Follow lessons from the trenches to improve your IRB

Complaints fell, response time rose

When faculty and researchers' anger and complaints rose heavily against a university's IRB, a new vice chancellor of health sciences took charge, hiring someone to answer the criticism through policy and personnel changes.

The IRB's overhaul has resulted in a paper published in Academic Medicine in January 2007, and it produced some best practices, including two-day turnarounds on investigator submissions that do not require a full committee review.1

The IRB at East Carolina University of Greenville, NC, was founded about three decades ago, but in recent years it had not kept up with increasing demands, says Kenneth De Ville, JD, PhD, a professor at the Brody School of Medicine in Greenville.

"There are regulatory goal posts moving all the time, and I don't think the IRB kept up with it in terms of the amount of staff and scrutiny needed," De Ville says.

When the university's administration first noted the large volume of staff, they reacted by making mechanical changes, such as increasing its full-time staff from one person to five, De Ville notes.

But the problem was that the full-time equivalent (FTE) employees they hired were all clerical workers who were largely unskilled in research and IRB work, he adds.

"My view of this is that even though IRBs have and are suffocating under paperwork, virtually none of the work is clerical in the traditional sense," De Ville explains. "So the institution did the right thing by providing more FTEs, but they were the wrong kind."

When the complaints continued, the vice chancellor responded by appointing De Ville to overhaul the IRB in June 2003. He reorganized the IRB over a 14-month period and remained involved, monitoring improvements, for a long period after that.

Since then, the IRB has been visited by the Office of Human Research Protections (OHRP) as part of its quality improvement outreach, and the result of the voluntary QI audit was very useful and positive, De Ville says.

"They said it was the most engaged IRB they had ever seen," De Ville says.

Also, the complaints have been greatly reduced, and investigators have developed collaborative relationships with the IRB staff.

"Investigators began to trust the IRB office and the advice they received," he says. "It really helped the relationship between investigators and the office once investigators began to believe in the capacity and credibility of the office staff."

Here's what institution officials learned from the experience of rejuvenating the IRB:

Hire the right staff.

"When they brought me in, I said, 'There are enough people, but the wrong kind,'" De Ville says.

De Ville listened to the faculty/investigator complaints about the IRB, and he concluded that the existing IRB staff did not understand the research environment and the dynamics of a clinical trial.

"So I tried to figure out how to remedy that," he says.

The solution was to replace existing IRB employees with staff who had clinical trial experience, including an associate director who had extensive clinical trial experience, De Ville says.

"Then I hired another research coordinator who had run trials for five years for outpatient drug trials, and the third person I hired was somebody who had worked in the industry at a big pharmaceutical company," he says. "So these people would know research better than I did, and they knew how research worked."

The IRB's remaining employee was the person who had five years of experience working on the same IRB.

"So the highest qualified person in the office turned into the lowest qualified person in the office," De Ville says.

The new IRB staff could talk with investigators, understand their material, know the institutional context of studies, and propose policy changes, he notes.

"I'm really convinced that personnel quality is where this really matters because even with a less than ideal system, you can run an office and work to make the system more perfect," De Ville explains. "In research, regulations are so fact-intensive, and there are judgments that need to be made, so you really need high quality people."

Change the way the IRB is structured.

The IRB had been operated for years with one employee and a board chairman who was in charge of both the committee and the office, in addition to his clinical duties, De Ville says.

"The chair's duties were too much of an overload," De Ville says.

Under the new format, the IRB was divided into two committees, with one handling behavioral/social science research and the other handling biomedical research.

The existing chairman, who is a professor in pediatric oncology, became the chairman of the biomedical IRB, and the chair for the new behavioral/social science IRB is a full professor in psychology, De Ville says.

"They are both researchers," he adds.

Also, De Ville recruited anthropologists, sociologists, and social science researchers to fill the new IRB's membership. There are some members who serve on both committees, including the chair of the behavioral/social science IRB.

Having a separate biomedical IRB stopped the complaints about the board having English majors review biomedical studies, De Ville notes.

De Ville found it easy to attract new board members: "I'd invite the people who had the most concerns about the committee to become members, and they could have input, and that helped a lot," he said.

The IRB meetings were streamlined, and a wider range of specialties were represented on the new boards, De Ville says.

Also, for some specialties, adjunct board members were recruited. For instance, a trauma surgeon is an adjunct board member who is called to a meeting when emergency research is being reviewed.

"For areas where we didn't have a specialist, such as an endocrinologist, we would sometimes use an in-house consultant," De Ville says.

Better educate IRB members and make processes more efficient.

The IRB has always used Internet education, but among the changes enacted was providing human subjects research textbooks to all IRB members and having a little education at each board meeting, De Ville says.

"The education piece is decided according to what's on the agenda," he explains. "So if there was an issue related to children on the agenda, then we'd do an education piece about that topic."

For example, De Ville noticed that IRB members had fallen into a habit of dissecting certain wording and phrases, often when these were not important issues.

"What I think happened was the committee members learned from the IRB, so as new members started on the board, they would take up the same habits," De Ville says.

"So the associate director and I would attend every meeting and encourage them to look at the more important issues and not focus so much on capitalizations and upper and lower case styles," he says. "This freed members to look at the real issues instead of style issues."

Also, whenever members review a protocol involving vulnerable populations, the IRB staff puts special templates into the minutes, and these templates follow all of the regulatory requirements. This ensures that nothing of importance is omitted from the review, De Ville says.

"So instead of someone saying, 'Yeah, that looks good for kids,' you can see how the board considered each point in the regulations," De Ville adds.

Reference:

  1. De Ville K, et al. Rejuvenating a foundering institutional review board: one institution's story. Acad Med. 2007;82:11-17.