About the Coalition
IRBs in the US have witnessed an increased workload, see a greater number of studies, have had additional responsibilities added regularly, and are subject to increased oversight. This burden is shared by the research community that conducts Human Subjects Research.
There are significant efforts underway by many institutions, Presidential Commissions, and professional societies to seek ways to alleviate these burdens through flexible approaches to current regulations as well as calls for significant change in the regulations and federal oversight.
One way that large numbers of IRBs have provided some reporting responsibility relief is to "uncheck the box" on their Federalwide Assurance. Other initiatives include policies that allow for extended approval periods and additional exempt categories for certain non-federally funded, minimal-risk research studies.
Representatives from at least a dozen institutions who have implemented, or are pursuing implementation of flexibility policies have formed a coalition, organized by Susan Rose, Executive Director of the USC Office for the Protection of Research Subjects, to share ideas and policies to find flexibility within the current federal regulations.
Any institution seeking to join the Flexibility Coalition or contribute to this effort, please contact Monica Aburto at oprs@usc.edu
Coalition Communications
Flex Coalition Meeting Notes April 19, 2012
Flex Coalition Conference Call January 11, 2012
Flex Coalition Conference Call Notes July 13, 2011
Coalition Meeting Notes April 7, 2011
Ideas for Future Flexibility
Policies and Initiatives
Stanford Extended Approval Policy
University of Southern California
University of Minnesota Policy for Research Not Covered by FWA
Flexibilty Resources & References
Title 45 Part 46: Protection of Human Subjects
Federalwide Assurance Terms
Finding Flexibility in the Federal Regulations (AAHRPP)
Request for Public Comment on Human Subjects Protection (Presidential Commission for the Study of Bioethical Issues)
Practical Guide for Reducing Regulatory Burden (Federal Demonstration Partnership)
Federal Demonstration Partnership Human Subject Subcommittee
Coalition Members
| Susan Rose, Kristin Craun, Darcy Spicer University of Southern California Los Angeles, CA |
Anastasia Doherty Stanford University Palo Alto, CA |
| Karen Allen University of California Irvine Irvine, CA |
John Heldons, Elizabeth Mendelsohn, Susan Corl University of California San Francisco San Francisco, CA |
| Sharon Friend, Alison Orkin University of California Los Angeles Los Angeles, CA |
Eifaang Li, Rebecca Flores Stella Cedars-Sinai Medical Center Los Angeles, CA |
|
Moira Keane University of Minnesota Minneapolis, MN |
Marjorie Speers (Advisor/Consultant) AAHRPP Washington D.C. |
|
Belinda Smith University of Kentuky Lexington, KY |
Mitchell Robertson Northwestern University Evanston, IL |
|
Lois Brako, Judy Birk University of Michigan Ann Arbor, MI |
Rachael Krebs Harvard University Cambridge, MA |
|
Elizabeth Bankert Dartmouth College Hanover, NH |
Jonathan Miller Mississippi State University Miss State, MS |
|
Gary Cseko, Jason Pitzen Mayo Clinic Rochester, MN |
Michael Kuby NORC at University of Chicago Chicago, IL |
|
Sim Ee Ling Singapore National Health Group Singapore |
Ashley Hicks Tufts Medical Center Boston, MA |
|
Jean Barone University of Pittsburgh Bradford, PA |
Sadie Quinn University of Utah Salt Lake City, UT |
Jenni Beadles, Eugene Gallagher Julie Ozier Vanderbilt University Nashville, TN |
Jean Larson Yale University New Haven, CT |
|
Deborah Barnard Children's Hospital of Philadelphia Philadelphia, PA |
Linda Halstead Loma Linda Loma Linda, CA |
|
Elizabeth Cothran Baylor Research Institute Dallas, TX |