It’s complicated for research organizations to operationalize oversight of studies when relying on a single IRB for review of a multisite study, and the Notice of Proposed Rulemaking (NPRM) might even complicate things more. The proposed rule would mandate the use of a single IRB that all institutions involved in cooperative research would rely on, and it would make the IRB of record responsible for compliance.
Whether or not the NPRM changes are realized, the key to success with a centralized IRB approach is communication, says Kimberly Irvine, executive vice president and chief operating officer at Biomedical Research Alliance of New York (BRANY) in Lake Success.
An IRB of record should have a model that focuses on immediate and thorough communication, connecting research stakeholders seamlessly, Irvine says. “Oversight is one of the challenges institutions will be grappling with in coming years.”
BRANY was formed in 1998 by academic medical centers with the goal of bringing more efficiency to the clinical trial process, she says.
“It had gotten to be a very long and laborious process to get industry-sponsored clinical trials up and running,” Irvine says. “The medical centers that formed BRANY decided they could centralize some of these requirements, like the IRB review and budget negotiation, to make the process more efficient.”
In the 18 years since its founding, BRANY has customized the process to make it easier for institutions to have oversight and to stay connected to research projects, she notes.
The result is a connected IRB process that keeps all parties well informed about each review step and action.
The following is how it works:
• The process relies on embedded notifications. The system has embedded notifications that send automatic alerts. The alerts might simply say that a particular physician has submitted a study for review, giving the doctor’s medical center an opportunity for oversight, Irvine says.
“They have an opportunity to put a hold on something if they want to,” she says. “This enhances the organization’s ability to oversee everything, and it will be more and more relevant as we see organizations utilize other IRBs under [rules by] the NPRM.”
There are a variety of embedded notifications in the forms and electronic system, all designed to help institutions manage their programs and to help them feel connected to the process, Irvine says.
For instance, the notices began immediately. “Notices are sent out prior to a study being submitted to the committee for review,” Irvine says. “It’s a simple, basic notice, saying the study will be presented at the IRB meeting on this date; here’s the principal investigator and the protocol title.”
Another notification example involves an institution’s pharmacy. Some organizations want an embedded notification that will send the pharmacy information about new studies, Irvine says.
• Screening makes sure all pre-review actions are completed. “The system asks investigators if they have gone through their internal committees,” Irvine says. “We’re following institutions’ requirements.”
Participating institutions can see at any time the status of research projects, she adds.
“If there are internal review committees, training requirements, or conflict of interest parameters for the organization, we can screen for that,” Irvine says. “If we understand what’s required, then we can build in screening for those things, and if an investigator has not met the threshold, an alert goes off.”
• Direct electronic access to IRB decisions is helpful. If someone at a research institution would like more information about an IRB’s decision regarding a particular protocol, they can log into the system and directly access the information, Irvine says.
The electronic list includes all active studies and, additionally, monthly reports, which give institutions easy access to the information, she says.
“Sometimes an institution will say to us, ‘We want to know whenever you get a Phase I study, so a system to notify institutional representatives can be built around this parameter,’” Irvine explains.
• Connected IRB model enhances local control. “One of the things organizations struggle with when they think about outsourcing is the feeling they’ll lose control,” Irvine says.
They worry they won’t know what’s going on with studies within their organization and that they’ll lose control of research under their authority, she adds.
Ever since BRANY was founded, it was offered as an option for IRBs — not a mandate. “Organizations can use their internal IRB or rely on the BRANY IRB,” Irvine says. “Each institution is different, and they’ve made certain rules within their organization about when an independent IRB can be utilized.”
As organizations now refine the way they have oversight of their research, one way to facilitate better management by institutions is to have a connected relationship with outside providers, she adds.
Better communication is the key, so if there is anything out of the ordinary that occurs, it will be communicated to the institution, and the two organizations will stay involved, Irvine says.
The connected IRB model provides immediate access to records, detailed reports, and ready contact with the BRANY IRB when institutions or researchers have questions, she says.
• Reports also enhance engagement. “A list of ongoing active studies with BRANY are provided to institutions’ liaisons on a monthly or quarterly basis, whichever is decided,” she says.
Adverse events also are communicated electronically to liaisons, which helps reduce some of the burden on principal investigators, she notes.
“Sometimes institutions have a duplicated reporting process where the investigator is required to report to the local IRB and to the IRB of record for the study,” Irvine says. “In our model, we’ve reduced the redundancy because we’re reporting back to the institution, so the investigator doesn’t have to do all of the reporting.”
One of the chief aspects of a connected IRB model is to operate the IRB of record in a way that reflects what relying institutions need, including implementing some operational and procedural processes that help them better manage their research in their institutions, Irvine says.
“By adding some of these unique processes that were specific to the institution gives them more confidence and improves the way they can manage research within their organization,” she adds. “We use information we receive to benefit all parties in the institution.”