By Melinda Young
An IRB revised its board meeting minutes process from a clunky system of writing everything into an electronic document to one in which the minutes are automatically populated through the IRB’s electronic system, saving staff time and work.1
“When we started, the electronic system was too static, not flexible enough to generate minutes,” says Erik V. Soliz, MS, CIP, IRB program manager of the human research protection program at the University of Texas Southwestern Medical Center.
The old way of creating board meeting minutes sometimes took as long as a month for IRB staff to generate. Since the IRB revised its process, the staff can generate board meeting minutes within a week.
“It’s impacted the turnaround time for creation and completion of minutes substantially,” Soliz says.
Before changing the process, these problems were common:
- Mistaken voting numbers or attendance;
- Incorrect determination entered;
- Incomplete/mistaken summaries of controverted issues;
- Lengthy and wordy regulatory narratives.
“We created minutes using Word documents and PDFs,” Soliz explains. “The system couldn’t create list determinations, so we had to create macros in our Word documents so the words were populated to help us create the minutes.”
This process was manual. IRB staff spent too long creating the minutes, and the documents were long, he adds. The IRB includes four boards, with one IRB staff person supporting each board.
It seemed unnecessarily cumbersome to manually input that information. Soliz sought an electronic solution to the problem. “We have a dedicated information systems group at our institution,” he says. “We met with them, and I explained what our minutes look like and what we wanted our system to do.”
The goal was to update the electronic system with help from the institution’s academic information system (AIS) team to include information about the board’s determinations. For example, the electronic system stored data on whether an investigational drug was studied for a use not approved by the Food and Drug Administration, as well as when a drug has already received approval for another purpose.
“Everything we needed to generate minutes was in the system already, so it was just letting AIS staff know what we needed,” Soliz says. “Those determinations were not being captured by the system, so we had those added to the system. We also provided the AIS team with a template of our board minutes, what that looked like, and which areas they could pull from the system to see what my staff needed to create the minutes. We went back to previous minutes and found a lot of incomplete and mistaken summaries and controverted issues that were captured incorrectly. There were wordy narratives.”
After meeting with the AIS team, they modified the system to create and simplify the board minutes. The changes to the electronic IRB submission system are something that other IRBs could do, even with different electronic products.
“It wouldn’t make a difference which electronic system is being used by an IRB because it’s a collaborative effort between the HRPP [human research protection program] staff and those responsible at the IRB and the information technology department,” Soliz explains. “If a system houses all the information they need, there shouldn’t be a need for reprogramming because everything is already in the system.”
When the electronic system pulls in the regulatory references and language, it eliminates the need for workaround, autofill solutions. “We rarely use macros anymore because the system is pulling the information we need,” Soliz says. “In addition to pulling the citation, entered by my staff as determinations after each agenda meeting, it pulls each step my staff needs to generate the minutes.”
Staff training was simple because IRB employees were part of the revision process. They attended meeting with the AIS team.
The revised system includes IRB staff recording minutes decisions based on the IRB’s regulatory determinations for all agenda items. The electronic minutes template features specific regulatory codified citations. Because of this, the determinations section is greatly streamlined and easier to read both visually and in word length.
For example, the pre-update minutes about a new study included lengthy paragraphs explaining what the study involved. Some excess words included: “In accordance with labeling and their use, will not involve a route of administration, dosage level, use in a patient population, or other factor that significantly increases the risks.”
This is eliminated in the new, updated minutes. There is a preamble about how the board made the appropriate determinations on the criteria for approval. Then, it goes directly into determinations, followed by a list of relevant determinations, such as:
- HIPAA partial waiver for identification/recruitment (45 CFR 164.512): Yes;
- Vulnerable populations included: Yes;
- Vulnerable population categories: Pregnant women;
- Populations: Pregnant women/fetus — no direct benefit to women/fetus, yields biomed knowledge;
- Drug: Yes.
“It’s a lot more simplified, and my staff no longer needs to use macros in the document, because the system is doing it,” Soliz says.
The minutes are saved to the network drive in the office, and Soliz reviews them for completeness and accuracy. His associate director also reviews them. When reviews are complete, Soliz sends the minutes to the IRB chair, who also reviews and approves them, and they are presented to the board.
The board has noticed how much faster and more efficient the minutes are, Soliz notes. “There might be one or two times I’ve seen the board request changes when something in the minutes is inaccurate, but it’s not like it was before. The board noticed there was a big change and fewer errors in the minutes.”
So far, there have been no mistakes caused by the electronic process. “We did a test run to see what was being pulled from the system, and I believe the first round AIS hit it right on target,” Soliz says. “Everything we needed, they had the system do for us.”
- Soliz E, Fedewa J. Simplifying IRB minutes generation and review. Poster presented at PRIM&R Advancing Ethical Research Virtual Conference, Dec. 1-2, 8-9, and 15-16, 2020. Poster/Abstract:52.