The Flexibility Coalition, created by USC, consists of institutions from across the nation that have joined each other to achieve more flexible approaches to increasingly burdensome federal requirements, by finding simpler ways to review and conduct research. The flexible approach began with institutions that 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 work together and share 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 establishing additional exempt categories and extending IRB approval dates 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 at the USC.
For questions, contact firstname.lastname@example.org
Flexibility Policies and Initiatives from Coalition Institutions
University of Southern California
Flexibility Resources & References
Creative Flexibility Packet
Flexible Multi-Site Reviews
Seven Habits of Highly Effective IRBs
Finding Flexibility in the Federal Regulations
Federal Demonstration Partnership Human Subject Subcommittee
Federalwide Assurance Terms
Protection of Human Subjects (45 CFR 46)