Tagged / collaboration

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

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

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.

STEM for Britain 2020 – Call for Posters

STEM for Britain, hosted by the Parliamentary and Scientific Committee, is a poster competition for early-career researchers, and will take place in the Houses of Parliament on Monday 9th March 2020.

Applications for posters will open on Monday 23rd September 2019 to early career research scientists, engineers, technologists and mathematicians to exhibit posters in one of the following five areas:

  • Biological and Biomedical Sciences
  • Chemistry
  • Engineering
  • Mathematical Sciences
  • Physics

Prizes will be awarded for the posters presented in each discipline which best communicate high level science, engineering or mathematics to a lay audience.

BU is inviting expressions of interest from those who would like to apply by Thursday 12th September. Please email Lisa Andrews, RDS Research Facilitator with two sentences on what your poster would cover. Applicants will be shortlisted on Monday 16th September. Those chosen to apply, will be supported to do so ahead of the Parliamentary and Scientific Committee’s external deadline of 2nd December.

Full details of the competition and exhibition, including the application form will be made available on www.stemforbritain.org.uk from 23rd September.

Health Research Authority #MakeItPublic Campaign – internal survey

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

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

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

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

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, you can book onto one of their face-to-face workshops, or via their online survey.

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.

NIHR Clinical Research Network Portfolio

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

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

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.