Special series: IRB Software for the Millennium

Georgia Tech designs on-line software for IRBs

Software permits complete system integration

Editor's note: In this issue of IRB Advisor, we will begin a special series on IRB software and how it is being used to make the jobs of IRBs easier, better organized, and to improve quality. This month, there is a profile of IRBWISE, designed by the Georgia Institute of Technology in Atlanta. Look in future issues for profiles of PRO IRB by ProIRB Plus Inc. of St. Petersburg, FL; iMedRIS by iMedRIS Data Corp. of Yucaipa, CA, and others.

The electronic race is on to develop an easy-to-learn and practical software that will help IRBs run more efficiently. While homegrown electronic systems worked well in the past, many IRBs now are finding that these are too cumbersome or inefficient as the IRB’s responsibilities and research needs grow. "We’re reviewing more and more studies every year, and when I started researching different software programs out there, I realized that they were able to offer a lot more than our current system does," says Dana Susa, MS, CIP, IRB administrator with the LeeCoast IRB in Fort Myers, FL.

Susa has collected business cards at research conferences and followed up with calls to software companies. While the IRB has not yet decided which software to purchase, the decision likely will hinge on how easily the system can be installed, how well it has been tested, and how much it costs, Susa says.

"I think we’ve narrowed down our decision to between two systems, but we also have the option of updating our homegrown system, which has worked well over the years," Susa says. "In my opinion, it’s worth going ahead with a regular software program when you consider the amount of time and money spent to upgrade the current system."

A major reason for an IRB to invest in management software systems is to help the IRB staff eliminate much of the paperwork and minor details that keep them from focusing on their role in protecting human subjects. So while a software system might not enable an IRB to reduce staff positions, it will help the IRB make better use of the staff’s time, suggests Scott Sherrill, software team lead for AIST at Georgia Institute of Technology (Georgia Tech) Research Institute in Atlanta, which has recently launched its own IRB software system called IRBWISE.

IRBWISE is a completely integrated, on-line system that supports on-line submission of applications, renewals, modifications, IRB meeting agendas and minutes, and assignment of reviewers. It has been under development since 2000 and now is fully in operation for research conducted at the institute. "We decided to design our own system because we did not feel there was a product available on the market that met the needs of our IRB," Sherrill says. "We wanted to design a totally on-line IRB management system."

The paper trail that IRBs follow is time-consuming and limiting, he notes. "In this day and age, we felt like the goal for all users of the system would be that they should be able to access the system anywhere, and they should be able to do their job at work or home or wherever they might be," Sherrill says. Georgia Tech’s IRB has been using the system since February, but the software designers always had a bigger goal in mind. "We built it with the idea in mind that it might have use in other universities," Sherrill explains.

So far, Georgia Tech’s IRB and research community have found that the software makes the IRB process faster and more efficient, says Barbara Henry, manager of research compliance. "We’ve got a system that allows us to manage protocols so much more effectively and efficiently than we were able to do before," Henry says. "It’s like having another person on staff in many ways."

Here’s a look at how IRBWISE works:

Efficiencies, including automatic agenda lists. The software has helped the IRB make all processes automatic, including having agenda items immediately listed on the electronic agenda form and skipping the paper route, Henry says. "It automatically generates minutes," Henry says. "And by doing minor keystrokes, we can enter things into the agenda and place items on different agendas."

For example, once information about a protocol or IRB meeting is put in the computer, it can be easily copied to various agendas and schedules, she explains. "Flexibility is very important, and having to not re-key information is wonderful."

The system handles time-consuming details, such as generating expiration notices and sending them by e-mail. It can send reminders to investigators to make certain they get their applications in for renewal on time, and sends out approval letters that indicate the type of review that was done and that approval was granted, Henry says.

Another major timesaver to the on-line software is that researchers will electronically send their protocols directly to the IRB. Some principal investigators (PI) have followed the on-line process without any training, but others will be given instructions on how to submit their protocols electronically and follow them on-line. "At Georgia Tech, we have a lot of computer-savvy principal investigators, but there will be one or two who don’t want to use a computer system, and we’ll be glad to accommodate them with the same old paperwork we had before," Henry says.

However, the reception so far has been very positive, she adds. "We find most folks are able to log on and put in a protocol with no problem." So far, there has been an open house to introduce the software to interested parties, and there was a special training session for IRB members.

Privacy and security. "Anybody with a user name and password can access the system at the principal investigator level," Sherrill says. "If someone needs a higher level of privileges, then there is a tool we build into the system so that the IRB administrator can assign a higher level of privilege to the people who deserve that."

Since Georgia Tech is involved in department of defense research, a chief concern was to make the system as secure and private as possible. "That’s why it’s a 128-bit encryption with secure socket layer [SSL] in order to provide security as far as people being able to access it from outside," Sherrill says. PIs can access from their home computers, as can anyone with an account with the system, but they are allowed only to see the protocols with which they are associated, Sherrill adds. "Beyond that, security is handled by the IRB administrators themselves," he explains. "Details of protocols and things of that nature are restricted to board members and administrators, who assign the level of privilege."

Modifying forms. Once a PI has submitted the protocol to the IRB and it is signed off on, then the original version of the form is frozen and can’t be changed. "If the PI realizes he wants to change something, or if a change is required by the IRB administrator, then it can be returned to the PI and modified," Sherrill says. "We maintain a history of every keystroke in the system, so we could say what the protocol looked like before and how it was changed."

Also, if a PI wants an amendment or modification to the approved protocol, it can be done with a prompt review and consideration by the board, he adds.

E-mail notification enhances system

IRB action. The system works in a logical fashion so that whenever an action is taken, the next step of action is automatically triggered through e-mails or in-box notifications or whatever else is needed, Sherrill says. For example, when a board member is assigned to review a protocol, an e-mail is sent to the board member along with a link directly to the protocol. When the board member logs on to the system, there will be a message in the in-box indicating that this protocol is on the to-do list, Sherrill says. "The goal is to keep the in-box empty, showing that you’ve done every task assigned to you."

The IRB administrator can easily append or change a message before it is sent out, and the customized e-mail is saved as part of the history of the protocol, Sherrill says. "We defined the messages that we want to go out on a cue automatically, based on the feedback from a focus group," Sherrill says.

Web site and server. Sherrill says the IRBWISE system was designed to work as a stand-alone application, but also is fully integrated within the university’s WEBWISE system, which contains all administrative and contractual tools. The system soon will be tested at other universities, which will need to set up their own web sites to support the system. "It could be hosted from Georgia Tech, but there’d be performance issues, so we expect the local universities to host it," Sherrill says. "We tried to build it in a way that it would fit within the normal expectations of the IT [information technology] personnel within the university."

[For more information, contact Scott Sherrill, Software Team Lead, Georgia Tech Research Institute, O’Keefe Building, Suite 139, Atlanta, GA 30332. Telephone: (404) 894-1190; e-mail: scott.sherrill@gtri.gatech.edu. Web site: www.irbwise.com.]