The GDPR and health research

St George’s researchers will already be aware of the EU General Data Protection Regulation (GDPR) and the new UK Data Protection Bill, which will govern how we handle personal data after 25 May 2018. While we have learnt a lot about our obligations under the new regulations, researchers may not be clear about what these obligations mean for research. The SGUL Joint Research and Enterprise Services (JRES), Governance and Legal Assurance Services and the Research Data Management Service have come together to clear up a number of misconceptions about what the new regulations may mean for health and social care research. Read on!

It is not clear how the GDPR relates to health and social care research

GDPR has a broad scope beyond clinical research but does relate to all personal data which includes web search engines, social media, and much more.  Specifically, data required in research (and the way it is managed) would be within its remit. Identifiers such as name, addresses, date of birth, and electronic medical numbers all constitute personal information. However, the GDPR expands the personal data definition to include information such as location information, genetic data and IP addresses. In sum, any data that could potentially be used to directly or indirectly identify a person is considered personal data. In addition, pseudonymised data will now be considered personal data and therefore governed by the GDPR.

We will have to change all of our research processes to meet the requirements of the GDPR

As many, including the Medical Research Council, have already acknowledged, the GDPR reiterates many of the key principles of good research practice when handling personal data. Research, particularly health research, is governed by very strict guidelines and many of the mechanisms currently in place for assuring good practice can provide the safeguards needed to comply with the GDPR, for example, our ethics procedures and data management plans already address many of the requirements for privacy impact assessments and privacy by design. What we need to ensure is that all of our research is included in these processes, not just our funded research.

The GDPR will stifle research innovation

The GDPR ensures that innovation in health research can continue, but with the appropriate safeguards for data subjects. The new Data Protection Bill (which will replace the current Data Protection Act 1998) is currently going through parliament. This will direct the way the GDPR is implemented within the UK and any specific exemptions or “derogations”. It is widely accepted, but yet to be confirmed, that clinical research will have a number of related derogations to ensure that we are able to carry on normally with the business of improving and transforming health.

The research community will not be able to re-use/re-purpose data for future research

We are aware that it is not always possible to know all the ways research data could be processed when we are collecting it. The legislation also recognises this. Article 6(4) allows for further processing of personal data beyond the purposes for which it was collected, as long as those operations are considered ‘compatible’ with the original purpose under which consent was given, for example, medical research.

Further, secondary processing of data not collected for research, can subsequently be used for research, as long as appropriate safeguards are met and the processing is in the public interest. This means we can continue to access health data to better understand and treat health conditions.

I am going to have to re-consent participants every few years if I want to continue to hold their personal data

Consent is not the lawful basis on which our researchers hold and process personal data. As a public authority, we will usually process personal data for health and social care research as a ‘task in the public interest’, as such your participants may not need to be re-consented under the GDPR. However, under GDPR you will need to ensure you have been lawful, fair and transparent about the personal data you have collected and how it is managed. It is important to understand what information has been provided to your participants already and does this meet the GDPR requirements for transparency and accountability. This may require updates to your participant information sheet, or the addition of an information leaflet. The Health Research Authority (HRA) is working on consistent templates and wording to support researchers and sponsors have confirmed, if required, this would be a non-substantial amendment, that is, one not requiring formal ethics approval.

Even though consent is not the legal basis for processing personal data for research, the common law duty of confidentiality is not changing, so consent is still needed for people outside the care team to access and use confidential patient information for research. Therefore, consent continues to be required to meet the high ethical and research governance expectations we place on our researchers.

How can I be fair and transparent?

Being fair and transparent with research participants means respecting their rights and wishes, and ensuring their personal data is used in line with their expectations.  The GDPR requires that the information provided should be concise and easy to understand. If you want to retain information you should state the reason and allow the participant to make that judgement.

Organisations should also display corporate level privacy information about their research in locations where it will be noticed, for example links on website homepages and in waiting rooms. Linking this to your information sheets is a good way of ensuring participants are aware of our institutional role in research.

The JRES is working on updating template documents such as protocol templates and information sheets, to ensure appropriate guidance is provided and considered during the development of our research.

My funder expects me to make my data openly available at the end of my project, the GDPR will prevent me from doing this

The GDPR does not preclude data sharing, it only requires that data is shared responsibly and robustly. This has always been the case with data sharing. The GDPR only covers data that personally identifies a living person. Research that does not involve personal data is not covered under the GDPR and can be shared. The legislation also does not cover data that has been appropriately anonymised according to the ICO’s Anonymisation Code. This is what the ICO calls de-identified data for publication. There are also options to share de-identified data for limited disclosure or access. The ICO Anonymisation Code covers different forms of data publication and the Research Data Management Service is available to discuss your options.

A participant has requested to withdraw from the study but my data has already been anonymised and analysed; I have to start all over

In exceptional circumstances research participants are exempted from erasure if it is “likely to render impossible or seriously impair the achievement of the objectives of that processing” (Article 17(3)(d)). So you can continue to use this data in some circumstances. For data that has already been thoroughly anonymised, the GDPR does not apply.

The responsibility for GDPR compliance falls solely on project teams

The responsibility for compliance is corporate, that is, the organisation is accountable to the ICO, so it is important that researchers do not make decisions about legal compliance alone.

For St George’s University initiated research, we will usually be the data controller. This means we are responsible for outlining what data needs to be collected, why and how it is to be used/managed. For studies we collaborate in (where we are not the lead) we may be the data processor. In this instance, we are being directed on the data requirements and management.

If you are in doubt you should check as this is particularly important if a research participant asks you about their personal data rights.

 

We hope this post has helped you to get better acquainted with how the new legislation will affect our research activities. With regards to health and social care research, the GDPR maintains existing best practice and we should use this opportunity to evaluate our systems and procedures to ensure that we are indeed engaging in good practice.

Queries about the GDPR not covered here can be emailed to dataprotection@sgul.ac.uk.


If you are interested receiving updates from the Library on all things open access, open data and scholarly research communications, you can subscribe to the Library Blog using the Follow button or click here for further posts from us.

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Get a Unique Researcher ID for Free and Help Identify Your Research Outputs

What is ORCID?

ORCID
Image from: https://members.orcid.org/sites/default/files/28-banners.png

ORCID stands for Open Researcher and Contributor ID

  • Creating an ID is free
  • The ORCID registry is maintained by a not for profit organization, funded through organizational membership and subscription fees

Why should I get one?

You can create a unique, persistent identifier which you can use to better identify yourself with your research outputs, such as publications and data sets.

  • It links you together with all your publications, whatever version of your name they are published under. That means if you change your name, or a different variation of it is used (eg middle name or initial), your publications will still be linked to your identity and will be collected in your ORCID record. And, what’s more, you can continue to use the same ID when you change organisations.

 

  • It’s also useful for clarifying which publications aren’t yours but have been published by someone with the same name – especially helpful if there’s someone with a similar name in the same field or the same organization as you.

 

  • It can link to many different types of research outputs, including datasets and software, as well as journal articles, meaning that you can easily get credit for all your published work.

 

  • ORCID integrates with a variety of other systems, such as funder applications and publisher manuscript systems, saving you from having to put the same information over again (see the section Who can see the information? below to find out how this works). Some actually require ORCID IDs, such as the Wellcome Trust’s grant applications system (and here’s some more on why they made that choice).

 

ref
Image from: http://www.ref.ac.uk/

ORCID and REF

HEFCE’s recent REF 2021: Decisions on staff and outputs says “The funding bodies consider that the benefits offered by persistent staff identifiers are significant, in terms of increased efficiency, transparency and interoperability in the research data landscape.” While not mandated for REF 2021, ORCIDs look likely to be required for future funding assessments, and HEFCE “strongly encourage” an ORCID ID to be provided for Category A submitted staff in REF 2021.

ORCID and CRIS

There will be some exciting developments with SGUL’s CRIS later this year when the CRIS is upgraded. If you have an ORCID ID, CRIS will retrieve records from data sources that have the ORCID ID in their metadata (such as Europe PubMed Central, PubMed, Web of Science). Once you have confirmed that the ORCID ID is yours, CRIS will retrieve any future records from those data sources with that ORCID ID in their metadata, and automatically add the records into your publications list.

How do I get an ORCID?

If you haven’t already got one, go to the ORCID website and click “Register now”. You can add your professional information and any other identifiers you might have to your account.

Who can see the information?

  • You control the content in your ORCID, who can see it
  • There are three visibility settings : everyone, trusted parties, or only me. Visibility to items can be set individually. For more information see Visibility settings
  • If you are happy to have the information visible to anyone, you can set visibility to ‘everyone’.
  • This means the profile will be visible via the orcid.org website, and importantly can be searched for via the API, which means the data can be reused.
  • If you want to be able to let the data update across systems that are registered /integrated to use ORCID data, then set it to ’trusted parties’
  • You can register your ORCID record with Research Fish, and this will enable you to add publications in your Research Fish portfolio to your ORCID record (so if it is in Research Fish, it will be included then in ORCID). Also you can use the publications search in Research Fish to fetch publications from ORCID and add them to your Research Fish portfolio.

Useful links:

Building your ORCID record and connecting your iD

ResearcherID & ORCID Integration – how to associate ORCID with ResearcherID

EPMC: How do I link my articles to my ORCID?

 

Jennifer Hughes, Research Publications Assistant

Jennifer Smith, Research Publications Librarian

Contact: openaccess@sgul.ac.uk


If you are interested receiving updates from the Library on all things open access, open data and scholarly research communications, you can subscribe to the Library Blog using the Follow button or click here for further posts from us.

Confused about Creative Commons licences?

Creative Commons licences offer a range of options for licensing your work, allowing you to share your work on your own terms. They’re intended to be straightforward, making it easy for you to control how your work is used and to understand what you can do with other people’s work.

The following graphic explains the different variations available:

CC(Creative Commons licenses explained ©Foter (adapted by Jisc) via Foter blog CC BY-SA)

The most permissive license available is the CC0 license, which allows anyone to copy, publish, modify or adapt the work, or change the license, without requiring that the original work be attributed.

The CC-BY license allows other people to copy, publish, modify or adapt your work, as long as you are credited – this is the license you’ll probably need to publish under if your work is funded and you’re publishing with immediate open access. (There’s more information on the library website about publishing open access and paying the fees for open access publication.)

The CC BY license can also be modified with one or more of the following terms:

  • ND (“No derivatives”): this prevents the work from being modified or adapted without permission from the copyright holder.
  • NC (“Non-commercial”): this prohibits commercial use of the work without permission from the copyright holder.
  • SA (“Share Alike”): means that any new works created using the work must be under the same licence as the original work was.

Making your work open access under licenses such as these benefits the research community by making knowledge accessible to everyone, enabling greater participation in research, and using Creative Commons licenses helps other people understand how they’re allowed to use your work.

To see some examples of what open research is enabling, take a look at SPARC’s website Open In Order To… And if you want to know more about open access at SGUL, email openaccess@sgul.ac.uk or visit our open access webpage.

Jennifer Hughes

Research Publications Assistant


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Open Access: Green and Gold

St George’s researchers: read on to find out how to make research open access, and how to win a £30 Amazon voucher…

There are two different ways to make your research articles open access: the green route and the gold route.

Green Open Access

Green Open Access: What is it?

Green open access means making your research articles freely available via a subject or institutional repository (such as SORA, SGUL’s institutional repository), after any embargo period required by the publisher has passed.

What do I need to do?

When your article is accepted for publication, create a basic record in the CRIS (Current Research Information System for St George’s Researchers) and upload your author’s accepted manuscript to it. . (This is the version after any changes resulting from peer review, but before the publisher’s formatting and copy editing.) We will then check the record and apply any embargo period before making it live in SORA.

For more guidance, please log in to your CRIS profile and click on the Help tab at the top right hand side.

If you have any questions, see our website or contact sora@sgul.ac.uk

 

Gold Open Access

Gold Open Access: What is it?

Gold open access means making your research articles freely available on the publisher’s website when they’re published, usually under a license which allows for reuse.

What do I need to do?

Find out if the journal you’re publishing in has an open access option, and then see if you have any funding available to pay for it.

Some publishers offer discounts or waivers for SGUL researchers: check our page on open access fees to see if any of them apply to you.

If your research is funded:

RCUK and COAF (a partnership of six health research charities) have provided us with funds to make articles arising from that research open access. To find out if you’re eligible, see our website or email openaccess@sgul.ac.uk

If your research is funded by another grant, check with your grants officer to see if there are any funds in it for open access publications.

If your research is unfunded:

Consider applying to our new Institutional Fund for open access publication fees – see the link on our open access webpage.


 

Open Access Week Competition

Win a £30 Amazon voucher: follow our Twitter account @sgullibrary to enter our competition on this year’s OA week theme “Open in order to…”  – tell us why you think ‘Open’ is good. (See our blog post and Terms and Conditions for how to enter).


If you are interested receiving updates from the Library on all things open access, open data and scholarly research communications, you can subscribe to the Library Blog using the Follow button or click here for further posts from us.

Open Access Open Research

SGUL’s open access institutional repository SORA now has over two thousand full text publications written by SGUL researchers freely available online, a great milestone for SGUL to celebrate in International Open Access Week 2017.

On average there are over 1800 downloads of papers per month from SORA, the papers are indexed in SGUL’s Hunter, and in Google for maximum discoverability:

Screenshot of St George's Online Research Archive website

Win a £30 Amazon voucher: follow the library’s Twitter account @sgullibrary to enter our competition on this year’s OA week theme “Open in order to…” – tell us why you think ‘Open’ is good. (See our blog post and Terms and Conditions for how to enter).

Open access publication is a requirement of many of the big funders in biomedical and life sciences research due to its role in making research more accessible, more discoverable and more impactful1.

On the 4th October the Wellcome Trust released a new science strategy, Improving health through the best research. In it, they reaffirm their commitment to open research:

“Scientific knowledge achieves its greatest value when it is readily available to be used by others. And if knowledge generated with Wellcome support can be used for the improvement of health, it should be.”

Open research is an umbrella term bringing together a variety of efforts to make scientific research transparent and reproducible, and to increase its impact on policy, practice and technological advances. Open access publication is an important part of open research, helping to make research outputs accessible and useable by anyone. Another key tenet of open research is open data, and St George’s has recently launched a data repository to enable researchers to share, store and preserve their research content.

Queen’s University, Belfast, has put together some examples of how open access has benefitted their researchers.


For further information, please visit our open access webpage or contact openaccess@sgul.ac.uk.

1 The Open Access Citation Advantage Service, SPARC (Scholarly Publishing and Academic Resources Coalition) Accessed 19 October 2017


If you are interested receiving updates from the Library on all things open access, open data and scholarly research communications, you can subscribe to the Library Blog using the Follow button or click here for further posts from us.

Open in order to…

The theme of this year’s International Open Access Week, which runs from 23rd-29th October, is “Open in order to…”. This year the focus is on thinking about possibilities are opened up by making research outputs open access.

Win a £30 Amazon voucher: follow the library’s Twitter account @sgullibrary to enter our competition on this year’s OA week theme “Open in order to…” – tell us why you think ‘Open’ is good. (For terms and conditions, and how to enter, see the end of this post.)

Open in Order to Open Access banner for 2017

Here are some reasons why research is made “open in order to…”

…improve public health

Breakthroughs in medical science are frequently in the news, but the research publications underpinning the headlines are often locked away behind a publisher’s paywall. For example, the research article referred to in this recent article from the BBC  is currently only available to subscribers to the British Journal of Obstetrics and Gynecology, and many publications cited in the recent award of the Nobel Prizes for Chemistry and Physics are not publicly accessible. By contrast, a recent study by SGUL researchers on meningitis in children was published in an open access journal, meaning that the full article can be read by anyone, anywhere in the world, at any time.

Open access research allows anyone who is interested to read and evaluate the research for themselves. This might include:

  • Medical professionals wanting to improve patient care;
  • Members of the public wanting to learn more about a condition they have;
  • Journalists wanting to report more accurately on the story;
  • Policy makers;
  • Researchers whose institutions don’t subscribe to the journal the research is published in, or who are operating outside an institution.

Opening up research helps improve public health by increasing access to academic research.

 

…raise the visibility of my research

Studies1 have consistently shown a citation advantage for open access publications over closed access ones. Depositing your work in a repository increases the avenues by which your research can be discovered, as well as helping readers to follow your research from paper to paper more easily by collecting them all together.

 

…enable global participation in research

Making research open enables all researchers to access it and removes the financial barrier for those working in less well funded institutions, as well as independent researchers working outside institutions. Making your data and publications accessible for free and licensing it under terms which allow for reuse means that other researchers can pick up on and build on your research, benefitting the global research community as a whole.

 

…find new collaborators

Making your work open helps researchers on related topics find it and identify possibilities for collaboration. Open access can also promote cross-disciplinary working by making it easier for researchers to access work outside their own discipline.

1 The Open Access Citation Advantage Service, SPARC (Scholarly Publishing and Academic Resources Coalition) Accessed 19 October 2017

 

How to enter:

Follow @sgullibrary on Twitter and complete the phrase “Open in order to…” using the hashtag #openinorderto and @sgullibrary’s Twitter handle.

Terms and Conditions:

  1. The competition will run from Monday 23 October 2017 until Sunday 29 October 2017.
  2. The prize draw is open to anyone with a valid SGUL ID.
  3. Winners will be chosen from all valid entries once the competition has closed on Sunday 29 October 2017.
  4. Winners will be contacted via Twitter. Be sure to check your account.
  5. The prize can only be collected in person from St George’s Library on production of a valid ID card.
  6. Prizes must be collected within two weeks of notification.
  7. The Judges’ decision is final and no correspondence will be entered in to.
  8. Photos of the prize winners will be taken to be used in publicity on Library media channels.
  9. One prize winner will be selected, unless the prize is not collected by the deadline, in which case the uncollected prize will be reselected (once only).
  10. Your tweets may be reused by St George’s Library for future promotional or informational purposes.
  11. Entries must contain the hashtag #openinorderto and must tag the library’s Twitter account @sgullibrary.

 


To find out more about open access, contact openaccess@sgul.ac.uk or visit the Library open access webpages.


If you are interested receiving updates from the Library on all things open access, open data and scholarly research communications, you can subscribe to the Library Blog using the Follow button or click here for further posts from us.

How to find Open Access articles

There are various tools to help you find open access versions of articles that are otherwise only available with a subscription to the journal (or by paying an access fee). These include:

  • OA DOI (https://oadoi.org/): If you know the DOI (digital object identifier) of the article you’re looking for, you can paste it onto the end of this web address to find open access versions of the article.
  • Unpaywall (http://unpaywall.org/): This is a browser extension for Firefox and Google Chrome. Once you’ve installed it, any time you find an article behind a paywall, you can click on the padlock icon on the right hand side of the screen and be taken straight to an open access version of the article, if there’s one available.
  • Open Access Button (https://openaccessbutton.org/): a similar tool to Unpaywall, this also allows you to search for an article directly from their website and request copies of articles from authors.
  • Canary Haz (http://www.canaryhaz.com/): a new tool, currently being tested, which as well as finding open access versions of articles can also help access content the library has subscribed to whilst off campus, and link from the pre-print to the final published version of an article. Sign up required for free service, company will be making a premium version available.

For more information on Open Access have a look at the Library Open Access FAQs


If you are interested receiving updates from the Library on all things open access, open data and scholarly research communications, you can subscribe to the Library Blog using the Follow button or click here for further posts from us.