The revised Common Rule requires IRBs and research institutions to become more efficient and attentive. It also makes clear that an IRB cannot do all things for all stakeholders.
“The biggest change with single IRB review has made us realize there are institutional components of research review that need to be separated out from the IRB review,” says Kimberly K. Summers, PharmD, director of research protection programs and adjoint assistant professor at University of Texas Health San Antonio (UT Health SA). “You have to develop some type of infrastructure in place to make that happen.”
UT Health SA created a human research protection program (HRPP) office to handle institutional components of research protection work. For example, the HRPP office reviews research staff to ensure that everyone working on research projects is appropriately trained, qualified, and credentialed to perform the research they are proposing, Summers says. The HRPP office also reviews conflicts of interest and ensures all non-IRB committee reviews are completed, such as safety committee reviews and HIPAA compliance.
Since opening the HRPP office, the IRB’s turnaround time has remained consistent at 28 to 30 days, Summers says. But the time from receipt of protocol to enrollment of the first subject has decreased significantly because HRPP staff help investigators navigate all ancillary committee and regulatory approvals, she adds.
“We do our institutional review process concurrently with the IRB review,” Summers says. “They will communicate any outcomes of the reviews when they have an effect on the IRB’s review.”
The HRPP office also handles local context reviews to ensure state laws and other local considerations are communicated to the external IRB.
“The local IRB’s job is to focus on regulatory criteria for any studies they review — anything for which they have IRB oversight,” Summers says. “Before, they only provided oversight for our site, but now they provide oversight for external institutions that we may not have had a relationship with before.”
The IRB and HRPP divide research protection duties this way: “If our institution provides oversight for other research sites, we are the IRB of record, and the IRB office handles it,” she explains. “If our institution refers the study to an [external] IRB, then our HRPP office handles that.”
The HRPP office is not involved in contract negotiations for IRB of record agreements, but they make sure all details are handled before activation is approved.
“The financial aspects, institutional issues with payments — we make sure all of those are in place and everything is done by the clinical trials office, which is outside of the HRPP,” Summers says. “The HRPP makes sure there is clearance from the clinical trials office before they get an activation letter.”
The activation letter is a green light to investigators. The activation letter means the study received IRB approval, clinical trials clearance, approval from all necessary committees and departments, such as the cancer center.
“They might still receive individual letters, but this activation letter is the one they’re looking for to get started,” Summers says. “The HRPP office is there to help investigators get through all the different offices and approvals they need to get the study up and going so they can enroll their first subject.”
Before the institution opened the HRPP office, investigators would seek IRB approval. But they often still could not enroll subjects after the IRB gave them a green light because there were other approvals pending.
“Now, there’s a whole office that helps them through that process,” Summers says. “HRPP and IRB are independent offices that don’t report to each other, but both offices report to me.”
The HRPP office runs a concierge service, making its manager and four analysts available during office hours to speak with investigators and answer questions. “We sent out satisfaction surveys about the process, and we received a lot of positive feedback,” Summers says.
Separating HRPP and IRB functions has enabled staff in both offices to specialize and be more efficient in what they do.
“When everything was handled in one office, sometimes it could be overwhelming,” Summers says. “Now, with the separation of the offices, each office knows they can depend on the other for their expertise.”
The IRB and HRPP have developed a close relationship, she adds.
“We’re becoming more and more comfortable with the process and are improving efficiencies over time,” Summers says. “It’s been a world of change over the last five years.”
The revised Common Rule requires IRBs and research institutions to become more efficient and attentive. It also makes clear that an IRB cannot do all things for all stakeholders. The University of Texas Health San Antonio created a human research protection program office to handle institutional components of research protection work.
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