Flexibility Policy and 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 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 by Susan Rose, the Executive Director of the Office for the Protection of Research Subjects at the USC.
For questions, contact oprs@usc.edu

Join the Flexibility Coalition

Flexibility Resources & References

Flexibility Policies and Initiatives from Coalition Institutions

INSTITUTION INITIATIVE
University of Southern California
University of Michigan
University of Minnesota
Cedars Sinai Medical Center
Children’s Hospital of Philadelphia (CHOP)
Stanford University
Michigan State University
University of California San Francisco

Flex Coalition Meetings’ Archive

Flex Coalition Conference Call Notes 6/12/14

Flex Coalition Meeting Notes 4/24/14

Flex Coalition Lunch Notes 11/7/13

Flex Coalition Conf. Call 6/21/13

Flex Coalition Meeting 4/4/13

  • 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.

Conference Call Notes 6/14/12

  • 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

Meeting Notes 4/19/12

  • 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

Conference Call Notes 1/11/12

  • 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

Conference Call Notes 7/13/11

  • Background of flexibility policies
  • Flexibility within Subparts B, C, and D

Meeting Notes 4/7/11

  • Goals of the group: share resources, correspond, potential lobbying for Human Subject Protection Issues
  • Unchecking FWA box
  • Naming flex categories

Flexibility Coalition Affiliates (Partial List)

AAHRPP Elyse Summers
Sarah Skiskaddon
Appalachia State Julie Taubman
Robin Tyndall
Baylor Research Institute Elizabeth Cothran
Boston Children’s Hospital Susan Corl

Susan Kornetsky

Matthew Stafford

Boston University Cynthia Monahan
Susan Carton-Lopez
Dorinda Williams
California State University at Northridge David Boyns
Cambridge Health Alliance Jennifer Graf
Cedars Sinai Rebecca Flores-Stella
Eifaang Li
Leah Silbert
Adam Pucci
Chesapeake IRB Felix Gyi
Children’s Hospital & Research Center Oakland Denyse Pettersson
Children’s Hospital of Los Angeles Rebecca Dahl
Michele Kipke
Children’s Hospital of Philadelphia Deborah Barnard
CHRISTUS Health Victoria Brown
Cincinnati Children’s Hospital Medical Center Jeremy Corsmo
College of the Canyons Daylene Meuschke
Colorado College Amanda Udis-Kessler
Compass Contracts Group Michael Simmons
Cornell University Amita Verma
Creighton University Mary Kunes-Connell
Patricia Nowatzke
Christine Scheuring
Dana Farber Cancer Institute Michele Russell-Einhorn
Dartmouth College Elizabeth Bankert
Dept of Energy Elizabeth White
Mary Mary
Dept of Veteran’s Affairs Becca Dubose
Drexel Donna Walsh
University of Wisconsin Stout Elizabeth Buchanan
Ethical and Independent Review Services Erica Heath
Fairleigh Dickinson University Kim Diccianni
Florida Department of Health Robert Hood
Donna West
Fred Hutchinson Cancer Research Center Karen Hansen
Grand Valley State University Paul Reitemeier
Harvard University John Ennever
HRP Consulting Group Jeffrey Cohen
Cheryl Savini
Nicholas Slack
Frank Conte
Jonathan Hunter
Madeleine Williams
Indiana University John R Baumann
Sara Benken
Interactive Research & Development Naila Baig-Ansari
IRBshare Emily Sheffer
Kaiser Permanente Arminda Ayala
Yvonne Hung
Lawrence Livermore National Laboratory Ann-Marie Dake
Lehigh Valley Health Network Scott Lipkin
Loma Linda University Linda Halstead
Anu Diekmann
Lorraine Sarmiento
Mark Testerman
Maine Medical Center Emily C. Berg
Linda K. Reinholdtsen
Patricia Robinson
Jan L. Trott
Marquette University Amanda Ahrndt
Mayo Clinic Nanette N. Bateman
Gary C. Cseko
Michelle K. Daiss
Jason Pitzen
Medical College of Wisconsin Connie Byrne
Kate Gaudreau
Michigan Public Health Institute (MPHI) Sally Hiner
Michigan State University Becky Gore
Judy McMillan
Mississippi State Jodi Roberts
National Cancer Institute Jackie Goldberg
National Jewish Health Wendy Charles
NMHS IRB Shelly Thompson
North Shore-LIJ Health System Meredith Burcyk
Jon Newlin
Ohio State University Karen  Hale
Oklahoma State University – Stillwater Dawnett Watkins
Oregon Health Sciences University Andrea Johnson
Kathryn Schuff
Lisa Leventhal
Partners Healthcare Cat Sutherland
Peer Consulting Group George Gasparis
Penn State University Sara Horn
Jodi Mathieu
Pennington Biomedical Research Center Melanie Spinks
Rush University Medical Center Stephanie Pittman
Sanford Health Deb Langstraat
Schulman Associates IRB Stephanie Pyle
Scott and White Healthcare Matt Ridley
Stephanie Worley
St Francis Care Ernesto Canalis
Carrie Schmedding
St. Jude Kathleen Price
Constance Coleman
Stanford Anastasia Doherty
Celia Molvin
Texas A&M University Catherine Higgins
Robert Nobles
The Children’s Hospital of Philadelphia Samantha Ferrante
The Pennsylvania State University Philip Frum
The University of Texas at Austin Lori Roalson
Tufts Medical Center Ashley Hicks
UC Berkeley Rebecca Armstrong
Tani Prestage
UC Irvine Karen Allen
UC Riverside William M Schmechel
UCLA Alison Orkin
University of Arizona Andi Encinas
Mariette Marsh
University of California San Francisco Lisa Denney
University of Colorado at Boulder Claire Dunne
University of Colorado Denver/Anschutz Medical Campus Alison Lakin
University of Colorado Health Tammy Felton-Noyle
University of Florida Peter Iafrate
University of Iowa John Bertolatus
Michele Countryman
University of Kentucky Ada Selwitz
Tammi J Gausepohl
Belinda Smith
University of Laverne Marcia Godwin
University of Massachusetts, Lowell Rachel Krebs
University of Michigan Judy Birk
Lois Brako
Cindy Shindledecker
Karin Teske
University of Minnesota Moira Keane
University of Mississippi Jennifer Caldwell
University of Montana Paula A. Baker
University of Nevada, Reno Valerie Smith
University of New Mexico Kevin Ferrell
University of Oklahoma Faustina Layne
University of Pittsburgh Medical Center Jean Barone
University of San Francisco John Heldens
University of South Florida Barry Bercu
University of Texas at Austin Wayne Patterson
University of Texas Health Science Center at San Antonio Joseph Schmelz
University of Utah Sadie Gabler
University of Virginia Bronwyn Blackwood
Katie Rees
University of Washington Shannon Sewards
University of Southern California Susan Rose
Kristin Craun
Sandra Jean
Darcy Spicer
Jennifer Hagemann
UT Health Science Center at San Antonio Rhonda Oilepo
Vanderbilt University Eugene A Gallagher
Julie Ozier
Jenni Beadles
Virginia Commonwealth University Christine Davison
Washington University in St. Louis Jonathan Green
Martha Jones
WIRB-Copernicus Group  IRB Jeffrey Cooper
Yale University Jan Hewett
Jean Larson