Preparation, Communication Key to Establishing IRB of Record
Nail down reliance agreement
The first time the Vanderbilt University and Medical Center IRB served as an IRB of record was 15 years ago — a decade before the concept began to catch on with multisite clinical trials and large IRBs.
The IRB also participated in an early-concept single IRB project in which five IRBs jointly developed standard operating procedures and took turns serving as the IRB of record. But this didn’t work. It was very premature, says Julie Ozier, MHL, CIP, director of the human research protection program at Vanderbilt University and Medical Center in Nashville, TN.
Clearly, the concept had potential, and once the National Institutes of Health (NIH) supported it, the Vanderbilt IRB prepared for the change. (For more information on the NIH single IRB policy, visit: http://bit.ly/2GQ1DdF.)
When the recent Common Rule changes were announced, “in it was this mandate for a single IRB for all multicenter studies, and that’s when we thought about what we could do to answer that call,” Ozier says. “Our single IRB team was formed in late 2016.”
Vanderbilt’s IRB now has reliance agreements with about 50 medical research sites, says Kari Campbell, PhD, CIP, regulatory compliance analyst in human research protection at Vanderbilt University and Medical Center.
There are 21 analysts that perform pre-reviews for the IRB, says Jenni Beadles, MEd, single IRB operations manager in human research protection at Vanderbilt University and Medical Center.
“We’ve taken those with a certain number of years of IRB experience and moved them into the role of the single IRB team,” Beadles says. “It’s been very beneficial overall to know you have point people who are well-versed with single IRBs.”
The following are some of the steps the IRB of record takes to facilitate successful reliance:
• Garner institutional support. Some IRBs will not choose to be the IRB of record because they lack the necessary manpower to make it work well, Beadles says.
“We are very well-supported by our institution,” she adds. “The decision depends on the resources available to you.”
The NIH has published guidelines on how an IRB can charge for the single IRB review, so there is a possibility of some direct cost recovery, Ozier notes.
The NIH guidance, published June 21, 2016, states, “The additional costs associated with sIRB [single IRB] review may be charged to grants or contracts as direct costs, provided that such costs are well-justified and consistently treated as either direct or indirect costs according to applicable cost principles in the NIH Grants Policy Statement and the FAR 31.202 (Direct Costs) and FAR 31.203 (Indirect Costs).” (The Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research can be viewed at: http://bit.ly/2F22cjQ.)
• Establish IRB of record agreements. The IRB of record needs to reach agreements with institutions that will be relying upon it even before the first study.
“The first step is to reach out to other IRBs participating on a study or in a network to negotiate a reliance agreement,” Ozier says. “The reliance agreement outlines who is responsible for what pieces.”
Once an agreement is ironed out for a group of research institutions, renegotiating isn’t needed when new studies begin, Campbell notes.
“It’s a lot easier to negotiate moving forward because you’re already a member of that group,” Campbell says.
The preparation work includes gathering information about each institution’s local context, paving the way for the IRB of record to begin a study review, Ozier says.
Establishing a single IRB can take time, but preparation makes everything that follows much simpler.
“The way we designed the process is we can review an entire study for the lead site first, and then, once that’s approved, it gives us the master study, and we can add on the other sites as children to the master,” Ozier explains. “So each site can be added quickly that way, as you already know the study is approvable.”
The additional sites bring their local context and questions.
“We’ve had one study that had an excess of a dozen to two dozen amendments to add, and it does create some fatigue for the committee,” says Heather Phillips, MBA, CIP, regulatory compliance analyst in human research protection at Vanderbilt University and Medical Center.
But it helped having the study approved for the lead site first. This gave the IRB of record time to focus on the local context of the additional site, and it facilitated a more efficient review process, she adds.
• Survey relying IRBs to collect data about their local context. “We’ve used two surveys through an IT platform here at Vanderbilt, and we’ve sent that one to the IRB and to the relying investigator, who helps collect that information,” Beadles says.
Survey questions include:
- Is there specific HIPAA language you have to use at your site?
- Is there a specific template you use?
- What subject injury language is used at your site?
For instance, the Vanderbilt IRB works with the ECHO network. ECHO is a research program launched by the NIH (http://echochildren.org/). It’s designed to learn about early environmental influences on child health and development. A lot of questions for IRBs reviewing those studies involve local laws and policies regarding children in research, Campbell says.
The goal is for the IRB of record to look at the overall risks of a study, while local IRBs assess the study according to their community’s concerns.
• Assess training quality of relying IRBs. “We make sure local training of key personnel is accurate and complete,” Campbell says. “Once we negotiate a reliance agreement, we know about the institution and the institution’s training.”
Each IRB and institution must be up-to-date on all required human subjects protection education and their individual organization’s policies and procedures.
• Make learning a two-way street. “We actively learn from each other,” Beadles says. “One way we are sharing information is through work with the Trial Innovation Network.”
The Trial Innovation Network brings several institutions together to facilitate training and share best practice models. It’s a collaborative national network that leverages resources from the Clinical & Translational Science Awards program (https://trialinnovationnetwork.org/).
“We hope to develop multiple models that other organizations can use,” Beadles says. “They can come to our network and say, ‘Here’s what works for us.’”
The first time the Vanderbilt University and Medical Center IRB served as an IRB of record was 15 years ago — a decade before the concept began to catch on with multisite clinical trials and large IRBs.
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