Cancer protocol IRB has streamlined reviews

It reduces duplication, improves efficiency

An IRB dedicated to handling cancer research has shown benefits in efficiency and expertise when such a specialty IRB model is employed.

Since beginning six years ago, the Case Cancer Institutional Review Board in Cleveland, OH, has reduced duplication, improved protocol turn-around time, and given oncology investigators and clinical trial staff an IRB office that understands and caters to their specific questions and concerns, says Mariesa Malinowski, BS, CIP, administrative director of the Case Cancer IRB at Case Western Reserve University, School of Medicine in Cleveland.

The Case Cancer IRB, formed by the University Hospitals Case Medical Center and the Cleveland Clinic, meets weekly with 13 members at each meeting. They deal with 15-20 submissions on each agenda. There are 30 members total, but they change rotation on attendance so no one member is overburdened, Malinowski says.

"We added a layer in our standard operating procedures that says we will have a representative from each institution in attendance," she adds. "We share best practices with each hospital and have a true collaboration."

The IRB reviews protocols from more than 20 hospitals and reviews about 250 new applications a year. Many of these are long-term projects, so the overall caseload is about 1,000 active projects.

"We work closely with the cancer regulatory office department, and we can customize our schedule based on a study's needs," she says.

For instance, federally-funded cancer therapy evaluation programs need to have IRB reviews complete and approvals received within 90 days, so the Case Cancer IRB works with principal investigators (PIs) to make sure those are done in a timely manner, Malinowski adds.

The dedicated IRB is much more efficient at its work and has built procedures and policies that other IRBs might not have the time to handle.

"At the end of the day there's probably an overall cost savings," Malinowski says.

"We build procedures and policies that other IRBs wouldn't entertain," she says.

For instance, Case Cancer IRB addresses handling these areas:

— Multiple amendments

— Time and delays in paperwork

— Developing programs and procedures

— Rehiring and training

— Medical leave and cross-coverage of staff.

An example of the IRB's tools includes its research staff log developed last year. It defines the roles of various research staff and provides a table for listing their names, degrees, sites where research duties will be performed, whether they will obtain informed consent, and expiration date of human protection testing requirements.

The roles are defined in the staff log as follows:

• Nurse coordinators: Any direct research subject caregiver that with a nursing license that may have delegated responsibilities for completion of conducting informed consent processes, research related procedures, recording of adverse event(s), recording of data and/or documentation of case report forms.

• Non-nurse coordinators: Any direct research subject caregiver without a nursing license that may have delegated responsibilities for completion of conducting informed consent processes, research related procedures, recording of data, and/or documentation of case report forms.

• Regulatory coordinators: Staff responsible for the completion, submission and record keeping requirements of IRB related documents.

• Data managers: Staff responsible for the transcription and/or data entry of research related data.

The Case Cancer IRB gives each protocol high priority focus, Malinowski notes.

"My experience before was that you couldn't cater to just one study when you have 23 different departments," she explains. "You can only do your best, but now we have a smaller group and only work with one department."

The dedicated IRB has resulted in reduced complaints from researchers and their staff, and it's resulted in an IRB that is very responsive to any concerns or issues that arise, Malinowski says.

"We work as liaisons with their needs, customizing and catering to their needs," she explains. "When they're not happy they have our full attention, and we have multiple opportunities to meet and discuss issues."

Communication is the key to maintaining a successful relationship with research sites.

"You have to build in opportunities to meet in person and discuss the needs of each of these institutions," Malinowski suggests. "Find the person or multiple people who are the key stakeholders in this and have regular meetings with them."

There often are cultural and operational differences between an IRB and research sites, so these face-to-face meetings are important for building trust and understanding.

This model for a specialized IRB could work for any large research institution that has a lot of research in one particular area, such as HIV disease, infectious diseases, transplant, heart surgery, etc.

"Look at your pool of protocols and see who are your dominating groups," Malinowski suggests. "It's worth your while to see who your collaborators are."

Launching a specialized IRB takes time because of the regulatory hurdles, including registering under one Federal Wide Assurance and entering institutional affiliation agreements.

"The agreements allow Case Western to be the IRB of record for all cancer-related research," Malinowski says. "It took eight months to complete the contract process."

The IRB decided to start with new protocols rather than to grandfather-in existing ones.

"In January, 2006, we established a committee, trained all members in all administrative details, setting a meeting place, and finding a way for the many physician members to commit to meetings every three to six weeks," she explains.

Having a large group of members who can alternate in attending meetings helps prevent member burnout.

One of the unanticipated benefits of forming the specialized IRB is that it has resulted in reduced duplication in various areas of human subjects research and review.

While the research institution knew it would create some efficiencies in cancer research reviews, there have been other efficiencies, as well.

For example, the old process in multisite studies was for each site to maintain its own paperwork and documentation. Now the sites can share this work, sharing the regulatory burden to reduce duplication and redundancy.

"They share a single review and now can share the need for emailing and communications and maintaining some files," Malinowski says.

"We started identifying duplication and saw more areas that could be reduced," she adds. "We are overall providing a cost savings."