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Overview of Important Changes to the Final Rule

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IRB OVERSIGHT FOR DATA AND/OR BIOSPECIMEN REPOSITORIES Developed by: U-MIC University of Michigan IRB Collaborative

IRB oversight for research repositories 3 Developed by: U-MIC Research repository also called a 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 research data or tissue bank

IRB oversight for research repositories 4 Developed by: U-MIC 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.”

IRB oversight for research repositories 5 Developed by: U-MIC 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 data and physical security repository governance

IRB oversight for research repositories 6 Developed by: U-MIC 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.

IRB oversight for research repositories 7 Developed by: U-MIC 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.

IRB oversight for research repositories 8 Developed by: U-MIC Repository guidance IRBMED boards/guidance/repository-overview IRB-HSBS regulatory and policy background tips on REP application frequently asked questions

IRB oversight for research repositories 9 Developed by: U-MIC Repository guidance eResearch Regulatory Management Training

IRB oversight for research repositories 10 Developed by: U-MIC Repository guidance eResearch Regulatory Management Training

IRB oversight for research repositories 11 Developed by: U-MIC Repository guidance eResearch Regulatory Management Training

12 Developed by: U-MIC 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 IRBMED boards/guidance/repository-overview IRB-HSBS

THANK YOU. Lark Speyer IRBMED 13 Developed by: U-MIC