1. FLEXIBILITY POLICY “Flex-ing” the regulations

2. What it is AAHRPP and University of M original pushers Why It is within regs,why, highlights of our policy Exclusions/ inclusions why Policy itself Others doing other things Coalition

3. B ACKGROUND An FWA assures that institutions follow the ethical principles of the Belmont Report and complies with federal regulations 45 CFR 46 pertaining to human subjects research USC has chosen to limit the scope of its FWA to federally funded research Thus, flexibility in federal regulations can be applied to non-federally funded research

4. P IONEERS : AAHRPP, U NIVERSITY OF M ICHIGAN AND U NIVERSITY OF M INNESOTA The Association for the Accreditation of Human Research Protection Programs (AAHRPP) encourages flexibility in: Exempt and expedited categories Consent documentation and disclosures Research with pregnant women, children and subjects who are incarcerated after enrollment Continuing review (non-federally funded studies) Reporting requirements (non-federally funded studies) University of Michigan launched IRB Demonstrations (9/2007): Two-year approvals for initial submissions of non-federally funded, minimal risk studies and exemptions for projects limited to analysis of identifiable data. Metrics available at: www.hrpp.umich.edu/irbs/indicators/2008Report.pdf University of Minnesota Expansion of expedited review for non-federal funded research, involving no greater than minimal risk (not listed in list of Expedited Review categories) Some flexibilities for non-federal funded research involving no greater than minimal risk in Subparts B, C and D Internal reporting requirements for non-federal funded research

5. T HE F LEX P OLICY @ USC Implemented in April 2011 Limited to unfunded studies involving no greater than minimal risk Provides protections commensurate with risk Inclusion/exclusion of any flex-qualified research project is at the discretion of the USC IRBs Investigators must report changes to “funded” status for any project that qualified under the Flex policy (e.g., unfunded study becomes funded)

6. USC F LEX P OLICY H IGHLIGHTS Added exempt Categories (not found in 45 CFR 46.101(2)(b): Exempt 7 Non-funded research, involving no greater than minimal risk, that does not conform to a specific exempt category under 45 CFR 46 Examples: online surveys of minors 14-17 y.o., behavioral games, focus groups, linguistic studies using eye-tracking technology Exempt 8 Research, involving no greater than minimal risk, where activity is limited to study of existing identifiable data Continuing review is not required but an initial HIPAA waiver may still be required All studies limited to data analysis qualify (regardless of initial risk determination) 2-year Approval Period Continuing review every two years for unfunded studies, involving no greater than minimal risk, that are not limited to data analysis

7. FLEXFLEX

8. E XCLUSIONS TO USC F LEX P OLICY Studies that are funded, including: Federal sponsorship (including training grants), “no-cost federal extensions” or other non-federal contractual obligations or restrictions Studies taking place in federally funded laboratory or program project grant Non-federally funded research may be “flexed” at IRB discretion Studies with FDA-regulated components Studies with clinical interventions Studies with prisoners as subjects Studies seeking or obtaining Certificates of Confidentiality

9. F LEX P OLICIES AT O THER I NSTITUTIONS Cedars-Sinai Stanford UC San Francisco

10. F LEXIBILITY C OALITION Goal: Collaborate, share and discuss flexibility initiatives across institutions Organized by OPRS Annual meetings & quarterly teleconferences Members include representatives from: University of MichiganStanford AAHRPPHarvard Cedars-SinaiDartmouth University of MinnesotaUniversity of Kentucky Northwestern UniversityMississippi State University Mayo ClinicNORC at University of Chicago Tufts Medical CenterSingapore National Health Group University of PittsburghUniversity of Utah VanderbiltYale Children’s Hospital of Philadelphia UCs (Los Angeles, Irvine, San Francisco)