Small research institution has some big tips

Cut paperwork; encourage research

Research sites can improve the way they handle regulatory requirements and encourage more investigators to conduct research by making simple changes, an expert says.

The clinical research policies and procedures at The Southern College of Optometry in Memphis, TN, discouraged researchers even as the college's overall aim was to promote investigation.

"This is a small, private institution with a specific mission of training professionals," says Patricia M. Cisarik, OD, PhD, an associate professor and IRB chair in the eye center administration of the college.

"Research is not a big part of the institution, but it's expected that faculty members will participate in some research as part of their ongoing education and promotion," Cisarik says.

However, potential researchers often were discouraged by the paperwork and regulatory burden of conducting research. So only a handful of investigators would initiate all the studies.

The college under Cisarik's leadership sought to encourage more researchers by making some specific changes to how protocols are approved and handled. As a result of the changes, the number of people engaging in research has doubled, Cisarik says.

"We had one person submit a study who had been here for 20 years, but who hasn't done a study in 10 years," Cisarik says.

Also, a summer research program for students had six-to-seven participants who each did a short research project, she adds.

"There's at least one who has an abstract waiting to be accepted," Cisarik says. "And we've actually participated in an FDA drug study, and they had not done one here in a very long time."

The drug sponsor was pleased with how efficiently and quickly the IRB approval process went, Cisarik notes.

"We had everything ready to go in a month's time," she adds.

Here are some of the ways the institution improved its regulatory process:

IRB information was posted online: "Like most institutions we have an Intranet, but nothing was put on there regarding the IRB process other than an application," Cisarik says.

"No procedures or protocols or procedures were posted," she adds. "There were 'Follow under various circumstances' rules."

Cisarik took advantage of SharePoint and MS Word software by posting information online and creating interactive documents with links between various protocol statements and procedures to Internet sites where regulations could be read.

"We made two different documents, one for exempt procedures and one for full procedures, and we put those online," Cisarik says. "As a person is filling out the documents, he or she could link to our Intranet Web sites."

Make it possible for protocol attachments: "Other institutions would have boxes for different parts of the protocol," Cisarik says. "And investigators say, 'If we need to make a change it's hard for me to go back in and make a change in the box itself.'"

So now they can attach a change to the protocol, using select headings.

"That makes it easier for the principal investigator," Cisarik says. "If they need to go back and make an edit on a protocol because of something we require, they don't have to go back in and refill the application."

Improve the IRB process: "We've increased the number of times the IRB meets," Cisarik says.

As IRB chair, Cisarik keeps everyone updated on IRB business, and she's facilitated the process of making the college's research more visible to the community.

"Most research we see are expedited procedures, so I've been very conscientious about getting their applications within three days," Cisarik says. "The university gives me four hours a week to work on IRB work."

From one-third to half the IRB submissions fall into an exempt category because they involve surveys or data already collected, she says.

Investigators of exempt research do not have to meet with the IRB, but the college still requires them to complete an IRB application so that there is some kind of oversight, Cisarik says.

"It helps the institution keep track of what research is going on here, and also from a public relations and marketing standpoint it's easier for them to figure out who is doing what," she adds.

Despite the fact that most research projects were exempt, investigators shied away.

"We'd have individuals who want to do this kind of research but wouldn't take the initiative," Cisarik adds. "I let them know that once they go through the IRB application process and answer the questions about study subjects and procedures that they have half the things they need when they write a paper on the results."

So completing an IRB application helps push their project forward.

The goal is to encourage investigators to start projects without worrying about a difficult and time-consuming IRB submission process, she notes.

"It's not as big a deal to get through the IRB process as they had the impression it was," she adds.

Educate and address HIPAA: "We did a one-hour presentation that required attendance of all faculty members," Cisarik says.

Also, the college established a hybrid entity status, showing which part of research falls under HIPAA regulations and which doesn't, she says.

"Now I have a document where I can look at it with the principal investigator to see why you do or don't have to fill out HIPAA documentation," she adds.

The hybrid entity document specifies an institution's status and outlines exactly which types of projects are impacted.

"If you're going to test a medication on a patient in your clinic, and you're trying a new medication to slow down progression of cataracts, then you have to follow HIPAA regulations because these involve patient care," Cisarik explains.

Another study might recruit 100 students or college employees to collect data on contact lens use, and this would not fall under HIPAA regulations because the study wouldn't be dealing with patient records, Cisarik adds.

The focus on reducing research regulatory burden has been so successful for the institution that college leaders have considered holding an annual research seminar to showcase the work of research students.

"It would provide a little padding for their resumes, and it gives us marketing and publicity opportunities," Cisarik says. "We're hoping to organize that for May."