Who has reviewed the project?
Participants should be told who has provided ethical review, and also whether any patients or members of the public were involved in design of the study or if they will be involved in its management and dissemination.
Who is organizing and funding the study?
Listing funders and partners can help participants to make a decision about whether they want to be involved, based on whether there appear to be any conflicts of interest. If there is a clear conflict, this may need to be explained.
A PIS often contains details of somebody who can be contacted for further information about the study, as well as somebody who is not formally involved in the research but who can provide more balanced advice about participation. There is often also a section providing details about who to contact if somebody is unhappy or has a complaint to make.
In addition to the sections outlined above, a PIS may contain other details tailored to the project. Patient and public involvement (PPI) can be of enormous support in selecting which information is most important to include, in highlighting if there are any questions that remain unanswered once the PIS has been read, and in checking that the PIS is comprehensible even to somebody not involved in the arts, healthcare, or medicine.
The exact length of PIS and the amount of detail needed will vary depending on the study. Repetition should be avoided between sections to minimize length and documents should be well formatted to make them easily readable. A PIS should also always be version-controlled, so there is a date and version number on it. This will ensure that the version that has received ethical approval is the one in circulation.
The UK’s Health Research Authority provides some excellent online guidance on writing a PIS, including advice on how to phrase responses to common questions, details on how to adapt a PIS to different reading levels (such as children versus adults) and checklists of what participants should be informed about: www.hra-decisiontools. org.uk/consent/content-sheet-support.html.