Monday, July 30, 2012

A Path to an Even More Effective Social-Behavioral and Educational Research Program

Case Study: Utah State University
AAHRPP Accredited Since 2009

The Situation
Utah State University (USU) focuses its human research portfolio primarily on social-behavioral and educational research (SBER) and has one institutional review board (IRB). The university became interested in AAHRPP accreditation early on “because we thought it was the right thing to do,” says Russ Price, Federal Compliance Manager, Compliance Assistance, USU Office of Research and Graduate Studies. “We felt it was a direction that made sense for the nation and for our program.”

USU also was seeking to differentiate itself from others engaged in social and behavioral research and thought accreditation might help achieve that objective. As one of the first SBER programs to achieve AAHRPP accreditation, “we continue to receive inquiries from SBER institutions that are considering applying for accreditation or that have decided to apply and have questions about the process,” says True Rubal, Director, USU IRB.

The Challenge
USU faced two challenges. Resources were tight. The IRB staff consisted of a single administrator, and it would fall to her to codify existing practices. In addition, USU was in the early stages of building consensus around the concept of a human research protection program (HRPP). The university was still delivering the message that responsibility for protections extends beyond the IRB and is shared across the institution.

The Solution
USU tackled the challenges on three different fronts:
  1. HRPP officials recruited “champions” throughout USU. Their role was not only to advocate for AAHRPP accreditation but also to make the case for increased resources and for a culture of shared responsibility for protecting research participants. 
  2. Partnering with the University of Utah to take advantage of a capacity-building grant, USU hired a part-time assistant to help formalize and communicate HRPP policies and procedures.
  3. USU relied on AAHRPP standards as the framework for policies on research, human subject protections, and institutional conflict of interest. “We started by formalizing policies,” Mr. Price recalls, “and ended up building momentum around the idea of organizational infrastructure.” 
The Results
For USU, the accreditation process made a good program even better. In preparation for AAHRPP accreditation, USU developed a comprehensive HRPP, complete with standardized policies and procedures. The HRPP was integrated with USU’s academic structure, especially with departments and schools—such as the Department of Psychology and the School for Teacher Education and Leadership—that are responsible for a sizable percentage of USU’s human research portfolio. To ensure continued quality improvement, USU now conducts an annual review of its HRPP and uses metrics to make decisions on issues such as training needs and IRB membership.

AAHRPP accreditation also cleared the way for USU to partner with the University of Utah, which now reviews all USU Food and Drug Administration (FDA)-related research. Since both organizations are AAHRPP accredited, they share common standards and are comfortable collaborating. The partnership gives USU an efficient, reliable review process and an assurance of quality for FDA-funded protocols.

“We were already a very effective organization,” Mr. Price says, “so for us, AAHRPP accreditation provided a path to evaluate and improve our processes. It changed the way we approach research and resulted in stronger scientific and ethical reviews of protocols. It absolutely strengthened our program.”

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