News

8.25.2015

Full Accreditation of Human Research Protection Program is Cause for Celebration

An unexpected summer downpour may have driven the festivities indoors, but nothing could dampen spirits last week when researchers and administrators gathered to celebrate the good news that the University of Miami’s Human Research Protection Program (HRPP) had been awarded full accreditation by the Association for the Accreditation of Human Research Protection Programs.

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.

“It is your dedication, your talent, your commitment that continues to strengthen our research programs and protect human subjects,” said Thomas J. LeBlanc, Ph.D., Executive Vice President and Provost of the University of Miami, who opened the remarks portion of the celebration. “This is something that we can all be proud of — another major milestone as we move forward together.”

“The University of Miami is ranked among the nation’s top research institutions,” said Pascal J. Goldschmidt, M.D., Senior Vice President for Medical Affairs and Dean of the Miller School of Medicine and CEO of UHealth. “Becoming accredited by the Association for the Accreditation of Human Research Protection Programs is very much aligned with the spirit of building a better ‘U.’ Provost LeBlanc and I, along with the leadership of the Cultural Transformation Team, recognize that it is through all of our combined efforts that we can continue to build on the solid foundation of our research enterprise and the world-renowned care we offer at UHealth.”

Goldschmidt pointed into the audience to credit 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, with instilling the mix of professionalism and compassion that characterize the entire research enterprise. He noted that Jayaweera had been recruited to UM in 1992 because of his interest in HIV/AIDS, and thanked Margaret A. Fischl, M.D., professor of medicine and Director of the AIDS Clinical Research Unit, for recruiting him.

John L. Bixby, Ph.D., professor of pharmacology and neurological surgery and Vice Provost for Research, was next at the podium.

“The AAHRPP site visitors explicitly pointed out how important the support from our top senior leadership was,” he said, “and that the level of support they found here was not typical of what they see elsewhere. They also acknowledged the critical contributions and the collective excellence of all of the research and administrative groups. Nonetheless, with the accreditation comes the responsibility for superior science and continuous improvement.”

Jayaweera was clearly feeling up to the challenge, speaking enthusiastically from the microphone and during the informal conversation that followed. He acknowledged the team effort required in building and maintaining a top-quality research compliance enterprise, but he saved special praise for Kenia Viamonte, M.A., Senior Manager for Compliance/IRB Affairs, and Jeanette Mestepey, M.A., Senior Finance Manager, who assembled the two parts of the lengthy application. He also offered thanks to all of the University of Miami leadership, Omaida Velazquez, M.D., the newly named Chair of the Department of Surgery who has provided strong support in her role as Executive Dean for Research, Research Education and Innovative Medicine, and the partners in the Human Research Protection Program.

“Now we have to keep going,” he said. “We are already collecting data for resubmission because you need to be regularly reaccredited. Still, all the hard work has paid off. When the NIH and Big Pharma want to do studies, they want us to be the Institutional Review Board of record. You know you have achieved a reputation for quality human subject protection when the other institutions are calling you to be the IRB of record.”

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