The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited HOPE Research Institute of Arizona as the first-ever independent investigative research facility to attain AAHRPP’s approval.
HOPE was one of nine organizations to achieve AAHRPP distinction in the third quarter. Since its founding in 2001, AAHRPP has accredited 138 parent organizations, representing more than 600 entities, but HOPE is the first private independent research facility to achieve this distinction.
HOPE began the process of applying for accreditation about a year and a half ago after AAHRPP president and CEO Marjorie Speers, Ph.D., visited HOPE’s Phoenix, Ariz., facility.
Although HOPE already met many of AAHRPP’s accreditation requirements, the process of achieving full AAHRPP distinction involved an overhaul of HOPE’s written policies and procedures, said HOPE managing partner Patricia Adams.
“Our investigators were trained and our staff was trained to have all those protections in place and we were doing all our reporting and working very diligently to protect all the subjects while they participated, but we didn’t have it in writing. In some ways, I say that we were practicing what we weren’t preaching,” Adams said.
This documentation process, while lengthy, was not difficult, Adams said. What was difficult, however, was complying with AAHRPP’s requirements around institutional review board (IRB) use.
AAHRPP requires that accredited facilities use only AAHRPP-accredited IRBs or develop a mechanism for ensuring that each independent IRB meets AAHRPP’s accreditation standards. HOPE committed to using only AAHRPP-accredited IRBs, of which there were only five at the time, Adams said.
“We do 40 to 50 trials at any given time, and we were using a number of IRBs that weren’t AAHRPP-accredited. We had to evolve our studies and, as we started new studies up, encourage our sponsors to use only accredited IRBs,” Adams explained.
Today, AAHRPP has accredited nine independent IRBs, as well as community hospitals, a contract research organization, teaching hospitals, universities, and, now, a private research center, Speers said.
“HOPE is important because it now opens up accreditation to another group of research facilities that previously hadn’t been participating in the accreditation process. I think that’s extremely important because the majority of industry-sponsored clinical trials are conducted in private research sites,” said AAHRPP president and CEO Speers. “From a subject protection perspective, more research subjects, I believe, will be better protected because they’ll be participating in trials that are being conducted by accredited research sites.”
Since the announcement of HOPE’s AAHRPP distinction, several private research centers have inquired about AAHRPP accreditation, Speers said, and some have already begun the accreditation process.
AAHRPP accreditations are announced quarterly and are valid for three years.
Now that HOPE is accredited, they must submit annual updates and regular reports, but this ongoing process, while rigorous, will benefit HOPE and the entire industry, Adams said.
“I really think the industry needs to move this way. It’s an industry that’s somewhat chaotic, and having an accreditation body that’s about protecting human subjects could be just exactly what we need to kind of standardize across the nation and hopefully across the world…This isn’t about making things difficult; this is about making things better,” Adams said.
Other newly accredited organizations include: