One-page checklist saves time for IRB staff
Short, succinct, comprehensive form
Investigators and student researchers repeatedly called the IRB at the University of the Incarnate Word, asking the same questions, and IRB reviewers complained of continually seeing the same mistakes. Clearly, it was time to make IRB office system and procedural changes.
"We’d see the same errors and misinterpretations of what we were asking for," says Rebecca Ohnemus, MAA, CRA, research officer at the University of the Incarnate Word in San Antonio.
"In talking with applicants — particularly student researchers — we figured out that our instructions were not very clear or helpful," she explains. "We never guided anyone and had not emphasized the importance of continuation and closure."
Ohnemus addressed this problem by creating new forms, guides, sample research examples, and checklists. One area of particular interest involved informed consent.
"We found students who didn’t understand that when you need to consent someone, the informed consent form has to include everything on the [regulatory] list," she says.
"And I found it incredibly frustrating to review consent forms and sit there with the IRB manual, counting off items on my fingers," Ohnemus adds. "It’s not efficient, and it seemed like there should be a better way of doing it."
The solution was a standardized process through the use of an informed consent checklist.
"I went to the regulations and pulled up the requirements for consent when writing the checklist," she says. "Some of the checklist items are rephrased into more common language for readability and comprehension so anyone can pull this up and understand what it’s asking for."
Ohnemus edited the checklist until it fit on one page.
"I wanted to keep it streamlined so people wouldn’t look at it and be overwhelmed by the quantity and arrangement of items or think it looks intimidating," she explains.
In keeping with how the IRB would like to see informed consent documents, Ohnemus created the checklist to allow enough white space and to organize items logically and simply.
"I’ve seen some single-page forms that are overwhelmed with text," she says. "There is a lot going on in a number of forms I’ve seen, but the less going on is better — easier to digest and apply the information."
When she had a rough draft complete, Ohnemus rewrote and edited items to make them as succinct and simple as possible. (See copy of informed consent checklist, page 103.)
"I did a test run with some students," she says. "I casually sent it to them when they sent in their IRB review application, saying, Your consent form is missing, so here’s a checklist to help identify items on the form.’"
She asked student researchers to look over the checklist and let her know if it was helpful or if they had any difficulty using it.
"I said, Hey, if you want to, there is no imperative to distribute this and no imperative to give feedback, but if you’d like to distribute it and give feedback — positive or negative — please do,’" Ohnemus says.
It received rave reviews from students and faculty members, she recalls.
"It was gaining traction before it was even a thing yet," Ohnemus says. "There are things we do every day that are largely unnoticed, so when someone turns around and says, This really helps and it saves a ton of time,’ it feels good."
Since implementing the informed consent checklist in early 2014, Ohnemus has noticed that informed consent documents are being submitted with fewer missing items. Also, her phone calls now are requests for additional tools.
"Now I get more phone calls from students asking about other checklists that we might be creating," Ohnemus says.
Investigators and student researchers repeatedly called the IRB at the University of the Incarnate Word, asking the same questions, and IRB reviewers complained of continually seeing the same mistakes. Clearly, it was time to make IRB office system and procedural changes.
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