Category / data management

Paper published outlining good practice for receiving informed consent

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.

Health Research Authority – new final report requirements

Please see below for an update from the HRA –

Changes to the way you submit your final report

The Health Research Authority has implemented changes to final study reporting requirements. The changes apply to all studies across the UK which require ethics approval and which have not yet submitted a final report.

The Make It Public strategy set out our commitment to make transparency easy, make transparency the norm and make information public. We have now developed a standard dataset on research transparency which will be collected in the study final reports. Coupled with changes we have already made to help you plan at the start of a study how you will inform participants at the end, these changes are steps towards fulfilling that commitment.

In the future we will be able to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).

In standardising the information we request from you and the form for collecting this, we hope it will be easier for you to know what is expected.

If you have any questions, please email research.transparency@hra.nhs.uk

NIHR Research Design Service – Starting Research Workshop

Please see below for the following training opportunity:

Date: 15 September 2021
Time: 09:15-13:30
Location: Online

Funded and hosted by the NIHR Research Design Service (RDS) South Central, discover how to move from thinking about doing research to taking your first steps in the getting support, dedicated time and funding to actually do it. Sign up to the workshop on Eventbrite.

Health Research Authority’s new student research eligibility criteria – live from today

New eligibility criteria for standalone student research go live today (1 September 2021). These changes are designed to ensure that students’ experience of research reflects how modern health and social care research is conducted.

This new criteria encourages innovative approaches to student research like group research, mock Research Ethics Committees (REC) or shadowing a range of people in an existing project.

The changes mean some master’s students will now be eligible to apply for approval to carry out their research.

To help students plan their research we have created a new student research toolkit. The toolkit has been designed to pull together the resources a student will need to understand what approvals are required and whether they are eligible to carry out their research in the UK.  It contains links to existing decision tools as well as some new ones developed especially for students. It uses a simple question and answer format and will provide answers to the following questions:

  • Is my study research?
  • Is my research taking place in the NHS and will it need NHS approval?
  • Do I need NHS REC review?
  • What type of NHS ethics review do I need?
  • Can I carry out my research?

Completing the tool will provide students with an understanding of what activities they can do and ensures that they do not waste time applying for approval for research that they are not able to carry out under the new student eligibility criteria. Through completion of the toolkit, students can access supplementary declarations that need to be completed by their academic supervisor, confirming that they meet the criteria for the type of approvals they need for their research. There are three separate declarations depending on the approvals needed – the toolkit guides the student to the right one based on their responses.

Please share this update and new resource with colleagues and students who might benefit. Further details about the new eligibility criteria can be found on the HRA website.

Please see our question and answer section for further information. If you have any other queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Please contact Suzy Wignall, Clinical Governance Advisor in RDS if you have any queries or concerns.

Research data: new dataset available in BORDaR

Prof. Amanda Korstjens recently published her research data on BORDaR, BU’s research data repository, for her paper: Environmental factors are stronger predictors of primate species’ distributions than basic biological traits.  

Many funders and journals require the data supporting research publications to be deposited for long-term preservation because of its value to future research. Here’s what Prof. Korstjens had to say:   

Q – What’s most exciting about your research?  

A – As environments are changing across the globe, we expect many animals to struggle to survive under the new conditions, but to predict how different species will cope with the new situation, we need to understand which biological traits of that animal explain their association with particular environments. If we understand the relationship between the biological traits needed for coping with particular environments, especially the kind of environments that will become more common in future, then we can develop more effective mitigation strategies to preserve these animals. For example, in theory we would expect a clear relationship between warm dry environments and primates that travel on the ground. This study looks at the environmental variables that influence the distribution of primates across the African continent and investigates for the first time which biological traits of different primate species are associated with which environmental variables.  

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

A – Most researchers would like to access datasets to use them for future comparative studies and to check for themselves how they agree or disagree with the findings of the study. Providing data open access improves traceability and accountability. Most journals also request open access data publication , where possible. 

Q – Any advice you would give to anyone about managing their data effectively for successful deposit? 

 A – Making sure your data is well organized and referenced. 

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

A – The process was relatively straightforward. You can ask questions about anything you don’t understand or are not sure about because you are safe in the knowledge that the library team will check your entry for you. This also makes it easier to feel confident that you are not releasing data that are sensitive or not allowed to be open access for other reasons. The library team was fantastic in guiding me through the process and checking what I uploaded, even when I was rushed and trying to do things last minute. 

The data can be accessed openly here: https://doi.org/10.18746/bmth.data.00000142 

 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, BU’s research data repository. Visit our research data management guide or email us at: bordar@bournemouth.ac.uk

Producing FAIR research data – Reusable

Findable Accessible Interoperable Reusable

FAIR guiding principles for data resources (SanguaPundir 2016) CC-BY-SA

FAIR aims to improve the value and impact of research data by ensuring it is Findable, Accessible, Interoperable and Re-useable. All data produced by researchers at BU should be FAIR, and many journals and funders have made it a condition for successful submission or grant applications. Over a series of posts I will look at each one and explain what this means for the data you produce. Click here if you want to read the previous posts on FindabilityAccessibility and Interoperability. 

Reusable

Imagine you have found a promising dataset to use in a study. It is freely available to download, and it is in an open format you can use. However, your heart sinks when the spreadsheet opens only to discover that it makes no sense! The column headings are in code, and the figures in the table are meaningless…  

Most data are only reusable if they come with appropriate labels or documentation. Most repositories require a READ ME file to be deposited along with the data. The question you should ask is:  

If I were to access this dataset as someone with no prior association with the project, what information would I need to make sense of the data and to use it in my own study with confidence”?   

The answer to this question will vary from project to project. Examples include: 

  • Descriptions of the column headings found in spreadsheets. 
  • The coding schema used to analyse interview transcripts. 
  • Descriptions of how data was collected (if more detail is needed for someone to replicate a study). 
  • Details of any changes made to the data. 
  • An annotated bibliography listing and describing any code/algorithms (particularly helpful if a lot of separate files containing code/algorithms were deposited). 

In addition to this sort of contextual information, an appropriate license should be applied to your data when it is deposited. The license will make clear under what conditions the data can be re-used. Creative Commons licenses are the most common. The CC-BY license, for example, will allow re-use for any reason provided the data creator is acknowledged (cited).    

 

For more information visit the Library’s Research Data Management guide or email bordar@bournemouth.ac.uk. 

 

Dan Bailyes 

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

 

References

SanguaPundir.,  2016. FAIR guiding principles for data resources [image]. Wikimedia Commons. Available from: https://commons.wikimedia.org/wiki/File:FAIR_data_principles.jpg [Accessed 08 July 2021].

Producing FAIR research data – Interoperable

Findable Accessible Interoperable Reusable

FAIR guiding principles for data resources (SanguaPundir 2016) CC-BY-SA

FAIR aims to improve the value and impact of research data by ensuring it is Findable, Accessible, Interoperable and Re-useable. All data produced by researchers at BU should be FAIR, and many journals and funders have made it a condition for successful submission or grant applications. Over a series of posts I will look at each one and explain what this means for the data you produce. Click here if you want to read the previous posts on Findability and Accessibility. 

Interoperable 

Researchers may well be able to find your data without restrictions (Findable, Accessible), but they may not be able to use your data if it is not available in a useable format. Imagine if valuable data was only available on a floppy disk… Not much use to most of us! 

Data can be opened-up to more people if we make them available in open, interoperable formats. The UK Data Service has a list of recommended formats. Spreadsheets, for example, should be saved as .csv files. This is an open format, so users do not necessarily need a paid for solution like Microsoft Excel to open it.  

 

For more information visit the Library’s Research Data Management guide or email bordar@bournemouth.ac.uk. 

 

Dan Bailyes 

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

 

References

SanguaPundir.,  2016. FAIR guiding principles for data resources [image]. Wikimedia Commons. Available from: https://commons.wikimedia.org/wiki/File:FAIR_data_principles.jpg [Accessed 08 July 2021].

Producing FAIR research data – Accessible

Findable Accessible Interoperable Reusable

FAIR guiding principles for data resources (SanguaPundir 2016) CC-BY-SA

FAIR aims to improve the value and impact of research data by ensuring it is Findable, Accessible,Interoperable and Re-useableMany journals and funders have made it a condition for successful submission or grant applications. Over a series of posts I will look at each one and explain what this means for the data you produce. Click here if you want to read the previous poson Findability. 

Accessible 

Research data should be “as open as possible, as closed as necessary” (Horizon 2020). It should be available freely for others to use and restricted only so far as to meet legal and ethical requirements. A few things should be considered at the planning stage to ensure that your data cannot only be found, but can also be accessed: 

Some repositories allow access to data to be restricted. For example, if it is not possible to anonymise sensitive data. This needs to be stated clearly in your Data Management Plan (DMP) as funders/journals will usually need to review this.   

 

For more information visit the Library’s Research Data Management guide or email bordar@bournemouth.ac.uk. 

 

Dan Bailyes 

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

 

References

SanguaPundir.,  2016. FAIR guiding principles for data resources [image]. Wikimedia Commons. Available from: https://commons.wikimedia.org/wiki/File:FAIR_data_principles.jpg [Accessed 08 July 2021].

Producing FAIR research data – Findable

Findable Accessible Interoperable Reusable

FAIR guiding principles for data resources (SanguaPundir 2016) CC-BY-SA

FAIR aims to improve the value and impact of research data by ensuring it is Findable, Accessible, Interoperable and Re-useable. All data produced by researchers at BU should be FAIR, and many journals and funders have made it a condition for successful submission or grant applications. Over a series of posts I will look at each one and explain what this means for the data you produce.

Findable

Data can only be used to validate findings or to make new discoveries if it can be found in the first place. How do you ensure your data is visible?

  1. At the conclusion of your research project, deposit your data in a suitable repository. Preferably this would be in a disciplinary repository recognised by your research community. Some funders and publishers will specify which repository they want. You need to be aware that some repositories charge for their services, so you need to take this into account in the planning stages if bidding for funding. The Registry of Research Data Repositories (re3data) is a good place to look.
  2. BU’s own data repository (BORDaR) is an option if no suitable alternative is available. There is no charge, and a Digital Object Identifier (DOI) will be generated which you can pass on to publishers to link any outputs to the original data. Even if data is deposited in an external repository, a record is created in BORDaR to link to it. This will make your data visible to anyone browsing/searching for data created by BU researchers. You will need to email bordar@bournemouth.ac.uk so we can create the record.
  3. Data in a repository is still effectively hidden if it is not provided with descriptive information (metadata) that can be picked up by search engines or people browsing. For example, consider:
  • Giving your dataset and file names descriptive titles. A title like ‘project data’ is not going to be terribly useful to anyone browsing a list of results.
  • Use controlled vocabularies, where available, to assign keywords to your data.
  • Provide an abstract that explains clearly what the data is and how it was used in your context.

If you were looking for datasets to support a future research project, what sort of information would you need to see to make the task as easy as possible?

For more information visit the Library’s Research Data Management guide or email bordar@bournemouth.ac.uk.

Dan Bailyes

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

 

References

SanguaPundir.,  2016. FAIR guiding principles for data resources [image]. Wikimedia Commons. Available from: https://commons.wikimedia.org/wiki/File:FAIR_data_principles.jpg [Accessed 08 July 2021].

Research data: new dataset available in BORDaR

Dr Liam Wignall (Senior Lecturer in Psychology) recently deposited data collected to research the sexual behaviours, desires and wellbeing of UK young adults during social lockdown due to COVID-19. The anonymised results of the survey, collected between the 14th and 18th May 2020 of 565 young adults, is available via BU’s research data repository, BORDaR.

 

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

 

Q – Can you tell us a bit more about your research?

A – This research provided insight into the impact of social lockdown on different aspects of peoples’ sex lives, such as changes in sexual behaviours and levels of sexual desire, changes in solo-sexual practices, and how technology was used in relation to sex. The research also explored the impact of social lockdown on general health and wellbeing.

 

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

A – Making the data available for others to explore and use could potentially lead to interesting associations being found that the research team were not explicitly looking for. We also believe it’s important to allow other researchers to check the claims we have made in our publications. Finally, if similar studies are conducted in other countries, having the data openly available allows for potential collaborations.

 

Q – Any advice you would give to anyone about managing their data effectively for successful deposit?  

A – Try to keep organised from the beginning, thinking about how best to make the data/questions clearly understandable by others not involved in the project. Use accurate labels for columns in SPSS/Excel and keep track of any acronyms used. Also get in touch with the BORDaR team if you have any questions – they were extremely helpful.

 

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, BU’s research data repository. 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)

Health Research Authority UPDATE: undergraduate and master’s research projects

New eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.

The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 the HRA paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, they are introducing new eligibility criteria for standalone student research.

The new criteria mean that some master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged. Full details are in table one – permitted student research table. They have also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator.

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of the HRA event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read the HRA website for further information and ideas https://www.hra.nhs.uk/student-research/.

The HRA are giving notice now so that course leaders and students have time to prepare for the new arrangements, including ensuring that any changes to institutional policies and procedures are made.

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk or swignall@bournemouth.ac.uk

Publisher research data requirements

Many journals either encourage or require that the data supporting published outputs be deposited in an open research data repository. If you’re looking at options for publishing your research, here are a few things to consider.

Why should I make my data open access?

Open data aims to increase trust in scholarly works by improving transparency and enabling research findings to be tested and reproduced. It can also lead to new research because the data can be used to inform new studies and prevent wasted effort by reducing duplication. Finally, research data is citable, so you can receive credit for the work put into creating it.

How do I find out what the publisher requires?

You will need to read the author information pages for your chosen journal. Springer Nature, Taylor & Francis and Wiley have examples of the different data requirements covered by their journals. These range from encouraging data deposits to mandating them as a condition of manuscript submission.

Where should I deposit my data?

You should check to see whether your chosen journal (or funder) specifies a particular repository. Most recommend disciplinary repositories recognised by those academic communities, and where these aren’t available, a generalist repository. You can search for repositories by discipline using the Registry of Research Data Repositories (re3data). Some repositories charge for data submission, so you’ll need to take this into account if applying for funding.

Can I deposit data in BU’s data repository, BORDaR?

Yes! There isn’t a charge, but you do need to check what the journal requirements are first. Even when data is published in an external repository, it’s required that a record is created in BORDaR linking to the data. That way your data will be visible to anyone browsing the repository. If you’ve had data published in an external repository, please let the library team know via the email below.

Where do I go for help and advice?

Visit the Library’s Research Data Management guide or email bordar@bournemouth.ac.uk.

 

Dan Bailyes

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

Research data: new dataset available

Prof. Mike Silk recently published his research data on ReShare, the UK Data Service’s research data repository, for his ESRC funded project Sex work in the context of sports mega events: Examining the impacts of Rio 2016. 

Many funders and journals require the data supporting research publications to be deposited for long-term preservation because of its value to future research. Here’s what Prof. Silk had to say:  

What’s most exciting/important about your research?  

Probably centring marginalisation / inequality and ensuring visibility / voice for those who are often excluded and/or peripheral to the juggernaut of mega-events (involving as it does securitisation, sterilisation of communities, event-led urban renewal that is often a guise for further marginalisation).  

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

The data being available means their voices live on past the event itself. Given this particular dataset is the first of its kind, having this data available will hopefully be a useful comparator for those addressing such issues at future events (e.g., Tokyo 2020 / Paris 2024). 

Any advice you would give to anyone about managing their data effectively for successful deposit? 

Most important thing for me was ensuring familiarity with the UK Data Service’s ‘Plan to Share’resource … essential to writing the bid and thereby study design. It meant data could be collected in a particular format that made it easy to deposit, as opposed to having to re-work the data at the conclusion of the project (once funding has run out!) to make it ‘shareable’! Going through this resource in advance of bid submission invariably strengthens the quality of the actual bid.  

The dataset is available on request via this link: 

https://doi.org/10.5255/UKDA-SN-853702 

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, BU’s research data repository. Visit our research data management guide or email us at bordar@bournemouth.ac.uk. 

NIHR virtual event – Equality, diversity and inclusion in applied health and social care research

The NIHR Research Design Service South East is hosting an event to discuss and explore what is meant by equality, diversity and inclusion in research and the importance of thinking about it when planning your health or social care research project.

Professor Kamlesh Khunti, Director of the NIHR Applied Research Collaborations East Midlands and Centre for BME Health, will talk about his recent research on COVID-19 in ethnic minority populations. Dr Esther Mukuka will talk about her new role as the Head of Equality, Diversity and Inclusion at the NIHR, and the increasing emphasis being put on those that apply for any NIHR funding to demonstrate their commitment to equality, diversity and inclusion and a healthy research culture more generally.

The presentations will be followed by informal workshops to look at different case studies demonstrating the application of equality, diversity and inclusion principles in research.

The event is open to anyone with an interest in applied health and social care research.

Sign up online

https://www.nihr.ac.uk/events/equality-diversity-and-inclusion-in-applied-health-and-social-care-research/27216?utm_source=newsletter-fs&utm_medium=email&utm_campaign=fs-2021-04

Health Research Authority UPDATE: undergraduate and master’s research projects

Please see below for a further update from the HRA on Master’s and undergraduate research. Any queries or concerns please email Suzy Wignall, Clinical Governance Advisor.

Update on student research – new eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.
The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 we paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, we are introducing new eligibility criteria for standalone student research.


New critera

The new criteria mean that some Master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged.

Full details are in table one – permitted student research table. We’ve also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator?


Alternative ways of learning about health and social care research

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of our event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read our website for further information and ideas: https://www.hra.nhs.uk/student-research/.


Queries

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Clinical Governance RKEDF sessions

As part of the RKEDF Academics and Researchers can book onto the following sessions, either as a one-to-one meeting or a bespoke team session:

Please contact Suzy Wignall, Clinical Governance Advisor if you are interested in any of these sessions.

NIHR RDS Researcher Roadshow – health and social care datasets

 

 

 

NIHR Research Design Service are pleased to offer the opportunity to attend the next in its series of ‘Researcher Road Shows’ – Using health and social care datasets in research: Practical advice to support your research journey. 

This event is taking place via Zoom and is aimed at all those seeking practical guidance on how to find, access and gain approvals to use health datasets, including early career researchers:

Monday 15 March, 10am to 2.30pm: ‘Lifting the Lid on Data – Meet the Data Custodians’

  • HQIP Datasets & top tips for accessing (Yvonne Silove)
  • NHS Digital Datasets & top tips for accessing (Garry Coleman)
  • Morning event close and details of this afternoon (Martin Williams)
  • GP Data (Kathryn Salt)
  • COVID-19 Data (Richard Irvine)

Wednesday 17 March, 10am to 2.30pm: ‘Navigating the system’

  • Research Approvals for Data-Driven Research (Alex Bailey)
  • Introducing the Innovation Gateway – the journey so far (Paola Quattroni & Peggy Barthes-Streit)
  • Recent Changes in Health Data Governance (Alex Bailey)
  • Innovation Gateway working session: from data discovery to access (Susheel Varma)

Find out more.

Your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU)

We can help with your application. We advise on all aspects of developing an application and can review application drafts as well as put them to a mock funding panel (run by RDS South West) known as Project Review Committee, which is a fantastic opportunity for researchers to obtain a critical review of a proposed grant application before this is sent to a funding body.

Contact us as early as possible to benefit fully from the advice

Feel free to call us on 01202 961939 or send us an email.

NIHR issues final update on implementation of the Restart Framework

The NIHR published a Framework on 21 May 2020 – when the NHS started to restore routine clinical services – to support the restarting of research paused due to COVID-19. Developed in partnership with multiple stakeholders and the devolved nations, the Framework provides a flexible structure for local decision-making.

You can read the latest and final update here.