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.
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
Stanford University
Michigan State University
University of California San Francisco

Flexibility Coalition Affiliates (Partial List)

AAHRPP
Washington D.C.
Elyse I. Summers, JD
Sarah Kiskaddon skiskaddon@aahrpp.org

Appalachian State University
Boone, NC
Robin Tyndall tyndallrs@appstate.edu
Julie Taubman taubmanjl@appstate.edu

Aurora Health Care, Inc
Milwaukee, WI
Lori Roesch lori.roesch@aurora.org

Baylor Research Institute
Dallas, TX
Elizabeth Cothran elizaco@baylorhealth.edu

Boston Children’s Hospital
Boston, MA
Susan Kornetsky susan.kornetsky@childrens.harvard.edu
Matt Stafford matthew.stafford@childrens.harvard.edu
Susan Corl susan.corl@childrens.harvard.edu

Boston University
Boston, MA
Cynthia Monahan cynthiam@bu.edu

Brown University
Providence, RI
Dorinda Williams dorinda_williams@brown.edu
Susan Carton-Lopez susan_carton-lopez@brown.edu

Cambridge Health Alliance
Cambridge, MA
Jennifer A. Graf
jgraf@challiance.org

Cedars-Sinai Medical Center
Los Angeles, CA
Eifaang Li eifaang.li@cshs.org
Keren Dunn keren.dunn@cshs.org
Rebecca Flores Stella rebecca.floresstella@cshs.org
Adam Pucci adam.pucci@cshs.org
Leah Silbert leah.silbert@cshs.org

Changhua Christian Hospital
Changhua, Taiwan
Cho-Yu Chan cychanfly@gmail.com
Wei-Wen Su 35301@cch.org.tw

Children’s Hospital of Philadelphia
Philadelphia, PA
Deborah Barnard barnardd@chop.edu

Colorado College
Colorado Springs, CO
Amanda Udis-Kessler audiskessler@coloradocollege.edu

Creighton University
Omaha, Nebraska
Patsy Nowatzke nowatzke@creighton.edu
Christine Scheuring christinescheuring@creighton.edu
Mary Kunes-Connell MaryKunes-Connell@creighton.edu

Dana-Farber Cancer Institute
Boston, MA
Michele Russell-Einhorn, JD Michele_Russell-Einhorn@dfci.harvard.edu

Dartmouth College
Hanover, NH
Elizabeth Bankert elizabeth.a.bankert@dartmouth.edu

Department of Energy
Washington, DC
Elizabeth White elizabeth.white@science.doe.gov
Mary Fields mary.fields@hq.doe.gov

Ethical and Independent Review Services
Erica Heath ericah@eandireview.com

Florida Department of Health
Tallahassee, FL
Donna M. West Donna_West@doh.state.fl.us

Fred Hutchinson Cancer Research Center
Seattle, WA
Karen Hansen khansen@fhcrc.org

Harvard University
Cambridge, Massachusetts
John F. Ennever  john_ennever@harvard.edu
Diana Weld dweld@fas.harvard.edu

HRP Consulting
Clifton Park, NY
Jeff Cohen cohenj@thehrpconsultinggroup.com
Cheryl Savini savinic@thehrpconsultinggroup.com
Nicholas Slack slackn@savinic@thehrpconsultinggroup.com

Huron Consulting Group
Chicago, IL
David Goldstein djgoldstein@huronconsultinggroup.com
Frank Conte fconte@huronconsultinggroup.com
Madeline Williams mwilliams@huronconsultinggroup.com

Indiana University
Indianapolis, IN

John R. Baumann baumannj@iu.edu

IRBshare
Emily Sheffer emily.sheffer@irbshare.org

Kaiser Permanente
Armida Ayala Armida.Ayala@kp.org
Yvonne Hung Yvonne.X.Hung@kp.org

Lehigh Valley Health Network
Scott Lipkin, scott.lipkin@lvhn.org

Loma Linda University
Loma Linda, CA
Linda Halstead lhalstead@llu.edu
Mark Testerman mtesterman@llu.edu
Anuradha Diekmann

Maine Medical Center
Emily Berg berge@mmc.org
Jan Trott trottj@mmc.org
Linda Reinholdtsen reinhl@mmc.org
Patricia Robinson robinp2@mmc.org
Sandra Parshall parshs@mmc.org

Marquette University
Amanda Ahrndt amanda.ahrndt@marquette.edu

Mayo Clinic
Rochester, MN
Gary Cseko cseko.gary@mayo.edu
Jason Pitzen pitzen.jason@mayo.edu

Nanette Bateman Bateman.Nanette@mayo.edu
Michelle Daiss daiss.michelle@may.edu

Medical College of Wisconsin
Milwaukee, WI
Kate Gaudreau kgaudrea@mcw.edu
Connie Byrne cbyrne@mcw.edu

Mississippi State University
Miss State, MS
Jodi Roberts jroberts@orc.msstate.edu

National Jewish Health
Denver, CO
Wendy M. Charles charlesw@njhealth.org

National Taiwan University Hospital
Taipei, Taiwan
Jih-Hsiang Lee leejihhsiang@ntu.edu.tw
Ian Chen ichen@ntuh.gov.tw

Northwestern University
Evanston, IL
Mitchell Robertson mrobertson@northwestern.edu

Oregon Health Science University
Andrea Johnson johnandr@ohsu.edu
Kathryn Schuff schuffk@ohsu.edu

PEER Consulting Group
Upper Sadle River, NJ
George Gasparis george@peercg.com

Pennsylvania State University
Sara Horn sjh246@psu.edu

Rush University Medical Center
Chicago, IL
Stephanie Pittman stephanie_R_Pittman@rush.edu

Samsung Medical Center
Seoul, Korea
Seil Jang sei.jang@samsung.com

Schulman Associates IRB
Cincinnati, OH 
Stephanie Pyle spyle@sairb.com

Scott & White Healthcare
Matt Ridley mridley@sw.org
Stephanie Worley sworley@sw.org

Stanford University
Palo Alto, CA
Anastasia Doherty anastasia.doherty@stanford.edu
Celia Molvin cmolvin@stanford.edu

Stratton VA Medical Center
Rebecca DuBose rebecca.dubose@va.gov

Texas University A&M
College Station, TX
Catherine Higgins clhiggins@tamu.edu
Robert Nobles robertnobles@tamu.edu

Tufts Medical Center
Boston, MA
Ashley Hicks ahicks1@tuftsmedicalcenter.org

University of Alabama Birmingham
Birmingham, AL
Tracey Craddock tcraddoc@uab.edu

University of California Berkeley
Berkeley, CA
Maria Savage mcsavage@berkeley.edu
Rebecca Armstrong rda@berkeley.edu

University of California Irvine
Irvine, CA
Karen Allen karen.allen@uci.edu

University of California Los Angeles
Los Angeles, CA
Alison Orkin aorkin@research.ucla.edu

University of California Riverside
Riverside, CA
William M. Schmechel william.schmechel@ucr.edu

University of California San Francisco
San Francisco, CA
John Heldons john.heldens@ucsf.edu
Elizabeth Mendelsohn elizabeth.mendelsohn@ucsf.edu
Susan Corl

University of Cincinnati
Mike Linke mjel.email@gmail.com

University of Colorado – Boulder
Claire Dunne claire.dunne@colorado.edu

University of Iowa
Iowa City, IA
John Bertolatus john-bertolatus@uiowa.edu
Jim Walker james-walker@uiowa.edu
Michele Countryman michele-countryman@uiowa.edu

University of Kentucky
Lexington, KY
Belinda Smith belinda.smith@uky.edu
Tammi Gausepohl tjnewb2@uky.edu

University of La Verne
Marcia Godwin mgodwin@laverne.edu

University of Massachusetts Lowell
Lowell, MA
Rachael Krebs rachel_krebs@uml.edu

University of Michigan
Ann Arbor, MI
Lois Brako lbrako@umich.edu
Judy Birk jbirk@umich.edu

University of Minnesota
Minneapolis, MN
Moira Keane keane002@umn.edu

University of Mississippi
Jennifer Caldwell olemissirb@gmail.com

University of Pittsburgh
Bradford, PA
Jean Barone baronej2@upmc.edu

University of Southern California
Los Angeles, CA
Susan Rose susanros@usc.edu
Kristin Craun kristija@usc.edu
Darcy Spicer dspicer@usc.edu

University of Texas Austin
Austin, TX
Lori Roalson orsc@uts.cc.utexas.edu
Wayne Patterson wpatters@austin.utexas.edu

University of Utah
Salt Lake City, UT
Sadie Gabler sadie.gabler@hsc.utah.edu

University of Virginia
Charlottesville, VA
Blackwood Bronwyn blb2u@eservices.virginia.edu

University of Washington
Seattle, WA
Shannon Sewards ssewards@u.washington.edu

University of Wisconsin
Menomonie, WI
Elizabeth Buchanan elizabeth.buchanan@gmail.com

Vanderbilt University
Nashville, TN
Jenni Beadles jenni.beadles@vanderbilt.edu
Eugene Gallagher eugene.a.gallagher@vanderbilt.edu
Julie Ozier julie.ozier@vanderbilt.edu
Emily Sheffer emily.sheffer@vanderbilt.edu

Dept. Veteran’s Affairs
Rebecca Dubose rebecca.dubose@va.gov
Pete Mestaz peter.mestaz@va.gov

WIRB Copernicus Group
Princeton, NJ
Jeffrey Cooper jcooper@wcgirb.com

Yale University
New Haven, CT
Jean Larson jean.larson@yale.edu
Jan L. Hewett jan.hewett@yale.edu

Flex Coalition Meetings’ Archive

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
emily.sheffer@irbshare.org