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Informed Consent Overview

For most research, informed consent is documented in writing to provide key information about the research. The consent form should:

  • provide information for the subject's current and future reference, and 
  • document the interaction between the subject and the investigator.

However, even when a signed consent form is used, this alone does not create an adequate consent process. "The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question and answer sessions, community meetings, and videotape presentations. In all circumstances, however, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis." (OHRP FAQs)

Guidance for specific research questions

Consent Writing Tips

Tips are offered to assist investigators to communicate effectively with potential research participants.

Write simply

    • Aim for 8th grade or lower reading level. Microsoft's Word readability tools can provide a general indication of the reading level. The IRB recognizes that 8th-grade level may be difficult to achieve in biomedical research; however, the suggestions below will lower the language level and improve comprehension.
    • Write short, simple, direct statements.
    • Use active verbs.
    • Keep paragraphs short and limited to one idea. Avoid large blocks of printed text.
    • Use a conversational tone. Some research indicates that comprehension is improved with a question-and-answer consent format.
    • Use lay language for medical terms. For example, substitute "high blood pressure" for hypertension; substitute "adjust" for titrate; substitute "measure" for assess.

      Resources / Lists

      Refer to our consent templates

      • When applicable, investigators are encouraged to use the IRB consent templates.
      • If none of the templates seem appropriate for your study, please contact the IRB office. Office staff can help you develop your consent document.
      Research Administration

      University of Kansas
      Medical Center

      Research Administration
      Mailstop 1039
      3901 Rainbow Boulevard
      Kansas City, KS 66160

      OFFICE LOCATION:
      Fairway North, 1000
      4330 Shawnee Mission Pkwy
      Fairway, KS 66205
      Phone: 913-588-1261
      Fax: 866-255-2129