The newly accredited organizations are Massachusetts-based Asentral IRB and Hummingbird IRB, and Mexico-based Facultad de Medicina y Hospital Universitario, Dr. José Eleuterio Gonzalez de la Universidad Autónoma de Nuevo León.
To earn AAHRPP accreditation, organizations must demonstrate that they have built safeguards into all levels of research operations and that they adhere to high standards for the research. In today’s global, collaborative research enterprise, organizations increasingly rely on AAHRPP accreditation status to help identify trusted research partners.
“These three organizations join the nearly 200 worldwide that have earned AAHRPP accreditation—the gold standard for quality research and research protections,” AAHRPP President and CEO Elyse Summers said.
Sarah Kiskaddon, director of global business development and public affairs at AAHRPP, told us that organizations have to abide by a set of more than 60 standards that raise the bar higher than what the regulations require.
By far the majority of those who apply to be accredited get accredited and very few don’t end up accredited when a change in policy is requested, Kiskaddon told us. Those who require additional information usually come back after several months and get accredited, and there are “very few who just drop out of the process,” she said, noting that “typically if there’s a flaw, they fix it and come back.”
To date, AAHRPP has accredited organizations in 46 states, Canada, China, India, Mexico, South Korea, Saudi Arabia, Singapore and Taiwan. All major US independent IRBs have earned AAHRPP accreditation. In addition, more than 60% of US research-intensive universities and over 65% of US medical schools are either AAHRPP-accredited or have begun the accreditation process.
The National Institutes of Health, the world’s largest public funder of research, also has earned accreditation, as has Pfizer.
Kiskaddon added that there are a lot of organizations close to accreditation in China and some in the Middle East.
After receiving accreditation, companies must be re-accredited after three years and then every five years, though they provide detailed annual reports. “If major leadership changes, we can do a site visit and make sure they’re still up to snuff,” Kiskaddon said.
CRO Accreditation
But despite the push to accreditation for major research universities and researchers, only one CRO– Celerion – has been accredited. Kiskaddon explained that because CROs don’t have their own IRBs, they’re usually relying on other, outside and accredited IRBs.