Starting or expanding an IRB office? It helps to know size, scope, culture

Expert offers this advice

When planning to expand an IRB office or start a new one to support one or more IRBs, the key principle to keep in mind is that one size does not fit all when it comes to IRBs, an expert says.

"Look at your own institution and the size of it, scope of it, and culture," advises Susan Kornetsky, MPH, CIP, director, clinical research compliance of Children's Hospital of Boston in Boston, MA.

"There's no one way that's better than the other," Kornetsky says. "That's the beauty of the IRB world — there are lots of different ways of doing things."

For a start, it's important to understand the role of the IRB administrative office and the role of the IRB chair, Kornetsky says.

"This varies from institution to institution," she explains. "Some IRB chairs are very involved in everyday processing and decision making, and other IRB chairs are not so involved."

The IRB administrative office's support role would be directed by how much involvement the IRB chair has in the day-to-day operations.

Cross-train or specialize?

Another decision to make involves how to structure the IRB office.

In some institutions, the IRB office follows the model of having each IRB professional learn all of the necessary tasks involved in IRB review: handling new protocols, continuing reviews, unanticipated problems, policies and procedures, amendments, revisions, informed consent changes, etc.

If the institution is small, then one person might handle everything for all protocols. If the office is large, then each IRB professional would be responsible for everything that needs to be done, but only for the protocols submitted by a particular department, Kornetsky suggests.

"The advantage of that is you'd become a resource to a group of individuals and departments and could understand and support the scope of research in that department, Kornetsky says. "You might realize when there are competing protocols, and you might become an expert in particular areas."

The other common model used by larger IRB offices is one in which each member of the staff is specialized in handling certain aspects of the office work.

"Each person is hired for a particular function," Kornetsky explains. "Work is divvied up among specific functions in that office."

This model is common in larger institutions where the IRB office's staff is large and there is a need for more defined roles and responsibilities, Kornetsky says.

"The model we have is having people [assigned to] different departments," she notes. "For right now, we'll keep our model of having each person do everything, but that may change as we do more clinical research."

When expanding or starting an IRB office, it's important to discuss these different models and their pros and cons with people at the research institution, including the IRB chair.

IRB office may offer investigator support

Another aspect of the IRB office involves its support role.

"There has to be some thoughts about whether your IRB office is just there to support the IRB, meaning your work begins once the investigator submits the protocol," Kornetsky says. "Or are you an office that provides a lot of information before the protocol is submitted?"

For example, ask these questions:

  • Will investigators be encouraged to call the office to ask questions before submitting protocols?
  • Will the IRB office pre-review the protocol before forwarding it to the IRB?

An IRB office that is designed to provide some educational support to investigators might invest time in new protocols and get back to the investigator with questions that he or she should answer before submitting the protocol to the board.

For example, a protocol might not spell out how subjects will be recruited, Kornetsky says.

"The IRB office can get back to the investigator and say, 'You don't have enough details about recruitment, and you didn't provide us with posters or letters, and we hope you will collect that information before this protocol comes to the IRB,'" she says.

The goal is to get the protocol into the best possible shape before it's reviewed by the IRB, Kornetsky says.

This is extra work for the IRB office staff, and this is where the institution should know its cultural issues and whether the resources and time will be adequate for this extra work, she adds.

Some institutions might decide the IRB itself should handle all of this type of education and that the IRB staff is too limited in time and manpower to handle the extra load of work.

On the other hand, some institutions have found that giving an IRB office this responsibility, along with the resources to handle it, has led to improved relationships with investigators and better response times on protocol reviews.

A research institution should consider budgetary issues, such as how much money will be available for training, conferences, educational materials, and even the occasional staff lunch, Kornetsky says.

And institutions should examine privacy concerns, which are particularly important when an office's physical structure involves cubicles and not offices, she adds.

"You also need to think about electronic versus paper systems," she says. "More and more IRB offices are moving toward electronic systems, but they're expensive and you have to decide whether to buy one or develop one in house."