Researchers must provide a patient information leaflet to everyone they invite to take part in a research study, to ensure people can make an informed decision about this. The leaflet explains what taking part will involve and should include details about:
• why the research is being done, how long it will last, and what methods will be used
• the possible risks and benefits
• what taking part will practically involve, for example extra visits to a hospital or a researcher coming to interview someone at home
• what interventions are being tested, or what topics an interview will cover
• how the researchers will keep participants’ information confidential
• what compensation is available to people if they are harmed as a result of taking part in the research
• who to contact for further information
• how the results will be shared with others.
