Tagged / research ethics

Good Clinical Practice refresher – Wednesday 14th August 2019

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.

Setting up clinical research – the ‘Organisation Information Document’

If you are currently conducting research within the NHS or Health & Social Care (HSC), then please bear in mind the following update if you wish/plan to add new NHS/HSC research sites to your study.

As of 5th June, the set-up procedure for clinical research projects involving NHS or HSC organisations changed (see blog post) –

  • If you applying for HRA/NHS REC approval you will be required to follow the new procedure using the Organisation Information Document (OID), as referenced in the above post;
  • If you are already conducting a study with HRA/NHS REC approval, in NHS/HSC organisations, and wish to involve new sites, then please be aware that the OID should be used, even if existing sites were set-up using the previous document, the Statement of Activities.

Further help and guidance

Guidance on the use of the new UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants with the change.

If you have any queries regarding any of the information provided above, information in the referenced blog post, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.

You can also take a look at the Clinical Governance blog for documents, links and training opportunities.

Workshop available – Ethical Thinking and Decision-making in Practice

Are you new or relatively new to research? Are you interested in attending a workshop that will allow you to improve your understanding and confidence in the application of ethical considerations to your research activity? Then take advantage of the following opportunity!

Dr Helen Kara will be delivering a one-day workshop on Monday 17th June, 09:30 – 16:30 on Talbot Campus, entitled Ethical Thinking and Decision-making in Practice.

The aims & objectives of this sessions are to:

  • To increase their awareness of the need for ethics compliance in research and, by the end of the workshop, be aware of their responsibilities and when to seek further assistance
  • To develop their skills in the following key areas, within the context of ethical research:
    a. Planning and design
    b. Gathering data and data analysis
    c. Reporting, including presentation and dissemination
    d. Consideration of ethical dilemmas, based on real-world examples and participants’ experience

If you want to book onto this workshop and take advantage of this great opportunity, then please see the following page for instructions.
If you are a PGR, please email Organisation Development to book your place.

HRA Research Transparency Strategy Group minutes available

The Health Research Authority (HRA) has formed the Research Transparency Strategy Group in response to the House of Commons Science and Technology Committee Report on clinical trials transparency.

You can read more about the first meeting of the expert group, including the minutes by clicking here

In relation to this, the HRA’s Director of Policy, Juliet Tizzard has released a blog post entitled What’s the point of research transparency? You can read the post 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. On ClinicalTrials.gov, it is free to do so.
Despite the name, the system may be used for other clinical research projects.

Setting up NHS / HSC research in the UK– upcoming changes

The UK Local Information Pack

A ‘UK Local Information Pack‘ will be introduced on the 5 June 2019 to support the set-up of NHS / HSC research in the UK.

The ‘UK Local Information Pack’ is the set of documents that NHS / HSC organisations use to formally start preparing to deliver the study. You can find more information here, including what comprises the pack. All researchers wishing to set-up their study at an NHS/HSC site from 5 June, will need to be aware of this change.

The Organisation Information Document

Researchers and research teams may be aware of a document called the ‘Statement of Activities’ – this is essentially a document that allows the sponsor to make clear to the research site, what activities will be undertaken locally. The document can also act as the agreement between the sponsor and site. Researchers setting up their study before 5 June should continue to use this document.

From 5 June the Statement of Activities will be replaced by a document called the ‘Organisation Information Document‘. For non-commercially sponsored studies, that are not clinical trials or clinical investigations, the ‘Organisation Information Document’ should be used as the agreement between sponsor and participating NHS / HSC organisation.

A new delegation log template

Another feature of the UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / HSC organisations. This will allow NHS/HSC organisations to locally record who will be working on the study and who is authorised to undertake study tasks.

Schedule of Events or Schedule and Events Cost Attribution Tool (SoECAT)

For non-commercially sponsored studies studies an IRAS Schedule of Events or a SoECAT will be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / HSC organisations on the cost attributions associated with a study.

Further help and guidance

Guidance on the use of the UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants get ready for the change.

If you are making an IRAS Form submission or planning to set up research in an NHS / HSC organisation from 5 June 2019 please read the transition guidance so that you prepare the correct materials.

If you have any queries regarding any of the information provided above, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.

You can also take a look at the Clinical Governance blog for documents, links and training opportunities.

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.

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.

EoIs invited for BU Ethics Panel Chairs and Deputy Chairs

Expressions of interest are invited for the Chairs and Deputy Chairs of the Social Science and Humanities Ethics Panel and the Science, Technology and Health Ethics Panel. These prestigious and honorary roles work across the university to champion the highest ethical standards in research undertaken by staff and students.

This document provides further information about the roles and the application process.

Expressions of interest, consisting of a CV and brief statement outlining suitability for the chair/deputy chair role, should be submitted to RKEO (researchethics@bournemouth.ac.uk) by 5pm on Wednesday 14 November 2018 (please note the deadline has been extended).

For an informal discussion about the roles please contact one of the current Chairs:

  • Dr Sean Beer, Chair of the Social Science and Humanities Ethics Panel
  • Prof Holger Schutkowski, Chair of the Science, Technology and Health Ethics Panel

If you have any questions regarding the process, please email Sarah Bell/Suzy Wignall using the researchethics@bournemouth.ac.uk email address.