1. 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

2. 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

3. 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

4. PSC website http://www.psc.isr.umich.edu/dis/data/ref/

5. Public Use Data at UM ICPSR Roper Selected Federal Agencies Census Bureau NCES NCHS Pre-approved

6. 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

7. 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

8. 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

9. 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”