The upswing in multisite studies is making coordination between sites and institutional review boards (IRBs) simultaneously more important and more challenging, says Allison Trainor, MPH, CPH, CCRC, a clinical research coordinator at UF Health Cancer Center in Florida.
It’s all too common for a site to find itself in a classic Catch-22 where there are two IRBs involved and one won’t approve the protocol until the other does.
How do you break this logjam?
First, take time to really know the IRBs and the sites you are working with, Trainor says. Are the study sites based at academic institutions? At private health clinics? In the latter case, a clinic might not have its own IRB, but may use the services of one based at a local university or hospital, or perhaps of a larger commercial IRB. Without proper due diligence, you could misunderstand what each IRB needs.
It’s also important to stay abreast of technological changes, such as those enabling remote monitoring. “Guidelines and procedures [for studies] are going to continue to change” and be accelerated by new tools, Trainor says.
Webinar: Tips to Streamline the Ethical Review Process with Multiple IRBs. Join Trainor April 13, 12:00-1:00pm ET, and learn to identify common differences in guidelines and structures of IRB offices, explore ways in which challenges of adapting to differences across regulatory offices can be overcome without compromising research excellence, and analyze case studies of single protocols where using multiple IRBs – and collaboration among investigators were approached with efficiency and simplicity. View Webinar Details
Don’t underestimate the human factor, Trainor adds. “Make a contact [with each IRB],” she says. “Tell them who you are, make friends with them.” Make sure they understand your goal with the study. “If they feel like you are willing to work with them, they will be more willing to work with you and help navigate the process.”
Acknowledging she might be in the minority, Trainor insists “I’ve actually found joy in working with IRBs. I’ve met some really incredible people and learned a lot.”
Another important thing to remember: “IRBs are not out there to stop us,” Trainor says. Despite the common misperception that IRBs are “evil gatekeepers” out to gut a project, they generally want to encourage research, she says. “They just want it to be ethical.”
Try to see things from the IRB’s perspective, Trainor advises. Find out why they have a certain procedure in place if you don’t understand the logic behind it. “When it’s there, it’s there for a reason,” she says. What’s the history behind that policy? What has the IRB or the site gone through in the past that inspired the policy?
Author: Michael Causey