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Developed by:
U-MIC
1
IRB OVERSIGHT FOR DATA
AND/OR BIOSPECIMEN
REPOSITORIES
Developed by:
U-MIC
University of Michigan IRB Collaborative
IRB oversight for research repositories
Research repository
also called a research data or tissue bank
• data and/or biospecimens for future research
 stores
 maintains
 distributes
• maximizes data/specimens’ utility to overall community
• increasingly a priority
o national level
o institutional level
Developed by:
U-MIC
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IRB oversight for research repositories
Research repository
• IRBs oversee repositories that hold
•
o individually identifiable data
o individually identifiable biospecimens
OHRP (“Issues to Consider the Research Use of Stored Data or Tissues”):
“The IRB should review and approve a protocol specifying the conditions
under which data and specimens may be accepted and shared, and ensuring
adequate provisions to protect the privacy of subjects and maintain the
confidentiality of data.”
Developed by:
U-MIC
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IRB oversight for research repositories
Repository oversight at UM
• formerly tracked in eResearch Regulatory Management
through traditional application type (HUM)
• now tracked through a repository application type (REP)
•
•
information required for IRB oversight
information required for compliance with UM policies on
•
•
Developed by:
U-MIC
data and physical security
repository governance
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IRB oversight for research repositories
Submitting a repository application to UM IRB
• Newly established repositories should request approval
through REP application for data and/or biospecimens




intake
storage
maintenance
distribution
• In certain cases, REP replaces HUM application.
• In other cases, REP is an adjunct of one or more HUM
“collection applications.”
Currently, no requirement to transition HUM applications to
REP applications
•
IRB staff will encourage transition case by case.
Developed by:
U-MIC
6
IRB oversight for research repositories
Researchers obtaining data and/or biospecimens
• Indicate a REP as data/specimen source in a HUM
application.
• One REP can be expected to distribute to multiple HUMs.
• eResearch allows for live links between related HUMs and
REPs.
Developed by:
U-MIC
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IRB oversight for research repositories
Repository guidance
IRBMED
http://medicine.umich.edu/medschool/research/office-research/institutional-reviewboards/guidance/repository-overview
IRB-HSBS
http://research-compliance.umich.edu/irb-repository-application
•
•
•
regulatory and policy background
tips on REP application
frequently asked questions
Developed by:
U-MIC
8
IRB oversight for research repositories
Repository guidance
eResearch Regulatory Management Training
Developed by:
U-MIC
9
IRB oversight for research repositories
Repository guidance
eResearch Regulatory Management Training
Developed by:
U-MIC
10
IRB oversight for research repositories
Repository guidance
eResearch Regulatory Management Training
Developed by:
U-MIC
11
IRB oversight for research repositories
IRB oversight for data
and/or biospecimen
repositories
OHRP: Issues to Consider in the Research Use of Stored Data or Tissues
http://www.hhs.gov/ohrp/policy/reposit.html
IRBMED
http://medicine.umich.edu/medschool/research/office-research/institutional-reviewboards/guidance/repository-overview
IRB-HSBS
http://research-compliance.umich.edu/irb-repository-application
Developed by:
U-MIC
12
THANK YOU.
Lark Speyer
IRBMED
Developed by:
U-MIC
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