The IRB’s meeting minutes process was too long, too wordy, and inefficient.
That was the conclusion reached by the office of research/responsible research practices at The Ohio State University (OSU) in Columbus.
“Our minutes’ process was exceedingly lengthy, especially when compared with other institutions we had talked to,” says Paul Montesanti, CIP, senior IRB protocol analyst at OSU.
The IRB and research office decided changes were needed.
“We convened a working group, and the first thing we did was take a look at the regulations,” says Erin M. Odor, MA, CIP, quality improvement specialist at OSU.
The working group also consulted guidance from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). They checked records of site visits and warning letters of deficiencies by regulators.
“We reached out to peer institutions, including commercial IRBs and other institutions,” Odor adds.
The revised minutes template was completed before an AARHPP visit in fall 2017. The IRB took into consideration the accrediting organization’s feedback, which was mostly positive, she says.
After revising the template IRB meeting minutes, the median time between when the IRB meeting took place and when the minutes were sent to investigators declined by about two days.
“This is a really good improvement from the investigator’s perspective,” Odor notes.
Before, the minutes of the Monday meetings might be written and sent to the IRB chair for approval by Friday afternoon. This meant that investigators would not receive a copy of the minutes until the following week.
“Once we got the draft’s time down to a median of two calendar days, we got correspondence out the same week,” Odor explains.
Before the revision, 23% of minutes were sent out within the same week as the IRB meeting, Montesanti says. Now, 63% of minutes are sent out during the same week.
“If our IRB chairs took no more than one business day to review the minutes, we could get 90% sent out in the same week,” Odor says.
The following are the main changes to the minutes template:
• Switch from narrative to table format. “The old version of the minutes was prose narrative with several sections of prose that described different parts of regulator findings that we wanted to include in the minutes,” Montesanti says. “We moved it to more of a table format, considerably stripped down when compared with the original one.”
The new format contains some prose, including one section that describes the board’s discussion and another that outlines specific regulatory criteria for waivers, he says.
This change eliminated long summaries of research, which are contained in other IRB records, and duplicate summaries of requested changes. Also, the main determinations were simplified to a couple of words, instead of whole sentences.
But most of the new format is in simple tables. Average total word count is 2,000 words — 20% less than the old format.
The change also made senior staff review of minutes unnecessary and reduced staff time spent writing information into the minutes before meetings.1
• Meeting minutes follow a summary of required elements. Most of the regulatory information to which the IRB might refer in a board meeting is documented in other paperwork and not included in the meeting minutes, Odor says.
The working group created a summary of required and recommended elements of IRB meeting minutes, including items that are required by federal agencies, recommended by federal agencies, and required by AAHRPP. Asterisks after an element indicate this item might be documented elsewhere in IRB records.
Here is a sample of the required and recommended elements related to actions taken by the IRB:
- approve, require modifications to secure approval, disapprove, suspension, or termination of IRB approval;
- actions related to review of events requiring prompt reporting;
- basis for requiring changes, disapproval, or suspension/termination;
- separate deliberations for each action;
- effective date of approval;
- approval period (initial and continuing review);
- process to ensure conditions/modifications are met.
• Simplify input for meeting minutes. The OSU IRB uses a Word template that is completed after meetings, Montesanti says.
“We take notes during the meeting, and then after the meeting, we finish composing the minutes in the Word document,” he explains. “We also have a data document we make that includes all of the studies on the meeting list, and we also use that to create minutes.”
One early hope was to create a template that was so simple it could be completed during the meeting, Odor notes.
“It turned out that wasn’t feasible. There still is clean-up work required, especially with lengthier discussions,” she says. “We are able to do some of the work ahead of time, and we do some of the writing at the meeting.”
Also, IRB staff can manually copy information from the electronic system, including the study title, principal investigator’s name, sponsor, and changes requested, into the template using an autofill process, she adds.
“Our hope is that our meeting electronic system down the road will be smart enough we can do a report and check these boxes in the meeting, so we don’t have to do it manually,” Odor says. “We’re not there yet, but we’re moving in that direction, and that’s one of our long-term goals.”
1. Odor EM, Montesanti PM. Every minute counts: improving the IRB minutes process. Poster presented at the 2018 PRIM&R conference: Poster 44.