2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. WRITING INFORMED CONSENT DOCUMENTS Part One: Fundamentals Developed by: U-MIC University of Michigan IRB Collaborative

4. Writing consent documents (part one) 3 Developed by: U-MIC informed consent required for adult subjects (unless IRB grants a waiver)  45 CFR 46.116 (HHS)  21 CFR 50 Subpart B (FDA) two components discussions document “The information that is given to the subject or representative shall be in language understandable to the subject or representative.” 45 CFR 46.116 and 21 CFR 50.20

5. Writing consent documents (part one) 4 Developed by: U-MIC Subjects’ literacy skills vary. Use simple, common language. can be difficult with complex research when unfamiliar language is necessary: Define terms and concepts. Gauge subjects’ understanding during discussions.

6. Writing consent documents (part one) 5 Developed by: U-MIC Most adult readers are comfortable reading text at a middle school level. between sixth and eighth grade Microsoft Word readability statistics Flesch-Kincaid Readability formulas estimate reading ease. Formulas cannot predict readers’ comprehension.

7. Writing consent documents (part one) 6 Developed by: U-MIC readable and comprehensible informed consent language accessibility brevity clarity directness

8. Writing consent documents (part one) 7 Developed by: U-MIC accessibility readability familiar vocabulary Avoid specialized terms. Avoid academic terms. comprehensibility Choose details that are essential to the consent process. requires judgment

9. Writing consent documents (part one) 8 Developed by: U-MIC brevity readability short words short sentences short paragraphs comprehensibility short document

10. Writing consent documents (part one) 9 Developed by: U-MIC clarity readability common sentence structure comprehensibility logical organization of content Present procedures chronologically. Define terms and concepts early.

11. Writing consent documents (part one) 10 Developed by: U-MIC directness readability Favor verbs in the active (rather than passive) voice. We will take a blood sample. A blood sample will be taken. Favor affirmative statements. comprehensibility from author to reader We would like you to take part in a study. The researchers are looking for subjects.

12. Writing consent documents (part one) 11 Developed by: U-MIC knowledge of subject population familiar language and simple concepts readability ≠ comprehensibility accessibility brevity clarity directness style guides The Elements of Style (Strunk and White) The Elements of Technical Writing (Bly and Blake) help from IRB office

13. Writing consent documents (part one) 12 Developed by: U-MIC Writing informed consent documents Part One: Fundamentals Part Two: Examples

14. THANK YOU. Brian Seabolt Technical Writer IRBMED 13 Developed by: U-MIC