Participant Information Sheet

The participant information sheet (PIS) should contain easy to understand details about how researchers will process participant data. The Health Research Authority offers guidance on the wording researchers should use to satisfy the requirements of GDPR in participant information sheets. However, researchers should be aware that individual sponsors and data providers may have additional requirements for what information must be included in the PIS. In general, participants should be provided with the following information regarding how their health systems data will be used and processed:

• Data source
• National Records for Scotland, NHS England, Office for National Statistics, etc
• Type of data collected
• Hospitalisations, diagnoses, procedures, medications, etc
• Identifiers sent to data holders to enable data linkage, eg NHS (CHI) number, postcode
• Commencement and duration of data collection
• Participants should be made aware of whether researchers will process any data collected before the start of the trial and/ or if there will be long-term follow-up.
• Need to collect personal data
• Explain to participants the purpose of collecting these data. How will these data help to answer the research question? How do health systems data differ from data collected from participants during the trial?
• Protection of data
• What safeguards are in place to protect confidentiality? Who will be able to access and/ or process the data? Will the data be re-used for other purposes, such as further research or onward data sharing with external partners or other researchers? If so, what additional safeguarding measures are in place to protect confidentiality? Will organisations from outside the UK have access to the data?
• Storage of data
• Inform participants where their data will be stored and for how long. Who will be able to access archived data? How will the data be destroyed when no longer needed?
• Lawful basis for processing
• Inform participants of the lawful basis for processing under GDPR, for example, a task in the public interest, or if they will be asked to explicitly consent to data processing. What does this mean for participants? What happens to the data if they withdraw their consent during the trial? Will you process data without explicit consent from participants? How will you inform participants of this?

If the information above is not provided in the PIS, it should be easily available, eg on an institutional webpage.

Where data flows are complex, researchers might consider using images or video to explain how they will process trial data (see multimedia consent). Similarly, the involvement of patients and patient advocacy groups can ensure that explanations of data processing are clear and easy to understand by the target trial population.

Suggestions from our Patient Advisory Group

Conveying information

• Graphics, charts, and diagrams can be useful tools to explain important trial information, eg how HSD is kept safe and how the law protects these data.
  
  

  Adding short videos or visuals would really help people understand how their data is used and kept safe.
  
  

  A picture speaks to a lot more people than text… you can have both.

• Keep materials clear and concise, ie data are collected in X way and Y legal conditions must be met to allow this collection.
  
  

  If you don’t understand, as a researcher yourself, what is the law/ GDPR, how do you expect us [participants]
  to understand it?

• Keep documents simple and provide more complex information in separate, additional documents. This allows participants to choose the level of detail they wish to engage with (see multimedia consent).

Lack of trust and lack of transparency

• PAG members expressed concern around what happens with their data outside the study and relayed a lack of trust that data won’t be misused.

A lot of people are concerned about their information being sold.

You are really scared what they [trials] will do to your data.

• Members suggested explicitly stating what will not happen to data in participant-facing materials, eg ‘We will not sell your data to commercial organisations.’
  
  

Saying what you don’t do [with the data] is probably easier than saying what you do… there are four or five popular myths about what happens to your data.

Lack of trust on the data is a concern that hasn’t been properly addressed… we don’t trust what is happening to our data.