A recent study revealed that an informed consent checklist of basic consent elements guides investigators on how to present key information required by the Common Rule.
As the deadline for the revised Common Rule approached, an IRB office reviewed its informed consent templates and worked to update key information, says Lisa Rigtrup, CIP, operations manager of the IRB at The University of Utah in Salt Lake City.
“Because we’re a biomedical campus and behavioral science campus, we had to create different templates to accommodate different study designs,” she explains. “One thing we found was it made our templates unwieldly.”
The templates were an inefficient way to help investigators with informed consent and all the ways these forms needed to be written according to the study’s type. “That’s when we came up with the idea of providing guidance and checklists to our research community,” Rigtrup says.
The solution was an informed consent checklist, similar to an internal checklist used by the IRB office to conduct pre-reviews of applications, she adds. “We reached out to our biggest departments and said, ‘We’re thinking about doing this checklist; can you give us some feedback?’” she says.
Engaging stakeholders and making the change transparent helped the IRB achieve buy-in when the checklists were rolled out. “It took away some of the shock and made sure some of the biggest departments and stakeholders around campus were prepared,” Rigtrup says. “Initial outreach softened the blow quite a bit.”
The online informed consent (IC) checklist provides users with basic IC elements, such as: “Is there a statement that the study involves research and an explanation of the purposes of the research?” It includes drop-down information under the categories of discussion, sample language, and regulatory references. (The University of Utah IRB’s checklist can be found at: https://irb.utah.edu/informed-consent/consent-document-checklist.php.)
Originally, the IRB used separate templates for various research authorizations, such as a HIPAA authorization. With the checklist, each area has its own tab.
“We’ve gotten really good feedback from our research community,” Rigtrup says. “It has required very little tweaking.”
The initial outreach in rolling out the checklist contributed to its positive feedback, she adds. Plus, researchers praise the checklist formatting. They use the checklist’s phrasing and topic priorities when they write IC forms.
“The impression I get is that the checklist is sensitive to their patient population, and they’re able to use informed consent wording that makes sense to people,” Rigtrup notes. “The checklist has helped them move wording in a way that the informed consent conversation makes more sense. Anything they can do to enhance the process is good.”
The checklist’s success led to the end of almost all informed consent templates: “Our templates are gone; they’re not using them anymore,” Rigtrup says.
The only exception is the oncology department, which created a template for its Phase III clinical drug trials. A template works in this case because the oncology trials are homogenous, so a template would need few adjustments.
“The oncology department said, ‘If the IRB does not want to handle this anymore, would it be acceptable to create our own template to use?’” Rigtrup says. “We said, ‘Absolutely, and if you want to run it by us, that’s fine.’”
The checklist’s chief benefit is that it helps investigators improve their review submissions, she says. “If they check off everything on the checklist, chances are their revisions are very low,” Rigtrup says. “Using it has reduced some of the basic errors.”
This saves time for IRB staff and members, giving them the opportunity to focus on bigger issues, she adds.
“We also are finding it has cut some of the apron strings with investigators,” she says. “You have researchers who would really depend on the IRB to catch a lot of things, and now we say, ‘Here are the tools, and you need to know this information in detail.’ We’re putting some of this information back on them.”
Study coordinators report that they appreciate the checklist because it helps them do their jobs better, and they require fewer simple revisions, Rigtrup says. “When researchers are collaborating with other universities, sharing their resources among multisite studies, they don’t have to change too much in their IC document because there is template language they have to adapt to each site,” she adds. “It seems to make things easier for multisite studies.”
IRB staff check human research protection program guidance regularly and compare new guidance to what is in the checklist, making sure everything is up to date.
When the checklist first rolled out, IRB members needed a little education about its language, content, and how these fit with regulatory requirements.
“Just because the language is not what they’re used to seeing doesn’t mean it’s not acceptable,” Rigtrup says. “We show people the part of the checklist a regulation goes with so they can see that it meets the requirements.”
The Common Rule’s flexibility has helped people accept the change, she notes.
From the IRB’s perspective, it is a case where trying something new has paid off: “It adds to our flexibility and ability to do things in an adaptable way, which is the future for IRBs,” Rigtrup says.