Transcript Document

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
1
CERTIFICATES OF
CONFIDENTIALITY
in human subjects research
Developed by:
U-MIC
University of Michigan IRB Collaborative
National Institutes of Health (NIH)
http://grants.nih.gov/grants/policy/coc/
Certificates of
Confidentiality
protect study data against
forced disclosure
• court orders
• subpoenas
Developed by:
U-MIC
federal
state
local
3
Certificates of
Confidentiality
adverse consequences
 sensitive information
 identifying characteristics
Developed by:
U-MIC
•
•
•
•
finances
employment
insurance coverage
reputation
4
sensitive information
examples
 genetics
 psychological health
 sexuality
 drug use
 illegal behavior
Developed by:
U-MIC
5
identifying characteristics
examples
 name
 address
 Social Security number
 fingerprints
 voiceprints
 images
 genetics and tissue
Developed by:
U-MIC
6
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
7
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
8
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
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
protect sensitive, identifiable information against
forced disclosure
• court orders
• subpoenas
Developed by:
U-MIC
14
National Institutes of Health (NIH)
http://grants.nih.gov/grants/policy/coc/
Certificates of
Confidentiality
Developed by:
U-MIC
15
THANK YOU.
Brian Seabolt
IRBMED
Developed by:
U-MIC
16