Monday, February 6, 2012

Flexibility Coalition Aims to Reduce Regulatory Burden While Equally Protecting Participants

A national coalition has been formed to seek further flexibility in the federal regulations governing human participant research. This effort, the Flexibility Coalition, is spearheaded by Dr. Susan Rose, executive director of the University of Southern California Office for the Protection of Research Subjects.

The coalition meets in person at national meetings hosted by groups such as PRIM&R and AAHRPP and conducts semiannual conference calls. The most recent call attracted representatives from more than two dozen institutions.

Flexibility efforts were initiated several years ago at the University of Michigan by Judy Birk, executive director of the Health Sciences and Behavioral Sciences IRB at the University of Michigan, and Moira Keene, executive director of the Human Research Protection Program at the University of Minnesota. AAHRPP supported these steps, which paved the way for accredited institutions to adopt the policies.

In a time of shrinking resources, increasing regulatory burdens, and a growing volume of research, the coalition seeks flexibility for reviewing research involving low risk while maintaining high standards of protection for participants.

California and many other states impose human participant research requirements beyond the federal regulations. Rose explains that California has a “Health and Safety Code and Experimental Subject Bill of Rights that are outdated or ambiguous and hinder the adoption of certain flexibility policies that institutions in other states can adopt.” Rose invited other interested California parties to discuss ways to approach flexibility in light of the California requirements. This group met for the first time during the AAHRPP annual conference in Washington, D.C., in April 2011.

The University of Michigan, the University of Southern California, Stanford University, and the University of Minnesota stand out for their “flex policies.” The University of Minnesota policy applies to research not covered by the university’s Federalwide Assurance of Compliance and provides flexible, equivalent protections for research involving children, prisoners, pregnant women, human fetuses and neonates, and multi-center research. In addition, the policy defines categories of research that may be reviewed by the expedited procedure and eliminates some external reporting requirements for non-federal research. The University of Southern California policy sets exempt categories for non-federally funded research such as a category for the analysis only of existing identifiable data. The University of Michigan has been conducting a four-year Flex Initiative/Demonstration Project that allows for a two-year approval period and a new exemption category. The University of Michigan’s Judy Birk says that more than 300 projects have garnered the new exemption and nearly 1,500 have received two-year approvals with no untoward effects for participants or publication problems for researchers. Birk points out that some researchers have requested standard IRB determinations, as they are concerned that some journals may not accept the outcomes that the demonstration projects afford, although there is no evidence for that requirement. The Stanford policy allows a three-year approval period for nonmedical human participant research involving no more than minimal risk and no federal sponsorship. (See references at the end of this article.)

AAHRPP has long encouraged flexibility in the regulations and providing equivalent appropriate protections for non-federally sponsored research. Dr. Marjorie Speers, president and CEO of AAHRPP, addressed the Flexibility Coalition and emphasized the use of equivalent standards along with the flexibility already in the regulations such as the exempt categories and waivers of the consent process and of consent documentation. For example, virtually all non-FDA regulated research involving no more than minimal risk may quality for a waiver of consent documentation, which can allow for more progressive and often more culturally appropriate methods for confirming a participant’s willingness to participate in research.

Rose says that “the Coalition is holding its breath that the proposed changes in the regulations will not take away the flexibilities in the current regulations.” Nevertheless, the Flexibility Coalition plans to continue the current demonstration projects and to look for additional flexibilities. Institutions interesting in joining the Flexibility Coalition or contributing to this effort should contact Monica Aburto at


Flexibility Coalition Webpage:

USC Flex Policy:

Stanford University Extended Approval Policy:

University of Michigan Demonstration Initiative:

University of Minnesota “Policy for Research Not Covered by FWA”:

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