Regulations now require that federally-sponsored research projects contain a concise and focused presentation of the key information that is most likely to help potential subjects understand why they might or might not want to participate in the study. The key information must be presented first and must include the following:
- Identification of the project as a research study and that participation is voluntary
- Purpose of the research, duration of participation, and a description of research procedures
- Foreseeable risks or discomforts, if any
- Expected benefits to subjects or others, if any
- Alternative procedures or treatments that might benefit the subject (Note: applies primarily to clinical research)
The text must be organized and presented in a way that does not merely provide lists of isolated facts. The written language should be at the 8th grade reading level and in the native language. Advice for revising the reading level of your texts can be found at the Plain Language site by the US Government.