Independent accreditation in the clinical research world had been slow to catch on, but now it suddenly appears to be a topic of high interest. Compliance with existing regulations is not enough, it seems.

Just take the numbers. In its first seven years of accrediting those in clinical research, the Association for the Accreditation of Human Research Protection Programs (AAHRRP) had only vetted and approved 107 organizations. Currently, though, it has 400 in the pipeline, says Marjorie Speers, president and CEO of AAHRPP, the only independent accrediting body in the industry.

Lots of Action

Why so much action? First, says Speers, those in clinical research wanted to wait to see if independent accreditation was going to take hold in an industry that is already heavily regulated. They see now that it’s starting to, so they’re leaping, too.  The second factor: scandal, and the desire to try to avoid it.

“In this business, we’ve had federal regulations for 30 years, and most thought they were sufficient,”  Speers says. “Then in the mid to late 1990s, there were government reports and inspections showing that IRBs (institutional review boards) were in trouble, and that clinical research wasn’t being conducted to high ethical standards.

“This is a country concerned about public trust and confidence in research,” she continued. “Organizations in the industry are starting to see that independent accreditation is one way to demonstrate their accountability to the industry and to the public.”

Birthed by Nonprofits

AAHRPP (pronounced “a-harp”) was spawned in 2001 by a collection of nonprofits, including the Association of American Medical Colleges, the Association of American Universities, and the National Health Council, which is an umbrella organization for 112 groups like the American Heart Association, the American Cancer Society and the March of Dimes.

For now, the Washington, D.C.-based AAHRPP has accredited mostly research sites, primarily at universities and hospitals. But there are also seven AAHRPP-accredited independent IRBs and one contract research organization (CRO), ethica Clinical Research of Montreal, Canada.

CROs Getting on Board

Speers says several medium to large U.S.-based CROs are going though the accreditation process at the moment. Currently, no sponsors are, but one—which Speers calls a “major pharmaceutical company”—is now seeking accreditation for its Phase I research facilities.

It all starts with a self-assessment. First, an IRB, site or CRO takes a look at its actual daily operations and compares them to AAHRPP accreditation standards (all available on the AAHRPP website), which go beyond what the FDA requires. Next, the potential accreditees work to bring all standard operating procedures (SOPs) in line with what it takes to get accredited. When the organization feel its ready, AAHRPP sends between two and six visitors to evaluate the organization for a few days. At the least, AAHRPP sends an IRB professional and a researcher; often a research compliance officer and a vice president of research or a medical director type also are part of the inspecting team.

Matching Visitors

“We match site visitors to the type of organization. If that organization only does industry-sponsored research, then we’ll send a team with that background,” says Speers, formerly acting executive director of the National Bioethics Advisory Commission and deputy associate director for science at the Centers for Disease Control and Prevention (CDC).

All 60 such professionals that AAHRPP uses have day jobs in the industry, and are ad hoc consultants to the organization. AAHRPP has 12 employees.

Pricey Fees

The application fee for AAHRPP accreditation starts at $6,200, and that’s for a small, IRB-less research site. A large institution with 7,000 or more active studies and its own IRBs must pay $77,700— the top of the scale—to get the process started. Then there are the annual fees. They range from $2,700 on the low end to $25,000 on the high end. That includes a site visit every three years.

Okay, but why? Why pay all that money and go through all that effort in an industry that’s already regulated fairly tightly?

Beyond the FDA

Because, says Speers, the FDA doesn’t go far enough with its regs. Several cases in point:

• The FDA requires IRBs to “conduct continuing review” of the research they oversee at least annually. But, Speers notes, the regs don’t spell out what has to happen during that continuing review. AAHRPP specifies the types of information that needs to be available to the IRB, and makes sure IRB members are getting that information.

• AAHRPP requires all research institutions to have a conflict-of-interest policy for investigators and staff, to make sure none have any investment in the compound they are testing. Ditto for commercial IRBs, whose members must not hold equity in that IRB. The FDA does not require this.

• AAHRPP requires that organizations have an ongoing mechanism for educating and training investigators and staff in human research protection. The FDA does not require this. We’re speculating, but some high-volume contract research organization sites might have more difficulty complying with this provision than sites in academia.

• AAHRPP also requires that research entities do outreach, providing materials to the local community on what it means to be in clinical trial, and offer a comfortable, easy-to-find place to go if community members have questions. The FDA does not require this. 

Better Business, Too

Not only does this type of going above and beyond elevate research in the minds of the public, it can also make for better business among those who get accredited.

“When sponsors have done audits (on their accredited sites vs. their non-accredited sites), they tell us they can see a difference,” Speers says. “Accredited sites have better written documents, SOPs, more efficiency and higher research quality.”

IRBs: A Must

For IRBs, it’s already gone beyond that. AAHRPP accreditation is a must-have. “Several have reported that sponsors will not work with them until they’re accredited,” Speers says.

At one point, AAHRPP had competition, but not anymore. An organization called the Partnership for Human Research Protection was also trying to accredit those in clinical research in the early 2000s. But it shut down in 2005 due to lack of business, Speers says. So now AAHRPP is alone.

More Stringent Soon?

The way Speers sees it, accreditation in the world of clinical research is still very new. And the organizations who have sought it thus far are the best of the best; they are the sites and IRBs (and one CRO) most committed to protecting subjects. The rest? Well, as they approach AAHRPP seeking a nod, a seal of approval, the standards may have to shift some.

“Accreditation, like many of the self-regulating mechanisms, is based somewhat on trust,” Speers says. “You do a site visit, then revisit in three years. But in that period, do you trust that organization to continue to meet high standards? Or will we have to start visiting more often, and maybe have unannounced visits? These are the things that, as our numbers grow, we’ll have to look at.”

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