Say your institutional review board (IRB) is stumbling, bungling paperwork, taking too long to approve—or not approve—your trial. It’s time to pick a new one, but you’ve had this IRB so long you have no idea how to start looking.

There’s not much literature offering a method. But Sue Hocker has some pointers.

Formerly product manager for Abbott Laboratories, then VP of Parexel’s recruiting arm, and now a principal of the consulting firm the Lindyn Group, Hocker recently moderated a teleconference on choosing a central (or commercial) IRB. She shared some of the highlights with us.

Many sponsors and contract research organizations (CROs) don’t belabor the selection of an IRB. But the choice can have ramifications. Says Hocker: “Choosing an IRB is an issue that doesn’t often get a lot of attention, but if poorly done it can cause a lot of delays for a sponsor and a CRO.”

Check OHRP

First, make sure any IRBs you’re considering are registered with the U.S. Dept. of Health and Human Services’ Office for Human Research Protection Institutional Review Board Registry. You can check it here. The vast majority of IRBs are listed, according to Hocker. But a small shop may not be. Avoid them if the OHRP doesn’t know about them.

Next, have the IRBs you’re scrutinizing had regulatory violations? Check the OHRP’s compliance letter page here. If any potential IRBs have wracked up violations, keep looking. There are too many central IRBs out there to pick one that has raised the ire of the OHRP, says Hocker, who formerly worked for a commercial IRB and now volunteers for LifeBridge Health IRB, a nonprofit IRB based at a Baltimore, Maryland hospital.

Now it’s time for an interview, says Hocker. Talk to the person who would be your project manager. This is a chance to get a glimpse into the way the IRB operates, and spot the flaws that may bother you or delay your trial later.

Hocker, along with Nancy Singer of the consulting firm Compliance Alliance, recently conducted a survey of sponsors and CROs to find out what irritated them about IRBs. These were the most common answers:

• Clerical or typographical errors
• The board didn’t understand the protocol
• Missed timelines
• Focus was on minutia and inappropriate
• IRB reviewers were inconsistent with each other

Capacity, Veracity

It’s crucial to ask a potential IRB about capacity. How many employees do they have? How many trials are they handling at once? “They need to have enough work not to lay off staff, but not so much that people are working 80 hours a week and dropping like flies,” and potentially adding errors into your documents, Hocker says.

It can be insightful to ask an IRB how many of its trials are medium- and high-risk, and thus must be reviewed every six to 12 months. Also, how many sites per trial? The amount of work for the IRB depends on how many sites each trial is using. Does the IRB have any megatrials with 100 or more sites? If so, beware.

“It’s the rare IRB that’s equipped to handle more than one of those at a time,” says Hocker. It’s fair to ask: when a megatrial comes due for follow-up reviews—an all-hands-on-deck situation—the IRB’s smaller trials may be slighted.

Rescheduled Meetings?

Next question for the prospective IRB’s project manager: How often does the board meet to discuss and consider new trials? Is it often enough that the board won’t get backed up, potentially shelving your trial for weeks or months? How often are such meetings scheduled and then postponed? That’s key to ask to get an accurate sense of the IRB’s commitment to staying on a schedule that keeps work flowing. 

Following that, you will want to find out who exactly with the IRB would handle your trial, and any interactions associated with it, including going through your documents. Who will be your contact person on what? A project manager? Or a project manager plus, say, a handful of assistant project managers? Once you get those details, ask what the IRB’s turnover rate is for each of those positions.

What if an IRB won’t answer such questions? Hocker says that would surprise her. “They don’t have to give you that information, but if they want your business, they will,” she says.

Toolbox Test

Another factor to explore is therapeutic area. Does the IRB have experience in the therapeutic area of your trial? Make sure they’ll understand the protocol, says Hocker. Ask to see a list of past trials in the same area. If they don’t have many, or any, will they call in an expert to help them understand that area of research? An IRB that doesn’t understand your trial will likely not approve your trial, Hocker says.

Technology is also an integral area to explore. “A lot of IRBs are going electronic,” says Hocker, “and the ease of use for each of their systems varies dramatically.”

For instance, says Hocker, one speaker on her recent panel worked with an IRB that required all comers—sponsors and CROs—to purchase an electronic card to access its system. This was very off putting to clients, she says. Before leaping, ask a lot of questions about an IRB’s document management system. Must you buy anything to be able to use it? How easy is it to use? It’s a good idea to have the project manager (or whomever you’re interviewing) pull up the system and review its functions on the spot.

Site Experience

Finally, ask for references. Any IRB should be willing to supply the names and contact information for sponsors and CROs they have worked with. In addition, ask for names and contact info for clinical sites. “That’s where the rubber meets the road,” says Hocker. “If a study coordinator at a clinical site has had an easy time or a difficult time with an IRB, that will tell you a lot.”

Price? The best approach, says Hocker, is to interview three or four IRBs and compare their prices. Since most central IRBs are privately held, there’s not much public information. But most tend to charge one fee for reviewing a protocol and another for each site that needs to be reviewed. Generally, she says, IRB fees are not exorbitant. “When you look at the total cost of a clinical trial, IRB expenses are nowhere near the top,” says Hocker.

—by Suz Redfearn

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