Flexibility Coalition

About

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

New

Flexible Multi-Site Reviews
Coalition Meeting Notes
Creative Flexibility Packet

 

Flexibility Policies and Initiatives from Coalition Institutions

University of Southern California

USC Flexibility Policy
Flex Implementation by Campus

University of Michigan

University of Michigan Demonstration Initiative for Flexibility
Exemption for Analysis of Identifiable Data
Information Sheet on Two Year Approval
Collaborating Institution Agreement

Boston Medical Center and Boston University Medical Campus

Flex Policy

Oregon State University

Flex Policy

University of Arizona

Guidance for research not covered by the Federalwide Assurance

Cedars Sinai Medical Center

Memorandum of Understanding for CTSI Research

Children’s Hospital of Philadelphia (CHOP)

Expansion of Expedited Category 5

Stanford University

Extended Approval Policy

University of Minnesota

Review Standards for Research Not Covered by Federalwide Assurance

Michigan State University

Demonstration Project
MSU Exemptions
MSU Expedited Review Categories

University of California San Francisco

Extended Approval for Minimal Risk Research
Flexibility with Review of Modifications to Exempt Research
Informed Consent for Exempt Research

Flex Coalition Meetings’ Archive

Flex Lunch at PRIMR 11/14/16

SMART IRB Overview

Flex Coalition Call 7/7/16

Boston Flex Policy

Flex Coalition Meeting 4/21/16

Streamlining Consent Review
AAHRPP Standards and Flexibility
Flex Policy of Oregon State

Flex Coalition Call Notes 2/17/16

UMi IRB Metrics
ResearchMatch

Flex Coalition Meeting 11/13/15

Does NPRM Coopt All Flexibilities?
AAHRPP Update and NPRM

Flex Coalition Meeting Notes 9/17/15

IRBrely_Harvard_Catalyst_9.17.15

Flex Coalition Meeting Notes 5/21/15

Flex IRB with External Support
Flex IRB without a Contractor

Flex Coalition Lunch Notes 12/5/14

Flex Meeting Agenda
UC IRB Reliance Service
Transformation of Penn’s HRPP
Oregon State University IRB Initiatives

Flex Coalition Conference Call Notes 6/12/14

Slides from Conf Call

Flex Coalition Meeting Notes 4/24/14

Creative Flexibility Packet

Flex Coalition Lunch Notes 11/7/13

Checklist for Flexibility
Options when Redefining Flexibility as Creativity
Re-configuring the Washington University IRB
Cedars Sinai Repository Use self-verification form

Flex Coalition Conference Call Meeting Notes 6/21/13

New AAHRPP Tip Sheet on equivalent protections for flexed studies
Stanford Initiative: Streamlining Administrative Burden on Research
Cedars Sinai IRB Rapid Activation process
USC flex options in IRB’s e-submission system

Flex Coalition Meeting 4/4/13

Showing the Feds the Right/Easy way
USC’s Flexibility 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  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 Flexibility categories

Flexibility Resources & References

Creative Flexibility Packet
Seven Habits of Highly Effective IRBs
Finding Flexibility in the Federal Regulations
Practical Guide for Reducing Regulatory Burden
Federal Demonstration Partnership Human Subject Subcommittee
Federalwide Assurance Terms
Protection of Human Subjects (45 CFR 46)

Articles about Flexibility Coalition

IRB Advisor
AAHRPP Newsletter[BROKEN LINK]
Newsletter from HRP Consulting Group

 Flexibility Coalition Affiliates (Partial List)

AAHRPP

  • Elyse Summers
  • Sarah KiskaddonAppalachia State
  • Julie Taubman
  • Robin Tyndall

Baylor Research Institute

  • Elizabeth Cothran
  • Boston Children’s Hospital
  • Susan Corl
  • Susan Kornetsky
  • Matthew Stafford

Boston University

  • Cynthia Monahan
  • Brown University
  • 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
  • Samantha Ferrante
  • Mark Schreiner

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

Connecticut Children’s Medical Center

  • Carrie Schmedding

Cornell University

  • Amita Verma

Creighton University

  • Mary Kunes-Connell
  • Patricia Nowatzke
  • Christine Scheuring

Dana Farber Cancer Institute

  • Michele Russell-Einhorn

Dartmouth College

  • Elizabeth Bankert
  • Kimberly Lyford
  • Ann O’Hara

Dept of Energy

  • Elizabeth White
  • Mary Fields

Dept of Veteran’s Affairs

  • Becca Dubose

Drexel

  • Donna Walsh

East Tennessee Children’s Hospital

  • Jacque Van Audenhove

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

Georgia State University

  • Christina Dobrovolny

Grand Valley State University

  • Paul Reitemeier

Harvard University

  • Shannon Sewards

Harvard Catalyst | The Harvard Clinical and Translational Science Center

  • Sabune Winkler

HRP Consulting Group

  • Karen Christianson
  • Jeffrey Cohen
  • Cheryl Savini
  • Nicholas Slack

Huron Consulting Group

  • 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
  • Alec Henderson
  • Yvonne Hung

Lahey Hospital & Medical Center (MA)

  • Antonia Holway

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
  • Marin General
  • Karin Ludwig

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

Nemours

  • Paul Garfinkel
  • Suzanne Murphy

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

Oregon State University

  • Lisa Leventhal

Partners Healthcare

  • Cat Sutherland

Penn State University

  • Philip Frum
  • Kathy Hay
  • Sara Horn
  • Jodi Mathieu

Pennington Biomedical Research Center

  • Melanie Spinks

Portland State University

  • Shannon Roth
  • Eve Chapman

Princeton University

  • Gloria Gaines
  • Stuart Leland

Rush University Medical Center

  • Stephanie Pittman

Rutgers University

  • Paula Bistak

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

Swarthmore College

  • Amy Hagelstein

Texas A&M University

  • Aline Lovings

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
  • Christine Melton-Lopez

University of California San Francisco

  • Lisa Denney
  • Eric Mah

University of Chicago

  • Katherine Lerner

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 Georgia

  • Benilda P. Pooser

University of Iowa

  • John Bertolatus
  • Michele Countryman

University of Kentucky

  • Ada Selwitz
  • Tammi J Gausepohl
  • Belinda Smith

University of Laverne

  • Sarah Dunn

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

  • Jean Barone
  • Patty Orndoff

University of Rhode Island

  • Ted Myatt

University of South Florida

  • Barry Bercu

University of Texas at Austin

  • Wayne Patterson
  • Holly Tieu

University of Texas Health Science Center at Houston

  • Sujatha Sridhar

University of Texas Health Science Center at San Antonio

  • Rhonda Oilepo
  • Joseph Schmelz

University of Utah

  • Sadie Gabler

University of Virginia

  • Bronwyn Blackwood
  • Katie Rees

University of Washington

University of Wisconsin Stout

  • Elizabeth Buchanan

University of Southern California

  • Susan Rose
  • Kristin Craun
  • Sandra Jean
  • Darcy Spicer
  • Jennifer Hagemann

Vanderbilt University

  • Eugene A Gallagher
  • Julie Ozier
  • Jenni Beadles

Virginia Commonwealth University

  • Christine Davison

Wake Forest University

  • Brian Moore
  • Joseph Andrews

Washington University in St. Louis

  • Jonathan Green
  • Martha Jones

WIRB

  • Elizabeth Weisenfeld

WIRB-Copernicus Group  IRB

  • Jeffrey Cooper

Yale University

  • Jan Hewett
  • Jean Larson