Category / data management

Improving information for people taking part in clinical research

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

The Health Research Authority (HRA) has launched new Quality Standards to improve information given to people who are invited to take part in research. The Quality Standards have been launched alongside Design and Review Principles, which show researchers and Research Ethics Committees (REC) what the important ethical considerations are for participant information.

  • The new HRA Participant Information Quality Standards will help research organisations to understand what good participant information looks like, and will make clear to researchers what the Research Ethics Committees will consider as part of the ethics review, including the review of participant information. The REC will support researchers to create information that meets the Quality Standards.
  • The aim of the Quality Standards and Design and Review Principles is to make participant information better, and to make the way that RECs review that information more consistent. The documents set out the basic criteria that all participant information must meet, and covers language, accessibility, and mandatory content.

Next steps

The Quality Standards and Design and Review Principles will be phased in from autumn 2023. As study materials are prepared in advance, REC reviews of participant information will initially be presented to research organisations as recommendations as opposed to actions required for approval.

From December 2023, the Quality Standards and Design and Review principles will become mandatory and will be applied to all research applications submitted for review.

Changes to participant information are currently the most likely reason for ethics committees to give a provisional opinion. Using this guidance will increase the possibility of receiving a favourable opinion.

Available templates

Remember that BU has Participant Information Sheet templates that provide much of the required wording to ensure your participants are making a fully informed decision before agreeing to participate.

It is vital that when compiling your information sheets that you remember to include the HRA GDPR transparency wording.

Questions or concerns?

If you have any questions regarding these new standards or about clinical research in general, please email Suzy Wignall, Clinical Governance Advisor – swignall@bournemouth.ac.uk or clinicalresearch@bournemouth.ac.uk

BU PhD student publishes in The Conversation

BU research, data management, Featured academics, international, Postgraduate Research, Publishing, research integrity, research methods, Student Engagement, the conversation, Uncategorized, Women's Academic Network, writing

Congratulations the Abier Hamidi, PhD student in the Faculty of Health & Social Sciences (FHSS) whose PhD work was published in The Conversation this week (24 April) under the title Social media now trumps traditional family networks in Libya – my Facebook survey reached 446,000 women.  Her piece in The Conversation on the recruitment of female participants for a PhD study in a rather patriarchal society brings together issues of anonymity, gender, and wider social culture.

This is Abier’s PhD research is supervised by Dr. Pramod Regmi, Senior Lecturer in International Health and the Global Engagement Lead in the Department of Nursing Sciences, and Prof. Edwin van Teijlingen in the Centre for Midwifery, Maternal & Perinatal Health (CMMPH).

Congratulations!

Prof. Edwin van Teijlingen

 

Free workshop – Data management basics: Ethical and legal issues in data sharing

BU research, data management, Guidance, Postgraduate Research, Research communication, Research Ethics, research governance, research integrity, research methods, Research Training

Data management is essential to make sure that well-organised, well-documented, high quality and shareable research data can be produced from our research projects.

The free introductory workshops on data management basics are intended for researchers and anyone who wants to learn about research data management.

The first session, scheduled for 4th May 10am – 11.30am: Introduction to data management and sharing, provides an overview of how to manage, document and store research data. This second session focuses on the ethical and legal aspects of data management.

In this free 90-minute online workshop, participants will learn about the relevant legislation, such as data protection legislation and the General Data Protection Regulation (GDPR). Participants will also learn about strategies that enable them to share research data. This includes carrying out an assessment of disclosure risk, obtaining informed consent, anonymising data and regulating access to enable data to be shared.

There will be time at the end for questions and discussion.

This event is part of our UK Data Service introductory training series: Spring 2023.

Register for this workshop here.

Researcher Roadshow – Exploring Health Data Science

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research Ethics, research integrity, research methods, Research Training, Training

Researcher Roadshow
Exploring Health Data Science

March 1st, 2023. 10:00 – 12:00

The NIHR Research Design Service, Health Data Research UK (HDR UK), the MRC Regulatory Support Centre and NHS Digital are pleased to offer the opportunity to attend the sixth in a series of virtual researcher roadshows.

This free to attend event is aimed at researchers and others working with health and social care datasets who would like to increase their understanding of roles of health data scientists and value of health data science.

The event will bring together health data scientists from the NHS, academia, and industry and provide insights and perspectives on the important work they do.

This event will include presentations on different roles and careers in health data science and different methods and approaches used by health data scientists.

Speakers will be confirmed in the New Year. 

Provisional registration is at: https://ukri.zoom.us/webinar/register/WN_GntzbzTITLmw0ghBRadQKQ

Recordings of previous Researcher Roadshows can be viewed here – Research Advisory Group (RAG) researcher roadshows – NHS Digital

Queries: If you have any questions about this event, please contact: rsc@mrc.ukri.org

Introduction to Patient and Public Involvement (PPI) for Researchers – free event

BU research, Clinical Governance, data management, Guidance, nhs, NHS, research integrity, research methods, Research news, Research Training

Introduction to Patient and Public Involvement (PPI) for Researchers

Date: Tuesday 10 January 2023
Time: 10:30 – 12:30

This event is aimed at people who are new to PPI or setting up their first PPI project, and is free for students and staff from the NIHR, NHS, UK universities, public sector institutions and registered charities based in the UK.

It will help them to discover the support available to plan, deliver and build PPI into their research, and highlight how PPI improves research for patients, services users and carers.

Free online course – Improving Healthcare Through Clinical Research

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

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and is be available now, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

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

Research data: new dataset available in BORDaR

data management, open access

Dr Constantina Panourgia (Senior Lecturer in Developmental Psychology) recently deposited in BORDaR (BU’s research data repository) the research data linked to the paper Self-compassion, coping strategies and gender differences in psychology, counselling and psychotherapy practitioners during COVID-19: Lessons learnt.

The dataset can be accessed here: https://doi.org/10.18746/bmth.data.00000247

We asked Dr Panourgia to share a bit about what this study was about, the benefits of making the data open access, and for any advice that can be passed on to help others manage data effectively for deposit in BORDaR. 

 

Q- Tell us about your research – what’s most exciting about it?

A – The current investigation highlighted the vital role of psychology, counselling and psychotherapy practitioners who played and still play an essential part in providing care for people whose mental health has adversely been affected by the pandemic. This study explored self-compassion’s ability to predict approach and avoidance coping in psychology, counselling and psychotherapy practitioners during COVID-19, and whether this differed between genders. The most exciting part of this project is that our findings have practical implications for training, supervision, and clinical practice for practitioners, to ensure they remain competent when faced with extreme stress. This paper is based on the final year project of a former UG Psychology student; working and publishing with one of our students was the most rewarding part of it.

Q – What do you see as being the benefits of making your data available?

A – There are several benefits. Making the data available allows other researchers not only to investigate further research questions but also to check the accuracy of our findings. Furthermore, making data available may lead to potential collaborations.

Q – Do you have any advice you would give other researchers to help them with depositing data?

A – Being organised is the key. When you work on your data, ask yourself “Does my dataset make sense for someone who is not involved in this project?”. Using precise labels for the variables of your dataset, keeping notes about the way that your variables were scored and what these scores mean can be very useful. Also, you need to be prepared to answer any questions about the ethical procedures you followed.

Q – Anything else you want to say about your data or the process?

A – You shouldn’t worry if you haven’t done this before. The process is very straightforward and the BORDaR team is incredibly helpful. When our paper was published and became available on BRIAN, I emailed the BORDaR team who sent me detailed instructions for uploading data to BORDaR. The dataset was processed and published very quickly. The final step of this process includes the generation of a DOI which you can share with the publisher of your paper.

 

What support is available for researchers?  

The library offers guidance and support for data management from bid preparation (Data Management Plans) to deposit in BORDaR. Visit our research data management guide or email us at bordar@bournemouth.ac.uk.   

 

Dan Bailyes  

Faculty Librarian (FMC) and LLS lead for Research Data Management (RDM)    

Could you help the Health Research Authority improve the research ethics review?

BU research, Clinical Governance, data management, Guidance, nhs, NHS, PG research, Postgraduate Research, Research communication, Research Ethics, research integrity, Research news

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS or social care – email the Clinical Research mailbox, and take a look at the Clinical Governance section of the website.

RKEDF Clinical Research Governance Sessions

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research communication, Research Ethics, research integrity, Research Training, RKE development framework

As you will be aware, RDS offers something called the RKEDF, or Research & Knowledge Exchange Development Framework – as part of this there are a number of sessions available surrounding clinical research governance. These sessions can be booked as a 1:2:1 or in bespoke group sessions with Suzy Wignall, BU’s Clinical Governance Advisor.

As always, general chats/specific discussions can also be booked in too – please just email!

The RKEDF sessions available are as follows:

Please get in touch if you are interested in any of these sessions.

For general guidance, documents and further information surrounding processes, take a look at the Clinical Governance website.

BU Integrity Week: 16th to the 20th May 2022

BU research, BU2025, Clinical Governance, data management, Doctoral College, ECR Network, Events, PG research, Research Ethics, Research Integritiy

Unlock greater potential by maximising your awareness and understanding of Integrity! 

The ability to utilise integrity in research, writing and teaching is vital for academic success. However, continuing to retain your integrity is fundamental but this can only be achieved by maintaining an ability to keep up-to date with the rules constituting academic dishonesty. Not so unlike technology rules and guidelines are continually changing. How then do you develop and maximise your understanding of honesty and dishonesty and continue to retain Integrity?  BU’s Integrity Week will give you the skills and resources to do just that! 

The importance of Academic Integrity will be highlighted at Bournemouth University’s Integrity Week. 

Organised by cross faculty departments for students, staff and faculty, the week will comprise of a combination of interesting workshops, cross faculty and professional presentations where experts will share their knowledge on differing aspects of honesty and dishonesty. Panel discussions, open to all, will provide a lively forum for the sharing of experiences. 

Reasons to attend! 

  • Unlock and achieve greater success through integrity
  • Discover Integrity resources 
  • Acquire skills to utilise integrity in research, writing and teaching
  • Learn how to maintain integrity in an evolving world of change

This will be an unparalleled week of opportunity for students, staff and faculty to ensure that through awareness and understanding BU stays at the forefront of everything that Integrity represents.  

 

Check out the programme and book here

Elsevier-UK Institutions Agreement

BU research, data management, Impact, open access, REF Subjects, Research assessment, Research communication, research integrity, writing

Elsevier and Jisc have established an agreement to enable continued reading access for UK researchers and to enable open access publishing. When publishing in eligible Elsevier journals, authors will be able to choose to publish open access at no additional cost to the author.

This agreement is effective until the end of December 2024.

This agreement supports corresponding authors affiliated with a Jisc participating institution (which BU is), regardless of the department in which they work.

Authors who publish under this agreement can:

  • Publish their peer-reviewed research open access in hybrid journals, at no charge to the author.
  • Publish their peer-reviewed research in fully gold open access journals at a discount on the list price APC.
  • Publish eligible articles in a wide variety of participating Elsevier journals across disciplines.
  • Rely on high-quality peer-review and experienced editorial support.

You can search for whether the intended journal falls under the agreement here.

Eligibility criteria

  • The author must be the submitting corresponding author affiliated with an eligible institution
  • Articles must have an acceptance date between 1.1.2022 and 31.12.2024

Instructions for corresponding authors

  • Once your article has been accepted for publication in a participating journal, you will receive an email containing a link to the “post-acceptance author journey”. Upon selecting your publishing options, your affiliation will be validated by your institution, and you will be informed if the APC will be covered by the agreement.
  • Upon publication, your final published open access article will be made freely available on ScienceDirect, the world’s largest publishing platform.

Other open access publishing options for authors

Authors can continue to choose to publish under the subscription model and self-archive their manuscript (Green Open Access) in line with Elsevier’s sharing policy.

Details of this agreement and others which BU holds with publishers such as Wiley and Springer, can be found here. Any queries, please contact openaccess@bournemouth.ac.uk

Elsevier-UK Institutions Agreement

BU research, data management, Impact, open access, Publishing, REF Subjects, Research communication, research integrity, writing

Elsevier and Jisc have established an agreement to enable continued reading access for UK researchers and to enable open access publishing. When publishing in eligible Elsevier journals, authors will be able to choose to publish open access at no additional cost to the author.

This agreement is effective until the end of December 2024.

This agreement supports corresponding authors affiliated with a Jisc participating institution (which BU is), regardless of the department in which they work.

Authors who publish under this agreement can:

  • Publish their peer-reviewed research open access in hybrid journals, at no charge to the author.
  • Publish their peer-reviewed research in fully gold open access journals at a discount on the list price APC.
  • Publish eligible articles in a wide variety of participating Elsevier journals across disciplines.
  • Rely on high-quality peer-review and experienced editorial support.

You can search for whether the intended journal falls under the agreement here.

Eligibility criteria

  • The author must be the submitting corresponding author affiliated with an eligible institution
  • Articles must have an acceptance date between 1.1.2022 and 31.12.2024

Instructions for corresponding authors

  • Once your article has been accepted for publication in a participating journal, you will receive an email containing a link to the “post-acceptance author journey”. Upon selecting your publishing options, your affiliation will be validated by your institution, and you will be informed if the APC will be covered by the agreement.
  • Upon publication, your final published open access article will be made freely available on ScienceDirect, the world’s largest publishing platform.

Other open access publishing options for authors

Authors can continue to choose to publish under the subscription model and self-archive their manuscript (Green Open Access) in line with Elsevier’s sharing policy.

Details of this agreement and others which BU holds with publishers such as Wiley and Springer, can be found here. Any queries, please contact openaccess@bournemouth.ac.uk

Request for feedback – MHRA clinical trials consultation

BU research, Clinical Governance, data management, nhs, NHS, Research communication, Research Ethics, research integrity

The Medicines & Healthcare products Regulatory Agency (the MHRA) have launched a public consultation into clinical trials.

The aim of the consultation is to streamline approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement.

There will be a 1 hour meeting on Monday 14th February at 1pm until 2pm, where you can offer your thoughts and feedback for BU’s institutional response.

If you wish to attend the meeting, please get in touch to be added to the invitation.

If you are unable to make the above time but wish to offer your thoughts, please email clinicalresearch@bournemouth.ac.uk to ensure your feedback is included.

Updated HRA amendment tool now live

BU research, Clinical Governance, data management, Guidance, nhs, NHS, Research communication, Research Ethics, Research news

Please see below and note that from now any amendment made should be using version 1.6 of the document.

‘What: An updated amendment tool has been released for use when submitting amendments for health research studies

Who: All researchers and sponsors

When: Released 6 December

We’ve also made some other changes to the amendment tool to make it easier to use including:

  • improved guidance in the submission tab
  • changes to the radio selection buttons to make it clearer to complete and view once converted to a pdf
  • changes to help users avoid common mistakes

You can get all details on the changes we’ve made in the Change Record in General Guidance tab on the tool. Please start to use the new version (1.6) for all new amendments from 6 December 2021. We will continue to accept amendments using version 1.5 for two weeks. We will not accept amendments submitted on V1.5 after 20 December 2021.’

Please see this link for further information.

Paper published outlining good practice for receiving informed consent

BU research, Clinical Governance, data management, nhs, NHS, Publishing, Research communication, Research Ethics, research integrity, Research news, Research Training, Training

A paper has been published by Hugh Davies (Chair, Oxford A NHS Research Ethics Committee) and the members of Oxford A Research Ethics Committee (REC) which includes a model for what the REC considers to be good practice in terms of consent for research participation. The paper proposes that there are four simple steps which consent processes should be built around:

  • Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.
  • Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.
  • Step 3: After a gap, if necessary, reviewing and checking understanding.
  • Step 4: Reaching agreement and recording consent.

The paper outlines common issues such as information provision to participants, inadequate public involvement, and lack of proportionality.

You can access the paper here.

Remember that RDS offers training in informed consent, as does the National Institute for Health Research. If you are interested in accessing this training, please email Research Ethics.

Template documents are also available via the Health Research Authority website.