Service effort puts human face on research oversight

A youngster participates in simulation research at The University of Iowa. The Human Subjects Office, which oversees all research conducted at the University involving human subjects, has made great strides toward improved efficiency and overall satisfaction with the office. Photo by Tom Jorgensen.

Andy Bertolatus looks quite comfortable in his office in the new University of Iowa Human Subjects Office (HSO) space on the first floor of Hardin Library. He became the executive director of the HSO on July 1.

His appointment is just the latest in a string of changes aimed at improving efficiency in and overall satisfaction with the office.

The HSO was established by the Vice President for Research to provide support to the University’s Institutional Review Board (IRB), which oversees all research conducted at the University involving human subjects. The IRB is an independent panel of people from various backgrounds—faculty, staff, and community members—that meets periodically to review applications for research studies that are considered greater than minimum risk to human subjects.

Bertolatus, who has served as chair of an IRB for the last 10 years, says the reviews are required by law.

“IRBs were basically created by federal regulations that came into existence in the ‘70s and early ‘80s arising from earlier periods of various scandals in the world of human subjects research that led to a belief that there was the need for more oversight,” Bertolatus says.

In an average year, the UI Human Subjects Office processes 2,850 active projects from all across campus and University of Iowa Hospitals and Clinics for IRB approval. In addition to that, the staff of 17 processes approximately 5,500 additional application submissions, which could be modifications, continuing reviews, or a combination of both.

According to Jim Walker, associate vice president for research—regulatory affairs, because of constantly changing federal regulations and the complexity of the application process, people were quick to criticize the IRB, and by extension, the HSO in the past.

“The IRB was a lightning rod for complaints. There were incredible concerns about it, not only here, but nationally,” Walker says.

So, in 2008, Walker and the HSO staff began looking at what could be done to improve the office. They went through a Lean event, which identified several areas that needed to be reviewed and improved.

One of the first improvements included expanding staffing and resources. Since fiscal year 2008, staffing has increased from 12 full-time employees to 17, allowing for several senior-level staff members to focus on specific tasks to decrease inefficiencies in the application process. They’ve also focused on making staff more accessible to researchers going through the application process by implementing office hours. Every Wednesday and Thursday researchers can come in with questions for the staff.

Michele Countryman, interim assistant director of the Human Subjects Office, says adding office hours is one thing that has already made a difference with researcher satisfaction.

“We’ve had really positive feedback from the researchers who have come in,” Countryman says. “We use HawkIRB, which is an electronic system for the application process, so it really seems like a black box to the researchers where correspondence goes back and forth. Office hours really puts a human face to our processes. I think it’s creating a much more personal kind of atmosphere.”

The HSO has also expanded training and education opportunities for researchers and IRB committee members. Staff have always been available to have individualized educational sessions for targeted audiences, but have started offering even more educational sessions throughout the year. The HSO is also in the process of launching an electronic education process through ICON. According to Countryman, these will be some of the same classes offered in person through the office, with the added bonus of flexibility, especially for students who may be embarking on human subjects research for the first time. The Center for Credit Programs has been helping the HSO record sessions and upload them to ICON. They hope to have the ICON classes available by the end of the year.

But perhaps the biggest change in the office is the implementation of a continuous quality improvement program, focusing on improving application review turnaround time.

“The University of Iowa is a biomedical research institution. We are unique because of our managed research hospital and our vibrant research enterprise. Time is always of the essence, so people want research to go through quickly,” Walker says.

Application workflow reviews were implemented and approval times are now being monitored by pulling data on a monthly, quarterly, and annual basis. Application review times are routinely monitored for individuals, boards, and other committee review times.

“We started really taking a look at how long it takes to process an application and then trying to find a basis for why some of them may take longer than others,” Countryman says. “As a result of that there were some changes based on the review structure.”

Minor modification reviews like research team member changes that used to take five to 10 days—and sometimes longer—are now turned around in about 24 hours. Modifications to expedited studies, which are those considered to have minimal risk to the human subjects, used to take around 30 days for review. Now they take between three to seven days.

Pat Winokur, associate dean for clinical and translational sciences in the Carver College of Medicine, has worked with the HSO in numerous capacities throughout the years, and has noticed the marked improvement and focus on researcher satisfaction.

“The HSO has worked very hard to speed the process for reviews and we now can often get our trials approved within three weeks, which is at least half the time it used to take for similar trials,” Winokur says. “Despite the fact that they are working faster, we still find that the team is quite careful with the reviews and are keeping safety for our participants at the top of their priorities.”

Walker is pleased with the continued positive feedback and acknowledges that the hard work of the last few years has paid off.

“The hard work of the office staff and the IRB over the last few years is paying off, but we are not finished yet. We actively seek input on our performance either through the recently convened IRB faculty advisory committee or through ongoing communications with researchers,” he says.

“The transformation has been good for everyone.”