Category / Clinical Governance

Introduction to Good Clinical Practice – Thursday 10th October

NHS, Research Ethics, 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

Guidance, NHS, Research Ethics

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

Guidance, NHS, Research Ethics, 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

Guidance, NHS, Research Ethics

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

NHS, Research Ethics, 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

Guidance, NHS, Research Ethics

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

NHS, Research Ethics, 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

NHS, open access, Research Ethics

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

NHS, Research Ethics, Research Integritiy, 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

NHS, Research Ethics, 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

NHS, Research Ethics, 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.

Setting up clinical research – the ‘Organisation Information Document’

NHS, Research Ethics

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.

NIHR Clinical Research Network Portfolio

NHS

The National Institute for Health Research (NIHR) is one of the largest funders of clinical research in Europe and have a number of funding streams that you can apply for in order to conduct health-related research. The NIHR then has a number of Clinical Research Networks or ‘CRNs’ that are spread out to each region of England. The local CRN is Wessex, based in Hedge End, Southampton.

The ‘Portfolio’

At the heart of CRN activities is the NIHR CRN Portfolio of studies. This consists of high-quality clinical research studies that are eligible for consideration for support from the CRN in England. Adoption onto the portfolio has a number of benefits for researchers, such as help in identifying potential research sites, access to patients and the public to carry out ‘PPI‘ and advice on recruitment strategy at any point during the study. The CRN offers support to researchers via their Study Support Service and likewise via each portfolio manager and their team. You can see a breakdown of each portfolio here on the Wessex CRN page.

The Portfolio and the NHS

Portfolio adoption is usually vital to participating NHS Trusts when considering the research studies they wish to undertake, as they are reimbursed for the resource given to conduct the study (e.g. research nurse support, data manager time). As a result, it is strongly advised that external funding is considered for BU clinical research projects – the amount of funding doesn’t have to be substantial.

Each CRN is given a budget for the financial year by the NIHR, which is then distributed to sites based on their recruitment figures.

Requirements

In order to be eligible for portfolio adoption, there are three criteria a study must meet:

  • The study must be ‘research’ (this is stipulated, as often what’s classed as research outside the NHS setting, is sometimes a service evaluation, quality improvement etc. within the NHS – see this table);
  • Have appropriate ethical approval; and Health Research Authority (HRA) Approval where required;
  • Have full research funding – this has to have been awarded via open competition and by the NIHR, other areas of central Government, or an NIHR non-commercial partner (for which there is a list). If the study has received support from multiple funders, then it will be still considered automatically eligible, if one of the funding streams is the NIHR, an area of central Government or a non-commercial partner.

You can read more about study eligibility here, including research funded by overseas partners.

The Portfolio and BU

The source of research funding is the principal determinant of eligibility for NIHR CRN support and so it is encouraged that researchers seek external funding where possible and appropriate, from the NIHR, another area of central Government or one of their non-commercial partners. The amount of funding doesn’t need to substantial in order to be eligible.

For any queries to do with the portfolio or for guidance regarding implementing your research in a healthcare setting, take a look at the Clinical Governance blog. You can also get in touch with BU’s Research Ethics team with any queries.

Setting up NHS / HSC research in the UK– changes from TODAY

Guidance, NHS, Research Ethics

The new ‘UK Local Information Pack‘  has been introduced today, 5th June 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 today, 5th June, 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.

From today the Statement of Activities has been 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 new 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. The delegation log can be found here and should be used for studies submitted for approvals from today.

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 new 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 today, 5th 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.

NIHR Research Participant Experience Survey 2018/19 – final report

Knowledge Exchange, NHS

You may have seen the blog post back in April regarding the results from a recent patient research experience survey, conducted by National Institute for Health Research (NIHR) Clinical Research Network (CRN) Wessex.

The survey results showed that across the 10 NHS organisations in Wessex, from the 400 responses received, 96% of participants had a good experience of taking part in research. It also showed that 98% of research participants surveyed had all the information that they needed in relation to the study.

The NIHR have released a recent report that shares the results of the Research Participant Experience Survey 2018-19, which was also conducted across the other 14 Clinical Research Network areas in England. You can take a look at the report here.

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

NHS, Research Ethics

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.

HRA Research Transparency Strategy Group minutes available

NHS, open access, Research Ethics

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.

Introduction to Good Clinical Practice – 15th May 2019

NHS, Research Ethics, 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 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.