Preparation Needed to Follow Common Rule Exemption Changes
More federal guidance needed
By Melinda Young
The number of exempt determinations is increasing as IRBs and research organizations adjust to the new Common Rule’s expanded definition of what types of research are exempt from IRB review.
Research can be approved as exempt when its risk is minimal and it meets criteria in one of the exempt review categories, which have expanded under the 2018 revisions to the Common Rule.
Studies that once were expedited review might now be exempt. IRBs need more detailed guidance in how to interpret the new categories of exemption, says Christine DeLussey, CIP, MS, IRB operations supervisor at Children’s Hospital of Philadelphia (CHOP).
“Back when we heard the regulations were changing, we worked together as an office to dive in and understand what these changes were and how we should interpret the changes,” she says. “Now, we’re living with the changes, and there isn’t that guidance we need from the federal government.”
Some research institutions are finding the Common Rule changes challenging. They might like the idea of the regulatory change providing flexibility, but the institutional tradition of providing more oversight than what is required by regulations gets in the way of institutions fully embracing the 2018 Common Rule changes.
“While the regulations allow more flexibility, institutions are concerned about liability issues and other concerns outside of the IRB’s purview,” says Adrienne Bonilla, Esq., assistant vice president for research and regulatory compliance officer at University at Albany, State University of New York. “Our research is 99% social, behavioral, and educational. The risk we’re dealing with is more emotional and privacy issues.”
Some institutional leaders believe they need to provide more protections to research participants. They might take a more conservative view of exempt and expedited determinations. “Our approach is to look for as much flexibility as the regulations allow and to try to work within the sphere of the regulations,” Bonilla explains. “Just adding another piece of paper or some bureaucratic requirement doesn’t protect people.”
When exemptions and expedited review were created and the rules were negotiated, there was a push to say that medical research should be regulated, but social-behavioral research should not, notes Erica Heath, CIP, an IRB consultant and retired IRB director in San Anselmo, CA.
Decades ago, those arguing in favor of not regulating social-behavioral research lost the argument, but exemptions were created, Heath says.
Creating exempt and expedited review categories has helped the social-behavioral world, providing flexibility. The 2018 Common Rule expands that mission, she adds.
The key is for human research protection programs (HRPPs) to decide who will make these determinations and how the regulatory language can be interpreted to create determination criteria. For instance, one important change to determining exempt status under the 2018 Common Rule changes is to exemption 3. Before the changes, exemption 3 applied to educational tests, surveys, interviews, or observations of public behavior. The revised Common Rule has expanded exemption 2 to cover the collection of identifiable information, provided the IRB determines that there are adequate privacy and confidentiality protections. Exemption 3 is largely unnecessary under the 2018 Common Rule. The only research that the new exemption 3 applies to are studies involving benign behavioral interventions among adults, and the information is limited to verbal or written responses. (More information is available at: http://bit.ly/3360idU.)
The CHOP IRB is trying to use regulatory language to know what questions to ask investigators and how to make determinations about exempt studies, DeLussey says. For example, before the 2018 Common Rule, the IRB often fielded investigator questions about whether chart reviews qualified for exemption. The IRB would ask them if they were reporting identifiable information and if the chart review was retrospective or prospective. The next question is about whether the data include health information, she explains.
“Post-2018 Common Rule, we’re talking about different types of studies. The deciding factor is whether the investigator is using data or specimens and whether health information is collected,” DeLussey says. “We’ve pointed out those decision points for investigators and are working on a flowchart, a simple tool that shows what qualifies for exemption.” The key is to show investigators how some research projects still will not qualify for exempt status, even if they meet some of the exempt criteria.
One common example involves benign behavioral interventions. The intervention must be brief, DeLussey says. The U.S. Department of Health and Human Services says a benign intervention also must be harmless, painless, and not physically invasive, and it must not be likely to produce a significant, and lasting, adverse effect on subjects.
“We looked at SACHRP guidance to get an idea of what ‘brief’ means. From what we’ve read, it’s maybe a few hours — not over weeks, months, or years,” DeLussey says. “We’ve had requests come in for a texting intervention that might go on for three months. Even though it’s just an adult receiving a text to remind them to complete a task or check with a doctor, it will go on for months, so it does not meet exempt research criteria and should be expedited review.”
The revised Common Rule adds exemption 8, covering the secondary research use of identifiable private information or identifiable biospecimens that originally were collected for nonresearch purposes or for research other than the study under consideration. The four requirements to use exemption 8 are:
- Obtain broad consent from subjects for the secondary research use of their identifiable materials;
- Document or obtain waiver of documentation of informed consent;
- An IRB must conduct a limited review to look at privacy, confidentiality protections, and broad consent;
- Investigators cannot mention in the study plan that they will return individual research results to subjects.
The revised rule also provides three options to conduct a secondary study that involves human subjects and does not qualify for an exemption. The options are:
- Obtain an informed consent waiver from the IRB;
- Obtain the study-specific informed consent of each potential subject;
- Obtain broad consent of each potential subject.
Investigators are pleased with the Common Rule changes, expanding the definition of exempt, DeLussey notes. “It gives them more flexibility,” she adds. “They’re happy with these changes and exempt criteria.”
The number of exempt determinations is increasing as IRBs and research organizations adjust to the new Common Rule’s expanded definition of what types of research are exempt from IRB review.
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