USF Human Research Protections Program fully accredited

– USF becomes the first Florida university to earn the AAHRPP distinction –

Tampa, FL (June 19, 2008) — The Association for the Accreditation of Human Research Protection Programs Inc, (AAHRPP) has granted full accreditation to the University of South Florida — the only university in Florida to achieve this milestone.

The AAHRPP is a non-profit organization that works with universities, hospitals, independent review boards, research institute and contract research organizations to raise the level of protection of research study participants and to promote ethically sound clinical research. AAHRPP accreditation is considered the “gold standard” for protection of human subjects involved in clinical research, demonstrating that its member institutions meet safeguards that surpass the threshold of state and federal requirements.

Currently, seeking accreditation by AAHRPP is voluntary. Since AAHRPP was established in 2001, only 129 organizations representing more than 550 entities have earned the credential. The latest accreditation of 22 new members, including USF, was nationally announced on June 19 in Washington, DC.

“USF sought AAHRPP accreditation because it is the right thing to do,” said USF President Judy Genshaft. “Many people volunteer their valuable time to be part of studies that ultimately could improve the health and quality of life of future generations. Their trust and confidence are very important to us, so we’ve taken the lead in putting their safety first and voluntarily embracing standards that are higher than those required by law.”

“USF now joins an elite group of academic institutions in the United States that have successfully obtained full AAHRPP accreditation, including Harvard, Johns Hopkins, University of California San Francisco, the University of Pittsburgh, University of Pennsylvania and Stanford, to name a few,” said Abdul Rao, MD, MA, DPhil, Senior Associate Vice President, USF Health and Medical Director, Tampa General Hospital. “It is a testament to the quality of our Human Research Protections Program that serves not only the patients and investigators at USF/USF Health but also at Tampa General Hospital, Moffitt Cancer Center and Research Institute, James Haley VA Hospital, Shriners Hospital and our other affiliate sites.” Dr. Rao oversees this program at USF.

“This monumental achievement is the culmination of much hard work by our university research community, which met all the challenges of a long and rigorous accreditation process,” said Caroline Fultz-Carver, PhD, MHA, interim director of the USF Division of Research Integrity and Compliance. “We have unequivocally demonstrated — and the AAHRPP has independently confirmed – our unwavering dedication to the protection of human research participants and our belief in ensuring the integrity and excellence of research.”

USF has approximately 3,600 active research studies involving thousands of human participants. Cutting-edge research is conducted in the areas of medicine, nursing, public health, biomedical, and social and behavioral sciences.

Every project involving human subjects is monitored by one of six Institutional Review Boards (IRBs) established at USF and supported by the voluntary time and effort of faculty, staff, students and community members.

Applicants for AAHRPP accreditation must demonstrate that they have built extensive safeguards into every level of their research operation and adhere to the highest standards of translational and clinical research. AAHRPP’s standards exceed federal regulations by requiring organizations to address conflict of interest, provide community outreach and education, and apply the same stringent protections to all research involving human participants. Under federal regulations, such protections are mandated only for federally-sponsored or regulated studies.

Since last summer, staff of USF’s Human Research Protections Program and its IRBs spent countless hours establishing five major accreditation domains covering organization, research review, investigators, research sponsors and participant outreach.

This painstaking work included ensuring a formal process to evaluate and continually improve research involving human participants; educating researchers and staff about their ethical responsibilities; addressing requirements of the USF’s Human Subject Research Protection Program with sponsors that fund the research studies; providing mechanisms to respond directly to concerns of study participants; to ensure the independence of ethical review and oversight; and to determine and improve the competence of investigators.

Members of USF’s AAHRPP Accreditation Task Force, which was led by Dr. Rao, included John Arnaldi, PhD, coordinator of education; Barry Bercu, MD, chair of Biomedical IRBs; Norma Epley, assistant director for IRB Administration; Dr. Fultz-Carver, Camille McWhirter, JD, director of Research Compliance, USF Health; Lesley Spencer, document control; Paul Stiles, PhD, chair of Social & Behavioral Sciences IRB; Vinita Witanachchi, JD, assistant director, HIPAA and Conflict of Interest, Research Integrity and Compliance; and Henry Zych, IRB coordinator.

AAHRPP accreditation is valid for three years, and accredited organizations submit yearly reports on the status of their human research protection programs. The federal Office of Human Research Protections, Food and Drug Administration, and the Association of American Medical Colleges, among other organizations, support this accreditation process.

For more information about AAHRPP, visit

– USF –

The University of South Florida is among the nation’s top 63 public research universities and one of 39 community engaged public universities as designated by the Carnegie Foundation for the Advancement of Teaching. It is one of Florida’s top three research universities. USF was awarded more than $300 million in research contracts and grants last year. The University offers 219 degree programs at the undergraduate, graduate, specialist and doctoral levels, including the doctor of medicine. The University has a $1.8 billion annual budget, an annual economic impact of $3.2 billion, and serves more than 45,000 students on campuses in Tampa, St. Petersburg, Sarasota-Manatee and Lakeland. USF is a member of the Big East Athletic Conference.