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Published byChristopher Ferguson Modified over 9 years ago
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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.
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CERTIFICATES OF CONFIDENTIALITY in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative
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National Institutes of Health (NIH) http://grants.nih.gov/grants/policy/coc/ http://grants.nih.gov/grants/policy/coc/ 3 Developed by: U-MIC forced disclosure court orders subpoenas federal state local protect study data against
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sensitive information identifying characteristics 4 Developed by: U-MIC adverse consequences finances employment insurance coverage reputation Certificates of Confidentiality
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sensitive information examples genetics psychological health sexuality drug use illegal behavior 5 Developed by: U-MIC
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name address Social Security number fingerprints voiceprints images genetics and tissue 6 Developed by: U-MIC identifying characteristics examples
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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
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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
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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
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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
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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
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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
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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
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14 Developed by: U-MIC forced disclosure court orders subpoenas protect sensitive, identifiable information against Certificates of Confidentiality
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15 Developed by: U-MIC National Institutes of Health (NIH) http://grants.nih.gov/grants/policy/coc/ Certificates of Confidentiality
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THANK YOU. Brian Seabolt IRBMED 16 Developed by: U-MIC
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