HRPP shares ideas for restructuring
Improved staff retention, turnaround time
In the fall of 2011, Indiana University’s Human Research Protection Program was in crisis. Turnaround time for review of protocols was "horrendous," says John R. Baumann, PhD, now the executive director of the HRPP at IU. In what Baumann calls a "perfect storm" of challenges, staff turnover was high, electronic systems were adding to problems rather than addressing them, and there was a large backlog of studies waiting for review. Researchers’ assessment of the Human Subjects Office was dismal.
"I don’t believe it was a problem of having the wrong people — there just were not the right processes and procedures in place," he says. "In addition, a new program for processing had been partially implemented and created a need for workarounds — it was sort of a perfect storm."
In November and December 2011, the leadership team worked to identify key issues in the program structure and began a reorganization of procedures and workflow in January 2012. Baumann was named the full-time executive director of the program in February 2012.
Creating more accountability
One of the first changes, he says, was to restructure the teams in the office. Previously, the HRPP office was divided into four teams, with Team 1 in charge of exempt studies. Every person on the team could review the studies, but only one person had the authority to sign off. Baumann and colleagues’ first step was to divide the office into three teams by academic unit — teams 1 and 2 have biomedical studies, while Team 3 has social and behavioral research. Each team has full responsibility over studies, from submission to closure and even post-study audits.
"In our opinion, there was not an alignment of responsibility, accountability, or authority," Baumann says. Studies had dividing points, including intake, screening and review, and outtake. Associate directors had responsibility for screening, but not for intake or outtake. "We said that doesn’t make any sense, and now each team has responsibility for studies from soup to nuts, from when it comes in the door, to closure and audit," he says.
In order to eliminate the backlog of exempt studies, approval authority was expanded throughout the team. Members who have been in the office for a minimum of six months can participate in specialized training in order to gain authority to confirm exempt status. "We didn’t do that and turn a blind eye; everyone who got the authority was monitored for six to eight months after completion to make sure they were meeting appropriate standards," Baumann says. Mean turnaround time for exempt studies is now at seven days, down from a mean time of 47 days in fiscal year 2012.
Another problem the office encountered was waiting for response from researchers if protocol review determined questions or issues with a study. "That clearly affects turnaround time because in every human research protections office, the time a study spends in the hands of the researcher is a significant part of the turnaround time," Baumann says. "If you give people 30 days to respond and they respond in 28, you can’t have turnaround time of less than 30 days."
In response, the HRPP created a policy requiring researchers to respond to questions within two weeks, or the study would be administratively withdrawn. That would not be punitive, or the end of the study, Baumann stresses; at resubmission, the process would be picked up where it left off. "What we found was that very few people complained," he says. "There were staff quite concerned about the faculty response, but there were very few complaints. This [policy] tells us that the researcher is ready for the study to be processed."
Improving turnaround time
Also contributing to approval delays was the repeated tabling of studies. Baumann notes that there were numerous cases in which a study would be tabled and not resubmitted for 60 days — and then it would be tabled again. The HRPP’s new policy states that studies cannot be tabled more than once, and resubmission must occur in time for the committee’s next meeting, 30 days later. At second review, the study must be approved or disapproved. "We did not do that in a punitive fashion — it just meant that studies didn’t sit out there, lingering," Baumann says. The IRB offers resources for researchers whose studies are tabled; they can speak to an IRB member for guidance on study design, attend an IRB meeting to answer questions, or use other resources for help. "Researchers found it more helpful, and reviewers like it because they don’t have to keep looking at the same study," he says.
The policies have decreased turnaround time significantly: In the second quarter of fiscal year 2012, full board studies had a mean turnaround time of 92 days. A year later, the mean time is 31 days.
The process for prior approval of research assistants was also simplified. "Any time there was a new person added or subtracted from a research team, it needed prior approval," Baumann says. "We were requiring co-investigator updates from everyone, no matter what." Instead, researchers are required to identify key and non-key research personnel, and only key personnel are required to have prior approval. Researchers still have to submit financial disclosures and proof of education for staff, but prior approval is no longer required for non-key staff. "We also implemented a monitoring procedure. Randomly during the year, we take a look at non-key personnel and make sure they completed educational training and disclosures before starting. So far, we have found no noncompliance. We regularly monitor a couple of times a year at random and never had a problem."
Another change focused on enhancing the utility of the IRB executive committee, which includes the chair and vice chair of each of the seven IRBs "Over time, the meetings lost focus and it became more of an opportunity for staff to report what was new," Baumann says. To enhance the function of the committee, the team implemented a new structure and the committee now has a chair, a vice chair, a new mission statement, and identified areas in the HRPP that would need its approval. "With the development of the new structure, they began looking at the processes and responsibilities of the committee members," he says. "The chairs became more active players in the process, and the committee is a more active group."
One of the HRPP’s most innovative pilot programs, Baumann says, involves getting studies to a convened meeting more quickly by reducing the back and forth between staff, researchers, and sponsor. For example, if staff had a question about an issue such as informed consent, the comments would go back to the investigator — and be bounced between investigator, sponsor, and committee multiple times. "Different offices do different things with the study — some administratively process it, some screen it and critique a lot," he says. "We were doing a lot of the screening."
Working with the IU cancer unit, the HRPP implemented a pilot program in which the study would be sent for review along with the staff’s comments, if all the basic study elements were there. The IRB would get the review and see the original edits and comments. "It eliminated one set of communications," Baumann says. "It was successful in getting reviews done quicker." The HRPP expanded the program to Team 1 and select units of Team 2. "The pilot is now standard operating procedure," he says. "We’re always looking to see what we can do differently, with no sacrifice to protection of subjects, to be more efficient."