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. INFORMED CONSENT FOR GENETIC SUB-STUDIES Developed by: U-MIC University of Michigan IRB Collaborative

4. Informed consent for genetic sub-studies 3 Developed by: U-MIC genetic research inherited human traits Genetic Information Nondiscrimination Act (GINA) health coverage employment

5. Informed consent for genetic sub-studies 4 Developed by: U-MIC genetic information a person’s genetic tests clinical research-related a family member’s genetic tests dependents up to fourth-degree relatives genetic tests of fetuses embryos a disease within a family family history genetic services testing counseling education does not include: sex age genetic test DNA RNA chromosomes proteins metabolites genotypes mutations chromosomal changes

6. Informed consent for genetic sub-studies 5 Developed by: U-MIC genetic research main study sub-study opt in subject takes part in both main study and sub-study opt out subject takes part in main study only

7. Informed consent for genetic sub-studies 6 Developed by: U-MIC genetic research sub-study consent separate signature in main study consent document separate sub-study consent document storage duration and location withdrawing specimen and information from study results of genetic tests controlling and sharing specimen financial benefits risks GINA

8. 7 Developed by: U-MIC informed consent for genetic sub-studies

9. THANK YOU. Judy Birk Brian Seabolt IRBMED 8 Developed by: U-MIC