Tagged / Health

RKEDF – Good Clinical Practice ‘Lite’

NHS, Research Ethics, Training

On Tuesday 4th February, Research Development & Support are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

By the end of this workshop you will have an understanding about:

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

If you’re interested in attending then reserve your place via Organisational Development.

NIHR resources – Patient and Public Involvement and Social Media Toolkit

Guidance, Knowledge Exchange, NHS, Research Ethics, Training

Two resources are now available on the NIHR Learn website for researchers –

  • Patient and Public Involvement: Inspiring New Researchers – an online course developed by the Department of Health and NIHR. It is intended to help researchers to understand the benefits of good Patient and Public involvement into their research.
  • Social Media Toolkit – a combination of practical resources on how to get started and real case studies from how colleagues across the NIHR Clinical Research Network are currently using social media to support their work.

To access the above resources you will need to have access to the NIHR Learn website. Once you have an account select the tab ‘Health Research Innovations’ and then click on ‘NIHR Endorsed Learning’. Both courses are free and do not require an enrolment key.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – get in touch with Research Ethics. You can also take a look at the Clinical Governance blog for resources and updates.

Community-Based Research Event – register your interest

Knowledge Exchange, Training

An exciting opportunity to attend a workshop, please see below for further details –

‘A team from the National Institute for Health Research (NIHR) are working on a project looking at how we recruit research study participants from commercial High Street health care providers (e.g. Boots, SpecSavers etc), or organisations that support health in some way (e.g. gyms, slimming clubs etc).

The project is titled Community-Based Research and we are looking to answer two specific questions:

  1. How can people with known health issues being seen only ‘on the high street’ access research?
  2. How can people with known health risk factors, who are pre-disease diagnosis, access research?

These two groups could miss out on research opportunities currently because they don’t come into the standard health system until they are either considered to be too severe for High Street treatment (in the case of group 1) or they already have a health problem (in the case of group 2).  We are looking to develop a process by which we can actively recruit participants at scale for trials before they need to access the health service, thus enabling better recruitment of milder disease and pre-disease phenotypes.  We are aware that research is happening in these two groups and would like to pull together researchers who have this experience in order to learn from their successes and challenges.

To support this ETI we are running a workshop on January 31st, 10.30-3.30, at The Wesley Euston Hotel & Conference Venue, London, which will bring together the research community to discuss:

a)      Examples of how we currently recruit from these settings, identifying successes and challenges

b)      Based on these, identifying the key elements of a recruitment strategy that the Clinical Research Network could use

We would like to invite researchers to attend if this would be of interest. Please could nominated representatives complete this Eventbrite registration page (https://www.eventbrite.co.uk/e/nihr-crn-community-based-research-event-tickets-83954384825) including indicating which Specialty they are representing.’

The last Christmas present

international, Publishing, writing

“On the twelfth day of Christmas ….” the editor  of the Journal of Health Research Ms Sunanta Wongchalee informed us that our paper ‘Silicone use in Nepali transgender women: The hazards of beauty’ has been accepted for publication [1].  That is nice belated Christmas present to receive on January 6th and a good start of the New Year.  The paper is written by FHSS’s Dr. Pramod Regmi and Prof. Edwin van Teijlingen with Sanjeev Raj Neupane in Nepal.  This is the second paper from this unique study on transgender women in Nepal, the first one was published last year in BMJ Open [2].

References:

  1. Regmi, P., van Teijlingen, E.,, Neupane, S. (2020) Silicone use in Nepali transgender women: The hazards of beauty, Journal of Health Research (accepted)
  2. Regmi, P., van Teijlingen, E., Neupane, S., Marahatta, S. (2019) Hormone use among Nepali transgender women: a qualitative study, BMJ Open 9: e030464. doi:10.1136/bmjopen-2019-030464.

 

Nepal’s migrant workers & risk at the workplace

international, PG research, Publishing, writing

For nearly a decade BU researchers have published widely about the hazards and risk of Nepali migrant workers in Asia and the Middle East [1-9].  Despite the fact that most migrant workers end up in semi-skilled and unskilled jobs in their host countries, only a minority report poor working environments.  For example, in Pratik Adhikary’s PhD study in FHSS only just over a fifth of migrant workers reported that their work environment in the Middle East or Malaysia was poor or very poor [4].  This relatively high level of satisfaction appears to seems contradict reports in local media on the risks associated with Nepali migrants working abroad, especially focusing on the football world cup in Qatar [7], official reports that many hundreds of bodies of dead Nepali migrants return home every year [10], and the fact that many of these Nepali migrant workers end up doing the jobs the local populations finds too dirty, dangerous and demeaning (colloquially referred to as 3D-jobs).  Why do so many who travel abroad take to do risky, dirty and otherwise undesirable jobs, but still assess their working environment as not too bad?

More theoretical papers on the drivers of migration have referred to many interconnected factors and links [11-12].  Local drivers in Nepal include poverty, lack of employment opportunities, having a history of work-related migration, a growing culture of migration (i.e. it becomes more or less an expectation) and many more.  One local element that is perhaps too easily ignored is that many Nepali migrant workers would have ended up in dirty, dangerous and demeaning jobs at home too.  And the risk, on for example building sites in Nepal might be even greater than that in Qatar or elsewhere in the Middle East as some of the photos below illustrate.  These photos of an accident involving an external building lift were taken today on a building site in Kathmandu.  

 

 

 

 

 

 

 

 

 

 

References:

  1. Adhikary P., Keen S., van Teijlingen E. (2011) Health Issues among Nepalese migrant workers in Middle East. Health Science Journal 5: 169-75. www.hsj.gr/volume5/issue3/532.pdf
  2. Adhikary, P, Sheppard, Z., Keen, S., van Teijlingen, E. (2017) Risky work: accidents among Nepalese migrant workers in Malaysia, Qatar & Saudi Arabia, Health Prospect 16(2): 3-10.
  3. Simkhada, P.P., Regmi, P.R., van Teijlingen, E., Aryal, N. (2017) Identifying the gaps in Nepalese migrant workers’ health and well-being: A review of the literature. Journal of Travel Medicine, 24 (4). https://doi.org/10.3126/nje.v9i3.25805
  4. Adhikary P, Sheppard, Z., Keen S., van Teijlingen E. (2018) Health and well-being of Nepalese migrant workers abroad, International Journal of Migration, Health & Social Care 14(1): 96-105.  https://doi.org/10.1108/IJMHSC-12-2015-0052
  5. Regmi, P., van Teijlingen, E., Mahato, P., Aryal, N., Jadhav, N., Simkhada, P., Zahiruddin, Q.S., Gaidhane, A. (2019) The Health of Nepali Migrants in India: A Qualitative Study of Lifestyles and Risks. International Journal of Environmental Research and Public Health, 16 (19). https://doi.org/10.3390/ijerph16193655
  6. Aryal, N., Regmi, P.R., Faller, E.M., van Teijlingen, E., Khoon, C.C., Pereira, A., Simkhada, P. (2019) Sudden cardiac death and kidney health related problems among Nepali migrant workers in Malaysia. Nepal Journal of Epidemiology, 9 (3), 788-791. https://doi.org/10.3126/nje.v9i3.25805
  7. Adhikary P, van Teijlingen E., Keen S. (2019) Workplace accidents among Nepali male workers in the Middle East and Malaysia: A qualitative study, Journal of Immigrant & Minority Health 21(5): 1115–1122. https://link.springer.com/article/10.1007/s10903-018-0801-y
  8. Regmi, P., van Teijlingen, E., Mahato, P., Aryal, N., Jadhav, N., Simkhada, P., Syed Zahiruddin, Q., Gaidhane, A., (2019) The health of Nepali migrants in India: A qualitative study of lifestyles and risks, Journal of Environmental Research & Public Health 16(19), 3655; doi:10.3390/ijerph16193655.
  9. Regmi, P., Aryal, N., van Teijlingen, E., Adhikary, P. (2019) Nepali migrant workers and the need for pre-departure training on mental health: a qualitative study, Journal of Immigrant & Minority Health https://link.springer.com/content/pdf/10.1007/s10903-019-00960-z.pdf
  10. Ministry of Labour and Employment, Government of Nepal. (2018) Labour migration for employment: a status report for Nepal: 2015/2016 – 2016/2017. In. Kathmandu, Nepal: Ministry of Labour and Employment.
  11. Van Hear, N., Bakewell, O., Long. K. (2018) Push-pull plus: reconsidering the drivers of migration, Journal of Ethnic & Migration Studies, 44:6, 927-944, DOI: 10.1080/1369183X.2017.1384135
  12. Iqbal, M., Gusman, Y. (2015) Pull and Push Factors of Indonesian women migrant workers from Indramayu (West Java) to work abroad. Mediterranean Journal of Social Sciences, 6(5): 167   https://www.mcser.org/journal/index.php/mjss/article/view/7893

Community-Based Research Event – register your interest

Knowledge Exchange, Training

An exciting opportunity to attend a workshop, please see below for further details –

‘A team from the National Institute for Health Research (NIHR) are working on a project looking at how we recruit research study participants from commercial High Street health care providers (e.g. Boots, SpecSavers etc), or organisations that support health in some way (e.g. gyms, slimming clubs etc).

The project is titled Community-Based Research and we are looking to answer two specific questions:

  1. How can people with known health issues being seen only ‘on the high street’ access research?
  2. How can people with known health risk factors, who are pre-disease diagnosis, access research?

These two groups could miss out on research opportunities currently because they don’t come into the standard health system until they are either considered to be too severe for High Street treatment (in the case of group 1) or they already have a health problem (in the case of group 2).  We are looking to develop a process by which we can actively recruit participants at scale for trials before they need to access the health service, thus enabling better recruitment of milder disease and pre-disease phenotypes.  We are aware that research is happening in these two groups and would like to pull together researchers who have this experience in order to learn from their successes and challenges.

To support this ETI we are running a workshop on January 31st, 10.30-3.30, at The Wesley Euston Hotel & Conference Venue, London, which will bring together the research community to discuss:

a)      Examples of how we currently recruit from these settings, identifying successes and challenges

b)      Based on these, identifying the key elements of a recruitment strategy that the Clinical Research Network could use

We would like to invite researchers to attend if this would be of interest. Please could nominated representatives complete this Eventbrite registration page (https://www.eventbrite.co.uk/e/nihr-crn-community-based-research-event-tickets-83954384825) including indicating which Specialty they are representing.’

Prostate Cancer Research Centre – your chance to influence their next call

Funding opportunities

Prostate Cancer Research Centre, who recently announced a £2m spend on seven new prostate cancer research projects across the UK, hope to launch their next grant call in the first half of 2020.

To help them finalise their next grant call, they are reaching out to UK cancer researchers at all career stages, as well as research support staff at UK institutions to invite them to participate in a short questionnaire. The purpose of this questionnaire is to explore the gaps in current research funding, so that they can best understand how funding can have the strongest possible impact both for science and for people affected by prostate cancer. If you’re looking for dietary supplement that helps correct prostate problems and also cleanses urinary system, click here for more info!

The questionnaire will take around 5 minutes to complete and all answers will be anonymous. The results will be used to inform their next grant call and may be shared via blog posts and reports.

The closing date for the survey is Monday, 13 January 2020. You can access the survey here: https://www.pcr.org.uk/research-gaps/

If you have any questions relating to the questionnaire or the charity, please do not hesitate to get in touch via info@pcr.org.uk.

 

CoPMRE Visiting Faculty bi-annual event

Knowledge Exchange, NHS

Yesterday CoPMRE welcomed 30 colleagues to our Visiting Faculty bi-annual event showcasing the exciting medical developments at BU from the new Bournemouth Gateway Building to the Institute of Medical Imaging and Visualisation. The key priorities to support delivery of BU2025 were presented by Dr Clare Wedderburn, Interim Head of Department of Medicine & Public Health presented.  Juan Campos-Perez, Clinical Research Co-ordinator, BUCRU spoke about Biobanks which were highlighted in Professor Emma King’s research presentation on immunotherapy.  Professor Jeffrey Wale, Lecturer in Law encouraged innovative medical cross faculty collaboration demonstrated by his recent research collaboration with Professor Sam Rowlands, Visiting Professor resulting in four co-authored papers. The main focus of the meeting centred around Visiting Faculty engagement in research and education to help us achieve our aims.  The audience reported that they were ‘very excited’ about these new developments at BU and were keen to support this vision.

Talk/session with the Wessex Clinical Research Network Study Support Service

Info Days, Knowledge Exchange, NHS, Research Ethics

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place next week on Tuesday 10th December at 2:30pm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

Checklist now available to support researchers undertaking clinical research

Guidance, NHS, Research Ethics

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

New UK Standards for Public Involvement

Guidance, NHS, Research Ethics

Involving the public in your study is important, especially at the research design stage. This is called ‘Public Involvement’ (also known as ‘PPI’ [Patient and Public Involvement]). Public involvement in research means research that is done ‘with’ or ‘by’ the public, not ‘to’, ‘about’ or ‘for’ them.

By seeking the opinions and recommendations of the public, it is a great way to ensure that your study is designed and set-up in a way that will be relevant to participants, and of good quality.
This can also help to avoid any setbacks once the project is underway.

The new UK Standards for Public Involvement have now been released and were developed over three years by a country-wide partnership between the National Institute for Health Research (NIHR), Chief Scientist Office (CSO) Scotland, Health
and Care Research Wales, and the Public Health Agency Northern Ireland

They describe what good public involvement looks like and encourage approaches and behaviours that are the hallmark of good public involvement such as flexibility, sharing and learning and respect for each other.

You can see the six UK standards and supporting materials, as well as further details about the partnership, project and the piloting of the new standards, here.

Further guidance is available via the Clinical Governance section of the Research blog and via the Health Research Authority and NIHR pages.

Introduction to Good Clinical Practice – Wednesday 15th January

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 well-being of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 15th January at Bournemouth University –08:45am – 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.

Checklist now available to support researchers undertaking clinical research

Guidance, NHS, Research Ethics

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

RKEDF – Clinical Research Documentation and Filing

Guidance, NHS, Training

On Tuesday 5th November, Research Development & Support are running a 2 hour workshop on clinical research documentation and filing.

This workshop is designed to share best practice in ensuring that records are completed, stored and shared appropriately, in accordance with the ‘ALCOAC’ general principle, and Good Clinical Practice standards.

The workshop will cover the ‘essential documents’ to be kept during the research project, as well as what to do once the study has ended. Also covered will be how to ensure compliance when storing data on paper and electronically and requirements for source data.

By the end of this workshop you will have an understanding about:

  • The ‘ALCOAC’ general principle and how it applies to your research
  • What to keep in your study file
  • How to maintain good and compliant research records, throughout the life-cycle of the study
  • Requirements for once the study has ended

If you’re interested in attending then reserve your place via Organisational Development.

Good Clinical Practice Refresher – Wednesday 4th December

NHS, Research Ethics, Training

Are you currently undertaking research within the NHS, and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Poole Hospital on Wednesday 4th December, 9:00am – 12:30pm.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics.

Talk/session with the Wessex Clinical Research Network Study Support Service

Info Days, Knowledge Exchange, NHS, Research Ethics

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place on Tuesday 10th December at 2:3opm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

Clinical Governance Standard Operation Procedures – now live

Guidance, NHS, Research Ethics

The Standard Operating Procedures relating to Clinical Governance at BU are now live and can be found on SharePoint.

A full list of documents and links to each are provided in this table, with a link also present on the Clinical Governance blog.

If you have any queries surrounding the information present within the SOPs, or cannot access the links, please email Research Ethics.

Remember – 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.

Happy reading!