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Accreditation Gains Major Foothold in Industry Sponsored Research
Washington, D.C., April 1, 2009—Accreditation of human research protection programs is expanding into clinical trials conducted by Pfizer Inc., and to three more of the nation’s social science and behavioral research universities, the Association for the Accreditation of Human Research Protection Programs, Inc., announced today.
AAHRPP has accredited another 16 organizations, expanding coverage to a total of 175 organizations representing more than 830 entities that have met its standards for accreditation since 2003. Pfizer, the world’s largest research-based pharmaceutical company, is the first in its industry to gain accreditation for its phase 1 clinical research units.
“The accreditation of Utah State University, Binghamton University, State University of New York, and the University of California, Riverside, as well as Pfizer, attests to the importance of protecting research participants at all universities and in industry, as well,” said the AAHRPP’s President and CEO Marjorie A. Speers, Ph.D., in announcing the new accreditations.
More people protected by the highest standards
“Binghamton University has built a reputation as an outstanding institution with ‘state-of-the-art’ research activities and facilities carried out by excellent faculty, students and staff. AAHRPP accreditation assures our excellence in human research studies,” said Gerald Sonnenfeld, Vice President for Research.
Charles Louis, Vice Chancellor for Research at the University of California, Riverside, said, “AAHRPP accreditation demonstrates to participants, researchers, funders, and other partners our commitment to ensuring the highest ethical standards in the conduct of research at UC Riverside.”
“Pfizer is proud to be the first pharmaceutical or biotech company to obtain AAHRPP accreditation and take our place alongside some of the best universities and hospitals that are also AAHRPP-accredited.” said Jeffrey B. Kindler, Chairman and Chief Executive Officer of Pfizer. “Accreditation is part of Pfizer’s ongoing efforts to demonstrate our commitment to integrity and increased transparency in research and operations,” a program initiated by Kindler when he became Pfizer’s Chairman and CEO two years ago.
Pfizer expands effort to earn public trust
In addition to earning accreditation for its Clinical Research Units, located in New Haven, CT, Brussels, Belgium, and Singapore, the company will use only central institutional review boards (IRBs) accredited by AAHRPP to approve its U.S. multi-site clinical trials.
Justin McCarthy, Chief Counsel for Pfizer Global Research and Development, said Pfizer will also encourage its study teams to use research sites accredited by AAHRPP, and “will continue to support the adoption of the AAHRPP standards internationally.”
“Pfizer’s commitment to accreditation will expand the number of participants covered by AAHRPP standards,” Speers said, “And that’s important, because setting uniform, high standards across the research enterprise―in industry, government, and non-profit sectors—will improve protections for research participants in the U.S. and internationally.”
The newly accredited organizations are:
- Binghamton University, State University of New York, Binghamton, NY
- VA Medical Center, Birmingham, AL
- Duke Medicine, Durham, NC
- James H. Quillen VA Medical Center, Mountain Home, TN
- Lehigh Valley Health Network, Allentown, PA
- Rhode Island Hospital, Hasbro Children’s Hospital, The Miriam Hospital, Emma Pendleton Bradley Hospital and Newport Hospital as part of Lifespan, Providence, RI
- Minneapolis Veterans Affairs Medical Center, Minneapolis, MN
- Nemours, Jacksonville, FL
- Pfizer Clinical Research Units, New Haven, CT, Brussels, Belgium, and Singapore
- RCRC Independent Review Board, LLC, Austin, TX
- San Francisco Veterans Affairs Medical Center, San Francisco, CA
- St. Cloud Veterans Affairs Medical Center, St. Cloud, MN
- University of California, Riverside, Riverside, CA
- Utah State University, Logan, UT
- Kansas City Veterans Administration Medical Center, Kansas City, MO
- White River Junction, VT, Veterans Affairs Medical Center, White River Junction, VT
AAHRPP is a non-profit organization that works with organizations that conduct human research to raise the level of protection for research participants. AAHRPP accredits organizations that can demonstrate they provide participant safeguards that surpass the threshold of state and federal requirements. The accreditation program utilizes a voluntary, peer-driven educational model. For organizations interested in learning more about accreditation, visit http://www.aahrpp.org/.
Through the rigorous accreditation process, organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to the highest standards for research. AAHRPP’s standards exceed federal regulations by requiring organizations to address conflict of interest, to provide community outreach and education and to apply the same stringent protections to all research involving human participants. (Under federal regulations, such protections are mandated only for federally sponsored or regulated research.) The accreditation process typically results in system-wide improvements that enhance protections for research participants and promote high-quality research.
Accreditation is available to U.S. and international organizations that conduct biomedical, behavioral or social sciences research involving human participants. Decisions on accreditation are announced quarterly, and accreditation is valid for three years.