The webinar panel  

• Medical Research Council - Alex Bailey
• University of Edinburgh - Elizabeth Lemmon
• University of Leeds - Paul Affleck
• use MY data - Pete Wheatstone, Advisory Group Member

The panel chair was Chris Carrigan, Expert Data Adviser to use MY data.

The webinar can be watched by clicking the video box to the right and the slides are available below:

• Alex Bailey slides
• Elizabeth Lemmon slides
• Paul Affleck slides
• Pete Wheatstone did not use slides

Dr Alex Bailey, Programme Manager, Medical Research Council Regulatory Support Centre

• Health data in the UK is very heavily regulated. Researchers need a minimum of 2 approvals - research approvals & approval for the data itself.
• Alex highlighted the types of approval, the depths and complexity of the process and the differences across the four nations.
• "Getting access to data isn't easy.  The best case scenario for a researcher is 2 research approvals and 1 data approval; the worst case is 5 or 6 research approvals and 5 or 6 data approvals" 
• What researchers do with the data/results when the research has finished shouldn’t be an afterthought – they need to think about this at the start. 
• "It's a heavily regulated environment...it's not just a free for all for data"

Dr Elizabeth Lemmon, Research Fellow, Edinburgh Health Economics, University of Edinburgh

• As a researcher, Elizabeth is “passionate about the use of routine data, including patient data, to improve outcomes for service users”
• Gave an overview of how to access NHS data in Scotland – there is one point of contact for researchers to go through, with one research coordinator. This system has been in place since 2015 and has made the process much more streamlined.
• She showed how complex her own journey is to accessing patient data; challenges include timing, preparation and approval.
• She noted that ‘including the patient voice in my research’ began after attending a use MY data workshop and grew from there
• Elizabeth started the eCRUSAders website, which includes a ‘people make data’ section. https://ecrusad.co.uk/
• Elizabeth is working to promote the inclusion of the patient/public voice among early career researchers in Scotland.

Paul Affleck, UK Colorectal Cancer Intelligence Hub Programme Manager, Independent Specialist Ethics Member of the Independent Group Advising on the Release of Data (IGARD) and Lay Member of the Ministry of Defence Research Ethics Committee (MODREC), University of Leeds

• There are significant advantages of having a highly regulated environment – it brings control – but it can also bring delays.
• In his overview of a research journey, he noted that “Patients can make a difference at every step of the research journey”
• It is really challenging, but an absolute requirement, for data-applicants to be clear on the legal basis for their research, the purpose of the research, and who will benefit.
• Data providers are in a challenging position, with competing demands for maintaining public confidence, safeguarding confidentiality and enabling research.

Pete Wheatstone, Advisory Group Member, use MY data

• Patient input is valuable – but how, where and when could they help more?
• Pete highlighted that patients should be involved from the outset, defining the research questions - “patients may not be able to provide the answers, but they can provide the questions”
• Do you make available to the public a data release register? Is it clear where the register is – if it’s not findable by a member of the public, it might as well not exist.
• “Public trust only comes through transparency and information that is provided in a manner that is accessible…”
• Pete ran through a series of questions researchers can ask, to ensure patient engagement.
• His questions for researchers:

1. 1. Do you exclusively focus on lived experience of the disease in question when recruiting PPI?
   2. Or do you also look for skills and additional experiences beyond that lived experience?
   3. Do you have patient co-applicants who are able to co-present to the local Research Ethics Committee (REC)?

• And for those institutions that hold the data:

1. 1. Do you have effective PPI embedded within your data access processes and assessment. Did you have patients involved in defining that process?
   2. Do you publish the Terms of Reference of your data access committee or equivalent?
   3. Do you publish the names of those on the committee? Beyond the ‘domain’ usual experts and Sir Humphrey Bufton types. Do you have at least two patients and members of the public on the committee who are able to articulate the views of the person on the street?
   4. Do you have policies relating to both membership of the panel and data release policies that take account of inclusion, diversity and equality?
   5. Do you make available to the public a data release register that members of the public can understand? And you do make it very clear where that document can be accessed?
   6. And what about audit control? Simply being told everything is OK by someone who the public has never heard of simply doesn’t cut the mustard anymore. Do you publish plain English versions of audit reports?
   7. Do you ensure that lay summaries are made available reviewed by patients? Do you demonstrate within those summaries the benefits of sharing data?

Summary and close

Highlighting the key points which had arisen during the webinar, Chris brought it to a close and informed delegates that the webinar would result in a Call to Action to be developed and publicised after the webinar.

"...the media message [about 'slurping up data' and giving it to commercial bodies] contrasts quite starkly with the reality of how difficult it is for somebody to get access to data"

Follow up actions from our Members

Following the webinar one of our Members, David Snelson, wrote to his MP, highlighting hos disappointment about the difficultly of data access for researchers.  He pointed out his own rare disease status and that devolved data sets subject to different access rules don’t help research into rare diseases. 

His MP wrote to the relevant Minister of State and David received this reply from the Lord Bethel, Parliamentary Under Secretary of State for Innovation.

Full list of questions from the delegates

The following is the full list of questions which were raised by delegates in the Q&A function.  Only a few of these could be answered during the webinar.  They are shown below in the format in which they were posted:

• What happens to data if patient dies?
• Can HDR-UK help with the process - in bringing data  together do the various permissions still apply?
• Fascinating hearing Alex's presentation showing the complexity of accessing data. Is there any way to streamline the process? Can the data providers etc set up standard processes to increase access?
• Is there one overarching body that we could take test cases demonstrating the complexity/cost/time delay etc. created by the various controls and ask the simple question: is this really what you want to see happening in the field of research?
• I imagine a researcher looking at a rare disease would want a large data set. An individual country (e.g. Scotland) might provide a sub optimal data set. How do do we enable researchers to get UK wide data?
• Simple question - do researchers have to navigate this approval system single handed, or is there any support available for them?
• It was great working with Elizabeth and the team on the Scottish dataset publication. I find it crazy that the setup for the dataset will have to be destroyed rather than it becoming the standard data repository. How can this be changed?
• We need to emphasise public benefit vs personal privacy. It isn't simply benefit vs privacy; it's the needs of the many outweighing (or not) the needs of the one or the few.
• Would it be useful and feasible for a blank CRF to be attached to Participant Information Sheets so that participants will know which of their data is used? Could this increase participation?
• If Scotland becomes independent, would that mean the data would be limited to England Wales and Northern Ireland
• Can I download the talks afterwards? I would have liked to take some notes
• From 6 May, President Biden authorised vaccination from (pay), chain like Walmart, Walgreens, Safeway, Stop & Shop, what do you think, please, in terms of data privacy and passport vaccination? (reference: https://www.nytimes.com/2021/05/06/health/pharmacy-walkin-virus.html)
• Is there a mechanism for coordinating data projects/applications so that researchers looking to kick off similar projects or access the same data are encouraged to work together?
• Is the upsurge in scamming and ransomware etc. making the relaxation/simplification of processes less likely?
• Could we have more examples of what the patient voice has done?
• Pete is right that some consent forms require sharing of data with other research institutions, but it is far from universal. It depends on the purpose of the trial, the institution running it, and of course on whether or not knowledgeable patient advocates have helped write the consent form (which is not the same as proof-reading the patient information sheet, which is what many patient advocates do). It also depends on whether or not the lay reps on the ethics committee are watching these things, and until the HRA decides to have some common standards across RECs, then that won't happen.  So many things still to do....
• Pete - you have just given the Researchers etc a wonderful "Do you / have you..?" shopping list of questions: could you put that in writing and share that with us?
• How do you define ‘for the public benefit’?
• I think it would be possible for researchers to map out timelines for specific projects, from application to data delivery. It might be more difficult to estimate costs.
• Is Pete proposing that his questions become part of use MY data's campaigning? Could they be put on the website for all patient advocates and uMd members to use?
• As mentioned before research is often not seen as a priority for data providers (they are focused on delivering NHS services) and analysts and are not properly trained/resourced leading to delays in producing the data. How can we expand and improve the workforce to support research?
• it needs to start with HCPs not being condescending towards patients when it comes to their health data and information. The fact that I do not get told the results of a blood test unless I ask for it or something is wrong is an example.
• Could we explain to devolved administrations that developing their own policies is not so much data protection as data isolation - which doesn't really help anyone?
• If people opt out of sharing their NHS data then they should opt out of NHS treatment. It's a moral issue.
• Thank you all, very interesting webinar!

Thank you

use MY data would like to thank all the delegates and speakers for their time and contributions.  Thank you to Trish Gray for the title graphic.