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CERTIFICATES OF CONFIDENTIALITY in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

National Institutes of Health (NIH) Developed by: U-MIC forced disclosure court orders subpoenas federal state local protect study data against

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

sensitive information examples  genetics  psychological health  sexuality  drug use  illegal behavior 5 Developed by: U-MIC

 name  address  Social Security number  fingerprints  voiceprints  images  genetics and tissue 6 Developed by: U-MIC identifying characteristics examples

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 7 Developed by: U-MIC Certificates of Confidentiality

protect sensitive information  collected prior to obtaining Certificate  maintained while Certificate is in effect  as long as investigator maintains data 8 Developed by: U-MIC 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 9 Developed by: U-MIC Certificates of Confidentiality

10 Developed by: U-MIC 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 Certificates of Confidentiality

11 Developed by: U-MIC 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 Certificates of Confidentiality

12 Developed by: U-MIC 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 Certificates of Confidentiality

13 Developed by: U-MIC 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 Certificates of Confidentiality

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

15 Developed by: U-MIC National Institutes of Health (NIH) Certificates of Confidentiality

THANK YOU. Brian Seabolt IRBMED 16 Developed by: U-MIC