Standardised – The standardised recommended text for this section is provided in the downloadable accessible PIL.
- Mistrust and fear can be a barrier to participation, and it is important that people feel that a clinical trial is safe.
- This section aims to acknowledge these concerns and provide reassurance that clinical trials are robustly regulated and that the safety and wellbeing of participants is a priority.
- Contact details should be provided for an independent organisation, such as the Patient Advice and Liaison Service, that people can contact if they want to report a concern or complaint about the trial.
- The term ‘ethics committee’ is not used as this term will be not familiar to everyone.
Image Guidance
Safety and trust are the important messages to convey with the image in this section, particularly for people who have had negative healthcare experiences.
Interpretation of these concepts may be different between people, so patient and public involvement is particularly important to inform the selection of an image that will be meaningful to your target trial population.
Below we have included a range of different images that were considered by people to represent trust or safety.
A green tick in a circle
A handshake
NHS logo and stethoscope
Smiling healthcare professional