Accreditation is not for the faint of heart
IRBs give lowdown on what to expect
With the first non-Veterans Affairs (VA)-affiliated IRBs now achieving accreditation, IRB coordinators may have their clearest look so far at how the process has worked and what might be gained from jumping into the accreditation waters.
The Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) of Washington, DC, announced late spring the names of three research organizations that were the first to be accredited. These were the Western Institutional Review Board (WIRB) of Olympia, WA, the University of Iowa in Iowa City, and the New England Institutional Review Board in Wellesley, MA.
The Partnership for Human Research Protection, which is a partnership between the Joint Commission on Accreditation of Healthcare Organizations of Oakbrook Terrace, IL, and the National Committee for Quality Assurance of Washington, DC, has begun the process of accrediting IRBs, but no announcements were made as of early August.
According to the people who gathered information, organized changes, and met with AAHRPP site visitors during the accreditation process, there are two words that aptly describe what IRBs seeking accreditation might expect: enormous undertaking.
"Other IRBs applying for accreditation should be aware that it is an enormous undertaking, and planning appropriate resources is critical," says Erin Thacker, MS, CIP, lead administrator for the New England IRB.
Nearly a year before becoming accredited, the University of Iowa hired a full-time IRB co-chair, whose job entailed putting together the AAHRPP application, reports Trish Wasek, CIP, director of the human subjects office.
At WIRB, an accreditation task force, consisting of the director of human resources, the chief financial officer, and a senior vice president led a team that spent several months preparing the accreditation application, says Angela Bowen, MD, president.
Here is an inside look at how these institutions prepared and succeeded in achieving full accreditation:
• Completing the application and preparing for site visit. The application process is time-consuming and requires a heavy load of files to be sent to AAHRPP. "We had sent in six copies of almost everything," Bowen says.
Besides putting one person in charge of completing the application, the University of Iowa held a major administrative meeting of the institution’s two IRBs. "We told all of the IRB members a little bit about AAHRPP, and we gave everyone electronically a copy of the application we had submitted," Wasek says.
"We went through a preliminary version of the site visit schedule and told people that certain IRB members would be interviewed, although we didn’t know who would be selected by site visitors," she says.
"Also, we gave them some background information and gave them a rough outline of what to expect during the visit," Wasek adds. "I think people had a lot of confidence in what we were doing."
The institution sent the accreditation application electronically and in a paper version, and the application included a thick set of additional documents, including IRB meeting minutes from the previous year, the institution’s standard operating procedures, a list of currently active protocols, consent application templates, monitoring reports, memos to IRB members, approval letters and memos to investigators, and just about anything else that was documented by the IRB office, she says.
IRB staff also assessed whether any of its current processes and policies needed updating or changing, and they decided that they could enhance the information that’s available for participants in research, Wasek says.
"We added a good deal of information on our web site for the public," she says. "We also developed a brochure with general information about participating in research, and we placed it in public locations all over campus, including the library," Wasek says.
Once the application was complete, it was about six weeks before the IRB heard from AAHRPP, and then the organization worked with the IRB to schedule a site visit for January 2003, she adds.
Since the University of Iowa IRB staff knew that the accreditation site visitors also would interview researchers, they sent a mass mailing to about 1,000 principal investigators, telling them about the accreditation application, Wasek says.
"We told them it was possible they’d be selected as one of the researchers the site visit team would interview on a rather short notice," she explains.
• Surviving the site visit. The site visit included four accreditation officials plus the deputy director of AAHRP, Wasek says.
The site visitors gave the IRB staff a list of active protocols that they wanted to review, she says.
"Half a day of the site visit was spent reviewing files," Wasek adds.
"I met with them for about 45 minutes, and the accreditation team split into two teams, so there were simultaneous interviews going on," she explains. "We had a very pleasant interview, talking about how our office operates and about the similarities between how we process biomedical applications and behavioral research applications."
It was clear to Wasek that the site visitors had reviewed the volumes of information sent with the application, and she says she felt her role was to explain everything in more detail, including how certain aspects of the IRB review process works.
For example, the University of Iowa IRBs hold two full board meetings per month on continuing review applications. Other institutions may do this differently, so Wasek explained to the site visitors specific details of how the IRBs handle continuing reviews.
Six accreditation site visitors spent four days at WIRB, reviewing files and interviewing department heads, Bowen says.
During Bowen’s interview, the site visitors asked about her career and how she manages the business affairs, Bowen recalls.
They were particularly interested in the types of systems she uses to manage WIRB. "They were asking, How do you keep up with whether there’s a quorum at the board?’" she says. "They asked how the board members are performing, how the staff are performing, and how I make sure everything is done within the regulations."
Most of the 100 or so WIRB members were interviewed by the site visitors, although some of the members who are located in Canada and California were interviewed by teleconference, Bowen notes.
WIRB had notified investigators and sponsors in advance that they might be interviewed as part of the accreditation process, so everyone who was contacted knew what to expect. Although the site visit interview is a time-consuming and intrusive process, all of the people who were interviewed responded very well to it, she says.
• Debriefing IRB members and staff. The New England IRB held an informal debriefing session with IRB members and staff after the site visit was completed, Thacker says.
"The outcome of the survey was discussed, as well as everyone’s opinion of the overall process, including the site visit and member interviews," she says. "Everyone felt as though they had learned from the process, including increasing their own personal knowledge base, as well as learning about AAHRPP’s mission and how it has helped to improve our organization."
IRB members expressed satisfaction with how they had done, and they were not surprised to learn that the IRB had excelled in most areas examined during the accreditation process, Thacker says. "Everyone concurred that the level of review provided by NEIRB reflects our commitment to the protection of human research subjects."
As a part of the New England IRB’s commitment to continuous quality improvement, the IRB recently has developed a national site visiting program and an investigator self-training CD, as well as having expanded its quality assurance and quality improvement program, she adds.
• Reaping accreditation rewards. After receiving word at the end of April 2003, of the board receiving full accreditation, WIRB staff and board members celebrated with a big cake and coffee, Bowen says.
Also, Bowen gave each staff person and board member a plaque that announced that person’s contribution to the pursuit of accreditation.
Better yet, the Washington state legislature gave WIRB a proclamation, stating support of the IRB’s having received accreditation, Bowen notes.
Achieving full accreditation has resulted in other benefits, as well. For example, some of WIRB’s research sponsors have been willing to accept the IRB’s accreditation as sufficient evidence of the IRB being in full compliance, and so they have not conducted audits as they had in previous years, she says.
"We do some portion in or in some cases all of the IRB work for some 80 institutions, and it was quite reassuring for the institutions for us to have public evidence of our adherence to proper process," Bowen reports.
When the New England IRB received word of full accreditation on May 30, 2003, the IRB held a small celebration and issued a press release announcing the good news, Thacker says.
"Many [of the staff] also expressed pride that our organization had decided to pursue the voluntary accreditation, as the accreditation provides NEIRB with a sense of distinction," she says. "For those directly involved with putting together the application, there was a feeling of relief as well as of fulfillment."
With the first non-Veterans Affairs (VA)-affiliated IRBs now achieving accreditation, IRB coordinators may have their clearest look so far at how the process has worked and what might be gained from jumping into the accreditation waters.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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