Category / NHS

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

BU research, Clinical Governance, data management, NHS, Research Ethics, research integrity, Research news

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.

Top ten cited paper in MIDWIFERY

BU research, Featured, Featured academics, international, NHS, Research news, Uncategorized, writing

Looking at the SCOPUS data for 5 May 2019 on the International Day of the Midwife showed that the theoretical paper ‘Risk, Theory, Social & Medical Models: critical analysis of the concept of risk in maternity care’ [1] is in the top ten mosted quoted articles in Midwifery.  Now in its 35th year, Midwifery is an international  journal published by Elsevier.  Since its inception in 1985 it has published 2,626 papers, and our paper ”Risk, Theory, Social & Medical Models’ has now been cited by 108 papers, making it the eighth most cited article.

Professor Edwin van Teijlingen

Centre for Midwifery, Maternal & Perinatal Health (CMMPH)

 

Reference:

  1. MacKenzie Bryers H., van Teijlingen, E. (2010) Risk, Theory, Social & Medical Models: critical analysis of the concept of risk in maternity care, Midwifery 26(5): 488-496.

HRA Research Transparency Strategy Group minutes available

Clinical Governance, data management, NHS, open access, policy, Research communication, Research Ethics, research integrity, Research news

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

BU research, Clinical Governance, data management, NHS, Research Ethics, research integrity, Research Training, 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.

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

BU research, Clinical Governance, data management, NHS, Research Ethics, research integrity, Research news

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.

Excellent scientific paper by Dr. Alison Taylor

BU research, Featured academics, NHS, PG research, Publishing, Research news, Uncategorized, writing

Congratulations to Dr. Alison Taylor and her Ph.D. supervisors on the acceptance of the paper ‘’Scrutinised, judged and sabotaged’: A qualitative video diary study of first-time breastfeeding mothers’ by Midwifery (published by Elsevier) [1].  This is the second paper from Alison’s extremely interesting Ph.D. research, the first one was accepted late last year.  The first article ‘The therapeutic role of video diaries: A qualitative study involving breastfeeding mothers’ was accepted by the international journal Women & Birth  [2].  Alison is Senior Lecturer in Midwifery in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH) and Infant Feeding Lead in the Faculty of Health & Social Sciences.  Her co-authors are Professor Emerita Jo Alexander, Prof. Edwin van Teijlingen (in CMMPH) and Prof. Kath Ryan based at the University of Reading.

 

 

 

Reference:

  1. Taylor, A.M., van Teijlingen, E., Ryan, K., Alexander, J.,  2019, Scrutinised, judged and sabotaged’: A qualitative video diary study of first-time breastfeeding mothers. Midwifery, 75: 16-23.
  2. Taylor, A.M., van Teijlingen, E., Alexander, J., Ryan, K., 2018, The therapeutic role of video diaries: A qualitative study involving breastfeeding mothers, Women and Birth, (online first) DOI. 10.1016/j.wombi.2018.08.160

 

Research in the NHS – HR Good Practice Resource Pack updated

BU research, Clinical Governance, data management, Guidance, NHS, PG research, Research communication, Research Ethics, student research

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.

NIHR RDS Residential Research Retreat – 26-28 November 2019

Events, Funding opportunities, NHS, pre-award

Do you have a great idea for a research project?

Are you planning to apply for research funding?

Do you need a dedicated period of quality time with support to develop your research project?

Dillington House, Somerset. 26 – 28 November 2019.

Applications open on 20 May 2019

The Residential Research Retreat provides protected time with expert coaching and support for you to develop your research proposal to the standard required to be competitive in seeking high quality research funding.

Register your interest with us by filling in the form here

And don’t forget, your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) on the 5th floor of Royal London House. Feel free to pop in and see us, call us on 61939 or send us an email.

NIHR RDS Grant Applications Seminar & Support Event – 2 May 2019

BU research, Funding opportunities, NHS, pre-award

Are you planning to submit a grant application to NIHR?

We are holding a one-day event at the University of Bristol that is aimed at helping you to improve your chances of success.

The morning seminar session is open to anyone to come and hear Simon Goodwin, RfPB Programme Manager for the South West, and RDS advisers give presentations on what makes a good grant proposal. Topics covered will include:

  • what does the NIHR (and in particular RfPB) look for?
  • the application as a marketing document: selling the topic, selling the method, and selling the team
  • the team
  • clarity of description and explanation
  • feasibility issues
  • identifying and avoiding potential pitfalls.

The afternoon support session of one-to-one appointments is for those who would like to discuss their own proposal with an RDS adviser.

This event is FREE and refreshments and lunch will be provided. Places are limited and will be allocated on a ‘first come, first served’ basis. In order to secure your place please register using our online form by 1pm, 24 April 2019. Find out more.

And don’t forget, your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) on the 5th floor of Royal London House. Feel free to pop in and see us, call us on 61939 or send us an email.

Wessex patients report positive experience of research for a second year

Clinical Governance, Impact, Knowledge Exchange, NHS, Research communication, Research news

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

BU research, Clinical Governance, data management, NHS

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

Clinical Governance, NHS, Research Ethics, research integrity, Research Training, Training

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 research, Clinical Governance, data management, Events, international, Knowledge Exchange, NHS, Research communication, Research Ethics, research integrity, Research news

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

BU research, Clinical Governance, data management, NHS, Research Ethics, research integrity, Research Training, 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.

Congratulations to Anita Immanuel on PhD paper

BU research, Featured academics, nhs, NHS, PG research, Publishing, Research news, student research, Uncategorized, writing

FHSS PhD student Anita Immanuel just had the first paper from her PhD “Quality of life in survivors of adult haematological malignancy” accepted by the international journal European Journal of Cancer Care.   This international journal is published by Wiley and has an Impact Factor 2.409.

Survivors of haematological malignancies endure long-term effects of both the treatment and the disease. This paper examines factors that influence their quality of lives through reporting on the results of a survey. The survey used previously validated quality of life questionnaires for use in cancer management. Participants were adults over the age of 18 years who had completed treatment for a haematological malignancy and were between 1-5 years post treatment.

Anita is currently working as Lead Clinical Research Nurse at East Suffolk and North Essex NHS Foundation Trust.  Her PhD research (see picture above) was conducted at  the Haematology Department of Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, which has one of the most extensive research portfolios in the Trust.   Her PhD is supervised by Dr. Jane Hunt (Dept of Nursing & Clinical Science), Dr. Helen McCarthy, Consultant Haematologist at the Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, and Prof. Edwin van Teijlingen in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH).