Advisor pilot program an immediate success

Reduction in returned protocols

The new IRB Advisor pilot program at Rutgers, The State University of New Jersey in New Brunswick, NJ, resulted in a reduction in protocol submissions that had to be returned to investigators, according to the IRB director.

"So far, we've seen a drastic improvement," says Michelle Gibel, IRB administrator at Rutgers. "We've seen some dramatic increases in better-written protocols submitted to the IRB. It's a positive trend."

Here's how the program works:

Experienced IRB reviewers provide information: "We have one of our seasoned IRB reviewers and faculty members — who is also a researcher and has been through the process successfully herself — provide information to researchers," Gibel says.

The IRB reviewer speaks at 45-minute educational sessions held monthly. "We've had 20 to 30 people show up for each session," Gibel says. "She has a PowerPoint presentation and goes over the whole aspect of human subjects research from soup to nuts."

For a start, the educator asks researchers to think about how research is defined and how human subjects are defined. "It's broken down in laymen terms," Gibel says. "Everyone comes from a different background, and [the IRB reviewer] takes it from a very pragmatic way of explaining research."

There is a 15-minute question and answer period at the end of each session.

The reviewer is available through email and office: "The IRB reviewer is available to whoever in the community might have additional questions," Gibel says. "She holds office hours before deadline submission." The office hours are held just before the 12th day of each month for about a week before the IRB submission deadline.

"So if people show up to seminars they can email and correspond with the reviewer if they have any specific questions or are addressing specific issues in their IRB application," Gibel says.

The response to her educational sessions and follow-up availability has been phenomenal, Gibel says. "She provides a great deal of information to the audience, and then she has an opportunity to meet with different individuals involved in research about potential IRB submissions," she adds. As the program evolves, increasing numbers of researchers are requesting information via email or telephone, and the education sessions have grown in popularity, Gibel notes.