One of the most important parts of any research study isn’t the protocol, data collection plan, or statistical analysis—it’s the information participants receive. Whether you’re creating an informed consent form, recruitment flyer, survey instructions, or follow-up communications, your study materials should be written with the participant in mind.
Clear, participant-friendly study materials help individuals make informed decisions about participating in research, improve comprehension, and support ethical research practices. They can also reduce questions during enrollment and help ensure participants understand what is expected of them throughout the study.
Here’s why readability matters and how researchers can create study materials that are both informative and easy to understand.
Why Readability Is Important
Research participants come from a wide variety of educational, cultural, and professional backgrounds. While some may be familiar with medical or research terminology, many are not.
If study materials are overly technical or difficult to read, participants may:
- Misunderstand the purpose of the study.
- Be unclear about the procedures involved.
- Misinterpret potential risks or benefits.
- Feel overwhelmed or discouraged from participating.
The goal is not to “simplify” the research—it is to communicate it in a way that participants can easily understand so they can make an informed decision.
This is especially important during the informed consent process, where participants should fully understand what they are agreeing to before choosing whether to participate.
Consider Health Literacy
Health literacy refers to a person’s ability to obtain, process, and understand health information needed to make informed decisions.
Not every participant has the same level of health literacy, and researchers should avoid assuming that everyone understands medical terminology or research concepts.
When preparing study materials:
- Use plain language whenever possible.
- Define necessary medical or scientific terms.
- Break complex ideas into smaller, easy-to-follow sections.
- Use headings and bullet points to improve readability.
Many organizations recommend aiming for approximately an 8th-grade reading level for participant-facing materials whenever possible. While this may not be achievable for every study, keeping language as clear and concise as possible helps ensure information is accessible to a broader audience.
Avoid Research and Medical Jargon
Researchers use specialized terminology every day, making it easy to forget that participants may never have encountered these terms before.
For example, instead of writing:
“Participants will undergo venipuncture for biomarker analysis.”
Consider:
“A small blood sample will be collected from a vein in your arm to help researchers measure certain substances in your blood.”
Similarly, instead of saying:
- Randomization
- Adverse event
- Placebo
- Longitudinal assessment
- Investigator
Consider explaining these concepts in everyday language or providing a brief definition the first time they appear.
Participants should never have to search online to understand your study materials.
Organize Information Clearly
Even well-written content can be difficult to follow if it isn’t organized effectively.
Participant-facing documents should have a logical flow that answers the questions participants are most likely to ask, including:
- Why is this study being conducted?
- Why was I invited?
- What will I be asked to do?
- How long will participation take?
- Are there any risks?
- Are there any benefits?
- Will my information be kept confidential?
- Who should I contact if I have questions?
Using descriptive headings, short paragraphs, and bullet points can make documents much easier to navigate.
Review Materials from a Participant’s Perspective
Before submitting study materials to the IRB, take a step back and read them as though you’ve never heard of the study before.
Ask yourself:
- Would someone outside my field understand this?
- Are technical terms explained?
- Are instructions clear?
- Is the document longer than it needs to be?
- Does the participant know exactly what to expect?
Having someone outside the research team review participant-facing materials can also be valuable. A fresh perspective often identifies confusing wording or assumptions that the study team may overlook.
The IRB’s Role
As part of the review process, the IRB evaluates participant-facing materials to help ensure they are clear, accurate, and not misleading.
This includes reviewing:
- Informed consent forms
- Recruitment materials
- Surveys and questionnaires
- Participant instructions
- Emails, text messages, and other participant communications
The IRB may recommend revisions to improve readability, clarify procedures, or ensure that information is presented in a balanced and understandable manner. These changes are intended to support informed decision-making and protect research participants.
At Solutions IRB, this review is strengthened by the inclusion of non-scientist board members on our IRB. These individuals provide the perspective of the general public and help evaluate whether study materials are understandable to someone without a scientific or medical background. While researchers may be accustomed to technical terminology, non-scientist members can identify language or concepts that may be confusing to the average participant. Their feedback helps ensure that informed consent forms and other participant-facing materials communicate study information in a clear, accessible way, allowing potential participants to make truly informed decisions about whether to take part in the research.
This diverse perspective is an important component of ethical IRB review and helps reinforce the principle that research participants should receive information they can readily understand—not just information that is scientifically accurate.
Final Thoughts
Writing participant-friendly study materials is about more than meeting a regulatory requirement—it’s about respecting the people who make research possible.
When participants can easily understand what a study involves, they are better equipped to make informed decisions about participation and are more likely to have a positive research experience.
At Solutions IRB, we review participant-facing materials with clarity and participant protection in mind. Clear communication supports ethical research, strengthens informed consent, and helps researchers build trust with the individuals who volunteer to advance science.
By taking the time to write materials that are readable, accessible, and free of unnecessary jargon, researchers can improve both the participant experience and the overall quality of their study.