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

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

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

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

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

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

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

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

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