Simplifying forms can save staff time, improve quality

Collect solid details; reduce questions

One issue regarding IRB submission compliance that often is overlooked has to do with the complexity of IRB forms. What if an IRB could make significant improvements in research site protocol compliance simply by simplifying and improving submission and other forms?

That is the theory behind the work one institution put into a quality improvement project involving its electronic forms.

And the changes have had positive anecdotal results: "The feedback has been outstandingly good," says Joann Margaret Glacken, MA, research support services specialist at the University of Illinois College of Medicine in Rockford, IL.

"People have said they like the new forms," Glacken adds. "The forms are longer, but they're easier to read because there's more white space."

The style is simpler, and the language used makes more sense intuitively. Some novice investigators have told Glacken that they now understand the forms for the very first time.

Glacken, who performs pre-submission reviews on each IRB application, expects the revised forms ultimately will help reduce IRB staff time in handling protocols.

"Using the new forms is helping reduce my frustration level," she says.

"This is something people don't talk about, but I believe wholeheartedly that people need to address in academia how to reduce both our man hours in the IRB office and our frustration with the workload," Glacken explains.

For example, Glacken found as she looked at IRB submissions that investigators and students conducting research stumbled over the same questions on each application. This suggested the problem was in the form itself.

"You can spend literally hours on a form pre-submission for review, and you don't even know how to advise that person anymore," she says. "That's when the form needs to be rewritten."

Glacken enlisted the help of the medical college's librarian, who also had served on the college's IRB for close to six years.

Ellen Schellhause, MSLS, health sciences librarian at the University of Illinois College of Medicine in Rockford, also is a member of a health literacy group on campus.

"We use principles of health literacy as we write these documents," Schellhause says. "I volunteered to head a subcommittee on the documents."

Here are some of the ways Glacken and Schellhause revised and improved IRB forms:

* Take existing university forms and tailor them for the campus: The University of Illinois had developed human subjects research forms for use by any of its satellite campuses. But as often happens with forms designed to work for a variety of groups, these contained features that were not relevant at the Rockford campus, and so the forms needed to be tailored to fit, Schellhause says.

A small committee met to go over the current forms and identify ways to improve and simplify them.

"We used a laptop computer and projected the forms on the wall, putting them where everyone could see them at one time," Schellhause says. "We identified themes as we were doing this."

The committee also sought logic in the forms, asking questions such as, "What do we need to see first when submitting a form?" she explains.

"The number one thing we wanted in the forms was clarity, but we changed them also to ensure we had a logical flow," Glacken says.

"There's only one of me on the Rockford campus, so that means in terms of man hours that it's very critical to my survival that I'm efficient," she explains. "If I have to write a request for a modification letter then that's one more hour out of my day."

They decided the first items they needed to see on the forms were the investigator's name, contact information, and qualifications, Schellhause says.

* Make type, format more readable:The revised IRB submission forms take full advantage of white space, bullet points, and checklists to make these pages of copy more readable.

"We broke down things into bullet points format so it would make it more logical for people using the forms to follow what we want them to do, and it's less confusing," Schellhause says.

"One other thing we did was for the more complicated forms, we did very simple checklists," she adds.

"As you print out the form and are filling it out, you can check off items to make sure you've completed everything," Schellhause says. "We've discovered that we have a lot less back and forth between the IRB and investigator because they can check everything themselves to make certain it's included."

* Make forms ask for information that will save IRB office time: As they continued to review and revise the forms, they decided it would be very helpful to the IRB office if the forms also listed the researcher's human subjects research protection training and dates, she adds.

"It makes it easier for the person who is checking these if the boxes are right in front of them," Schellhause says.

Although this seems like a very small item, it has a huge impact on Glacken's IRB work.

"Researchers need to be cognizant of their own training dates," Glacken says. "You can spend hours tracking down their training dates."

It was fairly common for a principal investigator or medical student to call Glacken when they're filling out an IRB application to ask her to look up their training dates, a task that might add hours to her work week.

This time-consuming extra work has been eliminated by the form revisions. Now that PIs are required to put their training dates and information on the IRB submission form, they have to do their own research to find the dates. And once they've completed the forms, they have the information readily available on their own computers, Glacken says.

"If you write an efficient form that asks everything from the PI that is critically important for the IRB reviewer to know, then you are forcing them to give complete disclosure," she explains. "This makes less work for me as a coordinator."

* Collect solid details in IRB submission forms: "The more detail you have in your application, the more it forces the PI to think about his protocol," Glacken says.

For instance, in the form's section about subject recruitment, the application should ask for details about how recruitment will take place, which kinds of materials will be distributed for recruitment, which venues will have advertisements, etc.

"If you put a place in the application that forces the PI to provide this detailed information, then you won't have an IRB reviewer later saying, 'This is too general — you have to tell me more information,'" Glacken says.

This also prevents IRB staff from having to send out modification requests.

* Take advantage of electronic form hyperlinks:IRB offices that have electronic submission forms can cut down on their forms' lengths without sacrificing important information necessary for a minority of studies by using hyperlinks.

For instance, if an institution's researchers rarely recruit vulnerable populations, then it might be overkill to have each submission form feature the same paragraphs and questions regarding the handling of vulnerable population subjects. But a simple 'yes' or 'no' question could serve the same function.

So if an investigator checks 'yes' when asked about recruiting vulnerable populations, the hyperlink could call up the additional information and questions.

"We changed the form so that the 'no' answer came first, so the investigator could easily go to the next question," Schellhause says. "If the answer is 'yes,' then you stop there and go to this other form, filling out an appendix."

Hyperlinks also can be used when there's a need to insert an explanation of research regulatory standards, additional legal language, or explanations for those who might not already know this information, she adds.

* Train PIs, staff about revised forms: After the submission form committee settled on revisions to more than 50 different IRB forms, the revisions were reviewed by investigators and others and then sent to the IRB for feedback.

When everyone was satisfied with the changes, they published the new forms on the research Intranet site.

"We started the process back in August, and the last new form went up in December," Glacken says. "It's an ongoing process, so if we find an error, we'll update the form."

What they've found is the new forms have been a good learning tool for new investigators. Some have even said that they wished they'd completed the IRB form before writing their protocols because the form helped them think more clearly and logically about their research project, Glacken notes.

"The form forced them to think about the small details," she adds.