Category / NHS

NIHR-CRN podcast – Research Ethics Committees

Guidance, NHS, Research Ethics

The latest podcast from the National Institute for Health Research is available and this time concentrates on Research Ethics Committees.

All research with human participants should have appropriate ethical reflection – the podcast this month contains the thoughts and guidance of Dr Hugh Davies who is an established Research Ethics Committee Chair and former Ethics Advisor for the Health Research Authority.

If you are interested in learning more about NHS Research Ethics Committees you can view the dedicated section on the HRA website here, and even register your interest to sit as an observer at a committee meeting.

Happy listening!

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 103 Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

New page on the Clinical Governance Blog – Public Involvement in Research

Guidance, NHS, Research Ethics

Involving the public in your study is important, especially at the research design stage, this is known as ‘Public Involvement’ or ‘Patient & Public Involvement’ (PPI). This involvement can greatly improve the quality of your study design and documentation.

To better support researchers with this process (in particular for the purposes of clinical research), there is now a dedicated space for guidance, resources and wider reading, on the Clinical Governance blog space.

You can find the page here – as always if there are any specific queries, please get in touch with Research Ethics.

Good Clinical Practice refresher – Wednesday 14th August 2019

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 Dorset County Hospital, Dorchester on Wednesday 14th August, 9am – 12:30pm.

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

Health Research Authority #MakeItPublic Campaign – internal survey

NHS, open access, Research Ethics

You will hopefully have seen numerous blog posts regarding the Health Research Authority’s (HRA) commitment to research transparency. This was prompted in response to the  House of Commons Science and Technology Committee report last year on clinical trials transparency, which showed that nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.

The HRA have recently launched a consultation on their new draft strategy for research transparency – #MakeItPublic. You can find out more about the campaign here on their website where there are also pages outlining their plans and visions for this area of improvement.

If you would like to have your say and be a part of the consultation, BU has an internal survey you can complete. The survey will close on Friday 16th August and replies will be combined to create an institutional response.

Training opportunity – completing and submitting your IRAS application

NHS, Research Ethics, Research Integritiy, 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 103 Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Good Clinical Practice refresher – Wednesday 14th August 2019

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 Dorset County Hospital, Dorchester on Wednesday 14th August, 9am – 12:30pm.

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

New collaborative paper BU-NHS colleagues

NHS, Publishing, writing

The month saw the publication of the latest collaborative paper between FHSS academics, BU Visiting Faculty and NHS clinicians.  Our paper ‘Design errors in vital sign charts used in consultant-led maternity units in the United Kingdom’ [1] is available for a free download from Elsevier until August 28, 2019. Till then no sign up, registration or fees are required, click here.

The authors, as part of the Modified Obstetric Warning Score (MObs) Research Group, lead by BU Visiting Faculty Richard Isaac, argue that obstetric observation charts in the UK contain poor design features. These charts have common errors such as an inappropriate use of colour, poor alignment and axes labelling.  Consequently, these design errors render charts difficult to use and could compromise patient safety. The article calls for an evidence-based, standardised obstetric observation chart, which should integrate ‘human factors’ and user experience.

This research team, earlier published ‘Vital signs and other observations used to detect deterioration in pregnant women: Analysis of vital sign charts in consultant-led maternity units’. [2]

References:

  1. Isaacs, R., Smith, G., Gale-Andrews, L., Wee, M., van Teijlingen, E., Bick, D.E., Hundley, V. on behalf of the Modified Obstetric Warning Score (MObs) Research Group. (2019) Design errors in vital sign charts used in consultant-led maternity units in the United Kingdom, International Journal of Obstetric Anesthesia 39:60-67.
  2. Smith, G., Isaacs, R., Gale-Andrews, L., Wee, M., van Teijlingen, E., Bick, D., Hundley, V. (2017) Vital signs and other observations used to detect deterioration in pregnant women: Analysis of vital sign charts in consultant-led maternity units. International Journal of Obstetric Anesthesia 30: 44-51.

 

Good Clinical Practice refresher – Wednesday 14th August 2019

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 Dorset County Hospital, Dorchester on Wednesday 14th August, 9am – 12:30pm.

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

New BU cross-faculty publication

international, NHS, Publishing, writing

This week Evidence-Based Midwifery published the latest article from the BU team working on the portrayal of midwifery and maternity in the media.  This qualitative paper ‘Changing the narrative around childbirth: whose responsibility is it?’ is co-authored by a multidisciplinary team including the disciplines of Midwifery, Sociology and Media.[1]  The lead author is Prof. Vanora Hundley in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH), one of longest established centres at BU, her co-authors are Dr. Ann Luce in the Faculty of Media & Communication, Prof. Edwin van Teijlingen director of CMMPH and Sophie Edlund, who was based at BU at the time of the research but who is now at Malmö University in Sweden.

The paper addresses societal’s interest in all aspects of childbirth, which is reflected in both social and traditional media. Stories often focus on dramatic, risky and mostly unrealistic events; misrepresenting childbirth and maternity care professionals. The authors raised the question: “Whose responsibility is it to ensure accurate representations of childbirth?”   Using semi-structured in-depth interviews with ten midwives working in the UK some working in the NHS, some in Higher Education or independent practice, the authors distilled four separate but inter-related themes:

(1) not my responsibility;

(2) fear of retribution;

(3) power balance; and

(4) social media.

The themes sat within two wider societal issues that reflect the current challenges for midwifery, these were (a) the ongoing battle between the social and the medical models of childbirth and (b) the impact of gender.  Finding that midwives fear the media resonates with experiences from a number of countries and professional groups. There is a need to change media discourse in both fictional and factual representations of childbirth and midwives have a critical role to play in this, but to do this they need to equip themselves with the skills necessary to engage with the media. Guidelines on responsible media reporting could ensure that media producers portray pregnancy, midwifery and maternity care as naturally as possible.

This paper is paper of a growing body of interdisciplinary research at BU across faculties, which had already resulted in six earlier publications. [2-7]  In addition last month Dr Chapleo from the Faculty of Management submitted a grant application to the ESRC under the title ‘Rebranding childbirth: understanding the role of marketing in influencing uptake of health services’, a joint application with CMMPH staff (Profs. Hundley & van Teijlingen) and the Media School (Dr. Luce).

 

References:

  1. Hundley, V., Luce, A., van Teijlingen, E., Edlund, S. (2019) Changing the narrative around childbirth: whose responsibility is it? Evidence-based Midwifery 17(2): 47-52.
  2. Luce, A., Cash, M., Hundley, V., Cheyne, H., van Teijlingen, E., Angell, C. (2016) “Is it realistic?” the portrayal of pregnancy and childbirth in the media BMC Pregnancy & Childbirth 16: 40 http://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-0827-x
  3. van Teijlingen, E., Simkhada, P., Luce, A., Hundley, V. (2016) Media, Health & Health Promotion in Nepal, Journal of Manmohan Memorial Institute of Health Sciences 2(1): 70-75. http://www.nepjol.info/index.php/JMMIHS/article/view/15799/12744
  4. Luce, A., Hundley, V., van Teijlingen, E. (Eds.) (2017) Midwifery, Childbirth and the Media, London: Palgrave Macmillan.
  5. Hundley, V., Duff, E., Dewberry, J., Luce, A., van Teijlingen, E. (2014) Fear in childbirth: are the media responsible? MIDIRS Midwifery Digest 24(4): 444-447.
  6. Hundley, V., Luce, A., van Teijlingen, E. (2015) Do midwives need to be more media savvy? MIDIRS Midwifery Digest 25(1):5-10.
  7. van Teijlingen, E., De Vries, R., Luce, A., Hundley, V. (2017) Meer bemoeien met media (In Dutch: more engagement with media). Tijdschrift voor Verloskundigen (in Dutch: Journal for Midwives), 41 (6):28-29.

Health Research Authority #MakeItPublic Campaign

NHS, open access, Research Ethics

You will hopefully have seen numerous blog posts regarding the Health Research Authority’s (HRA) commitment to research transparency. This was prompted in response to the  House of Commons Science and Technology Committee report last year on clinical trials transparency, which showed that nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.

The HRA have recently launched a consultation on their new draft strategy for research transparency – #MakeItPublic. You can find out more about the campaign here on their website where there are also pages outlining their plans and visions for this area of improvement.

If you would like to have your say and be a part of the consultation, you can book onto one of their face-to-face workshops, or via their online survey.

Setting up clinical research – the ‘Organisation Information Document’

NHS, Research Ethics

If you are currently conducting research within the NHS or Health & Social Care (HSC), then please bear in mind the following update if you wish/plan to add new NHS/HSC research sites to your study.

As of 5th June, the set-up procedure for clinical research projects involving NHS or HSC organisations changed (see blog post) –

  • If you applying for HRA/NHS REC approval you will be required to follow the new procedure using the Organisation Information Document (OID), as referenced in the above post;
  • If you are already conducting a study with HRA/NHS REC approval, in NHS/HSC organisations, and wish to involve new sites, then please be aware that the OID should be used, even if existing sites were set-up using the previous document, the Statement of Activities.

Further help and guidance

Guidance on the use of the new UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants with the change.

If you have any queries regarding any of the information provided above, information in the referenced blog post, or would like some guidance with regard to implementing your research in a healthcare setting – please get in touch with BU’s Research Ethics team.

You can also take a look at the Clinical Governance blog for documents, links and training opportunities.

Breastfeeding paper published today

NHS, PG research, Publishing, student research, writing

The journal Women and Birth (by Elsevier) published the latest academic paper by Dr. Alison Taylor today.  Alison’s paper ‘The therapeutic role of video diaries: A qualitative study involving breastfeeding mothers’ had been online as a pre-publication for a while but today in appeared officially in print [1].  Alison is a Senior Lecturer in Midwifery in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH) and this scientific paper is part of her completed PhD research project. 

 

 

The paper is based on a large number of video clips recorded by new mothers.  The total recording time exceeded 43 hours. This paper focuses on one theme, the therapeutic role of the camcorder in qualitative research. Four subthemes are discussed highlighting the therapeutic impact of talking to the camcorder: personifying the camcorder; using the camcorder as a confidante; a sounding board; and a mirror and motivator.  Dr. Taylor and colleagues conclude that frequent opportunities to relieve tension by talking to “someone” without interruption, judgement or advice can be therapeutic. Further research needs to explore how the video diary method can be integrated into standard postnatal care to provide benefits for a wider population.

This is the second paper originating from Alison’s PhD research, the first one appeared in Midwifery (also published by Elsevier) [2].   Dr. Taylor’s PhD thesis was supervised by Prof. Emerita Jo Alexander, Prof. Edwin van Teijlingen (in CMMPH) and Prof. Kath Ryan at the University of Reading.

[Drawing of Breastfeeding Woman by Allison Churchill.]

 

REFERENCES:

  1. Taylor AM, van Teijlingen E., Alexander J, Ryan K. (2019) The therapeutic role of video diaries: A qualitative study involving breastfeeding mothers, Women & Birth 32(3):276-83. https://www.sciencedirect.com/science/article/pii/S1871519218300064
  2. Taylor A, van Teijlingen E, Ryan K, Alexander J (2019) ‘Scrutinised, judged & sabotaged’: A qualitative video diary study of first-time breastfeeding mothers, Midwifery 75: 16-23.

NIHR Clinical Research Network Portfolio

NHS

The National Institute for Health Research (NIHR) is one of the largest funders of clinical research in Europe and have a number of funding streams that you can apply for in order to conduct health-related research. The NIHR then has a number of Clinical Research Networks or ‘CRNs’ that are spread out to each region of England. The local CRN is Wessex, based in Hedge End, Southampton.

The ‘Portfolio’

At the heart of CRN activities is the NIHR CRN Portfolio of studies. This consists of high-quality clinical research studies that are eligible for consideration for support from the CRN in England. Adoption onto the portfolio has a number of benefits for researchers, such as help in identifying potential research sites, access to patients and the public to carry out ‘PPI‘ and advice on recruitment strategy at any point during the study. The CRN offers support to researchers via their Study Support Service and likewise via each portfolio manager and their team. You can see a breakdown of each portfolio here on the Wessex CRN page.

The Portfolio and the NHS

Portfolio adoption is usually vital to participating NHS Trusts when considering the research studies they wish to undertake, as they are reimbursed for the resource given to conduct the study (e.g. research nurse support, data manager time). As a result, it is strongly advised that external funding is considered for BU clinical research projects – the amount of funding doesn’t have to be substantial.

Each CRN is given a budget for the financial year by the NIHR, which is then distributed to sites based on their recruitment figures.

Requirements

In order to be eligible for portfolio adoption, there are three criteria a study must meet:

  • The study must be ‘research’ (this is stipulated, as often what’s classed as research outside the NHS setting, is sometimes a service evaluation, quality improvement etc. within the NHS – see this table);
  • Have appropriate ethical approval; and Health Research Authority (HRA) Approval where required;
  • Have full research funding – this has to have been awarded via open competition and by the NIHR, other areas of central Government, or an NIHR non-commercial partner (for which there is a list). If the study has received support from multiple funders, then it will be still considered automatically eligible, if one of the funding streams is the NIHR, an area of central Government or a non-commercial partner.

You can read more about study eligibility here, including research funded by overseas partners.

The Portfolio and BU

The source of research funding is the principal determinant of eligibility for NIHR CRN support and so it is encouraged that researchers seek external funding where possible and appropriate, from the NIHR, another area of central Government or one of their non-commercial partners. The amount of funding doesn’t need to substantial in order to be eligible.

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