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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