The Flexibility Coalition consists of institutions from across the nation who 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. This limits HHS oversight to projects funded and regulated by OHRP.
The principal idea is 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 that they are providing equivalent protections for all human subjects participants. Examples of flex policies include extending IRB approval dates, and adding exempt and expedited review categories. All studies eligible for flex are non-federally funded and involve no more than minimal-risk research.
The coalition – inspired by the University of Michigan’s flex policies – was established in early 2011 by Susan Rose, the Executive Director of the Office for the Protection of Research Subjects at the University of Southern California (USC). Because California health and safety codes are different from federal regulations, USC initially sought out other California institutions’ input to confirm that their policy interpretations were accurate and that USC’s flex procedures did not conflict with state laws. Initially, the coalition was as an in-state collaboration among institutions that were interested in sharing ideas, providing support, and constructing policies.
As the initiative grew, other institutions were invited to participate in the process, as well as many others that requested to join. The Flexibility Coalition Affiliates currently include upwards of 40 institutions and membership continues to expand. The Coalition meets at the PRIM&R and AAHRPP conferences, as well as keeps in frequent contact via phone and email to share ideas and stay engaged.
To join the Flexibility Coalition contact Monica Aburto at firstname.lastname@example.org.
The Flexibility Coalition website can be found here and contains more information, resources and a list of affiliated institutions.
The HRP Consulting Group endorses Flexibility Coalition’s efforts at identifying additional areas of flexibility that can be implemented without diminishing the protection of human subjects. HRP also encourages organizations to better use the flexibility in the regulations for federally-funded research, and can assist organizations in these flexibility efforts.