Tips for improving writing of IRB meeting minutes
Tips for improving writing of IRB meeting minutes
Use "action" verbs actively
IRB staff can greatly improve how the IRB meeting minutes are written by following a few helpful hints, experts say.
For one thing, IRB meeting coordinators need to be able to follow the sometimes disjointed way IRB presenters discuss a protocol. So while a template is useful, it needs to be made very flexible.
"Sometimes a presenter, depending on experience level, may jump from one point to another," says Marion Olson, CIP, supervisor of human subject research regulations in the Office of Protocol Research.
For example, a presenter might briefly mention that the sponsor is holding the investigational new drug application and then move to the topic of biochemical blood draws, which might take up the bulk of the meeting discussion, Olson explains.
"So the IRB meeting coordinator takes notes about the issue that the IRB thinks is important," she adds.
Also, Olson meets with meeting coordinators before each IRB meeting to review the protocol and discuss the points that are likely to be most important to the board.
"We want to make sure all the important points are captured," Olson says.
"We put special considerations for each individual protocol in the coordinator's template for that meeting," says Martha Matza, MS, CIP, CIM, director of operations of protocol research in the Office of Protocol Research.
The minutes are put in a format that includes the title of the protocol, name of principal investigator, name of protocol presenter, presenter synopsis, committee discussion, final IRB committee motion, and final protocol contingencies/issues.1
Another key to improving meeting minutes involves mentoring IRB staff.
"Marion is a great mentor to her staff," says Wanda Quezada, CIP, manager of human subject research regulations in the Office of Protocol Research.
"We can develop templates and give them to the staff, but it's really important that the management staff develop a mentoring relationship with their meeting coordinators," Quezada says. "A lot of the coordinators do not have meeting experience when they're hired, so Marion tries to meet with her staff on a weekly basis."
Olson also meets with IRB staff before each IRB meeting to give them a chance to ask her questions or to explain why certain items have to be well documented.
"So they're educated about the protocol," Quezada says. "In the last four years, we've had the best minutes we've ever had in the IRB office because of the continuous education Marion provides."
Tips for the troops
Quezada, Olson, and Matza also offer these tips on improving IRB meeting minutes:
• Use action verbs: "Use action words like 'clarify' and 'justify' in the minutes," Matza says.
Other examples are 'provide,' 'document,' and 'revise.' An example, according to an abstract on the topic is the sentence: "Clarify and provide an assurance of how the data will be collected, reviewed, analyzed, and monitored…"
• Avoid pronouns and be more formal in capturing the discussion: Olson teaches meeting coordinators to avoid using "he" and "she." Instead, they need to refer to the speaker by title, such as "IRB chair" or "community member" or "committee member."
"I don't have them use pronouns because it's too confusing," Olson says. "You don't know who the speaker was or who the commentator was."
Also, meeting coordinators use complete sentences and avoid making word-for-word documentation of the discussion.
• Make the minutes readable: IRB meeting coordinators should read the minutes out loud to ensure they've accurately captured the discussion. And they need to write the minutes with language that would be clear to people outside of the IRB office, especially focusing on making the IRB's intent clear.1
"If we can keep the minutes in layman terms and not put in too much scientific jargon, then it seems to work well, and investigators can respond in a timely manner," Olson says.
• Use reference materials: The meeting minutes should include reference materials, including the protocol abstract, informed consent documentation, regulatory guidance, etc.
It's important for IRB directors to train staff on taking meeting minutes because this is not something they will know how to do without specific experience, Olson notes.
"When you bring in individuals who don't have a lot of IRB experience, they don't realize that taking minutes for an IRB meeting is not like taking minutes for a corporate board meeting," Olson says.
"Since doing it this way the minutes have been much more comprehensible," Olson says.
"Say someone wanted to review the minutes because of a critical issue that had been discussed at the meeting," she adds. "They could take the minutes and understand what the IRB was trying to convey to the principal investigator, even if they had not attended the meeting."
Reference
- Olson M, Quezada WA, Matza MJ. Guidelines for composing institutional review board (IRB) meeting minutes. Poster presented at 2008 PRIM&R Advancing Ethical Research Conference, held Nov. 17-19, 2008, in Orlando, FL.
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