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

 

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

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

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)