Special to UM News
CORAL GABLES, Fla. (June 23, 2015) —The University of Miami’s Human Research Protection Program (HRPP) has been awarded full accreditation by the Association for the Accreditation of Human Research Protection Programs.
“AAHRPP accreditation is a ‘gold seal’ that offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an HRPP is focused first and foremost on excellence,” said Dushyantha T. Jayaweera, M.D., professor of medicine and associate vice provost for human subject research, who directs the Miller School of Medicine’s Human Subject Research Office.
“Accreditation demonstrates our ongoing commitment to the most comprehensive protections for human research participants, and to high quality and ethically sound research,” Jayaweera said. “Becoming accredited is a remarkable achievement and a true testament to what we can accomplish together.”
The Institutional Review Boards, supported by the Human Subject Research Office, are the backbone on which UM’s HRPP is built, but accreditation acknowledges the critical contributions and collective excellence of the entire HRPP team. That includes principal investigators and their study teams, Research Compliance and Quality Assurance, Clinical Research Operations and Research Support, Research Information Technology, Disclosure and Conflict Management, and the Office of Research Administration.
“AAHRPP accreditation is a voluntary process that exemplifies the University of Miami’s commitment to high-quality clinical research and the protection of human subjects,” said UM Interim President Thomas J. LeBlanc, executive vice president and provost. “By choosing to undergo this accreditation process, we have demonstrated our confidence in the faculty and staff who conduct clinical research, serve on the Institutional Review Boards, and oversee human subject research.”
“When you hold yourself up to the highest standards, your efforts will be recognized and rewarded,” said Pascal J. Goldschmidt, M.D., senior vice president for medical affairs and dean of the Miller School of Medicine and CEO of UHealth. “The AAHRPP accreditation confirms that we meet the highest standards of research with human subjects, and it will open new doors to collaborative ventures and additional funding.”
“This accreditation is a real milestone for our HRPP on its journey to the top tier,” said John L. Bixby, Ph.D., professor of pharmacology and neurological surgery, and vice provost for research. “The process is demanding, and our Human Subject Research Office deserves huge praise for organizing and leading the entire effort.”
Jayaweera says the AAHRPP accreditation was an involved process that required two years of effort, but it was eased by strong support from top administration at the Miller School and at UM.
“It fosters a spirit of trust among research and industry partners, as well as federal agencies,” he said. “This enables us to be in a better position to compete for the pharmaceutically sponsored trials, serve as the IRB of record for national multi-center studies, and continuously look at our processes.
“The preparation for accreditation is a comprehensive review of the entire program. It serves as a form of quality assurance in an effort to minimize the risk of noncompliance to the institution, enhance protection of the human subjects, and make the operation more efficient.”
AAHRPP is an independent, nonprofit accrediting body that uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence—through policies, procedures and practices—of their commitment to scientifically and ethically sound research and to continuous improvement.