Best Practices Spotlight

Research program's RISE interviews avert problems

GCP presentations also help

Research institutions increasingly conduct internal research site reviews or audits as a way to improve research regulatory compliance and prevent problems. But one of the big issues they face involves how to conduct these audits in a resource-efficient way that best accomplishes these goals.

The human subject research office at the University of Pittsburgh (PA), like many research programs, began its quality assurance review program with full investigator site audits. These are the most resource-intensive.

In the 15 years since the audits began, the institution has transitioned to conducting RISE (Research Investigator Start-up Education) interviews, says Kelly Dornin-Koss, MPPM, RN, CIP, director of the education and compliance office for human subject research at the University of Pittsburgh.

"We like to do those reviews on studies recently approved by the IRB," Dornin-Koss says. "We sit and meet with the research team prior to their starting subject enrollment."

The RISE program has been a success with research teams and for the human subject research office's compliance goals, she notes.

It also accomplishes the goal of improving human subject research protection in a less resource-intensive way. Instead of identifying problems after they occur, RISE interviews prevent such problems through targeted education and compliance tools.

"We look at their protocol in depth, and we create protocol-specific forms that can be used as monitoring or audit tables," she says. "If the site by chance didn't have any study documentation tables created, this is something they can use for their own purposes."

The protocol-specific forms address eligibility screening, study procedures, follow-up procedures, and other areas.

When developing best practices in a program and documentation tools, it's important to have a talented and well-trained staff to assist with these projects, she notes.

"I have multiple staff members that have been instrumental with the development of our program," Dornin-Koss says.

"In particular, Nancy Nagel who has been with the office since 1998, as well as Cynthia Kern who now serves as the co-director of the office for investigator sponsored IND and IDE support, were very helpful," she adds.

The education and compliance office also continues to perform in-depth regulatory reviews. These encourage investigators to maintain all necessary files, including IRB approval letters, informed consent documents, lab certifications, training records of the research team, data safety monitoring minutes, and things like the signed financial disclosure forms and Food and Drug Administration (FDA reports) if the investigator doubles as sponsor.

"We also look for the occurrence of adverse events and unanticipated problems and make sure those are documented and reported appropriately," Dornin-Koss says. "We know we can't meet with every investigator, but we try to go out to each of the schools that are conducting research, including six schools of health sciences and schools of non-health sciences or other schools conducting human subject research."

At each of these schools, the education and compliance office staff provides other proactive compliance programs, such as good clinical practice (GCP) presentations and good research practice presentations. These types of programs help improve research compliance through preventive education and engagement with research sites. Dornin-Koss describes how they work:

• GCP presentations: "Several members of our staff meet with the research community, covering study preparation training, the informed consent process, study documentation, and drug and device accountability," Dornin-Koss says.

"This is a good research practice seminar," she says. "We send out an email notice to departments to see if they're interested in having us come in to do the presentation; it's not mandatory."

Attendance at GCP seminars varies per departments, but the advanced coordinator training has had up to 70 attendees. The advanced coordinator training program is among the most popular, she notes.

Sometimes IRB staff and education compliance officers speak at the GCP presentations. Also, the education and compliance office has videotaped some of these presentations, leaving them available for review on the website, Dornin-Koss says.

"We have taped sessions on reporting unanticipated problems and when an IND is needed," she adds.

• Orientation checklist: "We have an orientation checklist for the research community and another one for our office," Dornin-Koss says. (See sample orientation checklist..) Ideally, new employees already will have some research experience, but the orientation program is designed to bring everyone up to speed, she says.

"Typically I hire trained clinical research coordinators with nursing degrees or others who have experience with industry and monitoring protocols," she explains. "They are required to work with another member of the staff and review certain types of studies."

New employees receive an orientation that includes reviewing a study that involves children, reading the Belmont report, and attending an IRB meeting, she says.

"They also begin with a RISE interview before they are on their own with the full review," Dornin-Koss says. "Depending on their background, it takes people three to six months in orientation."