that we must not ignore the benefits that sharing patient data can have on quality in healthcare

Read the full blog post here.

Good Clinical Practice Refresher – Monday 4th February

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 Monday 4th February, 9am – 12:30pm.

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