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 flexible approach began with institutions that 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 at the USC.
For questions, contact flexcoalition@gmail.com

New

Creative Flexibility Packet
Flexibility with Consent

 

Flexibility Policies and Initiatives from Coalition Institutions

University of Southern California

USC Flexibility Policy (Revised for Common Rule)
Minimal-risk Flexibility Review Checklist
Minimal Risk Review Form

University of Michigan

University of Michigan Demonstration Initiative for Flexibility
Exemption for Analysis of Identifiable Data

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 Coalition Call 2/9/18

Flexibility at Oregon State University
Flexibility at University of New Mexico

Flex Lunch at PRIMR 11/6/17

What is local context review and how do I “do” it?

Flex Coalition Call/Webinar 8/2/17

CIRB in Your Future?

Flex Lunch at AAHRPP 5/11/17

Flex Meeting Notes 5/11/17

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
Flexible Multi-Site Reviews
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
Newsletter from HRP Consulting Group

 Flexibility Coalition Affiliates (Partial List)

AAHRP

Baylor Research Institute

Boston University

California State University at Northridge

Cedars Sinai

Children’s Hospital of Los Angeles

Children’s Hospital of Philadelphia

Cincinnati Children’s Hospital Medical Center

Colorado College

Connecticut Children’s Medical Center

Cornell University

Creighton University

Dana Farber Cancer Institute

Dartmouth College

Ethical and Independent Review Services

Fred Hutchinson Cancer Research Center

Georgia State University

Grand Valley State University

Harvard University

Harvard Catalyst | The Harvard Clinical and Translational Science Center

HRP Consulting Group

Huron Consulting Group

Indiana University

IRBshare

Kaiser Permanente

Lawrence Livermore National Laboratory

Lehigh Valley Health Network

Loma Linda University

Maine Medical Center

Marquette University

Mayo Clinic

Medical College of Wisconsin

Michigan Public Health Institute (MPHI)

Michigan State University

Mississippi State

National Cancer Institute

National Jewish Health

Nemours

NMHS IRB

North Shore-LIJ Health System

Ohio State University

Oklahoma State University – Stillwater

Oregon Health Sciences University

Oregon State University

Partners Healthcare

Penn State University

Pennington Biomedical Research Center

Portland State University

Princeton University

Rush University Medical Center

Rutgers University

Sanford Health

Schulman Associates IRB

Scott and White Healthcare

St Francis Care

St. Jude

Stanford

Swarthmore College

Texas A&M University

University of Texas at Austin

Tufts Medical Center

UC Berkeley

UC Irvine

UC Riverside

UCLA

University of Arizona

University of California San Francisco

University of Chicago

University of Colorado at Boulder

University of Colorado Denver/Anschutz Medical Campus

University of Colorado Health

University of Florida

University of Georgia

University of Iowa

University of Kentucky

University of Laverne

University of Massachusetts, Lowell

University of Michigan

University of Minnesota

University of Mississippi

University of Montana

University of Nevada, Reno

University of New Mexico

University of Oklahoma

University of Pittsburgh

University of Rhode Island

University of South Florida

University of Texas at Austin

University of Texas Health Science Center at Houston

University of Texas Health Science Center at San Antonio

University of Utah

University of Virginia

University of Washington

University of Wisconsin Stout

University of Southern California

Vanderbilt University

Virginia Commonwealth University

Wake Forest University

Washington University in St. Louis

WIRB-Copernicus Group  IRB

Yale University