IRB streamlines process to improve IRB response time
Reviews went from 24 days to 17 days
Intermountain Health Care Urban South Region of Provo, UT, revamped its IRB process with a goal of reducing its lengthy response time and to improve quality in IRB submissions.
After making changes that included hiring an IRB staff person, purchasing new software, and improving education, the institution was able to reduce the 24 days it took on average to bring a protocol from submission to IRB review to 17 days, and the average number of days from the IRB meeting to IRB correspondence was dropped from 22 days to five days, says Katreena Collette-Merrill, RN, a nursing practice and research coordinator at Intermountain Health Care.
The decrease in the days it takes the IRB to respond post-meeting was directly related to having the process computerized and the hiring of a dedicated IRB coordinator, Merrill says.
"And we had the expectation that we wanted to have a quicker turnaround," Merrill says.
Merrill describes how the institution improved its process with these guidelines:
• Address problem areas: When Merrill became the research coordinator at the institution, there were no formal policies, procedures, or checklists, she says.
"And not only was the initial response time from when they submitted the application slow, but the quality of submissions wasn't very good because investigators didn't know what we were looking for," Merrill explains. "So we went at the problem from a myriad of approaches."
First, a goal was set to reduce the time from submission to review by the IRB, and an IRB staff person was hired, Merrill says.
Then, the IRB purchased software and began an electronic system and then changed the entire filing system, Merrill says.
"We were still using hard copies at first, so we organized the filing system by year and the number of the study, and the first study submitted in 2005 was labeled 2005-01," Merrill explains.
• Develop checklists: Checklists are used to help reviewers find omissions and mistakes in IRB submissions.
One checklist includes information about protocol submission related to National Institutes of Health (NIH) guidelines, and it asks questions, such as these:
- What was the stated hypothesis?
- What was the design of the study?
Another checklist relates to the Food and Drug Administration (FDA) and it goes through all of the different FDA requirements.
A consent checklist asks whether the consent document indicates that the subject has the right to withdraw, Merrill says.
"Does it have the contract number for the principal investigator," she adds. "What is its readability on a readability scale?"
The consent checklist contains standard information of what should be on a consent and in the protocol, including the following, Merrill says.
- If someone is going to use pediatric patients, is there an assent attached?
- If someone is going to be working with patients who do not speak English, is there translation service available?
"We would take those checklists and give them to our primary reviewer, and the primary reviewer uses the list to check off items and say, 'They don't have this or that,' or 'I couldn't find this information,'" Merrill says. "It's a much, much easier process."
The IRB coordinator has received training, and now she understands the submission process and can use the checklist to make certain investigators have completed their information before protocols are submitted to the IRB, Merrill says.
"She can tell them, 'I can send this to the IRB, but you don't have this information, and you might want to do this before you submit it,'" Merrill says.
Some of the IRB review process bottlenecks were caused by repeat mistakes on the part of investigators.
• Make changes as necessary: As an IRB process is revamped, it's important to make adjustments and changes as new issues arise, Merrill notes.
For example, one physician who worked on newborn intensive care unit studies would omit an approval signature from the ICU manager on the submissions, and so a section was added to the submission form, saying that the investigator needs to obtain approval from these people prior to submitting the protocol to the IRB, Merrill says. "We've made a lot of changes," Merrill says.
The IRB coordinator, for instance, was a part-time position at first because the IRB is small, with only about 75 open studies, Merrill says.
Now, the IRB coordinator handles IRB work for the entire Intermountain Health Care system, which includes 22 hospitals, she says.
"With a central system, the IRB coordinator is half-time for us, and the other half of her time is for another region," Merrill says.
• Move to an electronic system: "We've created a virtual system where the IRB coordinator sends me all of the information and types the expedited review letters electronically, creating a pdf document, so it can't be changed," Merrill says. "It still has my signature, and no one can attach or unattach it."
Everything is available on a Web site, as well, she says.
Although the IRB coordinator is located an hour from each of the two research offices, the electronic system makes it as easy for the coordinator to work with investigators, IRBs, and research staff through telecommuting, Merrill says.
"If someone submits electronic data, then it's all electronic from the beginning," Merrill says. "But if someone submits a hard copy, it's copied and scanned and made into a pdf file."
Study changes that need expedited review can be seen by the IRB's chair or vice chair, Merrill says.
"We didn't have a vice chairman when we started all of this, and then we found out when the chairman goes out of town, you're stuck and can't do anything," Merrill notes.
Since this slowed down the system, a vice chair position was added.
• Provide formal training and education: After the first changes were made, the institution held a meeting for the IRB and staff and went over the checklists, Merrill says.
All protocol and checklist templates were put on a CD, and there also were hard copies for distribution, Merrill says.
Now all of the information is available on a Web site, she adds.
The formal training was done at a two-hour meeting, offered several times so all investigators and coordinators could find a convenient time to attend, Merrill says.
"We introduced a whole binder of hard copy information and introduced all policies and procedures and checklists," she says.
The training session explained why the institution was making the changes and what the goals were, Merrill says.
"They weren't too happy at first about the electronic submissions because some were doing a lot of protocols and didn't want to submit electronically, but we reassured them that it would decrease the response time," Merrill says.
Investigators weren't required to attend the meetings, but they did have to pick up the training material and review it, she says.
And the institution also required every person listed on a study, including principal investigators, co-investigators, study coordinators, and the people handling informed consent, to complete on-line human subjects research training coursework and receive a certificate, or else their study would be closed, Merrill says.
"Now they can't get an IRB application without having the training," Merrill says.
Some of the future plans for the streamlining process is to improve the electronic submission system to make it more user friendly, Merrill says.
"We still want to do more training for new investigators," she adds.
For example, the institution could offer courses on how to write protocols, Merrill says.
Also, the IRB may eventually become entirely electronic with laptops for members, and the institution might providing its own research training classes for certification, Merrill adds.
Intermountain Health Care Urban South Region of Provo, UT, revamped its IRB process with a goal of reducing its lengthy response time and to improve quality in IRB submissions.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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