When rolling out new forms, try this IRB's 'no-complaint' tactics
When rolling out new forms, try this IRB's 'no-complaint' tactics
IRB focuses on marketing, educational sessions
IRB policies and forms often need to be updated and revised as human subjects research rules and regulations evolve.
But how do you create interest and buy-in to new forms?
The IRB office at Saint Louis University in St. Louis, MO, has developed a thorough and effective process for introducing new forms to staff and the research community. Calling it a "no complaint tactic to new form development," the IRB office conducted a pilot study of its process and found that it led to decreased complaints.
Last year, the IRB office had several forms, including a continuing review form and an informed consent form, to revise.
"We thought that before we did the revisions and launched the new forms we should put a systematic format in place," says Melissa G. Fink, MA, a behavioral and social sciences IRB manager in the department of research compliance/IRB office.
The new process was a success. Complaints to the IRB office decreased, and there was increased consistency in how new forms were processed. Also, the IRB staff received positive feedback from investigators, and communication between the IRB office and the research community improved.1
Fink describes how the no-complaint process works:
• Form a team to handle the project. The IRB formed a team with members from the IRB staff, the board, and the research community.
"Then we assigned our small team and staff to make sure all necessary regulations were included in the new form," Fink explains. "They needed to consider who was using the form and make sure the form was clear and inclusive."
•Pilot the new form and identify problems. IRB staff used the form as a pilot test for IRB staff, researchers, and board members, and they made sure everyone understood the form's terminology, Fink says.
"Once we finished the initial draft we e-mailed it and asked people to read it for comprehension," she adds. "We asked researchers to make sure they could answer what we were asking, and we generally asked for feedback."
The pilot test was an informal way of gathering information, Fink notes.
The form was sent to a variety of researchers, including behavioral science investigators.
"You have to select people who take the time to look at the form," Fink notes. "A lot of time the people who were most apt to review the form were the people who were frequent users."
Those were the research coordinators and investigators who had the most at stake in switching to new forms, so they took time to look at it and provide their comments.
•Solicit input from the research community. The process of asking for feedback also was a first step in obtaining buy-in, Fink says.
"It was one more area where they could see we were taking their feedback into consideration and trying to be on the same team," Fink says. "It was one more thing that helped us form a better relationship with our research community."
Most of the feedback involved making the instructions more clear, including word changes, she notes.
"We didn't receive any comments suggesting a major overhaul of the form," she says. "It was really about fine-tuning the instruments."
Social/behavioral scientists suggested the form not use the word patient because the study participants are not patients, Fink says.
"So we eliminated the word patient from all of the forms and we use the word participant instead," she adds.
"When we piloted the form, it was understood that we were very appreciative of any comments or thoughts people had, but ultimately we were the authority on what would roll out," Fink says.
"Some feedback wasn't incorporated, but we'd get back to the person who suggested it with why we weren't using it," she adds. "It was very collaborative."
Once changes were incorporated, the original team gave the form a final edit. Then the IRB manager or administrative chair would approve the changes.
• Announce change to research community through networking. "We notified the whole campus and research community about the new changes on the form and why we had made changes," Fink says. "We spent a lot of time on the forms from a regulatory standpoint."
The IRB office set dates for training sessions and advertised the dates and locations of these.
There's an e-mail list of people in the research community, and notice was sent out through this e-mail list, as well.
"We put a notice on our web site," Fink says. "And we made an announcement at the IRB board meetings and at IRB staff meetings."
They notified all of the departmental scientific review committees.
"We blanketed the university with notices," Fink says. "We mentioned the new form at any brown bag sessions that month, and anytime the IRB staff communicated with a researcher, it was mentioned."
While past complaints had been that people didn't know about a new form, no such complaint could be made this time around, she adds.
"We made sure we were getting enough announcements out there and enough channels out there to communicate to people, and we had three training sessions in the month, as well," Fink says.
After one month of marketing the new form, the one-month grace period began, and the new form was placed on the IRB web site.
There were three notices sent out that month, letting people know that by the beginning of the following month the IRB office would no longer accept the old form, Fink says.
• Train IRB staff, members, and research community. A 30-60 minute training session on using the new forms was mandatory for IRB staff.
"We provided training at IRB meetings, taking the first 15 minutes to walk through the form for whoever was in attendance," Fink says. "For those who were not in attendance, we sent out the form by e-mail and encouraged them to call the staff if they had any questions."
The education specialist provided most of the training, she notes.
"We have a medical campus and a non-medical campus, and we made sure we had training on different days and times so we could catch anyone who was interested in attending," Fink says. "We had six sessions dedicated to the informed consent form revision."
On average, 10 people showed up for the training sessions on the informed consent form, and about 20 people would attend the continued review form sessions.
After six announcements and six training sessions, there were few complaints, Fink says.
"We really haven't had complaints in the last eight months, compared with what we would have faced prior to this systematic way of changing forms," Fink says.
Also, the extensive roll-out process made it easier for IRB staff when the new forms are submitted since there are fewer mistakes because researchers and research staff better understand how to complete the forms correctly, she adds.
Now that the new form roll-out process has been developed, there will be form changes done only twice a year, Fink says.
"If we do a fine-tuning of a form, a rewording of a question, we'll keep track of these things and then begin preparing for a June 1 or January 1 roll-out," she says. "This is how we'll do it for tweaks of the form, but if we had a major overhaul of a form we'd do the whole education roll-out again."
Reference
- Rich H, Moreland-Russell S. Fink M. No complaint tactic to new form development and roll-out. Poster presented at the 2007 Annual Public Responsibility In Medicine & Research (PRIM&R) Human Research Protection Programs Conference; Boston, MA: Dec. 1-4, 2007.
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