Category / Clinical Governance

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.

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.

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.

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.

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.

Research in the NHS – HR Good Practice Resource Pack updated

Researchers from BU wishing to conduct their research within NHS premises will require the appropriate documentation. There is plenty of guidance available to guide researchers through these processes.

The Human Resources (HR) Good Practice Resource Pack has been reviewed and updated in light of the Data Protection Act 2018 (DPA 2018) and the General Data Protection Regulation (GDPR) which came into force in the UK on 25 May 2018.

The HR Good Practice Resource Pack describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS.

Changes to the document include:

  1. Inclusion of a transparency notice, which informs and clarifies to the applicant the purpose of collecting their personal data, their rights relating to data processing, as well as fulfilling other GDPR transparency requirements.
  2. The data requested in the Research Passport application form has been minimised following discussion with Data Protection and Information Governance Officers and Human Resource experts.
  3. All references to the Data Protection Act 1998 have been updated to DPA 2018.

You can find all the updated documents here along with the RDS workflow here surrounding staffing and delegation.

Remember that there is guidance available at BU with regard to implementing your research in a healthcare setting. Take a look at the Clinical Governance blog for documents, links and training opportunities. You can also get in touch with BU’s Research Ethics team with any queries.

Wessex patients report positive experience of research for a second year

The National Institute for Health Research (NIHR) Clinical Research Network (CRN) Wessex has recently conducted a survey, distributed amongst the 10 NHS organisations in the Wessex region. This is the second time the CRN Wessex patient research experience survey (PRES) has been conducted, and ran throughout October 2018.

400 responses were received anonymously, and showed that 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.

Copied from the original article

‘Many of those surveyed reported that the research staff supporting them were friendly and helpful and that they had a considerable amount of time to spend with them in order to explain the study and answer any questions.

The survey also highlighted that one of the key motivators for taking part in research was a desire to help others, with one participant commenting: “It’s good to know that this research could help future generations of patients.”’

 

The survey will be conducted again in October of this year.

NIHR Clinical Research Network Portfolio

Structure

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).

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.

NIHR Valid Informed Consent training dates

Before agreeing to participate in your study, your participants should receive all the information they require in order to make an informed decision. Once they wish to participate, then an informed consent form should be completed and filed appropriately.
Although the process sounds complex, there are currently a great training opportunities to help familiarise yourself with the background to, and process of informed consent in clinical research.

The Wessex Clinical Research Network are hosting the following training sessions at University Hospital Southampton and Poole Hospital –

  • Wednesday 8th May, 8:30am – 12:30pm, Seminar Room, Level C, West Wing, NIHR WTCRF, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD;
  • Wednesday 8th May, 1:00pm – 5:00pm, Seminar Room, Level C, West Wing, NIHR WTCRF, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD;
  • Monday 20th May, 8:30am – 1:00pm, Seminar Room 3, Education Centre, Ground Floor, Poole Hospital NHS FT Longfleet Road, Poole, BH15 2JB.

If you’re interested in attending, get in touch with the Wessex CRN to book your place.

EDGE International Conference 2019 – CONNECTED

BU takes responsibility for a large number of NHS-based research projects, spanning a number of clinical areas. To better support BU’s position as Sponsor for these studies, last August the university adopted the EDGE system. This allows us to better collaborate with our NHS colleagues and to ensure our research data is held in a secure and central location. Currently the system is being piloted within the Faculty of Health and Social Sciences for a year.

Last week the EDGE International Conference took place at The Vox Conference Centre in Birmingham, hosted by Fergus Walsh, the BBC’s Medical Correspondent, and organised by the Clinical Informatics Research Unit at the University of Southampton.

Over the two days we heard from speakers from across various organisations during breakouts, workshops and meet & greet sessions. Topics ranged from how to get the best out of the system’s features, using EDGE to connect with colleagues, and use of the system to improve the recording of study data and procedures. Given our implementation of EDGE, and the rarity of use by Universities, BU’s Clinical Governance Advisor, Suzy Wignall was invited to present on how BU has integrated the system.

Across the two days we likewise had keynote sessions, including talks from colleagues in New Zealand and Belgium where the system has been implemented. We also heard from parents of children who have been given access to life-saving research projects, improving their quality of life and health conditions, substantially.

The full agenda can be found here, with EDGE’s twitter feed here, showing photos from the event, and numerous tweets by colleagues.

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

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.