Special Coverage: AAHRPP conference 2006

Getting through the accrediting process

Select a point person and anticipate corrections

Seeking accreditation for research institutions’ human subjects research protection programs is becoming an increasingly popular choice. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC, now lists more than 30 accredited institutions, and another 200 are undergoing the accreditation process.

Once an organization commits to seeking accreditation, the process is arduous but rewarding when an institution succeeds, says Larry D. Milne, PhD, vice chancellor for academic affairs and research administration at the University of Arkansas for Medical Sciences (UAMS) in Little Rock. The institution has had full AAHRPP accreditation since June 2005.

"AAHRPP’s original comment to us was We want you to be accredited, and we’ll help you in any way we can,’ and they delivered on that," Milne says. Milne offers these suggestions for how to achieve accreditation:

• Conduct a self-study. The first step in seeking accreditation is to conduct a self-assessment that will help an institution highlight weaknesses and strengths, Milne suggests. "We pulled together a lot of our policies and procedures, and it amounted to 4,600 pages," Milne says.

The AAHRPP application includes a two-page form, a program overview, copies of documents used by the organization, and an index. The institution decides whether to apply as a preliminary applicant or as a formal applicant.

• Prepare for a site visit. "After you’ve done your self-study, they set you up with a site visit, Milne says. "We had a team from AAHRPP come in to look at our whole program."

The institution’s human subjects protection program had grown from one IRB and no staff to three medical IRBs and one behavioral IRB, and the institution had 10 people on staff in the research compliance group, Milne recalls.

Then the initial report arrived on Jan. 10, 2005, and it listed observations and recommendations for each of 77 elements that AAHRPP feels are important for accreditation, Milne recalls. "Many are minor, but others we found needed to be completely overhauled or new," he says.

• Assign tasks. One way to tackle accreditation findings is to form a committee and assign tasks to different people, but it’s a good idea to have one person in charge, Milne says.

"We actually decided we needed one person to be responsible and take charge," Milne says. "We have one individual who was knowledgeable of the IRB process, and she was the best person to do this."

An executive committee, consisting of IRB chairs, the chief administrator for the IRB, the head of research compliance, the director of sponsored programs, and Milne, worked with the woman who had been put in charge of accreditation efforts. "So there were six of us, and we told everybody, You block out from 9 to 10 a.m. every Thursday," Milne says.

The idea was to expedite the process because institution officials wanted to get a report back to AAHRPP within one month, Milne notes.

Many decisions were made by e-mail ballots in which committee members voted either "I agree," "I disagree," or "Let’s discuss." Milne says. "We discussed it one time and then a policy was written," Milne says.

• Take advantage of available resources. Accreditation officials encourage institutions to use what works at other research sites, Milne says.

The visitation team included people who came from accredited sites, and they would say, "Don’t re-invent the wheel — our policies and procedures are on our web site, so take anything you want," Milne recalls.

Now that the UAMS is accredited, Milne and colleagues also share material and offer advice to those who call them.

• Do not give up when first you don’t succeed. After many hours of working on correcting problems, including having the IRB director take off time to devote to the process, the institution received an "accreditation pending" status, Milne says.

"We were thrown out there in never-never land," Milne says. "AAHRPP called and said, You have a lot of stuff to do, but we don’t know if you can do it by the next council meeting in June."

The institution had to make changes to the accreditation report and form another IRB, as well as hire additional staff, Milne notes. "They reviewed our updated report and felt we had made changes according to their suggestions and that we had a program that merited full accreditation," Milne says.

• Maintain accreditation. The institution’s full accreditation will last three years, and then it’s time to return to the process. However, there still is a lot of work to do in the interim, Milne says.

"The next self study should not be nearly as difficult," he says. "But I think the other thing that happens is you’re constantly changing." For instance, AAHRPP changes its policies and standards, and then an institution will have to respond to these changes. The executive committee has to continue to meet to discuss changes and decisions, Milne says.