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. SPECIALTY INFORMED CONSENT TEMPLATES One-time blood or tissue sample Eligibility screening Developed by: U-MIC University of Michigan IRB Collaborative

4. Specialty consent templates informed consent templates standard informed consent template  twelve sections  prompts for o federally required elements o other elements  designed for general use specialty templates  tailored to specific study situations  help develop consent documents that reflect the study 3 Developed by: U-MIC

5. specialty informed consent templates one-time blood or tissue sample eligibility screening Humanitarian Use Devices no section headings prepared text replace brackets with study-specific details Specialty consent templates 4 Developed by: U-MIC NEW

6. Specialty consent templates one-time blood or tissue sample template  single study visit  single blood or tissue collection a single blood or tissue sample no more than minimal risk Do not use this template if  study involves genetic analysis of samples  materials or data enter a repository 5 Developed by: U-MIC

7. Specialty consent templates eligibility screening template  consent to screen prior to full consent  e.g., likelihood of numerous ineligible individuals solely for determining eligibility no more than minimal risk Do not use this template if  screening involves genetic analysis  materials or data enter a repository 6 Developed by: U-MIC

8. Specialty consent templates specialty informed consent templates advantages prepared text may save time streamlined structure shorter documents limitations  less flexible or adaptable  may be inappropriate for complex, high-risk research 7 Developed by: U-MIC

9. Specialty consent templates specialty informed consent templates  continued development  recommendations welcome  contact IRBMED office 8 Developed by: U-MIC

10. Specialty consent templates 9 Developed by: U-MIC Specialty informed consent templates One-time blood or tissue sample Eligibility screening

11. THANK YOU. Brian Seabolt IRBMED 10 Developed by: U-MIC