Flexibility Coalition
About
The Flexibility Coalition consists of institutions from across the nation that have achieved a more flexible approach to increasingly burdensome federal requirements, by finding simpler ways of reviewing studies. The freedom to be compliant yet flexible, is permitted for institutions which have opted to “uncheck the box” on the Federalwide Assurance for the Protection of Human Subjects. Unchecking the box limits HHS oversight to projects funded and regulated by OHRP.
The coalition goals are to identify additional areas of flexibility that can be implemented without diminishing the protection of human subjects. It is important for affiliated institutions to have a strong policy statement providing equivalent protections for all human subjects participants. Examples of flex policies include extending IRB approval dates, and establishing additional exempt and expedited review categories. All studies eligible for flex must be non-federally funded and involve no more than minimal-risk research.
The coalition was founded in early 2011 by Susan Rose, the Executive Director of the Office for the Protection of Research Subjects at the USC.
Join the Flexibility Coalition
For Questions Contact: oprs@usc.edu
Flexibility Resources & References
- Notes from Flex Coalition Meetings
- Ideas for Future Flexibility
- Flexibility Coalition Aims to Reduce Regulatory Burden
- Protection of Human Subjects (45 CFR 46)
- Federalwide Assurance Terms
- Finding Flexibility in the Federal Regulations
- Practical Guide for Reducing Regulatory Burden
- Federal Demonstration Partnership Human Subject Subcommittee
Flexibility Policies and Initiatives from Coalition Institutions
| INSTITUTION | INITIATIVE |
|---|---|
| University of Southern California | |
| University of Michigan | |
| University of Minnesota | |
| Cedars Sinai Medical Center | |
| Stanford University | |
| Michigan State University | |
| University of California San Francisco |
Flexibility Coalition Affiliates
| AAHRPP Washington D.C. Marjorie Speers (Advisor/Consultant) mspeers@aahrpp.org Sarah Kiskaddon skiskaddon@aahrpp.orgAppalachian State University Boone, NC Robin Tyndall tyndallrs@appstate.eduAurora Health Care, Inc Milwaukee, WI Lori Roesch lori.roesch@aurora.org Baylor Research Institute Boston Children’s Hospital Boston University Brown University Cedars-Sinai Medical Center Changhua Christian Hospital Colorado College Creighton University Dana-Farber Cancer Institute Dartmouth College Department of Energy Florida Department of Health Fred Hutchinson Cancer Research Center Harvard University HRP Consulting Huron Consulting Group Indiana University Loma Linda University Mayo Clinic Medical College of Wisconsin Mississippi State University National Jewish Health National Taiwan University Hospital Northwestern University The PEER Consulting Group Rush University Medical Center Samsung Medical Center |
Schulman Associates IRB Cincinnati, OH Barry B. Bercu bbercu@usf.eduStanford University Palo Alto, CA Anastasia Doherty anastasia.doherty@stanford.edu Celia Molvin cmolvin@stanford.eduTexas University A&M College Station, TX Catherine Higgins clhiggins@tamu.edu Robert Nobles robertnobles@tamu.edu Tufts Medical Center University of Alabama Birmingham University of California Berkeley University of California Irvine University of California Los Angeles University of California Riverside University of California San Francisco University of Iowa University of Kentucky University of Massachusetts Lowell University of Michigan University of Minnesota University of Pittsburgh University of Southern California University of Texas Austin University of Utah University of Virginia University of Washington University of Wisconsin Vanderbilt University WIRB Copernicus Group Yale University |
Flex Coalition Meetings’ Archive
- Networking
- Emphasize and share new ideas
- Show the feds the right/easy way to do something
- USC’s flex initiative
- Flex options
- Role of IRB staff
Meeting Notes and Handouts 12/5/12
- Flex Policy updates from the following institutions: Cedars Sinai, Children’s Hospital of Pennsylvania, Copernicus Group IRB, Dana Farber Cancer Institute, Stanford, University of California Los Angeles, University of California San Francisco, University of Minnesota, University of Pittsburgh, and University of Southern California.
- For example – redefining “minimal risk,” developing MOUs, and 3-year IRB approvals.
- Broader/more generic IRB applications, flexibility with engagement
- Flexibility with meeting minutes
- Flexibility with engagement and International social-behavioral research
- Credentialing foreign-trained research staff
- Background and goals of flexibility coalition
- Ceding IRB review of ICOI studies
- IRB harmonization
- “IRBshare”
- Flexibility with submission and review of amendment/engagement criteria
- Auditing flexed studies
- Flexible review of community based research (CBR)
- Working together to meet “community” AHHRPP standard
- Introduction to Flexibility Coalition
- Flexibility opportunities
- Searching 45.46 for additional flexibility
- IRBshare centralized IRB review for CTSI studies
- Other models for shared IRB review
- Background of flexibility policies
- Flexibility within Subparts B, C, and D
- Goals of the group: share resources, correspond, potential lobbying for Human Subject Protection Issues
- Unchecking FWA box
- Naming flex categories