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Pfizer sets standard to require IRB accreditation
Pfizer's own CR unit is accredited
A major pharmaceutical company is leading the way to making accreditation as ubiquitous among IRBs as it is among health care organizations.
Pfizer of New York, NY, now requires central IRBs reviewing Pfizer-sponsored trials to be accredited by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) of Washington, DC.
Also, in April, 2009, which was the eighth anniversary of AAHRPP's founding, the Pfizer Clinical Research Units of New Haven, CT, Brussels, Belgium, and Singapore, achieved full accreditation.
"We sought AAHRPP-accreditation completely voluntarily," says Kristen E. Neese, director of worldwide communications for Pfizer.
"We believe it's a demonstration of our commitment to integrity in research," Neese adds.
"They're the first clinical trials sponsor to be accredited, and they're international," says David Ward, an AAHRPP spokesman.
For all of Pfizer's U.S.-based trials, they'll use only accredited central IRBs to review U.S. multisite research, says Marjorie Speers, PhD, president and chief executive officer of AAHRPP.
Pfizer's newly-accredited CR unit conducts phase I clinical trials, Speers says.
"What's important is that Pfizer is now the world's leader among sponsors, industry, and governmental sponsors of research in setting one standard for human subjects protection," Speers says. "They made the decision to use only accredited IRBs before achieving their own accreditation."
Pfizer made these moves because of the recognition that accreditation is seen as a gold standard in clinical research, Neese notes.
"We see this as the gold seal," she adds. "We recognize those organizations that are accredited, and we wanted to be among them."
So far, Pfizer is the only CR sponsor to make this announcement, although this soon could become a trend.
"I do believe there are other sponsors who use only accredited IRBs or who take accreditation into consideration," Speers says. "That's what we hear from the central IRBs: that they feel they need to be accredited."
Requiring central IRBs to be accredited is a reasonable move since the central IRB will review multisite clinical trial protocols, she adds.
Once the central IRB approves the protocol, a site can request a revision to consent documents, but sites can't change the essence of the study, Speers says.
"When the sponsor contracts with the various research sites, those research sites can use the central IRB or use their own IRB to review the study," Speers explains. "The fact that Pfizer is using AAHRPP-accredited central IRBs means a standard has been set."
Has trend been set?
More sponsors might follow suit.
"Pfizer is a thought leader and is leading the way for others," Speers says. "I fully expect to see other sponsors require accreditation, and, secondly, if they conduct their own research internally, then they would seek accreditation."
AAHRPP, which is the sole accreditation organization for human subjects research, has accredited 175 organizations, representing about 830 research entities.
"We've accredited 12 central IRBs," Speers adds.
The organization also has accredited organizations around the globe, including a medical center in Korea, a national health care group in Singapore, and a contract research organization in Canada, she says.
Organizations seeking accreditation for the first time typically spend 12 to 18 months on the process before they receive their accreditation notice, Speers says.
"In the next five to 10 years I do think there will be an expectation, if not a requirement, that organizations are accredited in order to conduct research," Speers says. "I think as more organizations get accredited and the benefits of accreditation become apparent then sponsors — whether they're from industry or the government — will rely on accreditation as a marker of excellence."