Certificates of confidentiality

1. 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. Developed by: U-MIC

2. Certificates of confidentiality in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

3. National Institutes of Health (NIH)http://grants.nih.gov/grants/policy/coc/ Certificates of Confidentiality protect study data against • forced disclosure • court orders • subpoenas federal state local Developed by: U-MIC

4. Certificates of Confidentiality • sensitive information • identifying characteristics • adverse consequences • finances • employment • insurance coverage • reputation Developed by: U-MIC

5. sensitive informationexamples • genetics • psychological health • sexuality • drug use • illegal behavior Developed by: U-MIC

6. identifying characteristicsexamples • name • address • Social Security number • fingerprints • voiceprints • images • genetics and tissue Developed by: U-MIC

7. Certificates of Confidentiality Investigators should • obtain IRB approval first • include Certificate of Confidentiality language in their consent documents • tell IRB that they plan to apply to NIH for a Certificate of Confidentiality Developed by: U-MIC

8. Certificates of Confidentiality protect sensitive information • collected prior to obtaining Certificate • maintained while Certificate is in effect • as long as investigator maintains data Developed by: U-MIC

9. Certificates of Confidentiality Certificate does not • automatically reduce all study risks • replace investigator’s responsibility to maintain confidentiality • protect against all forms of disclosure • protect against voluntary disclosure Developed by: U-MIC

10. Certificates of Confidentiality Certificate does not • automatically reduce all study risks • replace investigator’s responsibility to maintain confidentiality • protect against all forms of disclosure • protect against voluntary disclosure Developed by: U-MIC

11. Certificates of Confidentiality Certificate does not • automatically reduce all study risks • replace investigator’s responsibility to maintain confidentiality • protect against all forms of disclosure • protect against voluntary disclosure Developed by: U-MIC

12. Certificates of Confidentiality Certificate does not • automatically reduce all study risks • replace investigator’s responsibility to maintain confidentiality • protect against all forms of disclosure • protect against voluntary disclosure Developed by: U-MIC

13. Certificates of Confidentiality Certificate does not • automatically reduce all study risks • replace investigator’s responsibility to maintain confidentiality • protect against all forms of disclosure • protect against voluntary disclosure Developed by: U-MIC

14. Certificates of Confidentiality protect sensitive, identifiable information against • forced disclosure • court orders • subpoenas Developed by: U-MIC

15. National Institutes of Health (NIH) http://grants.nih.gov/grants/policy/coc/ Certificates of Confidentiality Developed by: U-MIC

16. Brian Seabolt IRBMED thank you. Developed by: U-MIC