Is accreditation the next big thing?

Self-evaluation is selling point

If you look on the web site of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), you’ll find a half-dozen reasons for why organizations that are involved in human research should consider going through the lengthy accreditation process. They range from the obvious "Builds Public Trust" to some reasons that are perhaps not as easy to understand, like "Improves Research Quality."

Ask David L. Wynes, PhD, associate vice president of research at the University of Iowa in Iowa City, why he put his organization through the half-year long effort, and he quickly notes the value — whether you win accreditation or not — of going through an extremely comprehensive self evaluation of the program. "There is no better way to know your strengths and weaknesses than to go through this process," says Wynes.

In a time of budgetary constraints, this kind of navel gazing has a concrete financial result, too, he adds. "Going through this tells me areas where I need to spend my limited resources and areas I don’t. I know I don’t have to throw money at some policy once outside experts have reviewed and reached the conclusion that it’s OK."

Wynes was keen on the idea of accreditation when the AAHRPP was formed in 2001. He commented on the proposed standards and when they were released in 2002, wanted to make sure the University of Iowa was among the first to get a completed application in. "I was a little upset that we didn’t get it in on the first day they accepted them," he says. "But we got it in the first month."

From the start, Wynes says he was convinced of the value the process could bring his organization and the necessity to get on the bandwagon early. He cites the example of the Association for Assessment and Accreditation of Laboratory Animal Care, the accreditation organization for animal research. "They are about 40 years old now; and if you are a major research institution and you aren’t accredited by them, it’s a red flag. Money won’t flow to your research programs."

This is a way, Wynes adds, to show the federal government that additional oversight isn’t needed and that those who conduct research on human subjects can regulate themselves.

So far, just five organizations have achieved accreditation. Four have full accreditation: Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, VA; New England Institutional Review Board in Wellesley, MA; the University of Iowa; and the Western Institutional Review Board in Olympia, WA. Baylor Research Institute in Dallas has qualified accreditation.

A number of labs from the federal Department of Energy are the latest to seek accreditation in 2004. According to AAHRPP executive director Marjorie Speers, PhD, hundreds of organizations have sought information and applications for accreditation. Many of those still are undergoing assessment; others haven’t completed the application forms yet, she says.

The entire process takes from six to nine months from start to finish. First, the organization fills out an application and conducts a self-assessment. When completed, the organization sends it in with a fee ranging from $7,000-$23,000, depending on the number of IRBs involved and the number of open protocols an organization has. If the AAHRPP awards the three-year accreditation, there is an annual fee to pay; but as long as the organization remains continuously accredited, there is no additional application fee assessed for re-accreditation.

Once the application and self-assessment are completed, AAHRPP spends about a month reviewing the materials and schedules a site visit. Most visits average about three days. The inspectors spend time interviewing investigators, administrators, and study participants. While there is some file audit work done, most of the visit is dedicated to talking to people.

After the visit, the inspectors write a report and send it to the applicant, who then has 30 days to either correct errors of fact, make any necessary changes in policies and procedures, and document those changes. The ultimate decision about accreditation is made by the Council on Accreditation, who award one of four outcomes: full accreditation (the organization meets all standards); qualified accreditation (the organization meets almost all standards and any issues that need addressing are minor and administrative); accreditation pending (there are substantial problems, but the council believes the organization is willing to make necessary changes); or accreditation withheld (there are many problems and the council doesn’t believe the organization will make the necessary changes). No actual numerical scores are given, but rather a narrative report. Organizations that don’t meet the standards are told in the report where they have to improve to achieve one of the two accreditation statuses.

Wynes says once the University of Iowa decided to go for accreditation, one staff member spent about half of her time for four months going through the application and the self-evaluation. "There is a lot of time and effort involved in this," he says.

Luckily, the evaluation pointed out minimal need for change. Wynes says that most of what they found was a lack of documentation — or clear documentation — of processes, policies, and procedures. "Most of what we did involved clarifying or adding to our written materials to make sure it was all crystal clear."

Worth the effort

Despite the rigors of the process, Wynes is quick to tout the value of the experience. "This is the most concrete way I know of to get validation of what you do," he says. "Whether we recognize it or not, we all spend a lot of time and effort evaluating what we are doing, trying to implement change, do the right thing, and accommodate new interpretations of existing issues and new issues as they arise. In the end, it can save you time, energy, and money because you have that external expertise telling you what you are doing is right and appropriate."

That Wynes found the process both rigorous and valuable doesn’t surprise Speers. "What we have heard from those who have gone through or are going through is that it adds value to their organizations," she says. "Every institution has said to us, Our program is better having done the self-assessment and having gone through the site visit.’"

Since the standards are almost all based on Department of Health and Human Services or Food and Drug Administration rules, going through the process can also help organizations comply with federal regulations. "If they meet our standards, then they are meeting regulatory requirements," she says, adding that this compliance comes without a government audit or inspection.

This amounts to an expert review of the human protections program at any organization seeking accreditation, Speers notes. At the very least, it can help ensure public trust in research. It also may speak to sponsors of research, be they public or private.

"Most importantly, the oversight system for protection is based on the good will of those who are involved in it doing what they have to do — IRBs and staff reviewing appropriately, investigators conducting research appropriately," says Speers. "If what we as a society want to achieve is deeper penetration of regulatory compliance, the only way I think that will occur is if institutions embrace it themselves and regulate themselves."

Another way to go

There is another accreditation option for organizations, too. The Partnership for Human Research Protection was formed about a year ago by the Joint Commission on Accreditation of Healthcare Organizations and the National Committee for Quality Assurance.

Ten organizations signed up for accreditation in March. Among them are Aurora Health Care, Milwaukee; Baylor Research Institute, Dallas; Chesapeake Research Review, Columbia, MD; Essex Institutional Review Board, Lebanon, NJ; Hartford (CT) Hospital; National Jewish Medical and Research Center, Denver; and Patient Advocacy Council, Mobile, AL.

Final standards for the PHRP accreditation process were announced at the end of May, and the 10 initial organizations were expected to undergo surveys late in 2003. To date, no organizations have completed the accreditation process with the PHRP.

You may get additional information on PHRP accreditation by going to www.phrp.org. More information on AAHRPP accreditation is available at www.aahrpp.org.

What’s in an Application?
• Overview and Purpose — a brief overview of the organization, its purpose, and how the human research protection program relates to the organization’s mission.

• Description of the Organization — including organizational charts, names and titles of staff from supervisor on up, and the number of personnel under each supervisor.

• Key Organizational Representatives — including the organization’s contact person, IRB chairperson(s), organizational officials, and individuals likely to participate in the site visit.

• Accreditation History — whether the organization has been accredited before by AAHRPP or another body.

• Types of Research Conducted — brief description of the major types of research involving human participants (e.g., clinical research, social science research, etc.); the approximate number of investigators and protocols involving the use of humans; the percentages of protocols reviewed by the full IRB, reviewed using the expedited process, or that are exempt; the proportions of human research sponsored by private or public sources; descriptions of research facilities, such as a clinical research center or a survey research center; and information on all current research studies.

Summary of Other Organizations that are part of the Human Research Protection Program — brief descriptions of other organizations that are part of your human research protection program.

Other Relevant Background — anything else that might help the AAHRPP in its review of the program.

Note: The above is an abbreviated list of elements appearing in the application.

Source: Association for the Accreditation of Human Research Protection Programs, Washington, DC.