Among the anticipated changes with the Common Rule’s recent Notice of Proposed Rulemaking (NPRM) is a shift from having IRBs make exempt determinations to researchers using an exempt status tool to make their own determination.
This raises questions about what will happen to small IRBs at social-behavioral research institutions where many of their submissions are for studies that qualify for exempt status. The changes also might mean they’ll have fewer reviews of multisite studies as these could be reviewed by larger, central IRBs.
As one comment to the NPRM noted, allowing investigators to determine their own research’s exempt status could be problematic for IRBs. “This would unnecessarily complicate matters in terms of increasing the burden of trying to determine what categories of exempt research would be suitable for use of the decision tool and not require further administrative review versus those that do require further administrative review,” Deb Elek wrote.
Others have wondered if the small IRB might be made obsolete with the proposed Common Rule changes.
But there’s another way to look at the small IRB’s role, says Shannon L. Harr, EdD, CRA, CIM, director of research integrity and compliance at Morehead State University in Morehead, KY.
“I don’t think outsourcing reviews strips away the need for a human research protection program [HRPP],” Harr says. “You can still have a clearly defined HRPP for your own institution and also have an IRB of record.”
The Morehead State University IRB has a reciprocal agreement with the local health system so that if any of the university’s researchers have a biomedical study, the health system’s IRB will review it. Likewise, if hospital employees have a social-behavioral study, the university’s IRB will review that, Harr explains.
“It’s not absolute; we can review any study, but if we feel the expertise lies at the other institution, then we’ll reciprocate,” he adds.
The IRB mostly sees submissions of social-behavioral research that is determined to be exempt from review, Harr says.
“What would change under the NPRM is that some researchers would not have to submit a protocol in the formal sense as they do now,” he says. “And there would be no need to grant exemption formally by the IRB.”
Plus, some of the protocols that now receive expedited review might be exempt under the Common Rule changes, he adds.
“The majority of the work we do is exempt and expedited,” Harr says. “But I’m not concerned about the changes putting me out of business.”
Although the NPRM could change significantly how the IRB operates, regulators are moving in the right direction, Harr notes.
“In my personal opinion, we may have been over-regulating some of these research projects in the past,” he says. “There are aspects where we can relax some of the regulatory burden on researchers.”
So how do institutions maintain their autonomy in human research protection programs in light of the changes? The answer is in putting resources into education, monitoring, and customer service, Harr suggests.
“Education is the key,” Harr says. “The NPRM would make the process of becoming approved to do research a bit more streamlined, but it doesn’t change the fact that we have to — throughout the life of research — maintain research participants’ protection.”
The IRB requires research teams to be trained in human research protection through CITI. “We hold workshops on how to do CITI training, getting people into the computer lab,” Harr says.
“The chair of the IRB goes with us to the training and is always available,” he adds.
“We invite people who are experts in human subject protection to hold seminars,” Harr says. “It’s important that we hold seminars and go over review processes with researchers so they better understand regulations, including newly proposed changes to the Common Rule.”
Education becomes even more important when IRBs have less contact with investigators, as might occur under the proposed Common Rule changes, Harr suggests.
“We need to rely more heavily on making sure folks do the required training and take refresher courses when necessary,” he says.
Also, IRBs could continue to require researchers to submit some notification of exempt studies.
“We might require exempt studies to notify our office and give us a brief explanation of the research they’re doing — even if they’re not required to do so within regulatory guidelines,” Harr says. “We want to know what’s going on.”
A proposed study might appear to have minimal or no potential harm to participants, but the risks could change over the course of the study, he notes.
“If someone makes a significant change to the study, it might not stay exempt,” Harr adds. “We can’t say, ‘You’re good to go and don’t tell us anything;’ we need to keep our finger on the pulse of what’s going on to make sure that we — as an institution — know what’s going on.”
Customer service is another area where an IRB and IRB office can offer value, Harr notes.
“We take great pride in our customer service in the office of research,” he says. “We provide pre-review services in the office.”
The IRB office typically can give feedback to researchers within 48 hours of a protocol’s submission, Harr says.
Everyone considering a research project can meet with a member of the IRB to talk about their study ideas. “We also meet with them when they have a protocol draft to make sure all the I’s are dotted and T’s crossed, so there will be a smooth submission process,” Harr says.
If exempt determinations change, the IRB will be available to investigators who need advice on using the exempt tool, he adds.
Other ways the IRB office enhances customer service is by attending departmental and faculty meetings and meeting people who might initiate research studies or mentor students with studies.
“We want people to know what we’re about, know our faces, and know they can contact us at any time,” Harr says.
The outreach has produced positive results, he notes.
“We’ve had faculty who asked for us on a regular basis,” Harr says. “There’s a newly created doctorate in educational leadership here, and they do an orientation for students in the summer; we’re always part of that orientation, talking with students about research and the specific steps that they have to go through to do research at Morehead State University.”
Other customer service strategies are to keep an open-door policy and to answer researchers’ questions via email, he adds.
Small research institutions sometimes combine IRB and research compliance efforts, with the IRB office handling monitoring.
“Most of our research is exempt,” Harr says. “We still ask investigators to submit a completion report and we ask them for their exempt protocols, and we do our best to keep up with those.”
As a small IRB’s mission and workload evolve, it’s important for IRB chairs and directors to keep their finger on the pulse of what’s going on, Harr suggests.
“These Common Rule changes will make it easier for researchers to be able to engage in research,” Harr adds. “But we still want to know what’s going on, and we want to engage our IRB committee more as a resource to the university community to talk about research and educate them about human research protection.”
Among the anticipated changes with the Common Rule’s recent Notice of Proposed Rulemaking (NPRM) is a shift from having IRBs make exempt determinations to researchers using an exempt status tool to make their own determination.
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