As increasing numbers of IRBs are entering into central IRB agreements, there are steps they can take to better prepare, including building trust with other research organizations and IRBs, experts say.
“It’s about having some good conversations about processes,” says Karen Hansen, director of the institutional review office at Fred Hutchinson Cancer Center in Seattle.
Fred Hutchinson has more than 100 sites that rely on the research organization for IRB review of one or more protocols. The organization has formed these types of cooperative agreements since the 1980s, Hansen says.
“There have been many investigators who ask our IRB to be the IRB of record,” Hansen says. “I require the PI [principal investigator] to talk with the PI at the other organization, and that PI needs to talk with his IRB office before I enter into a conversation with the other IRB.”
Those initial conversations are a first step to creating a new IRB reliance agreement.
“I let other organizations know there is no pressure on our IRB office’s part for them to rely on us,” Hansen says. “I try to approach it with no pressure on our part, saying, ‘I’m here to talk with you about it. Here’s how our process works. Just let me know what you decide.’”
This method appears to work: “We’ve received good feedback from people as to their receptivity to it,” Hansen says.
If an organization is relying on the Fred Hutchinson IRB, a local context reviewer is identified from the relying organization to provide input when the protocol is reviewed. He or she completes a local context reviewer form that describes confidentiality issues and confirms that there are no conflicts of interest with the protocol they are reviewing. The form also has questions about subject selection, the consent process, privacy and confidentiality, and other considerations, including the following:
- Do you find the selection and recruitment methods acceptable in the context of your local area?
- Is the participant compensation consistent with local laws and your institution’s policies?
- Are the provisions for privacy and confidentiality consistent with local laws and your institution’s policies?
- Have there been any recent events in the local community that may have created positive/negative attitudes toward human subjects research?
- Given the nature of this particular research study, are there any additional factors (community attitudes, ethnic diversity, language, etc.) that may contribute to the acceptability of this research in your area?
“The conversation with the other organization includes discussing how their IRB director or chair or another committee member can serve as a local context research reviewer,” Hansen says. “We ask someone from that organization to evaluate the protocol from their organization’s perspective, and that person is identified as being the local context reviewer.”
Local context questions include subject selection, recruitment process, and whether these processes comply with federal, state, and local laws and regulations, Hansen says.
“Are they acceptable in the context of your area?” she explains. “We ask about privacy and confidentiality, and they complete the four-page form, sign it, and turn it in to be uploaded for our IRB to review.”
To make it easier for relying organizations to use Fred Hutchinson’s protocol application, the process includes reminders and prompts. “We have some state laws related to research and human subjects, so we have those built into our policies,” Hansen says. “Every state might have different laws and requirements, and we really value our local research reviewer’s input.”
In some cases, a coordinating center will turn in an application for a site outside of the state of Washington, and study coordinators build unique consents that accommodate the consent documents that use that application, she adds.
“The protocol and application they have is built uniquely for them,” she says. “The IRB application and consent is customized to accommodate their model consent, which is used at the other organization.”
The organizations that rely on another IRB for a full convened board review should keep in mind that they still will need to do a number of tasks including looking at the informed consent document, maintaining records, have an administrative review of the file, and have the IRB chair sign off on files included in the cooperative agreement, Hansen notes.
“Make sure you have the resources and are willing to accommodate different workflows,” she advises. “Identify the main person you’ll work with on these agreements and arrangements, and then follow through, maintaining a good dialogue after the study is approved and activated.”