Small IRBs often have a resource dilemma: How do you help the IRB improve consistency and quality of reviews when staffing is limited?
One answer would be to have IRB members take on additional work. Few would find that solution practical.
However, one medical center with a small IRB has found success with another strategy: a special pre-IRB review group, called the facilitated review committee, which looks at protocols with the goal of improving consistency and quality. It is supported by the organization’s research and grants center, which also provides services in study design, contracts, and coordinators for investigators.
"We have a pre-IRB review process that entails a group of individuals with specific expertise in study design, IRB concerns, contracts, and ethical issues," says Maria J. Arnold, CIP, IRB clinical research manager at Baptist Health South Florida in Miami.
Members include Arnold, a compliance administrator, the institution’s attorney, a grants and contracts leader, and several researchers.
"We formed the group because we found that each of us had challenges with the review process and having the investigator go back and forth," Arnold says. "We came together and said there had to be a way to facilitate the process and make our jobs and the investigators’ jobs simplified."
That’s when the organization’s Centers for Research and Grants suggested they initiate a facilitated review process prior to the IRB review.
"We’re going into our third year, and it has worked very well," Arnold says.
The group’s meetings are triggered by protocol submissions. There might be a couple of submissions in one week, or there might be one in several weeks. The committee reviews the application and study documents. When there’s a new protocol, the information is sent by email to the pre-review group’s members. They have three days to send their comments to the committee chair, who is the supervisor for research at the Center for Research and Grants, Arnold explains.
Committee members can use a simple, one-page minutes checklist that lists the agenda items to be discussed, leaving space for the presenter’s name, time, and notes. (See facilitated review committee tool, page 125.)
The supervisor forwards comments to investigators, telling them they have four days to address these questions and issues. Once they reply, their answers are forwarded to the committee, and a conference call with the investigator is scheduled. Everyone in the group participates, and any remaining details are ironed out before the investigator’s application is forwarded to the IRB for a formal review, she adds.
The pre-review group looks for patterns to ensure consistency.
For example, if several protocols have a similar problem, the group will flag them to take a closer look at what is missing and why.
In another example, an investigator has submitted two similar studies but describes very different consent processes, Arnold says.
"We will ask the investigator why there is a change in the consent process from one study to the next one," she adds.
Committee findings and recommendations are compiled and sent to investigators, who are expected to clarify and address each issue.
Arnold might ask an investigator to clarify why a medical records review will not include informed consent. She also looks at the other committee members’ recommendations, gives these to investigators, and asks them to come to the facilitated review committee meeting prepared to answer these questions.
Each pre-review is documented and tracked. "We track all comments and recommendations that are made so that when something comes in for that investigator, it reminds us that we’ve seen that study," Arnold says. "We look at the concerns raised and whether there is a pattern or a difference in how things are handled."
Investigators learn a great deal from the pre-review process, and the IRB receives submissions that are more complete, she adds.
"We are a small institution with approximately 280 protocols, so this process is beneficial," Arnold says. "We have one-on-one communication with investigators, hold in-services, attend their research meetings, and personally meet with them."
The new pre-review process has resulted in greater consistency and a high approval rate for protocols, Arnold notes.
"A lot of issues have been addressed, and the investigator makes the recommended changes before the IRB review," she says.
"Even though a study goes through this process, it doesn’t guarantee that the IRB will approve it," she adds. "This is a mechanism to assist them with the committee and being consistent."
