Institutional Review Board: Communicating with Participants in Plain Language
The MDH IRB expects all participant communication materials to follow plain language best practices. This section provides information and tools to help investigators apply plain language principles. If materials submitted to the MDH IRB for review are not in plain language, the reviewer may require revisions that will delay the approval process.
What is plain language?
Plain language is defined as communication your audience can understand the first time they read or hear it. Written material is in plain language if your audience can:
- Find what they need;
- Understand what they find; and
- Use what they find to meet their needs.
Plain language is about communicating well, not “dumbing down” or “talking down." It consists of a range of strategies that keep the readers’ needs in the forefront.
How does plain language relate to human subjects protections?
Obtaining informed consent from human participants is essential for the conduct of ethical research. If potential participants cannot understand information and/or use it to make independent decisions about participation, they are not “informed”. All written and oral communications, both before and after study enrollment takes place, should be in plain language. Providing clear communication is one of many ways that researchers can foster trust, understanding and dialogue with potential participants and the communities from which they are selected.
Plain language principles
- PRISM Readability Toolkit, pages 7-9 (PDF)
Explains four major principles of plain language and several strategies that support these principles.
- NIH Plain Language: “Getting Started or Brushing Up” (PDF)
Includes five brief sections and a checklist.
Plain language “Before and After” examples
- CDC Everyday Words for PH Communication (PDF)
Offers many examples of how to re-write sentences containing health-related jargon into plain language.
- PRISM Readability Toolkit, Appendix C, pages 59-67 (PDF)
“Before-and-after” examples 1 through 4 are from participant invitation materials; examples 5 through 9 are from informed consent forms.
- Center for Plain Language, Consent for Coronary Angiography (Example 14 of 22) (PDF)
Shows how a consent for medical treatment form was re-written in plain language.
Informed consent forms must be in a language understandable to the potential participant or their legally authorized representative. This means at a level compatible with their reading comprehension. A common problem is that informed consent forms are written at a reading level several grades higher than the average person can understand. As a result, they fail to achieve their intended purpose.
For materials intended for the adult general population, aim for a 6th to 8th grade reading level. Best practices in health literacy recommend a 6th grade level or lower. The Flesch-Kincaid readability tool in Microsoft Word scores documents based on high school grade level. We recommend placing the grade level score in the header of each participant communications document you submit for IRB review.
Readability software does not take all plain language components into account, such as overall organization and formatting. The scores are only based on the average number of syllables per word and words per sentence. Even these factors do not always correspond to how easy it is to read a sentence. To ensure that your materials are truly understandable, meaningful, and easy to read, ask others who are unfamiliar with the research study to read and edit the document. Pre-test your materials with a sample group from your intended audience.
Be aware that readability software may inflate the grade level score due to specific elements in your document that are unrelated to plain language (e.g., insertion of a table, absence of a period at the end of a bulleted item). In this case, calculate the reading level without these problematic elements.
Plain Language Checklist
Prior to IRB submission, please review participant materials using the following plain language checklist. It is compiled from the sources noted above as well as CDC’s “Simply Put: A guide for creating easy-to-understand materials” (PDF).
- Is there adequate white space and margins?
- Is information presented in an order that is logical to your audience?
- Does each paragraph have a single theme?
- Is information broken into sections, using clear, meaningful headings and subheadings?
- Do lists include bullets (items equal in importance) or numbers (items in rank order/sequence)?
- Have you eliminated as much jargon and technical language as possible?
- Is necessary technical or scientific language explained using examples, analogies, or visual aids?
- Have you used concrete nouns, an active voice, and short words and sentences?
- Is the style conversational (using pronouns I, you, we)?
- Have you removed information that does not add value to your document?
- Have you tried to anticipate the readers’ concerns and questions and address them?
- Have you checked the reading level using a readability formula?
- Is language age- or culturally-appropriate to meet the needs of special populations?
- Have you pre-tested your materials?
Plain language resources for MDH staff
- Your division may have a communicator’s work group that specializes in communicating information related to your particular research area.
- Your assigned information officer can direct you to resources or staff with expertise to help you.
- Contact the MDH IRB administrator with any specific questions.