UMMC earns human research accreditation
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When people volunteer for a research study, they want to know that the scientists have their best interests in mind. The University of Mississippi Medical Center now has an accreditation to back it up.
The Association for the Accreditation of Human Research Protection Programs, or AAHRPP, announced UMMC's accreditation December 21, 2016.
A nonprofit organization, AAHRPP provides accreditation for organizations that conduct or review human research and can demonstrate that their protections exceed the safeguards required by the U.S. government. Only 231 organizations worldwide, including hospitals, universities and research institutes, hold a current accreditation. The Medical Center is the only health-care organization in Mississippi with this designation.
This means that clinical trial participants at UMMC can be confident that their welfare and safety are a top priority, said Nancy Olson, director of the human research office.
We were proud of the comprehensive policies we had in place before,” Olson said, “but this accreditation sends a message that we have stepped above and beyond the basic expectations and now hold a higher standard."
Olson and her team oversaw the more than 18-month application process. UMMC rewrote and prepared new policies to meet the highest standards. AAHRPP reviewed all offices connected to human research, from radiation safety to compliance. An August site visit showed the strength of the Medical Center's preparations.
“We received no citations in the accreditation process and a near perfect score on the evaluation,” said Dr. Richard Summers, associate vice chancellor for research. “It was a long, arduous process but worthwhile.”
Attaining accreditation has been a priority for Summers. He sees it as a way to strengthen UMMC's Institutional Review Board, the committees that evaluate, monitor and approve studies using human subjects.
Dr. Gailen Marshall, professor of medicine and medical director of the UMMC Clinical Research and Trials Units, studies asthma treatments and the relationship between stress and the immune system. He also served eight years as an IRB chair for UMMC.
“The value of the IRB process is that it allows a safety net,” he said. “I can be comforted that a diverse group of colleagues have reviewed a study, and we can collect maximum information with minimum risk to the participant.”
UMMC human research office staff from left, Seth Hall, Nancy Olson, Debrah Rogers, Kaye Cliburn and Melanie Fowler.
The accreditation also solidifies UMMC's clinical research partnership with the Mayo Clinic, which is already AAHRPP-accredited, Summers said. Mayo asked the Medical Center to earn the credential so they would share the same standards for human research safety and integrity as they plan and execute clinical trials.
Human research encompasses not only clinical trials but also epidemiological and observational studies. Dr. Michael Hall, assistant professor of medicine, is involved in several human studies, including a study on kidney function and hypertension.
“The participants give their time for our study,” Hall said. “We provide them with a great deal of explanation on the front end of any study. Their safety and privacy is very important to us.”
Olson said the AAHRPP designation allows UMMC to increase research activity and reputation.
“Sponsors will ask if your program is accredited” before entering a research agreement, Olson said, and now UMMC can answer yes. “Institutions can rely on us because they know we hold ourselves to a higher standard.”
Memorial Sloan-Kettering Cancer Center in New York, Northwestern University in Illinois and Boston University in Massachusetts also received accreditation in December.
“AAHRPP's mission is to help ensure robust research participant protections,” said AAHRPP President and CEO Elyse I. Summers in a press release. “Therefore, a good year for us means a good year for strengthening research protections worldwide.
“We applaud our newly accredited organizations and all organizations and individuals who are committed to the high standards required to attain and maintain AAHRPP accreditation.”