The Participant Information Quality Standards will be applied UK-wide by research ethics staff who will check if the participant information is compliant when a research application is validated for the research ethics review. Their findings will be included as part of the outcome of the ethics review meeting which is undertaken by the Research Ethics Committee.
1. All acronyms and abbreviations are explained the first time they are used.
2. British English is used throughout.
3. The information starts with a summary of the study specific details, including:
- an invitation to participate and an explanation on why the individual has been invited to take part
- what the study is about and its aims?
- who has been invited to participate and why?
- what the participation will involve?
- How long participation will last?
- When, where, and how many times will each study activity be carried out?
- potential risks and benefits of participation
- an explanation that people invited do not have to take part, have the right to withdraw at a later date, including details about how to withdraw
4. The HRA UK General Data Protection Regulation (GDPR) transparency templates or an approved sponsor-specific UK GDPR statement is used. Generic approval to use a sponsor-specific template has been obtained after the applicant has explained how they used public involvement to develop their UK GDPR statement, and how it complies with UK GDPR transparency requirements.
5. Contact details for:
- someone who can provide more information and discuss the information provided
- complaints or concerns
- a contact point for the duration of participation
At least one of these contacts must be able to point people directly to the sponsor’s Data Protection Officer.
The contact details may include placeholders for localised information to be added after approval.
6. The sponsor has its own specific participant information template text (for use over multiple similar studies), which has been incorporated within the participant information material. Information is provided in the Integrated Research Application System (IRAS) application form to explain and justify both similarities and differences between the current presented project and those which have previously been approved using the same template participant information text.
7. Captions or alt-text are and other appropriate accessible alternatives are used for images or graphics.
8. Where a video has been proposed, a transcript has been provided with the application. All videos should be subtitled.
9. In the IRAS application, it should be clear that people with relevant experience as patients, family members, carers or members of the public were involved in the development of the participant information. It should describe:
- who was involved
- how many people were involved
- how the feedback from public contributors was used to develop the information, including any sponsor-specific template text, and what changed because of the feedback