IRB application helps educate researchers

Submission process made easier

A new computerized tool developed at Vanderbilt University in Nashville, TN, provides investigators with information about IRB policies and human subject research regulations at a critical point in the research process — when they’re filling out their IRB applications.

Project PROTECT — PROvide Teaching of Ethical Clinical Research through Tactical Support — creates a computer-based IRB application that has links to relevant guidance and regulations buried in its text. By clicking on "Help" arrows, an investigator can get immediate answers to common questions about the application.

The new enhanced application helps not only the researchers, but IRB staff who otherwise would be spending more time answering questions from investigators, says Tonya Yarbrough, RN, a research nurse at Vanderbilt who helped develop the tool.

"We felt like our protocol analysts in the IRB were spending an enormous amount of time answering questions for investigators, the same questions over and over again," she says. "How am I supposed to answer this question?’ Where am I going to find this information?’ Why is this so important?’ How do I answer it if it doesn’t apply to me?’"

Yarbrough says the institution also wanted to find a better way to educate investigators about human subjects protections than a tutorial that might not spell out the relevance to their own research. "We wanted to have some information right there so they would know exactly what it was that they needed to be thinking about with regards to their own study," she says.

"And the idea was to have it be electronic so they wouldn’t have to go anywhere else to find the policies and procedures or the regulations or the template language when they are filling out the application. They could just click on an arrow right there in the application and have access to all of that information immediately."

Yarbrough says the enhanced application is part of a push by Vanderbilt’s assistant vice chancellor for research, Gordon Bernard, to find ways to help investigators overcome roadblocks to doing clinical research while still protecting human subjects.

"That’s our main goal: To make sure that our subjects are protected, but we also need to figure out a way that research can still get done," she says. "This was just one very small part of this very large restructuring process we’re doing."

When an investigator goes to the IRB web site and downloads the application to a computer, he or she will see a number of colored arrows below each question. Each arrow links to a different category of the Help function:

— clicking on a red arrow explains "Why does the IRB ask this?"

— a dark-blue arrow brings up "Investigator help," or suggestions to help answer the question properly;

— a yellow arrow links to "IRB Policy" for that question, taking the investigator directly to the applicable section of the policy;

— a green arrow links to "Federal Regulations and Guidance" regarding the question;

— a light-blue arrow links to "Examples, Suggestions, and Template Language" the investigator may use to craft his response. (See an explanation of how Project PROTECT works for one question on an IRB application.)

Yarbrough reports that when Vanderbilt first began developing the new application, it was planned as part of a switch to iMedRIS software for web-based on-line IRB applications. But that switch has taken longer than anticipated, so her group went ahead with the project, enlisting the help of a computer programmer to help create the interactive application.

Creating a system that can easily move the reader from the application to nearly 300 linked documents has proven challenging, Yarbrough says. To access the application, which was created in Microsoft Word, a researcher goes to the IRB web site, pulls up the application, and saves it to his or her own computer to fill it out.

"We had to do a lot of testing to make sure that we weren’t locking people’s computers up," she says. "And we found that we were in a lot of cases, because we were taking them from our server to the IRB server where template language and policies and procedures and things like that were."

Their answer was to put everything on a dedicated server, which has lessened the problem somewhat.

"We’ve made it clear that when you click on something, that it’ll keep you on our server," she says. "But if, say, you’re in an FDA regulation and it references another document, it will say in there This will take you outside of our server,’ and that way people will know that there’s a chance it might lock up their computer."

Technical support crucial

Yarbrough believes that when Vanderbilt goes to an entirely web-based system there will be fewer problems. That development also will make it easier to update the links as federal regulations and IRB policies change.

"Then, we’ll be able to just pull in the new policy from the federal government and whatever links they had within their policy would still work when it’s web-based," she says. "Right now, it doesn’t work that way, so we actually had to create links for everything that’s linked within a document so that slowed us down a lot."

Yarbrough says one important factor in creating this application was finding the right technical help. The computer programmer for the project had previously worked with the IRB, which gave her a useful perspective.

"You need someone who’s really familiar with computer programming and who can adequately test the process to make sure it works," she says. "Because there’s nothing more frustrating to either an IRB protocol analyst or an investigator than to go into an IRB application and it not work like it’s supposed to work. That took the most time, just making sure that everything worked appropriately."

Yarbrough also advises anyone interested in a similar project to test, test, test.

"Because there are so many different computer systems out there, we had to do a lot of testing — people access our IRB application from home, from the football field where the kids are playing, all different places."

The system has been up and running since July 2004. Since that time, Yarbrough says she has heard enthusiastic responses from investigators and research coordinators.

"But the people who surprised us the most were the actual protocol analysts in the IRB, who have found that when they get a telephone call now, they go to the IRB application and to the Help [function] to answer the question from the investigator on the telephone," she says.

"One of the things they like most is that they can send the investigator to that application and they have access immediately to the policies and procedures and the regulations. So that if an investigator is questioning why they have to do something or what’s the reasoning behind it, they have information to provide to them right there at their fingertips."

Having input from many different perspectives helped tremendously, Yarbrough says. Her team asked for feedback on the application and the Help function from the protocol analysts in the IRB, as well as investigators, nurses, and a research support services team that works with the IRB.

The director and assistant director for the IRB also reviewed it. "When you start reading through it, it kind of sparks your memory about something you did that you had to ask a question about so, we got lots of good suggestions," she says. "So it was really a collaborative effort."

(Editor’s note: The Vanderbilt IRB application can be viewed at