Patient information sheets (PIS) are a key tool in ensuring that patients are able to give informed consent before participating in a trial. MRC CTU at UCL has developed guidance and a template for writing a PIS for adult trials. The guidance and template use research evidence to ensure that the PIS is clear and easy to understand.
The MRC CTU is making these resources freely available to anyone with an interest in improving the quality of PIS. They have been developed by researchers and patient representatives who work with MRC CTU at UCL. They are based on work by Peter Knapp and colleagues.
The template is a Word document, which can be adapted for any trial or other type of study involving adults. It is not appropriate for studies involving children. It has a structure and format that has been designed to be both informative and easy to read, and meets all the criteria needed for ethics approval. It suggests standard wording, with appropriate "blanks" to be filled in that relate to the specifics of the trial or study involved.
The accompanying guidance includes advice about writing in plain English, formatting and layout guidance. There are real-world examples from two MRC CTU at UCL patient information sheets that have received ethical approval using this format, Add-Aspirin and SHINE.
We already have some ideas for further developments of PIS in the future, but we look forward to getting feedback from users of this current template to better inform future improvements.
To receive a copy of the template and guidance please visit the PPI Resources page