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Certificates of confidentiality

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Certificates of confidentiality

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  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

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