Tagged / medical research

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.

NIHR Clinical Research Network Portfolio

Structure

The National Institute for Health Research (NIHR) are 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.

BU at the THE Awards 2014

 

The Bournemouth University and Poole Hospital research team who developed a medical device to make epidurals safer and more effective, were celebrating being shortlisted for the THE Awards 2014 in London last night.

The project was nominated for Outstanding ICT initiative of the Year and – although pipped to the post by the Open University – being shortlisted for an award of this calibre is an incredible achievement and honour.

BU’s Pro Vice-Chancellor for Research and Innovation Professor John Fletcher was at the ceremony. He said: “Congratulations to the NHS-BU team for being shortlisted. We were very worthy contestants.  I felt privileged and proud to share the evening with such a successful team.”

The nominated team at the awards ceremonyThe clinical project was initially proposed by the senior consultant anesthetist at Poole Hospital, Professor Mike Wee. The device was developed by Dr Neil Vaughan for his PhD, supervised by Professor Wee and Dr Venky Dubey. Dr Richard Isaacs – now at Southampton General Hospital – was also part of the research team. All four, pictured here, were at the awards ceremony, along with colleagues from across the university who have supported this innovative and important project.

Comedian Jack Dee hosted proceedings, sharing his unique and entertaining take on the Higher Education sector!

A full list of categories and winners can be viewed on the THE website. The event organisers also took over £9000 in donations for the Institute of International Education’s ‘Scholar Rescue Fund’; a charity that has led global efforts to rescue threatened scholars and students.

Congratulations to all nominees and winners and thank you to THE for such organising such a fabulous evening!

Image: (Top left clockwise) Dr Venky Dubey, Dr Neil Vaughan, Dr Richard Isaacs, Professor Mike Wee.

CoPMRE Eleventh Annual Symposium: Impact in Healthcare Research and Education’

The Centre of Postgraduate Medical Research and Education are hosting their Eleventh Annual Symposium on Tuesday 14 October 2014.

The event will focus on developments and activities around impact in healthcare research and education. It will explore impact from the perspectives of the public, the research funder, the university, the provider, the student and the medical educator.

Speakers include:

  • Professor Trish Greenhalgh, Professor of Primary Care and Dean for Research Impact, Barts and the London School of Medicine and Dentistry
  • Simon Denegri, Chair INVOLVE
  • Natalie Carter, Head of Research Liaison and Evaluation, Arthritis Research UK
  • Jonathan Grant, Director, Kings Policy Institute.

This symposium is suitable for primary and secondary doctors, allied healthcare professionals, academics and anyone with an interest in medical research and education. Interested staff from across BU are invited and very welcome.

You can register on Eventbrite here. For more information please contact Audrey Dixon.

Wellcome Trust – University Awards in Medical History and Humanities

This scheme allows universities to attract outstanding research staff by providing support for up to five years, after which time the award holder takes up a guaranteed permanent post in the university.

A monograph and other substantial publications are expected to result from an award, so teaching and other non-research commitments are expected to be minimal during the period of full Wellcome Trust support.

Up to five years’ support is available, providing your full salary for three years, 50 per cent in the fourth year and 25 per cent in the fifth year.

Travel expenses to attend meetings are provided for five years, but research expenses are provided for the first three years of the award only.

You must be nominated by your prospective head of department and have an undertaking from the head of the institution, vice-chancellor, principal or dean that your personal support will be taken over by the institution at the end of the award.

Support is normally available only at lecturer level, although in exceptional cases awards to senior-lecturer level may be possible.

Initial enquiries about the scheme may be made by you (the potential candidate) or a department in an institution.

These enquiries should be followed by a preliminary application from you by e-mail or post including

  • an explicit statement from the head of the institution, vice-chancellor or dean demonstrating the institution’s commitment to the history of medicine field, and a statement confirming that the institution will provide 50 per cent salary costs in year four, 75 per cent in year five and full salary thereafter
  • CV and full publication list
  • an outline of no more than two pages of the proposed project
  • a letter of support from the head of department, including a statement on your expected teaching/administrative load for the five-year period (this can be sent by separate cover)
  • the approximate cost of the proposal, broken down into your salary, equipment and project running costs.

If successful, you will be invited to submit a full application.

A preliminary application must be submitted before a full application is invited.

Preliminary application deadlines are:
20 June
(with a full application deadline of 1 August)
1 December
(with a full application deadline of 1 February)

Contact: Grants Management – Medical History and Humanities
Wellcome Trust
Gibbs Building
215 Euston Road
London NW1 2BE, UK

T +44 (0)20 7611 8499
E
mhh@wellcome.ac.uk

The RKE Operations team can help you with your application.

British Heart Foundation – Funding opportunities

There are two health/medical science related funding opportunities available through the British Heart Foundation.

The first is ‘Clinical Study Grants (click the link for more information on how to apply).  A summary of the call is as follows:

For clinical trials and other clinical studies costing more than £300,000.

Entry requirements

  • The principal investigator will be a senior researcher working in an established research institution in the UK. S/he must have a strong track record of grant support, usually from us, and an internationally recognised research profile.
  • Any multicentre interventional clinical trial, while remaining under the scientific control of the principal investigator, should be managed by a UKCRC-registered Clinical Trials Unit (CTU) and should include a member of the CTU as a co-applicant or principal investigator.
  • For multicentre observational studies, applicants should consider a mentorship arrangement with a CTU — BHF will judge the need for this arrangement on a case by case basis.

Grant duration

Up to 5 years, with an interim review at the half way point. BHF may consider a staged award based on proof of adequate recruitment and progress if deemed appropriate. 

Award may include

  • Staff salaries. For example: research fellow, clinical trial co-ordinator, research nurse, where fully justified.  
  • Research consumables directly attributable to the project.
  • Research equipment essential for the project.

 

The second opportunity is ‘Immediate postdoctoral basic science research fellowships’ (click the link for more information on how to apply).  A summary of the call is as follows:

To provide an opportunity for the most promising newly qualified postdoctoral researchers to make an early start in developing their independent cardiovascular research careers in an established institution in the UK.

Entry requirements

  • Candidates should be in the final year of their PhD studies or have no more than one year of postdoctoral research experience from the date of the PhD viva.
  • Candidates must be able to show, by publications or otherwise, evidence of exceptional research ability.
  • The fellowship will not usually be held in the institution where the PhD was carried out.
  • Residency requirements apply – check eligibility.

Grant duration

  • 3 years with the possibility of a 1 year extension if a strong case can be made (e.g. that this will lead to a competitive application for a more senior personal award).
  • BHF strongly encourage that up to 1.5 years of the award are spent overseas or in a second UK institution.
  • A supervisor is required in each laboratory, who must be able to guarantee the candidate access to space and resources for the required period and provide relevant scientific guidance.

Award may include

  • Salary of applicant.
  • Reasonable research consumables and small items of equipment, directly attributable to the project.
  • Economy return travel costs to second laboratory for the fellow only.  

 

Decision process for both calls

There are no closing dates.  Please submit the application when it is ready.

 The RKE Operations team can help you with your application.

Health Related Funding Opportunities

There are a large number of calls that have been announced in the Medical and Healthcare remit.  A brief description of each of them is given below, together with a link to the call.

Medical Research Council:Joint Global Health trials scheme – this funds global health trials to generate new knowledge about interventions that will contribute to the improvement of health in low- and middle-income countries. The budget for the scheme is up to £12 million per year for three years.

Medical Research Council: Early Career Fellowship in economics of health – the scheme enables individuals to undertake challenging projects in excellent research and training environments. The fellowship is for a period of up to three years.

Medical Research Council: Methodology research fellowship – the scheme is aimed at researchers with a grounding in health research who wish to undertake a period of specialist training in the development and investigation of innovative research methods. The fellowship lasts up to four years and covers salary, training, consumables, and travel costs, capital equipment, and all other relevant costs under FEC.

Medical Research Council: New Investigator research grants – molecular and cellular medicine – these provide support for clinical and non-clinical researchers while they are establishing themselves as independent principal investigators. Grants are worth up to £600,000 and normally last three years. MRC will usually meet up to 80 per cent of the full economic cost.

Medical Research Council: Confidence in concept scheme – this provides awards to institutions to be used to support the earliest stages of multiple translational research projects. Grants will be between £300,000 and £1 million.

Cancer Research UK: Senior cancer research fellowships – this enables senior researchers to establish or to further develop an independent research group. Fellowships will last for six years and fund salaries for the fellow, up to two postdoctoral researchers, a technician and a PhD student. They also cover research expenses, consumables and equipment costs.

Cancer Research UK: Career Development Fellowships – these support non-clinical scientists who have shown promise in their initial studies in a cancer relevant research field, but may not yet have sufficient experience to obtain a more senior fellowship. Grants have a duration of six years and fund: salaries for the fellow, a postdoctoral researcher and a technician; consumables costs; equipment.

British Society for Antimicrobial Chemotherapy: Research grants support research efforts in the following areas: mechanisms of antibacterial action; mechanisms of antibacterial resistance; antiviral resistance; antivirals; antifungals; antibiotic methods; antibiotic prescribing; antibiotic therapy; antiparisitics; evidence based medicine/ systematic reviews. Grants are worth up to £50,000 for projects of one year’s duration.

British Society for Antimicrobial Chemotherapy: Project grants may be used for the following purposes: pump priming projects; supporting the completion of an existing project; introducing a novel technique for existing work; funding for trainees for projects/training (maximum value £5,000). Up to £10,000 is available for projects of one year ‘s duration.

Anatomical Society: Research Studentships provide basic maintenance and fees for postgraduate students working towards the award of a higher degree in the anatomical and related sciences. Studentships are tenable for a maximum of three years and must be held in a British or Irish university.

British Pharmacology Society: AstraZeneca prize for women in Pharmacology: This recognises women whose career achievements have contributed significantly to the understanding of a particular field in pharmacology through excellence in research. The prize is worth £1,000.

 The RKE Operations team can help you with your application.

Research missing in NHS reform?

The Association of Medical Research Charities has joined a coalition of charities and organisations calling for research to be better embedded and supported within the NHS.  In a response to the government’s “listening exercise” on the future of the healthcare system, submitted on 31 May, the group propose that the duty to promote research be included throughout the NHS.  The health secretary should take on a duty to promote research within his remit, and incentives to carry out research should be developed, it adds.  The exercise is a response to criticisms of the coalition government’s plans to shake up the NHS.