Most participant information sheets are written to satisfy a reviewer, a regulator, or a legal team, and it shows. They are accurate, thorough, and often nearly impossible for the person they're actually meant for to read in one sitting. A document that ticks every compliance box but leaves participants confused has not done its job.
The gap is bigger than most teams assume
The recommended reading level for patient information is grade 6, roughly the level expected of an 11 to 12 year old, on the reasoning that clear information should be accessible regardless of a participant's education level. A 2016 study analysing 522 real information sheets from the UK's National Institute for Health Research Clinical Research Network found the mean reading level actually achieved was grade 9.8, closer to 15 or 16 years old, nearly four grade levels above the recommendation. The same study found information sheets had grown longer over time, and that increasing length tracked with an increasing focus on legal content rather than participant understanding. Complexity itself didn't hurt recruitment numbers directly, which is arguably the more uncomfortable finding: a hard-to-read sheet doesn't necessarily stop someone signing up, it just makes it less likely they understood what they signed up for.
A structured approach to writing an effective information sheet
Section 1: What is this study about?
Start with a plain-language summary of the research, what question it is trying to answer and why it matters. Two or three sentences is usually enough. Avoid jargon, acronyms, and technical framing. If someone reads only this section, they should have a clear sense of what the study is for.
Section 2: What will taking part involve?
This is the section most participants want to find first. Describe exactly what they will be asked to do, in what order, and how much time it will take. Use concrete, specific language: "you'll fill in a short questionnaire once a week for six weeks" is clearer than "periodic data collection will occur throughout the study period."
Section 3: What are the risks and benefits?
Be honest about both sides. Describe any risks — physical, emotional, time-related — plainly. Describe the benefits proportionately: direct benefits to the participant if any, contribution to the research field if not. Overstating benefits or understating risks is one of the things reviewers look for, and one of the things that erodes trust.
Section 4: How will my data be used and protected?
Explain what data will be collected, how it will be stored, who will have access, whether it will be identifiable, and how long it will be kept. "Your data will be stored securely" is not sufficient. Participants deserve and expect a specific answer.
Section 5: Can I change my mind?
Describe withdrawal clearly and, critically, in a way that makes it feel genuinely safe and low-friction. Name the process, confirm no reason is required, and state explicitly that choosing to withdraw will not affect any care or relationship the participant has with the organising institution.
Section 6: Who do I contact if I have questions?
Provide a named person, a real email address or phone number, and a description of what that person can help with. An anonymous "info@" address does not build the same confidence as a named contact who has a role in the study.
Before submitting your information sheet, hand it to someone outside the research team, ideally someone who reflects your participant group, and ask them to read it and explain back what they understood. The gaps that surface in that conversation are exactly the gaps a participant would otherwise have faced alone. If they're confused, revise before you submit.
The reader is the point
Before drafting anything, picture the actual person who will read this: someone with no background in research, possibly anxious, possibly short on time, deciding whether to take part in something that affects them. Write for that person first, and fit the regulatory requirements around their understanding, rather than the other way round. A document that leaves participants genuinely informed has done something valuable — one that merely satisfies a checklist, and quietly sits four grade levels above where it should, has not.
