Thursday, April 5, 2012

AAHRPP’s Accomplishments Help Transform the Research Landscape

From the beginning, AAHRPP recognized that each accreditation would have a ripple effect throughout the research enterprise. Yet as we look back on the progress of the past decade, even we are surprised at the stature accreditation has gained and its positive ramifications.

From aspiration to expectation. At first, accreditation was perceived as a way for organizations to distinguish themselves from their peers—to demonstrate that they are part of an elite group with standards exceeding those set by the federal government. As more and more organizations attained accreditation, the perception began to change. Accreditation no longer is something that only a few can strive for. Instead, it has become a must.

AAHRPP’s standards remain the most rigorous in the world, and more than 240 organizations have demonstrated that they can meet these requirements. Increasingly, others are being asked, “Why not you?” Many organizations now include accreditation in their criteria for research partners. And IRBs report that their clients will not consider an unaccredited IRB.

An unwavering commitment to quality. Accreditation has value because, despite outside pressures, AAHRPP has consistently refused to yield on quality. In the early years, that position appeared to place AAHRPP at a disadvantage. Yet AAHRPP stood firm, convinced that enough organizations would make a commitment to AAHRPP’s higher standards. Ultimately, AAHRPP became the sole accrediting body for HRPPs.

Together, AAHRPP and its accredited organizations have raised the bar—for both accredited and non-accredited organizations―and have created a culture of continuous quality improvement. Consequently, in the years since AAHRPP accreditation took hold, the research enterprise has seen a dramatic decrease in major research abuses. Equally telling, accredited organizations are significantly less likely to receive determination letters from the Office of Human Research Protections identifying major deficiencies.

Measurable progress. AAHRPP has led the way in using metrics to evaluate the progress of HRPPs. Perhaps even more important, AAHRPP makes the data available to research organizations, researchers, sponsors, government agencies, and research participants. Detailed information—from types of research conducted and regulatory oversight to IRB resources and review times, to audits, deviations, and complaints—is available on the AAHRPP website.

A comprehensive, integrated approach. To attain accreditation, organizations must demonstrate that they have a systematic, comprehensive program that affords protections for all research participants. This requirement spreads the responsibility for research protections over the entire organization, not just the IRB. As a result, and in large measure because of AAHRPP, the past decade has witnessed the rise of the HRPP. In accredited organizations and, to a lesser extent, throughout the research enterprise, AAHRPP’s standards have helped improve communications, increase efficiency, and strengthen research protections.

One standard worldwide. Increasingly, AAHRPP’s standards are becoming the world’s standards. With accredited organizations in Canada, China, India, Korea, and Singapore, AAHRPP is earning an exemplary reputation in nations that are expected to see the most dramatic growth in clinical trials. That’s good news for researchers, sponsors, and participants, who benefit from accreditation’s assurances of higher quality and enhanced protections.

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