The language used in every consent form or script must be understandable to the research participants or their representatives. Commonly, HSRB approval of research is delayed due to inadequate consent forms that have either too much or too little information, are confusing, or are written above the average participant's reading level (the average American adult has an 8th grade reading level). Consent forms should be written for the average participant's level of understanding and avoid technical language or terminology.
Signed consent forms should be retained by the RPI for a period of at least three years after the research is finished. It's possible that consent forms might contain information (e.g., names, phone numbers,locations) that will vary with time or with circumstances of the project. The HSRB Office must be informed in writing of any modifications in consent forms and must approve revisions before new forms are used.