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Published byQuentin Brooks Modified over 9 years ago
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Faculty Meeting January 26, 2009 Awareness of services for restricted data access IRB focus Some “new” rules A few IRB process tips Guides to common forms
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Support for IRBs and Restricted Data at PSC Staff Lisa Neidert (lisan@umich.edu)lisan@umich.edu Rhonda Moats (rmoats@umich.edu)rmoats@umich.edu Ricardo Rodriguiz (rrrodrig@umich.edu)rrrodrig@umich.edu Mark Sandstrom (msandstr@umich.edu)msandstr@umich.edu IRBs Restricted Data Application Secure Data Environment Contracts/Affidavits Record maintenance Compliance/Reporting
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Awareness Public Use Data definition at UM New Exemption (#7) Students on projects Common mistake in Scheduled Continuing Review How to remedy Project site visits How to report
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PSC website http://www.psc.isr.umich.edu/dis/data/ref/
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Public Use Data at UM ICPSR Roper Selected Federal Agencies Census Bureau NCES NCHS Pre-approved
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Additional public use data on UM campus Pre-approved (by request) HRS National Election Studies PSID* Survey of Consumers* Demographic and Health Surveys* International Census files from IPUMS-i* * At the request of PSC
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Exemption 7 New classification No more than minimal risk Single dataset Not federally funded or using federal training grants Contract No NIH certificate of confidentiality No other contractual restrictions
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Scheduled Continuing Review Confusing choices on form Correct choice Renewal – activity limited to analysis of identifiable data Wrong choice Renewal – activity limited to analysis of de-identified data If “wrong choice is made, the project will be classified as ‘exempt’ which is usually inappropriate Unless it has been classified under Exemption 7
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Solutions Guides Filing a Scheduled Continuing Review (SCR) Filing an Adverse Event/ORIO Add Neidert and Moats to IRB as “staff” We can fill out/look over forms PI still has to review and “submit”
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