Tagged / collaboration

NIHR Valid Informed Consent training dates

NHS, Research Ethics, 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

international, Knowledge Exchange, NHS, Research Ethics

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

NHS, Research Ethics, Training

Are you interested in running your own research project within the NHS? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 15th May, at Bournemouth University, Lansdowne Campus (Bournemouth House) – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact Research Ethics.

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Health Research Authority public involvement guidance – third blog post

NHS, Research Ethics

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

NHS, Research Ethics

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

NHS, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 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.

Funding opportunity – Climate Environment and Health

Funding opportunities

NERC/MRC/ESRC in collaboration with the Belmont Forum, have issued a call to fund transdisciplinary, end-user focused approaches to investigate and address the linkages between climate, environment and health. Projects should seek to bridge knowledge gaps, understand health risks, improve predictability, and deliver usable data, information, and innovative solutions to planners and decision makers. The following themes are prioritised for this call; food systems and nutrition; heat and health and; climate-sensitive infectious diseases.

Projects must be eligible to receive funding from at least three partner organisations participating in this call established in three different countries, and should include researchers from the natural sciences, health/medical sciences, social and economical sciences or humanities, as well as societal partners.

The deadline for expressions of interest is 6th May 19, with full proposals due by 23rd July 19. More information is available on the website.

If you are interested in applying, please contact Lisa Andrews, RDS Research Facilitator or your Funding Development Officer, in the first instance.

 

Training opportunity – completing and submitting your IRAS application

NHS, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 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.

Clinical Research Transparency – Responsibilities

NHS, Research Ethics

‘Researchers, sponsors and funders have responsibilities – that may be legal requirements or ethical and moral expectations within an accepted governance framework of best practice and standards – to participants in research, patients and the wider public and research communities.’

The HRA have recently released a page of useful links and guidance that encompasses areas such as ‘top tips for transparency’, making your research results public, and also registering your study.
Related to this, hopefully you will have seen a recent blog post regarding the HRA’s commitment to ensuring research transparency. This has been a hot topic lately, and the subject of a recent House of Commons Science and Technology Committee report.

Take a look at the HRA guidance 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. It is free to use.
Despite the name, the system may be used for other clinical research projects.

Training opportunity – completing and submitting your IRAS application

NHS, Research assessment, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 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.

HRA help guides – data and technology

Guidance, NHS, Research Ethics

An updated Code of Conduct for the application of data-driven technologies in the NHS was published on Tuesday of this week – the code ‘sets out what the NHS expects from companies who are developing new technologies for the health system, and what they can expect in return.

In order to assist applicants and researchers, the HRA have created new pages that set out the approvals process for data-driven technology research.

The section incorporates two pages of support –

The help pages will be added to the Clinical Governance section of the blog, for ease of access.

Research transparency – HRA response to the Science and Technology Committee

Knowledge Exchange, NHS, Research Ethics

The House of Commons Science and Technology Committee released a report last year on clinical trials transparency, as it was evident that a 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.

At the time the HRA issued a response but today have published a further statement which sets out their commitment to research transparency. This is especially pertinent given the article published simultaneously in BMJ Open, which details the numbers of clinical trials that are publicly registered, compared with those that have received favourable opinion (approval) from a UK NHS research ethics committee.

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. It is free to register your study.
Despite the name, the system may be used for other clinical research projects.

NIHR – Making a difference: Improving treatment for advanced prostate cancer

NHS

The NIHR have recently published an article on the STAMPEDE trial which is helping to improve the prognosis and quality of life of those diagnosed with prostate cancer.

This is a research study that’s supported by the NIHR, and has been up and running since 2005, with more than 10,000 men having taken part. 125 UK sites are conducting the research, with local NHS Trusts amongst those 125.

The trial is multi-arm, so compares different treatments amongst the participant group – it is also ‘randomised’, so participants are allocated their treatment at random, reducing any bias in allocation.

The results to date from the trial have also influenced the NHS treatment for men with high risk, locally advanced metastatic prostate cancer. More STAMPEDE related news can be found on their website.

You can read the article here, which contains a testimony from a trial participant whose condition and quality of life have been vastly improved.

Training opportunity – completing and submitting your IRAS application

NHS, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 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.

HRA responds to paper outlining concerns over study set-up delays

NHS, Research assessment, Research Ethics, Research Integritiy

Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.

Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.

Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.

  • Approx. 89 individuals were involved in the study approvals;
  • 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
  • 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
  • 491 exhanges took place with the 89 individuals, generating 193 pages of text.

Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.

You can read the HRA’s response here, which signposts the reader to further resources.

Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.

BU Systematic Review Masterclass starting tomorrow

Publishing, Research assessment, writing

Looking forward to our annual Systematic Review Masterclass at Bournemouth University which will be starting tomorrow February 14th.  This year for the first time we have renamed it a ‘Systematic Review to Inform Clinical Practice’ as it is not only a free-standing masterclass but also a level 7 unit of Continuing Professional Development and Training .  This year we aim to provide students with the opportunity to choose an area of interest and undertake an in-depth, independent study in the form of a systematic review, focusing on a negotiated aspect of clinical practice.  Prof. Vanora Hundley and I had published over twenty systematic reviews (or papers about systematic reviewing) over the past two decades. [1-21]  The unit will have input from BU’s Academic Liaison Librarian, Caspian Dugdale, and BU academics such as Dr. Bibha Simkhada, Lecturer in Nursing.

Professors Vanora Hundley and Edwin van Teijlingen

Centre for Midwifery, Maternal & Perinatal Health (CMMPH)

 

References:

  1. van Teijlingen E, Wilson, B, Barry, N, Ralph, A, McNeill, G, Graham, W, Campbell, D. (eds.) (1998) Effectiveness of interventions to promote healthy eating in pregnant women & women of childbearing age: a review, London: Health Education Authority www.nice.org.uk/nicemedia/documents/effect_eatpregant.pdf  [ISBN: 0752110977].
  2. van Teijlingen ER, Bruce, J. (1999) Systematic reviews of health promotion initiatives: the Smokebusters experience, Health Education, 99: 76-83.
  3. Ryan M, Scott DA, Reeves C, Bate A., van Teijlingen E, Russell E, Napper M, Robb C (2001) Eliciting public preferences for healthcare: systematic review of techniques. Health Technology Assessment 5(5)
  4. Simkhada, B., van Teijlingen E., Porter, M., Simkhada, P. (2008) Factors affecting the utilisation of antenatal care in developing countries: a systematic review of the literature, Journal of Advanced Nursing 61(3): 244-260.
  5. Paul-Ebhohimhen, V.A., Poobalan, A., van Teijlingen E. (2008) Systematic review of effectiveness of school-based sexual health interventions in Sub-Saharan Africa, BMC Public Health, 8(4). www.biomedcentral.com/1471-2458/8/4
  6. Robertson L, Douglas F, Ludbrook A., Reid G., van Teijlingen E. (2008) What works with men? A systematic review of health promoting interventions targeting men, BMC Health Services Research 8(141). www.biomedcentral.com/1472-6963/8/141
  7. Acharya, D.R., Bhattarai, R, Poobalan, A, van Teijlingen E.R., Chapman, G. (2010) Factors associated with teenage pregnancy in South Asia: a systematic review. Health Sciences Journal 4(1): 3-14. www.hsj.gr/volume4/issue1/402.pdf
  8. Hundley V, Avan B, Braunholtz D, and Graham WJ (2012). Are birth kits a good idea? A systematic review of the evidence. Midwifery 28(2): 204-215
  9. Wasti, SP, van Teijlingen E., Simkhada, P., Randall, J., Baxter S, Kirkpatrick P, Vijay Singh Gc. (2012) Factors influencing adherence to antiretroviral treatment in Asian developing countries: a systematic review, Tropical Medicine & International Health 17(1): 71-81. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-3156.2011.02888.x/pdf
  10. VA Hundley, BI Avan, CJ Sullivan, WJ Graham. (2013) Should oral misoprostol be used to prevent postpartum haemorrhage in home-birth settings in low-resource countries? A systematic review of the evidence. BJOG: An International Journal of Obstetrics & Gynaecology, 120:277–287DOI: 10.1111/1471-0528.12049
  11. van Teijlingen, ER, Simkhada, B., Ireland J., Simkhada P., Bruce J. (2012) Evidence-based health care in Nepal: The importance of systematic reviews, Nepal Journal of Epidemiology 1(4): 114-118.
  12. Robertson, C, Archibald, D, Avenell, A, Douglas, F., Hoddinott, P., van Teijlingen E, et al. (2014) Systematic reviews of & integrated report on quantitative, qualitative & economic evidence base for the management of obesity in men. Health Technology Assessment 18(35): 1-424. http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0019/118180/FullReport-hta18350.pdf
  13. Stewart, F, Fraser, C, Robertson, C, Avenell, A, Archibald, D, Douglas, F, Hoddinott, P, van Teijlingen, E, Boyers, D. (2014) Are men difficult to find? Identifying male-specific studies in MEDLINE & Embase, Systematics Reviews 3,78
  14. Gyawali, B., Neupane, D., Sharma, R., Mishra, S.R., van Teijlingen, E., Kallestrup, P. (2015) Prevalence of type 2 diabetes in Nepal: Systematic review & meta-analysis from 2000 to 2014 Global Health Action 8: 29088 www.globalhealthaction.net/index.php/gha/article/view/29088/pdf_189
  15. Boyers, D, Stewart, F, Fraser, C, Robertson, C, Avenell, A, Archibald, D, Douglas, F, Hoddinott P, van Teijlingen E. (2015). A systematic review of the cost-effectiveness of non-surgical obesity interventions in men, Obesity Research & Clinical Practice 9(4), 310-327.
  16. Robertson, C, Avenell, A, Boachie, C., Stewart, F., Archibald D., Hoddinott, P, Douglas, F, van Teijlingen E, Boyers D. (2016) Should weight loss and maintenance programmes be designed differently for men? Systematic review of long-term RCTs presenting data for men & women: The ROMEO Project, Obesity Research & Clinical Practice 10: 70-84.
  17. Simkhada, P.P., Sharma, A., van Teijlingen, ER., Beanland, R,L. (2016) Factors influencing sexual behaviour between tourists and tourism employees: A systematic review. Nepal Journal of Epidemiology 6(1): 530-538. www.nepjol.info/index.php/NJE/article/view/14735/11952
  18. Symon, A., Pringle, J., Cheyne, H., Downe, S., Hundley, V., Lee, E., Lynn, F., McFadden, A., McNeill, J., Renfrew, M., Ross-Davie, M., van Teijlingen, E., Whitford, H, Alderdice, F. (2016) Midwifery-led antenatal care models: Mapping a systematic review to an evidence-based quality framework to identify key components & characteristics of care, BMC Pregnancy & Childbirth 16: 168 http://rdcu.be/uifu  
  19. Hanley GE, Munro S, Greyson D, Gross MM, Hundley V, Spiby H and Janssen PA (2016) Diagnosing onset of labor: A systematic review of definitions in the research literature. BMC Pregnancy and Childbirth 16: 71 http://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-0857-4
  20. Robertson, C., Avenell, A., Stewart, F., Archibald, D., Douglas, F., Hoddinott, P., van Teijlingen, E., Boyers, D. (2017) Clinical effectiveness of weight loss & weight maintenance interventions for men: a systematic review of men-only randomised controlled trials (ROMEO Project), American Journal of Men’s Health 11(4): 1096-1123.
  21. Symon, A., Pringle, J., Downe, S., Hundley, V., Lee, E., Lynn, F., McFadden, A., McNeill, J., Renfrew, M., Ross-Davie, M., van Teijlingen, E., Whitford, H., Alderdice, F. (2017) Antenatal care trial interventions: a systematic scoping review and taxonomy development of care models BMC Pregnancy & Childbirth 17:8 http://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-1186-3
  22. Pitchforth, E, Nolte, E, Corbett, J, Miani, C, Winpenny, E, van Teijlingen E, et al. (2017) Community hospitals and their services in the NHS: identifying transferable learning from international developments – scoping review, systematic review, country reports and case studies Health Services & Delivery Research 5(19): 1-248.
  23. Ochillo, M., van Teijlingen, E., Hind, M. (2017) Influence of faith-based organisations on HIV prevention strategies in Africa: a systematic review. African Health Sciences 17(3): 753-761.
  24. Mahato, P., van Teijlingen, E., Simkhada, P., Angell, C. (2017) Determinants of quality of care & access to Basic Emergency Obstetric & Neonatal Care facilities & midwife-led facilities in low & middle-income countries: A Systematic Review, Journal of Asian Midwives 4(2):25-51. https://ecommons.aku.edu/jam/vol4/iss2/4/
  25. Simkhada, P., van Teijlingen, E., Sharma, A., Bissell, P., Poobalan, A., Wasti, S.P. (2018) Health consequences of sex trafficking: A systematic review, Journal of Manmohan Memorial Institute of Health Sciences, 4(1): 130-149.