Switching to Web entry can result in challenges
Here’s how to overcome obstacles
The transition from a paper IRB submission process to an electronic one can be a long and, at times, frustrating journey. The key is to break goals into phases and deal with obstacles as they arise, an expert says.
"We have a brand-new system and are rolling it out in phases," says Kara Brocious, MPH, CIP, research compliance consultant, human subjects office, at Indiana University in Indianapolis.
"Several years ago, everything was submitted to the IRB by paper, and now everything is by email," Brocious says.
Email submissions require some behind-the-scenes work, with IRB staff putting information in electronic folders. Soon that will change, says Brocious.
"We’re transitioning into a Kuali Coeus IRB program where the system will do everything," she says. "Investigators will go into it and create their own submissions, like a new study or amendment or renewal, and they will revise documents directly in the system."
The new system will allow electronic reviews. "It’s all self-contained," Brocious says. "IRB reviewers will go into the system and do everything internally."
The first phase was implemented in August 2013 with a focus on new studies. Investigators were required to submit all new studies via the KC IRB system, and email submissions were stopped. Several IRB forms were discontinued as well, as all necessary documents were uploaded to the KC IRB system.
One of the obstacles as the transition unfolded was that some of the investigators and other people who needed to be trained to use the new system found it difficult to schedule time for training, Brocious says.
IRB staff addressed that problem through individualized training when investigators called in with questions, and with proactive outreach, Brocious explains.
Training was offered in July 2013, first only for information. "Here’s the new system, what it looks like," Brocious says. "We also had training guides, screen shots, and videos posted on our website."
Then more individualized training was offered.
"We go out into the departments and do mini-training sessions to help people get used to the system and to answer their questions and show them how it works," she says. "We have a feature in our system where we can share computer screens with someone who has a question about KC IRB."
Brocious or other IRB staff can see what investigators’ issues are and help them resolve them by sharing their computer screen images.
Another obstacle was that some people were resistant to the change to an electronic system, Brocious says.
"You have to ease them into the change," Brocious says. "We understand it’s complicated and much more challenging on their side than just filling out a form and sending it in to us, but pretty much everything on campus is computerized, and medical records are electronic, and internal document storage systems are electronic."
So while Brocious encourages staff to be gentle with those who are resistant to change and taking them by the hand to walk them through the system, she also makes sure investigators know that this system is what they will have to use.
A third obstacle involved the system itself.
As the system’s phases were implemented, some problems emerged: "Out of the box, it didn’t do everything we needed it to do," Brocious says.
"We have had IT [information technology] rewrite code," she says.
One of the drawbacks is that the system is not intuitive, she says. It works well once a user learns the step-by-step process, but that process needs to be repeated and memorized, she adds.
Some hurdles were anticipated and prevented through the pre-implementation phase. The research institution had training working groups, testing working groups, and communication working groups.
"It took a lot of work by a lot of people to implement this system," Brocious notes.
"Before we started rolling it out, there were maybe four to six weeks of prep work, and, since then, ongoing work to get the next piece ready and rolling out," she says.
In November 2013, the second phase began with ongoing study actions. Researchers were permitted to submit all study actions including renewals, amendments, and general information via the KC IRB system. They also began to have on-demand access to all study documentation.
The third phase began in April 2014 with implementation of the exempt questionnaire. The electronic system made the exempt research checklist unnecessary, and the information within the checklist was integrated directly into the KC IRB system. The amendment form was also unnecessary, helping to streamline the submission of exempt submissions.
Starting this summer, the fourth phase will mean the discontinuation of most IRB forms. All of the forms’ information will be entered directly into KC IRB. This will reduce duplication and streamline the submission process.
"Amendments and renewal forms are going away in phase four," Brocious says. "The close-out reports will continue beyond phase four to be something they submit as a form by email to us."
But most other forms will be discontinued, she adds.
"Phase four is our last roll-out for the research community to get them using the system," she says.