The consent calendar is a century-old tool, but it can work well in saving time during IRB meetings. Typically, IRBs review each study up for continuing review, discussing and voting for each, separately. But that might not be the most efficient way to handle these on the board meeting agenda, says Glenn Martin, MD, DLFAPA, CIP, senior associate dean for human subjects research, executive director of the program for the protection of human subjects, and associate professor of psychiatry, Icahn School of Medicine at Mount Sinai in New York City.

“If you have questions to be voted on, and they are straightforward, boring material, then you can put them together on one list [for a single vote],” Martin says. “This list of items can move to the consent calendar.”

Robert’s Rules of Order calls this time-saving tool a consent calendar, although it also is called a consent agenda. (More information is available at: http://bit.ly/2Hmx7u3.) “It dawned on us at our meetings that there are a lot of continuations that are straightforward, but require the full board,” Martin explains. “Maybe there were no unexpected adverse events, yet we were spending time on those items with a primary reviewer giving a brief synopsis, followed by a brief discussion.” These were needlessly wasting board time, he adds.

IRB staff and an IRB member examine the continuing reviews and send any questions to the principal investigator to resolve before the board meeting. All facts about the study are included in the agenda packet for every board member to see, Martin says.

IRB members can pull up the consent calendar on their laptops or tablets. If there are no questions or issues, the continuing review can be approved in a consent calendar. Icahn School of Medicine’s four IRBs made the switch more than a year ago, and they found that it has shortened meeting time and improved efficiency. A study revealed that the consent calendar saved about 30 minutes of a two-hour scheduled meeting.1

Initially, there was some resistance to the change, Martin notes. “At first, people were skeptical,” he says. “Some said, ‘It doesn’t feel right.’”

IRB Maintains Control

Martin pointed out that the IRB was not giving up control by switching to this faster way of approving continuing reviews. This was because any board member, at any time, could ask for a continuing review item to be taken off the consent calendar and placed back into the agenda to be discussed later in the meeting. “If you want more discussion, you’re in complete control of that,” Martin says.

Board members receive the list of continuing review items in advance so they can red-flag one if they have a question or concern. Since rolling out the consent calendar, fewer than 1% of items were withdrawn for further discussion and vote.1

“Every now and then, someone will pull an item out because of something they remember that happened with the study, and they want to talk about it,” Martin says. “We put it back on the agenda.”

When an item is removed from the consent calendar, the primary reviewer presents it, and the person who pulled it from the calendar can ask questions. Board members then discuss it and take a vote. All items on the consent calendar are approved with one vote.

“It’s a very transparent process,” Martin says. “Everyone has all the information they need before the meeting.”

Switching to a consent calendar is fairly easy, although explaining to board members what it is about and how it works can take time, he notes.

“Three or four people knew what I was talking about when it was introduced,” Martin says. “The rest asked to have it explained a couple of times.”

Within a month of using the tool, it became clear to everyone, he adds. “People like it, and we have had zero negative comments that I’m aware of,” Martin says. “The IRB staff likes it; it makes writing this into minutes automatic, and it makes the meeting a smoother operation.”

From a regulatory perspective, it is fine because items are discussed if necessary. The items on the consent calendar generally are noncontroversial and are unlikely to require further questions or discussion, so they can be approved by unanimous vote.1

“We rolled out the consent calendar for all of the IRBs in the same month,” Martin says. “At meetings, we do the consent calendar before we start anything else.”

REFERENCE

  1. Martin G, Bania T, Wilets I, et al. Consent calendar for continuing reviews improves an IRB meeting! All in favor say aye! Presented at the 2019 PRIM&R Advancing Ethical Research Conference, Nov. 17-20, 2019, Boston. Poster: 56.